Pending: 32008D0654

                                January 16, 2026                            

9.8.2008
EN
Official Journal of the European Union
L 214/56

(1)
Regulation (EC) No 882/2004 lays down general rules for the performance of official controls by the Community or the competent authority of the Member States to verify compliance with rules concerning feed and food law, animal health and animal welfare rules.

(2)
Pursuant to Article 1(3) of Regulation (EC) No 882/2004 that Regulation is to be without prejudice to specific Community provisions concerning official controls.

(3)
Article 41 of Regulation (EC) No 882/2004 provides that each Member State is to prepare a single integrated multiannual national control plan to ensure the effective implementation of Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2), of animal health and animal welfare rules and of Article 45 of Regulation (EC) No 882/2004 (‘the national control plan’).

(4)
The purpose of the national control plans is also to establish a solid basis for Community controls in the Member States.

(5)
Article 27a of Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(3)provides that Articles 41 to 46 of Regulation (EC) No 882/2004 concerning national control plans, annual reports, and Community controls in Member States and third countries are to apply, as appropriate, in order to ensure the effective implementation of that Directive.

(6)
Article 43(1)(e) of Regulation (EC) No 882/2004 provides that the Commission is to draw up guidelines encouraging the adoption of best practices at all levels of the control systems.

(7)
Article 43(1)(j) of Regulation (EC) No 882/2004 provides that the Commission is to draw up guidelines laying down the structure of, and information to be included in the annual reports provided for in Article 44 of that Regulation

(8)
Article 44(1) of Regulation (EC) No 882/2004 provides that Member States are to submit to the Commission an annual report on the implementation of the national control plan. That report is to be submitted annually commencing one year after starting the implementation of the national control plans. In addition, Article 44(1) sets out the information to be provided in the annual reports.

(9)
Article 44(2) of Regulation (EC) No 882/2004 provides that the information to be submitted in the annual reports is to take account of guidelines, to be drawn up by the Commission in order to promote a consistent presentation of such reports. The guidelines are not binding but serve to provide useful guidance to the Member States in the implementation of that Regulation.

(10)
Article 45 of Regulation (EC) No 882/2004 provides that Community audits are to be carried out in the Member States on a regular basis mainly in order to verify that official controls are carried out in accordance with the national control plans and in compliance with Community law.

(11)
The Commission is to keep the guidelines set out in this Decision under review and update them, as necessary, following the receipt and examination of the Member States annual reports, taking account of conclusions and recommendations contained in the annual report to be established by the Commission pursuant to Article 44(4) of Regulation (EC) No 882/2004 and in the light of the experience of the Member States in implementing that Regulation.

(12)
For the purposes of the guidelines set out in this Decision, the ongoing work of Eurostat in the context of the Community statistical programme in developing a ‘control and monitoring activities’ database which comprises various classification schemes, including harmonised terms and definitions for feed and food data management should be taken into account.

(13)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)
meet the legal obligations for reporting laid down in Article 44(1) of Regulation (EC) No 882/2004;

(b)
outline progress on the implementation of the national control plan and make an assessment of the effectiveness of the control arrangements and the control systems based on the results and outcomes of official controls in the Member State.

(a)
developing its annual control programmes (desk analysis, audits, inspections); and

(b)
the preparation of the Commission’s report to the European Parliament and the Council in accordance with Article 44(4) and (6) of Regulation (EC) No 882/2004.

(a)
any amendments made to the multiannual national control plans to take account of the factors referred to in Article 42(3);

(b)
the results of official controls and audits conducted in the previous year under the provisions of the multiannual control plan;

(c)
the type and number of cases of non-compliance identified;

(d)
actions to ensure the effective operation of multiannual national control plans, including enforcement action and its results.

(a)
‘annual control programme’ means the annual programme for Community controls referred to in Article 45(4) of Regulation (EC) No 882/2004;

(b)
‘control strategy’ means the approach taken to determine the nature, frequency, time, point/stage of the production chain, method and techniques of official controls (refer to Section 3.7.2 of the Annex to Decision 2007/363/EC);

(c)
‘national control plan’ means the single integrated multiannual national control plan provided for in Article 41 of Regulation (EC) No 882/2004.

(a)
official controlsperformed by the Member State as provided for in Article 3 of Regulation (EC) No 882/2004 and national control plans — Section 9.1;

(b)
overall compliancewith feed and food law, animal health and animal welfare rules — Section 9.2;

(c)
auditscarried out as provided for in Article 4(6) of Regulation (EC) No 882/2004 including, where appropriate, the results of audits or inspections of control bodies as provided for in Article 5(3) of that Regulation — Section 9.3;

(d)
actions to ensure effectivenessin operating the national control plans — Section 9.4;

(e)
statement on the overall performanceof the control system in operating the national control plans — Section 9.5;

(f)
amendmentsto the national control plans — Section 9.6.

(a)
describe or define the classification used;

(b)
classify the non-compliances detected by type;

(c)
describe the type and number of non-compliances identified.

(a)
what was the frequency of non-compliances in various sectors? This is particularly relevant in cases where significant deviations from the overall compliance are evident in some sectors or in official controls carried out by certain competent authorities;

(b)
were the non-compliances randomly distributed in time and space or was there some clustering at particular points or production stages and were there indications of emerging trends?

(c)
the type of non-compliances, that is whether they were related to structural, operational or end-product related requirements? Other types may include non-compliances related to self-controls, administrative aspects or documentation (for example traceability). Non-compliances may also be categorised as major/minor, systematic/sporadic etc.;

(d)
were the non-compliances scattered all along the feed and food chain or concentrated at primary production or further down the chain?

(e)
were there possibly multiple clusters of non-compliances along certain chains?

(f)
does the pattern of non-compliances indicate that there are critical control stages along the production chain(s)?

(g)
are there any patterns indicating that different (types) of food and feed business operators and other relevant producers and business operators or production chains were more compliant than others?

(a)
the identification of non-compliances that have a potentially significant impact on humans, animals or plants;

(b)
the description of the potential serious consequences or ‘risk’ of those non-compliances;

(c)
the description as to whether the risk is related to a specific hazard only or a general increase in risk arising from the incidence of multiple hazards or hazard-groups.

(a)
the lack of awareness by the food and feed business operators and other relevant producers and business operators and reasons therefor;

(b)
the lack of competence by the food and feed business operators and other relevant producers and business operators and reasons therefor;

(c)
the cost of compliance;

(d)
the insufficient tools and/or resources to enforce requirements;

(e)
the lack of effective and/or proportionate and/or dissuasive sanctions.

(a)
the extent to which the audit programme, developed by the competent authority, for the reporting period was achieved;

(b)
the extent to which overall compliance with planned arrangements for official controls by the competent authorities was achieved;

(c)
the conclusions as to the overall effectiveness of the official controls applied by the competent authorities;

(d)
the conclusions as to the overall suitability of the official control systems operated by the competent authorities to achieve the objectives.

(a)
Actions taken to ensure compliance by food and feed business operators and other relevant producers and business operators as provided for in Article 31(2)(e), Article 54(2) and Article 55 of Regulation (EC) No 882/2004.

(b)
Actions taken to ensure the effective operation of official control services as provided for in Article 4(2) and Article 8(3) of Regulation (EC) No 882/2004, including actions taken in response to audits carried out in accordance with Article 4(6) of Regulation (EC) No 882/2004, and audits or inspections carried out in accordance with Article 5(3) of that Regulation, where appropriate. In the case of actions taken in response to audit conclusions this may include corrective and preventive actions, or improvement actions based on the identification of best practice.

(a)
restrictions or prohibitions on the placing on the market, import, export or use of feed, food or animals;

(b)
withdrawal or suspension of approval or registration to operate a feed or food business;

(c)
administrative fines and other administrative sanctions;

(d)
prosecution of food and feed business operators and other relevant producers and business operators for non-compliance (criminal sanctions).

(a)
new, updated or revised control procedures;

(b)
training initiatives;

(c)
provision of additional resources;

(d)
reallocation of existing resources following review of priorities;

(e)
special control initiatives;

(f)
changes to the organisation or management of competent authorities;

(g)
provision of guidance or information to feed and food business operators;

(h)
new legislation;

(i)
suspension or withdrawal of delegation in the case of control bodies.

(a)
progress towards achievement of the strategic objectives as described in the national control plan;

(b)
effectiveness of the official controls carried out under the national control plan and their suitability to achieve the objectives of Article 17(2) of Regulation (EC) No 178/2002, Regulation (EC) No 882/2004, animal health, animal welfare and, as applicable, plant health rules.

(a)
the performance indicators applied to those objectives, where appropriate; and

(b)
results for each objective, where appropriate.

(a)
new legislation;

(b)
the emergence of new diseases or other health risks;

(c)
significant changes to the structure, management or operation of the competent authorities;

(d)
significant changes to the agri-food production sector;

(e)
the results of Member States’ official controls;

(f)
any amendment of the guidelines referred to in Article 43 of Regulation (EC) No 882/2004;

(g)
scientific findings;

(h)
the outcome of audits carried out in accordance with Article 4(6) of Regulation (EC) No 882/2004;

(i)
the outcome of Community controls carried out in accordance with Article 45 of Regulation (EC) No 882/2004(5);

(j)
the outcome of audits performed by a third country in a Member State;

(k)
outcome of root-cause analysis.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(1), and in particular Article 44(2) thereof,

(1) Regulation (EC) No 882/2004 lays down general rules for the performance of official controls by the Community or the competent authority of the Member States to verify compliance with rules concerning feed and food law, animal health and animal welfare rules.

(2) Pursuant to Article 1(3) of Regulation (EC) No 882/2004 that Regulation is to be without prejudice to specific Community provisions concerning official controls.

(3) Article 41 of Regulation (EC) No 882/2004 provides that each Member State is to prepare a single integrated multiannual national control plan to ensure the effective implementation of Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2), of animal health and animal welfare rules and of Article 45 of Regulation (EC) No 882/2004 (‘the national control plan’).

(4) The purpose of the national control plans is also to establish a solid basis for Community controls in the Member States.

(5) Article 27a of Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(3)provides that Articles 41 to 46 of Regulation (EC) No 882/2004 concerning national control plans, annual reports, and Community controls in Member States and third countries are to apply, as appropriate, in order to ensure the effective implementation of that Directive.

(6) Article 43(1)(e) of Regulation (EC) No 882/2004 provides that the Commission is to draw up guidelines encouraging the adoption of best practices at all levels of the control systems.

(7) Article 43(1)(j) of Regulation (EC) No 882/2004 provides that the Commission is to draw up guidelines laying down the structure of, and information to be included in the annual reports provided for in Article 44 of that Regulation

(8) Article 44(1) of Regulation (EC) No 882/2004 provides that Member States are to submit to the Commission an annual report on the implementation of the national control plan. That report is to be submitted annually commencing one year after starting the implementation of the national control plans. In addition, Article 44(1) sets out the information to be provided in the annual reports.

(9) Article 44(2) of Regulation (EC) No 882/2004 provides that the information to be submitted in the annual reports is to take account of guidelines, to be drawn up by the Commission in order to promote a consistent presentation of such reports. The guidelines are not binding but serve to provide useful guidance to the Member States in the implementation of that Regulation.

(10) Article 45 of Regulation (EC) No 882/2004 provides that Community audits are to be carried out in the Member States on a regular basis mainly in order to verify that official controls are carried out in accordance with the national control plans and in compliance with Community law.

(11) The Commission is to keep the guidelines set out in this Decision under review and update them, as necessary, following the receipt and examination of the Member States annual reports, taking account of conclusions and recommendations contained in the annual report to be established by the Commission pursuant to Article 44(4) of Regulation (EC) No 882/2004 and in the light of the experience of the Member States in implementing that Regulation.

(12) For the purposes of the guidelines set out in this Decision, the ongoing work of Eurostat in the context of the Community statistical programme in developing a ‘control and monitoring activities’ database which comprises various classification schemes, including harmonised terms and definitions for feed and food data management should be taken into account.

(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1

The guidelines provided for in Article 44(2) of Regulation (EC) No 882/2004 to be taken into account in the annual reports provided for in Article 44(1) of that Regulation (‘the annual report’) are set out in the Annex to this Decision.
Article 2

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(1), and in particular Article 44(2) thereof,

(1) Regulation (EC) No 882/2004 lays down general rules for the performance of official controls by the Community or the competent authority of the Member States to verify compliance with rules concerning feed and food law, animal health and animal welfare rules.

(2) Pursuant to Article 1(3) of Regulation (EC) No 882/2004 that Regulation is to be without prejudice to specific Community provisions concerning official controls.

(3) Article 41 of Regulation (EC) No 882/2004 provides that each Member State is to prepare a single integrated multiannual national control plan to ensure the effective implementation of Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2), of animal health and animal welfare rules and of Article 45 of Regulation (EC) No 882/2004 (‘the national control plan’).

(4) The purpose of the national control plans is also to establish a solid basis for Community controls in the Member States.

(5) Article 27a of Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(3)provides that Articles 41 to 46 of Regulation (EC) No 882/2004 concerning national control plans, annual reports, and Community controls in Member States and third countries are to apply, as appropriate, in order to ensure the effective implementation of that Directive.

(6) Article 43(1)(e) of Regulation (EC) No 882/2004 provides that the Commission is to draw up guidelines encouraging the adoption of best practices at all levels of the control systems.

(7) Article 43(1)(j) of Regulation (EC) No 882/2004 provides that the Commission is to draw up guidelines laying down the structure of, and information to be included in the annual reports provided for in Article 44 of that Regulation

(8) Article 44(1) of Regulation (EC) No 882/2004 provides that Member States are to submit to the Commission an annual report on the implementation of the national control plan. That report is to be submitted annually commencing one year after starting the implementation of the national control plans. In addition, Article 44(1) sets out the information to be provided in the annual reports.

(9) Article 44(2) of Regulation (EC) No 882/2004 provides that the information to be submitted in the annual reports is to take account of guidelines, to be drawn up by the Commission in order to promote a consistent presentation of such reports. The guidelines are not binding but serve to provide useful guidance to the Member States in the implementation of that Regulation.

(10) Article 45 of Regulation (EC) No 882/2004 provides that Community audits are to be carried out in the Member States on a regular basis mainly in order to verify that official controls are carried out in accordance with the national control plans and in compliance with Community law.

(11) The Commission is to keep the guidelines set out in this Decision under review and update them, as necessary, following the receipt and examination of the Member States annual reports, taking account of conclusions and recommendations contained in the annual report to be established by the Commission pursuant to Article 44(4) of Regulation (EC) No 882/2004 and in the light of the experience of the Member States in implementing that Regulation.

(12) For the purposes of the guidelines set out in this Decision, the ongoing work of Eurostat in the context of the Community statistical programme in developing a ‘control and monitoring activities’ database which comprises various classification schemes, including harmonised terms and definitions for feed and food data management should be taken into account.

(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
The guidelines provided for in Article 44(2) of Regulation (EC) No 882/2004 to be taken into account in the annual reports provided for in Article 44(1) of that Regulation (‘the annual report’) are set out in the Annex to this Decision.
This Decision is addressed to the Member States.
Guidelines for annual reports on the implementation of Member States national control plansANNEX1.   PURPOSE OF THE GUIDELINESThe purpose of these guidelines is to promote and assist the consistent presentation by the Member States of their annual reports on the implementation of their national control plans and in particular the results of their official controls.

2.   PURPOSE OF THE ANNUAL REPORTThe purpose of the Member States annual report is to:
(a) | meet the legal obligations for reporting laid down in Article 44(1) of Regulation (EC) No 882/2004;

(b) | outline progress on the implementation of the national control plan and make an assessment of the effectiveness of the control arrangements and the control systems based on the results and outcomes of official controls in the Member State.The process of compiling and analysing the control data for the purpose of the annual report may facilitate Member States in reviewing the effectiveness of their control systems and contribute towards development and continual improvement of their control systems.

The information provided in the annual reports should also be utilised by the Commission in:
(a) | developing its annual control programmes (desk analysis, audits, inspections); and

(b) | the preparation of the Commission’s report to the European Parliament and the Council in accordance with Article 44(4) and (6) of Regulation (EC) No 882/2004.3.   LEGAL BASISArticle 44 of Regulation (EC) No 882/2004 provides:
‘1.   One year after starting the implementation of multiannual national control plans, and subsequently every year, Member States shall submit to the Commission a report indicating:

(a) any amendments made to the multiannual national control plans to take account of the factors referred to in Article 42(3);

(b) the results of official controls and audits conducted in the previous year under the provisions of the multiannual control plan;

(c) the type and number of cases of non-compliance identified;

(d) actions to ensure the effective operation of multiannual national control plans, including enforcement action and its results. 2.   In order to promote the consistent presentation of this report and in particular the results of official controls, the information referred to in paragraph 1 shall take account of guidelines to be drawn up by the Commission in accordance with the procedure referred to in Article 62(2). 3.   Member States shall finalise their reports and transmit them to the Commission, within six months of the end of the year to which the reports relate.’

4.   DEFINITIONSFor the purpose of these guidelines the definitions laid down in the relevant Community legislation and, in particular, the definitions in Article 2 of Regulation (EC) No 882/2004, Articles 2 and 3 of Regulation (EC) No 178/2002, Article 2 of Directive 2000/29/EC, Commission Decision 2006/677/EC of 29 September 2006 setting out the guidelines laying down criteria for the conduct of audits under Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls to verify compliance with feed and food law, animal health and animal welfare rules(1), and Commission Decision 2007/363/EC of 21 May 2007 on guidelines to assist Member States in preparing the single integrated multiannual national control plan provided for in Regulation (EC) No 882/2004 of the European Parliament and the Council(2)shall apply.

In addition the following definitions apply for the purposes of these guidelines:
(a) | ‘annual control programme’ means the annual programme for Community controls referred to in Article 45(4) of Regulation (EC) No 882/2004;

(b) | ‘control strategy’ means the approach taken to determine the nature, frequency, time, point/stage of the production chain, method and techniques of official controls (refer to Section 3.7.2 of the Annex to Decision 2007/363/EC);

(c) | ‘national control plan’ means the single integrated multiannual national control plan provided for in Article 41 of Regulation (EC) No 882/2004.5.   SCOPE OF THE ANNUAL REPORTThe annual report should cover the scope of the national control plan, including plant health, in so far as Article 27a of Directive 2000/29/EC provides for plant health matters to be included in that plan.

6.   REPORTING PERIOD AND SUBMISSION OF ANNUAL REPORTSPursuant to Article 42(1)(a) of Regulation (EC) No 882/2004 the latest date for implementing the national control plan for the first time is 1 January 2007. Pursuant to Article 44(3) of that Regulation Member States are to finalise their reports and transmit them to the Commission, within six month of the end of the year to which the reports relate. Therefore the first annual reports are to be transmitted to the Commission by 30 June 2008, at the latest, and for subsequent years those reports are to be submitted by 30 June at the latest.

7.   RELATIONSHIP TO OTHER SPECIFIC REPORTSRegulation (EC) No 882/2004 is without prejudice to specific Community provisions concerning official controls. Therefore, the annual reports do not replace the annual or other reports on specific control plans or other official controls provided for under other Community legislation. However, as the performance of the official controls under those specific control plans form an essential part of the overall implementation of the national control plans, the results of those official controls are relevant for the purposes of the annual reports.

When reporting on official controls relating to those specific control plans in the annual reports, it is not necessary to repeat the information contained in the specific reports thereon; a cross reference to the most recent specific report submitted is sufficient. However, the outcome of the official controls carried out in implementation of those specific control plans should be integrated into the analysis of results in general terms, in the context of reviewing the overall outcome of official controls in the relevant sector.

The dates specified for submission of such specific reports in the relevant Community legislation are not amended by either Article 44 of Regulation (EC) No 882/2004 or by these guidelines.

8.   GENERAL GUIDANCERegulations (EC) No 178/2002 and (EC) No 882/2004 provide for a systems-based approach to official controls. An essential part of such an approach is the compilation and analysis of the results of official controls and drawing conclusions thereon, with a view to the determination of appropriate system-based corrective actions and adjustment or amendment of national control plans where necessary. The annual report should therefore be a synthesis of that activity and also take account of the conclusions of the audits carried out in accordance with Article 4(6) of Regulation (EC) No 882/2004.

A simple statistical account of the number of official controls and audits will not satisfy that requirement. For the purpose of compiling the annual report Member States should provide an overview of the overall or aggregate national results on which the analysis of the results of official controls is based, presented on the basis of sectors and stages in the production chain. The choice of sectors and production stages to be reported on is a matter for the individual Member State to decide. The scope of each sector and production stage should be clearly defined and be consistent with the structure of the description of the control systems in the national control plan. In order to place the results and analysis in context, the relevant official control (including sampling) strategies, audit programmes and performance indicators, set out in the national control plan should be referred to by means of cross-references, and where such information is not included in the national control plan, a brief description of those strategies should be provided in the annual report.

The issues to be covered in the overview and analysis of the results of official controls are outlined in Section 9 of these guidelines. The analysis of those results should identify trends and comment on their significance and possible future consequences for official controls. The identification of trends may require the review of data on results of official controls covering a number of years and for the purpose of such analysis reference should be made to data relating to previous official controls where appropriate. Taking account of Article 43(1)(e) of Regulation (EC) No 882/2004 these guidelines provide some guidance as to how that analysis may be carried out.

For the purposes of compilation of the raw control data, where Community legislation prescribes the data to be collected for the purpose of specific reports, in relation to feed or food law, animal health, animal welfare or plant heath, these data should form the basis of the analysis of the results of official controls for the sector in question. Where there are no such provisions Member States are free to decide the appropriate means of data collection and compilation appropriate to their national systems and may decide to continue with earlier arrangements for the compilation of data on official controls in relation to those activities.

For the purposes of classifying non-compliances, where Community legislation provides for such classification, this classification should be followed for the purposes of the annual reports. In the absence of any specific provision Member States are free to decide a classification system appropriate to their requirements and should briefly describe the system used in their annual reports.

Member States who wish to develop their systems for classifying and recording control data may take into account the ongoing work in Eurostat on ‘food safety statistics’ and in particular, the ‘control and monitoring activities’ database(3). In order to ensure coherence and avoid duplication of work, Member States are encouraged to closely cooperate with Eurostat in the development of those classification schemes. The results of such cooperation may be reflected in future amendments of these guidelines, as appropriate.

The background data supporting the results and analysis of official controls supplied in the annual report may be required by the Commission for the purposes of Community controls provided for in Article 45 of Regulation (EC) No 882/2004 and should therefore be retained and provided to the Commission on request.

9.   GUIDANCE ON CONTENT AND FORMAT OF THE ANNUAL REPORTThe annual report should cover the following areas:
(a) | official controlsperformed by the Member State as provided for in Article 3 of Regulation (EC) No 882/2004 and national control plans — Section 9.1;

(b) | overall compliancewith feed and food law, animal health and animal welfare rules — Section 9.2;

(c) | auditscarried out as provided for in Article 4(6) of Regulation (EC) No 882/2004 including, where appropriate, the results of audits or inspections of control bodies as provided for in Article 5(3) of that Regulation — Section 9.3;

(d) | actions to ensure effectivenessin operating the national control plans — Section 9.4;

(e) | statement on the overall performanceof the control system in operating the national control plans — Section 9.5;

(f) | amendmentsto the national control plans — Section 9.6.The annual report should contain the overall results of the performance of official controls in the relevant areas, analysis of those results and conclusions at national level, which may be presented on the basis of sectors and production stages, and/or on the basis of the structure established in the national control plan of the Member State, as appropriate. A summary of the data supporting that analysis and those conclusions may be given as a separate Annex, if necessary, and the level of detail of such data is left to the Member State to decide bearing in mind that the background data should be retained as indicated in the seventh paragraph of Section 8. The corrective actions or amendments to the national control plan arising from those conclusions should be included as appropriate.

9.1.   Official controlsThe annual report should indicate the extent to which annual operational targets (where Member States have established such operational targets), and strategic objectives set out in the national control plan were achieved. A brief description of relevant performance indicators and/or operational targets applied should be included here, unless provided in the national control plan, in which case they should be referred to by means of cross-references. This should be presented on a sectoral basis in line with the national control plan.

The annual report should include both planned or ongoing official controls and, where applicable, specific control activities focused on a particular issue. For planned official controls the extent to which the frequency or intensity and nature of official controls set out in the national control plan were achieved should be addressed. In the event that operational targets for planned official controls are not achieved, an analysis of relevant mitigating and/or contributing factors should be provided. Unplanned official controls(4)should also be reported — particularly when they have diverted resources from planned official controls — and a brief explanation of the reason for the unplanned official controls should be provided.

With regard to official controls relating to animal health and plant health, this section of the annual report should include the results of official controls carried out for the purpose of disease monitoring, surveillance, eradication or control, including official controls to verify or determine health status with regard to a particular disease.

9.2.   Overall compliance by operators and productsThe annual report should provide a description on how the overall compliance with food and feed law, animal health and animal welfare rules and plant health law (by the food and feed business operators and other relevant producers and business operators or of products) was measured during the reporting period as well as an overview of the results. A statement or conclusion on the overall level of compliance should provide an overview of results on the basis of sectors, production stages and competent authorities. That statement or conclusion should be based on and supported by the information provided in Sections 9.2.1-9.2.2.

9.2.1.   Frequency and type of non-complianceThe annual report should describe the non-compliances observed. The annual report should, where appropriate:
(a) | describe or define the classification used;

(b) | classify the non-compliances detected by type;

(c) | describe the type and number of non-compliances identified.The annual report should compile the non-compliances identified nationally on a sectoral basis and these compiled data should feed into the analysis outlined in Section 9.2.2.

9.2.2.   Analysis of non-complianceAnalysis of non-compliance is an integral part of determining the appropriate corrective measures to be taken to ensure effective operation of control systems. This section includes examples of factors which may be taken into account in the performance of such an analysis and which may contribute to determining the subsequent actions to be taken to ensure the effectiveness of the national control plans (refer to Section 9.4).

That analysis of non-compliance, in line with best practice, may for each sector consider the occurrence, the risk arising and where relevant the root causes of non-compliance. Conclusions may be provided on the basis of the following analyses, and may assess the potential significant consequences of the non-compliances in terms of risks to humans, animals or plants, and where relevant the root causes of these non-compliances. In order to carry out such analysis it may be necessary to consider data collected over a period of years, and if appropriate, reference may be made to previous official controls.

9.2.2.1.   Occurrence of non-complianceThe purpose of this section is to provide some guidance as to how an analysis of the frequency and type of non-compliances may be performed. The analysis may be broken down by sectors and/or competent authorities, as appropriate. The analysis may, where appropriate, provide answers to questions such as:
(a) | what was the frequency of non-compliances in various sectors? This is particularly relevant in cases where significant deviations from the overall compliance are evident in some sectors or in official controls carried out by certain competent authorities;

(b) | were the non-compliances randomly distributed in time and space or was there some clustering at particular points or production stages and were there indications of emerging trends?

(c) | the type of non-compliances, that is whether they were related to structural, operational or end-product related requirements? Other types may include non-compliances related to self-controls, administrative aspects or documentation (for example traceability). Non-compliances may also be categorised as major/minor, systematic/sporadic etc.;

(d) | were the non-compliances scattered all along the feed and food chain or concentrated at primary production or further down the chain?

(e) | were there possibly multiple clusters of non-compliances along certain chains?

(f) | does the pattern of non-compliances indicate that there are critical control stages along the production chain(s)?

(g) | are there any patterns indicating that different (types) of food and feed business operators and other relevant producers and business operators or production chains were more compliant than others?9.2.2.2.   Nature of the risk arising from non-complianceThe purpose of this section is to provide some guidance on the analysis required to provide information on the potential consequences of non-compliances. The analysis may include the following:
(a) | the identification of non-compliances that have a potentially significant impact on humans, animals or plants;

(b) | the description of the potential serious consequences or ‘risk’ of those non-compliances;

(c) | the description as to whether the risk is related to a specific hazard only or a general increase in risk arising from the incidence of multiple hazards or hazard-groups.9.2.2.3.   Root cause(s) of non-complianceWhere relevant, and in particular, where patterns of significant non-compliances or repeated offences are detected, an analysis of possible underlying causes may be carried out. Such analysis may contribute towards development and continual improvement of control systems in the Member State. While carrying out that analysis, consideration may be given to the following factors:
(a) | the lack of awareness by the food and feed business operators and other relevant producers and business operators and reasons therefor;

(b) | the lack of competence by the food and feed business operators and other relevant producers and business operators and reasons therefor;

(c) | the cost of compliance;

(d) | the insufficient tools and/or resources to enforce requirements;

(e) | the lack of effective and/or proportionate and/or dissuasive sanctions.9.3.   Audits9.3.1.   Audits carried out as provided for in Article 4(6) of Regulation (EC) No 882/2004This guidance refers exclusively to the audits provided for in Article 4(6) of Regulation (EC) No 882/2004. The results of such audits should be presented on a national basis, by sector if appropriate, in accordance with the arrangements for such audits in the national control plan.

Taking account of the provisions of Decision 2006/677/EC the annual report should summarise the following:
(a) | the extent to which the audit programme, developed by the competent authority, for the reporting period was achieved;

(b) | the extent to which overall compliance with planned arrangements for official controls by the competent authorities was achieved;

(c) | the conclusions as to the overall effectiveness of the official controls applied by the competent authorities;

(d) | the conclusions as to the overall suitability of the official control systems operated by the competent authorities to achieve the objectives.If the description of the audit arrangements set out in the national control plan, does not indicate the methods or performance indicators used for measuring compliance, effectiveness and suitability of the official controls a brief description should be included in the annual report.

9.3.2.   Audits and inspections of control bodies — Article 5(3) of Regulation (EC) No 882/2004Describe to what extent the programme for audits or inspections of control bodies, was achieved, and summarise the conclusions of these audits or inspections.

9.4.   Actions to ensure effectivenessThis should be an account of the actions taken to ensure effective operation of the national control plan. The annual report should address actions taken in the following areas. This information may be presented on the basis of sectors or production stages.
(a) | Actions taken to ensure compliance by food and feed business operators and other relevant producers and business operators as provided for in Article 31(2)(e), Article 54(2) and Article 55 of Regulation (EC) No 882/2004.

(b) | Actions taken to ensure the effective operation of official control services as provided for in Article 4(2) and Article 8(3) of Regulation (EC) No 882/2004, including actions taken in response to audits carried out in accordance with Article 4(6) of Regulation (EC) No 882/2004, and audits or inspections carried out in accordance with Article 5(3) of that Regulation, where appropriate. In the case of actions taken in response to audit conclusions this may include corrective and preventive actions, or improvement actions based on the identification of best practice.9.4.1.   Actions to ensure compliance by food and feed business operators and other relevant producers and business operatorsThe annual report should include an overview of actions taken. These may include:
(a) | restrictions or prohibitions on the placing on the market, import, export or use of feed, food or animals;

(b) | withdrawal or suspension of approval or registration to operate a feed or food business;

(c) | administrative fines and other administrative sanctions;

(d) | prosecution of food and feed business operators and other relevant producers and business operators for non-compliance (criminal sanctions).9.4.2.   Actions taken to ensure the effective operation of official control servicesSubstantial actions taken to ensure effective operation of official control services may require amendment of the national control plan and should in such case be included in Section 9.6. However, some significant actions might not require an amendment of the national control plan and should in such cases be included in this point in the annual report, in order to indicate positive actions taken by the Member State. This information may be presented on the basis of sectors or production stages and should cover actions not included as amendments to the national control plan, such as:
(a) | new, updated or revised control procedures;

(b) | training initiatives;

(c) | provision of additional resources;

(d) | reallocation of existing resources following review of priorities;

(e) | special control initiatives;

(f) | changes to the organisation or management of competent authorities;

(g) | provision of guidance or information to feed and food business operators;

(h) | new legislation;

(i) | suspension or withdrawal of delegation in the case of control bodies.9.5.   Statement on the overall performanceAssess the overall:
(a) | progress towards achievement of the strategic objectives as described in the national control plan;

(b) | effectiveness of the official controls carried out under the national control plan and their suitability to achieve the objectives of Article 17(2) of Regulation (EC) No 178/2002, Regulation (EC) No 882/2004, animal health, animal welfare and, as applicable, plant health rules.That self-assessment should also address issues like overall effectiveness, coordination between and within competent authorities, delivery of a farm-to-fork approach and overall risk-based targeting of official controls. The statement on the overall performance should be based on an analysis and synthesis of results of the previous sections and provide descriptions of:
(a) | the performance indicators applied to those objectives, where appropriate; and

(b) | results for each objective, where appropriate.9.6.   Amendments to the national control planThe annual report should outline amendments made to the national control plan during the year to which that report relates. Particular attention should be paid to the need to ensure that amendments made in response to the factors referred to in Article 42(3), Article 44(5) and Article 45(5)(a) of Regulation (EC) No 882/2004 are addressed and explained. In particular relevant changes to the official control systems as described in the national control plan and relevant changes to the risk categorisation of activities (refer to Section 3.4 of the Annex to Decision 2007/363/EC) should be described.

The annual report should describe the nature and reasons for such amendments. For example, and where applicable:
(a) | new legislation;

(b) | the emergence of new diseases or other health risks;

(c) | significant changes to the structure, management or operation of the competent authorities;

(d) | significant changes to the agri-food production sector;

(e) | the results of Member States’ official controls;

(f) | any amendment of the guidelines referred to in Article 43 of Regulation (EC) No 882/2004;

(g) | scientific findings;

(h) | the outcome of audits carried out in accordance with Article 4(6) of Regulation (EC) No 882/2004;

(i) | the outcome of Community controls carried out in accordance with Article 45 of Regulation (EC) No 882/2004(5);

(j) | the outcome of audits performed by a third country in a Member State;

(k) | outcome of root-cause analysis.The amendments should be consistent with the analysis and conclusions provided for in Sections 9.3-9.5 of these guidelines and include cross-references to the relevant section(s), as appropriate.
(1)  

            OJ L 278, 10.10.2006, p. 15.

(2)  

            OJ L 138, 30.5.2007, p. 24.

(3)  This work, carried on within the context of the Community Statistical Programme and its annual work programmes, comprises various classification schemes like the classification of control and monitoring activities, the data dictionaries of products and activities of the establishments, a common glossary, the definition of sampling strategies and indicators of control and monitoring activities.

(4)  Official controls that involve a significant temporary departure from the national control plan due to unforeseen circumstances.

(5)  Community controls in Member States may identify issues for which the corrective or preventative actions taken in response to the Commission recommendations require amendment to the national control plan. Such amendments should be included in the annual report, notwithstanding that they may also be covered by a Member State’s response to the recommendations.

Pending: 32008D0630

                                January 16, 2026                            

1.8.2008
EN
Official Journal of the European Union
L 205/49

(1)
Regulation (EC) No 178/2002 lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level. It provides for emergency measures where it is evident that food or feed imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned.

(2)
Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(2)provides that the production process of animals and primary products of animal origin is to be monitored for the purpose of detecting the presence of certain residues and substances in live animals, their excrements and body fluids and in tissue, animal products, animal feed and drinking water.

(3)
Residues of veterinary medicinal products and unauthorised substances have been detected in crustaceous imported from Bangladesh and intended for human consumption. The presence of those products and substances in food presents a potential risk for human health.

(4)
The results of the latest Community inspection visit to Bangladesh have revealed serious shortcomings as regards the residue control system in live animals and animal products and a lack of appropriate laboratory capacity for the testing of certain residues of veterinary medicinal products in live animals and animal products.

(5)
Bangladesh has recently taken measures concerning those shortcomings as regards the handling and testing of fishery products.

(6)
Since those measures are not sufficient, it is appropriate to adopt, at Community level, certain emergency measures applicable to importations of crustaceous from Bangladesh in order to ensure the effective and uniform protection of human health in all Member States.

(7)
Accordingly, Member States should allow importations of crustaceous from Bangladesh only if it can be shown that they have been subjected to an analytical test at origin to verify that they do not contain any unauthorised substances and that the levels of certain residues of veterinary medicinal products do not exceed the maximum residue levels laid down in Community legislation.

(8)
However, it is appropriate to authorise, the importation of consignments that are not accompanied by the results of the analytical tests at origin, provided that the importing Member States ensures that those consignments undergo appropriate checks on arrival at the Community border.

(9)
This Decision should be reviewed in the light of the guarantees offered by Bangladesh and on the basis of the results of the analytical tests carried out by the Member States.

(10)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)
the presence of any substances not authorised under Community legislation; or

(b)
residues of veterinary medicinal products that exceed the maximum residue limits laid down in Community legislation.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1), and in particular Article 53(1)(b)(ii) thereof,

(1) Regulation (EC) No 178/2002 lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level. It provides for emergency measures where it is evident that food or feed imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned.

(2) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(2)provides that the production process of animals and primary products of animal origin is to be monitored for the purpose of detecting the presence of certain residues and substances in live animals, their excrements and body fluids and in tissue, animal products, animal feed and drinking water.

(3) Residues of veterinary medicinal products and unauthorised substances have been detected in crustaceous imported from Bangladesh and intended for human consumption. The presence of those products and substances in food presents a potential risk for human health.

(4) The results of the latest Community inspection visit to Bangladesh have revealed serious shortcomings as regards the residue control system in live animals and animal products and a lack of appropriate laboratory capacity for the testing of certain residues of veterinary medicinal products in live animals and animal products.

(5) Bangladesh has recently taken measures concerning those shortcomings as regards the handling and testing of fishery products.

(6) Since those measures are not sufficient, it is appropriate to adopt, at Community level, certain emergency measures applicable to importations of crustaceous from Bangladesh in order to ensure the effective and uniform protection of human health in all Member States.

(7) Accordingly, Member States should allow importations of crustaceous from Bangladesh only if it can be shown that they have been subjected to an analytical test at origin to verify that they do not contain any unauthorised substances and that the levels of certain residues of veterinary medicinal products do not exceed the maximum residue levels laid down in Community legislation.

(8) However, it is appropriate to authorise, the importation of consignments that are not accompanied by the results of the analytical tests at origin, provided that the importing Member States ensures that those consignments undergo appropriate checks on arrival at the Community border.

(9) This Decision should be reviewed in the light of the guarantees offered by Bangladesh and on the basis of the results of the analytical tests carried out by the Member States.

(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1

This Decision shall apply to consignments of crustaceous imported from Bangladesh and intended for human consumption (the products).
Article 2

Member States shall authorise the importation into the Community of the products provided that they are accompanied by the results of an analytical test carried out at origin to ensure that they do not present a danger to human health (the analytical test).

The analytical tests must be carried out, in particular, with a view to detecting the presence of chloramphenicol, metabolites of nitrofurans, tetracycline, malachite green and crystal violet in conformity with Council Regulation (EEC) No 2377/90(3)and Commission Decision 2002/657/EC(4).
Article 3

By way of derogation from Article 2, Member States shall authorise the importation of products that are not accompanied by the results of the analytical test provided that the importing Member State ensures that each consignment of such products undergoes all appropriate checks on arrival at the Community border to ensure that they do not present a danger to human health.

However, those consignments must be detained at the Community border until laboratory tests show that the substances referred to in Article 2 that are not authorised under Community legislation are not present or that the maximum residues laid down in Community legislation for the veterinary medical products referred to in that Article are not exceeded.
Article 4

1.   Member States shall immediately inform the Commission if the analytical tests reveal:

(a)

the presence of any substances not authorised under Community legislation; or

(b)

residues of veterinary medicinal products that exceed the maximum residue limits laid down in Community legislation.

Member States shall use, for the submission of any such information, the rapid alert system for food and feed set up by Regulation (EC) No 178/2002.

2.   Member States shall submit to the Commission every three months a report of all the results of the analytical tests.

Those reports shall be submitted during the month following each quarter (April, July, October, and January).
Article 5

All expenditure incurred in the application of this Decision shall be charged to the consignor, the consignee or the agent of either.
Article 6

Member States shall immediately inform the Commission of the measures they take to comply with this Decision.
Article 7

This Decision shall be reviewed on the basis of the guarantees offered by Bangladesh, and the results of the analytical tests carried out by the Member States.
Article 8

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1), and in particular Article 53(1)(b)(ii) thereof,

(1) Regulation (EC) No 178/2002 lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level. It provides for emergency measures where it is evident that food or feed imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned.

(2) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(2)provides that the production process of animals and primary products of animal origin is to be monitored for the purpose of detecting the presence of certain residues and substances in live animals, their excrements and body fluids and in tissue, animal products, animal feed and drinking water.

(3) Residues of veterinary medicinal products and unauthorised substances have been detected in crustaceous imported from Bangladesh and intended for human consumption. The presence of those products and substances in food presents a potential risk for human health.

(4) The results of the latest Community inspection visit to Bangladesh have revealed serious shortcomings as regards the residue control system in live animals and animal products and a lack of appropriate laboratory capacity for the testing of certain residues of veterinary medicinal products in live animals and animal products.

(5) Bangladesh has recently taken measures concerning those shortcomings as regards the handling and testing of fishery products.

(6) Since those measures are not sufficient, it is appropriate to adopt, at Community level, certain emergency measures applicable to importations of crustaceous from Bangladesh in order to ensure the effective and uniform protection of human health in all Member States.

(7) Accordingly, Member States should allow importations of crustaceous from Bangladesh only if it can be shown that they have been subjected to an analytical test at origin to verify that they do not contain any unauthorised substances and that the levels of certain residues of veterinary medicinal products do not exceed the maximum residue levels laid down in Community legislation.

(8) However, it is appropriate to authorise, the importation of consignments that are not accompanied by the results of the analytical tests at origin, provided that the importing Member States ensures that those consignments undergo appropriate checks on arrival at the Community border.

(9) This Decision should be reviewed in the light of the guarantees offered by Bangladesh and on the basis of the results of the analytical tests carried out by the Member States.

(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
This Decision shall apply to consignments of crustaceous imported from Bangladesh and intended for human consumption (the products).
Member States shall authorise the importation into the Community of the products provided that they are accompanied by the results of an analytical test carried out at origin to ensure that they do not present a danger to human health (the analytical test).

The analytical tests must be carried out, in particular, with a view to detecting the presence of chloramphenicol, metabolites of nitrofurans, tetracycline, malachite green and crystal violet in conformity with Council Regulation (EEC) No 2377/90(3)and Commission Decision 2002/657/EC(4).
By way of derogation from Article 2, Member States shall authorise the importation of products that are not accompanied by the results of the analytical test provided that the importing Member State ensures that each consignment of such products undergoes all appropriate checks on arrival at the Community border to ensure that they do not present a danger to human health.

However, those consignments must be detained at the Community border until laboratory tests show that the substances referred to in Article 2 that are not authorised under Community legislation are not present or that the maximum residues laid down in Community legislation for the veterinary medical products referred to in that Article are not exceeded.
1.   Member States shall immediately inform the Commission if the analytical tests reveal:

(a)

the presence of any substances not authorised under Community legislation; or

(b)

residues of veterinary medicinal products that exceed the maximum residue limits laid down in Community legislation.

Member States shall use, for the submission of any such information, the rapid alert system for food and feed set up by Regulation (EC) No 178/2002.

2.   Member States shall submit to the Commission every three months a report of all the results of the analytical tests.

Those reports shall be submitted during the month following each quarter (April, July, October, and January).
All expenditure incurred in the application of this Decision shall be charged to the consignor, the consignee or the agent of either.
Member States shall immediately inform the Commission of the measures they take to comply with this Decision.
This Decision shall be reviewed on the basis of the guarantees offered by Bangladesh, and the results of the analytical tests carried out by the Member States.
This Decision is addressed to the Member States.

Pending: 32008D0603

                                January 16, 2026                            

23.7.2008
EN
Official Journal of the European Union
L 194/9

(1)
On 21 February 2008 Mauritius requested, in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007, derogation from the rules of origin set out in that Annex for a period of five years. On 10 March 2008 Mauritius submitted additional information relating to its request. The request covers a total annual quantity of 5 000 tonnes of canned tuna and 2 000 tonnes of tuna loins of HS heading 1604. The request is made because catches and supply of originating raw tuna have decreased in the South West Indian Ocean.

(2)
According to the information provided by Mauritius the catches of raw tuna in late 2007 and early 2008 were unusually low even compared to the normal seasonal variations. This abnormal situation makes it impossible for Mauritius to comply with the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 during a certain period.

(3)
A temporary derogation from the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 would not cause serious injury to an established Community industry taking into account the imports concerned, provided that certain conditions relating to quantities, surveillance and duration are respected.

(4)
It is therefore justified to grant a temporary derogation under Article 36(1)(a) of Annex II to Regulation (EC) No 1528/2007.

(5)
Mauritius will benefit from an automatic derogation from the rules of origin for canned tuna and tuna loins of HS heading 1604 pursuant to Article 42(8) of the Origin Protocol attached to the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States on the one part and the European Community and its Member States on the other part (ESA-EU Interim Partnership Agreement), when that Agreement enters into force or is provisionally applied.

(6)
In accordance with Article 4(2) of Regulation (EC) No 1528/2007 the rules of origin set out in Annex II to that Regulation and the derogations from them are to be superseded by the rules of the ESA-EU Interim Partnership Agreement, the entry into force or provisional application of which is expected to take place in 2008. The derogation therefore should not be granted for the requested period of five years, but should be granted for the period from January to December 2008.

(7)
In accordance with Article 42(8) of the Origin Protocol attached to the ESA-EU Interim Partnership Agreement, the automatic derogation from the rules of origin is limited to an annual quota of 8 000 tonnes of canned tuna and 2 000 tonnes of tuna loins for the countries having initialled the ESA-EU Interim Partnership Agreement (Comoros, Mauritius, Madagascar, Seychelles and Zimbabwe). Requests for a temporary derogation in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 from other countries of the ESA region are to be expected, notably from Madagascar and Seychelles. It would be inappropriate to grant derogations under Article 36 of Annex II to Regulation (EC) No 1528/2007 which exceed the annual quota granted to the ESA region under the ESA-EU Interim Partnership Agreement. The derogation therefore should not be granted for the requested quantities, but should be granted for 3 000 tonnes of preserved tuna and 600 tonnes of tuna loins.

(8)
Accordingly a derogation should be granted to Mauritius in respect of 3 000 tonnes of canned tuna and 600 tonnes of tuna loins for a period of one year.

(9)
Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code(2)lays down rules relating to the management of tariff quotas. In order to ensure efficient management carried out in close cooperation between the authorities of Mauritius, the customs authorities of the Community and the Commission, those rules should applymutatis mutandisto the quantities imported under the derogation granted by this Decision.

(10)
In order to allow more efficient monitoring of the operation of the derogation, the authorities of Mauritius should communicate regularly to the Commission details of the EUR.1 movement certificates issued.

(11)
The measures provided for in this Decision are in accordance with the opinion of the Customs Code Committee,

Order No
CN code
Description of goods
Period
Quantities

09.1668
1604 14 11 , 1604 14 18 , 1604 20 70
Preserved tuna(1)
1.1.2008 to 31.12.2008
3 000 tonnes

09.1669
1604 14 16
Tuna loins
1.1.2008 to 31.12.2008
600 tonnes

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1528/2007 of 20 December 2007 applying the arrangements for goods originating in certain states which are part of the African, Caribbean and Pacific (ACP) Group of States provided for in agreements establishing, or leading to the establishment of, Economic Partnership Agreements(1), and in particular Article 36(4) of Annex II thereto,

(1) On 21 February 2008 Mauritius requested, in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007, derogation from the rules of origin set out in that Annex for a period of five years. On 10 March 2008 Mauritius submitted additional information relating to its request. The request covers a total annual quantity of 5 000 tonnes of canned tuna and 2 000 tonnes of tuna loins of HS heading 1604. The request is made because catches and supply of originating raw tuna have decreased in the South West Indian Ocean.

(2) According to the information provided by Mauritius the catches of raw tuna in late 2007 and early 2008 were unusually low even compared to the normal seasonal variations. This abnormal situation makes it impossible for Mauritius to comply with the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 during a certain period.

(3) A temporary derogation from the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 would not cause serious injury to an established Community industry taking into account the imports concerned, provided that certain conditions relating to quantities, surveillance and duration are respected.

(4) It is therefore justified to grant a temporary derogation under Article 36(1)(a) of Annex II to Regulation (EC) No 1528/2007.

(5) Mauritius will benefit from an automatic derogation from the rules of origin for canned tuna and tuna loins of HS heading 1604 pursuant to Article 42(8) of the Origin Protocol attached to the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States on the one part and the European Community and its Member States on the other part (ESA-EU Interim Partnership Agreement), when that Agreement enters into force or is provisionally applied.

(6) In accordance with Article 4(2) of Regulation (EC) No 1528/2007 the rules of origin set out in Annex II to that Regulation and the derogations from them are to be superseded by the rules of the ESA-EU Interim Partnership Agreement, the entry into force or provisional application of which is expected to take place in 2008. The derogation therefore should not be granted for the requested period of five years, but should be granted for the period from January to December 2008.

(7) In accordance with Article 42(8) of the Origin Protocol attached to the ESA-EU Interim Partnership Agreement, the automatic derogation from the rules of origin is limited to an annual quota of 8 000 tonnes of canned tuna and 2 000 tonnes of tuna loins for the countries having initialled the ESA-EU Interim Partnership Agreement (Comoros, Mauritius, Madagascar, Seychelles and Zimbabwe). Requests for a temporary derogation in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 from other countries of the ESA region are to be expected, notably from Madagascar and Seychelles. It would be inappropriate to grant derogations under Article 36 of Annex II to Regulation (EC) No 1528/2007 which exceed the annual quota granted to the ESA region under the ESA-EU Interim Partnership Agreement. The derogation therefore should not be granted for the requested quantities, but should be granted for 3 000 tonnes of preserved tuna and 600 tonnes of tuna loins.

(8) Accordingly a derogation should be granted to Mauritius in respect of 3 000 tonnes of canned tuna and 600 tonnes of tuna loins for a period of one year.

(9) Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code(2)lays down rules relating to the management of tariff quotas. In order to ensure efficient management carried out in close cooperation between the authorities of Mauritius, the customs authorities of the Community and the Commission, those rules should applymutatis mutandisto the quantities imported under the derogation granted by this Decision.

(10) In order to allow more efficient monitoring of the operation of the derogation, the authorities of Mauritius should communicate regularly to the Commission details of the EUR.1 movement certificates issued.

(11) The measures provided for in this Decision are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS DECISION:
Article 1

By way of derogation from Annex II to Regulation (EC) No 1528/2007 and in accordance with Article 36(1)(a) of that Annex, preserved tuna and tuna loins of HS Heading 1604 manufactured from non-originating materials shall be regarded as originating in Mauritius in accordance with the terms set out in Articles 2, 3 and 4 of this Decision.
Article 2

The derogation provided for in Article 1 shall apply to the products and the quantities set out in the Annex which are declared for free circulation into the Community from Mauritius during the period from 1 January 2008 to 31 December 2008.
Article 3

The quantities set out in the Annex to this Decision shall be managed in accordance with Articles 308a, 308b and 308c of Regulation (EEC) No 2454/93.
Article 4

The customs authorities of Mauritius shall take the necessary measures to carry out quantitative checks on exports of the products referred to in Article 1.

To that end, all the EUR.1 movement certificates they issue in relation to those products shall bear a reference to this Decision. The competent authorities of Mauritius shall forward to the Commission a quarterly statement of the quantities in respect of which EUR.1 movement certificates have been issued pursuant to this Decision and the serial numbers of those certificates.
Article 5

Box 7 of EUR.1 movement certificates issued under this Decision shall contain the following:

‘Derogation — Decision C(2008) 3568’.
Article 6

This Decision shall apply from 1 January 2008.

It shall apply until the rules of origin set out in Annex II to Regulation (EC) No 1528/2007 are superseded by those annexed to any agreement with Mauritius when that agreement is either provisionally applied, or enters into force, whichever is the earlier, but in any event this Decision shall not apply after 31 December 2008.
Article 7

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1528/2007 of 20 December 2007 applying the arrangements for goods originating in certain states which are part of the African, Caribbean and Pacific (ACP) Group of States provided for in agreements establishing, or leading to the establishment of, Economic Partnership Agreements(1), and in particular Article 36(4) of Annex II thereto,

(1) On 21 February 2008 Mauritius requested, in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007, derogation from the rules of origin set out in that Annex for a period of five years. On 10 March 2008 Mauritius submitted additional information relating to its request. The request covers a total annual quantity of 5 000 tonnes of canned tuna and 2 000 tonnes of tuna loins of HS heading 1604. The request is made because catches and supply of originating raw tuna have decreased in the South West Indian Ocean.

(2) According to the information provided by Mauritius the catches of raw tuna in late 2007 and early 2008 were unusually low even compared to the normal seasonal variations. This abnormal situation makes it impossible for Mauritius to comply with the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 during a certain period.

(3) A temporary derogation from the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 would not cause serious injury to an established Community industry taking into account the imports concerned, provided that certain conditions relating to quantities, surveillance and duration are respected.

(4) It is therefore justified to grant a temporary derogation under Article 36(1)(a) of Annex II to Regulation (EC) No 1528/2007.

(5) Mauritius will benefit from an automatic derogation from the rules of origin for canned tuna and tuna loins of HS heading 1604 pursuant to Article 42(8) of the Origin Protocol attached to the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States on the one part and the European Community and its Member States on the other part (ESA-EU Interim Partnership Agreement), when that Agreement enters into force or is provisionally applied.

(6) In accordance with Article 4(2) of Regulation (EC) No 1528/2007 the rules of origin set out in Annex II to that Regulation and the derogations from them are to be superseded by the rules of the ESA-EU Interim Partnership Agreement, the entry into force or provisional application of which is expected to take place in 2008. The derogation therefore should not be granted for the requested period of five years, but should be granted for the period from January to December 2008.

(7) In accordance with Article 42(8) of the Origin Protocol attached to the ESA-EU Interim Partnership Agreement, the automatic derogation from the rules of origin is limited to an annual quota of 8 000 tonnes of canned tuna and 2 000 tonnes of tuna loins for the countries having initialled the ESA-EU Interim Partnership Agreement (Comoros, Mauritius, Madagascar, Seychelles and Zimbabwe). Requests for a temporary derogation in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 from other countries of the ESA region are to be expected, notably from Madagascar and Seychelles. It would be inappropriate to grant derogations under Article 36 of Annex II to Regulation (EC) No 1528/2007 which exceed the annual quota granted to the ESA region under the ESA-EU Interim Partnership Agreement. The derogation therefore should not be granted for the requested quantities, but should be granted for 3 000 tonnes of preserved tuna and 600 tonnes of tuna loins.

(8) Accordingly a derogation should be granted to Mauritius in respect of 3 000 tonnes of canned tuna and 600 tonnes of tuna loins for a period of one year.

(9) Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code(2)lays down rules relating to the management of tariff quotas. In order to ensure efficient management carried out in close cooperation between the authorities of Mauritius, the customs authorities of the Community and the Commission, those rules should applymutatis mutandisto the quantities imported under the derogation granted by this Decision.

(10) In order to allow more efficient monitoring of the operation of the derogation, the authorities of Mauritius should communicate regularly to the Commission details of the EUR.1 movement certificates issued.

(11) The measures provided for in this Decision are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS DECISION:
By way of derogation from Annex II to Regulation (EC) No 1528/2007 and in accordance with Article 36(1)(a) of that Annex, preserved tuna and tuna loins of HS Heading 1604 manufactured from non-originating materials shall be regarded as originating in Mauritius in accordance with the terms set out in Articles 2, 3 and 4 of this Decision.
The derogation provided for in Article 1 shall apply to the products and the quantities set out in the Annex which are declared for free circulation into the Community from Mauritius during the period from 1 January 2008 to 31 December 2008.
The quantities set out in the Annex to this Decision shall be managed in accordance with Articles 308a, 308b and 308c of Regulation (EEC) No 2454/93.
The customs authorities of Mauritius shall take the necessary measures to carry out quantitative checks on exports of the products referred to in Article 1.

To that end, all the EUR.1 movement certificates they issue in relation to those products shall bear a reference to this Decision. The competent authorities of Mauritius shall forward to the Commission a quarterly statement of the quantities in respect of which EUR.1 movement certificates have been issued pursuant to this Decision and the serial numbers of those certificates.
Box 7 of EUR.1 movement certificates issued under this Decision shall contain the following:

‘Derogation — Decision C(2008) 3568’.
This Decision shall apply from 1 January 2008.

It shall apply until the rules of origin set out in Annex II to Regulation (EC) No 1528/2007 are superseded by those annexed to any agreement with Mauritius when that agreement is either provisionally applied, or enters into force, whichever is the earlier, but in any event this Decision shall not apply after 31 December 2008.
This Decision is addressed to the Member States.
ANNEX

Order No | CN code | Description of goods | Period | Quantities

09.1668 | 1604 14 11 , 1604 14 18 , 1604 20 70 | Preserved tuna(1) | 1.1.2008 to 31.12.2008 | 3 000  tonnes

09.1669 | 1604 14 16 | Tuna loins | 1.1.2008 to 31.12.2008 | 600 tonnes

(1)  In any form of packaging whereby the product is considered as preserved within the meaning of HS heading 1604.

Pending: 32008D0458

                                January 16, 2026                            

27.6.2008
EN
Official Journal of the European Union
L 167/135

(1)
It is necessary to lay down the conditions under which Member States should implement the action under the Fund, in particular to identify under which circumstances the responsible authority may implement projects directly. Further provisions should also be laid down for delegated authorities.

(2)
It is necessary to identify a list of procedures and/or practical arrangements that the different designated authorities should lay down and follow for implementation of the Fund.

(3)
It is necessary to lay down the obligations which the responsible authorities should have with regard to final beneficiaries in the phase leading to selection and approval of the projects to be funded and with regard to the aspects which should be covered by the verifications of the expenditure declared by the final beneficiary and/or by the partners in the project, including administrative verifications of the applications for reimbursement and on-the-spot verifications of individual projects.

(4)
In order to ensure that expenditure under annual programmes can be properly audited, it is necessary to set out the criteria with which audit trails should comply in order to be considered adequate.

(5)
The audits of projects and of systems are carried out under the responsibility of the audit authority. To ensure that the audits offer adequate scope and effectiveness and are carried out in accordance with the same standards in all Member States, it is necessary to set out the conditions which the audits should fulfil, including the basis for sampling.

(6)
The Member States must submit to the Commission, together with their multiannual programme, a description of their management and control systems. Since this document is one of the principal bases on which the Commission relies, in the context of shared management of the Community budget, to determine whether the financial assistance concerned is used by the Member States in accordance with the applicable rules and principles for protecting the Community's financial interests, it is necessary to set out in detail the information that this document should contain.

(7)
In order to harmonise standards for programming, following up the implementation of the Fund, auditing and certifying expenditure, it is necessary to clearly define the contents of the multiannual programme, the annual programme, the progress report, the final report, the applications for payments as well as the audit strategy, the annual audit report, the declaration of validity and the certification of expenditure.

(8)
Since Member States are required to report and monitor irregularities and to recover sums wrongly paid in connection with the financing from the Fund, it is necessary to define requirements for the data sent to the Commission.

(9)
Experience has shown that citizens of the European Union are insufficiently aware of the role played by the Community in funding programmes. It is therefore appropriate to define in detail the information and publicity measures necessary to bridge this communication and information gap.

(10)
In order to guarantee that information on possible funding opportunities is disseminated widely to all interested parties and for the sake of transparency, the minimum measures needed to inform potential final beneficiaries about the financing opportunities offered jointly by the Community and the Member States through the Fund should be set out. In order to enhance transparency about use of the Fund, the list of final beneficiaries, the names of the projects and the amount of public funding allocated to projects should be published.

(11)
In the light of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(2)and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data(3), it is necessary to provide, in relation to the information and publicity measures and audit work under this Decision, that the Commission and the Member States should prevent any unauthorised disclosure of or access to personal data and to specify the purpose for which the Commission and the Member States may process such data.

(12)
Use of electronic means to exchange information and financial data between the Member States and the Commission leads to simplification, increased efficiency, transparency and time savings. In order to capitalise fully on these advantages while preserving the security of exchanges, a common computer system may be established by the Commission.

(13)
To ensure efficient implementation of the Fund in the Member States, in accordance with the principles of sound financial management, a series of common rules should be adopted on the eligibility of expenditure from the Fund. In order to reduce the administrative burden on final beneficiaries and designated authorities, flat rates for indirect costs should be eligible under certain conditions.

(14)
In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom is bound by the basic act and, as a consequence, by this Decision.

(15)
In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Ireland is bound by the basic act and, as a consequence, by this Decision.

(16)
In accordance with Article 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not bound by this Decision nor subject to application thereof.

(17)
The measures provided for in this Decision are in accordance with the opinion of the Management Committee of the Fund,

Part I
Introduction
139

Chapter I
Subject and definitions
139

Article 1
Subject matter
139

Article 2
Definitions
139

Part II
Provisions common to the four Funds
140

Chapter 1
Designated authorities
140

Article 3
Common authorities
140

Article 4
Delegated authority
140

Article 5
Outsourcing of tasks
140

Chapter 2
Management and control systems
140

Article 6
Manual of procedures
140

Article 7
Implementation of the Fund by the responsible authority
141

Article 8
Conditions under which the responsible authority acts as executing body
141

Article 9
Selection and award procedure when the responsible authority acts as awarding body
141

Article 10
Grant agreements with final beneficiaries when the responsible authority acts as awarding body
142

Article 11
Implementation contracts
143

Article 12
Determination of the final Community contribution
143

Article 13
Technical assistance
143

Article 14
Technical assistance expenditure in the case of a common authority
143

Article 15
Verifications by the responsible authority
143

Article 16
Audit trail
144

Article 17
Audits of systems and audits of projects
144

Article 18
Verifications by the certifying authority
145

Chapter 3
Information to be provided regarding use of the Fund
145

Article 19
Principle of proportionality
145

Article 20
Description of management and control systems
145

Article 21
Revision of the description of management and control systems
145

Article 22
Programming documents
146

Article 23
Revision of financial breakdown in annual programmes
146

Article 24
Progress and final reports on implementation of annual programmes
146

Article 25
Documents established by the audit authority
146

Article 26
Documents established by the certifying authority
146

Chapter 4
Reporting irregularities
147

Article 27
Initial reporting — derogations
147

Article 28
Reporting of follow-up — Non-recovery
147

Article 29
Contacts with Member States
148

Article 30
Use of information
148

Chapter 5
Information and publicity
148

Article 31
Information for potential final beneficiaries
148

Article 32
Information for final beneficiaries
148

Article 33
Responsibilities of the responsible authority relating to information and publicity for the general public
148

Article 34
Responsibilities of final beneficiaries relating to information and publicity for the general public
149

Article 35
Technical characteristics of information and publicity for the operation
149

Chapter 6
Personal data
149

Article 36
Protection of personal data
149

Chapter 7
Electronic exchange of documents
149

Article 37
Electronic exchange of documents
149

Article 38
Computer system for the exchange of documents
149

Part III
Provisions specific to the European Return Fund
150

Chapter 1
Eligibility rules
150

Article 39
Eligibility rules
150

Part IV
FINAL PROVISIONS
150

Article 40
Addressees
150

ANNEXES

151

(a)
designated authorities;

(b)
management and control systems;

(c)
information to be provided by the Member States to the Commission regarding use of the Fund;

(d)
reporting of irregularities;

(e)
information and publicity;

(f)
personal data;

(g)
electronic exchange of documents.

—
‘basic act’: Decision No 575/2007/EC,

—
‘Fund’: the European Return Fund, as established by the basic act,

—
‘four Funds’: the European Refugee Fund, the External Borders Fund, the European Return Fund and the European Fund for the Integration of third-country nationals, as established by Decision No 573/2007/EC(5), Decision No 574/2007/EC(6)and Decision No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC(7)as part of the General programme ‘Solidarity and Management of Migration Flows’,

—
‘responsible authority’: the body designated by a Member State under Article 25 (1)(a) of the basic act,

—
‘certifying authority’: the body designated by a Member State under Article 25 (1)(b) of the basic act,

—
‘audit authority’: the body designated by a Member State under Article 25(1)(c) of the basic act,

—
‘delegated authority’: the body designated by a Member State under Article 25 (1)(d) of the basic act,

—
‘designated authorities’: all the authorities designated by a Member State under Article 25 of the basic act,

—
‘action’: action under the Fund, as defined in Article 4 of the basic act,

—
‘project’: specific, practical means deployed to implement all or part of an action by the final beneficiaries of grants,

—
‘final beneficiary’: the legal entity responsible for implementing projects such as NGOs, federal, national, regional or local authorities, other non-profit organisations, private or public-law companies or international organisations,

—
‘partner in the project’: any legal entity which implements a project in cooperation with a final beneficiary by providing the project with resources and by receiving part of the Community contribution through the final beneficiary,

—
‘strategic guidelines’: the framework for intervention by the Fund, as adopted by Commission Decision 2007/837/EC(8),

—
‘priority’: set of actions defined as a priority in the strategic guidelines,

—
‘specific priority’: set of actions defined as a specific priority in the strategic guidelines, allowing co-financing at a higher rate, in accordance with Article 15(4) of the basic act,

—
‘primary administrative or judicial finding’: first written assessment by a competent authority, either administrative or judicial, concluding on the basis of specific facts that an irregularity has been committed, without prejudice to the possibility that this conclusion may subsequently have to be revised or withdrawn as a result of developments in the course of the administrative or judicial procedure,

—
‘irregularity’: any infringement of a provision of Community law resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the European Union by charging an unjustified item of expenditure to the general budget,

—
‘suspected fraud’: an irregularity giving rise to the initiation of administrative or judicial proceedings at national level in order to establish the presence of intentional behaviour, in particular fraud, as referred to in point (a) of Article 1(1) of the Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities' financial interests(9),

—
‘bankruptcy’: insolvency proceedings, as defined in Article 2(a) of Council Regulation (EC) No 1346/2000(10),

—
‘grant agreement’: an agreement or an equivalent form of legal instrument on the basis of which Member States provide grants to the final beneficiary for the purpose of implementing the project under the Fund.

(a)
the references of the relevant Community legislation;

(b)
the task entrusted to the delegated authority;

(c)
the rights and duties of the delegated authority and the responsibilities it assumes;

(d)
the obligation for the delegated authority to put in place and to maintain an organisational structure and a management and control system adapted to performance of its duties;

(e)
the assurance to be provided concerning sound financial management and the legality and regularity of the delegated tasks.

(a)
functioning of the designated authorities;

(b)
arrangements ensuring appropriate separation of functions;

(c)
where appropriate, monitoring of delegated authorities and other outsourced tasks;

(d)
establishment of multiannual and annual programmes;

(e)
establishment of audit strategy and annual audit plans;

(f)
selection of projects, award of grants and monitoring and financial management of the projects;

(g)
management of irregularities, financial corrections and recoveries;

(h)
preparation and implementation of audit missions;

(i)
preparation of audit reports and declarations;

(j)
certification of expenditure;

(k)
evaluation of the programme;

(l)
reporting to the Commission;

(m)
audit trail.

(a)
the audit authority shall not be part of the same body as the responsible authority, except when its audit independence is guaranteed and it also reports to another body outside the body of which it and the responsible authority form part;

(b)
the tasks of the responsible authority, as defined in Article 27 of the basic act, shall not be affected when the responsible authority also implements projects directly.

(a)
the objectives;

(b)
the selection criteria, which shall comply with Article 15(5) of the basic act, and the relevant supporting documents;

(c)
the arrangements for Community and, if applicable, national financing;

(d)
the arrangements and final date for submission of proposals.

(a)
the eligibility rules for the expenditure;

(b)
the time-limit for implementation; and

(c)
the financial and other information to be kept and communicated.

(a)
signature of grant agreements with selected final beneficiaries;

(b)
follow-up of agreements and any amendment thereto by establishing a system for administrative monitoring of projects (exchange of correspondence, issuing and monitoring amendments and reminder letters, receipt and processing of reports, etc.).

(a)
the maximum amount of the grant;

(b)
the maximum percentage of the Community contribution in accordance with Article 15(4) of the basic act;

(c)
a detailed description and timetable of the project supported;

(d)
if applicable, the part of the tasks and related costs that the final beneficiary intends to subcontract to third parties;

(e)
the agreed forward budget and financing plan for the project, including the fixed percentage of indirect costs as defined in Annex XI regarding the rules on eligibility of expenditure;

(f)
the timetable and provisions for implementation of the agreement (reporting obligations, amendments and termination);

(g)
the operational objectives of the project and the indicators to be used;

(h)
the definition of eligible costs;

(i)
the conditions relating to payment of the grant and bookkeeping requirements;

(j)
the conditions relating to audit trail;

(k)
the relevant provisions relating to data protection;

(l)
the relevant provisions relating to publicity.

(a)
the maximum amount stated in the grant agreement;

(b)
the maximum co-financing resulting from multiplication of the total eligible costs of the project concerned by the percentage laid down in Article 15(4) of the basic act (i.e. 50 % or 75 %); and

(c)
the amount resulting from application of the principle of non-profit, as defined in point I.3.3 of Annex XI.

(a)
administrative and financial verifications of each application for reimbursement sent by the final beneficiaries;

(b)
verifications, at least on a representative sample of the supporting documents covering all headings of the budget annexed to the grant agreement, of the relevance, accuracy and eligibility of the expenses, income and costs covered by assigned income declared by the final beneficiaries;

(c)
on-the-spot verifications of individual projects, at least on a sample representing an appropriate mix of types and sizes of projects and taking account of any risk factors already identified, in order to achieve reasonable assurance as to the legality and regularity of the underlying transactions, having regard to the level of risk identified by the responsible authority.

(a)
it permits reconciliation of the amounts certified to the Commission with the detailed accounting records and supporting documents held by the certifying authority, responsible authority, delegated authorities and final beneficiaries on projects co-financed under the Fund;

(b)
it permits verification of payment of the public contribution to the final beneficiary, of allocation and transfer of the Community funding granted under the Fund and of the sources of co-financing of the project;

(c)
it permits verification of application of the selection criteria established for the annual programme;

(d)
it contains in respect of each project, as appropriate, the technical specifications and financing plan, documents concerning grant approval, documents relating to public procurement procedures and reports on the verifications and audits carried out.

(a)
include an appropriate mix of types and sizes of projects;

(b)
take account of any risk factors which have been identified by national or Community controls and the cost-benefit aspects of the verifications.

(a)
the project meets the selection criteria for the annual programme, has been implemented in accordance with the grant agreement and fulfils any applicable conditions concerning its functionality and use or the objectives to be attained;

(b)
the expenditure declared corresponds to the accounting records and supporting documents held by the final beneficiary and/or by the partners in the project, and those records correspond to the supporting documents kept by the responsible authority or any delegated body;

(c)
the items of expenditure correspond to the eligibility requirements set out in Annex XI, to the requirements specified during the national selection procedure, to the terms of the grant agreement and to the works actually carried out and, where appropriate, to other Community and national rules;

(d)
the use or intended use of the project is consistent with the objectives, action or measures set out in Articles 2, 3, 4, 5 and 17 of the basic act and, where appropriate, covers the target population;

(e)
the public or private contribution has been paid to the final beneficiary in accordance with Article 15(2) of the basic act;

(f)
there is an adequate audit trail;

(g)
there are no conflicts of interest and good value for money has been achieved, in particular in cases where the responsible authority acts as executing body of the project.

(a)
when submitting the draft annual programme, report whether changes have been made to the management and control systems;

(b)
notify the Commission of any substantial change at the latest once any such change has taken effect;

(c)
at the request of the Commission, provide a revised description in the event of multiple substantial changes.

(a)
the Fund, the annual programme and the project concerned;

(b)
the provision which has been infringed;

(c)
the date and the source of the first information leading to suspicion that an irregularity has been committed;

(d)
the practices employed in committing the irregularity;

(e)
where appropriate, whether the practice gives rise to a suspicion of fraud;

(f)
the manner in which the irregularity was discovered;

(g)
the amount of the Community contribution concerned.

(a)
cases where the irregularities relate to amounts of less than 10 000 euros chargeable to the general budget of the European Communities;

(b)
cases where the irregularity consists solely of failure to implement, in whole or in part, a project included in the annual programme owing to the bankruptcy of the final beneficiary;

(c)
cases brought to the attention of the responsible authority by the final beneficiary voluntarily and before detection by the responsible authority, whether before or after payment of the public contribution;

(d)
cases detected and corrected by the responsible authority before any payment of the public contribution to the final beneficiary and before inclusion of the expenditure concerned in a declaration of expenditure submitted to the Commission.

(a)
where appropriate, the other Member States and third countries involved;

(b)
the period during which, or the moment at which, the irregularity was committed;

(c)
the national authorities or bodies which drew up the official report on the irregularity and the authorities responsible for the administrative or judicial follow-up;

(d)
the date on which the primary administrative or judicial finding on the irregularity was established;

(e)
the identity of the natural and legal persons involved or of any other participating entities, except where this information is irrelevant for the purposes of combating irregularities, given the nature of the irregularity concerned;

(f)
the total budget and the public contribution approved for the project and the distribution of its co-financing between the Community and national contributions;

(g)
the amount of the public contribution affected by the irregularity and the corresponding Community contribution at risk;

(h)
where no payment of the public contribution referred to under point (g) has been made to the persons or other entities identified, the amounts which would have been unduly paid had the irregularity not been identified;

(i)
the suspension of payments, where applicable, and the possibilities of recovery;

(j)
the nature of the irregular expenditure.

(a)
any interim measures taken by Member States to safeguard recovery of sums unduly paid;

(b)
any judicial and administrative procedures instituted with a view to recovering sums unduly paid and to imposing sanctions;

(c)
the reasons for any abandonment of recovery procedures;

(d)
the reasons for any abandonment of criminal prosecutions.

(a)
the conditions of eligibility to be met in order to qualify for financing under an annual programme;

(b)
a description of the procedures for examining applications for funding and of the time periods involved;

(c)
the criteria for selecting the projects to be financed;

(d)
the contacts who can provide information on the annual programmes.

(a)
at least one information activity a year, presenting, as of 2008, the launch of the multiannual programme or the achievements of the annual programme(s);

(b)
annual publication, at least on a website, of the list of final beneficiaries, the names of the projects and the amount of public and Community funding allocated to them. Individuals belonging to the target groups defined in Article 7 of the basic act shall not be named. The address of the website shall be communicated to the Commission.

(a)
the total Community contribution to the project exceeds 100 000 euros; and

(b)
the operation consists of purchasing a physical object or of financing infrastructure or construction projects.

1)
the emblem of the European Union, in accordance with the graphic standards indicated in Annex X, and a reference to the European Union;

2)
a reference to the Fund;

3)
a statement chosen by the responsible authority, highlighting the added value of the contribution from the Community.

ANNEX I
Model description of management and control systems
152

ANNEX II
Model multiannual programme
168

ANNEX III
Model annual programme
170

ANNEX IV
Model progress report on implementation of the annual programme
172

A.
Technical report
172

B.
Request for the second pre-financing payment
174

ANNEX V
Model final report on implementation of the annual programme
176

A.
Technical report
176

B.
Request for payment of the balance/Statement of reimbursement
181

ANNEX VI
Model audit strategy
182

Annex(es) to the audit strategy: Annual plans
183

ANNEX VII
Model report by the audit authority
184

A.
Annual audit report
184

B.
Opinion on the functioning of the management and control systems
185

C.
Validation of the payment request
187

ANNEX VIII
Model declaration of expenditure for the second pre-financing
189

ANNEX IX
Model declaration of expenditure for payment of the balance
190

ANNEX X
Instructions concerning the emblem and definition of the standard colours
191

ANNEX XI
Rules on the eligibility of expenditure — return fund
193


Initial version


Revised version (number, date dd/mm/year) following dialogue with the Commission


Version revised for other reasons

1.1.
General information on the designated authorities

1.1.1.
Short description of the choices made on the designation of the different authorities

1.1.2.
Indication of whether these management and control systems are operationalIf not, indication of the date when they will be operational

1.1.3.
Indication of whether these management and control systems have been accredited by the Commission for other Community financial instruments (if applicable)

1.2.
Organisation chart(s) of the entire body(-ies) within which the designated authorities are functioning

1.3.
Responsible authority

1.3.1.
The date and form of the formal designation of the responsible authority

1.3.2.
Legal status of the responsible authority

1.3.3.
Specification of the functions carried out directly by the responsible authority and (if applicable and/or foreseen) by other bodies under the responsibility of the responsible authority (outsourcing of tasks, excluding the tasks entrusted to the delegated authority(ies) under point 1.4)

1.3.4.
Organisation chart and specification of the functions of the units (including the indicative number of posts allocated)

1.3.5.
Information whether the responsible authority can also act as executing body for the projects co-financed by the Fund

1.3.6.
If the responsible authority is the same for more than one of the four Funds, a description of the common functions and systems

1.4.
The delegated authority(ies)

1.4.1.
The reasons for establishing any delegated authority

1.4.2.
The date and form of the formal designation of the delegated authority(ies)

1.4.3.
Legal status of the delegated authority(ies)

1.4.4.
Specification of the functions carried out directly by the delegated authority(ies) and (if applicable and/or foreseen) by other bodies under the responsibility of the delegated authority(ies) (outsourcing of tasks)

1.4.5.
Organisation chart and specification of the functions of the units (including indicative number of posts allocated)

1.4.6.
Information whether delegated authority(ies) can also act as executing body for the projects co-financed by the Fund

1.4.7.
If the delegated authority(ies) is (are) the same for more than one of the four Funds, a description of the common functions and systems

1.5.
Certifying authority

1.5.1.
The date and form of the formal designation of the certifying authority

1.5.2.
Legal status of the certifying authority

1.5.3.
Specification of the functions carried out directly by the certifying authority and (if applicable and/or foreseen) by other bodies under the responsibility of the certifying authority (outsourcing of tasks)

1.5.4.
Organisation chart and specification of the functions of the units (including indicative number of posts allocated)

1.5.5.
If the certifying authority is the same for more than one of the four Funds, a description of the common functions and systems

1.6.
Audit authority

1.6.1.
The date and form of the formal designation of the audit authority

1.6.2.
Legal status of the audit authority

1.6.3.
Specification of the functions carried out directly by the audit authority and (if applicable and/or foreseen) by other bodies under the responsibility of the audit authority (outsourcing of tasks)

1.6.4.
Organisation chart and specification of the functions of the units (including indicative number of posts allocated)

1.6.5.
Staff qualifications for the audit authority and (if applicable and/or foreseen) of the other bodies expected to carry out audit work (outsourcing of tasks)

1.6.6.
If the audit authority is the same for more than one of the four Funds, a description of the common functions and systems

1.6.7.
If a responsible authority can also act as executing body for the projects co-financed by the Fund, a description of arrangements ensuring the independent position of the audit authority in accordance with article 8

2.1.Designation and supervision of the designated authorities
2.1.
Designation and supervision of the designated authorities

2.1.
Designation and supervision of the designated authorities

Short description of the process of setting up each of the designated authorities[The description should include all authorities]

Key targets
Achieved?
Comments

1
Rules governing the relations of the Member State with the designated authorities identify the respective responsibilities
Y/N

2
Member State have provided guidance to the designated authorities to ensure sound financial management (through training and/or manuals)
Y/N

3
Each authority will inform their staff of the mission statement of the organisation as well as their job description and expected results
Y/N

4
Steps have been taken to ensure that the different authorities are adequately staffed in terms of numbers, seniority and experience in order to carry out their functions
Y/N

2.1.
Designation and supervision of the designated authorities

2.2.Separation of functions
2.2.
Separation of functions

2.2.
Separation of functions

Short description of the arrangements defined to ensure a proper separation of functions[The description should include all authorities]

Key targets
Achieved?
Comments

1
Rules are defined to ensure a proper separation of functions between actors within the responsible authority for the signature of contracts/grant agreements
Y/N

2
Rules are defined to ensure a proper separation of functions between actors within the responsible authority for the initiation, verification and approval of financial transactions
Y/N

3
The audit authority will be functionally independent of the responsible authority and the certifying authority.
Y/N

4
The certifying authority will not be involved in the selection, implementation and financial transactions related to Community resources
Y/N

2.2.
Separation of functions

2.3.Monitoring of delegated authority(ies) — if applicable
2.3.
Monitoring of delegated authority(ies) — if applicable

2.3.
Monitoring of delegated authority(ies) — if applicable

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
The tasks to be delegated are clearly defined
Y/N

2
Procedures are established concerning the delegated tasks and their compliance with the rules defined in the basic act/implementing rules has been checked
Y/N

3
Supervisory controls will take place to ensure that the tasks are carried out according to established procedures
Y/N

2.3.
Monitoring of delegated authority(ies) — if applicable

2.4.Monitoring of other tasks not carried out by the authorities themselves — if applicable
2.4.
Monitoring of other tasks not carried out by the authorities themselves — if applicable

2.4.
Monitoring of other tasks not carried out by the authorities themselves — if applicable

Short description of the process[This description should include all authorities]

Key targets
Achieved?
Comments

1
In case of bodies acting under the responsibility of the responsible authority (and not considered as delegated authorities), supervisory mechanisms are in place to ensure sound financial management
Y/N

2
In case of outsourcing of audit activities and in case of bodies acting under the responsibility of the audit authority, supervisory mechanisms are in place to ensure a common audit methodology and consistency of the audit work
Y/N

3
In case of outsourcing of certifying activities and in case of bodies acting under the responsibility of the certifying authority, supervisory mechanisms are in place to ensure a common approach to certification
Y/N

4
In case of outsourcing to private bodies without a public-service mission, mechanisms are defined to ensure that the tasks which may be entrusted do not include the exercise of public authority or require the use of discretionary powers of judgment
Y/N

2.4.
Monitoring of other tasks not carried out by the authorities themselves — if applicable

3.1.Establishing multi-annual programmes
3.1.
Establishing multi-annual programmes

3.1.
Establishing multi-annual programmes

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
Arrangements are foreseen to ensure the implementation of the principle of partnership in accordance with current national rules and practices
Y/N

2
Procedures are defined to check that the multi-annual programme is consistent with the strategic guidelines and complies with Community law, in particular with Community law aiming at ensuring the free movement of persons in conjunction with the directly related flanking measures with respect to external border controls, asylum and immigration
Y/N

3
The multi-annual programme will be approved by a duly authorised person
Y/N

3.1.
Establishing multi-annual programmes

3.2.Establishing annual programmes
3.2.
Establishing annual programmes

3.2.
Establishing annual programmes

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
Procedures are established to ensure:—consistency between the annual programmes and the multi-annual programme—the eligibility of the actions envisaged in the annual programmes—consistency and complementarity of these actions with other national and Community instruments—the compliance with the rules concerning co-financing percentage—consistency with the priorities/specific priorities stated in the strategic guidelines
—
consistency between the annual programmes and the multi-annual programme
—
the eligibility of the actions envisaged in the annual programmes
—
consistency and complementarity of these actions with other national and Community instruments
—
the compliance with the rules concerning co-financing percentage
—
consistency with the priorities/specific priorities stated in the strategic guidelines
Y/N

—
consistency between the annual programmes and the multi-annual programme

—
the eligibility of the actions envisaged in the annual programmes

—
consistency and complementarity of these actions with other national and Community instruments

—
the compliance with the rules concerning co-financing percentage

—
consistency with the priorities/specific priorities stated in the strategic guidelines

2
Procedures are established to enable the revision of an annual programme in case of duly substantiated emergency situations as described in the basic act, if applicable
Y/N

3
Procedures are established to enable the submission of a revision of an annual programme when required under Article 23(1) of this decision
Y/N

4
Any modification to the financial breakdown of an annual programme and the reasons for it is documented
Y/N

5.
Any modification in the implementation of the annual programme not relating to the financial breakdown (e.g. on nature and timing of the calls for proposals or the scope of technical assistance) and the reason for it is documented
Y/N

3.2.
Establishing annual programmes

—
consistency between the annual programmes and the multi-annual programme

—
the eligibility of the actions envisaged in the annual programmes

—
consistency and complementarity of these actions with other national and Community instruments

—
the compliance with the rules concerning co-financing percentage

—
consistency with the priorities/specific priorities stated in the strategic guidelines

3.3.Establishing the audit strategy and the annual audit plans
3.3.
Establishing the audit strategy and the annual audit plans

3.3.
Establishing the audit strategy and the annual audit plans

Short description of the process[This description concerns the audit authority]

Key targets
Achieved?
Comments

1
Rules are defined to ensure a transparent and appropriate communication from the responsible authority to the audit authority on management procedures implemented and on projects prior to and throughout the programming period
Y/N

2
Procedures are established to define annual audit plans (to be annexed each year to the audit strategy) and to send them to the Commission in time (if applicable)
Y/N

3
The audit strategy and the annual audit plans are approved by a duly authorised person
Y/N

3.3.
Establishing the audit strategy and the annual audit plans

3.4.Responsible authority acting as an executing body — if applicable
3.4.
Responsible authority acting as an executing body — if applicable

3.4.
Responsible authority acting as an executing body — if applicable

Short description of the reasons leading the responsible authority to implement projects directly and the specific arrangements foreseen to strengthen the management and control systems[This description should include all authorities]

Key targets
Achieved?
Comments

1
The justification of the need for the responsible authority to implement projects will be documented and endorsed at the appropriate level
Y/N

2
Specific arrangements are put in place to ensure that the nature and the objectives of the projects comply with the provisions defined for the Fund

3
Specific arrangements are put in place in order to prevent conflict of interest for the projects implemented by the responsible authority
Y/N

4
Specific arrangements are put in place to ensure the principle of value for money is respected in the implementation of projects by the responsible authority
Y/N

5
Procedures are defined to ensure that the contractual terms governing these projects are clear and complete in particular with regard to the financing conditions, the payment terms, the eligibility rules and the obligations regarding operational and financial reporting
Y/N

6
Specific arrangements are put in place in order to ensure that the main functions of the responsible authority as provided for in the basic act are not affected in relation to the projects implemented by the responsible authority
Y/N

7
When the responsible authority acts as an executing body, the audit authority is located in another body than the responsible authority (if not, please describe the additional guarantees put in place to ensure the proper independence of the audit authority)
Y/N

8
The audit strategy will cover the specific risks which may be related to the implementation of projects by the responsible authority
Y/N

3.4.
Responsible authority acting as an executing body — if applicable

3.5.Selection and implementation of the projects (Responsible authority acting as an awarding body)
3.5.
Selection and implementation of the projects (Responsible authority acting as an awarding body)

3.5.
Selection and implementation of the projects (Responsible authority acting as an awarding body)

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
In the case of call for proposals (or tenders), rules are defined to ensure open competition and adequate publicity
Y/N

2
Selection criteria will comply with the minimum criteria defined in the basic act
Y/N

3
Procedures are defined for the receipt of proposals (or tenders)
Y/N

4
Procedures are defined to ensure that the proposals (or tenders) are assessed against the predefined rules and criteria in a transparent and non-discriminatory manner
Y/N

5
The award decisions and the contracts/grant agreements will be approved by a duly authorised person
Y/N

6
Procedures are defined to ensure adequate ex-post information on the results of the selection process to the applicants
Y/N

7
Procedures are defined to ensure the monitoring of the implementation of grant agreements/contracts according to the contractual terms
Y/N

3.5.
Selection and implementation of the projects (Responsible authority acting as an awarding body)

3.6.Monitoring of the projects implemented by the final beneficiaries
3.6.
Monitoring of the projects implemented by the final beneficiaries

3.6.
Monitoring of the projects implemented by the final beneficiaries

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
Key operational and financial indicators will be established, monitored and communicated to the responsible authority for each project
Y/N

2
On-the-spot verifications by the responsible authority are foreseen to allow monitoring (of both the operational and financial aspects) of the projects
Y/N

3
The responsible authority will ensure that final beneficiaries make use of an appropriate accounting system in computerised form
Y/N

4
The responsible authority will ensure that final beneficiaries implement the provisions on the visibility of the EU funding
Y/N

3.6.
Monitoring of the projects implemented by the final beneficiaries

3.7.Financial management of the project
3.7.
Financial management of the project

3.7.
Financial management of the project

Short description of the process[involves the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
Financial transactions will be approved by duly authorised persons
Y/N

2
Prior to making any payments/recoveries, verifications will be carried out in particular in order to monitor:—the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)—that products and/or services co-financed by the project have actually been delivered—the accuracy, completeness and effective payment of other contributions received from public or private resources—that the results of any audit activity have been taken into account
—
the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)
—
that products and/or services co-financed by the project have actually been delivered
—
the accuracy, completeness and effective payment of other contributions received from public or private resources
—
that the results of any audit activity have been taken into account
Y/N

—
the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)

—
that products and/or services co-financed by the project have actually been delivered

—
the accuracy, completeness and effective payment of other contributions received from public or private resources

—
that the results of any audit activity have been taken into account

3
Verifications will be carried out in order to have a reasonable assurance of the legality and regularity of the underlying transactions
Y/N

4
Supervisory controls will be carried out throughout the programming period to ensure that the established financial procedures are respected.
Y/N

5
Verifications will be performed on the complementarity with other Community financial programmes in order to avoid double funding
Y/N

3.7.
Financial management of the project

—
the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)

—
that products and/or services co-financed by the project have actually been delivered

—
the accuracy, completeness and effective payment of other contributions received from public or private resources

—
that the results of any audit activity have been taken into account

3.8.Irregularities, corrections and recoveries
3.8.
Irregularities, corrections and recoveries

3.8.
Irregularities, corrections and recoveries

Short description of the process[This description should include the responsible authority, the delegated authority(ies) and the certifying authority]

Key targets
Achieved?
Comments

1
Definitions of irregularities are established and comply with the Community requirements
Y/N

2
Mechanisms are in place to ensure that irregularities can be detected in due time and immediate corrective measures are taken
Y/N

3
Procedures are in place to ensure that the Commission is kept informed of irregularities detected, and if appropriate, of any corrective measure taken in accordance with the obligations set out in this decision
Y/N

4
Procedures are in place to ensure a proper follow-up of recovery orders issued and, if applicable, of default interest
Y/N

5
In case recovery orders cannot be cashed in, causes will be identified to evaluate whether Member States should reimburse the funds to the Community Budget or not
Y/N

3.8.
Irregularities, corrections and recoveries

3.9.Preparation and implementation of audit missions
3.9.
Preparation and implementation of audit missions

3.9.
Preparation and implementation of audit missions

Short description of the process[This description should include the audit authority and, as potential auditees, the responsible authority and the delegated authority(ies) and, as recipient of the conclusions, the certifying authority]

Key targets
Achieved?
Comments

1
The audit practice is in line with internationally accepted standards
Y/N

2
An audit manual is established for use by the auditors on the basis of the requirements defined in the basic act
Y/N

3
Audits will be carried out to verify the effective functioning of the management and control systems
Y/N

4
The checks to be carried on the eligible expenditure will be based on an appropriate sample, and will consist of at least 10 % of eligible expenses
Y/N

5
The verifications on eligible expenses will verify at least the compliance, effectiveness and efficiency of the following elements: selection procedure, objectives of the project, reality of the achievements, eligibility of the expenses, valid supporting documents for the expenses, national co-financing, audit trail
Y/N

6
A follow-up of earlier recommendations will take place on a regular basis
Y/N

7
The projects implemented by the responsible authority will be subject to robust scrutiny
Y/N

3.9.
Preparation and implementation of audit missions

3.10.Audit report on annual programmes and related declarations
3.10.
Audit report on annual programmes and related declarations

3.10.
Audit report on annual programmes and related declarations

Short description of the process[This description should involved the audit authority]

Key targets
Achieved?
Comments

1
Procedures are established to consolidate the conclusions of the systems audit and the audit of projects for each annual programme
Y/N

2
Checks will be performed to assess the validity of the requests for payment
Y/N

3
Further examination will be launched in case of systemic errors or errors over the materiality threshold are detected
Y/N

4
The report and the related declarations will be approved by a duly authorised person
Y/N

3.10.
Audit report on annual programmes and related declarations

3.11.Certification of expenditure
3.11.
Certification of expenditure

3.11.
Certification of expenditure

Short description of the process[involves primarily the certifying authority but also the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
Procedures are established to ensure that the necessary information is received from the responsible authority for the purpose of certification
Y/N

2
Procedures are established to ensure that the audit report on each annual programme and the related declarations are received from the audit authority
Y/N

3
Procedures are established to ensure that recoveries are taken into account for the final declaration of expenditure and to follow on-going legal proceedings or administrative appeals with suspensive effect regarding recoveries
Y/N

4
Verifications will be performed to ensure the accuracy and completeness of the declaration of expenditure (in particular, on any interest generated by the pre-financing received from the Commission as well as its effective use as national contribution)
Y/N

5
In case of local currency, the methods used for the calculation in EUR comply with the rules defined by the Commission
Y/N

3.11.
Certification of expenditure

3.12.Evaluation of the programme
3.12.
Evaluation of the programme

3.12.
Evaluation of the programme

Short description of the process[involves the responsible authority and the delegated authority(ies)]

Key targets
Achieved?
Comments

1
The guidance documents from the Commission on evaluations are disseminated widely and made available to all potential final beneficiaries and other interested parties
Y/N

2
The key operational and financial indicators provided by the final beneficiaries to measure the achievements of the project will be recorded
Y/N

3
The responsible authority (and/or delegated authorities) will ensure that the indicators provided are appropriate to measure the outcome and results of each project
Y/N

4
Procedures are in place to ensure that the necessary evaluation will be carried out as required by the basic act
Y/N

3.12.
Evaluation of the programme

4.1.Documentation on the procedures
4.1.
Documentation on the procedures

4.1.
Documentation on the procedures

Short description of the process[involves all authorities]

Key targets
Achieved?
Comments

1
The authorities will ensure that the established procedures referred to in Article 7 of this decision comply with national and Community law (e.g. public procurement, accounting rules, etc.)
Y/N

2
The procedures are approved by a duly authorised person
Y/N

3
The established procedures set out clear instructions concerning each of the main operations and explain the decision-making circuits concerning the performance of functions
Y/N

4
Arrangements are in place to ensure that all relevant staff is informed of the established procedures
Y/N

5
Where appropriate, these procedures include the use of check-lists summarising the key controls to be performed
Y/N

6
Arrangements are in place to ensure the protection of personal data
Y/N

4.1.
Documentation on the procedures

4.2.Accounting and book keeping
4.2.
Accounting and book keeping

4.2.
Accounting and book keeping

Short description of the process[involves the responsible authority, the delegated authority(ies) and the certifying authority]

Key targets
Achieved?
Comments

1
Arrangements are in place to ensure that accounting data is complete, reliable and correct. In particular, the accounting system will allow:—a full traceability of the Community resources at the level of the final beneficiaries and projects—the identification of any interest generated by the pre-financing received from the Commission—the identification of recovery orders issued and if applicable, whether they have been cashed
—
a full traceability of the Community resources at the level of the final beneficiaries and projects
—
the identification of any interest generated by the pre-financing received from the Commission
—
the identification of recovery orders issued and if applicable, whether they have been cashed
Y/N

—
a full traceability of the Community resources at the level of the final beneficiaries and projects

—
the identification of any interest generated by the pre-financing received from the Commission

—
the identification of recovery orders issued and if applicable, whether they have been cashed

2
The accounting and financial reporting system complies with the national data protection legislation
Y/N

3
The accounting and financial reporting system to be used will be in computerised form
Y/N

4
A back-up system exists to guarantee the continuity of operations should the need arise
Y/N

5
In case of local currency, the methods used for the calculation in Euro comply with the rules defined by the Commission
Y/N

4.2.
Accounting and book keeping

—
a full traceability of the Community resources at the level of the final beneficiaries and projects

—
the identification of any interest generated by the pre-financing received from the Commission

—
the identification of recovery orders issued and if applicable, whether they have been cashed

4.3.Reporting to the Commission
4.3.
Reporting to the Commission

4.3.
Reporting to the Commission

Short description of the process[involves all authorities]

Key targets
Achieved?
Comments

1
Reporting obligations have been identified as well as the implications for resources
Y/N

2
The established procedures allow proper, timely and complete input by the designated authorities
Y/N

3
Reports are approved by a duly authorised person
Y/N

4.3.
Reporting to the Commission

4.4.Audit trail
4.4.
Audit trail

4.4.
Audit trail

Short description of the process[involves all authorities]

Where are the following documents kept?
Body/Unit in charge
How long for?

Description of the management and control systems including manual(s) of procedures

Audit strategy

National multi-annual programme and possible revisions

National annual programmes and possible revisions

European Commission Decisions on multi-annual and annual programmes

Calls for proposals/Calls for tender

Applicant files/Contract files

Administrative, technical and financial analysis of proposals/tenders received (evaluation grids) and evaluation committee reports

Funding decisions or rejections

Project funding agreements

Financial commitment decisions for each of the projects

Progress reports and final reports submitted by funding recipients

Financial reports and payment applications submitted by funded Project

Supporting documents for expenditure and revenue for funded Project

Payments/recovery authorisations for funding (proof of verifications performed)

Payments/recovery orders for funding

Proof of payments/recovery of funding

Documentation related to the sampling methodology for the audit activity

Reports on audits carried out on projects

Reports on audits carried out at national level on management and control systems

Audit reports on annual programmes

Audit opinions on the management and control systems

Audit declarations on the validity of the requests for payment

Requests for payment sent to the European Commission

Certification of expenditure sent to the European Commission

Progress implementation reports sent to the European Commission

Final implementation reports sent to the European Commission

Proof of payment received from the European Commission

Evaluation reports sent to the European Commission

4.4.
Audit trail

Authority
Declaration
Date and signature

Responsible Authority
I certify the accuracy and completeness of the information about the identification and internal control systems of the Responsible Authority
Name:Function:Date:

signature

Certifying Authority
I certify the accuracy and completeness of the information about the identification and internal control systems of the Certifying Authority
Name:Function:Date:

signature

Audit Authority
I certify the accuracy and completeness of the information about the identification and internal control systems of the Audit AuthorityandI can confirm that what has been described provides a reliable picture of all the management and control systems
Name:Function:Date:

signature


Initial version


Revised version (number, date dd/mm/year) following dialogue with the Commission


Version revised in the light of evaluations and/or following implementation difficulties


Version revised following the revision of the strategic guidelines

1.1.
The national situation and the migratory flows affecting it

1.2.
The measures undertaken by the Member State so far

1.3.
The total national resources allocated

2.1.
The requirements in the Member State in relation to the baseline situation

2.2.
The operational objectives of the Member State designed to meet its requirements

3.1.
Priority 1

3.2.
Priority 2

3.3.
Etc.Breakdown when presenting the information on the priorities chosena)The objective(s) of the strategy and examples of key actionsb)Description of target(s) concerned and the indicator(s) usedc)If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority
a)
The objective(s) of the strategy and examples of key actions
b)
Description of target(s) concerned and the indicator(s) used
c)
If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority

a)
The objective(s) of the strategy and examples of key actions

b)
Description of target(s) concerned and the indicator(s) used

c)
If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority

a)
The objective(s) of the strategy and examples of key actions

b)
Description of target(s) concerned and the indicator(s) used

c)
If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority

4.1.
Priority 1

4.2.
Priority 2

4.3.
Etc.

5.1.
The publication of the programme

5.2.
The approach chosen to implement the principle of partnership

6.1.
Community Contribution

6.1.1.
TableMultiannual Programme — Draft Financial PlanTable 1Community ContributionMember State: […]Fund: […](in 000’ EUR — current prices)200820092010201120122013TotalPriority 1: […]0Priority 2: […]0Priority 3: […]0Priority …: […]0Technical Assistance0Total0000000
Multiannual Programme — Draft Financial Plan
Table 1Community Contribution
Member State: […]
Fund: […]
(in 000’ EUR — current prices)
2008
2009
2010
2011
2012
2013
Total
Priority 1: […]

0
Priority 2: […]

0
Priority 3: […]

0
Priority …: […]

0
Technical Assistance

0
Total
0
0
0
0
0
0
0

Multiannual Programme — Draft Financial Plan

Table 1Community Contribution

Member State: […]

Fund: […]

(in 000’ EUR — current prices)
2008
2009
2010
2011
2012
2013
Total

Priority 1: […]

0

Priority 2: […]

0

Priority 3: […]

0

Priority …: […]

0

Technical Assistance

0

Total
0
0
0
0
0
0
0

Multiannual Programme — Draft Financial Plan

Table 1Community Contribution

Member State: […]

Fund: […]

(in 000’ EUR — current prices)
2008
2009
2010
2011
2012
2013
Total

Priority 1: […]

0

Priority 2: […]

0

Priority 3: […]

0

Priority …: […]

0

Technical Assistance

0

Total
0
0
0
0
0
0
0

6.1.2.
Comments on the figures/trends

6.2.
Overall financing plan

6.2.1.
TableMultiannual Programme — Draft Financial PlanTable 2Overall Financing PlanMember State: […]Fund: […](in 000’ EUR — current prices)200820092010201120122013TotalCommunity ContributionPublic cofinancingPrivate cofinancingTotal0000000% Community Contribution%%%%%%%
Multiannual Programme — Draft Financial Plan
Table 2Overall Financing Plan
Member State: […]
Fund: […]
(in 000’ EUR — current prices)
2008
2009
2010
2011
2012
2013
Total
Community Contribution

Public cofinancing

Private cofinancing

Total
0
0
0
0
0
0
0
% Community Contribution
%
%
%
%
%
%
%

Multiannual Programme — Draft Financial Plan

Table 2Overall Financing Plan

Member State: […]

Fund: […]

(in 000’ EUR — current prices)
2008
2009
2010
2011
2012
2013
Total

Community Contribution

Public cofinancing

Private cofinancing

Total
0
0
0
0
0
0
0

% Community Contribution
%
%
%
%
%
%
%

Multiannual Programme — Draft Financial Plan

Table 2Overall Financing Plan

Member State: […]

Fund: […]

(in 000’ EUR — current prices)
2008
2009
2010
2011
2012
2013
Total

Community Contribution

Public cofinancing

Private cofinancing

Total
0
0
0
0
0
0
0

% Community Contribution
%
%
%
%
%
%
%

6.2.2.
Comments on the figures/trends[signature of the responsible person]


Initial version


Revised version (number, date dd/mm/year) following dialogue with the Commission


Version revised for other reasons

1.
GENERAL RULES FOR SELECTION OF PROJECTS TO BE FINANCED UNDER THE PROGRAMME

2.
CHANGES IN THE MANAGEMENT AND CONTROL SYSTEMS (if appropriate)

3.1.
Actions implementing priority 1

3.2.
Actions implementing priority 2

3.3.
Etc.

1.
Purpose and scope of the action

2.
Expected grant recipients

3.
Where appropriate, justification regarding project(s) implemented directly by the responsible authority acting as an executing body

4.
Expected quantified results and indicators to be used

5.
Visibility of EC funding

6.
Complementarity with similar actions financed by other EC instruments, if appropriate

7.
Financial information

4.1.
Purpose of the technical assistance

4.2.
Expected quantified results

4.3.
Visibility of EC funding

Annual Programme — Draft Financial Plan

Table 1Overview table

Member State: […]

Annual programme concerned: […]

Fund: […]

Ref. priority
Ref. specific priority(1)
Community Contribution
Public Allocation
Private Allocation
Total
% CE
Share of total

(all figures in EUR)

(a)
(b)
(c)
(d = a + b + c)
(e = a/d)
(d/total d)

Action 1: […]

0

Action 2: […]

0

Action 3: […]

0

Action 4: […]

0

Action 5: […]

0

Action …: […]

0

Action N: […]

0

Technical assistance

0

Other operations(2)

0

Total

0
0
0
0
%
100 %

1.1.
Time table for the implementation of the programme

1.2.
Description of the organisation of the selection of projects and tenders and their outcomes

1.3.
Progress made in implementing the actions of the programme under the priorities chosen

1.3.1.
Actions implementing Priority 1

1.3.2.
Actions implementing Priority 2

1.4.
Use of technical assistance

1.5.
Problems encountered and measures taken

Progress report on the implementation of the annual programme

Table 1Financial report

Member State: […]

Annual programme concerned: […]

Situation at: [day/month/year]

Pre-financing payment(s) received from EC: [amount]

(all figures in EUR)
Ref. priority
Ref. specificpriority(1)
Programmed MS
Committed at the level of the MS
EC contributionpaid by MS to final beneficiaries
Total eligible costs incurred to date by final beneficiaries

Total programmed costs
EC contribution
% EC contribution
Total eligible costs
EC contribution
% EC contribution

(a)
(b)
(c = b/a)
(d)
(e)
(f = e/d)

Action 1: […]

Action 2: […]

Action 3: […]

Action 4: […]

Action 5: […]

Action N: […]

Technical assistance

Other operations(2)

Total

0
0
0
0
0
0
0
0

↓
↓

> 60 % of pre-financing payment(s) received?

Yes/No
Yes/No

Notification of new irregularities(3)?
No
Yes (if Yes, fill in table 2)

Progress report on the implementation of the annual programme

Table 2Initial reporting on irregularity

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference
Annual Programme
Project
Provision infringed
Type of irregularity
Date/Source of first information
Method of detection
Possibility of fraud (Y/N)
Amount concerned in EUR (Community contribution)

Follow-up of previous irregularities?
No
Yes (if Yes, fill in table 3)

Progress report on the implementation of the annual programme

Table 3Reporting of follow-up of irregularities

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference
Annual Programme
Project
Provision infringed
Amount concerned (EC contrib.) in EUR
Follow-up actions
Recovery order (amounts in EUR)
Cancellation of EC contrib.

Issued
Paid
Default interest
Waived

EUR(4)

a)
a progress report on implementation of the annual programme has been submitted to the Commission or is attached;

b)
a certified declaration of expenditure drawn up accounting for at least 60 % of the amount of the first pre-financing has been submitted or is attached;

c)
the annual programme has been implemented according to the principle of sound financial management and there is a reasonable assurance that the underlying transactions are legal and regular;

d)
there is no reasoned opinion by the Commission in respect of an infringement under Article 226 of the Treaty, as regards the actions for which the expenditure is declared in the request.

Authority responsible for receiving payments

Bank

Bank account No

Account holder (if not the same as the authority responsible for receiving payments)

Date
Name in capital letters, stamp, position and signature of competent authority

1.1.
Time table on the implementation of the programme

1.2.
Update from the progress report on the description of the organisation of the selection of projects and tenders and their outcomes, if appropriate

1.3.
The achievements in implementing the actions of the programme under the priorities chosen

1.3.1.
Actions implementing priority 1

1.3.2.
Actions implementing priority 2

1.3.3.
Etc.

1.
Purpose and scope of the action

2.
Changes from the programme as approved by the Commission (if appropriate)

3.
Monitoring activities undertaken during and after the implementation

4.
Actual results

5.
Assessment of the actual results in comparison to the targets and indicators set in the programme

1.4.
The results of the technical assistance

1.5.
Problems encountered and measures taken on the implementation of the programme

1.6
Procedures applied when the responsible authority implemented project(s) directly acting as an executing body (if appropriate)

1.7.
Coherence and complementarity with other instruments

2.
ASSESSMENT OF THE PROGRESS MADE IN IMPLEMENTING THE MULTI-ANNUAL PROGRAMME

3.1.
Measures taken to make the multi-annual(1)and annual programme public

3.2.
Implementation of the visibility principle

Final report on the implementation of the annual programme

Table 1Detailed financial report

Member State: […]

Annual programme concerned: […]

Priority/other actions: […]

Situation at: [day/month/year]

(all figures in EUR)
Programmed by MS
Committed at the level of the MS
Actual figures accepted by the Responsible Authority(costs incurred by the beneficiaries and final EC contribution)

Actions
Projects
Ref. priority
Ref. specific priority(2)
Total programmed costs
EC contribution
% EC contribution
Total eligible costs
EC contribution
% EC contribution
Total eligible costs
EC contribution due
% EC contribution
EC contribution paid
EC still to pay/to recover by the RA

(a)
(b)
(c = b/a)
(d)
(e)
(f = e/d)
(g)
(h)
(i = h/g)
(j)
(k = h – j)

Action 1: […]
project 1: […]

project N: […]

Total Action 1

Action …: […]
project 1: […]

project N: […]

Total Action…: […]

Action N: […]
project 1: […]

project N: […]

Total Action N

Technical assistance

Other operations(2)

Total
0
0
0 %
0
0
0 %
0
0
0 %
0
0

4.1.
List of all pending recoveries at 30 June of the year N + 2 (N = year of this annual programme)Final report on the implementation of the annual programmeTable 2List of pending recovery ordersMember State: […]Fund: […]Situation at: [day/month/year]ReferenceAnnual ProgrammeProjectTotal amount to be recoveredEC contribution to be recoveredDeduced from the related financial report (Y/N)Reasons for recovery
Final report on the implementation of the annual programme
Table 2List of pending recovery orders
Member State: […]
Fund: […]
Situation at: [day/month/year]
Reference
Annual Programme
Project
Total amount to be recovered
EC contribution to be recovered
Deduced from the related financial report (Y/N)
Reasons for recovery

Final report on the implementation of the annual programme

Table 2List of pending recovery orders

Member State: […]

Fund: […]

Situation at: [day/month/year]

Reference
Annual Programme
Project
Total amount to be recovered
EC contribution to be recovered
Deduced from the related financial report (Y/N)
Reasons for recovery

Final report on the implementation of the annual programme

Table 2List of pending recovery orders

Member State: […]

Fund: […]

Situation at: [day/month/year]

Reference
Annual Programme
Project
Total amount to be recovered
EC contribution to be recovered
Deduced from the related financial report (Y/N)
Reasons for recovery

4.2.
List of recovery ordersnotincluded in the financial reports of the previous annual programmes (if appropriate)Final report on the implementation of the annual programmeTable 3List of recovery orders not already deducted from previous declarations of expenditureMember State: […]Fund: […]Situation at: [day/month/year]ReferenceAnnual ProgrammeProjectTotal amount recoveredEC contribution recoveredDate of recoveryReasons for recovery
Final report on the implementation of the annual programme
Table 3List of recovery orders not already deducted from previous declarations of expenditure
Member State: […]
Fund: […]
Situation at: [day/month/year]
Reference
Annual Programme
Project
Total amount recovered
EC contribution recovered
Date of recovery
Reasons for recovery

Final report on the implementation of the annual programme

Table 3List of recovery orders not already deducted from previous declarations of expenditure

Member State: […]

Fund: […]

Situation at: [day/month/year]

Reference
Annual Programme
Project
Total amount recovered
EC contribution recovered
Date of recovery
Reasons for recovery

Final report on the implementation of the annual programme

Table 3List of recovery orders not already deducted from previous declarations of expenditure

Member State: […]

Fund: […]

Situation at: [day/month/year]

Reference
Annual Programme
Project
Total amount recovered
EC contribution recovered
Date of recovery
Reasons for recovery

Notification of new irregularities(3)?
No
Yes (if Yes, fill in table 4)

Final report on the implementation of the annual programme

Table 4Initial reporting on irregularity

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference
Annual Programme
Project
Provision infringed
Type of irregularity
Date/Source of first information
Method of detection
Possibility of fraud(Y/N)
Amount concerned in EUR (Community contribution)

Follow-up of previous irregularities?
No
Yes (if Yes, fill in table 5)

Final report on the implementation of the annual programme

Table 5Reporting of follow-up of irregularities

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference
Annual Programme
Project
Provision infringed
Amount concerned
Follow-up actions
Recovery order (amounts in €)
Cancellation of EC contrib.

(EC contrib.) in EUR
Issued
Paid
Default interest
Waived

Final report on the implementation of the annual programme

Table 6Report per project

Project reference and title: […]
Priority: […]

Final Beneficiary: […]
Specific priority: […]

Situation at: [day/month/year]
Action: […]

TECHNICAL SUMMARY

Objectives/achievements:

Relevant indicators:

Justification (in case of a specific priority):

FINANCIAL SUMMARY(all figures in EUR)Committed by the responsible authorityRequested by the final beneficiaryAccepted by the responsible authorityEC Contribution paid by the responsible authoritya: Direct Costs1st Pre-financing paymentb: Indirect Costs2nd Pre-financing paymentc: Costs covered by assigned income (if applicable)Final paymenta + b + c: Total Eligible Costs000Recovery orderd: EC contributione: Contribution from final beneficiary and partners (public bodies)of which assigned incomef: Contribution from final beneficiary and partners (non public bodies)g: Contribution from third partiesh: Receipts generated by the projectEC contribution dued + e + f + g + h: Total Income000EC contribution still to pay/to recover% EC Contribution/Total Costs (d/(a + b + c))%%%
(all figures in EUR)
Committed by the responsible authority
Requested by the final beneficiary
Accepted by the responsible authority

EC Contribution paid by the responsible authority
a: Direct Costs

1st Pre-financing payment

b: Indirect Costs

2nd Pre-financing payment

c: Costs covered by assigned income (if applicable)

Final payment

a + b + c: Total Eligible Costs
0
0
0

Recovery order

d: EC contribution

e: Contribution from final beneficiary and partners (public bodies)

of which assigned income

f: Contribution from final beneficiary and partners (non public bodies)

g: Contribution from third parties

h: Receipts generated by the project

EC contribution due

d + e + f + g + h: Total Income
0
0
0

EC contribution still to pay/to recover

% EC Contribution/Total Costs (d/(a + b + c))
%
%
%

(all figures in EUR)
Committed by the responsible authority
Requested by the final beneficiary
Accepted by the responsible authority

EC Contribution paid by the responsible authority

a: Direct Costs

1st Pre-financing payment

b: Indirect Costs

2nd Pre-financing payment

c: Costs covered by assigned income (if applicable)

Final payment

a + b + c: Total Eligible Costs
0
0
0

Recovery order

d: EC contribution

e: Contribution from final beneficiary and partners (public bodies)

of which assigned income

f: Contribution from final beneficiary and partners (non public bodies)

g: Contribution from third parties

h: Receipts generated by the project

EC contribution due

d + e + f + g + h: Total Income
0
0
0

EC contribution still to pay/to recover

% EC Contribution/Total Costs (d/(a + b + c))
%
%
%

(all figures in EUR)
Committed by the responsible authority
Requested by the final beneficiary
Accepted by the responsible authority

EC Contribution paid by the responsible authority

a: Direct Costs

1st Pre-financing payment

b: Indirect Costs

2nd Pre-financing payment

c: Costs covered by assigned income (if applicable)

Final payment

a + b + c: Total Eligible Costs
0
0
0

Recovery order

d: EC contribution

e: Contribution from final beneficiary and partners (public bodies)

of which assigned income

f: Contribution from final beneficiary and partners (non public bodies)

g: Contribution from third parties

h: Receipts generated by the project

EC contribution due

d + e + f + g + h: Total Income
0
0
0

EC contribution still to pay/to recover

% EC Contribution/Total Costs (d/(a + b + c))
%
%
%

—
request payment of the following amount:EUR(4)+[exact figure to two decimal places]OR
EUR(4)
+

EUR(4)
+

EUR(4)
+

—
declare for reimbursement the following amount:EUR(5)—[exact figure to two decimal places]
EUR(5)
—

EUR(5)
—

EUR(5)
—

a)
a final report on implementation of the annual programme has been submitted to the Commission or is attached;

b)
a certified declaration of expenditure has been submitted or is attached;

c)
an annual audit report, an opinion on the functioning of the management and control system and a declaration on the validity of the payment request prepared by the audit authority have been submitted or are attached;

d)
any interest generated by the pre-financing payments has been posted to the annual programme, being regarded as national contribution and has been taken into account in the declaration of expenditure;

e)
the annual programme has been implemented according to the principle of sound financial management and there is a reasonable assurance that the underlying transactions are legal and regular;

f)
there is no reasoned opinion by the Commission in respect of an infringement under Article 226 of the Treaty, as regards the actions for which the expenditure is declared in the request.

Authority responsible for receiving payments

Bank

Bank account No

Account holder (if not the same as the authority responsible for receiving payments)

Date,
Name in capital letters, stamp, position and signature of competent authority

1.1.
Scope of the strategy (Funds covered)

1.2.
Period covered by the strategy

1.3.
Audit standards applied

2.1.
Risk identification and assessment

2.2.
Risk response and residual risk

3.1.
Objectives of the audits

3.2.
Priorities for the audits

4.1.1.
The responsible body/-ies for the audit work

4.1.2.
The authorities to be audited

4.1.3.
Horizontal issues to be covered by the system audits

4.1.4.
Indicative multi-annual plan for system audits (if possible)

4.2.1.
The responsible body/-ies for the audit work

4.2.2.
Description of the sampling methodology

Year 2007

System audits

Funds
Authorities concerned
Processes concerned
Scope of the audit
Man-days
Planning

Audits of projects

Funds
Programme Year
Priority
Project
Final Beneficiary
Total eligible costs of the project
Costs to be audited
Man-days
Planning

1.
CHANGES TO THE AUDIT STRATEGY, WHERE APPLICABLE

2.
MAIN RESULTS OF AUDITS OF THE PREVIOUS YEAR

3.
AUDIT PLAN YEAR 20XX

1.1.
The bodies that have been involved in preparing the report

1.2.
Identification and justification of major changes in the implementation of the audit plans related to the annual programme concerned

1.3.
Summary table of the results of the auditsAudit reportMember State: […]Annual programme concerned: […]Situation at: [day/month/year]System audits closed since last reportFund(s)Authorities concernedProcesses concernedScope of the auditMan-days spentDate of final reportAudits of projects linked to annual programme 20xxFund(s)ProjectFinal BeneficiaryTotal Eligible CostsEligible Costs auditedFinancial correctionError rate(a)(b)(c)(d = c/b)Total000%Total annual programme(e)(f)Coverage rate: (=f/e)
Audit report
Member State: […]
Annual programme concerned: […]
Situation at: [day/month/year]
System audits closed since last report
Fund(s)
Authorities concerned
Processes concerned
Scope of the audit
Man-days spent
Date of final report

Audits of projects linked to annual programme 20xx
Fund(s)
Project
Final Beneficiary
Total Eligible Costs
Eligible Costs audited
Financial correction
Error rate

(a)
(b)
(c)
(d = c/b)

Total
0
0
0
%
Total annual programme
(e)
(f)
Coverage rate: (=f/e)

Audit report

Member State: […]

Annual programme concerned: […]

Situation at: [day/month/year]

System audits closed since last report

Fund(s)
Authorities concerned
Processes concerned
Scope of the audit
Man-days spent
Date of final report

Audits of projects linked to annual programme 20xx

Fund(s)
Project
Final Beneficiary
Total Eligible Costs
Eligible Costs audited
Financial correction
Error rate

(a)
(b)
(c)
(d = c/b)

Total
0
0
0
%

Total annual programme
(e)
(f)
Coverage rate: (=f/e)

Audit report

Member State: […]

Annual programme concerned: […]

Situation at: [day/month/year]

System audits closed since last report

Fund(s)
Authorities concerned
Processes concerned
Scope of the audit
Man-days spent
Date of final report

Audits of projects linked to annual programme 20xx

Fund(s)
Project
Final Beneficiary
Total Eligible Costs
Eligible Costs audited
Financial correction
Error rate

(a)
(b)
(c)
(d = c/b)

Total
0
0
0
%

Total annual programme
(e)
(f)
Coverage rate: (=f/e)

2.1.
The bodies that carried out audits

2.2.
A summary list of the audits carried out

2.3.
The principal findings, recommendations and the conclusions drawn from the audit work for the management and control systems

2.4.
Financial impact of the audit findings

2.5.
Additional work, where appropriate

2.6.
Indication whether any problems identified were considered to be systemic in nature and the measures taken, including a quantification of any financial corrections

2.7.
Information on the follow-up of the audit recommendations

3.1.
The bodies that carried out the audits

3.2.
A summary list of audits carried out and the percentage of expenditure checked in relation to total eligible expenditure declared to the Commission

3.3.
The principal findings, recommendations and conclusions of the audits with regard to the projects implemented

3.4.
The conclusions drawn from the results of the audits with regard to the effectiveness of the management and control system

3.5.
Financial impact of the audit findings

3.6.
Additional work, where appropriate

3.7.
Information on the follow-up of audit recommendations

3.8.
Indication whether any problems identified were considered to be systemic in nature and the measures taken, including a quantification of any financial corrections

4.1.
Information on the follow-up to previous system audit recommendations

4.2.
Information on results of audits of actions of a systemic nature from previous annual programmes[signature of the responsible person]

a)
[…]

b)
[…]

c)
Etc.

a)
[…]

b)
[…]

c)
Etc.

a)
[…]

b)
[…]

c)
Etc.

a)
[…]

b)
[…]

c)
Etc.

a)
[…]

b)
[…]

c)
Etc.

a)
[…]

b)
[…]

c)
Etc.

EUR(1)

1)
the declaration of expenditure is accurate, results from reliable accounting systems and is based on verifiable supporting documents;

2)
the expenditure declared complies with the applicable Community and national rules and has been incurred in respect of actions selected for funding in accordance with the criteria applicable to the annual programme and the applicable Community and national rules, in particular with public procurement rules;

3)
for the purpose of certification, I have received adequate information from the Responsible Authority on the procedures and verifications carried out in relation to expenditure included in statements of expenditure;

4)
the declaration of expenditure and the request for the second pre-financing payment take account, where applicable, of any amounts recovered and of any interest received under the annual programme.

Date
Name in capital letters, stamp, position and signature of certifying authority

EUR(1)

1)
the declaration of expenditure is accurate, results from reliable accounting systems and is based on verifiable supporting documents;

2)
the expenditure declared complies with the applicable Community and national rules and has been incurred in respect of actions selected for funding in accordance with the criteria applicable to the annual programme and the applicable Community and national rules, in particular with public procurement rules;

3)
I have a reasonable assurance that the underlying transactions are legal and regular;

4)
for the purpose of certification, I have received adequate information from the Responsible Authority on the procedures and verifications carried out in relation to expenditure included in statements of expenditure;

5)
the results of all audits carried out by or under the responsibility of the audit authority have been duly taken into account;

6)
the declaration of expenditure and the request for the balance payment take account, where applicable, of any amounts recovered and of any interest received under the annual programme.

Date
Name in capital letters, stamp, position and signature of certifying authority

1.
In accordance with the basic act, for it to be eligible, expenditure must be:a)within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act;b)within the eligible actions and measures listed in Articles 4 and 5 of the basic act;c)needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission;d)reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness;e)incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project;f)linked to the target groups defined in Article 7 of the basic act;g)incurred in accordance with the specific provisions in the grant agreement.
a)
within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act;
b)
within the eligible actions and measures listed in Articles 4 and 5 of the basic act;
c)
needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission;
d)
reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness;
e)
incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project;
f)
linked to the target groups defined in Article 7 of the basic act;
g)
incurred in accordance with the specific provisions in the grant agreement.

a)
within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act;

b)
within the eligible actions and measures listed in Articles 4 and 5 of the basic act;

c)
needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission;

d)
reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness;

e)
incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project;

f)
linked to the target groups defined in Article 7 of the basic act;

g)
incurred in accordance with the specific provisions in the grant agreement.

a)
within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act;

b)
within the eligible actions and measures listed in Articles 4 and 5 of the basic act;

c)
needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission;

d)
reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness;

e)
incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project;

f)
linked to the target groups defined in Article 7 of the basic act;

g)
incurred in accordance with the specific provisions in the grant agreement.

2.
In the case of multiannual actions within the meaning of Article 15(6) of the basic act, only the part of the action co-financed by an annual programme is considered to be a project for the application of these eligibility rules.

3.
Projects supported by the Fund shall not be financed by other sources covered by the Community budget. Projects supported by the Fund shall be co-financed by public or private sources.

Expenditure
Income

+Direct costs (DC)+Indirect costs(fixed percentage of DC, defined in the grant agreement)+Costs covered by assigned income (if applicable)
+
Direct costs (DC)
+
Indirect costs(fixed percentage of DC, defined in the grant agreement)
+
Costs covered by assigned income (if applicable)
+contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision)+contribution from the final beneficiary and the partners in the project1(1)+contribution from third parties+receipts generated by the project
+
contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision)
+
contribution from the final beneficiary and the partners in the project1(1)
+
contribution from third parties
+
receipts generated by the project

+
Direct costs (DC)

+
Indirect costs(fixed percentage of DC, defined in the grant agreement)

+
Costs covered by assigned income (if applicable)

+
contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision)

+
contribution from the final beneficiary and the partners in the project1(1)

+
contribution from third parties

+
receipts generated by the project

= Total Eligible Cost(TEC)
= Total Income

+
Direct costs (DC)

+
Indirect costs(fixed percentage of DC, defined in the grant agreement)

+
Costs covered by assigned income (if applicable)

+
contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision)

+
contribution from the final beneficiary and the partners in the project1(1)

+
contribution from third parties

+
receipts generated by the project

1.
Projects supported by the Fund must be of a non-profit-making nature. If, at the end of the project, the sources of income, including receipts, exceed expenditure, the contribution to the project from the Fund shall be reduced accordingly. All sources of income for the project must be recorded in the final beneficiary's accounts or tax documents, and must be identifiable and controllable.

2.
Project income shall come from all financial contributions granted to the project by the Fund, from public or private sources, including the final beneficiary's own contribution, and from any receipts generated by the project. ‘Receipts’ for the purpose of this rule covers revenue received by a project during the eligibility period as described in point I.4, from sales, rentals, services, enrolment/fees or other equivalent income.

3.
The Community contribution resulting from the application of the principle of non-profit, as referred to under Article 12(c) of this Decision, will be the ‘total eligible cost’ minus the ‘contribution from third parties’ and ‘receipts generated by the project’.

1.
Costs relating to a project must be incurred and the respective payments (except for depreciation) made after 1 January of the year referred to in the financing decision approving the annual programmes of the Member States. The eligibility period is until 31 December of the year N(2)+1, meaning that the costs relating to a project must be incurred before this date.

2.
An exception to the above-mentioned eligibility period is made for technical assistance for Member States (refer to point V(3)).

1.
Expenditure shall correspond to payments made by the final beneficiary. These must be in the form of financial (cash) transactions, with the exception of depreciation.

2.
As a rule, expenditure shall be justified by official invoices. Where this cannot be done, expenditure shall be supported by accounting documents or supporting documents of equivalent evidential value.

3.
Expenditure must be identifiable and verifiable. In particular,a)it must be recorded in the accounting records of the final beneficiary;b)it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; andc)it must be declared in accordance with the requirements of applicable tax and social legislation.
a)
it must be recorded in the accounting records of the final beneficiary;
b)
it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; and
c)
it must be declared in accordance with the requirements of applicable tax and social legislation.

a)
it must be recorded in the accounting records of the final beneficiary;

b)
it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; and

c)
it must be declared in accordance with the requirements of applicable tax and social legislation.

a)
it must be recorded in the accounting records of the final beneficiary;

b)
it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; and

c)
it must be declared in accordance with the requirements of applicable tax and social legislation.

4.
Where applicable, the final beneficiaries are obliged to keep certified copies of the accounting documents justifying income and expenditure incurred by the partners in relation to the project concerned.

5.
The storage and processing of such records must comply with the national data protection legislation.

1.
Expenditure for actions and measures described in Articles 4 and 5 of the basic act must be:a)incurred by the final beneficiaries defined in point I.1(e); andb)incurred in the territory of the Member States or of third countries.
a)
incurred by the final beneficiaries defined in point I.1(e); and
b)
incurred in the territory of the Member States or of third countries.

a)
incurred by the final beneficiaries defined in point I.1(e); and

b)
incurred in the territory of the Member States or of third countries.

a)
incurred by the final beneficiaries defined in point I.1(e); and

b)
incurred in the territory of the Member States or of third countries.

2.
Partners in the project registered and established in third countries may participate in projects on a no-cost basis, except in the case of international governmental organisations. Therefore, costs incurred by these partners are ineligible.

1.
Direct costs for staff are eligible only for persons that have a key and direct role in the project, such as project managers and other staff operationally involved in the project, for example planning project activities, implementing (or monitoring) operational activities, delivering services to the final recipients of the project, etc.Costs for other members of staff in the final beneficiary organisation who only provide a supporting role (such as the general manager, accountant, procurement support, human resources support, information technology support, administrative assistant, receptionist, etc.) are not eligible as direct costs and are considered to be indirect costs (see point II.2).

2.
Staff costs shall be detailed in the forward budget, indicating functions, number of staff and names.If the names of the persons are not yet known or cannot be disclosed, indication shall be provided of the professional and technical capacities of the persons set to implement the relevant functions/tasks within the project.

3.
The cost of staff assigned to the project, i.e. salaries and social security contributions and other statutory costs, shall be eligible, provided that this does not exceed the average rates as regards the final beneficiary's usual policy on remuneration. Where applicable, this figure may include all the usual contributions paid by the employer, but it must exclude any bonuses, incentive payments or profit-sharing schemes. Levies, taxes or charges (in particular, direct taxes and social security contributions on wages) arising from projects co-financed by the Fund amount to eligible costs only where they are actually borne by the final beneficiary of the grant.

a)
a person contracted by the final beneficiary solely for the purpose of implementing the project;

b)
a person employed on a permanent basis by the final beneficiary who:—fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or—is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation.
—
fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or
—
is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation.

—
fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or

—
is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation.

—
fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or

—
is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation.

1.
Travel and subsistence costs are only eligible as direct costs for:a)staff of the final beneficiary whose costs are eligible as defined in point II.1.1;b)in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1;c)other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence.
a)
staff of the final beneficiary whose costs are eligible as defined in point II.1.1;
b)
in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1;
c)
other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence.

a)
staff of the final beneficiary whose costs are eligible as defined in point II.1.1;

b)
in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1;

c)
other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence.

a)
staff of the final beneficiary whose costs are eligible as defined in point II.1.1;

b)
in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1;

c)
other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence.

2.
Travel costs shall be eligible on the basis of the actual costs incurred. Reimbursement rates shall be based on the cheapest form of public transport and flights shall, as a rule, be permitted only for journeys over 800 km (return trip), or where the geographical destination justifies travelling by air. Boarding passes must be kept. Where a private car is used, reimbursement is normally made either on the basis of the cost of public transport, or on the basis of mileage rates in accordance with published official rules in the Member State concerned or used by the final beneficiary.

3.
Subsistence costs shall be eligible on the basis of real costs or a daily allowance. Where an organisation has its own daily rates (subsistence allowances), they shall be applied within ceilings established by the Member State in accordance with national legislation and practice. Subsistence allowances are normally understood to cover local transport (including taxis), accommodation, meals, local telephone calls and sundries.

1.
Costs pertaining to the acquisition of equipment (based on depreciation of purchased assets, leasing or rental) are only eligible if they are essential to the implementation of the project. Equipment shall have the technical properties needed for the project and comply with applicable norms and standards.

2.
Costs for day-to-day administrative equipment (such as printer, laptop, fax, copier, phone, cabling, etc.) are not eligible as direct costs and are to be considered as indirect costs (see point II.2).

3.
The choice between leasing, rental or purchase must always be based on the least expensive option. However, if leasing or renting are not possible because of the short duration of the project or the rapid depreciation in value, purchase is accepted and the costs related to depreciation, as described below, may be eligible on the basis of national depreciation rules.

1.
Where equipment is purchased before or during the lifetime of the project, only the portion of equipment depreciation corresponding to the duration of use for the project and the rate of actual use for the project is eligible.

2.
Equipment that was purchased before the lifetime of the project, but which is used for the purpose of the project, is eligible on the basis of depreciation. However these costs are ineligible if the equipment was originally purchased through a Community grant.

3.
Purchase costs of equipment shall correspond to normal market costs and the value of the items concerned is written off in accordance with the tax and accounting rules applicable to the final beneficiary.

4.
For individual items costing below 1 000 euros, the full purchase cost is eligible, provided that the equipment is purchased during the first three months of the project.

1.
Where the acquisition of real estate is essential for implementation of the project and is clearly linked with its objectives, the purchase of real estate, i.e. buildings already constructed, or construction of real estate, is eligible for co-financing under the conditions set out below, without prejudice to the application of stricter national rules:a)A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project;b)The real estate has not been purchased through a Community grant at any time prior to the implementation of the project;c)The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise;d)Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules.
a)
A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project;
b)
The real estate has not been purchased through a Community grant at any time prior to the implementation of the project;
c)
The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise;
d)
Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules.

a)
A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project;

b)
The real estate has not been purchased through a Community grant at any time prior to the implementation of the project;

c)
The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise;

d)
Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules.

a)
A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project;

b)
The real estate has not been purchased through a Community grant at any time prior to the implementation of the project;

c)
The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise;

d)
Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules.

2.
In the case of renovation, only conditions (c) and (d) above apply.

a)
The real estate shall not have been purchased through a Community grant;

b)
The real estate should only be used for implementation of the project. If not, only the portion of the costs corresponding to the use for the project is eligible.

1.
The costs of consumables, supplies and general services are eligible provided that they are identifiable and directly necessary for the implementation of the project.

2.
However, office supplies as well as all kinds of small administrative consumables, supplies, hospitality costs and general services (such as telephone, internet, postage, office cleaning, utilities, insurance, staff training, recruitment, etc.) are not direct eligible costs; they are included in indirect costs, as referred to in point II.2.

1.
As a general rule, final beneficiaries must have the capacity to carry out the activities relating to the project themselves. Therefore, subcontracting must be limited and shall not exceed 40 % of the direct eligible costs of a project unless duly justified and approved in advance by the responsible authority.

2.
Expenditure relating to the following subcontracts is ineligible for co-financing by the Fund:a)subcontracting of tasks relating to the overall management of the project;b)subcontracting that adds to the cost of the project without adding proportionate value to it;c)subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided.
a)
subcontracting of tasks relating to the overall management of the project;
b)
subcontracting that adds to the cost of the project without adding proportionate value to it;
c)
subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided.

a)
subcontracting of tasks relating to the overall management of the project;

b)
subcontracting that adds to the cost of the project without adding proportionate value to it;

c)
subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided.

a)
subcontracting of tasks relating to the overall management of the project;

b)
subcontracting that adds to the cost of the project without adding proportionate value to it;

c)
subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided.

3.
For all subcontracts, subcontractors shall undertake to provide all audit and control bodies with all the necessary information relating to subcontracted activities.

1.
Specific expenses for the target groups in accordance with the measures listed in Article 5 of the basic act will consist of full or partial support in the form of:a)Costs incurred by the beneficiary for the target groups;b)Costs incurred by returnees which are then reimbursed by the final beneficiary; orc)Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act).
a)
Costs incurred by the beneficiary for the target groups;
b)
Costs incurred by returnees which are then reimbursed by the final beneficiary; or
c)
Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act).

a)
Costs incurred by the beneficiary for the target groups;

b)
Costs incurred by returnees which are then reimbursed by the final beneficiary; or

c)
Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act).

a)
Costs incurred by the beneficiary for the target groups;

b)
Costs incurred by returnees which are then reimbursed by the final beneficiary; or

c)
Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act).

2.
These costs are eligible under the following conditions:a)The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance;b)The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance;c)The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.The storage and processing of the above-mentioned information must comply with national data protection legislation.
a)
The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance;
b)
The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance;
c)
The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.

a)
The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance;

b)
The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance;

c)
The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.

a)
The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance;

b)
The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance;

c)
The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.

3.
Assistance measures following the return to the third country, such as training and employment assistance, short-term measures necessary for the reintegration process and post-return assistance as described in Article 5(5), (8) and (9) of the basic act respectively shall not exceed the duration of six months following the date of the return of the third-country national.

1.
Indirect costs relate to categories of expenditure that are not identifiable as specific costs directly linked to the project. A fixed percentage of the total amount ofdirect eligible costsmay be eligible as indirect costs, provided that:a)the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs;b)the indirect costs are anticipated in the forward budget of the project;c)the indirect costs do not include costs assigned to another heading of the budget for the project;d)the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget;e)as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs.
a)
the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs;
b)
the indirect costs are anticipated in the forward budget of the project;
c)
the indirect costs do not include costs assigned to another heading of the budget for the project;
d)
the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget;
e)
as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs.
—
where the responsible authority acts as an executing body as defined in Article 7(3), or
—
where subcontracting exceeds 40 % of the eligible direct costs.

a)
the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs;

b)
the indirect costs are anticipated in the forward budget of the project;

c)
the indirect costs do not include costs assigned to another heading of the budget for the project;

d)
the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget;

e)
as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs.
—
where the responsible authority acts as an executing body as defined in Article 7(3), or
—
where subcontracting exceeds 40 % of the eligible direct costs.

—
where the responsible authority acts as an executing body as defined in Article 7(3), or

—
where subcontracting exceeds 40 % of the eligible direct costs.

a)
the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs;

b)
the indirect costs are anticipated in the forward budget of the project;

c)
the indirect costs do not include costs assigned to another heading of the budget for the project;

d)
the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget;

e)
as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs.
—
where the responsible authority acts as an executing body as defined in Article 7(3), or
—
where subcontracting exceeds 40 % of the eligible direct costs.

—
where the responsible authority acts as an executing body as defined in Article 7(3), or

—
where subcontracting exceeds 40 % of the eligible direct costs.

—
where the responsible authority acts as an executing body as defined in Article 7(3), or

—
where subcontracting exceeds 40 % of the eligible direct costs.

2.
The percentage allocated to indirect costs shall cover the following costs in particular:a)staff costs that are ineligible as direct costs as per point II.1.1.1 (1);b)administration and management expenses, such as costs identified in II.1.5.2;c)bank fees and charges (except bank guarantees as defined in section II.1.7);d)depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4;e)all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’.
a)
staff costs that are ineligible as direct costs as per point II.1.1.1 (1);
b)
administration and management expenses, such as costs identified in II.1.5.2;
c)
bank fees and charges (except bank guarantees as defined in section II.1.7);
d)
depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4;
e)
all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’.

a)
staff costs that are ineligible as direct costs as per point II.1.1.1 (1);

b)
administration and management expenses, such as costs identified in II.1.5.2;

c)
bank fees and charges (except bank guarantees as defined in section II.1.7);

d)
depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4;

e)
all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’.

a)
staff costs that are ineligible as direct costs as per point II.1.1.1 (1);

b)
administration and management expenses, such as costs identified in II.1.5.2;

c)
bank fees and charges (except bank guarantees as defined in section II.1.7);

d)
depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4;

e)
all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’.

a)
VAT, except where the final beneficiary can show that he is unable to recover it;

b)
return on capital, debt and debt service charges, debit interest, foreign exchange commissions and exchange losses, provisions for losses or potential future liabilities, interest owed, doubtful debts, fines, financial penalties, litigation costs, and excessive or reckless expenditure;

c)
entertainment costs exclusively for project staff. Reasonable hospitality costs at social events justified by the project, such as an event at the end of the project or meetings of the project steering group, are permitted;

d)
costs declared by the final beneficiary and covered by another project or work programme receiving a Community grant;

e)
purchase of land;

f)
staff costs for officials who contribute to project implementation by accomplishing tasks that are part of their normal routine;

g)
contributions in kind.

1.
In duly substantiated cases, co-financing of the project as regards the contribution from the final beneficiary and the partners in the project may be made up in part of contributions in terms of work carried out by permanent officials employed by these bodies and involved in the project. In this case these costs are not eligible as direct or indirect staff costs as defined under points II.1.1 and II.2 but as costs covered by assigned income.

2.
Such contributions shall not exceed 50 % of the total contribution given by the final beneficiary. In this case, the following rules shall apply:a)tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority;b)public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority;c)the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority.
a)
tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority;
b)
public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority;
c)
the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority.

a)
tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority;

b)
public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority;

c)
the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority.

a)
tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority;

b)
public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority;

c)
the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority.

1.
At the initiative of each Member State, the following technical assistance measures are eligible for each annual programme, within the limits specified in Article 17 of the basic act:a)expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables);b)expenditure relating to audits and on-the-spot checks of actions or projects;c)expenditure relating to evaluations of actions or projects;d)expenditure relating to information, dissemination and transparency in relation to actions;e)expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds;f)expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions;g)expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.
a)
expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables);
b)
expenditure relating to audits and on-the-spot checks of actions or projects;
c)
expenditure relating to evaluations of actions or projects;
d)
expenditure relating to information, dissemination and transparency in relation to actions;
e)
expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds;
f)
expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions;
g)
expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.
—
civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),
—
other staff employed to carry out tasks referred to in points a) to f),
—
the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

a)
expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables);

b)
expenditure relating to audits and on-the-spot checks of actions or projects;

c)
expenditure relating to evaluations of actions or projects;

d)
expenditure relating to information, dissemination and transparency in relation to actions;

e)
expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds;

f)
expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions;

g)
expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.
—
civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),
—
other staff employed to carry out tasks referred to in points a) to f),
—
the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

—
civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),

—
other staff employed to carry out tasks referred to in points a) to f),

—
the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

a)
expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables);

b)
expenditure relating to audits and on-the-spot checks of actions or projects;

c)
expenditure relating to evaluations of actions or projects;

d)
expenditure relating to information, dissemination and transparency in relation to actions;

e)
expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds;

f)
expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions;

g)
expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.
—
civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),
—
other staff employed to carry out tasks referred to in points a) to f),
—
the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

—
civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),

—
other staff employed to carry out tasks referred to in points a) to f),

—
the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

—
civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),

—
other staff employed to carry out tasks referred to in points a) to f),

—
the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

2.
Technical assistance may finance expenses incurred by any of the following bodies: responsible authority, delegated authority, audit authority, certifying authority.

3.
Activities linked to technical assistance must be performed and the corresponding payments made after 1 January of the year referred to in the financing decision approving the annual programmes of Member States. The eligibility period lasts until the end of June of the year N(3)+2 or any later date compatible with the deadline for the submission of the final report on implementation of the annual programme.

4.
Any procurement must be carried out in accordance with national procurement rules established in the Member State.

5.
Member States may implement technical assistance measures for this Fund together with technical assistance measures for some or all of the four Funds. However, in that case only the portion of the costs used to implement the common measure corresponding to this Fund shall be eligible for financing under this Fund, and Member States shall ensure that:a)the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; andb)there is no double financing of costs.
a)
the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; and
b)
there is no double financing of costs.

a)
the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; and

b)
there is no double financing of costs.

a)
the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; and

b)
there is no double financing of costs.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 575/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Return Fund for the period 2008 to 2013 as part of the General programme ‘Solidarity and Management of Migration Flows’(1), and in particular Articles 23, 31(5), 33(6) and 35(4) thereof,

(1) It is necessary to lay down the conditions under which Member States should implement the action under the Fund, in particular to identify under which circumstances the responsible authority may implement projects directly. Further provisions should also be laid down for delegated authorities.

(2) It is necessary to identify a list of procedures and/or practical arrangements that the different designated authorities should lay down and follow for implementation of the Fund.

(3) It is necessary to lay down the obligations which the responsible authorities should have with regard to final beneficiaries in the phase leading to selection and approval of the projects to be funded and with regard to the aspects which should be covered by the verifications of the expenditure declared by the final beneficiary and/or by the partners in the project, including administrative verifications of the applications for reimbursement and on-the-spot verifications of individual projects.

(4) In order to ensure that expenditure under annual programmes can be properly audited, it is necessary to set out the criteria with which audit trails should comply in order to be considered adequate.

(5) The audits of projects and of systems are carried out under the responsibility of the audit authority. To ensure that the audits offer adequate scope and effectiveness and are carried out in accordance with the same standards in all Member States, it is necessary to set out the conditions which the audits should fulfil, including the basis for sampling.

(6) The Member States must submit to the Commission, together with their multiannual programme, a description of their management and control systems. Since this document is one of the principal bases on which the Commission relies, in the context of shared management of the Community budget, to determine whether the financial assistance concerned is used by the Member States in accordance with the applicable rules and principles for protecting the Community’s financial interests, it is necessary to set out in detail the information that this document should contain.

(7) In order to harmonise standards for programming, following up the implementation of the Fund, auditing and certifying expenditure, it is necessary to clearly define the contents of the multiannual programme, the annual programme, the progress report, the final report, the applications for payments as well as the audit strategy, the annual audit report, the declaration of validity and the certification of expenditure.

(8) Since Member States are required to report and monitor irregularities and to recover sums wrongly paid in connection with the financing from the Fund, it is necessary to define requirements for the data sent to the Commission.

(9) Experience has shown that citizens of the European Union are insufficiently aware of the role played by the Community in funding programmes. It is therefore appropriate to define in detail the information and publicity measures necessary to bridge this communication and information gap.

(10) In order to guarantee that information on possible funding opportunities is disseminated widely to all interested parties and for the sake of transparency, the minimum measures needed to inform potential final beneficiaries about the financing opportunities offered jointly by the Community and the Member States through the Fund should be set out. In order to enhance transparency about use of the Fund, the list of final beneficiaries, the names of the projects and the amount of public funding allocated to projects should be published.

(11) In the light of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(2)and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data(3), it is necessary to provide, in relation to the information and publicity measures and audit work under this Decision, that the Commission and the Member States should prevent any unauthorised disclosure of or access to personal data and to specify the purpose for which the Commission and the Member States may process such data.

(12) Use of electronic means to exchange information and financial data between the Member States and the Commission leads to simplification, increased efficiency, transparency and time savings. In order to capitalise fully on these advantages while preserving the security of exchanges, a common computer system may be established by the Commission.

(13) To ensure efficient implementation of the Fund in the Member States, in accordance with the principles of sound financial management, a series of common rules should be adopted on the eligibility of expenditure from the Fund. In order to reduce the administrative burden on final beneficiaries and designated authorities, flat rates for indirect costs should be eligible under certain conditions.

(14) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom is bound by the basic act and, as a consequence, by this Decision.

(15) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Ireland is bound by the basic act and, as a consequence, by this Decision.

(16) In accordance with Article 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not bound by this Decision nor subject to application thereof.

(17) The measures provided for in this Decision are in accordance with the opinion of the Management Committee of the Fund,

HAS ADOPTED THIS DECISION:
Subject matter

Article 1

1.   This Decision lays down rules for implementation of the Fund as regards:

(a)

designated authorities;

(b)

management and control systems;

(c)

information to be provided by the Member States to the Commission regarding use of the Fund;

(d)

reporting of irregularities;

(e)

information and publicity;

(f)

personal data;

(g)

electronic exchange of documents.

2.   The provisions set out below shall apply without prejudice to Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities(4).
Definitions

Article 2

For the purposes of this Decision the following definitions shall apply:

—

‘basic act’: Decision No 575/2007/EC,

—

‘Fund’: the European Return Fund, as established by the basic act,

—

‘four Funds’: the European Refugee Fund, the External Borders Fund, the European Return Fund and the European Fund for the Integration of third-country nationals, as established by Decision No 573/2007/EC(5), Decision No 574/2007/EC(6)and Decision No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC(7)as part of the General programme ‘Solidarity and Management of Migration Flows’,

—

‘responsible authority’: the body designated by a Member State under Article 25 (1)(a) of the basic act,

—

‘certifying authority’: the body designated by a Member State under Article 25 (1)(b) of the basic act,

—

‘audit authority’: the body designated by a Member State under Article 25(1)(c) of the basic act,

—

‘delegated authority’: the body designated by a Member State under Article 25 (1)(d) of the basic act,

—

‘designated authorities’: all the authorities designated by a Member State under Article 25 of the basic act,

—

‘action’: action under the Fund, as defined in Article 4 of the basic act,

—

‘project’: specific, practical means deployed to implement all or part of an action by the final beneficiaries of grants,

—

‘final beneficiary’: the legal entity responsible for implementing projects such as NGOs, federal, national, regional or local authorities, other non-profit organisations, private or public-law companies or international organisations,

—

‘partner in the project’: any legal entity which implements a project in cooperation with a final beneficiary by providing the project with resources and by receiving part of the Community contribution through the final beneficiary,

—

‘strategic guidelines’: the framework for intervention by the Fund, as adopted by Commission Decision 2007/837/EC(8),

—

‘priority’: set of actions defined as a priority in the strategic guidelines,

—

‘specific priority’: set of actions defined as a specific priority in the strategic guidelines, allowing co-financing at a higher rate, in accordance with Article 15(4) of the basic act,

—

‘primary administrative or judicial finding’: first written assessment by a competent authority, either administrative or judicial, concluding on the basis of specific facts that an irregularity has been committed, without prejudice to the possibility that this conclusion may subsequently have to be revised or withdrawn as a result of developments in the course of the administrative or judicial procedure,

—

‘irregularity’: any infringement of a provision of Community law resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the European Union by charging an unjustified item of expenditure to the general budget,

—

‘suspected fraud’: an irregularity giving rise to the initiation of administrative or judicial proceedings at national level in order to establish the presence of intentional behaviour, in particular fraud, as referred to in point (a) of Article 1(1) of the Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities’ financial interests(9),

—

‘bankruptcy’: insolvency proceedings, as defined in Article 2(a) of Council Regulation (EC) No 1346/2000(10),

—

‘grant agreement’: an agreement or an equivalent form of legal instrument on the basis of which Member States provide grants to the final beneficiary for the purpose of implementing the project under the Fund.
Common authorities

Article 3

Member States may designate the same responsible authority, audit authority or certifying authority for two or more of the four Funds.
Delegated authority

Article 4

1.   Any delegation of tasks shall comply with the principle of sound financial management, which requires effective and efficient internal control, and shall ensure compliance with the principle of non-discrimination and the visibility of Community funding. No implementing tasks delegated may give rise to conflicts of interest.

2.   The scope of the tasks delegated by the responsible authority to the delegated authority and the detailed procedures for implementation of the delegated tasks shall be formally recorded in writing.

The act of delegation shall mention at least:

(a)

the references of the relevant Community legislation;

(b)

the task entrusted to the delegated authority;

(c)

the rights and duties of the delegated authority and the responsibilities it assumes;

(d)

the obligation for the delegated authority to put in place and to maintain an organisational structure and a management and control system adapted to performance of its duties;

(e)

the assurance to be provided concerning sound financial management and the legality and regularity of the delegated tasks.

3.   The handling of communication with the Commission referred to in Article 25(1)(a) of the basic act shall not be delegated. The delegated authority shall communicate with the Commission via the responsible authority.

4.   If the delegated authority is not a public administration or a body governed by the private law of the Member State which has a public-service mission, the responsible authority may not delegate to that authority any executive powers which involve a large measure of discretion implying political choices.

5.   Delegation of tasks to the delegated authorities shall not affect the liability of the responsible authority, which shall remain answerable for the tasks it has delegated.

6.   Where the responsible authority has delegated tasks to the delegated authority, all provisions of this Decision relating to the responsible authority shall applymutatis mutandisto the delegated authority.
Outsourcing of tasks

Article 5

Designated authorities may outsource some of their tasks but they shall remain answerable for the outsourced tasks in accordance with the responsibilities defined in Articles 27, 29 and 30 of the basic act.
Manual of procedures

Article 6

In accordance with Article 31(2) of the basic act and having regard to the principle of proportionality, Member States shall establish a manual setting out procedures and practical arrangements regarding:

(a)

functioning of the designated authorities;

(b)

arrangements ensuring appropriate separation of functions;

(c)

where appropriate, monitoring of delegated authorities and other outsourced tasks;

(d)

establishment of multiannual and annual programmes;

(e)

establishment of audit strategy and annual audit plans;

(f)

selection of projects, award of grants and monitoring and financial management of the projects;

(g)

management of irregularities, financial corrections and recoveries;

(h)

preparation and implementation of audit missions;

(i)

preparation of audit reports and declarations;

(j)

certification of expenditure;

(k)

evaluation of the programme;

(l)

reporting to the Commission;

(m)

audit trail.
Implementation of the Fund by the responsible authority

Article 7

1.   For implementation of the Fund, the responsible authority may act as awarding body and/or as executing body.

2.   The responsible authority acts as awarding body in cases where it implements the projects, as a general rule, on the basis of annual open calls for proposals.

Neither the responsible authority nor any delegated authority may apply in response to these calls for proposals.

In duly justified cases, including continuation of multiannual projects in accordance with Article 15(6) of the basic act which were selected after a previous call for proposals or in emergency situations, grants may be awarded without a call for proposals.

3.   The responsible authority acts as executing body in cases where it decides to implement the projects directly because the characteristics of the projects leave no other choice for implementation, such asde juremonopoly situations or security reasons. In these cases, the rules concerning the final beneficiary shall applymutatis mutandisto the responsible authority.
Conditions under which the responsible authority acts as executing body

Article 8

1.   The reasons which led the responsible authority to act as executing body for implementation of projects shall be identified and communicated to the Commission within the framework of the annual programme concerned.

2.   When implementing the projects, the responsible authority shall ensure the principle of value for money and prevent conflicts of interest.

3.   The responsible authority may implement the projects identified in accordance with Article 7(3) directly and/or in association with any national authority competent on account of its technical expertise, its high degree of specialisation or its administrative powers. The main national authorities involved in implementation shall also be identified in the annual programme concerned.

4.   The administrative decision to co-finance a project under the Fund shall contain the information necessary to monitor the co-financed products and services and to check the expenditure incurred. All relevant provisions laid down for a grant agreement in Article 10(2) shall be specified in an equivalent form of legal instrument.

5.   The final report on implementation of the annual programme shall include information on the procedures and practices applied to ensure adequate separation of functions, effective control and satisfactory protection of the European Communities’ financial interests and shall provide explanations on how conflicts of interest have been avoided.

6.   When the responsible authority is expected to be executing body on a regular basis for projects co-financed by the Fund:

(a)

the audit authority shall not be part of the same body as the responsible authority, except when its audit independence is guaranteed and it also reports to another body outside the body of which it and the responsible authority form part;

(b)

the tasks of the responsible authority, as defined in Article 27 of the basic act, shall not be affected when the responsible authority also implements projects directly.

7.   When a delegated authority is expected to be executing body for projects co-financed by the Fund, this delegated authority may not be the sole final beneficiary of the appropriations which it was delegated to manage.
Selection and award procedure when the responsible authority acts as awarding body

Article 9

1.   The calls for proposals defined in Article 7(2) shall be published in a way that ensures maximum publicity among potential beneficiaries. Any change to the content of the calls for proposals shall also be published under the same conditions.

The calls for proposals shall specify:

(a)

the objectives;

(b)

the selection criteria, which shall comply with Article 15(5) of the basic act, and the relevant supporting documents;

(c)

the arrangements for Community and, if applicable, national financing;

(d)

the arrangements and final date for submission of proposals.

2.   For the purposes of selection of projects and award of grants, the responsible authority shall ensure that potential beneficiaries are informed of the following specific conditions concerning the projects to be implemented:

(a)

the eligibility rules for the expenditure;

(b)

the time-limit for implementation; and

(c)

the financial and other information to be kept and communicated.

Before the award decision is taken the responsible authority shall satisfy itself that the final beneficiary and/or the partners in the project have the capacity to fulfil these conditions.

3.   The responsible authority shall ensure that projects awarded grants have been subject to a formal, technical and budgetary analysis and qualitative assessment applying the criteria laid down in the call for proposals. The reasons for rejection of the other projects shall be recorded.

4.   Member States shall determine who shall have the power to award projects and shall ensure that conflicts of interest are avoided in all cases and, in particular, when the applicants are national bodies.

5.   The award decision shall indicate at least the name of the final beneficiary and/or of the partners in the project, the essential details of the project and its operational objectives, the maximum amount of co-financing from the Fund and the maximum rate of co-financing of the total eligible costs.

6.   Written information shall be sent to each applicant on the results of the selection process containing an explanation of the selection decisions. If provided for in national legislation, the relevant review procedure shall be mentioned.
Grant agreements with final beneficiaries when the responsible authority acts as awarding body

Article 10

1.   The responsible authority shall lay down detailed project management procedures covering,inter alia:

(a)

signature of grant agreements with selected final beneficiaries;

(b)

follow-up of agreements and any amendment thereto by establishing a system for administrative monitoring of projects (exchange of correspondence, issuing and monitoring amendments and reminder letters, receipt and processing of reports, etc.).

2.   The grant agreements shall lay down,inter alia:

(a)

the maximum amount of the grant;

(b)

the maximum percentage of the Community contribution in accordance with Article 15(4) of the basic act;

(c)

a detailed description and timetable of the project supported;

(d)

if applicable, the part of the tasks and related costs that the final beneficiary intends to subcontract to third parties;

(e)

the agreed forward budget and financing plan for the project, including the fixed percentage of indirect costs as defined in Annex XI regarding the rules on eligibility of expenditure;

(f)

the timetable and provisions for implementation of the agreement (reporting obligations, amendments and termination);

(g)

the operational objectives of the project and the indicators to be used;

(h)

the definition of eligible costs;

(i)

the conditions relating to payment of the grant and bookkeeping requirements;

(j)

the conditions relating to audit trail;

(k)

the relevant provisions relating to data protection;

(l)

the relevant provisions relating to publicity.

3.   If appropriate, the final beneficiaries shall ensure that all partners in the project are subject to the same obligations as them. The partners shall engage their responsibility through the final beneficiary which remains answerable, in last resort, for the respect of the contractual conditions by itself and all partners in the project.

The final beneficiaries shall keep certified copies of the accounting documents justifying income and expenditure incurred by the partners in relation to the project concerned.

4.   The grant agreements shall provide expressly for the Commission and the Court of Auditors to exercise their powers of control, based on documents and on the premises, over all final beneficiaries, partners in the project and subcontractors.
Implementation contracts

Article 11

Without prejudice to the applicable Community and national public procurement rules, the grant agreements shall lay down that, when implementing the projects, the final beneficiaries and/or the partners in the project shall award the procurement contract, following a tendering procedure, to the tender offering best value for money and that care be taken to avoid any conflict of interest. However, without prejudice to the applicable Community and national public procurement rules, contracts with a value of less than 5 000 euros may be awarded on the basis of a single offer without a call for tender.
Determination of the final Community contribution

Article 12

For calculation of the final payment to the final beneficiary, the total Community contribution to each project shall be the lowest of the following three amounts:

(a)

the maximum amount stated in the grant agreement;

(b)

the maximum co-financing resulting from multiplication of the total eligible costs of the project concerned by the percentage laid down in Article 15(4) of the basic act (i.e. 50 % or 75 %); and

(c)

the amount resulting from application of the principle of non-profit, as defined in point I.3.3 of Annex XI.
Technical assistance

Article 13

1.   Technical assistance at the initiative of the Commission, as defined in Article 16 of the basic act, may be financed up to 100 % by the Fund.

2.   Technical assistance at the initiative of the Member States, as defined in Article 17 of the basic act, may be financed up to 100 % by the Fund.

3.   Technical assistance at the initiative of the Commission or the Member States may take the form of procurement contracts, expert fees and/or any administrative expenditure subject to the eligibility rules defined in Part III, Chapter 1.
Technical assistance expenditure in the case of a common authority

Article 14

1.   When one or more designated authorities are common to two or more of the four Funds, the appropriations for the technical assistance expenditure on each of the annual programmes concerned may be merged, partly or entirely.

2.   The expenditure on technical assistance shall be allocated between the Funds concerned, preferably on the basis of simple and representative apportionment formulae. Application of the formulae shall not lead to any increase in the maximum amount of technical assistance expenditure on each annual programme concerned.
Verifications by the responsible authority

Article 15

1.   The verifications to be carried out by, or under the responsibility of, the responsible authority under Article 27(1)(g) of the basic act shall cover administrative, financial, technical and physical aspects of projects, as appropriate.

The verifications shall ensure that the expenditure declared is real and justified for the purpose of the project, that the projects granted have been delivered in accordance with the grant agreements, that the Community contribution complies with the rules, in particular regarding the financing structure defined in Article 15 of the basic act, that the applications for reimbursement by the final beneficiary are correct and that the projects and expenditure comply with Community and national rules and avoid double-financing of expenditure with other Community or national schemes and with other programming periods.

Moreover, the verifications shall include:

(a)

administrative and financial verifications of each application for reimbursement sent by the final beneficiaries;

(b)

verifications, at least on a representative sample of the supporting documents covering all headings of the budget annexed to the grant agreement, of the relevance, accuracy and eligibility of the expenses, income and costs covered by assigned income declared by the final beneficiaries;

(c)

on-the-spot verifications of individual projects, at least on a sample representing an appropriate mix of types and sizes of projects and taking account of any risk factors already identified, in order to achieve reasonable assurance as to the legality and regularity of the underlying transactions, having regard to the level of risk identified by the responsible authority.

The verifications indicated in points (a) and (b) do not have to be carried out if an obligation is imposed on the final beneficiary to provide an audit certificate from an independent auditor which covers all the aspects mentioned in points (a) and (b).

2.   Records shall be kept of each verification, stating the work performed, the date, the results and the measures taken in response to errors detected. The responsible authority shall ensure that all the supporting documents regarding the verifications performed are kept available for the Commission and the Court of Auditors for a period of five years following closure of the project. This period shall be interrupted in the event of legal proceedings or at the duly substantiated request of the Commission.

3.   Where the responsible authority acts as executing body under the annual programme, as defined in Article 7(3), the verifications referred to in paragraph 1 shall be implemented in accordance with the principle of adequate separation of functions.
Audit trail

Article 16

1.   For the purposes of Article 27(1)(k) of the basic act, an audit trail shall be considered adequate if it complies with the following criteria:

(a)

it permits reconciliation of the amounts certified to the Commission with the detailed accounting records and supporting documents held by the certifying authority, responsible authority, delegated authorities and final beneficiaries on projects co-financed under the Fund;

(b)

it permits verification of payment of the public contribution to the final beneficiary, of allocation and transfer of the Community funding granted under the Fund and of the sources of co-financing of the project;

(c)

it permits verification of application of the selection criteria established for the annual programme;

(d)

it contains in respect of each project, as appropriate, the technical specifications and financing plan, documents concerning grant approval, documents relating to public procurement procedures and reports on the verifications and audits carried out.

2.   The responsible authority shall ensure that a record is kept of the location of all documents relating to specific payments made under the Fund.
Audits of systems and audits of projects

Article 17

1.   The audits referred to in Article 30(1)(a) and (b) of the basic act shall be carried out on the management and control systems established by the Member States and on a sample of projects selected by a method approved by the audit authority.

The sampling method shall:

(a)

include an appropriate mix of types and sizes of projects;

(b)

take account of any risk factors which have been identified by national or Community controls and the cost-benefit aspects of the verifications.

The sample shall also include projects implemented by the responsible authority acting as executing body at least on a proportional basis.

The method used to select the sample shall be documented.

2.   The audit on the management and control systems shall cover each of the following processes at least once before 2013: programming, delegation of tasks, selection and award, monitoring of the projects, payment, certification of expenditure, reporting to the Commission, detection and treatment of potential irregularities and evaluation of the programmes.

3.   The audits of projects shall be carried out on the spot on the basis of documentation and records held by the final beneficiary and/or the partners in the project. The audits shall verify that:

(a)

the project meets the selection criteria for the annual programme, has been implemented in accordance with the grant agreement and fulfils any applicable conditions concerning its functionality and use or the objectives to be attained;

(b)

the expenditure declared corresponds to the accounting records and supporting documents held by the final beneficiary and/or by the partners in the project, and those records correspond to the supporting documents kept by the responsible authority or any delegated body;

(c)

the items of expenditure correspond to the eligibility requirements set out in Annex XI, to the requirements specified during the national selection procedure, to the terms of the grant agreement and to the works actually carried out and, where appropriate, to other Community and national rules;

(d)

the use or intended use of the project is consistent with the objectives, action or measures set out in Articles 2, 3, 4, 5 and 17 of the basic act and, where appropriate, covers the target population;

(e)

the public or private contribution has been paid to the final beneficiary in accordance with Article 15(2) of the basic act;

(f)

there is an adequate audit trail;

(g)

there are no conflicts of interest and good value for money has been achieved, in particular in cases where the responsible authority acts as executing body of the project.

4.   Only expenditure within the scope of an audit carried out under paragraph 3 shall be counted towards the amount of expenditure audited for the purpose of Article 30(1)(b) of the basic act. If the audit is performed before the project has been closed, only the expenditure actually audited is taken into account to calculate the coverage rate.

5.   Where problems detected appear to be systemic in nature and may therefore entail a risk to other projects, the audit authority shall ensure that further examination is carried out, including additional audits where necessary, to establish the scale of such problems. The necessary preventive and corrective measures shall be taken by the relevant authorities.

6.   The audit authority shall draw conclusions on the basis of the results of the audits relating to expenditure declared to the Commission and shall communicate the conclusions to the Commission in the annual audit report. In annual programmes for which the error rate is above the materiality level of 2 % of the Community contribution, the audit authority shall analyse the significance of this error and take the necessary measures, including making appropriate recommendations, which shall be communicated at least in the annual audit report.
Verifications by the certifying authority

Article 18

1.   In cases where the audit authority gives a qualified opinion or an adverse opinion on the functioning of the management and control system, the certifying authority shall verify that this information has been sent to the Commission. It shall also ensure that an adequate action plan has been implemented by the responsible authority to restore effectively functioning management and control systems and to assess the impact of the malfunctioning on the declaration of expenditure.

2.   If the request for payment or statement of reimbursement is not validated by the audit authority for the final report on implementation of the annual programme, the certifying authority shall ensure that a correct request for payment or statement of reimbursement is established without delay.
Principle of proportionality

Article 19

1.   Pursuant to Article 10(2) of the basic act, the extent to which the information available to a Member State on use of the Fund is transmitted to the Commission in the documents referred to in this chapter may be proportionate to the amount of the Community contribution allocated to the Member State concerned and, where appropriate, this information may be provided in summarised form.

2.   However, upon a request from the Commission, the Member State shall nevertheless provide more detailed information. The Commission may request this information if it appears necessary in order for the Commission to fulfil effectively its obligations under the basic act and the Financial Regulation.
Description of management and control systems

Article 20

1.   The description of the management and control systems referred to in Articles 31(4) and 32(2) of the basic act shall be submitted in accordance with the model in Annex I.

2.   The responsible authority shall validate the description of the systems implemented by any delegated authority. Each of the designated authorities shall confirm the accuracy of the description of the management and control systems which concerns it. In addition, the audit authority shall also confirm the completeness of the description.

3.   When examining the description, the Commission may request clarifications and propose measures to comply with the provisions defined in the basic act. If necessary, on-site visits may be carried out by Commission officials or authorised Commission representatives.

4.   If the responsible authority is the same for two or more of the four Funds or where common systems apply to two or more of the Funds, a description of the common management and control systems may be submitted highlighting, where appropriate, any specific features.
Revision of the description of management and control systems

Article 21

1.   The responsible authority shall:

(a)

when submitting the draft annual programme, report whether changes have been made to the management and control systems;

(b)

notify the Commission of any substantial change at the latest once any such change has taken effect;

(c)

at the request of the Commission, provide a revised description in the event of multiple substantial changes.

2.   Substantial changes are changes which are likely to have an impact on the separation of functions, on the effectiveness of selection, award, control and payment mechanisms and on communication with the Commission. They shall include, in particular, changes in one of the designated authorities, in the accounting system and in the payment and certification processes.

3.   Revision of the management and control systems shall follow the same procedure as laid down in Article 20.
Programming documents

Article 22

1.   Member States shall submit to the Commission a multiannual programme, as referred to in Article 19 of the basic act, in accordance with the model in Annex II.

2.   Member States shall submit to the Commission the annual programmes, as referred to in Article 21 of the basic act, in accordance with the model in Annex III.

3.   The financial plans linked to the multiannual programme shall present a breakdown of the budgeted amounts by priority, as defined in the strategic guidelines.

The financial plans linked to the annual programmes shall present a breakdown of the budgeted amounts by category of action, as defined in Article 4 of the basic act, with a reference to the priorities.
Revision of financial breakdown in annual programmes

Article 23

1.   In order to revise the annual programme approved by the Commission pursuant to Article 21(5) of the basic act, the Member State concerned shall submit a revised draft annual programme to the Commission before 1 May of the year following the reference year. The Commission shall examine and, as soon as possible, approve the revised programme in accordance with the procedure laid down in Article 21(5) of the basic act.

2.   Changes to the financial breakdown without revision of the annual programme pursuant to paragraph 1 shall not exceed 10 % of the total contribution from the Fund and shall be allowed only in circumstances justified by causes beyond the control of the responsible authority. An adequate explanation of any such changes shall be provided in the progress report and/or in the final report on the implementation of the annual programme.
Progress and final reports on implementation of annual programmes

Article 24

1.   Member States shall submit to the Commission the progress reports on implementation of the annual programme and payment requests, as referred to in Article 39(4) of the basic act, in accordance with the model in Annex IV.

2.   Member States shall submit to the Commission the final reports on implementation of the annual programme and payment requests, as referred to in Article 40(1)(b) of the basic act, in accordance with the model in Annex V.

3.   The financial tables linked to the progress reports and final reports shall present a breakdown of the amounts both by priority, as defined in the strategic guidelines, and by projects for each category of action, as defined in Article 4 of the basic act.
Documents established by the audit authority

Article 25

1.   The audit strategy referred to in Article 30(1)(c) of the basic act shall be established in accordance with the model in Annex VI.

2.   Except when each of the last two annual programmes adopted by the Commission corresponds to an annual Community contribution below 1 million euros, the audit authority shall submit an annual audit plan before 15 February each year, as from 2009. The audit plan shall be established as an annex to the audit strategy in accordance with the model in Annex VI. In the case of a combined audit strategy, as provided for in Article 30(2) of the basic act, a combined annual audit plan may be submitted.

3.   The audit report and the opinions referred to in Articles 30(3)(a) and 30(3)(b) of the basic act shall be based on the systems audits and audits of projects carried out in accordance with the audit strategy and shall be drawn up in accordance with the models in Annexes VII.A and VII.B.

4.   The validity declaration referred to in Article 30(3)(c) of the basic act shall be based on all the audit work carried out by the audit authority and on additional checks, if necessary. The validity declaration shall be drawn up in accordance with the model in Annex VII.C.

5.   If there is any limitation on the scope of the examination or if the level of irregular expenditure detected does not allow provision of an unqualified opinion for the annual opinion referred to in Article 30(3)(b) of the basic act or in the declaration referred to in point (c) of the same Article, the audit authority shall give the reasons and estimate the scale of the problem and its financial impact.
Documents established by the certifying authority

Article 26

1.   The certified declaration of expenditure relating to the request for a second pre-financing payment referred to in Article 39(4) of the basic act shall be drawn up and transmitted to the Commission in the format in Annex VIII.

2.   The certified declaration of expenditure relating to the request for a final payment referred to in Article 40(1)(a) of the basic act shall be drawn up and transmitted to the Commission in the format in Annex IX.
Initial reporting — derogations

Article 27

1.   In accordance with the models in Annexes IV and V, Member States shall report to the Commission any irregularity which has been the subject of a primary administrative or judicial finding in the progress or final reports on implementation of the annual programmes.

The report shall indicate:

(a)

the Fund, the annual programme and the project concerned;

(b)

the provision which has been infringed;

(c)

the date and the source of the first information leading to suspicion that an irregularity has been committed;

(d)

the practices employed in committing the irregularity;

(e)

where appropriate, whether the practice gives rise to a suspicion of fraud;

(f)

the manner in which the irregularity was discovered;

(g)

the amount of the Community contribution concerned.

However, the following cases need not be reported, except in cases of suspected fraud:

(a)

cases where the irregularities relate to amounts of less than 10 000 euros chargeable to the general budget of the European Communities;

(b)

cases where the irregularity consists solely of failure to implement, in whole or in part, a project included in the annual programme owing to the bankruptcy of the final beneficiary;

(c)

cases brought to the attention of the responsible authority by the final beneficiary voluntarily and before detection by the responsible authority, whether before or after payment of the public contribution;

(d)

cases detected and corrected by the responsible authority before any payment of the public contribution to the final beneficiary and before inclusion of the expenditure concerned in a declaration of expenditure submitted to the Commission.

2.   At the request of the Commission, Member States shall in all cases give further details concerning:

(a)

where appropriate, the other Member States and third countries involved;

(b)

the period during which, or the moment at which, the irregularity was committed;

(c)

the national authorities or bodies which drew up the official report on the irregularity and the authorities responsible for the administrative or judicial follow-up;

(d)

the date on which the primary administrative or judicial finding on the irregularity was established;

(e)

the identity of the natural and legal persons involved or of any other participating entities, except where this information is irrelevant for the purposes of combating irregularities, given the nature of the irregularity concerned;

(f)

the total budget and the public contribution approved for the project and the distribution of its co-financing between the Community and national contributions;

(g)

the amount of the public contribution affected by the irregularity and the corresponding Community contribution at risk;

(h)

where no payment of the public contribution referred to under point (g) has been made to the persons or other entities identified, the amounts which would have been unduly paid had the irregularity not been identified;

(i)

the suspension of payments, where applicable, and the possibilities of recovery;

(j)

the nature of the irregular expenditure.

3.   Where some of the information referred to in paragraph 2, in particular on the practices employed in committing the irregularity and on the manner in which the irregularity was discovered, is not available, Member States shall as far as possible supply the missing information when forwarding subsequent reports of irregularities to the Commission.
Reporting of follow-up — Non-recovery

Article 28

1.   Member States shall inform the Commission, with reference to any previous report made under Article 27, of the procedures instituted with respect to all irregularities previously notified and of significant changes resulting from them. This information shall be given in the progress reports or final reports on implementation of the annual programmes in accordance with the models in Annexes IV and V.

The report shall indicate the amounts which have been, or are expected to be, recovered.

2.   At the request of the Commission, Member States shall in all cases give further details concerning:

(a)

any interim measures taken by Member States to safeguard recovery of sums unduly paid;

(b)

any judicial and administrative procedures instituted with a view to recovering sums unduly paid and to imposing sanctions;

(c)

the reasons for any abandonment of recovery procedures;

(d)

the reasons for any abandonment of criminal prosecutions.

Member States shall report to the Commission all administrative or judicial decisions terminating such procedures, or the main points thereof, and shall state, in particular, whether or not the findings are such that fraud is suspected.
Contacts with Member States

Article 29

1.   The Commission shall maintain appropriate contacts with the Member States concerned for the purpose of supplementing the information supplied on the irregularities referred to in Article 27 and on the procedures referred to in Article 28 on the possibility of recovery.

2.   Independently of the contacts referred to in paragraph 1, the Commission shall inform Member States in cases where the nature of the irregularity is such as to suggest that identical or similar practices could occur in other Member States.
Use of information

Article 30

1.   The Commission may use any information of a general or operational nature communicated by Member States under this Decision to perform risk analyses and may, on the basis of the information obtained, produce reports and develop early-warning systems serving to identify risks more effectively.

2.   The Commission shall regularly inform the Member States concerned of the use made of information under paragraph 1.
Information for potential final beneficiaries

Article 31

1.   The responsible authority shall ensure that the key indications regarding the multiannual and annual programmes are disseminated widely, with details of the financial contributions concerned, and that they are made available to all interested parties.

However, the responsible authority may decide to keep confidential the internal management arrangements laid down in the multiannual programme or in the annual programmes and any other information relating to implementation of the Fund on grounds of public security.

2.   The responsible authority shall provide potential final beneficiaries with at least the following information:

(a)

the conditions of eligibility to be met in order to qualify for financing under an annual programme;

(b)

a description of the procedures for examining applications for funding and of the time periods involved;

(c)

the criteria for selecting the projects to be financed;

(d)

the contacts who can provide information on the annual programmes.

In addition, the responsible authority shall inform potential final beneficiaries of the publication provided for in Article 33(2)(b).
Information for final beneficiaries

Article 32

The responsible authority shall inform final beneficiaries that acceptance of funding also implies acceptance of their inclusion on the list of final beneficiaries published in accordance with Article 33(2)(b).
Responsibilities of the responsible authority relating to information and publicity for the general public

Article 33

1.   The responsible authority shall ensure that information and publicity measures are implemented with the aim of the widest possible media coverage using various forms and methods of communication at the appropriate territorial level.

2.   The responsible authority shall organise at least the following information and publicity measures:

(a)

at least one information activity a year, presenting, as of 2008, the launch of the multiannual programme or the achievements of the annual programme(s);

(b)

annual publication, at least on a website, of the list of final beneficiaries, the names of the projects and the amount of public and Community funding allocated to them. Individuals belonging to the target groups defined in Article 7 of the basic act shall not be named. The address of the website shall be communicated to the Commission.
Responsibilities of final beneficiaries relating to information and publicity for the general public

Article 34

1.   The final beneficiary shall be responsible for informing the public, by means of the measures laid down in paragraphs 2, 3 and 4, about the assistance obtained from the Fund.

2.   The final beneficiary shall put up a permanent prominent plaque of significant size no later than three months after completion of any project that fulfils the following conditions:

(a)

the total Community contribution to the project exceeds 100 000 euros; and

(b)

the operation consists of purchasing a physical object or of financing infrastructure or construction projects.

The plaque shall state the type and name of the project. In addition, the information referred to in Article 35 shall take up at least 25 % of the plaque.

3.   Where a project receives funding under an annual programme co-financed by the Fund, the final beneficiary shall ensure that those taking part in the project have been informed of that funding.

4.   Any document, including any attendance or other certificate, concerning such projects shall include a statement indicating that the project is co-financed by the Fund.
Technical characteristics of information and publicity for the operation

Article 35

All information and publicity measures aimed at final beneficiaries, potential final beneficiaries and the general public shall include:

1)

the emblem of the European Union, in accordance with the graphic standards indicated in Annex X, and a reference to the European Union;

2)

a reference to the Fund;

3)

a statement chosen by the responsible authority, highlighting the added value of the contribution from the Community.

For small promotional items or for promotional items linked to two or more of the four Funds, points 1 and 3 shall not apply.
Protection of personal data

Article 36

1.   Member States and the Commission shall take all necessary measures to prevent any unauthorised disclosure of, or illegitimate access to, the information referred to in Article 27(1)(h) of the basic act, information collected by the Commission in the course of its on-the-spot checks and the information referred to in Chapter 4.

2.   The information referred to in Chapter 4 may not be sent to persons other than those in the Member States or within the Community institutions whose duties require that they have access to it, unless the Member State supplying such information has expressly agreed so.
Electronic exchange of documents

Article 37

In addition to the duly signed paper versions of the documents referred to in Chapter 3, the information shall also be sent, whenever possible, by electronic means.
Computer system for the exchange of documents

Article 38

1.   If the Commission develops a computer system for secure data exchange between the Commission and each Member State for implementation of the Fund, the Member States shall be informed of and, at their request, involved in development of any such computer system.

2.   The Commission and the designated authorities, along with the bodies to which the tasks have been delegated, shall record the documents referred to in Chapter 3 in the computer system mentioned in paragraph 1.

3.   In addition, Member States may be invited voluntarily to provide information referred to in Articles 27 and 28 using the existing specific system managed by the Commission for collecting the irregularities detected under the Structural Funds.

4.   Any costs of an interface between the common computer system and national, regional and local computer systems and any costs of adapting national, regional and local systems to the technical requirements of the common system shall be eligible under Article 17 of the basic act.
Eligibility rules

Article 39

1.   The rules set out in Annex XI shall be used to determine the eligibility of expenditure on action financed under the annual programmes referred to in Article 35(4) of the basic act.

2.   The rules are applicable to expenditure incurred by the final beneficiaries and shall applymutatis mutandisto expenditure incurred by the partners in the project.

3.   Member States may apply national eligibility rules that are more rigorous than those laid down in this Decision.

It shall be for the Commission to evaluate whether the applicable national eligibility rules comply with this condition.
Addressees

Article 40

This Decision is addressed to the Kingdom of Belgium, the Republic of Bulgaria, the Czech Republic, the Federal Republic of Germany, the Republic of Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Grand Duchy of Luxembourg, the Republic of Hungary, the Republic of Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of Poland, the Portuguese Republic, Romania, the Republic of Slovenia, the Slovak Republic, the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 575/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Return Fund for the period 2008 to 2013 as part of the General programme ‘Solidarity and Management of Migration Flows’(1), and in particular Articles 23, 31(5), 33(6) and 35(4) thereof,

(1) It is necessary to lay down the conditions under which Member States should implement the action under the Fund, in particular to identify under which circumstances the responsible authority may implement projects directly. Further provisions should also be laid down for delegated authorities.

(2) It is necessary to identify a list of procedures and/or practical arrangements that the different designated authorities should lay down and follow for implementation of the Fund.

(3) It is necessary to lay down the obligations which the responsible authorities should have with regard to final beneficiaries in the phase leading to selection and approval of the projects to be funded and with regard to the aspects which should be covered by the verifications of the expenditure declared by the final beneficiary and/or by the partners in the project, including administrative verifications of the applications for reimbursement and on-the-spot verifications of individual projects.

(4) In order to ensure that expenditure under annual programmes can be properly audited, it is necessary to set out the criteria with which audit trails should comply in order to be considered adequate.

(5) The audits of projects and of systems are carried out under the responsibility of the audit authority. To ensure that the audits offer adequate scope and effectiveness and are carried out in accordance with the same standards in all Member States, it is necessary to set out the conditions which the audits should fulfil, including the basis for sampling.

(6) The Member States must submit to the Commission, together with their multiannual programme, a description of their management and control systems. Since this document is one of the principal bases on which the Commission relies, in the context of shared management of the Community budget, to determine whether the financial assistance concerned is used by the Member States in accordance with the applicable rules and principles for protecting the Community’s financial interests, it is necessary to set out in detail the information that this document should contain.

(7) In order to harmonise standards for programming, following up the implementation of the Fund, auditing and certifying expenditure, it is necessary to clearly define the contents of the multiannual programme, the annual programme, the progress report, the final report, the applications for payments as well as the audit strategy, the annual audit report, the declaration of validity and the certification of expenditure.

(8) Since Member States are required to report and monitor irregularities and to recover sums wrongly paid in connection with the financing from the Fund, it is necessary to define requirements for the data sent to the Commission.

(9) Experience has shown that citizens of the European Union are insufficiently aware of the role played by the Community in funding programmes. It is therefore appropriate to define in detail the information and publicity measures necessary to bridge this communication and information gap.

(10) In order to guarantee that information on possible funding opportunities is disseminated widely to all interested parties and for the sake of transparency, the minimum measures needed to inform potential final beneficiaries about the financing opportunities offered jointly by the Community and the Member States through the Fund should be set out. In order to enhance transparency about use of the Fund, the list of final beneficiaries, the names of the projects and the amount of public funding allocated to projects should be published.

(11) In the light of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(2)and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data(3), it is necessary to provide, in relation to the information and publicity measures and audit work under this Decision, that the Commission and the Member States should prevent any unauthorised disclosure of or access to personal data and to specify the purpose for which the Commission and the Member States may process such data.

(12) Use of electronic means to exchange information and financial data between the Member States and the Commission leads to simplification, increased efficiency, transparency and time savings. In order to capitalise fully on these advantages while preserving the security of exchanges, a common computer system may be established by the Commission.

(13) To ensure efficient implementation of the Fund in the Member States, in accordance with the principles of sound financial management, a series of common rules should be adopted on the eligibility of expenditure from the Fund. In order to reduce the administrative burden on final beneficiaries and designated authorities, flat rates for indirect costs should be eligible under certain conditions.

(14) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom is bound by the basic act and, as a consequence, by this Decision.

(15) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Ireland is bound by the basic act and, as a consequence, by this Decision.

(16) In accordance with Article 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not bound by this Decision nor subject to application thereof.

(17) The measures provided for in this Decision are in accordance with the opinion of the Management Committee of the Fund,

HAS ADOPTED THIS DECISION:
Subject matter1.   This Decision lays down rules for implementation of the Fund as regards:

(a)

designated authorities;

(b)

management and control systems;

(c)

information to be provided by the Member States to the Commission regarding use of the Fund;

(d)

reporting of irregularities;

(e)

information and publicity;

(f)

personal data;

(g)

electronic exchange of documents.

2.   The provisions set out below shall apply without prejudice to Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities(4).
DefinitionsFor the purposes of this Decision the following definitions shall apply:

—

‘basic act’: Decision No 575/2007/EC,

—

‘Fund’: the European Return Fund, as established by the basic act,

—

‘four Funds’: the European Refugee Fund, the External Borders Fund, the European Return Fund and the European Fund for the Integration of third-country nationals, as established by Decision No 573/2007/EC(5), Decision No 574/2007/EC(6)and Decision No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC(7)as part of the General programme ‘Solidarity and Management of Migration Flows’,

—

‘responsible authority’: the body designated by a Member State under Article 25 (1)(a) of the basic act,

—

‘certifying authority’: the body designated by a Member State under Article 25 (1)(b) of the basic act,

—

‘audit authority’: the body designated by a Member State under Article 25(1)(c) of the basic act,

—

‘delegated authority’: the body designated by a Member State under Article 25 (1)(d) of the basic act,

—

‘designated authorities’: all the authorities designated by a Member State under Article 25 of the basic act,

—

‘action’: action under the Fund, as defined in Article 4 of the basic act,

—

‘project’: specific, practical means deployed to implement all or part of an action by the final beneficiaries of grants,

—

‘final beneficiary’: the legal entity responsible for implementing projects such as NGOs, federal, national, regional or local authorities, other non-profit organisations, private or public-law companies or international organisations,

—

‘partner in the project’: any legal entity which implements a project in cooperation with a final beneficiary by providing the project with resources and by receiving part of the Community contribution through the final beneficiary,

—

‘strategic guidelines’: the framework for intervention by the Fund, as adopted by Commission Decision 2007/837/EC(8),

—

‘priority’: set of actions defined as a priority in the strategic guidelines,

—

‘specific priority’: set of actions defined as a specific priority in the strategic guidelines, allowing co-financing at a higher rate, in accordance with Article 15(4) of the basic act,

—

‘primary administrative or judicial finding’: first written assessment by a competent authority, either administrative or judicial, concluding on the basis of specific facts that an irregularity has been committed, without prejudice to the possibility that this conclusion may subsequently have to be revised or withdrawn as a result of developments in the course of the administrative or judicial procedure,

—

‘irregularity’: any infringement of a provision of Community law resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the European Union by charging an unjustified item of expenditure to the general budget,

—

‘suspected fraud’: an irregularity giving rise to the initiation of administrative or judicial proceedings at national level in order to establish the presence of intentional behaviour, in particular fraud, as referred to in point (a) of Article 1(1) of the Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities’ financial interests(9),

—

‘bankruptcy’: insolvency proceedings, as defined in Article 2(a) of Council Regulation (EC) No 1346/2000(10),

—

‘grant agreement’: an agreement or an equivalent form of legal instrument on the basis of which Member States provide grants to the final beneficiary for the purpose of implementing the project under the Fund.
Common authoritiesMember States may designate the same responsible authority, audit authority or certifying authority for two or more of the four Funds.
Delegated authority1.   Any delegation of tasks shall comply with the principle of sound financial management, which requires effective and efficient internal control, and shall ensure compliance with the principle of non-discrimination and the visibility of Community funding. No implementing tasks delegated may give rise to conflicts of interest.

2.   The scope of the tasks delegated by the responsible authority to the delegated authority and the detailed procedures for implementation of the delegated tasks shall be formally recorded in writing.

The act of delegation shall mention at least:

(a)

the references of the relevant Community legislation;

(b)

the task entrusted to the delegated authority;

(c)

the rights and duties of the delegated authority and the responsibilities it assumes;

(d)

the obligation for the delegated authority to put in place and to maintain an organisational structure and a management and control system adapted to performance of its duties;

(e)

the assurance to be provided concerning sound financial management and the legality and regularity of the delegated tasks.

3.   The handling of communication with the Commission referred to in Article 25(1)(a) of the basic act shall not be delegated. The delegated authority shall communicate with the Commission via the responsible authority.

4.   If the delegated authority is not a public administration or a body governed by the private law of the Member State which has a public-service mission, the responsible authority may not delegate to that authority any executive powers which involve a large measure of discretion implying political choices.

5.   Delegation of tasks to the delegated authorities shall not affect the liability of the responsible authority, which shall remain answerable for the tasks it has delegated.

6.   Where the responsible authority has delegated tasks to the delegated authority, all provisions of this Decision relating to the responsible authority shall applymutatis mutandisto the delegated authority.
Outsourcing of tasksDesignated authorities may outsource some of their tasks but they shall remain answerable for the outsourced tasks in accordance with the responsibilities defined in Articles 27, 29 and 30 of the basic act.
Manual of proceduresIn accordance with Article 31(2) of the basic act and having regard to the principle of proportionality, Member States shall establish a manual setting out procedures and practical arrangements regarding:

(a)

functioning of the designated authorities;

(b)

arrangements ensuring appropriate separation of functions;

(c)

where appropriate, monitoring of delegated authorities and other outsourced tasks;

(d)

establishment of multiannual and annual programmes;

(e)

establishment of audit strategy and annual audit plans;

(f)

selection of projects, award of grants and monitoring and financial management of the projects;

(g)

management of irregularities, financial corrections and recoveries;

(h)

preparation and implementation of audit missions;

(i)

preparation of audit reports and declarations;

(j)

certification of expenditure;

(k)

evaluation of the programme;

(l)

reporting to the Commission;

(m)

audit trail.
Implementation of the Fund by the responsible authority1.   For implementation of the Fund, the responsible authority may act as awarding body and/or as executing body.

2.   The responsible authority acts as awarding body in cases where it implements the projects, as a general rule, on the basis of annual open calls for proposals.

Neither the responsible authority nor any delegated authority may apply in response to these calls for proposals.

In duly justified cases, including continuation of multiannual projects in accordance with Article 15(6) of the basic act which were selected after a previous call for proposals or in emergency situations, grants may be awarded without a call for proposals.

3.   The responsible authority acts as executing body in cases where it decides to implement the projects directly because the characteristics of the projects leave no other choice for implementation, such asde juremonopoly situations or security reasons. In these cases, the rules concerning the final beneficiary shall applymutatis mutandisto the responsible authority.
Conditions under which the responsible authority acts as executing body1.   The reasons which led the responsible authority to act as executing body for implementation of projects shall be identified and communicated to the Commission within the framework of the annual programme concerned.

2.   When implementing the projects, the responsible authority shall ensure the principle of value for money and prevent conflicts of interest.

3.   The responsible authority may implement the projects identified in accordance with Article 7(3) directly and/or in association with any national authority competent on account of its technical expertise, its high degree of specialisation or its administrative powers. The main national authorities involved in implementation shall also be identified in the annual programme concerned.

4.   The administrative decision to co-finance a project under the Fund shall contain the information necessary to monitor the co-financed products and services and to check the expenditure incurred. All relevant provisions laid down for a grant agreement in Article 10(2) shall be specified in an equivalent form of legal instrument.

5.   The final report on implementation of the annual programme shall include information on the procedures and practices applied to ensure adequate separation of functions, effective control and satisfactory protection of the European Communities’ financial interests and shall provide explanations on how conflicts of interest have been avoided.

6.   When the responsible authority is expected to be executing body on a regular basis for projects co-financed by the Fund:

(a)

the audit authority shall not be part of the same body as the responsible authority, except when its audit independence is guaranteed and it also reports to another body outside the body of which it and the responsible authority form part;

(b)

the tasks of the responsible authority, as defined in Article 27 of the basic act, shall not be affected when the responsible authority also implements projects directly.

7.   When a delegated authority is expected to be executing body for projects co-financed by the Fund, this delegated authority may not be the sole final beneficiary of the appropriations which it was delegated to manage.
Selection and award procedure when the responsible authority acts as awarding body1.   The calls for proposals defined in Article 7(2) shall be published in a way that ensures maximum publicity among potential beneficiaries. Any change to the content of the calls for proposals shall also be published under the same conditions.

The calls for proposals shall specify:

(a)

the objectives;

(b)

the selection criteria, which shall comply with Article 15(5) of the basic act, and the relevant supporting documents;

(c)

the arrangements for Community and, if applicable, national financing;

(d)

the arrangements and final date for submission of proposals.

2.   For the purposes of selection of projects and award of grants, the responsible authority shall ensure that potential beneficiaries are informed of the following specific conditions concerning the projects to be implemented:

(a)

the eligibility rules for the expenditure;

(b)

the time-limit for implementation; and

(c)

the financial and other information to be kept and communicated.

Before the award decision is taken the responsible authority shall satisfy itself that the final beneficiary and/or the partners in the project have the capacity to fulfil these conditions.

3.   The responsible authority shall ensure that projects awarded grants have been subject to a formal, technical and budgetary analysis and qualitative assessment applying the criteria laid down in the call for proposals. The reasons for rejection of the other projects shall be recorded.

4.   Member States shall determine who shall have the power to award projects and shall ensure that conflicts of interest are avoided in all cases and, in particular, when the applicants are national bodies.

5.   The award decision shall indicate at least the name of the final beneficiary and/or of the partners in the project, the essential details of the project and its operational objectives, the maximum amount of co-financing from the Fund and the maximum rate of co-financing of the total eligible costs.

6.   Written information shall be sent to each applicant on the results of the selection process containing an explanation of the selection decisions. If provided for in national legislation, the relevant review procedure shall be mentioned.
Grant agreements with final beneficiaries when the responsible authority acts as awarding body1.   The responsible authority shall lay down detailed project management procedures covering,inter alia:

(a)

signature of grant agreements with selected final beneficiaries;

(b)

follow-up of agreements and any amendment thereto by establishing a system for administrative monitoring of projects (exchange of correspondence, issuing and monitoring amendments and reminder letters, receipt and processing of reports, etc.).

2.   The grant agreements shall lay down,inter alia:

(a)

the maximum amount of the grant;

(b)

the maximum percentage of the Community contribution in accordance with Article 15(4) of the basic act;

(c)

a detailed description and timetable of the project supported;

(d)

if applicable, the part of the tasks and related costs that the final beneficiary intends to subcontract to third parties;

(e)

the agreed forward budget and financing plan for the project, including the fixed percentage of indirect costs as defined in Annex XI regarding the rules on eligibility of expenditure;

(f)

the timetable and provisions for implementation of the agreement (reporting obligations, amendments and termination);

(g)

the operational objectives of the project and the indicators to be used;

(h)

the definition of eligible costs;

(i)

the conditions relating to payment of the grant and bookkeeping requirements;

(j)

the conditions relating to audit trail;

(k)

the relevant provisions relating to data protection;

(l)

the relevant provisions relating to publicity.

3.   If appropriate, the final beneficiaries shall ensure that all partners in the project are subject to the same obligations as them. The partners shall engage their responsibility through the final beneficiary which remains answerable, in last resort, for the respect of the contractual conditions by itself and all partners in the project.

The final beneficiaries shall keep certified copies of the accounting documents justifying income and expenditure incurred by the partners in relation to the project concerned.

4.   The grant agreements shall provide expressly for the Commission and the Court of Auditors to exercise their powers of control, based on documents and on the premises, over all final beneficiaries, partners in the project and subcontractors.
Implementation contractsWithout prejudice to the applicable Community and national public procurement rules, the grant agreements shall lay down that, when implementing the projects, the final beneficiaries and/or the partners in the project shall award the procurement contract, following a tendering procedure, to the tender offering best value for money and that care be taken to avoid any conflict of interest. However, without prejudice to the applicable Community and national public procurement rules, contracts with a value of less than 5 000 euros may be awarded on the basis of a single offer without a call for tender.
Determination of the final Community contributionFor calculation of the final payment to the final beneficiary, the total Community contribution to each project shall be the lowest of the following three amounts:

(a)

the maximum amount stated in the grant agreement;

(b)

the maximum co-financing resulting from multiplication of the total eligible costs of the project concerned by the percentage laid down in Article 15(4) of the basic act (i.e. 50 % or 75 %); and

(c)

the amount resulting from application of the principle of non-profit, as defined in point I.3.3 of Annex XI.
Technical assistance1.   Technical assistance at the initiative of the Commission, as defined in Article 16 of the basic act, may be financed up to 100 % by the Fund.

2.   Technical assistance at the initiative of the Member States, as defined in Article 17 of the basic act, may be financed up to 100 % by the Fund.

3.   Technical assistance at the initiative of the Commission or the Member States may take the form of procurement contracts, expert fees and/or any administrative expenditure subject to the eligibility rules defined in Part III, Chapter 1.
Technical assistance expenditure in the case of a common authority1.   When one or more designated authorities are common to two or more of the four Funds, the appropriations for the technical assistance expenditure on each of the annual programmes concerned may be merged, partly or entirely.

2.   The expenditure on technical assistance shall be allocated between the Funds concerned, preferably on the basis of simple and representative apportionment formulae. Application of the formulae shall not lead to any increase in the maximum amount of technical assistance expenditure on each annual programme concerned.
Verifications by the responsible authority1.   The verifications to be carried out by, or under the responsibility of, the responsible authority under Article 27(1)(g) of the basic act shall cover administrative, financial, technical and physical aspects of projects, as appropriate.

The verifications shall ensure that the expenditure declared is real and justified for the purpose of the project, that the projects granted have been delivered in accordance with the grant agreements, that the Community contribution complies with the rules, in particular regarding the financing structure defined in Article 15 of the basic act, that the applications for reimbursement by the final beneficiary are correct and that the projects and expenditure comply with Community and national rules and avoid double-financing of expenditure with other Community or national schemes and with other programming periods.

Moreover, the verifications shall include:

(a)

administrative and financial verifications of each application for reimbursement sent by the final beneficiaries;

(b)

verifications, at least on a representative sample of the supporting documents covering all headings of the budget annexed to the grant agreement, of the relevance, accuracy and eligibility of the expenses, income and costs covered by assigned income declared by the final beneficiaries;

(c)

on-the-spot verifications of individual projects, at least on a sample representing an appropriate mix of types and sizes of projects and taking account of any risk factors already identified, in order to achieve reasonable assurance as to the legality and regularity of the underlying transactions, having regard to the level of risk identified by the responsible authority.

The verifications indicated in points (a) and (b) do not have to be carried out if an obligation is imposed on the final beneficiary to provide an audit certificate from an independent auditor which covers all the aspects mentioned in points (a) and (b).

2.   Records shall be kept of each verification, stating the work performed, the date, the results and the measures taken in response to errors detected. The responsible authority shall ensure that all the supporting documents regarding the verifications performed are kept available for the Commission and the Court of Auditors for a period of five years following closure of the project. This period shall be interrupted in the event of legal proceedings or at the duly substantiated request of the Commission.

3.   Where the responsible authority acts as executing body under the annual programme, as defined in Article 7(3), the verifications referred to in paragraph 1 shall be implemented in accordance with the principle of adequate separation of functions.
Audit trail1.   For the purposes of Article 27(1)(k) of the basic act, an audit trail shall be considered adequate if it complies with the following criteria:

(a)

it permits reconciliation of the amounts certified to the Commission with the detailed accounting records and supporting documents held by the certifying authority, responsible authority, delegated authorities and final beneficiaries on projects co-financed under the Fund;

(b)

it permits verification of payment of the public contribution to the final beneficiary, of allocation and transfer of the Community funding granted under the Fund and of the sources of co-financing of the project;

(c)

it permits verification of application of the selection criteria established for the annual programme;

(d)

it contains in respect of each project, as appropriate, the technical specifications and financing plan, documents concerning grant approval, documents relating to public procurement procedures and reports on the verifications and audits carried out.

2.   The responsible authority shall ensure that a record is kept of the location of all documents relating to specific payments made under the Fund.
Audits of systems and audits of projects1.   The audits referred to in Article 30(1)(a) and (b) of the basic act shall be carried out on the management and control systems established by the Member States and on a sample of projects selected by a method approved by the audit authority.

The sampling method shall:

(a)

include an appropriate mix of types and sizes of projects;

(b)

take account of any risk factors which have been identified by national or Community controls and the cost-benefit aspects of the verifications.

The sample shall also include projects implemented by the responsible authority acting as executing body at least on a proportional basis.

The method used to select the sample shall be documented.

2.   The audit on the management and control systems shall cover each of the following processes at least once before 2013: programming, delegation of tasks, selection and award, monitoring of the projects, payment, certification of expenditure, reporting to the Commission, detection and treatment of potential irregularities and evaluation of the programmes.

3.   The audits of projects shall be carried out on the spot on the basis of documentation and records held by the final beneficiary and/or the partners in the project. The audits shall verify that:

(a)

the project meets the selection criteria for the annual programme, has been implemented in accordance with the grant agreement and fulfils any applicable conditions concerning its functionality and use or the objectives to be attained;

(b)

the expenditure declared corresponds to the accounting records and supporting documents held by the final beneficiary and/or by the partners in the project, and those records correspond to the supporting documents kept by the responsible authority or any delegated body;

(c)

the items of expenditure correspond to the eligibility requirements set out in Annex XI, to the requirements specified during the national selection procedure, to the terms of the grant agreement and to the works actually carried out and, where appropriate, to other Community and national rules;

(d)

the use or intended use of the project is consistent with the objectives, action or measures set out in Articles 2, 3, 4, 5 and 17 of the basic act and, where appropriate, covers the target population;

(e)

the public or private contribution has been paid to the final beneficiary in accordance with Article 15(2) of the basic act;

(f)

there is an adequate audit trail;

(g)

there are no conflicts of interest and good value for money has been achieved, in particular in cases where the responsible authority acts as executing body of the project.

4.   Only expenditure within the scope of an audit carried out under paragraph 3 shall be counted towards the amount of expenditure audited for the purpose of Article 30(1)(b) of the basic act. If the audit is performed before the project has been closed, only the expenditure actually audited is taken into account to calculate the coverage rate.

5.   Where problems detected appear to be systemic in nature and may therefore entail a risk to other projects, the audit authority shall ensure that further examination is carried out, including additional audits where necessary, to establish the scale of such problems. The necessary preventive and corrective measures shall be taken by the relevant authorities.

6.   The audit authority shall draw conclusions on the basis of the results of the audits relating to expenditure declared to the Commission and shall communicate the conclusions to the Commission in the annual audit report. In annual programmes for which the error rate is above the materiality level of 2 % of the Community contribution, the audit authority shall analyse the significance of this error and take the necessary measures, including making appropriate recommendations, which shall be communicated at least in the annual audit report.
Verifications by the certifying authority1.   In cases where the audit authority gives a qualified opinion or an adverse opinion on the functioning of the management and control system, the certifying authority shall verify that this information has been sent to the Commission. It shall also ensure that an adequate action plan has been implemented by the responsible authority to restore effectively functioning management and control systems and to assess the impact of the malfunctioning on the declaration of expenditure.

2.   If the request for payment or statement of reimbursement is not validated by the audit authority for the final report on implementation of the annual programme, the certifying authority shall ensure that a correct request for payment or statement of reimbursement is established without delay.
Principle of proportionality1.   Pursuant to Article 10(2) of the basic act, the extent to which the information available to a Member State on use of the Fund is transmitted to the Commission in the documents referred to in this chapter may be proportionate to the amount of the Community contribution allocated to the Member State concerned and, where appropriate, this information may be provided in summarised form.

2.   However, upon a request from the Commission, the Member State shall nevertheless provide more detailed information. The Commission may request this information if it appears necessary in order for the Commission to fulfil effectively its obligations under the basic act and the Financial Regulation.
Description of management and control systems1.   The description of the management and control systems referred to in Articles 31(4) and 32(2) of the basic act shall be submitted in accordance with the model in Annex I.

2.   The responsible authority shall validate the description of the systems implemented by any delegated authority. Each of the designated authorities shall confirm the accuracy of the description of the management and control systems which concerns it. In addition, the audit authority shall also confirm the completeness of the description.

3.   When examining the description, the Commission may request clarifications and propose measures to comply with the provisions defined in the basic act. If necessary, on-site visits may be carried out by Commission officials or authorised Commission representatives.

4.   If the responsible authority is the same for two or more of the four Funds or where common systems apply to two or more of the Funds, a description of the common management and control systems may be submitted highlighting, where appropriate, any specific features.
Revision of the description of management and control systems1.   The responsible authority shall:

(a)

when submitting the draft annual programme, report whether changes have been made to the management and control systems;

(b)

notify the Commission of any substantial change at the latest once any such change has taken effect;

(c)

at the request of the Commission, provide a revised description in the event of multiple substantial changes.

2.   Substantial changes are changes which are likely to have an impact on the separation of functions, on the effectiveness of selection, award, control and payment mechanisms and on communication with the Commission. They shall include, in particular, changes in one of the designated authorities, in the accounting system and in the payment and certification processes.

3.   Revision of the management and control systems shall follow the same procedure as laid down in Article 20.
Programming documents1.   Member States shall submit to the Commission a multiannual programme, as referred to in Article 19 of the basic act, in accordance with the model in Annex II.

2.   Member States shall submit to the Commission the annual programmes, as referred to in Article 21 of the basic act, in accordance with the model in Annex III.

3.   The financial plans linked to the multiannual programme shall present a breakdown of the budgeted amounts by priority, as defined in the strategic guidelines.

The financial plans linked to the annual programmes shall present a breakdown of the budgeted amounts by category of action, as defined in Article 4 of the basic act, with a reference to the priorities.
Revision of financial breakdown in annual programmes1.   In order to revise the annual programme approved by the Commission pursuant to Article 21(5) of the basic act, the Member State concerned shall submit a revised draft annual programme to the Commission before 1 May of the year following the reference year. The Commission shall examine and, as soon as possible, approve the revised programme in accordance with the procedure laid down in Article 21(5) of the basic act.

2.   Changes to the financial breakdown without revision of the annual programme pursuant to paragraph 1 shall not exceed 10 % of the total contribution from the Fund and shall be allowed only in circumstances justified by causes beyond the control of the responsible authority. An adequate explanation of any such changes shall be provided in the progress report and/or in the final report on the implementation of the annual programme.
Progress and final reports on implementation of annual programmes1.   Member States shall submit to the Commission the progress reports on implementation of the annual programme and payment requests, as referred to in Article 39(4) of the basic act, in accordance with the model in Annex IV.

2.   Member States shall submit to the Commission the final reports on implementation of the annual programme and payment requests, as referred to in Article 40(1)(b) of the basic act, in accordance with the model in Annex V.

3.   The financial tables linked to the progress reports and final reports shall present a breakdown of the amounts both by priority, as defined in the strategic guidelines, and by projects for each category of action, as defined in Article 4 of the basic act.
Documents established by the audit authority1.   The audit strategy referred to in Article 30(1)(c) of the basic act shall be established in accordance with the model in Annex VI.

2.   Except when each of the last two annual programmes adopted by the Commission corresponds to an annual Community contribution below 1 million euros, the audit authority shall submit an annual audit plan before 15 February each year, as from 2009. The audit plan shall be established as an annex to the audit strategy in accordance with the model in Annex VI. In the case of a combined audit strategy, as provided for in Article 30(2) of the basic act, a combined annual audit plan may be submitted.

3.   The audit report and the opinions referred to in Articles 30(3)(a) and 30(3)(b) of the basic act shall be based on the systems audits and audits of projects carried out in accordance with the audit strategy and shall be drawn up in accordance with the models in Annexes VII.A and VII.B.

4.   The validity declaration referred to in Article 30(3)(c) of the basic act shall be based on all the audit work carried out by the audit authority and on additional checks, if necessary. The validity declaration shall be drawn up in accordance with the model in Annex VII.C.

5.   If there is any limitation on the scope of the examination or if the level of irregular expenditure detected does not allow provision of an unqualified opinion for the annual opinion referred to in Article 30(3)(b) of the basic act or in the declaration referred to in point (c) of the same Article, the audit authority shall give the reasons and estimate the scale of the problem and its financial impact.
Documents established by the certifying authority1.   The certified declaration of expenditure relating to the request for a second pre-financing payment referred to in Article 39(4) of the basic act shall be drawn up and transmitted to the Commission in the format in Annex VIII.

2.   The certified declaration of expenditure relating to the request for a final payment referred to in Article 40(1)(a) of the basic act shall be drawn up and transmitted to the Commission in the format in Annex IX.
Initial reporting — derogations1.   In accordance with the models in Annexes IV and V, Member States shall report to the Commission any irregularity which has been the subject of a primary administrative or judicial finding in the progress or final reports on implementation of the annual programmes.

The report shall indicate:

(a)

the Fund, the annual programme and the project concerned;

(b)

the provision which has been infringed;

(c)

the date and the source of the first information leading to suspicion that an irregularity has been committed;

(d)

the practices employed in committing the irregularity;

(e)

where appropriate, whether the practice gives rise to a suspicion of fraud;

(f)

the manner in which the irregularity was discovered;

(g)

the amount of the Community contribution concerned.

However, the following cases need not be reported, except in cases of suspected fraud:

(a)

cases where the irregularities relate to amounts of less than 10 000 euros chargeable to the general budget of the European Communities;

(b)

cases where the irregularity consists solely of failure to implement, in whole or in part, a project included in the annual programme owing to the bankruptcy of the final beneficiary;

(c)

cases brought to the attention of the responsible authority by the final beneficiary voluntarily and before detection by the responsible authority, whether before or after payment of the public contribution;

(d)

cases detected and corrected by the responsible authority before any payment of the public contribution to the final beneficiary and before inclusion of the expenditure concerned in a declaration of expenditure submitted to the Commission.

2.   At the request of the Commission, Member States shall in all cases give further details concerning:

(a)

where appropriate, the other Member States and third countries involved;

(b)

the period during which, or the moment at which, the irregularity was committed;

(c)

the national authorities or bodies which drew up the official report on the irregularity and the authorities responsible for the administrative or judicial follow-up;

(d)

the date on which the primary administrative or judicial finding on the irregularity was established;

(e)

the identity of the natural and legal persons involved or of any other participating entities, except where this information is irrelevant for the purposes of combating irregularities, given the nature of the irregularity concerned;

(f)

the total budget and the public contribution approved for the project and the distribution of its co-financing between the Community and national contributions;

(g)

the amount of the public contribution affected by the irregularity and the corresponding Community contribution at risk;

(h)

where no payment of the public contribution referred to under point (g) has been made to the persons or other entities identified, the amounts which would have been unduly paid had the irregularity not been identified;

(i)

the suspension of payments, where applicable, and the possibilities of recovery;

(j)

the nature of the irregular expenditure.

3.   Where some of the information referred to in paragraph 2, in particular on the practices employed in committing the irregularity and on the manner in which the irregularity was discovered, is not available, Member States shall as far as possible supply the missing information when forwarding subsequent reports of irregularities to the Commission.
Reporting of follow-up — Non-recovery1.   Member States shall inform the Commission, with reference to any previous report made under Article 27, of the procedures instituted with respect to all irregularities previously notified and of significant changes resulting from them. This information shall be given in the progress reports or final reports on implementation of the annual programmes in accordance with the models in Annexes IV and V.

The report shall indicate the amounts which have been, or are expected to be, recovered.

2.   At the request of the Commission, Member States shall in all cases give further details concerning:

(a)

any interim measures taken by Member States to safeguard recovery of sums unduly paid;

(b)

any judicial and administrative procedures instituted with a view to recovering sums unduly paid and to imposing sanctions;

(c)

the reasons for any abandonment of recovery procedures;

(d)

the reasons for any abandonment of criminal prosecutions.

Member States shall report to the Commission all administrative or judicial decisions terminating such procedures, or the main points thereof, and shall state, in particular, whether or not the findings are such that fraud is suspected.
Contacts with Member States1.   The Commission shall maintain appropriate contacts with the Member States concerned for the purpose of supplementing the information supplied on the irregularities referred to in Article 27 and on the procedures referred to in Article 28 on the possibility of recovery.

2.   Independently of the contacts referred to in paragraph 1, the Commission shall inform Member States in cases where the nature of the irregularity is such as to suggest that identical or similar practices could occur in other Member States.
Use of information1.   The Commission may use any information of a general or operational nature communicated by Member States under this Decision to perform risk analyses and may, on the basis of the information obtained, produce reports and develop early-warning systems serving to identify risks more effectively.

2.   The Commission shall regularly inform the Member States concerned of the use made of information under paragraph 1.
Information for potential final beneficiaries1.   The responsible authority shall ensure that the key indications regarding the multiannual and annual programmes are disseminated widely, with details of the financial contributions concerned, and that they are made available to all interested parties.

However, the responsible authority may decide to keep confidential the internal management arrangements laid down in the multiannual programme or in the annual programmes and any other information relating to implementation of the Fund on grounds of public security.

2.   The responsible authority shall provide potential final beneficiaries with at least the following information:

(a)

the conditions of eligibility to be met in order to qualify for financing under an annual programme;

(b)

a description of the procedures for examining applications for funding and of the time periods involved;

(c)

the criteria for selecting the projects to be financed;

(d)

the contacts who can provide information on the annual programmes.

In addition, the responsible authority shall inform potential final beneficiaries of the publication provided for in Article 33(2)(b).
Information for final beneficiariesThe responsible authority shall inform final beneficiaries that acceptance of funding also implies acceptance of their inclusion on the list of final beneficiaries published in accordance with Article 33(2)(b).
Responsibilities of the responsible authority relating to information and publicity for the general public1.   The responsible authority shall ensure that information and publicity measures are implemented with the aim of the widest possible media coverage using various forms and methods of communication at the appropriate territorial level.

2.   The responsible authority shall organise at least the following information and publicity measures:

(a)

at least one information activity a year, presenting, as of 2008, the launch of the multiannual programme or the achievements of the annual programme(s);

(b)

annual publication, at least on a website, of the list of final beneficiaries, the names of the projects and the amount of public and Community funding allocated to them. Individuals belonging to the target groups defined in Article 7 of the basic act shall not be named. The address of the website shall be communicated to the Commission.
Responsibilities of final beneficiaries relating to information and publicity for the general public1.   The final beneficiary shall be responsible for informing the public, by means of the measures laid down in paragraphs 2, 3 and 4, about the assistance obtained from the Fund.

2.   The final beneficiary shall put up a permanent prominent plaque of significant size no later than three months after completion of any project that fulfils the following conditions:

(a)

the total Community contribution to the project exceeds 100 000 euros; and

(b)

the operation consists of purchasing a physical object or of financing infrastructure or construction projects.

The plaque shall state the type and name of the project. In addition, the information referred to in Article 35 shall take up at least 25 % of the plaque.

3.   Where a project receives funding under an annual programme co-financed by the Fund, the final beneficiary shall ensure that those taking part in the project have been informed of that funding.

4.   Any document, including any attendance or other certificate, concerning such projects shall include a statement indicating that the project is co-financed by the Fund.
Technical characteristics of information and publicity for the operationAll information and publicity measures aimed at final beneficiaries, potential final beneficiaries and the general public shall include:

1)

the emblem of the European Union, in accordance with the graphic standards indicated in Annex X, and a reference to the European Union;

2)

a reference to the Fund;

3)

a statement chosen by the responsible authority, highlighting the added value of the contribution from the Community.

For small promotional items or for promotional items linked to two or more of the four Funds, points 1 and 3 shall not apply.
Protection of personal data1.   Member States and the Commission shall take all necessary measures to prevent any unauthorised disclosure of, or illegitimate access to, the information referred to in Article 27(1)(h) of the basic act, information collected by the Commission in the course of its on-the-spot checks and the information referred to in Chapter 4.

2.   The information referred to in Chapter 4 may not be sent to persons other than those in the Member States or within the Community institutions whose duties require that they have access to it, unless the Member State supplying such information has expressly agreed so.
Electronic exchange of documentsIn addition to the duly signed paper versions of the documents referred to in Chapter 3, the information shall also be sent, whenever possible, by electronic means.
Computer system for the exchange of documents1.   If the Commission develops a computer system for secure data exchange between the Commission and each Member State for implementation of the Fund, the Member States shall be informed of and, at their request, involved in development of any such computer system.

2.   The Commission and the designated authorities, along with the bodies to which the tasks have been delegated, shall record the documents referred to in Chapter 3 in the computer system mentioned in paragraph 1.

3.   In addition, Member States may be invited voluntarily to provide information referred to in Articles 27 and 28 using the existing specific system managed by the Commission for collecting the irregularities detected under the Structural Funds.

4.   Any costs of an interface between the common computer system and national, regional and local computer systems and any costs of adapting national, regional and local systems to the technical requirements of the common system shall be eligible under Article 17 of the basic act.
Eligibility rules1.   The rules set out in Annex XI shall be used to determine the eligibility of expenditure on action financed under the annual programmes referred to in Article 35(4) of the basic act.

2.   The rules are applicable to expenditure incurred by the final beneficiaries and shall applymutatis mutandisto expenditure incurred by the partners in the project.

3.   Member States may apply national eligibility rules that are more rigorous than those laid down in this Decision.

It shall be for the Commission to evaluate whether the applicable national eligibility rules comply with this condition.
AddresseesThis Decision is addressed to the Kingdom of Belgium, the Republic of Bulgaria, the Czech Republic, the Federal Republic of Germany, the Republic of Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Grand Duchy of Luxembourg, the Republic of Hungary, the Republic of Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of Poland, the Portuguese Republic, Romania, the Republic of Slovenia, the Slovak Republic, the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.
ANNEXES

ANNEX I | Model description of management and control systems | 152

ANNEX II | Model multiannual programme | 168

ANNEX III | Model annual programme | 170

ANNEX IV | Model progress report on implementation of the annual programme | 172

A. | Technical report | 172

B. | Request for the second pre-financing payment | 174

ANNEX V | Model final report on implementation of the annual programme | 176

A. | Technical report | 176

B. | Request for payment of the balance/Statement of reimbursement | 181

ANNEX VI | Model audit strategy | 182

 | Annex(es) to the audit strategy: Annual plans | 183

ANNEX VII | Model report by the audit authority | 184

A. | Annual audit report | 184

B. | Opinion on the functioning of the management and control systems | 185

C. | Validation of the payment request | 187

ANNEX VIII | Model declaration of expenditure for the second pre-financing | 189

ANNEX IX | Model declaration of expenditure for payment of the balance | 190

ANNEX X | Instructions concerning the emblem and definition of the standard colours | 191

ANNEX XI | Rules on the eligibility of expenditure — return fund | 193
1.   IDENTIFICATION OF THE DESIGNATED AUTHORITIESANNEX IMODEL DESCRIPTION OF MANAGEMENT AND CONTROL SYSTEMS

 | Initial version

 | Revised version (number, date dd/mm/year) following dialogue with the Commission

 | Version revised for other reasons

MEMBER STATE:

FUND(S):

MAIN CONTACT POINT:

THE INFORMATION PROVIDED DESCRIBES THE SITUATION ON:
 | 1.1. | General information on the designated authorities

 | 1.1.1. | Short description of the choices made on the designation of the different authorities

 | 1.1.2. | Indication of whether these management and control systems are operationalIf not, indication of the date when they will be operational

 | 1.1.3. | Indication of whether these management and control systems have been accredited by the Commission for other Community financial instruments (if applicable)

 | 1.2. | Organisation chart(s) of the entire body(-ies) within which the designated authorities are functioning

 | 1.3. | Responsible authority

 | 1.3.1. | The date and form of the formal designation of the responsible authority

 | 1.3.2. | Legal status of the responsible authority

 | 1.3.3. | Specification of the functions carried out directly by the responsible authority and (if applicable and/or foreseen) by other bodies under the responsibility of the responsible authority (outsourcing of tasks, excluding the tasks entrusted to the delegated authority(ies) under point 1.4)

 | 1.3.4. | Organisation chart and specification of the functions of the units (including the indicative number of posts allocated)

 | 1.3.5. | Information whether the responsible authority can also act as executing body for the projects co-financed by the Fund

 | 1.3.6. | If the responsible authority is the same for more than one of the four Funds, a description of the common functions and systems

 | 1.4. | The delegated authority(ies)

 | 1.4.1. | The reasons for establishing any delegated authority

 | 1.4.2. | The date and form of the formal designation of the delegated authority(ies)

 | 1.4.3. | Legal status of the delegated authority(ies)

 | 1.4.4. | Specification of the functions carried out directly by the delegated authority(ies) and (if applicable and/or foreseen) by other bodies under the responsibility of the delegated authority(ies) (outsourcing of tasks)

 | 1.4.5. | Organisation chart and specification of the functions of the units (including indicative number of posts allocated)

 | 1.4.6. | Information whether delegated authority(ies) can also act as executing body for the projects co-financed by the Fund

 | 1.4.7. | If the delegated authority(ies) is (are) the same for more than one of the four Funds, a description of the common functions and systems

 | 1.5. | Certifying authority

 | 1.5.1. | The date and form of the formal designation of the certifying authority

 | 1.5.2. | Legal status of the certifying authority

 | 1.5.3. | Specification of the functions carried out directly by the certifying authority and (if applicable and/or foreseen) by other bodies under the responsibility of the certifying authority (outsourcing of tasks)

 | 1.5.4. | Organisation chart and specification of the functions of the units (including indicative number of posts allocated)

 | 1.5.5. | If the certifying authority is the same for more than one of the four Funds, a description of the common functions and systems

 | 1.6. | Audit authority

 | 1.6.1. | The date and form of the formal designation of the audit authority

 | 1.6.2. | Legal status of the audit authority

 | 1.6.3. | Specification of the functions carried out directly by the audit authority and (if applicable and/or foreseen) by other bodies under the responsibility of the audit authority (outsourcing of tasks)

 | 1.6.4. | Organisation chart and specification of the functions of the units (including indicative number of posts allocated)

 | 1.6.5. | Staff qualifications for the audit authority and (if applicable and/or foreseen) of the other bodies expected to carry out audit work (outsourcing of tasks)

 | 1.6.6. | If the audit authority is the same for more than one of the four Funds, a description of the common functions and systems

 | 1.6.7. | If a responsible authority can also act as executing body for the projects co-financed by the Fund, a description of arrangements ensuring the independent position of the audit authority in accordance with article 8

Guidance for sections 2-4

1st part of each table

The description of the processes should include the tasks to be carried out by each of the designated authorities (or bodies under their responsibility) and the interaction between them. The description should be concise but nevertheless allow a clear understanding of how the processes would work in practice.

2nd part of each table

The checklist should be completed by indicating whether each target has been achieved or not and providing any relevant information. If the target has not been achieved, please provide an explanation and, if relevant, indicate the expected date for completion.

If procedures are formalised, a reference to the document should be included.

2.   FUNCTIONING OF DESIGNATED AUTHORITIES

2.1.Designation and supervision of the designated authorities | 2.1. | Designation and supervision of the designated authorities

2.1. | Designation and supervision of the designated authorities

Short description of the process of setting up each of the designated authorities[The description should include all authorities]

 | Key targets | Achieved? | Comments

1 | Rules governing the relations of the Member State with the designated authorities identify the respective responsibilities | Y/N | 

2 | Member State have provided guidance to the designated authorities to ensure sound financial management (through training and/or manuals) | Y/N | 

3 | Each authority will inform their staff of the mission statement of the organisation as well as their job description and expected results | Y/N | 

4 | Steps have been taken to ensure that the different authorities are adequately staffed in terms of numbers, seniority and experience in order to carry out their functions | Y/N | 
2.2.Separation of functions | 2.2. | Separation of functions

2.2. | Separation of functions

Short description of the arrangements defined to ensure a proper separation of functions[The description should include all authorities]

 | Key targets | Achieved? | Comments

1 | Rules are defined to ensure a proper separation of functions between actors within the responsible authority for the signature of contracts/grant agreements | Y/N | 

2 | Rules are defined to ensure a proper separation of functions between actors within the responsible authority for the initiation, verification and approval of financial transactions | Y/N | 

3 | The audit authority will be functionally independent of the responsible authority and the certifying authority. | Y/N | 

4 | The certifying authority will not be involved in the selection, implementation and financial transactions related to Community resources | Y/N | 
2.3.Monitoring of delegated authority(ies) — if applicable | 2.3. | Monitoring of delegated authority(ies) — if applicable

2.3. | Monitoring of delegated authority(ies) — if applicable

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | The tasks to be delegated are clearly defined | Y/N | 

2 | Procedures are established concerning the delegated tasks and their compliance with the rules defined in the basic act/implementing rules has been checked | Y/N | 

3 | Supervisory controls will take place to ensure that the tasks are carried out according to established procedures | Y/N | 
2.4.Monitoring of other tasks not carried out by the authorities themselves — if applicable | 2.4. | Monitoring of other tasks not carried out by the authorities themselves — if applicable

2.4. | Monitoring of other tasks not carried out by the authorities themselves — if applicable

Short description of the process[This description should include all authorities]

 | Key targets | Achieved? | Comments

1 | In case of bodies acting under the responsibility of the responsible authority (and not considered as delegated authorities), supervisory mechanisms are in place to ensure sound financial management | Y/N | 

2 | In case of outsourcing of audit activities and in case of bodies acting under the responsibility of the audit authority, supervisory mechanisms are in place to ensure a common audit methodology and consistency of the audit work | Y/N | 

3 | In case of outsourcing of certifying activities and in case of bodies acting under the responsibility of the certifying authority, supervisory mechanisms are in place to ensure a common approach to certification | Y/N | 

4 | In case of outsourcing to private bodies without a public-service mission, mechanisms are defined to ensure that the tasks which may be entrusted do not include the exercise of public authority or require the use of discretionary powers of judgment | Y/N | 3.   OPERATIONAL AND FINANCIAL PROCESSES

3.1.Establishing multi-annual programmes | 3.1. | Establishing multi-annual programmes

3.1. | Establishing multi-annual programmes

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | Arrangements are foreseen to ensure the implementation of the principle of partnership in accordance with current national rules and practices | Y/N | 

2 | Procedures are defined to check that the multi-annual programme is consistent with the strategic guidelines and complies with Community law, in particular with Community law aiming at ensuring the free movement of persons in conjunction with the directly related flanking measures with respect to external border controls, asylum and immigration | Y/N | 

3 | The multi-annual programme will be approved by a duly authorised person | Y/N | 
3.2.Establishing annual programmes | 3.2. | Establishing annual programmes

3.2. | Establishing annual programmes

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | Procedures are established to ensure:—consistency between the annual programmes and the multi-annual programme—the eligibility of the actions envisaged in the annual programmes—consistency and complementarity of these actions with other national and Community instruments—the compliance with the rules concerning co-financing percentage—consistency with the priorities/specific priorities stated in the strategic guidelines | — | consistency between the annual programmes and the multi-annual programme | — | the eligibility of the actions envisaged in the annual programmes | — | consistency and complementarity of these actions with other national and Community instruments | — | the compliance with the rules concerning co-financing percentage | — | consistency with the priorities/specific priorities stated in the strategic guidelines | Y/N | 

— | consistency between the annual programmes and the multi-annual programme

— | the eligibility of the actions envisaged in the annual programmes

— | consistency and complementarity of these actions with other national and Community instruments

— | the compliance with the rules concerning co-financing percentage

— | consistency with the priorities/specific priorities stated in the strategic guidelines

2 | Procedures are established to enable the revision of an annual programme in case of duly substantiated emergency situations as described in the basic act, if applicable | Y/N | 

3 | Procedures are established to enable the submission of a revision of an annual programme when required under Article 23(1) of this decision | Y/N | 

4 | Any modification to the financial breakdown of an annual programme and the reasons for it is documented | Y/N | 

5. | Any modification in the implementation of the annual programme not relating to the financial breakdown (e.g. on nature and timing of the calls for proposals or the scope of technical assistance) and the reason for it is documented | Y/N | 
3.3.Establishing the audit strategy and the annual audit plans | 3.3. | Establishing the audit strategy and the annual audit plans

3.3. | Establishing the audit strategy and the annual audit plans

Short description of the process[This description concerns the audit authority]

 | Key targets | Achieved? | Comments

1 | Rules are defined to ensure a transparent and appropriate communication from the responsible authority to the audit authority on management procedures implemented and on projects prior to and throughout the programming period | Y/N | 

2 | Procedures are established to define annual audit plans (to be annexed each year to the audit strategy) and to send them to the Commission in time (if applicable) | Y/N | 

3 | The audit strategy and the annual audit plans are approved by a duly authorised person | Y/N | 
3.4.Responsible authority acting as an executing body — if applicable | 3.4. | Responsible authority acting as an executing body — if applicable

3.4. | Responsible authority acting as an executing body — if applicable

Short description of the reasons leading the responsible authority to implement projects directly and the specific arrangements foreseen to strengthen the management and control systems[This description should include all authorities]

 | Key targets | Achieved? | Comments

1 | The justification of the need for the responsible authority to implement projects will be documented and endorsed at the appropriate level | Y/N | 

2 | Specific arrangements are put in place to ensure that the nature and the objectives of the projects comply with the provisions defined for the Fund |  | 

3 | Specific arrangements are put in place in order to prevent conflict of interest for the projects implemented by the responsible authority | Y/N | 

4 | Specific arrangements are put in place to ensure the principle of value for money is respected in the implementation of projects by the responsible authority | Y/N | 

5 | Procedures are defined to ensure that the contractual terms governing these projects are clear and complete in particular with regard to the financing conditions, the payment terms, the eligibility rules and the obligations regarding operational and financial reporting | Y/N | 

6 | Specific arrangements are put in place in order to ensure that the main functions of the responsible authority as provided for in the basic act are not affected in relation to the projects implemented by the responsible authority | Y/N | 

7 | When the responsible authority acts as an executing body, the audit authority is located in another body than the responsible authority (if not, please describe the additional guarantees put in place to ensure the proper independence of the audit authority) | Y/N | 

8 | The audit strategy will cover the specific risks which may be related to the implementation of projects by the responsible authority | Y/N | 
3.5.Selection and implementation of the projects (Responsible authority acting as an awarding body) | 3.5. | Selection and implementation of the projects (Responsible authority acting as an awarding body)

3.5. | Selection and implementation of the projects (Responsible authority acting as an awarding body)

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | In the case of call for proposals (or tenders), rules are defined to ensure open competition and adequate publicity | Y/N | 

2 | Selection criteria will comply with the minimum criteria defined in the basic act | Y/N | 

3 | Procedures are defined for the receipt of proposals (or tenders) | Y/N | 

4 | Procedures are defined to ensure that the proposals (or tenders) are assessed against the predefined rules and criteria in a transparent and non-discriminatory manner | Y/N | 

5 | The award decisions and the contracts/grant agreements will be approved by a duly authorised person | Y/N | 

6 | Procedures are defined to ensure adequate ex-post information on the results of the selection process to the applicants | Y/N | 

7 | Procedures are defined to ensure the monitoring of the implementation of grant agreements/contracts according to the contractual terms | Y/N | 
3.6.Monitoring of the projects implemented by the final beneficiaries | 3.6. | Monitoring of the projects implemented by the final beneficiaries

3.6. | Monitoring of the projects implemented by the final beneficiaries

Short description of the process[This description should include the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | Key operational and financial indicators will be established, monitored and communicated to the responsible authority for each project | Y/N | 

2 | On-the-spot verifications by the responsible authority are foreseen to allow monitoring (of both the operational and financial aspects) of the projects | Y/N | 

3 | The responsible authority will ensure that final beneficiaries make use of an appropriate accounting system in computerised form | Y/N | 

4 | The responsible authority will ensure that final beneficiaries implement the provisions on the visibility of the EU funding | Y/N | 
3.7.Financial management of the project | 3.7. | Financial management of the project

3.7. | Financial management of the project

Short description of the process[involves the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | Financial transactions will be approved by duly authorised persons | Y/N | 

2 | Prior to making any payments/recoveries, verifications will be carried out in particular in order to monitor:—the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)—that products and/or services co-financed by the project have actually been delivered—the accuracy, completeness and effective payment of other contributions received from public or private resources—that the results of any audit activity have been taken into account | — | the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s) | — | that products and/or services co-financed by the project have actually been delivered | — | the accuracy, completeness and effective payment of other contributions received from public or private resources | — | that the results of any audit activity have been taken into account | Y/N | 

— | the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)

— | that products and/or services co-financed by the project have actually been delivered

— | the accuracy, completeness and effective payment of other contributions received from public or private resources

— | that the results of any audit activity have been taken into account

3 | Verifications will be carried out in order to have a reasonable assurance of the legality and regularity of the underlying transactions | Y/N | 

4 | Supervisory controls will be carried out throughout the programming period to ensure that the established financial procedures are respected. | Y/N | 

5 | Verifications will be performed on the complementarity with other Community financial programmes in order to avoid double funding | Y/N | 
3.8.Irregularities, corrections and recoveries | 3.8. | Irregularities, corrections and recoveries

3.8. | Irregularities, corrections and recoveries

Short description of the process[This description should include the responsible authority, the delegated authority(ies) and the certifying authority]

 | Key targets | Achieved? | Comments

1 | Definitions of irregularities are established and comply with the Community requirements | Y/N | 

2 | Mechanisms are in place to ensure that irregularities can be detected in due time and immediate corrective measures are taken | Y/N | 

3 | Procedures are in place to ensure that the Commission is kept informed of irregularities detected, and if appropriate, of any corrective measure taken in accordance with the obligations set out in this decision | Y/N | 

4 | Procedures are in place to ensure a proper follow-up of recovery orders issued and, if applicable, of default interest | Y/N | 

5 | In case recovery orders cannot be cashed in, causes will be identified to evaluate whether Member States should reimburse the funds to the Community Budget or not | Y/N | 
3.9.Preparation and implementation of audit missions | 3.9. | Preparation and implementation of audit missions

3.9. | Preparation and implementation of audit missions

Short description of the process[This description should include the audit authority and, as potential auditees, the responsible authority and the delegated authority(ies) and, as recipient of the conclusions, the certifying authority]

 | Key targets | Achieved? | Comments

1 | The audit practice is in line with internationally accepted standards | Y/N | 

2 | An audit manual is established for use by the auditors on the basis of the requirements defined in the basic act | Y/N | 

3 | Audits will be carried out to verify the effective functioning of the management and control systems | Y/N | 

4 | The checks to be carried on the eligible expenditure will be based on an appropriate sample, and will consist of at least 10 % of eligible expenses | Y/N | 

5 | The verifications on eligible expenses will verify at least the compliance, effectiveness and efficiency of the following elements: selection procedure, objectives of the project, reality of the achievements, eligibility of the expenses, valid supporting documents for the expenses, national co-financing, audit trail | Y/N | 

6 | A follow-up of earlier recommendations will take place on a regular basis | Y/N | 

7 | The projects implemented by the responsible authority will be subject to robust scrutiny | Y/N | 
3.10.Audit report on annual programmes and related declarations | 3.10. | Audit report on annual programmes and related declarations

3.10. | Audit report on annual programmes and related declarations

Short description of the process[This description should involved the audit authority]

 | Key targets | Achieved? | Comments

1 | Procedures are established to consolidate the conclusions of the systems audit and the audit of projects for each annual programme | Y/N | 

2 | Checks will be performed to assess the validity of the requests for payment | Y/N | 

3 | Further examination will be launched in case of systemic errors or errors over the materiality threshold are detected | Y/N | 

4 | The report and the related declarations will be approved by a duly authorised person | Y/N | 
3.11.Certification of expenditure | 3.11. | Certification of expenditure

3.11. | Certification of expenditure

Short description of the process[involves primarily the certifying authority but also the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | Procedures are established to ensure that the necessary information is received from the responsible authority for the purpose of certification | Y/N | 

2 | Procedures are established to ensure that the audit report on each annual programme and the related declarations are received from the audit authority | Y/N | 

3 | Procedures are established to ensure that recoveries are taken into account for the final declaration of expenditure and to follow on-going legal proceedings or administrative appeals with suspensive effect regarding recoveries | Y/N | 

4 | Verifications will be performed to ensure the accuracy and completeness of the declaration of expenditure (in particular, on any interest generated by the pre-financing received from the Commission as well as its effective use as national contribution) | Y/N | 

5 | In case of local currency, the methods used for the calculation in EUR comply with the rules defined by the Commission | Y/N | 
3.12.Evaluation of the programme | 3.12. | Evaluation of the programme

3.12. | Evaluation of the programme

Short description of the process[involves the responsible authority and the delegated authority(ies)]

 | Key targets | Achieved? | Comments

1 | The guidance documents from the Commission on evaluations are disseminated widely and made available to all potential final beneficiaries and other interested parties | Y/N | 

2 | The key operational and financial indicators provided by the final beneficiaries to measure the achievements of the project will be recorded | Y/N | 

3 | The responsible authority (and/or delegated authorities) will ensure that the indicators provided are appropriate to measure the outcome and results of each project | Y/N | 

4 | Procedures are in place to ensure that the necessary evaluation will be carried out as required by the basic act | Y/N | 4.   INFORMATION MANAGEMENT

4.1.Documentation on the procedures | 4.1. | Documentation on the procedures

4.1. | Documentation on the procedures

Short description of the process[involves all authorities]

 | Key targets | Achieved? | Comments

1 | The authorities will ensure that the established procedures referred to in Article 7 of this decision comply with national and Community law (e.g. public procurement, accounting rules, etc.) | Y/N | 

2 | The procedures are approved by a duly authorised person | Y/N | 

3 | The established procedures set out clear instructions concerning each of the main operations and explain the decision-making circuits concerning the performance of functions | Y/N | 

4 | Arrangements are in place to ensure that all relevant staff is informed of the established procedures | Y/N | 

5 | Where appropriate, these procedures include the use of check-lists summarising the key controls to be performed | Y/N | 

6 | Arrangements are in place to ensure the protection of personal data | Y/N | 
4.2.Accounting and book keeping | 4.2. | Accounting and book keeping

4.2. | Accounting and book keeping

Short description of the process[involves the responsible authority, the delegated authority(ies) and the certifying authority]

 | Key targets | Achieved? | Comments

1 | Arrangements are in place to ensure that accounting data is complete, reliable and correct. In particular, the accounting system will allow:—a full traceability of the Community resources at the level of the final beneficiaries and projects—the identification of any interest generated by the pre-financing received from the Commission—the identification of recovery orders issued and if applicable, whether they have been cashed | — | a full traceability of the Community resources at the level of the final beneficiaries and projects | — | the identification of any interest generated by the pre-financing received from the Commission | — | the identification of recovery orders issued and if applicable, whether they have been cashed | Y/N | 

— | a full traceability of the Community resources at the level of the final beneficiaries and projects

— | the identification of any interest generated by the pre-financing received from the Commission

— | the identification of recovery orders issued and if applicable, whether they have been cashed

2 | The accounting and financial reporting system complies with the national data protection legislation | Y/N | 

3 | The accounting and financial reporting system to be used will be in computerised form | Y/N | 

4 | A back-up system exists to guarantee the continuity of operations should the need arise | Y/N | 

5 | In case of local currency, the methods used for the calculation in Euro comply with the rules defined by the Commission | Y/N | 
4.3.Reporting to the Commission | 4.3. | Reporting to the Commission

4.3. | Reporting to the Commission

Short description of the process[involves all authorities]

 | Key targets | Achieved? | Comments

1 | Reporting obligations have been identified as well as the implications for resources | Y/N | 

2 | The established procedures allow proper, timely and complete input by the designated authorities | Y/N | 

3 | Reports are approved by a duly authorised person | Y/N | 
4.4.Audit trail | 4.4. | Audit trail

4.4. | Audit trail

Short description of the process[involves all authorities]

Where are the following documents kept? | Body/Unit in charge | How long for?

Description of the management and control systems including manual(s) of procedures |  | 

Audit strategy |  | 

National multi-annual programme and possible revisions |  | 

National annual programmes and possible revisions |  | 

European Commission Decisions on multi-annual and annual programmes |  | 

Calls for proposals/Calls for tender |  | 

Applicant files/Contract files |  | 

Administrative, technical and financial analysis of proposals/tenders received (evaluation grids) and evaluation committee reports |  | 

Funding decisions or rejections |  | 

Project funding agreements |  | 

Financial commitment decisions for each of the projects |  | 

Progress reports and final reports submitted by funding recipients |  | 

Financial reports and payment applications submitted by funded Project |  | 

Supporting documents for expenditure and revenue for funded Project |  | 

Payments/recovery authorisations for funding (proof of verifications performed) |  | 

Payments/recovery orders for funding |  | 

Proof of payments/recovery of funding |  | 

Documentation related to the sampling methodology for the audit activity |  | 

Reports on audits carried out on projects |  | 

Reports on audits carried out at national level on management and control systems |  | 

Audit reports on annual programmes |  | 

Audit opinions on the management and control systems |  | 

Audit declarations on the validity of the requests for payment |  | 

Requests for payment sent to the European Commission |  | 

Certification of expenditure sent to the European Commission |  | 

Progress implementation reports sent to the European Commission |  | 

Final implementation reports sent to the European Commission |  | 

Proof of payment received from the European Commission |  | 

Evaluation reports sent to the European Commission |  | 5.   APPROVAL OF THE DESCRIPTION OF THE MANAGEMENT AND CONTROL SYSTEMS

Authority | Declaration | Date and signature

Responsible Authority | I certify the accuracy and completeness of the information about the identification and internal control systems of the Responsible Authority | Name:Function:Date:

 |  | signature

Certifying Authority | I certify the accuracy and completeness of the information about the identification and internal control systems of the Certifying Authority | Name:Function:Date:

 |  | signature

Audit Authority | I certify the accuracy and completeness of the information about the identification and internal control systems of the Audit AuthorityandI can confirm that what has been described provides a reliable picture of all the management and control systems | Name:Function:Date:

 |  | signature
1.   SITUATION IN THE MEMBER STATEANNEX IIMODEL MULTI-ANNUAL PROGRAMME

 | Initial version

 | Revised version (number, date dd/mm/year) following dialogue with the Commission

 | Version revised in the light of evaluations and/or following implementation difficulties

 | Version revised following the revision of the strategic guidelines

MEMBER STATE:

FUND:

RESPONSIBLE AUTHORITY:

PERIOD COVERED:

A description of the baseline situation in the Member State in the policy field covered by the Fund’s objectives
 | 1.1. | The national situation and the migratory flows affecting it

 | 1.2. | The measures undertaken by the Member State so far

 | 1.3. | The total national resources allocated2.   ANALYSIS OF REQUIREMENTS IN THE MEMBER STATE

 | 2.1. | The requirements in the Member State in relation to the baseline situation

 | 2.2. | The operational objectives of the Member State designed to meet its requirements3.   STRATEGY TO ACHIEVE THE OBJECTIVESA description of how the Fund contributes to meeting the requirements, which priorities have been chosen and why
 | 3.1. | Priority 1

 | 3.2. | Priority 2

 | 3.3. | Etc.Breakdown when presenting the information on the priorities chosena)The objective(s) of the strategy and examples of key actionsb)Description of target(s) concerned and the indicator(s) usedc)If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority | a) | The objective(s) of the strategy and examples of key actions | b) | Description of target(s) concerned and the indicator(s) used | c) | If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority

a) | The objective(s) of the strategy and examples of key actions

b) | Description of target(s) concerned and the indicator(s) used

c) | If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority4.   COMPATIBILITY WITH OTHER INSTRUMENTSAn indication of how this strategy is compatible with other regional, national and Community instruments
 | 4.1. | Priority 1

 | 4.2. | Priority 2

 | 4.3. | Etc.5.   FRAMEWORK FOR IMPLEMENTATION OF THE STRATEGY

 | 5.1. | The publication of the programme

 | 5.2. | The approach chosen to implement the principle of partnership6.   INDICATIVE FINANCING PLAN

 | 6.1. | Community Contribution

 | 6.1.1. | TableMultiannual Programme — Draft Financial PlanTable 1Community ContributionMember State: […]Fund: […](in 000’ EUR — current prices)200820092010201120122013TotalPriority 1: […]0Priority 2: […]0Priority 3: […]0Priority …: […]0Technical Assistance0Total0000000 | Multiannual Programme — Draft Financial Plan | Table 1Community Contribution | Member State: […] | Fund: […] | (in 000’ EUR — current prices) | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | Total | Priority 1: […] |  |  |  |  |  |  | 0 | Priority 2: […] |  |  |  |  |  |  | 0 | Priority 3: […] |  |  |  |  |  |  | 0 | Priority …: […] |  |  |  |  |  |  | 0 | Technical Assistance |  |  |  |  |  |  | 0 | Total | 0 | 0 | 0 | 0 | 0 | 0 | 0

Multiannual Programme — Draft Financial Plan

Table 1Community Contribution

Member State: […]

Fund: […]

(in 000’ EUR — current prices) | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | Total

Priority 1: […] |  |  |  |  |  |  | 0

Priority 2: […] |  |  |  |  |  |  | 0

Priority 3: […] |  |  |  |  |  |  | 0

Priority …: […] |  |  |  |  |  |  | 0

Technical Assistance |  |  |  |  |  |  | 0

Total | 0 | 0 | 0 | 0 | 0 | 0 | 0

 | 6.1.2. | Comments on the figures/trends

 | 6.2. | Overall financing plan

 | 6.2.1. | TableMultiannual Programme — Draft Financial PlanTable 2Overall Financing PlanMember State: […]Fund: […](in 000’ EUR — current prices)200820092010201120122013TotalCommunity ContributionPublic cofinancingPrivate cofinancingTotal0000000% Community Contribution%%%%%%% | Multiannual Programme — Draft Financial Plan | Table 2Overall Financing Plan | Member State: […] | Fund: […] | (in 000’ EUR — current prices) | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | Total | Community Contribution |  |  |  |  |  |  |  | Public cofinancing |  |  |  |  |  |  |  | Private cofinancing |  |  |  |  |  |  |  | Total | 0 | 0 | 0 | 0 | 0 | 0 | 0 | % Community Contribution | % | % | % | % | % | % | %

Multiannual Programme — Draft Financial Plan

Table 2Overall Financing Plan

Member State: […]

Fund: […]

(in 000’ EUR — current prices) | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | Total

Community Contribution |  |  |  |  |  |  | 

Public cofinancing |  |  |  |  |  |  | 

Private cofinancing |  |  |  |  |  |  | 

Total | 0 | 0 | 0 | 0 | 0 | 0 | 0

% Community Contribution | % | % | % | % | % | % | %

 | 6.2.2. | Comments on the figures/trends[signature of the responsible person]
3.   ACTIONS TO BE SUPPORTED BY THE PROGRAMME UNDER THE PRIORITIES CHOSENANNEX IIIMODEL ANNUAL PROGRAMME

 | Initial version

 | Revised version (number, date dd/mm/year) following dialogue with the Commission

 | Version revised for other reasons

MEMBER STATE:

FUND:

RESPONSIBLE AUTHORITY:

YEAR COVERED:
 | 1. | GENERAL RULES FOR SELECTION OF PROJECTS TO BE FINANCED UNDER THE PROGRAMME

 | 2. | CHANGES IN THE MANAGEMENT AND CONTROL SYSTEMS (if appropriate)

 | 3.1. | Actions implementing priority 1

 | 3.2. | Actions implementing priority 2

 | 3.3. | Etc.

When presenting the actions under points 3.1 to etc., where relevant, provide a breakdown according to the description of categories of actions in the basic act

Aspects of the action presented when describing each action under points 3.1 to etc.

 1. Purpose and scope of the action 2. Expected grant recipients 3. Where appropriate, justification regarding project(s) implemented directly by the responsible authority acting as an executing body 4. Expected quantified results and indicators to be used 5. Visibility of EC funding 6. Complementarity with similar actions financed by other EC instruments, if appropriate 7. Financial information

4.   TECHNICAL ASSISTANCE

 | 4.1. | Purpose of the technical assistance

 | 4.2. | Expected quantified results

 | 4.3. | Visibility of EC funding5.   DRAFT FINANCING PLAN

Annual Programme — Draft Financial Plan

Table 1Overview table

Member State: […]

Annual programme concerned: […]

Fund: […]

 | Ref. priority | Ref. specific priority(1) | Community Contribution | Public Allocation | Private Allocation | Total | % CE | Share of total

(all figures in EUR) |  |  | (a) | (b) | (c) | (d = a + b + c) | (e = a/d) | (d/total d)

Action 1: […] |  |  |  |  |  | 0 |  | 

Action 2: […] |  |  |  |  |  | 0 |  | 

Action 3: […] |  |  |  |  |  | 0 |  | 

Action 4: […] |  |  |  |  |  | 0 |  | 

Action 5: […] |  |  |  |  |  | 0 |  | 

Action …: […] |  |  |  |  |  | 0 |  | 

Action N: […] |  |  |  |  |  | 0 |  | 

Technical assistance |  |  |  |  |  | 0 |  | 

Other operations(2) |  |  |  |  |  | 0 |  | 

Total |  |  | 0 | 0 | 0 | 0 | % | 100 %[signature of the responsible person]
(1)  If applicable.

(2)  If applicable.
A.   Technical reportANNEX IVMODEL PROGRESS REPORT ON IMPLEMENTATION OF THE ANNUAL PROGRAMME

MEMBER STATE:

FUND:

RESPONSIBLE AUTHORITY:

YEAR COVERED:

1.   OPERATIONAL IMPLEMENTATION

 | 1.1. | Time table for the implementation of the programme

 | 1.2. | Description of the organisation of the selection of projects and tenders and their outcomes

 | 1.3. | Progress made in implementing the actions of the programme under the priorities chosen

 | 1.3.1. | Actions implementing Priority 1

 | 1.3.2. | Actions implementing Priority 2Etc.
 | 1.4. | Use of technical assistance

 | 1.5. | Problems encountered and measures taken2.   FINANCIAL IMPLEMENTATION

Progress report on the implementation of the annual programme

Table 1Financial report

Member State: […]

Annual programme concerned: […]

Situation at: [day/month/year]

Pre-financing payment(s) received from EC: [amount]

(all figures in EUR) | Ref. priority | Ref. specificpriority(1) | Programmed MS | Committed at the level of the MS | EC contributionpaid by MS to final beneficiaries | Total eligible costs incurred to date by final beneficiaries

Total programmed costs | EC contribution | % EC contribution | Total eligible costs | EC contribution | % EC contribution

 |  |  | (a) | (b) | (c = b/a) | (d) | (e) | (f = e/d) |  | 

Action 1: […] |  |  |  |  |  |  |  |  |  | 

Action 2: […] |  |  |  |  |  |  |  |  |  | 

Action 3: […] |  |  |  |  |  |  |  |  |  | 

Action 4: […] |  |  |  |  |  |  |  |  |  | 

Action 5: […] |  |  |  |  |  |  |  |  |  | 

Action N: […] |  |  |  |  |  |  |  |  |  | 

Technical assistance |  |  |  |  |  |  |  |  |  | 

Other operations(2) |  |  |  |  |  |  |  |  |  | 

Total |  |  | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0

 |  | 

 |  |  |  |  |  |  |  |  | ↓ | ↓

 |  |  |  |  |  |  |  |  | > 60 % of pre-financing payment(s) received?

 |  |  |  |  |  |  |  |  | Yes/No | Yes/No3.   REPORTING ON IRREGULARITIES

Notification of new irregularities(3)? | No | Yes (if Yes, fill in table 2)

Progress report on the implementation of the annual programme

Table 2Initial reporting on irregularity

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference | Annual Programme | Project | Provision infringed | Type of irregularity | Date/Source of first information | Method of detection | Possibility of fraud (Y/N) | Amount concerned in EUR (Community contribution)

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 
Follow-up of previous irregularities? | No | Yes (if Yes, fill in table 3)

Progress report on the implementation of the annual programme

Table 3Reporting of follow-up of irregularities

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference | Annual Programme | Project | Provision infringed | Amount concerned (EC contrib.) in EUR | Follow-up actions | Recovery order (amounts in EUR) | Cancellation of EC contrib.

Issued | Paid | Default interest | Waived

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | B.   Request for the second pre-financing paymentI, the undersigned [name in capitals of the person in charge],

representing the responsible authority for managing and implementing the [name of the Fund] request payment of the following amount as the second pre-financing payment.
EUR(4) | [exact figure to two decimal places]

This request for payment is admissible because:
a) | a progress report on implementation of the annual programme has been submitted to the Commission or is attached;

b) | a certified declaration of expenditure drawn up accounting for at least 60 % of the amount of the first pre-financing has been submitted or is attached;

c) | the annual programme has been implemented according to the principle of sound financial management and there is a reasonable assurance that the underlying transactions are legal and regular;

d) | there is no reasoned opinion by the Commission in respect of an infringement under Article 226 of the Treaty, as regards the actions for which the expenditure is declared in the request.Payment should be made by the Commission to:
Authority responsible for receiving payments | 

Bank | 

Bank account No | 

Account holder (if not the same as the authority responsible for receiving payments) | 
Date | Name in capital letters, stamp, position and signature of competent authority

(1)  If applicable.

(2)  If applicable.

(3)  Since the last progress/final report sent to the Commission.

(4)  Total amount requested to complement the first pre-financing.
A.   Technical reportANNEX VMODEL FINAL REPORT ON IMPLEMENTATION OF THE ANNUAL PROGRAMME

MEMBER STATE:

FUND:

RESPONSIBLE AUTHORITY:

YEAR COVERED:

1.   OPERATIONAL IMPLEMENTATION

 | 1.1. | Time table on the implementation of the programme

 | 1.2. | Update from the progress report on the description of the organisation of the selection of projects and tenders and their outcomes, if appropriate

 | 1.3. | The achievements in implementing the actions of the programme under the priorities chosen

 | 1.3.1. | Actions implementing priority 1

 | 1.3.2. | Actions implementing priority 2

 | 1.3.3. | Etc.

Aspects of the action presented when describing each action under point 1.3 to etc. 1. Purpose and scope of the action 2. Changes from the programme as approved by the Commission (if appropriate) 3. Monitoring activities undertaken during and after the implementation 4. Actual results 5. Assessment of the actual results in comparison to the targets and indicators set in the programme
 | 1.4. | The results of the technical assistance

 | 1.5. | Problems encountered and measures taken on the implementation of the programme

 | 1.6 | Procedures applied when the responsible authority implemented project(s) directly acting as an executing body (if appropriate)

 | 1.7. | Coherence and complementarity with other instruments

 | 2. | ASSESSMENT OF THE PROGRESS MADE IN IMPLEMENTING THE MULTI-ANNUAL PROGRAMME3.   MEASURES TAKEN TO PROVIDE INFORMATION ON THE PROGRAMME

 | 3.1. | Measures taken to make the multi-annual(1)and annual programme public

 | 3.2. | Implementation of the visibility principle4.   FINANCIAL IMPLEMENTATION

Final report on the implementation of the annual programme

Table 1Detailed financial report

Member State: […]

Annual programme concerned: […]

Priority/other actions: […]

Situation at: [day/month/year]

(all figures in EUR) | Programmed by MS | Committed at the level of the MS | Actual figures accepted by the Responsible Authority(costs incurred by the beneficiaries and final EC contribution)

Actions | Projects | Ref. priority | Ref. specific priority(2) | Total programmed costs | EC contribution | % EC contribution | Total eligible costs | EC contribution | % EC contribution | Total eligible costs | EC contribution due | % EC contribution | EC contribution paid | EC still to pay/to recover by the RA

 |  |  |  | (a) | (b) | (c = b/a) | (d) | (e) | (f = e/d) | (g) | (h) | (i = h/g) | (j) | (k = h – j)

Action 1: […] | project 1: […] |  |  |  |  |  |  |  |  |  |  |  |  | 

 | project N: […] |  |  |  |  |  |  |  |  |  |  |  |  | 

Total Action 1 |  |  |  |  |  |  |  |  |  |  | 

Action …: […] | project 1: […] |  |  |  |  |  |  |  |  |  |  |  |  | 

 | project N: […] |  |  |  |  |  |  |  |  |  |  |  |  | 

Total Action…: […] |  |  |  |  |  |  |  |  |  |  | 

Action N: […] | project 1: […] |  |  |  |  |  |  |  |  |  |  |  |  | 

 | project N: […] |  |  |  |  |  |  |  |  |  |  |  |  | 

Total Action N |  |  |  |  |  |  |  |  |  |  | 

Technical assistance |  |  |  |  |  |  |  |  |  |  | 

Other operations(2) |  |  |  |  |  |  |  |  |  |  | 

Total | 0 | 0 | 0 % | 0 | 0 | 0 % | 0 | 0 | 0 % | 0 | 0

 | 4.1. | List of all pending recoveries at 30 June of the year N + 2 (N = year of this annual programme)Final report on the implementation of the annual programmeTable 2List of pending recovery ordersMember State: […]Fund: […]Situation at: [day/month/year]ReferenceAnnual ProgrammeProjectTotal amount to be recoveredEC contribution to be recoveredDeduced from the related financial report (Y/N)Reasons for recovery | Final report on the implementation of the annual programme | Table 2List of pending recovery orders | Member State: […] | Fund: […] | Situation at: [day/month/year] | Reference | Annual Programme | Project | Total amount to be recovered | EC contribution to be recovered | Deduced from the related financial report (Y/N) | Reasons for recovery |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

Final report on the implementation of the annual programme

Table 2List of pending recovery orders

Member State: […]

Fund: […]

Situation at: [day/month/year]

Reference | Annual Programme | Project | Total amount to be recovered | EC contribution to be recovered | Deduced from the related financial report (Y/N) | Reasons for recovery

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 | 4.2. | List of recovery ordersnotincluded in the financial reports of the previous annual programmes (if appropriate)Final report on the implementation of the annual programmeTable 3List of recovery orders not already deducted from previous declarations of expenditureMember State: […]Fund: […]Situation at: [day/month/year]ReferenceAnnual ProgrammeProjectTotal amount recoveredEC contribution recoveredDate of recoveryReasons for recovery | Final report on the implementation of the annual programme | Table 3List of recovery orders not already deducted from previous declarations of expenditure | Member State: […] | Fund: […] | Situation at: [day/month/year] | Reference | Annual Programme | Project | Total amount recovered | EC contribution recovered | Date of recovery | Reasons for recovery |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

Final report on the implementation of the annual programme

Table 3List of recovery orders not already deducted from previous declarations of expenditure

Member State: […]

Fund: […]

Situation at: [day/month/year]

Reference | Annual Programme | Project | Total amount recovered | EC contribution recovered | Date of recovery | Reasons for recovery

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 5.   REPORTING ON IRREGULARITIES

Notification of new irregularities(3)? | No | Yes (if Yes, fill in table 4)

Final report on the implementation of the annual programme

Table 4Initial reporting on irregularity

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference | Annual Programme | Project | Provision infringed | Type of irregularity | Date/Source of first information | Method of detection | Possibility of fraud(Y/N) | Amount concerned in EUR (Community contribution)

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 
Follow-up of previous irregularities? | No | Yes (if Yes, fill in table 5)

Final report on the implementation of the annual programme

Table 5Reporting of follow-up of irregularities

Member State: […]

Situation at: [day/month/year]

Fund: […]

Reference | Annual Programme | Project | Provision infringed | Amount concerned | Follow-up actions | Recovery order (amounts in €) | Cancellation of EC contrib.

(EC contrib.) in EUR | Issued | Paid | Default interest | Waived

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 6.   ANNEXESSummary description of individual projects (one page per project) presenting objectives, achievements, relevant indicators, financial table.
Final report on the implementation of the annual programme

Table 6Report per project

Project reference and title: […] | Priority: […]

Final Beneficiary: […] | Specific priority: […]

Situation at: [day/month/year] | Action: […]

TECHNICAL SUMMARY

Objectives/achievements:

Relevant indicators:

Justification (in case of a specific priority):

FINANCIAL SUMMARY(all figures in EUR)Committed by the responsible authorityRequested by the final beneficiaryAccepted by the responsible authorityEC Contribution paid by the responsible authoritya: Direct Costs1st Pre-financing paymentb: Indirect Costs2nd Pre-financing paymentc: Costs covered by assigned income (if applicable)Final paymenta + b + c: Total Eligible Costs000Recovery orderd: EC contributione: Contribution from final beneficiary and partners (public bodies)of which assigned incomef: Contribution from final beneficiary and partners (non public bodies)g: Contribution from third partiesh: Receipts generated by the projectEC contribution dued + e + f + g + h: Total Income000EC contribution still to pay/to recover% EC Contribution/Total Costs (d/(a + b + c))%%% | (all figures in EUR) | Committed by the responsible authority | Requested by the final beneficiary | Accepted by the responsible authority |  | EC Contribution paid by the responsible authority | a: Direct Costs |  |  |  |  | 1st Pre-financing payment |  | b: Indirect Costs |  |  |  |  | 2nd Pre-financing payment |  | c: Costs covered by assigned income (if applicable) |  |  |  |  | Final payment |  | a + b + c: Total Eligible Costs | 0 | 0 | 0 |  | Recovery order |  | d: EC contribution |  |  |  |  |  |  | e: Contribution from final beneficiary and partners (public bodies) |  |  |  |  |  |  | of which assigned income |  |  |  |  |  |  | f: Contribution from final beneficiary and partners (non public bodies) |  |  |  |  |  |  | g: Contribution from third parties |  |  |  |  |  |  | h: Receipts generated by the project |  |  |  |  | EC contribution due |  | d + e + f + g + h: Total Income | 0 | 0 | 0 |  | EC contribution still to pay/to recover |  | % EC Contribution/Total Costs (d/(a + b + c)) | % | % | % | 

(all figures in EUR) | Committed by the responsible authority | Requested by the final beneficiary | Accepted by the responsible authority |  | EC Contribution paid by the responsible authority

a: Direct Costs |  |  |  |  | 1st Pre-financing payment | 

b: Indirect Costs |  |  |  |  | 2nd Pre-financing payment | 

c: Costs covered by assigned income (if applicable) |  |  |  |  | Final payment | 

a + b + c: Total Eligible Costs | 0 | 0 | 0 |  | Recovery order | 

d: EC contribution |  |  |  |  |  | 

e: Contribution from final beneficiary and partners (public bodies) |  |  |  |  |  | 

of which assigned income |  |  |  |  |  | 

f: Contribution from final beneficiary and partners (non public bodies) |  |  |  |  |  | 

g: Contribution from third parties |  |  |  |  |  | 

h: Receipts generated by the project |  |  |  |  | EC contribution due | 

d + e + f + g + h: Total Income | 0 | 0 | 0 |  | EC contribution still to pay/to recover | 

% EC Contribution/Total Costs (d/(a + b + c)) | % | % | % | B.   Request for payment of the balance/Statement of reimbursementI, the undersigned [name in capitals of the person in charge],

representing the responsible authority for the [name of the Fund]
— | request payment of the following amount:EUR(4)+[exact figure to two decimal places]OR | EUR(4) | +

EUR(4) | +

— | declare for reimbursement the following amount:EUR(5)—[exact figure to two decimal places] | EUR(5) | —

EUR(5) | —This amount results from the balance between the total amount of pre-financing payment(s) received for this annual programme and the actual expenditure declared.

This request for payment is admissible because:
a) | a final report on implementation of the annual programme has been submitted to the Commission or is attached;

b) | a certified declaration of expenditure has been submitted or is attached;

c) | an annual audit report, an opinion on the functioning of the management and control system and a declaration on the validity of the payment request prepared by the audit authority have been submitted or are attached;

d) | any interest generated by the pre-financing payments has been posted to the annual programme, being regarded as national contribution and has been taken into account in the declaration of expenditure;

e) | the annual programme has been implemented according to the principle of sound financial management and there is a reasonable assurance that the underlying transactions are legal and regular;

f) | there is no reasoned opinion by the Commission in respect of an infringement under Article 226 of the Treaty, as regards the actions for which the expenditure is declared in the request.Payment should be made by the Commission to:
Authority responsible for receiving payments | 

Bank | 

Bank account No | 

Account holder (if not the same as the authority responsible for receiving payments) | 
Date, | Name in capital letters, stamp, position and signature of competent authority

(1)  Applicable only for the final report on implementation of the first annual programme.

(2)  If applicable.

(3)  Since the last progress/final report sent to the Commission.

(4)  Total amount requested to complement the pre-financing payment(s).

(5)  Total amount to be reimbursed after the clearing of the pre-financing payment(s).
1.   THE AUDIT UNIVERSEANNEX VIMODEL AUDIT STRATEGY

MEMBER STATE:

FUND(S):

RESPONSIBLE AUTHORITY:
 | 1.1. | Scope of the strategy (Funds covered)

 | 1.2. | Period covered by the strategy

 | 1.3. | Audit standards applied2.   RISK ASSESSMENT

 | 2.1. | Risk identification and assessment

 | 2.2. | Risk response and residual risk3.   OBJECTIVES AND PRIORITIES

 | 3.1. | Objectives of the audits

 | 3.2. | Priorities for the audits4.   AUDIT APPROACH4.1.   System audits

 | 4.1.1. | The responsible body/-ies for the audit work

 | 4.1.2. | The authorities to be audited

 | 4.1.3. | Horizontal issues to be covered by the system audits

 | 4.1.4. | Indicative multi-annual plan for system audits (if possible)4.2.   Audits of projects

 | 4.2.1. | The responsible body/-ies for the audit work

 | 4.2.2. | Description of the sampling methodology5.   AUDIT PLANS COVERING CALENDAR YEARS 2007 AND 20085.1.   Year 2007 (1) 

Year 2007

System audits

Funds | Authorities concerned | Processes concerned | Scope of the audit | Man-days | Planning

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Audits of projects

Funds | Programme Year | Priority | Project | Final Beneficiary | Total eligible costs of the project | Costs to be audited | Man-days | Planning

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 5.2.   Year 2008Insert data using the model table defined for year 2007

Annex(es) to the audit strategy

                            (2) : Annual plans

MEMBER STATE:

FUND:

RESPONSIBLE AUTHORITY:

CALENDAR YEAR COVERED:
 | 1. | CHANGES TO THE AUDIT STRATEGY, WHERE APPLICABLE

 | 2. | MAIN RESULTS OF AUDITS OF THE PREVIOUS YEAR

 | 3. | AUDIT PLAN YEAR 20XXInsert data using the model table defined for year 2007
(1)  If applicable.

(2)  To be submitted after the audit strategy, in accordance with article 25(2).
A.   Annual audit reportANNEX VIIMODEL REPORT BY THE AUDIT AUTHORITY

MEMBER STATE:

FUND:

RESPONSIBLE AUTHORITY:

ANNUAL PROGRAMME COVERED BY THE REPORT:

1.   GENERAL INFORMATION

 | 1.1. | The bodies that have been involved in preparing the report

 | 1.2. | Identification and justification of major changes in the implementation of the audit plans related to the annual programme concerned

 | 1.3. | Summary table of the results of the auditsAudit reportMember State: […]Annual programme concerned: […]Situation at: [day/month/year]System audits closed since last reportFund(s)Authorities concernedProcesses concernedScope of the auditMan-days spentDate of final reportAudits of projects linked to annual programme 20xxFund(s)ProjectFinal BeneficiaryTotal Eligible CostsEligible Costs auditedFinancial correctionError rate(a)(b)(c)(d = c/b)Total000%Total annual programme(e)(f)Coverage rate: (=f/e) | Audit report | Member State: […] | Annual programme concerned: […] | Situation at: [day/month/year] | System audits closed since last report | Fund(s) | Authorities concerned | Processes concerned | Scope of the audit | Man-days spent | Date of final report |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Audits of projects linked to annual programme 20xx | Fund(s) | Project | Final Beneficiary | Total Eligible Costs | Eligible Costs audited | Financial correction | Error rate |  |  |  | (a) | (b) | (c) | (d = c/b) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Total | 0 | 0 | 0 | % | Total annual programme | (e) | (f) | Coverage rate: (=f/e)

Audit report

Member State: […]

Annual programme concerned: […]

Situation at: [day/month/year]

System audits closed since last report

Fund(s) | Authorities concerned | Processes concerned | Scope of the audit | Man-days spent | Date of final report

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Audits of projects linked to annual programme 20xx

Fund(s) | Project | Final Beneficiary | Total Eligible Costs | Eligible Costs audited | Financial correction | Error rate

 |  |  | (a) | (b) | (c) | (d = c/b)

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total | 0 | 0 | 0 | %

Total annual programme | (e) | (f) | Coverage rate: (=f/e)2.   SYSTEMS AUDITS

 | 2.1. | The bodies that carried out audits

 | 2.2. | A summary list of the audits carried out

 | 2.3. | The principal findings, recommendations and the conclusions drawn from the audit work for the management and control systems

 | 2.4. | Financial impact of the audit findings

 | 2.5. | Additional work, where appropriate

 | 2.6. | Indication whether any problems identified were considered to be systemic in nature and the measures taken, including a quantification of any financial corrections

 | 2.7. | Information on the follow-up of the audit recommendations3.   AUDITS ON PROJECTS

 | 3.1. | The bodies that carried out the audits

 | 3.2. | A summary list of audits carried out and the percentage of expenditure checked in relation to total eligible expenditure declared to the Commission

 | 3.3. | The principal findings, recommendations and conclusions of the audits with regard to the projects implemented

 | 3.4. | The conclusions drawn from the results of the audits with regard to the effectiveness of the management and control system

 | 3.5. | Financial impact of the audit findings

 | 3.6. | Additional work, where appropriate

 | 3.7. | Information on the follow-up of audit recommendations

 | 3.8. | Indication whether any problems identified were considered to be systemic in nature and the measures taken, including a quantification of any financial corrections4.   FOLLOW UP OF AUDIT ACTIVITY COVERED BY PREVIOUS REPORTS, IF APPROPRIATE

 | 4.1. | Information on the follow-up to previous system audit recommendations

 | 4.2. | Information on results of audits of actions of a systemic nature from previous annual programmes[signature of the responsible person]B.   Opinion on the functioning of the management and control systemsTo the European Commission

1.   INTRODUCTIONI, the undersigned, representing the [name of audit authority designated by Member State], have examined the functioning of the management and control systems in the [name of the Fund] regarding the actions implemented under the Annual Programme for the year [20XX], in order to issue an opinion on whether the systems functioned effectively so as to provide reasonable assurance that declarations of expenditure presented to the Commission are correct and, as a consequence, reasonable assurance that the underlying transactions are legal and regular.

2.   SCOPE OF THE EXAMINATIONThe examination was carried out in accordance with the audit strategy in respect of this Fund during the period [dd/mm/year] to [dd/mm/year] and reported in the annual audit report under section A.

Either

There were no limitations on the scope of the examination.

Or

The scope of the examination was limited by the following factors:
a) | […]

b) | […]

c) | Etc.(Indicate any limitation on the scope of the examination, for example any systemic problems, weaknesses in the management and control system, lack of supporting documentation, cases under legal proceedings, etc., and estimate the amounts of expenditure and the Community contribution affected. If the audit authority does not consider that the limitations have an impact on the expenditure declared, this should be stated.)

3.   OPINIONEither (Unqualified opinion)Based on the examination referred to above, it is my opinion that, for the above-mentioned Annual Programme, the management and control systems established for the [name of the Fund] complied with the applicable requirements of the basic act Decision No 575/2007/EC [and Commission Decision 2008/458/EC] and functioned effectively so as to provide reasonable assurance that declarations of expenditure presented to the Commission are correct and, as a consequence, reasonable assurance that the underlying transactions are legal and regular.

Or (Qualified opinion)Based on the examination referred to above, it is my opinion that, for the above-mentioned Annual Programme, the management and control systems established for the [name of the Fund] complied with the applicable requirements of the basic act Decision No 575/2007/EC [and Commission Decision 2008/458/EC] and functioned effectively so as to provide reasonable assurance that declarations of expenditure presented to the Commission are correct and, as a consequence, reasonable assurance that the underlying transactions are legal and regular, except in the following respects:
a) | […]

b) | […]

c) | Etc.My reasons for considering that this (these) aspect(s) of the systems did not comply with the requirements and/or did not operate in such a way as to give a reasonable assurance on the correctness of the declarations of expenditure presented to the Commission are as follows:
a) | […]

b) | […]

c) | Etc.I estimate the impact of the qualification(s) to be […] % of the total expenditure declared. The Community contribution affected is thus […]

Or (Adverse opinion)Based on the examination referred to above, it is my opinion that, for the above-mentioned Annual Programme, the management and control system established for the [name of the Fund] did not comply with the requirements of Articles […] of the basic act Decision No 575/2007/EC [and Commission Decision 2008/458/EC] and did not function effectively so as to provide reasonable assurance that declarations of expenditure presented to the Commission are correct and, as a consequence, does not provide reasonable assurance that the underlying transactions are legal and regular.

This adverse opinion is based on:
a) | […]

b) | […]

c) | Etc.Date

Signature

[signature of the responsible person]

C.   Validation of the payment requestTo the European Commission

1.   INTRODUCTIONI, the undersigned, representing the (name of the Audit Authority designated by Member State), have, for the annual programme [20xx] of the [name of the Fund], examined the results of the audit work carried out on this annual programme [and have carried out the additional work I judged necessary as set out in the report].

I have planned and performed this work with a view to assessing whether the request for payment of the balance of the Community contribution to the annual programme [20xx] is valid and the underlying transactions covered by the declarations of expenditure regarding this annual programme are legal and regular.

2.   SCOPE OF THE EXAMINATIONEither

There were no limitations on the scope of the examination.

Or

The scope of the examination was limited by the following factors:
a) | […]

b) | […]

c) | Etc.3.   OPINIONEither (Unqualified opinion)Based on the examination referred to above, it is my opinion that the declarations of expenditure present fairly, in all material respects, the expenditure paid under the annual programme and that the request for payment of the balance of the Community contribution to this annual programme is valid.

Or (Qualified opinion)Based on the examination referred to above, it is my opinion that the declarations of expenditure present fairly, in all material respects, the expenditure paid under the annual programme and that the request for payment of the balance of the Community contribution to this annual programme is valid, except with regard to the following points:
a) | […]

b) | […]

c) | Etc.I estimate the impact of these qualifications to be … of the total expenditure declared. The Community contribution affected is thus…..

Or (Adverse opinion)Based on the examination referred to above, it is my opinion that the declarations of expenditure do not present fairly, in all material respects, the expenditure paid under the annual programme and that, as a consequence, the request for payment of the balance of the Community contribution to this annual programme is not valid.

Date

Signature

[signature of the responsible person]
ANNEX VIIIMODEL DECLARATION OF EXPENDITURE FOR THE SECOND PRE-FINANCING

MEMBER STATE:

FUND:

CERTIFYING AUTHORITY:

ANNUAL PROGRAMME COVERED BY THE CERTIFICATION:

I, the undersigned, [name of the person in charge]

representing the certifying authority designated for the [name of the Fund]

hereby certify that all expenditure included in the progress report on the implementation of the annual programme amounts to:
EUR(1) | [exact figure to two decimal places]

I also certify that actions are progressing in pursuance with the objectives laid down in the Commission Decision adopting the annual programme and in accordance with the basic act and its implementing rules, and in particular, that:
1) | the declaration of expenditure is accurate, results from reliable accounting systems and is based on verifiable supporting documents;

2) | the expenditure declared complies with the applicable Community and national rules and has been incurred in respect of actions selected for funding in accordance with the criteria applicable to the annual programme and the applicable Community and national rules, in particular with public procurement rules;

3) | for the purpose of certification, I have received adequate information from the Responsible Authority on the procedures and verifications carried out in relation to expenditure included in statements of expenditure;

4) | the declaration of expenditure and the request for the second pre-financing payment take account, where applicable, of any amounts recovered and of any interest received under the annual programme.This declaration of expenditure is based on accounts provisionally closed on [dd/mm/20yy].

In accordance with Article 43 of the basic act, the supporting documents are and will continue to be available for at least five years following the closure of the annual programme by the Commission.
Date | Name in capital letters, stamp, position and signature of certifying authority

(1)  Total amount of eligible expenditure paid by final beneficiaries or used for the technical assistance.
ANNEX IXMODEL DECLARATION OF EXPENDITURE FOR PAYMENT OF THE BALANCE

MEMBER STATE:

FUND:

CERTIFYING AUTHORITY:

ANNUAL PROGRAMME COVERED BY THE CERTIFICATION:

I, the undersigned, [name of the person in charge]

representing the certifying authority designated for the [name of the Fund]

hereby certify that all expenditure included in the final report on the implementation of the annual programme amounts to:
EUR(1) | [exact figure to two decimal places]

I also certify that actions are progressing in pursuance with the objectives laid down in the Commission Decision adopting the annual programme and in accordance with the basic act, and in particular that:
1) | the declaration of expenditure is accurate, results from reliable accounting systems and is based on verifiable supporting documents;

2) | the expenditure declared complies with the applicable Community and national rules and has been incurred in respect of actions selected for funding in accordance with the criteria applicable to the annual programme and the applicable Community and national rules, in particular with public procurement rules;

3) | I have a reasonable assurance that the underlying transactions are legal and regular;

4) | for the purpose of certification, I have received adequate information from the Responsible Authority on the procedures and verifications carried out in relation to expenditure included in statements of expenditure;

5) | the results of all audits carried out by or under the responsibility of the audit authority have been duly taken into account;

6) | the declaration of expenditure and the request for the balance payment take account, where applicable, of any amounts recovered and of any interest received under the annual programme.This declaration of expenditure is based on accounts closed on [dd/mm/20yy].

In accordance with Article 43 of the basic act, the supporting documents are and will continue to be available for at least five years following the closure of the annual programme by the Commission.
Date | Name in capital letters, stamp, position and signature of certifying authority

(1)  Total amount of eligible expenditure paid by final beneficiaries or used for the technical assistance.
Symbolic descriptionANNEX XINSTRUCTIONS CONCERNING THE EMBLEM AND DEFINITION OF THE STANDARD COLOURSAgainst a background of blue sky, twelve golden stars form a circle representing the union of the peoples of Europe. The number of stars is fixed, twelve being the symbol of perfection and unity.

Heraldic descriptionOn an azure field a circle of twelve golden mullets, their points not touching.

Geometric description

The emblem has the form of a blue rectangular flag of which the fly is one and a half times the length of the hoist. Twelve gold stars situated at equal intervals form an invisible circle whose centre is the point of intersection of the diagonals of the rectangle. The radius of the circle is equal to one third of the height of the hoist. Each of the stars has five points which are situated on the circumference of an invisible circle whose radius is equal to one eighteenth of the height of the hoist. All the stars are upright, i.e. with one point vertical and two points in a straight line at right angles to the mast. The circle is arranged so that the stars appear in the position of the hours on the face of a clock. Their number is invariable.

Regulation coloursThe emblem is in the following colours: PANTONE REFLEX BLUE for the surface of the rectangle; PANTONE YELLOW for the stars.

Four-colour processIf the four-colour process is used, recreate the two standard colours by using the four colours of the four-colour process.

PANTONE YELLOW is obtained by using 100 % ‘Process Yellow’.

PANTONE REFLEX BLUE is obtained by mixing 100 % ‘Process Cyan’ and 80 % ‘Process Magenta’.

InternetIn the web-palette PANTONE REFLEX BLUE corresponds to colour RGB:0/0/153 (hexadecimal: 000099) and PANTONE YELLOW to colour RGB:255/204/0 (hexadecimal: FFCC00).

Monochrome reproduction processUsing black, outline the rectangle in black and print the stars in black on white.
Using blue (Reflex Blue), use 100 % with the stars reproduced in negative white.
Reproduction on a coloured backgroundIf there is no alternative to a coloured background, put a white border around the rectangle, the width of the border being 1/25th of the height of the rectangle.
I.   General principlesANNEX XIRULES ON THE ELIGIBILITY OF EXPENDITURE — EUROPEAN RETURN FUNDI.1.   Basic Principles

 | 1. | In accordance with the basic act, for it to be eligible, expenditure must be:a)within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act;b)within the eligible actions and measures listed in Articles 4 and 5 of the basic act;c)needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission;d)reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness;e)incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project;f)linked to the target groups defined in Article 7 of the basic act;g)incurred in accordance with the specific provisions in the grant agreement. | a) | within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act; | b) | within the eligible actions and measures listed in Articles 4 and 5 of the basic act; | c) | needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission; | d) | reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness; | e) | incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project; | f) | linked to the target groups defined in Article 7 of the basic act; | g) | incurred in accordance with the specific provisions in the grant agreement.

a) | within the scope of the Fund and within its objectives, as described in Articles 1, 2 and 3 of the basic act;

b) | within the eligible actions and measures listed in Articles 4 and 5 of the basic act;

c) | needed to carry out the activities covered by the project, forming part of the multiannual and annual programmes, as approved by the Commission;

d) | reasonable and comply with the principles of sound financial management, in particular, value for money and cost-effectiveness;

e) | incurred by the final beneficiary and/or the partners in the project, who shall be established and registered in a Member State, except in the case of international governmental organisations that pursue the same objectives laid down in the basic act. With regard to Article 39(2) of this Decision, the rules applicable to the final beneficiary shall applymutatis mutandisto the partners in the project;

f) | linked to the target groups defined in Article 7 of the basic act;

g) | incurred in accordance with the specific provisions in the grant agreement.

 | 2. | In the case of multiannual actions within the meaning of Article 15(6) of the basic act, only the part of the action co-financed by an annual programme is considered to be a project for the application of these eligibility rules.

 | 3. | Projects supported by the Fund shall not be financed by other sources covered by the Community budget. Projects supported by the Fund shall be co-financed by public or private sources.I.2.   Budget of a projectThe budget of a project shall be presented as follows:
Expenditure | Income

+Direct costs (DC)+Indirect costs(fixed percentage of DC, defined in the grant agreement)+Costs covered by assigned income (if applicable) | + | Direct costs (DC) | + | Indirect costs(fixed percentage of DC, defined in the grant agreement) | + | Costs covered by assigned income (if applicable) | +contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision)+contribution from the final beneficiary and the partners in the project1(1)+contribution from third parties+receipts generated by the project | + | contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision) | + | contribution from the final beneficiary and the partners in the project1(1) | + | contribution from third parties | + | receipts generated by the project

+ | Direct costs (DC)

+ | Indirect costs(fixed percentage of DC, defined in the grant agreement)

+ | Costs covered by assigned income (if applicable)

+ | contribution from the EC(defined as the lowest of the three amounts indicated in Article 12 of this Decision)

+ | contribution from the final beneficiary and the partners in the project1(1)

+ | contribution from third parties

+ | receipts generated by the project

= Total Eligible Cost(TEC) | = Total IncomeThe budget shall be balanced: Total Eligible Cost shall be equal to Total Income.

I.3.   Income and Non-Profit Principle

 | 1. | Projects supported by the Fund must be of a non-profit-making nature. If, at the end of the project, the sources of income, including receipts, exceed expenditure, the contribution to the project from the Fund shall be reduced accordingly. All sources of income for the project must be recorded in the final beneficiary’s accounts or tax documents, and must be identifiable and controllable.

 | 2. | Project income shall come from all financial contributions granted to the project by the Fund, from public or private sources, including the final beneficiary’s own contribution, and from any receipts generated by the project. ‘Receipts’ for the purpose of this rule covers revenue received by a project during the eligibility period as described in point I.4, from sales, rentals, services, enrolment/fees or other equivalent income.

 | 3. | The Community contribution resulting from the application of the principle of non-profit, as referred to under Article 12(c) of this Decision, will be the ‘total eligible cost’ minus the ‘contribution from third parties’ and ‘receipts generated by the project’.I.4.   Eligibility Period

 | 1. | Costs relating to a project must be incurred and the respective payments (except for depreciation) made after 1 January of the year referred to in the financing decision approving the annual programmes of the Member States. The eligibility period is until 31 December of the year N(2)+1, meaning that the costs relating to a project must be incurred before this date.

 | 2. | An exception to the above-mentioned eligibility period is made for technical assistance for Member States (refer to point V(3)).I.5.   Record of expenditure

 | 1. | Expenditure shall correspond to payments made by the final beneficiary. These must be in the form of financial (cash) transactions, with the exception of depreciation.

 | 2. | As a rule, expenditure shall be justified by official invoices. Where this cannot be done, expenditure shall be supported by accounting documents or supporting documents of equivalent evidential value.

 | 3. | Expenditure must be identifiable and verifiable. In particular,a)it must be recorded in the accounting records of the final beneficiary;b)it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; andc)it must be declared in accordance with the requirements of applicable tax and social legislation. | a) | it must be recorded in the accounting records of the final beneficiary; | b) | it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; and | c) | it must be declared in accordance with the requirements of applicable tax and social legislation.

a) | it must be recorded in the accounting records of the final beneficiary;

b) | it must be determined in accordance with the applicable accounting standards of the country where the final beneficiary is established and with the usual cost accounting practices of the final beneficiary; and

c) | it must be declared in accordance with the requirements of applicable tax and social legislation.

 | 4. | Where applicable, the final beneficiaries are obliged to keep certified copies of the accounting documents justifying income and expenditure incurred by the partners in relation to the project concerned.

 | 5. | The storage and processing of such records must comply with the national data protection legislation.I.6.   Territorial scope

 | 1. | Expenditure for actions and measures described in Articles 4 and 5 of the basic act must be:a)incurred by the final beneficiaries defined in point I.1(e); andb)incurred in the territory of the Member States or of third countries. | a) | incurred by the final beneficiaries defined in point I.1(e); and | b) | incurred in the territory of the Member States or of third countries.

a) | incurred by the final beneficiaries defined in point I.1(e); and

b) | incurred in the territory of the Member States or of third countries.

 | 2. | Partners in the project registered and established in third countries may participate in projects on a no-cost basis, except in the case of international governmental organisations. Therefore, costs incurred by these partners are ineligible.II.   Categories of eligible costs (at project level)II.1.   Direct eligible costsThe direct eligible costs of the project are costs that, with due regard to the general conditions of eligibility set out in part I above, are identifiable as specific costs directly linked to the implementation of the project. Direct costs shall be included in the estimated overall budget of the project.

The following direct costs are eligible:

II.1.1.   Staff costs

II.1.1.1.   General rules

 | 1. | Direct costs for staff are eligible only for persons that have a key and direct role in the project, such as project managers and other staff operationally involved in the project, for example planning project activities, implementing (or monitoring) operational activities, delivering services to the final recipients of the project, etc.Costs for other members of staff in the final beneficiary organisation who only provide a supporting role (such as the general manager, accountant, procurement support, human resources support, information technology support, administrative assistant, receptionist, etc.) are not eligible as direct costs and are considered to be indirect costs (see point II.2).

 | 2. | Staff costs shall be detailed in the forward budget, indicating functions, number of staff and names.If the names of the persons are not yet known or cannot be disclosed, indication shall be provided of the professional and technical capacities of the persons set to implement the relevant functions/tasks within the project.

 | 3. | The cost of staff assigned to the project, i.e. salaries and social security contributions and other statutory costs, shall be eligible, provided that this does not exceed the average rates as regards the final beneficiary’s usual policy on remuneration. Where applicable, this figure may include all the usual contributions paid by the employer, but it must exclude any bonuses, incentive payments or profit-sharing schemes. Levies, taxes or charges (in particular, direct taxes and social security contributions on wages) arising from projects co-financed by the Fund amount to eligible costs only where they are actually borne by the final beneficiary of the grant.II.1.1.2.   Specific conditions for staff costs of public bodiesStaff costs of public bodies implementing the project are considered to be direct eligible costs only in the following situations:
a) | a person contracted by the final beneficiary solely for the purpose of implementing the project;

b) | a person employed on a permanent basis by the final beneficiary who:—fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or—is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation. | — | fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or | — | is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation.

— | fulfils tasks specifically linked to the implementation of the project on the basis of overtime remuneration, or

— | is seconded by a duly documented decision of the organisation to tasks that are specifically linked to the implementation of the project which do not form part of his/her normal routine and he/she is replaced for his/her usual tasks by another person recruited by the organisation.II.1.2.   Travel and subsistence costs
 | 1. | Travel and subsistence costs are only eligible as direct costs for:a)staff of the final beneficiary whose costs are eligible as defined in point II.1.1;b)in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1;c)other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence. | a) | staff of the final beneficiary whose costs are eligible as defined in point II.1.1; | b) | in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1; | c) | other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence.

a) | staff of the final beneficiary whose costs are eligible as defined in point II.1.1;

b) | in duly exceptional and justified cases, staff of the final beneficiary providing a supporting role as defined in point II.1.1;

c) | other persons outside the final beneficiary who participate in the activities of the project. In this case, attendance lists should be kept as supporting evidence.

 | 2. | Travel costs shall be eligible on the basis of the actual costs incurred. Reimbursement rates shall be based on the cheapest form of public transport and flights shall, as a rule, be permitted only for journeys over 800 km (return trip), or where the geographical destination justifies travelling by air. Boarding passes must be kept. Where a private car is used, reimbursement is normally made either on the basis of the cost of public transport, or on the basis of mileage rates in accordance with published official rules in the Member State concerned or used by the final beneficiary.

 | 3. | Subsistence costs shall be eligible on the basis of real costs or a daily allowance. Where an organisation has its own daily rates (subsistence allowances), they shall be applied within ceilings established by the Member State in accordance with national legislation and practice. Subsistence allowances are normally understood to cover local transport (including taxis), accommodation, meals, local telephone calls and sundries.II.1.3.   Equipment

II.1.3.1.   General rules

 | 1. | Costs pertaining to the acquisition of equipment (based on depreciation of purchased assets, leasing or rental) are only eligible if they are essential to the implementation of the project. Equipment shall have the technical properties needed for the project and comply with applicable norms and standards.

 | 2. | Costs for day-to-day administrative equipment (such as printer, laptop, fax, copier, phone, cabling, etc.) are not eligible as direct costs and are to be considered as indirect costs (see point II.2).

 | 3. | The choice between leasing, rental or purchase must always be based on the least expensive option. However, if leasing or renting are not possible because of the short duration of the project or the rapid depreciation in value, purchase is accepted and the costs related to depreciation, as described below, may be eligible on the basis of national depreciation rules.II.1.3.2.   Renting and leasingExpenditure in relation to renting and leasing operations is eligible for co-financing subject to the rules established in the Member State, national legislation and practice and the duration of the rental or lease for the purpose of the project.

II.1.3.3.   Purchasing

 | 1. | Where equipment is purchased before or during the lifetime of the project, only the portion of equipment depreciation corresponding to the duration of use for the project and the rate of actual use for the project is eligible.

 | 2. | Equipment that was purchased before the lifetime of the project, but which is used for the purpose of the project, is eligible on the basis of depreciation. However these costs are ineligible if the equipment was originally purchased through a Community grant.

 | 3. | Purchase costs of equipment shall correspond to normal market costs and the value of the items concerned is written off in accordance with the tax and accounting rules applicable to the final beneficiary.

 | 4. | For individual items costing below 1 000 euros, the full purchase cost is eligible, provided that the equipment is purchased during the first three months of the project.II.1.4.   Real estate

II.1.4.1.   General rulesIn the case of either purchase of real estate, construction or renovation of real estate, or rental of real estate, it shall have the technical properties needed for the project and comply with the applicable norms and standards.

II.1.4.2.   Purchase, construction or renovation

 | 1. | Where the acquisition of real estate is essential for implementation of the project and is clearly linked with its objectives, the purchase of real estate, i.e. buildings already constructed, or construction of real estate, is eligible for co-financing under the conditions set out below, without prejudice to the application of stricter national rules:a)A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project;b)The real estate has not been purchased through a Community grant at any time prior to the implementation of the project;c)The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise;d)Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules. | a) | A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project; | b) | The real estate has not been purchased through a Community grant at any time prior to the implementation of the project; | c) | The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise; | d) | Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules.

a) | A certificate shall be obtained from an independent qualified valuer or duly authorised official body establishing that the price does not exceed the market value, either attesting that the real estate is in conformity with national regulations or specifying the points which are not in conformity that the final beneficiary plans to rectify as part of the project;

b) | The real estate has not been purchased through a Community grant at any time prior to the implementation of the project;

c) | The real estate is to be used solely for the purpose stated in the project for a period of at least five years after the end date of the project unless the Commission specifically authorises otherwise;

d) | Only the portion of the depreciation of these assets corresponding to the duration of use for the project and the rate of actual use for the project is eligible. Depreciation shall be calculated according to national accounting rules.

 | 2. | In the case of renovation, only conditions (c) and (d) above apply.II.1.4.3.   RentalRental of real estate is eligible for co-financing where there is a clear link between the rental and the objectives of the project concerned, under the conditions set out below and without prejudice to the application of stricter national rules:
a) | The real estate shall not have been purchased through a Community grant;

b) | The real estate should only be used for implementation of the project. If not, only the portion of the costs corresponding to the use for the project is eligible.II.1.4.4.   Office space for the final beneficiaryCosts for the purchase, construction, renovation or rental of office space for the routine activities of the final beneficiary are not eligible. Such costs are considered to be indirect costs (see point II.2).

II.1.5.   Consumables, supplies and general services
 | 1. | The costs of consumables, supplies and general services are eligible provided that they are identifiable and directly necessary for the implementation of the project.

 | 2. | However, office supplies as well as all kinds of small administrative consumables, supplies, hospitality costs and general services (such as telephone, internet, postage, office cleaning, utilities, insurance, staff training, recruitment, etc.) are not direct eligible costs; they are included in indirect costs, as referred to in point II.2.II.1.6.   Subcontracting
 | 1. | As a general rule, final beneficiaries must have the capacity to carry out the activities relating to the project themselves. Therefore, subcontracting must be limited and shall not exceed 40 % of the direct eligible costs of a project unless duly justified and approved in advance by the responsible authority.

 | 2. | Expenditure relating to the following subcontracts is ineligible for co-financing by the Fund:a)subcontracting of tasks relating to the overall management of the project;b)subcontracting that adds to the cost of the project without adding proportionate value to it;c)subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided. | a) | subcontracting of tasks relating to the overall management of the project; | b) | subcontracting that adds to the cost of the project without adding proportionate value to it; | c) | subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided.

a) | subcontracting of tasks relating to the overall management of the project;

b) | subcontracting that adds to the cost of the project without adding proportionate value to it;

c) | subcontracting with intermediaries or consultants where payment is defined as a percentage of the total cost of the project, unless such payment is justified by the final beneficiary by reference to the actual value of the work or services provided.

 | 3. | For all subcontracts, subcontractors shall undertake to provide all audit and control bodies with all the necessary information relating to subcontracted activities.II.1.7.   Costs deriving directly from the requirements linked to EU co-financing

Costs needed to meet the requirements linked to EU co-financing, such as publicity, transparency, evaluation of the project, external audit, bank guarantees, translation costs, etc., are eligible as direct costs.

II.1.8.   Expert fees

Legal consultancy fees, notarial fees and costs of technical and financial experts are eligible.

II.1.9.   Specific expenses in relation to the target groups
 | 1. | Specific expenses for the target groups in accordance with the measures listed in Article 5 of the basic act will consist of full or partial support in the form of:a)Costs incurred by the beneficiary for the target groups;b)Costs incurred by returnees which are then reimbursed by the final beneficiary; orc)Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act). | a) | Costs incurred by the beneficiary for the target groups; | b) | Costs incurred by returnees which are then reimbursed by the final beneficiary; or | c) | Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act).

a) | Costs incurred by the beneficiary for the target groups;

b) | Costs incurred by returnees which are then reimbursed by the final beneficiary; or

c) | Non-reimbursable lump sums (as in the case of limited start-up support for economic activities and cash incentives for returnees, as described in Article 5(8) and (9) of the basic act).

 | 2. | These costs are eligible under the following conditions:a)The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance;b)The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance;c)The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.The storage and processing of the above-mentioned information must comply with national data protection legislation. | a) | The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance; | b) | The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance; | c) | The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.

a) | The final beneficiary shall keep the necessary information and evidence that the persons correspond to the specific target groups and situations defined in Article 5 of the basic act making them eligible to receive such assistance;

b) | The final beneficiary shall keep the necessary information on the returnees receiving this assistance to allow proper identification of these persons, the date of their return to their country, and evidence that these persons have received this assistance;

c) | The final beneficiary shall keep evidence of the support provided (such as invoices and receipts) and in the case of lump-sums evidence must be kept that the persons have received this support.

 | 3. | Assistance measures following the return to the third country, such as training and employment assistance, short-term measures necessary for the reintegration process and post-return assistance as described in Article 5(5), (8) and (9) of the basic act respectively shall not exceed the duration of six months following the date of the return of the third-country national.II.2.   Indirect eligible costs

 | 1. | Indirect costs relate to categories of expenditure that are not identifiable as specific costs directly linked to the project. A fixed percentage of the total amount ofdirect eligible costsmay be eligible as indirect costs, provided that:a)the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs;b)the indirect costs are anticipated in the forward budget of the project;c)the indirect costs do not include costs assigned to another heading of the budget for the project;d)the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget;e)as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs. | a) | the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs; | b) | the indirect costs are anticipated in the forward budget of the project; | c) | the indirect costs do not include costs assigned to another heading of the budget for the project; | d) | the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget; | e) | as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs. | — | where the responsible authority acts as an executing body as defined in Article 7(3), or | — | where subcontracting exceeds 40 % of the eligible direct costs.

a) | the indirect costs are kept to a minimum and the exact percentage of indirect costs is set by the Member State in relation to needs;

b) | the indirect costs are anticipated in the forward budget of the project;

c) | the indirect costs do not include costs assigned to another heading of the budget for the project;

d) | the indirect costs are not financed from other sources. Organisations receiving an operating grant received from the EU budget and/or from the Member States cannot include indirect costs in their forward budget;

e) | as a general rule, the fixed percentage of indirect costs in relation to the total amount of direct eligible costs does not exceed 20 %. However, the fixed percentage of indirect costs shall not exceed 10 %:—where the responsible authority acts as an executing body as defined in Article 7(3), or—where subcontracting exceeds 40 % of the eligible direct costs. | — | where the responsible authority acts as an executing body as defined in Article 7(3), or | — | where subcontracting exceeds 40 % of the eligible direct costs.

— | where the responsible authority acts as an executing body as defined in Article 7(3), or

— | where subcontracting exceeds 40 % of the eligible direct costs.

 | 2. | The percentage allocated to indirect costs shall cover the following costs in particular:a)staff costs that are ineligible as direct costs as per point II.1.1.1 (1);b)administration and management expenses, such as costs identified in II.1.5.2;c)bank fees and charges (except bank guarantees as defined in section II.1.7);d)depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4;e)all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’. | a) | staff costs that are ineligible as direct costs as per point II.1.1.1 (1); | b) | administration and management expenses, such as costs identified in II.1.5.2; | c) | bank fees and charges (except bank guarantees as defined in section II.1.7); | d) | depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4; | e) | all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’.

a) | staff costs that are ineligible as direct costs as per point II.1.1.1 (1);

b) | administration and management expenses, such as costs identified in II.1.5.2;

c) | bank fees and charges (except bank guarantees as defined in section II.1.7);

d) | depreciation of real estate and maintenance costs when linked to day-to-day administrative operations, such as costs identified in II.1.4.4;

e) | all costs linked to the project but excluded from section II.1 — ‘Direct Eligible Costs’.III.   Ineligible expenditureThe following costs are not eligible:
a) | VAT, except where the final beneficiary can show that he is unable to recover it;

b) | return on capital, debt and debt service charges, debit interest, foreign exchange commissions and exchange losses, provisions for losses or potential future liabilities, interest owed, doubtful debts, fines, financial penalties, litigation costs, and excessive or reckless expenditure;

c) | entertainment costs exclusively for project staff. Reasonable hospitality costs at social events justified by the project, such as an event at the end of the project or meetings of the project steering group, are permitted;

d) | costs declared by the final beneficiary and covered by another project or work programme receiving a Community grant;

e) | purchase of land;

f) | staff costs for officials who contribute to project implementation by accomplishing tasks that are part of their normal routine;

g) | contributions in kind.IV.   Costs covered by assigned income

 | 1. | In duly substantiated cases, co-financing of the project as regards the contribution from the final beneficiary and the partners in the project may be made up in part of contributions in terms of work carried out by permanent officials employed by these bodies and involved in the project. In this case these costs are not eligible as direct or indirect staff costs as defined under points II.1.1 and II.2 but as costs covered by assigned income.

 | 2. | Such contributions shall not exceed 50 % of the total contribution given by the final beneficiary. In this case, the following rules shall apply:a)tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority;b)public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority;c)the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority. | a) | tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority; | b) | public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority; | c) | the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority.

a) | tasks of public officials are specifically linked to implementation of the project and do not arise from the statutory responsibilities of the public authority;

b) | public officials entrusted with implementing a project are seconded by a duly documented decision of the competent authority;

c) | the value of these contributions can be audited and may not exceed the costs actually borne and duly supported by accounting documents of the public authority.V.   Technical assistance at the initiative of member states

 | 1. | At the initiative of each Member State, the following technical assistance measures are eligible for each annual programme, within the limits specified in Article 17 of the basic act:a)expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables);b)expenditure relating to audits and on-the-spot checks of actions or projects;c)expenditure relating to evaluations of actions or projects;d)expenditure relating to information, dissemination and transparency in relation to actions;e)expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds;f)expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions;g)expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance. | a) | expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables); | b) | expenditure relating to audits and on-the-spot checks of actions or projects; | c) | expenditure relating to evaluations of actions or projects; | d) | expenditure relating to information, dissemination and transparency in relation to actions; | e) | expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds; | f) | expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions; | g) | expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance. | — | civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f), | — | other staff employed to carry out tasks referred to in points a) to f), | — | the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

a) | expenditure relating to the preparation, selection, appraisal, management and monitoring of actions (including computer equipment and consumables);

b) | expenditure relating to audits and on-the-spot checks of actions or projects;

c) | expenditure relating to evaluations of actions or projects;

d) | expenditure relating to information, dissemination and transparency in relation to actions;

e) | expenditure on the acquisition, installation and maintenance of computerised systems for the management, monitoring and evaluation of the Funds;

f) | expenditure on meetings of monitoring committees and sub-committees relating to the implementation of actions. This expenditure may also include the costs of experts and other participants in these committees, including third-country participants, where their presence is essential to the effective implementation of actions;

g) | expenditure on salaries, including social security contributions, although only in the following cases:—civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),—other staff employed to carry out tasks referred to in points a) to f),—the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance. | — | civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f), | — | other staff employed to carry out tasks referred to in points a) to f), | — | the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

— | civil servants or other public officials seconded by duly documented decision of the competent authority to carry out tasks referred to in points a) to f),

— | other staff employed to carry out tasks referred to in points a) to f),

— | the period of secondment or employment may not exceed the final date for the eligibility of expenditure laid down in the decision approving the assistance.

 | 2. | Technical assistance may finance expenses incurred by any of the following bodies: responsible authority, delegated authority, audit authority, certifying authority.

 | 3. | Activities linked to technical assistance must be performed and the corresponding payments made after 1 January of the year referred to in the financing decision approving the annual programmes of Member States. The eligibility period lasts until the end of June of the year N(3)+2 or any later date compatible with the deadline for the submission of the final report on implementation of the annual programme.

 | 4. | Any procurement must be carried out in accordance with national procurement rules established in the Member State.

 | 5. | Member States may implement technical assistance measures for this Fund together with technical assistance measures for some or all of the four Funds. However, in that case only the portion of the costs used to implement the common measure corresponding to this Fund shall be eligible for financing under this Fund, and Member States shall ensure that:a)the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; andb)there is no double financing of costs. | a) | the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; and | b) | there is no double financing of costs.

a) | the portion of costs for common measures is charged to the corresponding Fund in a reasonable and verifiable manner; and

b) | there is no double financing of costs.

(1)  Including assigned income as described in point IV.

(2)  Where ‘N’ is the year referred to in the financing decision approving the annual programmes of Member States.

(3)  Where ‘N’ is the year referred to in the financing decision approving the annual programmes of Member States.

Pending: 32008D0426

                                January 16, 2026                            

18.6.2008
EN
Official Journal of the European Union
L 159/46

(1)
According to Article 2 of Commission Decision 2002/253/EC(2)the case definitions laid down in Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data.

(2)
In accordance with Article 9 of the Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control(3)(ECDC), the ECDC provided, at the request of the Commission and in agreement with its Advisory Forum, a technical document on case definitions aiding the Commission in the development of intervention strategies in the field of surveillance and response. The technical document has been further published on the web site of the ECDC. The case definitions listed in the Annex to Decision 2002/253/EC should be updated on the basis of this contribution.

(3)
Those case definitions have the purpose of facilitating the reporting on the diseases and special health issues listed in Annex I to Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council(4). Decision 2002/253/EC however does not entail any reporting obligation.

(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Decision No 2119/98/EC,

—
human to human transmission: Any person who has had contact with a laboratory confirmed human case in such a way as to have had the opportunity to acquire the infection,

—
animal to human transmission: Any person who has had contact with an animal with a laboratory confirmed infection/colonisation in such a way as to have had the opportunity to acquire the infection,

—
exposure to a common source: Any person who has been exposed to the same common source or vehicle of infection, as a confirmed human case,

—
exposure to contaminated food/drinking water: Any person who has consumed food or drinking water with a laboratory confirmed contamination or a person who has consumed potentially contaminated products from an animal with a laboratory confirmed infection/colonisation,

—
environmental exposure: Any person who has bathed in water or has had contact with a contaminated environmental source that has been laboratory confirmed,

—
laboratory exposure: Any person working in a laboratory where there is a potential for exposure.

—
airborne, by projection of aerosol from an infected person onto the mucous membranes while coughing, spitting, singing or talking, or when microbial aerosols dispersed into the atmosphere are inhaled by others,

—
contact, direct contact with an infected person (faecal-oral, respiratory droplets, skin or sexual exposure) or animal (e.g. biting, touching) or indirect contact to infected materials or objects (infected fomites, body fluids, blood),

—
vertical, from mother to child, often in utero, or as a result of the incidental exchange of body fluids usually during the perinatal period,

—
vector transmission, indirect transmission by infected mosquitoes, mites, flies and other insects which transmit disease to humans through their bites,

—
food or water, consumption of potentially contaminated food or drinking water.

—
Adults and adolescents ≥ 13 years(1)

—
Children < 13 years of age(2)

—
Adults, adolescents and children aged ≥ 18 monthsAt least one of the following three:—Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot)—Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test—Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV
—
Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot)
—
Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test
—
Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV
—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)
—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay
—
Isolation of HIV

—
Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot)

—
Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test

—
Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV
—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)
—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay
—
Isolation of HIV

—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay

—
Isolation of HIV

—
Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot)

—
Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test

—
Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV
—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)
—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay
—
Isolation of HIV

—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay

—
Isolation of HIV

—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay

—
Isolation of HIV

—
Children aged < 18 monthsPositive results on two separate specimens (excluding cord blood) from at least one of the following three:—Isolation of HIV—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of age
—
Isolation of HIV
—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)
—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of age

—
Isolation of HIV

—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of age

—
Isolation of HIV

—
Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

—
Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of age

—
HIV infectionAny person meeting the laboratory criteria for HIV infection

—
AIDSAny person meeting the clinical criteria for AIDS and the laboratory criteria for HIV infection

—
Papular or vesicular lesion

—
Depressed black eschar with surrounding oedema

—
Fever or feverishness

—
Severe abdominal pain

—
Diarrhoea

—
Fever or feverishness

—
Acute respiratory distress

—
Radiological evidence of mediastinal widening

—
Fever

—
Convulsions

—
Loss of consciousness

—
Meningeal signs

—
Isolation ofBacillus anthracisfrom a clinical specimen

—
Detection ofBacillus anthracisnucleic acid in a clinical specimen

—
Animal to human transmission

—
Exposure to a common source

—
Exposure to contaminated food/drinking water

—
Fever AND signs and symptoms of acute respiratory infection

—
Death from an unexplained acute respiratory illness

—
Isolation of influenza A/H5N1 from a clinical specimen

—
Detection of influenza A/H5 nucleic acid in a clinical specimen

—
Influenza A/H5 specific antibody response (fourfold or greater rise or single high titre)

—
Human to human transmission by having been in close contact (within one metre) to a person reported as probable or confirmed case

—
Laboratory exposure: where there is a potential exposure to influenza A/H5N1

—
Close contact (within one metre) with an animal with confirmed A/H5N1 infection other than poultry or wild birds (e.g. cat or pig)

—
Reside in or have visited an area where influenza A/H5N1 is currently suspected or confirmed(3)AND at least one of the following two:—Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area—Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area
—
Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area
—
Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area

—
Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area

—
Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area

—
Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area

—
Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area

—
Bilateral cranial nerve impairment (e.g. diplopia, blurred vision, dysphagia, bulbar weakness)

—
Peripheral symmetric paralysis

—
Constipation

—
Lethargy

—
Poor feeding

—
Ptosis

—
Dysphagia

—
General muscle weakness

—
Isolation ofC. botulinumfor infant botulism (stool) or wound botulism (wound) (isolation ofC. botulinumin stool of adults not relevant for the diagnosis of food-borne botulism)

—
Detection of botulinum toxin in a clinical specimen

—
Exposure to a common source (e.g. food, sharing of needles or other devices)

—
Exposure to contaminated food/drinking water

—
Sweating (profuse, malodorous, specially nocturnal)

—
Chills

—
Arthralgia

—
Weakness

—
Depression

—
Headache

—
Anorexia

—
Isolation ofBrucella spp.from a clinical specimen

—
Brucellaspecific antibody response (Standard Agglutination Test, Complement Fixation, ELISA)

—
Exposure to contaminated food/drinking water

—
Exposure to products from a contaminated animal (milk or milk products)

—
Animal to human transmission (contaminated secretions or organs e.g. vaginal discharge, placenta)

—
Exposure to a common source

—
Diarrhoea

—
Abdominal pain

—
Fever

—
Isolation ofCampylobacter spp.from stool or blood

—
Animal to human transmission

—
Human to human transmission

—
Exposure to a common source

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
Urethritis

—
Epididymitis

—
Acute salpingitis

—
Acute endometritis

—
Cervicitis

—
Proctitis

—
Conjunctivitis

—
Pneumonia

—
Urethritis

—
Genital ulcer

—
Inguinal lymphadenopathy

—
Cervicitis

—
Proctitis

—
Isolation ofChlamydia trachomatisfrom a specimen of the ano-genital tract or from the conjunctiva

—
Demonstration ofChlamydia trachomatisby DFA test in a clinical specimen

—
Detection ofChlamydia trachomatisnucleic acid in a clinical specimen

—
Isolation ofChlamydia trachomatisfrom a specimen of the ano-genital tract or from the conjunctiva

—
Detection ofChlamydia trachomatisnucleic acid in a clinical specimenAND

—
Identification of serovar (genovar) L1, L2 or L3

—
Diarrhoea

—
Vomiting

—
Isolation ofVibrio choleraefrom a clinical specimenAND

—
Demonstration of O1 or O139 antigen in the isolateAND

—
Demonstration of cholera-enterotoxin or the cholera-enterotoxin gene in the isolate

—
Exposure to a common source

—
Human to human transmission

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
Any person with a progressive neuropsychiatric disorder with a duration of illness of at least six months

—
Routine investigations do not suggest an alternative diagnosis

—
No history of exposure to human pituitary hormones or human dura mater graft

—
No evidence of a genetic form of transmissible spongiform encephalopathy

—
Early psychiatric symptoms(5)

—
Persistent painful sensory symptoms(6)

—
Ataxia

—
Myoclonus or chorea or dystonia

—
Dementia

—
Neuropathological confirmation: spongiform change and extensive prion protein deposition with florid plaques throughout the cerebrum and cerebellum

—
EEG does not show the typical appearance(7)of sporadic CJD(8)in the early stages of the illness

—
Bilateral pulvinar high signal on MRI brain scan

—
A positive tonsil biopsy(9)

—
meeting the clinical criteriaAND

—
a negative EEG for sporadic CJD(8)

—
meeting the clinical criteriaAND

—
a negative EEG for sporadic CJD(8)AND

—
a positive MRI brain scanOR

—
a positive tonsil biopsy

—
meeting the diagnostic criteria for case confirmation

—
Diarrhoea

—
Abdominal pain

—
Demonstration ofCryptosporidiumoocysts in stool

—
Demonstration ofCryptosporidiumin intestinal fluid or small-bowel biopsy specimens

—
Detection ofCryptosporidiumnucleic acid in stool

—
Detection ofCryptosporidiumantigen in stool

—
Human to human transmission

—
Exposure to a common source

—
Animal to human transmission

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
CroupOR

—
an adherent membrane in at least one of the following three locations:—Tonsil—Pharynx—Nose
—
Tonsil
—
Pharynx
—
Nose

—
Tonsil

—
Pharynx

—
Nose

—
Tonsil

—
Pharynx

—
Nose

—
Uni- or bilateral nasal discharge initially clear and becoming bloody

—
Skin lesion

—
Lesion of conjunctiva or mucous membranes

—
Isolation of toxin-producingC. diphtheriaeorC. ulceransfrom a clinical specimen

—
Histopathology or parasitology compatible withEchinococcus multilocularisorgranulosus(e.g. direct isvisualisation of the protoscolex in cyst fluid)

—
Detection ofEchinoccocus granulosuspathognomonic macroscopic morphology of cyst(s) in surgical specimens

—
Typical organ lesions detected by imaging techniques (e.g.: computerised tomography, sonography, MRI) AND confirmed by a serological test

—
Echinococcusspp. specific serum antibodies by high-sensitivity serological test AND confirmed by a high specificity serological test

—
Detection ofEchinococcus multilocularisorgranulosusnucleic acid in a clinical specimen

—
Diarrhoea

—
Abdominal pain

—
Microangiopatic haemolytic anaemia

—
Thrombocytopenia

—
Isolation of Shigatoxin/Verotoxin (STEC/VTEC) producingE. coli

—
Detection of stx1 or stx2 gene(s) nucleic acid

—
Detection of free shigatoxins.

—
E. coliserogroups specific antibody response

—
Human to human transmission

—
Exposure to a common source

—
Animal to human transmission

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
Diarrhoea

—
Abdominal pain

—
Bloating

—
Signs of malabsorption (e.g. steatorrhoea, weight loss)

—
Demonstration ofGiardia lambliacysts or trophozoites in stool, duodenal fluid or small-bowel biopsy

—
Demonstration ofGiardia lambliaantigen in stool

—
Exposure to contaminated food/drinking water

—
Human to human transmission

—
Exposure to a common source

—
Environmental exposure

—
Urethritis

—
Acute salpingitis

—
Pelvic inflammatory disease

—
Cervicitis

—
Epididymitis

—
Proctitis

—
Pharyngitis

—
Arthritis

—
Isolation ofNeisseria gonorrhoeaefrom a clinical specimen

—
Detection ofNeisseria gonorrhoeaenucleic acid in a clinical specimen

—
Demonstration ofNeisseria gonorrhoeaeby a non amplified nucleic acid probe test in a clinical specimen

—
Microscopic detection of intracellular gram negative diploccocci in an urethral male specimen

—
Isolation ofHaemophilus influenzaefrom a normally sterile site

—
Detection ofHaemophilus influenzaenucleic acid from a normally sterile site

—
Fever

—
Jaundice

—
Elevated serum aminotransferase levels

—
Detection of hepatitis A virus nucleic acid in serum or stool

—
Hepatitis A virus specific antibody response

—
Detection of hepatitis A virus antigen in stool

—
Human to human transmission

—
Exposure to a common source

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
Fever

—
Jaundice

—
Elevated serum aminotransferase levels

—
Detection of hepatitis C virus nucleic acid in serum

—
Hepatitis C virus specific antibody response confirmed by a different antibody test

—
Sudden onset of symptomsAND

—
at least one of the followingfoursystemic symptoms:—Fever or feverishness—Malaise—Headache—MyalgiaAND
—
Fever or feverishness
—
Malaise
—
Headache
—
Myalgia

—
Fever or feverishness

—
Malaise

—
Headache

—
Myalgia

—
Fever or feverishness

—
Malaise

—
Headache

—
Myalgia

—
at least one of the following three respiratory symptoms:—Cough—Sore throat—Shortness of breath
—
Cough
—
Sore throat
—
Shortness of breath

—
Cough

—
Sore throat

—
Shortness of breath

—
Cough

—
Sore throat

—
Shortness of breath

—
Sudden onset of symptomsAND

—
At least one of the followingfourrespiratory symptoms:—Cough—Sore throat—Shortness of breath—CoryzaAND
—
Cough
—
Sore throat
—
Shortness of breath
—
Coryza

—
Cough

—
Sore throat

—
Shortness of breath

—
Coryza

—
Cough

—
Sore throat

—
Shortness of breath

—
Coryza

—
A clinician's judgement that the illness is due to an infection

—
Isolation of influenza virus from a clinical specimen

—
Detection of influenza virus nucleic acid in a clinical specimen

—
Identification of influenza virus antigen by DFA test in a clinical specimen

—
Influenza specific antibody response

—
Laboratory criteria for case confirmationAt least one of the followingthree:—Isolation ofLegionella spp. from respiratory secretions or any normally sterile site—Detection ofLegionella pneumophilaantigen in urine—Legionella pneumophilaserogroup 1 specific antibody response
—
Isolation ofLegionella spp. from respiratory secretions or any normally sterile site
—
Detection ofLegionella pneumophilaantigen in urine
—
Legionella pneumophilaserogroup 1 specific antibody response

—
Isolation ofLegionella spp. from respiratory secretions or any normally sterile site

—
Detection ofLegionella pneumophilaantigen in urine

—
Legionella pneumophilaserogroup 1 specific antibody response

—
Isolation ofLegionella spp. from respiratory secretions or any normally sterile site

—
Detection ofLegionella pneumophilaantigen in urine

—
Legionella pneumophilaserogroup 1 specific antibody response

—
Laboratory criteria for a probable caseAt least one of the following four:—Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents—Detection ofLegionella spp.nucleic acid in a clinical specimen—Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response—L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibody
—
Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents
—
Detection ofLegionella spp.nucleic acid in a clinical specimen
—
Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response
—
L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibody

—
Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents

—
Detection ofLegionella spp.nucleic acid in a clinical specimen

—
Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response

—
L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibody

—
Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents

—
Detection ofLegionella spp.nucleic acid in a clinical specimen

—
Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response

—
L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibody

—
Environmental exposure

—
Exposure to the same common source

—
Fever

—
Chills

—
Headache

—
Myalgia

—
Conjunctival suffusion

—
Haemorrhages into skin and mucous membranes

—
Rash

—
Jaundice

—
Myocarditis

—
Meningitis

—
Renal impairment

—
Respiratory symptoms such as haemoptysis

—
Isolation ofLeptospira interrogansfrom a clinical specimen

—
Detection ofLeptospira interrogansnucleic acid in a clinical specimen

—
Demonstration ofLeptospira interrogansby immunofluorescence in a clinical specimen

—
Leptospira interrogansspecific antibody response

—
Animal to human transmission

—
Environmental exposure

—
Exposure to a common source

—
Listeriosis of newborns defined asStillbirthORAt least one of the followingfivein the first month of life:—Granulomatosis infantiseptica—Meningitis or meningoencephalitis—Septicaemia—Dyspnoea—Lesions on skin, mucosal membranes or conjunctivae
—
Granulomatosis infantiseptica
—
Meningitis or meningoencephalitis
—
Septicaemia
—
Dyspnoea
—
Lesions on skin, mucosal membranes or conjunctivae

—
Granulomatosis infantiseptica

—
Meningitis or meningoencephalitis

—
Septicaemia

—
Dyspnoea

—
Lesions on skin, mucosal membranes or conjunctivae

—
Granulomatosis infantiseptica

—
Meningitis or meningoencephalitis

—
Septicaemia

—
Dyspnoea

—
Lesions on skin, mucosal membranes or conjunctivae

—
Listeriosis in pregnancy defined as at least one of the following three:—Abortion, miscarriage, stillbirth or premature birth—Fever—Influenza-like symptoms
—
Abortion, miscarriage, stillbirth or premature birth
—
Fever
—
Influenza-like symptoms

—
Abortion, miscarriage, stillbirth or premature birth

—
Fever

—
Influenza-like symptoms

—
Abortion, miscarriage, stillbirth or premature birth

—
Fever

—
Influenza-like symptoms

—
Other form of listeriosis defined as at least one of the following four:—Fever—Meningitis or meningoencephalitis—Septicaemia—isLocalised infections such as arthritis, endocarditis, and abscesses
—
Fever
—
Meningitis or meningoencephalitis
—
Septicaemia
—
isLocalised infections such as arthritis, endocarditis, and abscesses

—
Fever

—
Meningitis or meningoencephalitis

—
Septicaemia

—
isLocalised infections such as arthritis, endocarditis, and abscesses

—
Fever

—
Meningitis or meningoencephalitis

—
Septicaemia

—
isLocalised infections such as arthritis, endocarditis, and abscesses

—
Isolation ofListeria monocytogenesfrom a normally sterile site

—
Isolation ofListeria monocytogenesfrom a normally non-sterile site in a foetus, stillborn, newborn or the mother at or within 24 hours of birth

—
Exposure to a common source

—
Human to human transmission (vertical transmission)

—
Exposure to contaminated food/drinking water

—
Demonstration of malaria parasites by light microscopy in blood films

—
Detection ofPlasmodiumnucleic acid in blood

—
Detection ofPlasmodiumantigen

—
Maculo-papular rash

—
Cough

—
Coryza

—
Conjunctivitis

—
Isolation of measles virus from a clinical specimen

—
Detection of measles virus nucleic acid in a clinical specimen

—
Measles virus specific antibody response characteristic for acute infection in serum or saliva

—
Detection of measles virus antigen by DFA in a clinical specimen using measles specific monoclonal antibodies

—
Fever

—
Meningeal signs

—
Petechial rash

—
Septic shock

—
Septic arthritis

—
Isolation ofNeisseria meningitidisfrom a normally sterile site, including purpuric skin lesions

—
Detection ofNeisseria meningitidisnucleic acid from a normally sterile site, including purpuric skin lesions

—
Detection ofNeisseria meningitidisantigen in CSF

—
Detection of gram negative stained diplococcus in CSF

—
Fever

—
Sudden onset of tender swelling of the parotid or other salivary glands

—
Orchitis

—
Meningitis

—
Isolation of mumps virus from a clinical specimen

—
Detection of mumps virus nucleic acid

—
Mumps virus specific antibody response characteristic for acute infection in serum or saliva

—
Paroxysms of coughing

—
Inspiratory ‘whooping’

—
Post-tussive vomiting

—
Isolation ofBordetella pertussisfrom a clinical specimen

—
Detection ofBordetella pertussisnucleic acid in a clinical specimen

—
Bordetella pertussisspecific antibody response

—
FeverAND

—
Sudden onset of painful lymphadenitis

—
Fever

—
FeverAND

—
Cough

—
Chest pain

—
Haemoptysis

—
Isolation ofYersinia pestisfrom a clinical specimen

—
Detection ofYersinia pestisnucleic acid from a clinical specimen (F1 antigen)

—
Yersinia pestisanti-F1 antigen specific antibody response

—
Human to human transmission

—
Animal to human transmission

—
Laboratory exposure (where there is a potential exposure to plague)

—
Exposure to a common source

—
Isolation ofS. pneumoniaefrom a normally sterile site

—
Detection ofS. pneumoniaenucleic acid from a normally sterile site

—
Detection ofS. pneumoniaeantigen from a normally sterile site

—
Isolation of a polio virus and intratypic differentiation — Wild polio virus (WPV)

—
Vaccine derived poliovirus (VDPV) (for the VDPV at least 85 % similarity with vaccine virus in the nucleotide sequences in the VP1 section)

—
Sabin-like poliovirus: intratypic differentiation performed by a WHO-accredited polio laboratory (for the VDPV a >1 % up to 15 % VP1 sequence difference compared with vaccine virus of the same serotype)

—
Human to human transmission

—
An history of travel to a polio-endemic area or an area with suspected or confirmed circulation of poliovirus

—
Fever

—
Pneumonia

—
Hepatitis

—
Isolation ofCoxiella burnetiifrom a clinical specimen

—
Detection ofCoxiella burnetiinucleic acid in a clinical specimen

—
Coxiella burnetiispecific antibody response (IgG or IgM phase II)

—
Exposure to a common source

—
Animal to human transmission

—
Sensory changes referred to the site of a preceding animal bite

—
Paresis or paralysis

—
Spasms of swallowing muscles

—
Hydrophobia

—
Delirium

—
Convulsions

—
Anxiety

—
Isolation of Lyssa virus from a clinical specimen

—
Detection of Lyssa virus nucleic acid in a clinical specimen (e.g. saliva or brain tissue)

—
Detection of viral antigens by a DFA in a clinical specimen

—
Lyssa virus specific antibody response by virus isneutralisation assay in serum or CSF

—
Animal to human transmission (animal with suspected or confirmed infection)

—
Exposure to a common source (same animal)

—
Human to human transmission (e.g. transplantation of organs)

—
Cervical adenopathy

—
Sub-occipital adenopathy

—
Post-auricular adenopathy

—
Arthralgia

—
Arthritis

—
Laboratory criteria for case confirmationAt least one of the following three:

—
Isolation of rubella virus from a clinical specimen

—
Detection of rubella virus nucleic acid in a clinical specimen

—
Rubella virus specific antibody response (IgG) in serum or saliva

—
Laboratory criteria for probable case

—
Rubella virus specific antibody response (IgM)(10)

—
An epidemiological link

—
Meeting the laboratory criteria for a probable case

—
At least two of the conditions listed in (A)OR

—
One in category (A) and one in category (B)

—
Cataract(s)

—
Congenital glaucoma

—
Congenital heart disease

—
Loss of hearing

—
Pigmentary retinopathy

—
Purpura

—
Splenomegaly

—
Microcephaly

—
Developmental delay

—
Meningo-encephalitis

—
Radiolucent bone disease

—
Jaundice that begins within 24 hours after birth

—
Isolation of rubella virus from a clinical specimen

—
Detection of Rubella virus nucleic acid

—
Rubella virus specific antibody response (IgM)

—
Persistence of rubella IgG between 6 and 12 months of age (at least two samples with similar concentration of rubella IgG)

—
An epidemiological link AND at least one category ‘A’ CRS clinical criteria

—
Meeting the clinical criteria for CRS

—
An epidemiological link

—
At least one category ‘A’ CRS clinical criteria

—
Diarrhoea

—
Fever

—
Abdominal pain

—
Vomiting

—
Isolation ofSalmonella(other thanS. TyphiandS. Paratyphi)from stool or blood

—
Human to human transmission

—
Exposure to a common source

—
Animal to human transmission

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
Cough

—
Difficulty in breathing

—
Shortness of breath

—
Radiographic evidence of pneumonia

—
Radiographic evidence of acute respiratory distress syndrome

—
Autopsy findings of pneumonia

—
Autopsy findings of acute respiratory distress syndrome

—
Laboratory criteria for case confirmationAt least one of the following three:—Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR—Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing
—
Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR
—
Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing
—
At least two different clinical specimens (e.g. nasopharyngeal swab and stool)
—
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)
—
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

—
Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR

—
Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing
—
At least two different clinical specimens (e.g. nasopharyngeal swab and stool)
—
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)
—
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

—
At least two different clinical specimens (e.g. nasopharyngeal swab and stool)

—
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)

—
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

—
Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR

—
Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing
—
At least two different clinical specimens (e.g. nasopharyngeal swab and stool)
—
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)
—
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

—
At least two different clinical specimens (e.g. nasopharyngeal swab and stool)

—
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)

—
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

—
At least two different clinical specimens (e.g. nasopharyngeal swab and stool)

—
The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)

—
Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

—
SARS-CoV specific antibody response by one of the following two:—Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel—Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel
—
Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel
—
Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel

—
Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel

—
Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel

—
Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel

—
Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel

—
Laboratory criteria for a probable caseAt least one of the following two:—A single positive antibody test for SARS-CoV—A positive PCR result for SARS-CoV on a single clinical specimen and assay
—
A single positive antibody test for SARS-CoV
—
A positive PCR result for SARS-CoV on a single clinical specimen and assay

—
A single positive antibody test for SARS-CoV

—
A positive PCR result for SARS-CoV on a single clinical specimen and assay

—
A single positive antibody test for SARS-CoV

—
A positive PCR result for SARS-CoV on a single clinical specimen and assay

—
Any person with at least one of the followingthree:—Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)—Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS—History of travel to, or residence in, an area experiencing an outbreak of SARS
—
Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)
—
Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS
—
History of travel to, or residence in, an area experiencing an outbreak of SARS

—
Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)

—
Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS

—
History of travel to, or residence in, an area experiencing an outbreak of SARS

—
Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)

—
Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS

—
History of travel to, or residence in, an area experiencing an outbreak of SARS

—
Two or more health-care workers(12)with clinical evidence of SARS in the same health-care unit and with onset of illness in the same 10-day period

—
Three or more persons (health-care workers and/or patients and/or visitors) with clinical evidence of SARS with onset of illness in the same 10-day period and epidemiologically linked to a healthcare facility

—
Any person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a WHO SARS verification and reference laboratory

—
Any nationally confirmed case with an epidemiological link to a chain of transmission where at least one case has been independently verified by a WHO SARS reference and verification laboratory

—
Any person meeting the clinical criteria and with laboratory criteria for probable case with an epidemiological link to a chain of transmission where at least one case has been independently verified by a WHO SARS reference and verification laboratory

—
Diarrhoea

—
Fever

—
Vomiting

—
Abdominal pain

—
Isolation ofShigella spp. from a clinical specimen

—
Human to human transmission

—
Exposure to a common source

—
Animal to human transmission

—
Exposure to contaminated food/drinking water

—
Environmental exposure

—
Fever

—
Atypical presentations defined as at least one of the following four:—Haemorrhagic lesions—Flat velvety lesions not progressing to vesicles—Variola sine eruptione—Milder type
—
Haemorrhagic lesions
—
Flat velvety lesions not progressing to vesicles
—
Variola sine eruptione
—
Milder type

—
Haemorrhagic lesions

—
Flat velvety lesions not progressing to vesicles

—
Variola sine eruptione

—
Milder type

—
Haemorrhagic lesions

—
Flat velvety lesions not progressing to vesicles

—
Variola sine eruptione

—
Milder type

—
Laboratory criteria for case confirmationAt least one of the following two laboratory tests:—Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)—Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing
—
Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)
—
Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing

—
Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)

—
Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing

—
Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)

—
Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing

—
Laboratory criteria for a probable case

—
Identification of orthopox virus particles by EM

—
Human to human transmission

—
Laboratory exposure (where there is a potential exposure to Variola virus)

—
An epidemiological link to a confirmed human case by human to human transmission

—
Meeting the laboratory criteria for a probable case

—
Primary syphilisAny person with one or several (usually painless) chancres in the genital, perineal, anal area or mouth or pharyngeal mucosa or elsewhere extragenitally

—
Secondary syphilisAny person with at least one of the following three:—Diffuse maculo-papular rash often involving palms and soles—Generalised lymphadenopathy—Condyloma lata—Enanthema—Allopetia diffusa
—
Diffuse maculo-papular rash often involving palms and soles
—
Generalised lymphadenopathy
—
Condyloma lata
—
Enanthema
—
Allopetia diffusa

—
Diffuse maculo-papular rash often involving palms and soles

—
Generalised lymphadenopathy

—
Condyloma lata

—
Enanthema

—
Allopetia diffusa

—
Diffuse maculo-papular rash often involving palms and soles

—
Generalised lymphadenopathy

—
Condyloma lata

—
Enanthema

—
Allopetia diffusa

—
Early latent syphilis (< 1 year)A history of symptoms compatible with those of the earlier stages of syphilis within the previous 12 months

—
Late latent syphilis (> 1 year)Any person meeting laboratory criteria (specific serological tests)

—
Demonstration ofTreponema pallidumin lesion exudates or tissues by dark-field microscopic examination

—
Demonstration ofTreponema pallidumin lesion exudates or tissues by DFA test

—
Demonstration ofTreponemain lesion exudates or tissues by PCR

—
Detection ofTreponema pallidumantibodies by screening test (TPHA, TPPA or EIA) AND additionally detection of Tp-IgM antibodies (by IgM-ELISA, IgM immunoblot or 19S-IgM-FTA-abs) — confirmed by a second IgM assay

—
Primary/secondary syphilisAn epidemiological link by human to human (sexual contact)

—
Early latent syphilis (< 1 year)An epidemiological link by human to human (sexual contact) within the 12 previous months

—
Hepatospenomegaly

—
Mucocutaneous lesions

—
Condyloma lata

—
Persistent rhinitis

—
Jaundice

—
Pseudoparalysis (due to periostitis and osteochondritis)

—
Central nervous involvement

—
Anaemia

—
Nephrotic syndrome

—
Malnutrition

—
Laboratory criteria for case confirmationAt least one of the following three:—Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material—Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material—Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)AND a reactive non treponemal test (VDRL, RPR) in the child's serum
—
Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material
—
Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material
—
Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)

—
Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material

—
Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material

—
Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)

—
Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material

—
Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material

—
Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)

—
Laboratory criteria for a probable caseAt least one of the following three:—Reactive VDRL-CSF test result—Reactive non treponemal and treponemal serologic tests in the mother's serum—Infant's non treponemal antibody titre is fourfold or greater than the antibody titre in the mother's serum
—
Reactive VDRL-CSF test result
—
Reactive non treponemal and treponemal serologic tests in the mother's serum
—
Infant's non treponemal antibody titre is fourfold or greater than the antibody titre in the mother's serum

—
Reactive VDRL-CSF test result

—
Reactive non treponemal and treponemal serologic tests in the mother's serum

—
Infant's non treponemal antibody titre is fourfold or greater than the antibody titre in the mother's serum

—
Reactive VDRL-CSF test result

—
Reactive non treponemal and treponemal serologic tests in the mother's serum

—
Infant's non treponemal antibody titre is fourfold or greater than the antibody titre in the mother's serum

—
An epidemiological link

—
Meeting the laboratory criteria for a probable case

—
Painful muscular contractions primarily of the masseter and neck muscles leading to facial spasms known as trismus and ‘risus sardonicus’

—
Painful muscular contractions of trunk muscles

—
Generalised spasms, frequently position of opisthotonus

—
Isolation ofClostridium tetanifrom an infection site

—
Detection of tetanus toxin in a serum sample

—
Demonstration ofT. gondiiin body tissues or fluids

—
Detection ofT. gondiinucleic acid in a clinical specimen

—
T. gondii specific antibody response (IgM, IgG, IgA) in a newborn

—
Persistently stable IgGT. gondiititres in an infant (<12 months of age)

—
Fever

—
Muscle soreness and pain

—
Diarrhoea

—
Facial oedema

—
Eosinophilia

—
Subconjunctival, subungual and retinal haemorrhages

—
Demonstration ofTrichinellalarvae in tissue obtained by muscle biopsy

—
Trichinellaspecific antibody response (IFA test, ELISA or Western Blot)

—
Exposure to contaminated food (meat)

—
Exposure to a common source

—
Signs, symptoms and/or radiological findings consistent with active tuberculosis in any siteAND

—
A clinician's decision to treat the person with a full course of anti-tuberculosis therapy

—
Laboratory criteria for case confirmationAt least one of the following two:—Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen—Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy
—
Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen
—
Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

—
Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen

—
Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

—
Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen

—
Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

—
Laboratory criteria for a probable caseAt least one of the following three:—Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy—Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen—Histological appearance of granulomata
—
Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy
—
Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen
—
Histological appearance of granulomata

—
Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

—
Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen

—
Histological appearance of granulomata

—
Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

—
Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen

—
Histological appearance of granulomata

—
Ulceroglandular tularaemia—Cutaneous ulcerAND—Regional lymphadenopathy
—
Cutaneous ulcerAND
—
Regional lymphadenopathy

—
Cutaneous ulcerAND

—
Regional lymphadenopathy

—
Cutaneous ulcerAND

—
Regional lymphadenopathy

—
Glandular tularaemia—Enlarged and painful lymph nodes without apparent ulcer
—
Enlarged and painful lymph nodes without apparent ulcer

—
Enlarged and painful lymph nodes without apparent ulcer

—
Enlarged and painful lymph nodes without apparent ulcer

—
Oculoglandular tularaemia—ConjunctivitisAND—Regional lymphadenopathy
—
ConjunctivitisAND
—
Regional lymphadenopathy

—
ConjunctivitisAND

—
Regional lymphadenopathy

—
ConjunctivitisAND

—
Regional lymphadenopathy

—
Oropharyngeal tularaemia—Cervical lymphadenopathyANDat least one of the following three:—Stomatitis—Pharyngitis—Tonsillitis
—
Cervical lymphadenopathyAND
—
Stomatitis
—
Pharyngitis
—
Tonsillitis

—
Cervical lymphadenopathyAND

—
Stomatitis

—
Pharyngitis

—
Tonsillitis

—
Cervical lymphadenopathyAND

—
Stomatitis

—
Pharyngitis

—
Tonsillitis

—
Intestinal tularaemiaAt least one of the following three:—Abdominal pain—Vomiting—Diarrhoea
—
Abdominal pain
—
Vomiting
—
Diarrhoea

—
Abdominal pain

—
Vomiting

—
Diarrhoea

—
Abdominal pain

—
Vomiting

—
Diarrhoea

—
Pneumonic tularaemia—Pneumonia
—
Pneumonia

—
Pneumonia

—
Pneumonia

—
Typhoidal tularaemiaAt least one of the following two:—Fever without early localising signs and symptoms—Septicaemia
—
Fever without early localising signs and symptoms
—
Septicaemia

—
Fever without early localising signs and symptoms

—
Septicaemia

—
Fever without early localising signs and symptoms

—
Septicaemia

—
Isolation ofFrancisella tularensisfrom a clinical specimen

—
Detection ofFrancisella tularensisnucleic acid in a clinical specimen

—
Francisella tularensisspecific antibody response

—
Exposure to a common source

—
Animal to human transmission

—
Exposure to contaminated food/drinking water

—
Onset of sustained fever

—
At least two of the following four:—Headache—Relative bradycardia—Non productive cough—Diarrhoea, constipation, malaise or abdominal pain
—
Headache
—
Relative bradycardia
—
Non productive cough
—
Diarrhoea, constipation, malaise or abdominal pain

—
Headache

—
Relative bradycardia

—
Non productive cough

—
Diarrhoea, constipation, malaise or abdominal pain

—
Headache

—
Relative bradycardia

—
Non productive cough

—
Diarrhoea, constipation, malaise or abdominal pain

—
Isolation ofSalmonellaTyphi or Paratyphi from a clinical specimen

—
Exposure to a common source

—
Human to human transmission

—
Exposure to contaminated food/drinking water

—
Fever

—
Haemorrhagic manifestations in various forms that may lead to multi-organ failure

—
Isolation of specific virus from a clinical specimen

—
Detection of specific virus nucleic acid in a clinical specimen and genotyping

—
Travel in the last 21 days to a region where VHF cases are known or believed to have occurred

—
Exposure within the last 21 days to a probable or confirmed case of a Viral Hemorrhagic Fever whose onset of illness was within the last six months

—
Encephalitis

—
Meningitis

—
Laboratory test for case confirmationAt least one of the following four:—Isolation of WNV from blood or CSF—Detection of WNV nucleic acid in blood or CSF—WNV specific antibody response (IgM) in CSF—WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation
—
Isolation of WNV from blood or CSF
—
Detection of WNV nucleic acid in blood or CSF
—
WNV specific antibody response (IgM) in CSF
—
WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation

—
Isolation of WNV from blood or CSF

—
Detection of WNV nucleic acid in blood or CSF

—
WNV specific antibody response (IgM) in CSF

—
WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation

—
Isolation of WNV from blood or CSF

—
Detection of WNV nucleic acid in blood or CSF

—
WNV specific antibody response (IgM) in CSF

—
WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation

—
Laboratory test for a probable caseWNV specific antibody response in serumLaboratory results need to be interpreted according to flavivirus vaccination status

—
Animal to human transmission (residing, having visited or having been exposed to mosquito bites in an area where WNV is endemic in horses or birds)

—
Human to human transmission (vertical transmission, blood transfusion, transplants)

—
an epidemiological link

—
a laboratory test for a probable case

—
Jaundice

—
Generalised haemorrhage

—
Isolation of yellow fever virus from a clinical specimen

—
Detection of yellow fever virus nucleic acid

—
Detection of yellow fever antigen

—
Yellow fever specific antibody response

—
Demonstration of typical lesions in post mortem liver histopathology

—
Fever

—
Diarrhoea

—
Vomiting

—
Abdominal pain (pseudoappendicitis)

—
Tenesmus

—
Isolation of human pathogenicYersinia enterocoliticaorYersinia pseudotuberculosisfrom a clinical specimen

—
Human to human transmission

—
Exposure to a common source

—
Animal to human transmission

—
Exposure to contaminated food

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(1), and in particular Article 3(c) thereof,

(1) According to Article 2 of Commission Decision 2002/253/EC(2)the case definitions laid down in Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data.

(2) In accordance with Article 9 of the Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control(3)(ECDC), the ECDC provided, at the request of the Commission and in agreement with its Advisory Forum, a technical document on case definitions aiding the Commission in the development of intervention strategies in the field of surveillance and response. The technical document has been further published on the web site of the ECDC. The case definitions listed in the Annex to Decision 2002/253/EC should be updated on the basis of this contribution.

(3) Those case definitions have the purpose of facilitating the reporting on the diseases and special health issues listed in Annex I to Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council(4). Decision 2002/253/EC however does not entail any reporting obligation.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Decision No 2119/98/EC,

HAS ADOPTED THIS DECISION:
Article 1

The Annex to Decision 2002/253/EC is replaced by the Annex to this Decision.
Article 2

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(1), and in particular Article 3(c) thereof,

(1) According to Article 2 of Commission Decision 2002/253/EC(2)the case definitions laid down in Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data.

(2) In accordance with Article 9 of the Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control(3)(ECDC), the ECDC provided, at the request of the Commission and in agreement with its Advisory Forum, a technical document on case definitions aiding the Commission in the development of intervention strategies in the field of surveillance and response. The technical document has been further published on the web site of the ECDC. The case definitions listed in the Annex to Decision 2002/253/EC should be updated on the basis of this contribution.

(3) Those case definitions have the purpose of facilitating the reporting on the diseases and special health issues listed in Annex I to Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council(4). Decision 2002/253/EC however does not entail any reporting obligation.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Decision No 2119/98/EC,

HAS ADOPTED THIS DECISION:
The Annex to Decision 2002/253/EC is replaced by the Annex to this Decision.
This Decision is addressed to the Member States.
Clinical criteriaANNEXEXPLANATION OF THE SECTIONS USED FOR THE DEFINITION AND CLASSIFICATION OF CASESThese should include common and relevant signs and symptoms of the disease which either individually or in combination constitutes a clear or indicative clinical picture of the disease. The clinical criteria give the general outline of the disease and do not necessarily indicate all the features needed for individual clinical diagnosis.

Laboratory criteriaLaboratory criteria should be a list of laboratory methods that are used to confirm a case. Usually only one of the listed tests will be enough to confirm the case. If a combination of methods is needed to meet the laboratory confirmation, this is specified. The type of specimen to be collected for the laboratory tests is only specified when only certain specimen types are considered relevant for the confirmation of a diagnosis. For some agreed exceptions, laboratory criteria for a probable case are included. This is a list of laboratory methods which can be used to support the diagnosis of a case but which are not confirmatory.

Epidemiological criteria and epidemiological linkEpidemiological criteria are deemed to have been met when an epidemiological link can be established.

Epidemiological link, during the incubation period, is defined as one of the six following:
— | human to human transmission: Any person who has had contact with a laboratory confirmed human case in such a way as to have had the opportunity to acquire the infection,

— | animal to human transmission: Any person who has had contact with an animal with a laboratory confirmed infection/colonisation in such a way as to have had the opportunity to acquire the infection,

— | exposure to a common source: Any person who has been exposed to the same common source or vehicle of infection, as a confirmed human case,

— | exposure to contaminated food/drinking water: Any person who has consumed food or drinking water with a laboratory confirmed contamination or a person who has consumed potentially contaminated products from an animal with a laboratory confirmed infection/colonisation,

— | environmental exposure: Any person who has bathed in water or has had contact with a contaminated environmental source that has been laboratory confirmed,

— | laboratory exposure: Any person working in a laboratory where there is a potential for exposure.A person may be considered epidemiologically linked to a confirmed case if at least one case in the chain of transmission is laboratory confirmed. In case of an outbreak of faeco-oral or airborne transmitted infections, the chain of transmission does not necessarily need to be established to consider a case epidemiologically linked.

Transmission may occur by one or more of the following routes:
— | airborne, by projection of aerosol from an infected person onto the mucous membranes while coughing, spitting, singing or talking, or when microbial aerosols dispersed into the atmosphere are inhaled by others,

— | contact, direct contact with an infected person (faecal-oral, respiratory droplets, skin or sexual exposure) or animal (e.g. biting, touching) or indirect contact to infected materials or objects (infected fomites, body fluids, blood),

— | vertical, from mother to child, often in utero, or as a result of the incidental exchange of body fluids usually during the perinatal period,

— | vector transmission, indirect transmission by infected mosquitoes, mites, flies and other insects which transmit disease to humans through their bites,

— | food or water, consumption of potentially contaminated food or drinking water.Case classificationCases will be classified as ‘possible’, ‘probable’ and ‘confirmed’. The incubation periods for diseases are given in the additional information to facilitate the assessment of the epidemiological link.

Possible caseDefined as a case that is classified as possible for reporting purposes. It is usually a case with the clinical criteria as described in the case definition without epidemiological or laboratory evidence of the disease in question. The definition of a possible case has high sensitivity and low specificity. It allows for detection of most cases but some false positives cases will be included into this category.

Probable caseDefined as a case that is classified as probable for reporting purposes. It is usually a case with clinical criteria and an epidemiological link as described in the case definition. Laboratory tests for probable cases are specified only for some diseases.

Confirmed caseDefined as a case that is classified as confirmed for reporting purposes. Confirmed cases should be laboratory confirmed and may fulfil the clinical criteria or not as described in the case definition. The definition of a confirmed case is highly specific and less sensitive; therefore most of the collected cases will be true cases although some will be missed.

The clinical criteria of some diseases do not allude to the fact that many acute cases are asymptomatic, (e.g. hepatitis A, B and C, campylobacter, salmonellosis) although these cases may still be important from a public health perspective on national level.

Confirmed cases will fall in one of the three subcategories listed below. These subcategories will be created during the analysis of data using the variables collected with the case information.

Laboratory-confirmed case with clinical criteriaThe case meets the laboratory criteria for case confirmation and the clinical criteria included in the case definition.

Laboratory-confirmed case with unknown clinical criteriaThe case meets the laboratory criteria for case confirmation but there is no information available regarding the clinical criteria (e.g. only laboratory report).

Laboratory-confirmed case without clinical criteriaThe case meets the laboratory criteria for case confirmation but doesn’t meet the clinical criteria in the case definition or is asymptomatic.

ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTIONClinical criteria (AIDS)Any person who has any of the clinical conditions as defined in the European AIDS case definition for:
— | Adults and adolescents ≥ 13 years(1)

— | Children < 13 years of age(2)Laboratory criteria (HIV)

— | Adults, adolescents and children aged ≥ 18 monthsAt least one of the following three:—Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot)—Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test—Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV | — | Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot) | — | Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test | — | Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV | — | Detection of HIV nucleic acid (HIV-RNA, HIV-DNA) | — | Demonstration of HIV by HIV p24 antigen test, including neutralisation assay | — | Isolation of HIV

— | Positive result of a HIV screening antibody test or a combined screening test (HIV antibody and HIV p24 antigen) confirmed by a more specific antibody test (e.g. Western blot)

— | Positive result of 2 EIA antibody test confirmed by a positive result of a further EIA test

— | Positive results on two separate specimens from at least one of the following three:—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay—Isolation of HIV | — | Detection of HIV nucleic acid (HIV-RNA, HIV-DNA) | — | Demonstration of HIV by HIV p24 antigen test, including neutralisation assay | — | Isolation of HIV

— | Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

— | Demonstration of HIV by HIV p24 antigen test, including neutralisation assay

— | Isolation of HIV

— | Children aged < 18 monthsPositive results on two separate specimens (excluding cord blood) from at least one of the following three:—Isolation of HIV—Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)—Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of age | — | Isolation of HIV | — | Detection of HIV nucleic acid (HIV-RNA, HIV-DNA) | — | Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of age

— | Isolation of HIV

— | Detection of HIV nucleic acid (HIV-RNA, HIV-DNA)

— | Demonstration of HIV by HIV p24 antigen test, including neutralisation assay in a child ≥1 month of ageEpidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed case

— | HIV infectionAny person meeting the laboratory criteria for HIV infection

— | AIDSAny person meeting the clinical criteria for AIDS and the laboratory criteria for HIV infectionANTHRAX(Bacillus anthracis)Clinical criteriaAny person with at least one of the following clinical forms:

Cutaneous anthraxAt least one the following two:
— | Papular or vesicular lesion

— | Depressed black eschar with surrounding oedemaGastrointestinal anthrax

— | Fever or feverishnessAND at least one of the following two:
— | Severe abdominal pain

— | DiarrhoeaInhalational anthrax

— | Fever or feverishnessAND at least one of the following two:
— | Acute respiratory distress

— | Radiological evidence of mediastinal wideningMeningeal/meningoencephalitic anthrax

— | FeverAND at least one of the following three:
— | Convulsions

— | Loss of consciousness

— | Meningeal signsAnthrax septicaemia

Laboratory criteria

— | Isolation ofBacillus anthracisfrom a clinical specimen

— | Detection ofBacillus anthracisnucleic acid in a clinical specimenPositive nasal swab without clinical symptoms does not contribute to a confirmed diagnosis of a case.

Epidemiological criteriaAt least one of the following three epidemiological links:
— | Animal to human transmission

— | Exposure to a common source

— | Exposure to contaminated food/drinking waterCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

AVIAN INFLUENZA A/H5 OR A/H5N1 IN HUMANSClinical criteriaAny person with one of the following two:
— | Fever AND signs and symptoms of acute respiratory infection

— | Death from an unexplained acute respiratory illnessLaboratory criteriaAt least one of the following three:
— | Isolation of influenza A/H5N1 from a clinical specimen

— | Detection of influenza A/H5 nucleic acid in a clinical specimen

— | Influenza A/H5 specific antibody response (fourfold or greater rise or single high titre)Epidemiological criteriaAt least one of the following four:
— | Human to human transmission by having been in close contact (within one metre) to a person reported as probable or confirmed case

— | Laboratory exposure: where there is a potential exposure to influenza A/H5N1

— | Close contact (within one metre) with an animal with confirmed A/H5N1 infection other than poultry or wild birds (e.g. cat or pig)

— | Reside in or have visited an area where influenza A/H5N1 is currently suspected or confirmed(3)AND at least one of the following two:—Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area—Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area | — | Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area | — | Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected area

— | Having been in close contact (within one metre) with sick or dead domestic poultry or wild birds(4)in the affected area

— | Having been in a home or a farm where sick or dead domestic poultry have been reported in the previous month in the affected areaCase classificationA.   Possible caseAny person meeting the clinical and the epidemiological criteria

B.   Probable caseAny person with a positive test for influenza A/H5 or A/H5N1 performed by a laboratory which is not a National Reference Laboratory participating in the EU Community Network of Reference Laboratories for human influenza (CNRL)

C.   Nationally confirmed caseAny person with a positive test for influenza A/H5 or A/H5N1 performed by a National Reference Laboratory participating in the EU Community Network of Reference Laboratories for human influenza (CNRL)

D.   WHO confirmed caseAny person with a laboratory confirmation by a WHO Collaborating Centre for H5

BOTULISM(Clostridium botulinum)Clinical criteriaAny person with at least one of the following clinical forms:

Food-borne and wound botulismAt least one of the following two:
— | Bilateral cranial nerve impairment (e.g. diplopia, blurred vision, dysphagia, bulbar weakness)

— | Peripheral symmetric paralysisInfant botulismAny infant with at least one of the following six:
— | Constipation

— | Lethargy

— | Poor feeding

— | Ptosis

— | Dysphagia

— | General muscle weaknessThe type of botulism usually encountered in infants (< 12 months of age) can affect children also over 12 months of age and occasionally adults, with altered gastrointestinal anatomy and microflora.

Laboratory criteriaAt least one of the following two:
— | Isolation ofC. botulinumfor infant botulism (stool) or wound botulism (wound) (isolation ofC. botulinumin stool of adults not relevant for the diagnosis of food-borne botulism)

— | Detection of botulinum toxin in a clinical specimenEpidemiological criteriaAt least one of the following two epidemiological links:
— | Exposure to a common source (e.g. food, sharing of needles or other devices)

— | Exposure to contaminated food/drinking waterCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

BRUCELLOSIS(Brucella spp.)Clinical criteriaAny person with fever

AND at least one of followingseven:
— | Sweating (profuse, malodorous, specially nocturnal)

— | Chills

— | Arthralgia

— | Weakness

— | Depression

— | Headache

— | AnorexiaLaboratory criteriaAt least one of the following two:
— | Isolation ofBrucella spp.from a clinical specimen

— | Brucellaspecific antibody response (Standard Agglutination Test, Complement Fixation, ELISA)Epidemiological criteriaAt least one of the following four epidemiological links:
— | Exposure to contaminated food/drinking water

— | Exposure to products from a contaminated animal (milk or milk products)

— | Animal to human transmission (contaminated secretions or organs e.g. vaginal discharge, placenta)

— | Exposure to a common sourceCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

CAMPYLOBACTERIOSIS(Campylobacter spp.)Clinical criteriaAny person with at least one of the following three:
— | Diarrhoea

— | Abdominal pain

— | FeverLaboratory criteria

— | Isolation ofCampylobacter spp.from stool or bloodDifferentiation ofCampylobacter spp.should be performed if possible

Epidemiological criteriaAt least one of the following five epidemiological links:
— | Animal to human transmission

— | Human to human transmission

— | Exposure to a common source

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

CHLAMYDIAL INFECTION(Chlamydia trachomatis)

INCLUDING LYMPHOGRANULOMA VENEREUM (LGV)

Clinical criteriaAny person with at least one of the following clinical forms:

Chlamydial infection non-LGVAt least one of the following six:
— | Urethritis

— | Epididymitis

— | Acute salpingitis

— | Acute endometritis

— | Cervicitis

— | ProctitisIn newborn children at least one of the following two:
— | Conjunctivitis

— | PneumoniaLGVAt least one of the following five:
— | Urethritis

— | Genital ulcer

— | Inguinal lymphadenopathy

— | Cervicitis

— | ProctitisLaboratory criteriaChlamydial infection non-LGVAt least one of the following three:
— | Isolation ofChlamydia trachomatisfrom a specimen of the ano-genital tract or from the conjunctiva

— | Demonstration ofChlamydia trachomatisby DFA test in a clinical specimen

— | Detection ofChlamydia trachomatisnucleic acid in a clinical specimenLGVAt least one of the following two:
— | Isolation ofChlamydia trachomatisfrom a specimen of the ano-genital tract or from the conjunctiva

— | Detection ofChlamydia trachomatisnucleic acid in a clinical specimenAND

— | Identification of serovar (genovar) L1, L2 or L3Epidemiological criteriaAn epidemiological link by Human to human transmission (sexual contact or vertical transmission)

Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the laboratory criteria

CHOLERA(Vibrio cholerae)Clinical criteriaAny person with at least one of the following two:
— | Diarrhoea

— | VomitingLaboratory criteria

— | Isolation ofVibrio choleraefrom a clinical specimenAND

— | Demonstration of O1 or O139 antigen in the isolateAND

— | Demonstration of cholera-enterotoxin or the cholera-enterotoxin gene in the isolateEpidemiological criteriaAt least one of the following four epidemiological links:
— | Exposure to a common source

— | Human to human transmission

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

VARIANT CREUTZFELDT-JAKOB DISEASE (VCJD)Preconditions

— | Any person with a progressive neuropsychiatric disorder with a duration of illness of at least six months

— | Routine investigations do not suggest an alternative diagnosis

— | No history of exposure to human pituitary hormones or human dura mater graft

— | No evidence of a genetic form of transmissible spongiform encephalopathyClinical criteriaAny person with at least four of the following five:
— | Early psychiatric symptoms(5)

— | Persistent painful sensory symptoms(6)

— | Ataxia

— | Myoclonus or chorea or dystonia

— | DementiaDiagnostic criteriaDiagnostic criteria for case confirmation:

— | Neuropathological confirmation: spongiform change and extensive prion protein deposition with florid plaques throughout the cerebrum and cerebellumDiagnostic criteria for a probable or a possible case:

— | EEG does not show the typical appearance(7)of sporadic CJD(8)in the early stages of the illness

— | Bilateral pulvinar high signal on MRI brain scan

— | A positive tonsil biopsy(9)Epidemiological criteriaAn epidemiological link by human to human transmission (e.g. blood transfusion)

Case classificationA.   Possible caseAny person fulfilling the preconditions

AND
— | meeting the clinical criteriaAND

— | a negative EEG for sporadic CJD(8)B.   Probable caseAny person fulfilling the preconditions

AND
— | meeting the clinical criteriaAND

— | a negative EEG for sporadic CJD(8)AND

— | a positive MRI brain scanORAny person fulfilling the preconditions

AND
— | a positive tonsil biopsyC.   Confirmed caseAny person fulfilling the preconditions

AND
— | meeting the diagnostic criteria for case confirmationCRYPTOSPORIDIOSIS(Cryptosporidium spp)Clinical criteriaAny person with at least one of the following two:
— | Diarrhoea

— | Abdominal painLaboratory criteriaAt least one of the following four:
— | Demonstration ofCryptosporidiumoocysts in stool

— | Demonstration ofCryptosporidiumin intestinal fluid or small-bowel biopsy specimens

— | Detection ofCryptosporidiumnucleic acid in stool

— | Detection ofCryptosporidiumantigen in stoolEpidemiological criteriaOne of the following five epidemiological links:
— | Human to human transmission

— | Exposure to a common source

— | Animal to human transmission

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

DIPHTHERIA(Corynebacterium diphtheriae and Corynebacterium ulcerans)Clinical criteriaAny person with at least one of the following clinical forms:

Respiratory diphtheria:An upper respiratory tract illness with fever AND one of the following two:
— | CroupOR

— | an adherent membrane in at least one of the following three locations:—Tonsil—Pharynx—Nose | — | Tonsil | — | Pharynx | — | Nose

— | Tonsil

— | Pharynx

— | NoseNasal diphtheria:

— | Uni- or bilateral nasal discharge initially clear and becoming bloodyCutaneous diphtheria:

— | Skin lesionDiphtheria of other sites:

— | Lesion of conjunctiva or mucous membranesLaboratory criteria

— | Isolation of toxin-producingC. diphtheriaeorC. ulceransfrom a clinical specimenEpidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria for respiratory diphtheria

B.   Probable caseAny person meeting the clinical criteria for diphtheria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

ECHINOCOCCOSIS(Echinococcus spp)Clinical criteriaNot relevant for surveillance purposes

Diagnostic criteriaAt least one of the following five:
— | Histopathology or parasitology compatible withEchinococcus multilocularisorgranulosus(e.g. direct isvisualisation of the protoscolex in cyst fluid)

— | Detection ofEchinoccocus granulosuspathognomonic macroscopic morphology of cyst(s) in surgical specimens

— | Typical organ lesions detected by imaging techniques (e.g.: computerised tomography, sonography, MRI) AND confirmed by a serological test

— | Echinococcusspp. specific serum antibodies by high-sensitivity serological test AND confirmed by a high specificity serological test

— | Detection ofEchinococcus multilocularisorgranulosusnucleic acid in a clinical specimenEpidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed caseAny person meeting the diagnostic criteria

SHIGA/VERO TOXIN PRODUCING ESCHERICHIA COLI INFECTION (STEC/VTEC)Clinical criteriaSTEC/VTEC diarrhoeaAny person with at least one of the following two:
— | Diarrhoea

— | Abdominal painHUSAny person with acute renal failure and at least one of the following two:
— | Microangiopatic haemolytic anaemia

— | ThrombocytopeniaLaboratory criteriaAt least one of the following three:
— | Isolation of Shigatoxin/Verotoxin (STEC/VTEC) producingE. coli

— | Detection of stx1 or stx2 gene(s) nucleic acid

— | Detection of free shigatoxins.Only for HUS the following can be used as laboratory criterion to confirm STEC/VTEC:
— | E. coliserogroups specific antibody responseIsolation and additional ischaracterisation by serotype, phage type,eaegenes, and subtypes of stx1/stx2should be performed if possible

Epidemiological criteriaAt least one of the followingfive epidemiologicallinks:
— | Human to human transmission

— | Exposure to a common source

— | Animal to human transmission

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible case of STEC-associated HUSAny person meeting the clinical criteria for HUS

B.   Probable case of STEC/VTECAny person meeting the clinical criteria and with an epidemiological link or a laboratory confirmed case without clinical criteria

C.   Confirmed case of STEC/VTECAny person meeting the clinical and the laboratory criteria

GIARDIASIS(Giardia lamblia)Clinical criteriaAny person with at least one of the following four:
— | Diarrhoea

— | Abdominal pain

— | Bloating

— | Signs of malabsorption (e.g. steatorrhoea, weight loss)Laboratory criteriaAt least one of the following two:
— | Demonstration ofGiardia lambliacysts or trophozoites in stool, duodenal fluid or small-bowel biopsy

— | Demonstration ofGiardia lambliaantigen in stoolEpidemiological criteriaAt least one of the followingfourepidemiological links:
— | Exposure to contaminated food/drinking water

— | Human to human transmission

— | Exposure to a common source

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

GONORRHOEA(Neisseria gonorrhoeae)Clinical criteriaAny person with at least one of the following eight:
— | Urethritis

— | Acute salpingitis

— | Pelvic inflammatory disease

— | Cervicitis

— | Epididymitis

— | Proctitis

— | Pharyngitis

— | ArthritisOR

Any newborn child with conjunctivitis

Laboratory criteriaAt least one of the following four:
— | Isolation ofNeisseria gonorrhoeaefrom a clinical specimen

— | Detection ofNeisseria gonorrhoeaenucleic acid in a clinical specimen

— | Demonstration ofNeisseria gonorrhoeaeby a non amplified nucleic acid probe test in a clinical specimen

— | Microscopic detection of intracellular gram negative diploccocci in an urethral male specimenEpidemiological criteriaAn epidemiological link by human to human transmission (sexual contact or vertical transmission)

Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the laboratory criteria

HAEMOPHILUS MENINGITIS, INVASIVE DISEASE(Haemophilus influenzae)Clinical criteriaNot relevant for surveillance purposes

Laboratory criteriaLaboratory criteria for case definition

At least one of the following two:
— | Isolation ofHaemophilus influenzaefrom a normally sterile site

— | Detection ofHaemophilus influenzaenucleic acid from a normally sterile siteTyping of the isolates should be performed, if possible

Epidemiological linkNA

Case ClassificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed caseAny person meeting the laboratory criteria for case confirmation

HEPATITIS A(Hepatitis A Virus)Clinical criteriaAny person with a discrete onset of symptoms (e.g. fatigue, abdominal pain, loss of appetite, intermittent nausea and vomiting)

AND

At least one of the followingthree:
— | Fever

— | Jaundice

— | Elevated serum aminotransferase levelsLaboratory criteriaAt least one of the following three:
— | Detection of hepatitis A virus nucleic acid in serum or stool

— | Hepatitis A virus specific antibody response

— | Detection of hepatitis A virus antigen in stoolEpidemiological criteriaAt least one of the following four:
— | Human to human transmission

— | Exposure to a common source

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

HEPATITIS B, ACUTE(Hepatitis B virus)Clinical criteriaAny person with a discrete onset of symptoms (e.g. fatigue, abdominal pain, loss of appetite, intermittent nausea and vomiting)

AND

At least one of the followingthree:
— | Fever

— | Jaundice

— | Elevated serum aminotransferase levelsLaboratory criteriaHepatitis B virus core IgM antigen specific antibody response

Laboratory results need to be interpreted according to the vaccination status

Epidemiological criteriaAn epidemiological link by human to human transmission (e.g. sexual contact, vertical transmission or blood transmission)

Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

HEPATITIS C(Hepatitis C virus)Clinical criteriaNot relevant for surveillance purposes

Laboratory criteriaAt least one of the followingtwo:
— | Detection of hepatitis C virus nucleic acid in serum

— | Hepatitis C virus specific antibody response confirmed by a different antibody testEpidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed caseAny person meeting the laboratory criteria

INFLUENZA(influenza virus)Clinical criteriaAny person with at least one of the following clinical forms:

Influenza-like illness (ILI)

— | Sudden onset of symptomsAND

— | at least one of the followingfoursystemic symptoms:—Fever or feverishness—Malaise—Headache—MyalgiaAND | — | Fever or feverishness | — | Malaise | — | Headache | — | Myalgia

— | Fever or feverishness

— | Malaise

— | Headache

— | Myalgia

— | at least one of the following three respiratory symptoms:—Cough—Sore throat—Shortness of breath | — | Cough | — | Sore throat | — | Shortness of breath

— | Cough

— | Sore throat

— | Shortness of breathAcute respiratory infection (ARI)

— | Sudden onset of symptomsAND

— | At least one of the followingfourrespiratory symptoms:—Cough—Sore throat—Shortness of breath—CoryzaAND | — | Cough | — | Sore throat | — | Shortness of breath | — | Coryza

— | Cough

— | Sore throat

— | Shortness of breath

— | Coryza

— | A clinician’s judgement that the illness is due to an infectionLaboratory criteriaAt least one the following four:
— | Isolation of influenza virus from a clinical specimen

— | Detection of influenza virus nucleic acid in a clinical specimen

— | Identification of influenza virus antigen by DFA test in a clinical specimen

— | Influenza specific antibody responseSub typing of the influenza isolate should be performed, if possible

Epidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria (ILI or ARI)

B.   Probable caseAny person meeting the clinical criteria (ILI or ARI) and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical (ILI or ARI) and the laboratory criteria

LEGIONNAIRES’ DISEASE(Legionella spp.)Clinical criteriaAny person with pneumonia

Laboratory criteria

— | Laboratory criteria for case confirmationAt least one of the followingthree:—Isolation ofLegionella spp. from respiratory secretions or any normally sterile site—Detection ofLegionella pneumophilaantigen in urine—Legionella pneumophilaserogroup 1 specific antibody response | — | Isolation ofLegionella spp. from respiratory secretions or any normally sterile site | — | Detection ofLegionella pneumophilaantigen in urine | — | Legionella pneumophilaserogroup 1 specific antibody response

— | Isolation ofLegionella spp. from respiratory secretions or any normally sterile site

— | Detection ofLegionella pneumophilaantigen in urine

— | Legionella pneumophilaserogroup 1 specific antibody response

— | Laboratory criteria for a probable caseAt least one of the following four:—Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents—Detection ofLegionella spp.nucleic acid in a clinical specimen—Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response—L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibody | — | Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents | — | Detection ofLegionella spp.nucleic acid in a clinical specimen | — | Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response | — | L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibody

— | Detection ofLegionella pneumophilaantigen in respiratory secretions or lung tissue e.g. by DFA staining using monoclonal-antibody derived reagents

— | Detection ofLegionella spp.nucleic acid in a clinical specimen

— | Legionella pneumophilanon-serogroup 1 or otherLegionella spp.specific antibody response

— | L. pneumophilaserogroup 1, other serogroups or otherLegionella species:single high titre in specific serum antibodyEpidemiological criteriaAt least one of the following two epidemiological links:
— | Environmental exposure

— | Exposure to the same common sourceCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria AND at least one positive laboratory test for a probable case OR an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria for case confirmation

LEPTOSPIROSIS(Leptospira interrogans)Clinical criteriaAny person with
— | FeverOR

At least two of the following eleven:
— | Chills

— | Headache

— | Myalgia

— | Conjunctival suffusion

— | Haemorrhages into skin and mucous membranes

— | Rash

— | Jaundice

— | Myocarditis

— | Meningitis

— | Renal impairment

— | Respiratory symptoms such as haemoptysisLaboratory criteriaAt least one of the followingfour:
— | Isolation ofLeptospira interrogansfrom a clinical specimen

— | Detection ofLeptospira interrogansnucleic acid in a clinical specimen

— | Demonstration ofLeptospira interrogansby immunofluorescence in a clinical specimen

— | Leptospira interrogansspecific antibody responseEpidemiological criteriaAt least one of the following three epidemiological links:
— | Animal to human transmission

— | Environmental exposure

— | Exposure to a common sourceCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

LISTERIOSIS(Listeria monocytogenes)Clinical criteriaAny person with at least one of the following three:
— | Listeriosis of newborns defined asStillbirthORAt least one of the followingfivein the first month of life:—Granulomatosis infantiseptica—Meningitis or meningoencephalitis—Septicaemia—Dyspnoea—Lesions on skin, mucosal membranes or conjunctivae | — | Granulomatosis infantiseptica | — | Meningitis or meningoencephalitis | — | Septicaemia | — | Dyspnoea | — | Lesions on skin, mucosal membranes or conjunctivae

— | Granulomatosis infantiseptica

— | Meningitis or meningoencephalitis

— | Septicaemia

— | Dyspnoea

— | Lesions on skin, mucosal membranes or conjunctivae

— | Listeriosis in pregnancy defined as at least one of the following three:—Abortion, miscarriage, stillbirth or premature birth—Fever—Influenza-like symptoms | — | Abortion, miscarriage, stillbirth or premature birth | — | Fever | — | Influenza-like symptoms

— | Abortion, miscarriage, stillbirth or premature birth

— | Fever

— | Influenza-like symptoms

— | Other form of listeriosis defined as at least one of the following four:—Fever—Meningitis or meningoencephalitis—Septicaemia—isLocalised infections such as arthritis, endocarditis, and abscesses | — | Fever | — | Meningitis or meningoencephalitis | — | Septicaemia | — | isLocalised infections such as arthritis, endocarditis, and abscesses

— | Fever

— | Meningitis or meningoencephalitis

— | Septicaemia

— | isLocalised infections such as arthritis, endocarditis, and abscessesLaboratory criteriaAt least one of the followingtwo:
— | Isolation ofListeria monocytogenesfrom a normally sterile site

— | Isolation ofListeria monocytogenesfrom a normally non-sterile site in a foetus, stillborn, newborn or the mother at or within 24 hours of birthEpidemiological criteriaAt least one of the followingthreeepidemiological links:
— | Exposure to a common source

— | Human to human transmission (vertical transmission)

— | Exposure to contaminated food/drinking waterAdditional informationIncubation period 3-70 days, most often 21 days

Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the laboratory criteria

OR

Any mother with a laboratory confirmed listeriosis infection in her foetus, stillborn or newborn

MALARIA(Plasmodium spp.)Clinical criteriaAny person with fever OR a history of fever

Laboratory criteriaAt least one of the following three:
— | Demonstration of malaria parasites by light microscopy in blood films

— | Detection ofPlasmodiumnucleic acid in blood

— | Detection ofPlasmodiumantigenDifferentiation ofPlasmodium spp. should be performed if possible

Epidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

MEASLES(Measles virus)Clinical criteriaAny person with fever

AND
— | Maculo-papular rashAND at least one of the followingthree:
— | Cough

— | Coryza

— | ConjunctivitisLaboratory criteriaAt least one of the following four:
— | Isolation of measles virus from a clinical specimen

— | Detection of measles virus nucleic acid in a clinical specimen

— | Measles virus specific antibody response characteristic for acute infection in serum or saliva

— | Detection of measles virus antigen by DFA in a clinical specimen using measles specific monoclonal antibodiesLaboratory results need to be interpreted according to the vaccination status. If recently vaccinated, investigate for wild virus

Epidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person not recently vaccinated and meeting the clinical and the laboratory criteria

MENINGOCCOCAL DISEASE, INVASIVE(Neisseria meningitidis)Clinical criteriaAny person with at least one of the following five:
— | Fever

— | Meningeal signs

— | Petechial rash

— | Septic shock

— | Septic arthritisLaboratory criteriaAt least one of the following four:
— | Isolation ofNeisseria meningitidisfrom a normally sterile site, including purpuric skin lesions

— | Detection ofNeisseria meningitidisnucleic acid from a normally sterile site, including purpuric skin lesions

— | Detection ofNeisseria meningitidisantigen in CSF

— | Detection of gram negative stained diplococcus in CSFEpidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the laboratory criteria

MUMPS(Mumps virus)Clinical criteriaAny person with
— | FeverAND

At least two of the following three:
— | Sudden onset of tender swelling of the parotid or other salivary glands

— | Orchitis

— | MeningitisLaboratory criteriaAt least one of the following three:
— | Isolation of mumps virus from a clinical specimen

— | Detection of mumps virus nucleic acid

— | Mumps virus specific antibody response characteristic for acute infection in serum or salivaLaboratory results need to be interpreted according to the vaccination status

Epidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person not recently vaccinated and meeting the laboratory criteria

In case of recent vaccination: any person with detection of wild-type mumps virus strain

PERTUSSIS(Bordetella pertussis)Clinical criteriaAny person with a cough lasting at least two weeks

AND

at least one of the following three:
— | Paroxysms of coughing

— | Inspiratory ‘whooping’

— | Post-tussive vomitingOR

Any person diagnosed as pertussis by a physician

OR

Apnoeic episodes in infants

Laboratory criteriaAt least one of the following three:
— | Isolation ofBordetella pertussisfrom a clinical specimen

— | Detection ofBordetella pertussisnucleic acid in a clinical specimen

— | Bordetella pertussisspecific antibody responseEpidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

PLAGUE(Yersinia pestis)Clinical criteriaAny person with at least one of the following clinical forms:

Bubonic plague:

— | FeverAND

— | Sudden onset of painful lymphadenitisSepticaemic plague:

— | FeverPneumonic plague:

— | FeverANDAt least one of the followingthree:
— | Cough

— | Chest pain

— | HaemoptysisLaboratory criteriaAt least one of the following three:
— | Isolation ofYersinia pestisfrom a clinical specimen

— | Detection ofYersinia pestisnucleic acid from a clinical specimen (F1 antigen)

— | Yersinia pestisanti-F1 antigen specific antibody responseEpidemiological criteriaAt least one of the following four epidemiological links:
— | Human to human transmission

— | Animal to human transmission

— | Laboratory exposure (where there is a potential exposure to plague)

— | Exposure to a common sourceCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the laboratory criteria

PNEUMOCOCCAL INVASIVE DISEASE(S)(Streptococcus pneumoniae)Clinical criteriaNot relevant for surveillance purposes

Laboratory criteriaAt least one of the following three:
— | Isolation ofS. pneumoniaefrom a normally sterile site

— | Detection ofS. pneumoniaenucleic acid from a normally sterile site

— | Detection ofS. pneumoniaeantigen from a normally sterile siteEpidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed caseAny person meeting the laboratory criteria

POLIOMYELITIS(Polio virus)Clinical criteriaAny person < 15 years of age with acute flaccid paralysis (AFP)

OR

Any person in whom polio is suspected by a physician

Laboratory criteriaAt least one of the following three:
— | Isolation of a polio virus and intratypic differentiation — Wild polio virus (WPV)

— | Vaccine derived poliovirus (VDPV) (for the VDPV at least 85 % similarity with vaccine virus in the nucleotide sequences in the VP1 section)

— | Sabin-like poliovirus: intratypic differentiation performed by a WHO-accredited polio laboratory (for the VDPV a >1 % up to 15 % VP1 sequence difference compared with vaccine virus of the same serotype)Epidemiological criteriaAt least one of the following two epidemiological links:
— | Human to human transmission

— | An history of travel to a polio-endemic area or an area with suspected or confirmed circulation of poliovirusCase classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

Q FEVER(Coxiella burnetii)Clinical criteriaAny person with at least one of the following three:
— | Fever

— | Pneumonia

— | HepatitisLaboratory criteriaAt least one of the following three:
— | Isolation ofCoxiella burnetiifrom a clinical specimen

— | Detection ofCoxiella burnetiinucleic acid in a clinical specimen

— | Coxiella burnetiispecific antibody response (IgG or IgM phase II)Epidemiological criteriaAt least one of the following two epidemiological links:
— | Exposure to a common source

— | Animal to human transmissionCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

RABIES(Lyssa virus)Clinical criteriaAny person with an acute encephalomyelitis

AND

At least two of the following seven:
— | Sensory changes referred to the site of a preceding animal bite

— | Paresis or paralysis

— | Spasms of swallowing muscles

— | Hydrophobia

— | Delirium

— | Convulsions

— | AnxietyLaboratory criteriaAt least one of the following four:
— | Isolation of Lyssa virus from a clinical specimen

— | Detection of Lyssa virus nucleic acid in a clinical specimen (e.g. saliva or brain tissue)

— | Detection of viral antigens by a DFA in a clinical specimen

— | Lyssa virus specific antibody response by virus isneutralisation assay in serum or CSFLaboratory results need to be interpreted according to the vaccination or immunisation status

Epidemiological criteriaAt least one of the following three epidemiological links:
— | Animal to human transmission (animal with suspected or confirmed infection)

— | Exposure to a common source (same animal)

— | Human to human transmission (e.g. transplantation of organs)Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

RUBELLA(Rubella virus)Clinical criteriaAny person with sudden onset of generalised maculo-papular rash

AND

At least one of the following five:
— | Cervical adenopathy

— | Sub-occipital adenopathy

— | Post-auricular adenopathy

— | Arthralgia

— | ArthritisLaboratory criteria

— | Laboratory criteria for case confirmationAt least one of the following three:

— | Isolation of rubella virus from a clinical specimen

— | Detection of rubella virus nucleic acid in a clinical specimen

— | Rubella virus specific antibody response (IgG) in serum or saliva

— | Laboratory criteria for probable case

— | Rubella virus specific antibody response (IgM)(10)Laboratory results need to be interpreted according to the vaccination status

Epidemiological criteriaAn epidemiological link by human to human transmission

Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with at least one of the following two:
— | An epidemiological link

— | Meeting the laboratory criteria for a probable caseC.   Confirmed caseAny person not recently vaccinated and meeting the laboratory criteria for case confirmation

In case of recent vaccination, a person with detection of wild-type rubella virus strain

RUBELLA, CONGENITAL(Including congenital rubella syndrome)Clinical criteriaCongenital rubella infection (CRI)No clinical criteria can be defined for CRI

Congenital rubella syndrome (CRS)Any infant < 1 year of age or any stillborn with:
— | At least two of the conditions listed in (A)OR

— | One in category (A) and one in category (B)(A)
— | Cataract(s)

— | Congenital glaucoma

— | Congenital heart disease

— | Loss of hearing

— | Pigmentary retinopathy(B)
— | Purpura

— | Splenomegaly

— | Microcephaly

— | Developmental delay

— | Meningo-encephalitis

— | Radiolucent bone disease

— | Jaundice that begins within 24 hours after birthLaboratory criteriaAt least one of the following four:
— | Isolation of rubella virus from a clinical specimen

— | Detection of Rubella virus nucleic acid

— | Rubella virus specific antibody response (IgM)

— | Persistence of rubella IgG between 6 and 12 months of age (at least two samples with similar concentration of rubella IgG)Laboratory results need to be interpreted according to the vaccination status

Epidemiological criteriaAny infant or any stillborn born to a woman with a laboratory confirmed rubella infection during pregnancy by human to human transmission vertical transmission)

Case classification Congenital RubellaA.   Possible caseNA

B.   Probable caseAny stillborn or infant either not tested OR with negative laboratory results with at least one of the following two:
— | An epidemiological link AND at least one category ‘A’ CRS clinical criteria

— | Meeting the clinical criteria for CRSC.   Confirmed caseAny stillborn meeting the laboratory criteria

OR

Any infant meeting the laboratory criteria AND at least one of the following two:
— | An epidemiological link

— | At least one category ‘A’ CRS clinical criteriaAn infant with positive laboratory criteria only without a history of rubella in the mother during the pregnancy and without ‘A’ clinical criteria will therefore be reported as rubella case.

SALMONELLOSIS(Salmonella spp. other than S. Typhi and S. Paratyphi)Clinical criteriaAny person with at least one of the following four:
— | Diarrhoea

— | Fever

— | Abdominal pain

— | VomitingLaboratory criteria

— | Isolation ofSalmonella(other thanS. TyphiandS. Paratyphi)from stool or bloodEpidemiological criteriaAt least one of the following five epidemiological links:
— | Human to human transmission

— | Exposure to a common source

— | Animal to human transmission

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

SEVERE ACUTE RESPIRATORY SYNDROME — SARS(SARS-coronavirus, SARS-CoV)Clinical criteriaAny person with fever or a history of fever

AND

At least one of the followingthree:
— | Cough

— | Difficulty in breathing

— | Shortness of breathAND

At least one of the following four:
— | Radiographic evidence of pneumonia

— | Radiographic evidence of acute respiratory distress syndrome

— | Autopsy findings of pneumonia

— | Autopsy findings of acute respiratory distress syndromeAND

No alternative diagnosis which can fully explain the illness

Laboratory criteria

— | Laboratory criteria for case confirmationAt least one of the following three:—Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR—Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing | — | Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR | — | Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing | — | At least two different clinical specimens (e.g. nasopharyngeal swab and stool) | — | The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates) | — | Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

— | Isolation of virus in cell culture from any clinical specimen and identification of SARS-CoV using method such as RT-PCR

— | Detection SARS-CoV nucleic acid in at least one of the following three:—At least two different clinical specimens (e.g. nasopharyngeal swab and stool)—The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)—Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing | — | At least two different clinical specimens (e.g. nasopharyngeal swab and stool) | — | The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates) | — | Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

— | At least two different clinical specimens (e.g. nasopharyngeal swab and stool)

— | The same clinical specimen collected on two or more occasions during the course of the illness (e.g. sequential nasopharyngeal aspirates)

— | Two different assays or repeat RT-PCR using a new RNA extract from the original clinical sample on each occasion of testing

— | SARS-CoV specific antibody response by one of the following two:—Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel—Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel | — | Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel | — | Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel

— | Seroconversion by ELISA or IFA in acute and convalescent phase serum tested in parallel

— | Fourfold or greater rise in antibody titre between acute and convalescent phase sera tested in parallel

— | Laboratory criteria for a probable caseAt least one of the following two:—A single positive antibody test for SARS-CoV—A positive PCR result for SARS-CoV on a single clinical specimen and assay | — | A single positive antibody test for SARS-CoV | — | A positive PCR result for SARS-CoV on a single clinical specimen and assay

— | A single positive antibody test for SARS-CoV

— | A positive PCR result for SARS-CoV on a single clinical specimen and assayEpidemiological criteriaAt least one of the following three:
— | Any person with at least one of the followingthree:—Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)—Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS—History of travel to, or residence in, an area experiencing an outbreak of SARS | — | Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.) | — | Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS | — | History of travel to, or residence in, an area experiencing an outbreak of SARS

— | Employed in an occupation associated with an increased risk of SARS-CoV exposure (e.g. staff in a laboratory working with live SARS-CoV/SARS-CoV-like viruses or storing clinical specimens infected with SARS-CoV; persons with exposure to wildlife or other animals considered a reservoir of SARS-CoV, their excretions or secretions, etc.)

— | Close contact(11)of one or more persons with confirmed SARS or under investigation for SARS

— | History of travel to, or residence in, an area experiencing an outbreak of SARS

— | Two or more health-care workers(12)with clinical evidence of SARS in the same health-care unit and with onset of illness in the same 10-day period

— | Three or more persons (health-care workers and/or patients and/or visitors) with clinical evidence of SARS with onset of illness in the same 10-day period and epidemiologically linked to a healthcare facilityCase classification for the inter-epidemic periodAlso applies during an outbreak in a non-affected country or area

A.   Possible caseAny person meeting the clinical criteria and with an epidemiological link

B.   Probable caseAny person meeting the clinical criteria AND with an epidemiological link AND meeting the laboratory criteria for a probable case

C.   Nationally confirmed caseAny person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a national reference laboratory

D.   Confirmed caseAny person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a WHO SARS verification and reference laboratory

Case classification during an outbreakApplies during an outbreak in a country/area where at least one person has been laboratory confirmed by a WHO SARS verification and reference laboratory

A.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link to a nationally confirmed or a confirmed case

C.   Nationally confirmed caseAny person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a national reference laboratory

D.   Confirmed caseOne of the following three:
— | Any person meeting the clinical and the laboratory criteria for case confirmation where the testing has been performed at a WHO SARS verification and reference laboratory

— | Any nationally confirmed case with an epidemiological link to a chain of transmission where at least one case has been independently verified by a WHO SARS reference and verification laboratory

— | Any person meeting the clinical criteria and with laboratory criteria for probable case with an epidemiological link to a chain of transmission where at least one case has been independently verified by a WHO SARS reference and verification laboratorySHIGELLOSIS(Shigella spp.)Clinical criteriaAny person with at least one of the following four:
— | Diarrhoea

— | Fever

— | Vomiting

— | Abdominal painLaboratory criteria

— | Isolation ofShigella spp. from a clinical specimenEpidemiological criteriaAt least one of the following five epidemiological links:
— | Human to human transmission

— | Exposure to a common source

— | Animal to human transmission

— | Exposure to contaminated food/drinking water

— | Environmental exposureCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

SMALLPOX(Variola virus)Clinical criteriaAny person with at least one of the following two:
— | FeverAND

Vesicles or firm pustules rash at the same stage of development with a centrifugal distribution
— | Atypical presentations defined as at least one of the following four:—Haemorrhagic lesions—Flat velvety lesions not progressing to vesicles—Variola sine eruptione—Milder type | — | Haemorrhagic lesions | — | Flat velvety lesions not progressing to vesicles | — | Variola sine eruptione | — | Milder type

— | Haemorrhagic lesions

— | Flat velvety lesions not progressing to vesicles

— | Variola sine eruptione

— | Milder typeLaboratory criteria

— | Laboratory criteria for case confirmationAt least one of the following two laboratory tests:—Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)—Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing | — | Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only) | — | Detection of Variola virus nucleic acid in a clinical specimen followed by sequencing

— | Isolation of smallpox (variola virus) from a clinical specimen followed by sequencing (designated P4 laboratories only)

— | Detection of Variola virus nucleic acid in a clinical specimen followed by sequencingLaboratory results need to be interpreted according to the vaccination status
— | Laboratory criteria for a probable case

— | Identification of orthopox virus particles by EMEpidemiological criteriaAt least one of the following two epidemiological links:
— | Human to human transmission

— | Laboratory exposure (where there is a potential exposure to Variola virus)Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and with at least one of the following two:
— | An epidemiological link to a confirmed human case by human to human transmission

— | Meeting the laboratory criteria for a probable caseC.   Confirmed caseAny person meeting the laboratory criteria for case confirmation

During an outbreak: any person meeting the clinical criteria and with an epidemiological link

SYPHILIS(Treponema pallidum)Clinical criteria

— | Primary syphilisAny person with one or several (usually painless) chancres in the genital, perineal, anal area or mouth or pharyngeal mucosa or elsewhere extragenitally

— | Secondary syphilisAny person with at least one of the following three:—Diffuse maculo-papular rash often involving palms and soles—Generalised lymphadenopathy—Condyloma lata—Enanthema—Allopetia diffusa | — | Diffuse maculo-papular rash often involving palms and soles | — | Generalised lymphadenopathy | — | Condyloma lata | — | Enanthema | — | Allopetia diffusa

— | Diffuse maculo-papular rash often involving palms and soles

— | Generalised lymphadenopathy

— | Condyloma lata

— | Enanthema

— | Allopetia diffusa

— | Early latent syphilis (< 1 year)A history of symptoms compatible with those of the earlier stages of syphilis within the previous 12 months

— | Late latent syphilis (> 1 year)Any person meeting laboratory criteria (specific serological tests)Laboratory criteriaAt least one of the following four laboratory tests:
— | Demonstration ofTreponema pallidumin lesion exudates or tissues by dark-field microscopic examination

— | Demonstration ofTreponema pallidumin lesion exudates or tissues by DFA test

— | Demonstration ofTreponemain lesion exudates or tissues by PCR

— | Detection ofTreponema pallidumantibodies by screening test (TPHA, TPPA or EIA) AND additionally detection of Tp-IgM antibodies (by IgM-ELISA, IgM immunoblot or 19S-IgM-FTA-abs) — confirmed by a second IgM assayEpidemiological criteria

— | Primary/secondary syphilisAn epidemiological link by human to human (sexual contact)

— | Early latent syphilis (< 1 year)An epidemiological link by human to human (sexual contact) within the 12 previous monthsCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the laboratory criteria for case confirmation

SYPHILIS, CONGENITAL AND NEONATAL(Treponema pallidum)Clinical criteriaAny infant < 2 years of age with at least one of the following 10:
— | Hepatospenomegaly

— | Mucocutaneous lesions

— | Condyloma lata

— | Persistent rhinitis

— | Jaundice

— | Pseudoparalysis (due to periostitis and osteochondritis)

— | Central nervous involvement

— | Anaemia

— | Nephrotic syndrome

— | MalnutritionLaboratory criteria

— | Laboratory criteria for case confirmationAt least one of the following three:—Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material—Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material—Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)AND a reactive non treponemal test (VDRL, RPR) in the child’s serum | — | Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material | — | Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material | — | Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)

— | Demonstration ofTreponema pallidumby dark field microscopy in the umbilical cord, the placenta, a nasal discharge or skin lesion material

— | Demonstration ofTreponema pallidumby DFA-TP in the umbilical cord, the placenta, a nasal discharge or skin lesion material

— | Detection ofTreponema pallidum— specific IgM (FTA-abs, EIA)

— | Laboratory criteria for a probable caseAt least one of the following three:—Reactive VDRL-CSF test result—Reactive non treponemal and treponemal serologic tests in the mother’s serum—Infant’s non treponemal antibody titre is fourfold or greater than the antibody titre in the mother’s serum | — | Reactive VDRL-CSF test result | — | Reactive non treponemal and treponemal serologic tests in the mother’s serum | — | Infant’s non treponemal antibody titre is fourfold or greater than the antibody titre in the mother’s serum

— | Reactive VDRL-CSF test result

— | Reactive non treponemal and treponemal serologic tests in the mother’s serum

— | Infant’s non treponemal antibody titre is fourfold or greater than the antibody titre in the mother’s serumEpidemiological criteriaAny infant with an epidemiological link by human to human transmission (vertical transmission)

Case classificationA.   Possible caseNA

B.   Probable caseAny infant or child meeting the clinical criteria and with at least one of the following two:
— | An epidemiological link

— | Meeting the laboratory criteria for a probable caseC.   Confirmed caseAny infant meeting the laboratory criteria for case confirmation

TETANUS(Clostridium tetani)Clinical criteriaAny person with at least two of the following three:
— | Painful muscular contractions primarily of the masseter and neck muscles leading to facial spasms known as trismus and ‘risus sardonicus’

— | Painful muscular contractions of trunk muscles

— | Generalised spasms, frequently position of opisthotonusLaboratory criteriaAt least one of the following two:
— | Isolation ofClostridium tetanifrom an infection site

— | Detection of tetanus toxin in a serum sampleEpidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

TOXOPLASMOSIS, CONGENITAL(Toxoplasma gondii)Clinical criteriaNot relevant for surveillance purposes

Laboratory criteriaAt least one of the following four:
— | Demonstration ofT. gondiiin body tissues or fluids

— | Detection ofT. gondiinucleic acid in a clinical specimen

— | T. gondii specific antibody response (IgM, IgG, IgA) in a newborn

— | Persistently stable IgGT. gondiititres in an infant (<12 months of age)Epidemiological criteriaNA

Case classificationA.   Possible caseNA

B.   Probable caseNA

C.   Confirmed caseAny infant meeting the laboratory criteria

TRICHINELLOSIS(Trichinella spp.)Clinical criteriaAny person with at least three of the following six:
— | Fever

— | Muscle soreness and pain

— | Diarrhoea

— | Facial oedema

— | Eosinophilia

— | Subconjunctival, subungual and retinal haemorrhagesLaboratory criteriaAt least one of the following two:
— | Demonstration ofTrichinellalarvae in tissue obtained by muscle biopsy

— | Trichinellaspecific antibody response (IFA test, ELISA or Western Blot)Epidemiological criteriaAt least one of the following two epidemiological links:
— | Exposure to contaminated food (meat)

— | Exposure to a common sourceCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical criteria and the laboratory criteria

TUBERCULOSIS(Mycobacterium tuberculosis complex)Clinical criteriaAny person with the following two:
— | Signs, symptoms and/or radiological findings consistent with active tuberculosis in any siteAND

— | A clinician’s decision to treat the person with a full course of anti-tuberculosis therapyOR

A case discovered post-mortem with pathological findings consistent with active tuberculosis that would have indicated anti-tuberculosis antibiotic treatment had the patient been diagnosed before dying

Laboratory criteria

— | Laboratory criteria for case confirmationAt least one of the following two:—Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen—Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy | — | Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen | — | Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

— | Isolation ofMycobacterium tuberculosiscomplex (excludingMycobacterium bovis-BCG) from a clinical specimen

— | Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen AND positive microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

— | Laboratory criteria for a probable caseAt least one of the following three:—Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy—Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen—Histological appearance of granulomata | — | Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy | — | Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen | — | Histological appearance of granulomata

— | Microscopy for acid-fast bacilli or equivalent fluorescent staining bacilli on light microscopy

— | Detection ofMycobacterium tuberculosiscomplex nucleic acid in a clinical specimen

— | Histological appearance of granulomataEpidemiological criteriaNA

Case classificationA.   Possible caseAny person meeting the clinical criteria

B.   Probable caseAny person meeting the clinical criteria and the laboratory criteria for a probable case

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria for case confirmation

TULARAEMIA(Francisella tularensis)Clinical criteriaAny person with at least one of the following clinical forms:
— | Ulceroglandular tularaemia—Cutaneous ulcerAND—Regional lymphadenopathy | — | Cutaneous ulcerAND | — | Regional lymphadenopathy

— | Cutaneous ulcerAND

— | Regional lymphadenopathy

— | Glandular tularaemia—Enlarged and painful lymph nodes without apparent ulcer | — | Enlarged and painful lymph nodes without apparent ulcer

— | Enlarged and painful lymph nodes without apparent ulcer

— | Oculoglandular tularaemia—ConjunctivitisAND—Regional lymphadenopathy | — | ConjunctivitisAND | — | Regional lymphadenopathy

— | ConjunctivitisAND

— | Regional lymphadenopathy

— | Oropharyngeal tularaemia—Cervical lymphadenopathyANDat least one of the following three:—Stomatitis—Pharyngitis—Tonsillitis | — | Cervical lymphadenopathyAND | — | Stomatitis | — | Pharyngitis | — | Tonsillitis

— | Cervical lymphadenopathyAND

— | Stomatitis

— | Pharyngitis

— | Tonsillitis

— | Intestinal tularaemiaAt least one of the following three:—Abdominal pain—Vomiting—Diarrhoea | — | Abdominal pain | — | Vomiting | — | Diarrhoea

— | Abdominal pain

— | Vomiting

— | Diarrhoea

— | Pneumonic tularaemia—Pneumonia | — | Pneumonia

— | Pneumonia

— | Typhoidal tularaemiaAt least one of the following two:—Fever without early localising signs and symptoms—Septicaemia | — | Fever without early localising signs and symptoms | — | Septicaemia

— | Fever without early localising signs and symptoms

— | SepticaemiaLaboratory criteriaAt least one of the following three:
— | Isolation ofFrancisella tularensisfrom a clinical specimen

— | Detection ofFrancisella tularensisnucleic acid in a clinical specimen

— | Francisella tularensisspecific antibody responseEpidemiological criteriaAt least one of the following three epidemiological links:
— | Exposure to a common source

— | Animal to human transmission

— | Exposure to contaminated food/drinking waterCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

TYPHOID/PARATYPHOID FEVER(Salmonella Typhi/Paratyphi)Clinical criteriaAny person with at least one of the following two:
— | Onset of sustained fever

— | At least two of the following four:—Headache—Relative bradycardia—Non productive cough—Diarrhoea, constipation, malaise or abdominal pain | — | Headache | — | Relative bradycardia | — | Non productive cough | — | Diarrhoea, constipation, malaise or abdominal pain

— | Headache

— | Relative bradycardia

— | Non productive cough

— | Diarrhoea, constipation, malaise or abdominal painParatyphoid fever has the same symptoms as typhoid fever, however usually a milder course.

Laboratory criteria

— | Isolation ofSalmonellaTyphi or Paratyphi from a clinical specimenEpidemiological criteriaAt least one of the following three epidemiological links:
— | Exposure to a common source

— | Human to human transmission

— | Exposure to contaminated food/drinking waterCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

VIRAL HAEMORRHAGIC FEVERSClinical criteriaAny person with at least one of the following two:
— | Fever

— | Haemorrhagic manifestations in various forms that may lead to multi-organ failureLaboratory criteriaAt least one of the following two:
— | Isolation of specific virus from a clinical specimen

— | Detection of specific virus nucleic acid in a clinical specimen and genotypingEpidemiological criteriaAt least one of the following:
— | Travel in the last 21 days to a region where VHF cases are known or believed to have occurred

— | Exposure within the last 21 days to a probable or confirmed case of a Viral Hemorrhagic Fever whose onset of illness was within the last six monthsCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria

WEST NILE FEVER(West Nile virus infection, WNV)Clinical criteriaAny person with fever

OR

At least one of the following two:
— | Encephalitis

— | MeningitisLaboratory criteria

— | Laboratory test for case confirmationAt least one of the following four:—Isolation of WNV from blood or CSF—Detection of WNV nucleic acid in blood or CSF—WNV specific antibody response (IgM) in CSF—WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation | — | Isolation of WNV from blood or CSF | — | Detection of WNV nucleic acid in blood or CSF | — | WNV specific antibody response (IgM) in CSF | — | WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation

— | Isolation of WNV from blood or CSF

— | Detection of WNV nucleic acid in blood or CSF

— | WNV specific antibody response (IgM) in CSF

— | WNV IgM high titre AND detection of WNV IgG, AND confirmation by neutralisation

— | Laboratory test for a probable caseWNV specific antibody response in serumLaboratory results need to be interpreted according to flavivirus vaccination statusEpidemiological criteriaAt least one of the following two epidemiological links:
— | Animal to human transmission (residing, having visited or having been exposed to mosquito bites in an area where WNV is endemic in horses or birds)

— | Human to human transmission (vertical transmission, blood transfusion, transplants)Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria AND with at least one of the following two:
— | an epidemiological link

— | a laboratory test for a probable caseC.   Confirmed caseAny person meeting the laboratory criteria for case confirmation

YELLOW FEVER(Yellow fever virus)Clinical criteriaAny person with fever

AND

At least one of the following two:
— | Jaundice

— | Generalised haemorrhageLaboratory criteriaAt least one of the following five:
— | Isolation of yellow fever virus from a clinical specimen

— | Detection of yellow fever virus nucleic acid

— | Detection of yellow fever antigen

— | Yellow fever specific antibody response

— | Demonstration of typical lesions in post mortem liver histopathologyLaboratory results need to be interpreted according to flavivirus vaccination status

Epidemiological criteriaTravel in the last one week to a region where yellow fever cases are known or believed to have occurred

Case classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person not recently vaccinated meeting the clinical and the laboratory criteria

In case of recent vaccination, a person with detection of wild-type yellow fever virus strain.

YERSINIOSIS(Yersinia enterocolitica, Yersinia pseudotuberculosis)Clinical criteriaAny person with at least one of the following five:
— | Fever

— | Diarrhoea

— | Vomiting

— | Abdominal pain (pseudoappendicitis)

— | TenesmusLaboratory criteria

— | Isolation of human pathogenicYersinia enterocoliticaorYersinia pseudotuberculosisfrom a clinical specimenEpidemiological criteriaAt least one of the following four epidemiological links:
— | Human to human transmission

— | Exposure to a common source

— | Animal to human transmission

— | Exposure to contaminated foodCase classificationA.   Possible caseNA

B.   Probable caseAny person meeting the clinical criteria and with an epidemiological link

C.   Confirmed caseAny person meeting the clinical and the laboratory criteria
(1)  European Centre for the Epidemiological Monitoring of AIDS. 1993 revision of the European AIDS surveillance case definition. AIDS Surveillance in Europe, Quarterly Report 1993; No 37: 23-28

(2)  European Centre for the Epidemiological Monitoring of AIDS. European case definition for AIDS surveillance in children — revision 1995. HIV/AIDS Surveillance in Europe, Quarterly Report 1995; No 48: 46-53

(3)  See World isOrganisation for Animal Health — OIE — and European Commission (SANCO) Animal Disease Notification System (ADNS), available at: http://www.oie.int/eng/en_index.htm and http://ec.europa.eu/food/animal/diseases/adns/index_en.htm#)

(4)  This does not include seemingly well birds that have been killed, for example by hunting.

(5)  Depression, anxiety, apathy, withdrawal, delusions.

(6)  This includes both frank pain and/or dysaesthesia.

(7)  The typical appearance of the EEG in sporadic CJD consists of generalised periodic complexes at approximately one per second. These may occasionally be seen in the late stages of VCJD.

(8)  The typical appearance of the EEG in sporadic CJD consists of generalised periodic complexes at approximately one per second. These may occasionally be seen in the late stages of VCJD.

(9)  Tonsil biopsy is not recommended routinely nor in cases with EEG appearances typical of sporadic CJD, but may be useful in suspect cases in which the clinical features are compatible with VCJD and MRI does not show pulvinar high signal.

(10)  When rubella in pregnancy is suspected, further confirmation of a positive rubella IgM results is required (e.g. a rubella specific IgG avidity test showing a low avidity). In certain situations, such as confirmed rubella outbreaks detection of rubella virus IgM can be considered confirmatory in non-pregnant cases.

(11)  A close contact is a person who has cared for, lived with, or having had direct contact with the respiratory secretions, body fluids and/or excretions (e.g. faeces) of cases of SARS.

(12)  In this context the term ‘health-care worker’ includes all hospital staff. The definition of the health care unit in which the cluster occurs will depend on the local situation. Unit size may range from an entire health care facility if small, to a single department or ward of a large tertiary hospital.

Pending: 32008D0425

                                January 16, 2026                            

18.6.2008
EN
Official Journal of the European Union
L 159/1

(1)
Decision 90/424/EEC lays down the procedures governing the Community's financial contribution towards the programmes for the eradication, control and monitoring of animal diseases and zoonoses. Pursuant to that Decision, a Community financial measure is to be introduced to reimburse the expenditure incurred by the Member States for the financing of national programmes for the eradication, control and monitoring of the animal diseases and zoonoses listed in the Annex to that Decision.

(2)
Decision 90/424/EEC provides that each year, by 30 April at the latest, Member States are to submit to the Commission the annual or multi-annual programmes starting in the following year for which they wish to receive a financial contribution from the Community.

(3)
Based on Article 3 of Decision 90/424/EEC, as amended by Decision 2006/965/EC, programmes for Enzootic bovine leucosis (EBL) and Aujeszky's disease may be funded until 31 December 2010.

(4)
Commission Decision 2004/450/EC of 29 April 2004 laying down standard requirements for the content of applications for Community financing for programmes for the eradication, monitoring and control of animal diseases(2)provides that Member States seeking a financial contribution from the Community for programmes for the eradication, monitoring and control of certain animal diseases are to submit applications containing certain information set out in that Decision.

(5)
Commission Decision 2008/341/EC of 25 April 2008 laying down Community criteria for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses(3)lays down criteria to be fulfilled by the national programmes in order to be approved by the Commission under the Community financial measure provided for in Article 24(1) of Decision 90/424/EEC.

(6)
Following the adoption of Decision 2008/341/EC and in order to further improve the process of submission, approval and assessment of progress during the implementation of the programmes, the standard requirements for the applications by Member States for Community financing for national programmes should be updated and made consistent with those criteria. For the sake of clarity, Decision 2004/450/EC should be repealed and replaced by this Decision.

(7)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)
Annex I to this Decision in respect of:—bovine tuberculosis,—bovine brucellosis,—ovine and caprine brucellosis (B. melitensis),—bluetongue in endemic or high risk areas,—African swine fever,—swine vesicular disease,—classical swine fever,—anthrax,—contagious bovine pleuropneumonia,—rabies,—echinococcosis,—trichinellosis,—verotoxigenicE. coli,—enzootic bovine leucosis (EBL) and Aujeszky's disease;
—
bovine tuberculosis,
—
bovine brucellosis,
—
ovine and caprine brucellosis (B. melitensis),
—
bluetongue in endemic or high risk areas,
—
African swine fever,
—
swine vesicular disease,
—
classical swine fever,
—
anthrax,
—
contagious bovine pleuropneumonia,
—
rabies,
—
echinococcosis,
—
trichinellosis,
—
verotoxigenicE. coli,
—
enzootic bovine leucosis (EBL) and Aujeszky's disease;

—
bovine tuberculosis,

—
bovine brucellosis,

—
ovine and caprine brucellosis (B. melitensis),

—
bluetongue in endemic or high risk areas,

—
African swine fever,

—
swine vesicular disease,

—
classical swine fever,

—
anthrax,

—
contagious bovine pleuropneumonia,

—
rabies,

—
echinococcosis,

—
trichinellosis,

—
verotoxigenicE. coli,

—
enzootic bovine leucosis (EBL) and Aujeszky's disease;

—
bovine tuberculosis,

—
bovine brucellosis,

—
ovine and caprine brucellosis (B. melitensis),

—
bluetongue in endemic or high risk areas,

—
African swine fever,

—
swine vesicular disease,

—
classical swine fever,

—
anthrax,

—
contagious bovine pleuropneumonia,

—
rabies,

—
echinococcosis,

—
trichinellosis,

—
verotoxigenicE. coli,

—
enzootic bovine leucosis (EBL) and Aujeszky's disease;

(b)
Annex II to this Decision in respect of salmonellosis (zoonotic salmonella);

(c)
Annex III to this Decision in respect of transmissible spongiform encephalopathies (TSE) (bovine spongiform encephalopathy (BSE), scrapie and chronic waste disease (CWD);

(d)
Annex IV to this Decision in respect of avian influenza in poultry and wild birds;

(e)
Annex V to this Decision in respect of:—infectious haematopoietic necrosis,—infectious salmon anaemia,—spring viraemia of carp (SVC),—viral haemorrhagic septicæmia (VHS),—koi herpes virus infection (KHV),—infection withBonamia ostreae,—infection withMarteilia refringens,—white spot disease in crustaceans.
—
infectious haematopoietic necrosis,
—
infectious salmon anaemia,
—
spring viraemia of carp (SVC),
—
viral haemorrhagic septicæmia (VHS),
—
koi herpes virus infection (KHV),
—
infection withBonamia ostreae,
—
infection withMarteilia refringens,
—
white spot disease in crustaceans.

—
infectious haematopoietic necrosis,

—
infectious salmon anaemia,

—
spring viraemia of carp (SVC),

—
viral haemorrhagic septicæmia (VHS),

—
koi herpes virus infection (KHV),

—
infection withBonamia ostreae,

—
infection withMarteilia refringens,

—
white spot disease in crustaceans.

—
infectious haematopoietic necrosis,

—
infectious salmon anaemia,

—
spring viraemia of carp (SVC),

—
viral haemorrhagic septicæmia (VHS),

—
koi herpes virus infection (KHV),

—
infection withBonamia ostreae,

—
infection withMarteilia refringens,

—
white spot disease in crustaceans.

2.
Historical data on the epidemiological evolution of the disease(s)(4):

3.
Description of the submitted programme(5):

First year:
Last year:

Control

Control
Eradication

Eradication


Control


Eradication

Testing

Testing
Testing

Testing


Testing


Testing

Slaughter of animals tested positive

Slaughter of animals tested positive
Slaughter of positive animals tested

Slaughter of positive animals tested


Slaughter of animals tested positive


Slaughter of positive animals tested

Killing of animals tested positive

Killing of animals tested positive
Killing of animals tested positive

Killing of animals tested positive


Killing of animals tested positive


Killing of animals tested positive

Vaccination

Vaccination
Extended slaughter or killing

Extended slaughter or killing


Vaccination


Extended slaughter or killing

Treatment

Treatment
Disposal of products

Disposal of products


Treatment


Disposal of products

Disposal of products

Disposal of products


Disposal of products

Eradication, control or monitoring.

Eradication, control or monitoring.
Other measures(specify):

Other measures(specify):


Eradication, control or monitoring.


Other measures(specify):


Control


Eradication


Testing


Testing


Slaughter of animals tested positive


Slaughter of positive animals tested


Killing of animals tested positive


Killing of animals tested positive


Vaccination


Extended slaughter or killing


Treatment


Disposal of products


Disposal of products


Eradication, control or monitoring.


Other measures(specify):

4.2.
Organisation, supervision and role of all stakeholders(6)involved in the programme:

4.3.
Description and demarcation of the geographical and administrative areas in which the programme is to be implemented(7):

4.4.1.
Notification of the disease:

4.4.2.
Target animals and animal population:

4.4.3.
Identification of animals and registration of holdings:

4.4.4.
Qualifications of animals and herds(9):

4.4.5.
Rules on the movement of animals:

4.4.6.
Tests used and sampling schemes:

4.4.7.
Vaccines used and vaccination schemes:

4.4.8.
Information and assessment on bio-security measures management and infrastructure) in place in the holdings involved:

4.4.9.
Measures in case of a positive result(10):

4.4.10.
Compensation scheme for owners of slaughtered and killed animals:

4.4.11.
Control on the implementation of the programme and reporting:

5.
Benefits of the programme(11):

Year:Disease(2):

Situation on date:Animal species:

Region(3)
Total number of herds(4)
Total number of herds under the programme
Number of herds checked(5)
Number of positive herds(6)
Number of new positive herds(7)
Number of herds depopulated
% positive herds depopulated
Indicators

% herd coverage
% positive herdsPeriod herd prevalence
% new positive herdsHerd incidence

1
2
3
4
5
6
7
8 = (7/5)×100
9 = (4/3)×100
10 = (5/4)×100
11 = (6/4)×100

Total

Year:Disease(8):

Situation on date:Animal species:

Region(9)
Total number of animals(10)
Number of animals(11)to be tested under the programme
Number of animals(11)tested
Number of animals tested individually(12)
Number of positive animals
Slaughtering
Indicators

Number of animals with positive result slaughtered or culled
Total number of animals slaughtered(13)
% coverage at animal level
% positive animalsAnimal prevalence

1
2
3
4
5
6
7
8
9=(4/3)×100
10=(6/4)×100

Total

Year:
Disease(14):
Animal species/category:

Description of the used serological tests:Description of the used microbiological or virological tests:Description of the other used tests:

Region(15)
Serological tests
Microbiological or virological tests
Other tests

Number of samples tested(16)
Number of positive samples(17)
Number of samples tested(16)
Number of positive samples(17)
Number of samples tested(16)
Number of positive samples(17)

Total

Year:
Disease(18):
Animal species:

Region(19)
Number of herds infected(20)
Number of animals infected

Total

Year:
Disease(21):
Animal species:

Region(22)
Status of herds and animals under the programme(23)

Total number of herds and animals under the programme
Unknown(24)
Not free or not officially free from disease
Free or officially free from disease status suspended(27)
Free from disease(28)
Officially free from disease(29)

Last check positive(25)
Last check negative(26)

Herds
Animals(30)
Herds
Animals(30)
Herds
Animals(30)
Herds
Animals(30)
Herds
Animals(30)
Herds
Animals(30)
Herds
Animals(30)

Total

Year:
Disease(31):
Animal species:

Description of the used vaccination, therapeutic or other scheme:

Region(32)
Total number of herds(33)
Total number of animals
Information on vaccination or treatment programme

Number of herds(33)in vaccination or treatment programme
Number of herds(33)vaccinated or treated
Number of animals vaccinated or treated
Number of doses of vaccine or treatment administered
Number of adults(34)vaccinated
Number of young(34)animals vaccinated

Total

Year:
Method of estimation(35):

Regions(36)
Estimation of the population of the concerned wild species

Species:
Species:
Species:
Species:

Total

Year:
Disease(37):
Animal species:

Description of the used serological tests:Description of the used microbiological or virological tests:Description of the other used tests:

Region(38)
Microbiological or virological tests
Serological tests
Other tests

Number of samples tested
Number of positive samples
Number of samples tested
Number of positive samples
Number of samples tested
Number of positive samples

Total

Year:

Disease(39):

Animal species:

Description of the used vaccination, therapeutic or other scheme:

Region(40)
Square km
Vaccination or treatment programme

Number of doses of vaccine or treatment to be administered
Number of campaigns
Total number of doses of vaccine or treatment administered

Total

Disease(41):
Animal species:

Region(42)
Type of the test(43)
Target population(44)
Type of sample(45)
Objective(46)
Number of planned tests

Total

Disease(48):

Animal species:

Region(49)
Total number of herds(50)
Total number of herds under the programme
Number of herds expected to be checked(51)
Number of expected positive herds(52)
Number of expected new positive herds(53)
Number of herds expected to be depopulated
% positive herds expected to be depopulated
Target indicators

Expected % herd coverage
% positive herdsExpected period herd prevalence
% new positive herdsExpected herd incidence

1
2
3
4
5
6
7
8 = (7/5)×100
9 = (4/3)×100
10 = (5/4)×100
11 = (6/4)×100

Total

Disease(54):

Animal species:

Region(55)
Total number of animals(56)
Number of animals(57)under the programme
Number of animals(57)expected to be tested
Number of animals to be tested individually(58)
Number of expected positive animals
Slaughtering
Target indicators

Number of animals with positive result expected to be slaughtered or culled
Total number of animals expected to be slaughtered(59)
Expected % coverage at animal level
% positive animals (Expected animal prevalence)

1
2
3
4
5
6
7
8
9=(4/3)×100
10=(6/4)×100

Total

Disease(60):

Animal species:

Region(61)
Total number of herds and animals under the programme
Targets on the status of herds and animals under the programme(62)

Expected unknown(63)
Expected not free or not officially free from disease
Expected free or officially free from disease status suspended(66)
Expected free from disease(67)
Expected officially free from disease(68)

Last check positive(64)
Last check negative(65)

Herds
Animals(69)
Herds
Animals(69)
Herds
Animals(69)
Herds
Animals(69)
Herds
Animals(69)
Herds
Animals(69)
Herds
Animals(69)

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

Total

Disease(70):

Animal species:

Region(71)
Total number of herds(72)in vaccination or treatment programme
Total number of animals in vaccination or treatment programme
Targets on vaccination or treatment programme

Number of herds(72)in vaccination or treatment programme
Number of herds(72)expected to be vaccinated or treated
Number of animals expected to be vaccinated or treated
Number of doses of vaccine or treatment expected to be administered
Number of adults(73)expected to be vaccinated
Number of young(73)animals expected to be vaccinated

Total

Disease(74):
Animal species:

Region(75)
Square km
Targets on the vaccination or treatment programme

Number of doses of vaccine or treatments expected to be administered in the campaign
Expected number of campaigns
Total number of doses of vaccine or treatment expected to be administered

Total

Costs related to
Specification
Number of units
Unitary cost in EUR
Total amount in EUR
Community funding requested (yes/no)

1.Testing
1.
Testing

1.
Testing

1.1.Cost of the analysis
1.1.
Cost of the analysis
Test:

1.1.
Cost of the analysis

Test:

Test:

1.2.Cost of sampling
1.2.
Cost of sampling

1.2.
Cost of sampling

1.3.Other costs
1.3.
Other costs

1.3.
Other costs

2.Vaccination or treatment
2.
Vaccination or treatment

2.
Vaccination or treatment

2.1.Purchase of vaccine/treatment
2.1.
Purchase of vaccine/treatment

2.1.
Purchase of vaccine/treatment

2.2.Distribution costs
2.2.
Distribution costs

2.2.
Distribution costs

2.3.Administering costs
2.3.
Administering costs

2.3.
Administering costs

2.4.Control costs
2.4.
Control costs

2.4.
Control costs

3.Slaughter and destruction
3.
Slaughter and destruction

3.
Slaughter and destruction

3.1.Compensation of animals
3.1.
Compensation of animals

3.1.
Compensation of animals

3.2.Transport costs
3.2.
Transport costs

3.2.
Transport costs

3.3.Destruction costs
3.3.
Destruction costs

3.3.
Destruction costs

3.4.Loss in case of slaughtering
3.4.
Loss in case of slaughtering

3.4.
Loss in case of slaughtering

3.5.Costs from treatment of products (milk, eggs, hatching eggs, etc.)
3.5.
Costs from treatment of products (milk, eggs, hatching eggs, etc.)

3.5.
Costs from treatment of products (milk, eggs, hatching eggs, etc.)

4.Cleaning and disinfection
4.
Cleaning and disinfection

4.
Cleaning and disinfection

5.Salaries (staff contracted for the programme only)
5.
Salaries (staff contracted for the programme only)

5.
Salaries (staff contracted for the programme only)

6.Consumables and specific equipment
6.
Consumables and specific equipment

6.
Consumables and specific equipment

7.Other costs
7.
Other costs

7.
Other costs

Total

1.
Testing

1.1.
Cost of the analysis

1.2.
Cost of sampling

1.3.
Other costs

2.
Vaccination or treatment

2.1.
Purchase of vaccine/treatment

2.2.
Distribution costs

2.3.
Administering costs

2.4.
Control costs

3.
Slaughter and destruction

3.1.
Compensation of animals

3.2.
Transport costs

3.3.
Destruction costs

3.4.
Loss in case of slaughtering

3.5.
Costs from treatment of products (milk, eggs, hatching eggs, etc.)

4.
Cleaning and disinfection

5.
Salaries (staff contracted for the programme only)

6.
Consumables and specific equipment

7.
Other costs

(a)
State the aim of the programme

(b)
Demonstrate the evidence that it complies with the minimum sampling requirements laid down in part B of Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council(1)indicating the relevant animal population and phases of production which sampling must coverBreeding flocks ofGallus gallus:—rearing flocks—day-old chicks,—four-week-old birds—two weeks before moving to laying phase or laying unit—adult breeding flocks — every second week during the laying period,Laying hens:—rearing flocks—day-old chicks,—pullets two weeks before moving to laying phase or laying unit—laying flocks — every 15 weeks during the laying phase,Broilers — birds leaving for slaughterTurkeys — birds leaving for slaughterHerds of pigs:—breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse,—slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse;
—rearing flocks
—
rearing flocks
—day-old chicks,
—
day-old chicks,

—four-week-old birds
—
four-week-old birds

—two weeks before moving to laying phase or laying unit
—
two weeks before moving to laying phase or laying unit
—
adult breeding flocks — every second week during the laying period,
—rearing flocks
—
rearing flocks
—day-old chicks,
—
day-old chicks,

—pullets two weeks before moving to laying phase or laying unit
—
pullets two weeks before moving to laying phase or laying unit
—
laying flocks — every 15 weeks during the laying phase,
—
breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse,
—
slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse;

—rearing flocks
—
rearing flocks
—day-old chicks,
—
day-old chicks,

—
rearing flocks

—
day-old chicks,

—four-week-old birds
—
four-week-old birds

—
four-week-old birds

—two weeks before moving to laying phase or laying unit
—
two weeks before moving to laying phase or laying unit

—
two weeks before moving to laying phase or laying unit

—
adult breeding flocks — every second week during the laying period,

—rearing flocks
—
rearing flocks
—day-old chicks,
—
day-old chicks,

—
rearing flocks

—
day-old chicks,

—pullets two weeks before moving to laying phase or laying unit
—
pullets two weeks before moving to laying phase or laying unit

—
pullets two weeks before moving to laying phase or laying unit

—
laying flocks — every 15 weeks during the laying phase,

—
breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse,

—
slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse;

—rearing flocks
—
rearing flocks
—day-old chicks,
—
day-old chicks,

—
rearing flocks

—
day-old chicks,

—four-week-old birds
—
four-week-old birds

—
four-week-old birds

—two weeks before moving to laying phase or laying unit
—
two weeks before moving to laying phase or laying unit

—
two weeks before moving to laying phase or laying unit

—
rearing flocks

—
day-old chicks,

—
four-week-old birds

—
two weeks before moving to laying phase or laying unit

—
adult breeding flocks — every second week during the laying period,

—rearing flocks
—
rearing flocks
—day-old chicks,
—
day-old chicks,

—
rearing flocks

—
day-old chicks,

—pullets two weeks before moving to laying phase or laying unit
—
pullets two weeks before moving to laying phase or laying unit

—
pullets two weeks before moving to laying phase or laying unit

—
rearing flocks

—
day-old chicks,

—
pullets two weeks before moving to laying phase or laying unit

—
laying flocks — every 15 weeks during the laying phase,

—
breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse,

—
slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse;

(c)
demonstrate the evidence that it complies with the specific requirements laid down in Parts C, D and E of Annex II to Regulation (EC) No 2160/2003; and

(d)
specify the following points:1.General1.1.A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes.1.2.The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme.1.3.Approved laboratories where samples collected within the programme are analysed.1.4.Methods used in the examination of the samples in the framework of the programme.1.5.Official controls (including sampling schemes) at feed, flock and/or herd level.1.6.Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination.1.7.National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme.1.8.Any financial assistance provided to food and feed businesses in the context of the programme.2.Concerning food and feed businesses covered by the programme2.1.The structure of the production of the given species and products thereof.2.2.The structure of the production of feed.2.3.Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms.2.4.Routine veterinary supervision of farms.2.5.Registration of farms.2.6.Record-keeping at farms.2.7.Documents to accompany animals when dispatched.2.8.Other relevant measures to ensure the traceability of animals.
1.
General
1.1.
A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes.
1.2.
The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme.
1.3.
Approved laboratories where samples collected within the programme are analysed.
1.4.
Methods used in the examination of the samples in the framework of the programme.
1.5.
Official controls (including sampling schemes) at feed, flock and/or herd level.
1.6.
Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination.
1.7.
National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme.
1.8.
Any financial assistance provided to food and feed businesses in the context of the programme.
2.
Concerning food and feed businesses covered by the programme
2.1.
The structure of the production of the given species and products thereof.
2.2.
The structure of the production of feed.
2.3.
Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms.
—
hygiene management at farms,
—
measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and
—
hygiene in transporting animals to and from farms.
2.4.
Routine veterinary supervision of farms.
2.5.
Registration of farms.
2.6.
Record-keeping at farms.
2.7.
Documents to accompany animals when dispatched.
2.8.
Other relevant measures to ensure the traceability of animals.

1.
General

1.1.
A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes.

1.2.
The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme.

1.3.
Approved laboratories where samples collected within the programme are analysed.

1.4.
Methods used in the examination of the samples in the framework of the programme.

1.5.
Official controls (including sampling schemes) at feed, flock and/or herd level.

1.6.
Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination.

1.7.
National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme.

1.8.
Any financial assistance provided to food and feed businesses in the context of the programme.

2.
Concerning food and feed businesses covered by the programme

2.1.
The structure of the production of the given species and products thereof.

2.2.
The structure of the production of feed.

2.3.
Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms.
—
hygiene management at farms,
—
measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and
—
hygiene in transporting animals to and from farms.

—
hygiene management at farms,

—
measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and

—
hygiene in transporting animals to and from farms.

2.4.
Routine veterinary supervision of farms.

2.5.
Registration of farms.

2.6.
Record-keeping at farms.

2.7.
Documents to accompany animals when dispatched.

2.8.
Other relevant measures to ensure the traceability of animals.

1.
General

1.1.
A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes.

1.2.
The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme.

1.3.
Approved laboratories where samples collected within the programme are analysed.

1.4.
Methods used in the examination of the samples in the framework of the programme.

1.5.
Official controls (including sampling schemes) at feed, flock and/or herd level.

1.6.
Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination.

1.7.
National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme.

1.8.
Any financial assistance provided to food and feed businesses in the context of the programme.

2.
Concerning food and feed businesses covered by the programme

2.1.
The structure of the production of the given species and products thereof.

2.2.
The structure of the production of feed.

2.3.
Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms.
—
hygiene management at farms,
—
measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and
—
hygiene in transporting animals to and from farms.

—
hygiene management at farms,

—
measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and

—
hygiene in transporting animals to and from farms.

—
hygiene management at farms,

—
measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and

—
hygiene in transporting animals to and from farms.

2.4.
Routine veterinary supervision of farms.

2.5.
Registration of farms.

2.6.
Record-keeping at farms.

2.7.
Documents to accompany animals when dispatched.

2.8.
Other relevant measures to ensure the traceability of animals.

2.
Historical data on the epidemiological evolution of zoonotic salmonellosis specified in point 1(3):

3.
Description of the submitted programme(4):

First year:
Last year:

Control

Control
Control/eradication

Control/eradication


Control


Control/eradication

Testing

Testing
Testing

Testing


Testing


Testing

Slaughter of animals tested positive

Slaughter of animals tested positive
Slaughter of animals tested positive

Slaughter of animals tested positive


Slaughter of animals tested positive


Slaughter of animals tested positive

Killing of animals tested positive

Killing of animals tested positive
Killing of animals tested positive

Killing of animals tested positive


Killing of animals tested positive


Killing of animals tested positive

Vaccination

Vaccination
Extended slaughter or killing

Extended slaughter or killing


Vaccination


Extended slaughter or killing

Treatment of animal products

Treatment of animal products
Disposal of products

Disposal of products


Treatment of animal products


Disposal of products

Disposal of products

Disposal of products


Disposal of products

Monitoring or surveillance

Monitoring or surveillance


Monitoring or surveillance

Other measures(specify):

Other measures(specify):


Other measures(specify):


Control


Control/eradication


Testing


Testing


Slaughter of animals tested positive


Slaughter of animals tested positive


Killing of animals tested positive


Killing of animals tested positive


Vaccination


Extended slaughter or killing


Treatment of animal products


Disposal of products


Disposal of products


Monitoring or surveillance


Other measures(specify):

4.2.
Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme(5):

4.3.
Description and delimitation of the geographical and administrative areas in which the programme is to be implemented(6):

4.4.
Measures implemented under the programme(7)

4.4.1.
Measures and applicable legislation as regards the registration of holdings:

4.4.2.
Measures and applicable legislation as regards the identification of animals(8):

4.4.3.
Measures and applicable legislation as regards the notification of the disease:

4.4.4.
Measures and applicable legislation as regards the measures in case of a positive result(9):

4.4.5.
Measures and applicable legislation as regards the different qualifications of animals and herds:

4.4.6.
Control procedures and in particular rules on the movement of animals liable to be affected or contaminated by a given disease and the regular inspection of the holdings or areas concerned(10):

4.4.7.
Measures and applicable legislation as regards the control (testing, vaccination, etc.) of the disease:

4.4.8.
Measures and applicable legislation as regards the compensation for owners of slaughtered and killed animals:

4.4.9.
Information and assessment on bio-security measures management and infrastructure in place in the flocks/holdings involved.

5.
General description of the costs and benefits(11):

Year:Animal species:
Situation on date:Disease/infection(1):

Region(1)
Type of flock(2)
Total number of flocks(3)
Total number of animals
Total number of flocks under the programme
Total number of animals under the programme
Number of flocks checked(4)
Number of positive(5)flocks(1)
Number of flocks depopulated(1)
Total number of animals slaughtered or destroyed(1)
Quantity of eggs destroyed (number or kg)(1)
Quantity of eggs channelled to egg products (number or kg)(1)

(a1)
(a2)
(a3)
(a3)
(a4)
(a4)
(a3)
(a4)
(a3)
(a4)
(a3)

Total

Year:
Animal species(6):
Category(7):

Description of the used serological tests:Description of the used microbiological or virological tests:Description of the other used tests:

Region(8)
Serological tests
Microbiological or virological tests
Other tests

Number of samples tested(9)
Number of positive samples(10)
Number of samples tested(9)
Number of positive samples(10)
Number of samples tested(9)
Number of positive samples(10)

Total

Year:
Animal species(11):

Region(12)
Number of herds infected(13)
Number of animals infected

Total

Year:

Animal species:(14):

Description of the used vaccination

Region(15)
Total number of herds(16)
Total number of animals
Information on vaccination programme

Number of herds(16)in vaccination programme
Number of herds(16)vaccinated
Number of animals vaccinated
Number of doses of vaccine administered

Total

Animal species:(17):

Region(18)
Type of the test(19)
Target population(20)
Type of sample(21)
Objective(22)
Number of planned tests

Total

Year:Animal species:

Situation on date:infection(23):

Region(2)
Type of flock(24)
Total number of flocks(25)
Total number of animals
Total number of flocks under the programme
Total number of animals under the programme
Expected number of flocks to be checked(26)
Number of flocks(27)expected to be positive(23)
Number of flocks expected to be depopulated(23)
Total number of animals expected to be slaughtered or destroyed(23)
Expected quantity of eggs to be destroyed (number or kg)(23)
Expected quantity of eggs channelled to egg products (number or kg)(23)

(a1)
(a2)
(a3)
(a4)
(a3)
(a4)
(a3)
(a4)
(a3)
(a4)
(a3)

Total

Animal species:(28):

Region(29)
Total number of herds(30)in vaccination programme
Total number of animals in vaccination programme
Targets on vaccination programme

Number of herds(30)in vaccination programme
Number of herds(30)expected to be vaccinated
Number of animals expected to be vaccinated
Number of doses of vaccine expected to be administered

Total

Costs related to
Specification
Number of units
Unitary cost in EUR
Total amount in EUR
Community funding requested (yes/no)

1.Testing
1.
Testing

1.
Testing

1.1.Cost of the analysis
1.1.
Cost of the analysis
Test: Number of bacteriological tests (cultivation) planned to be carried out in the framework of official sampling

1.1.
Cost of the analysis

Test: Number of serotyping of relevant isolates tests planned to be carried out

1.2.Cost of sampling
1.2.
Cost of sampling

1.2.
Cost of sampling

1.3.Other costs
1.3.
Other costs

1.3.
Other costs

2.Vaccination or treatment of animal products
2.
Vaccination or treatment of animal products

2.
Vaccination or treatment of animal products

2.1.Purchase of vaccine/treatment of animal products
2.1.
Purchase of vaccine/treatment of animal products

2.1.
Purchase of vaccine/treatment of animal products

Number of purchase of vaccine doses planned if a vaccination policy is part of the programme as set out explicitly under point 4 of Annex II

2.2.Distribution costs
2.2.
Distribution costs

2.2.
Distribution costs

2.3.Administering costs
2.3.
Administering costs

2.3.
Administering costs

2.4.Control costs
2.4.
Control costs

2.4.
Control costs

3.Slaughter and destruction
3.
Slaughter and destruction

3.
Slaughter and destruction

3.1.Compensation of animals
3.1.
Compensation of animals

3.1.
Compensation of animals

3.2.Transport costs
3.2.
Transport costs

3.2.
Transport costs

3.3.Destruction costs
3.3.
Destruction costs

3.3.
Destruction costs

3.4.Loss in case of slaughtering
3.4.
Loss in case of slaughtering

3.4.
Loss in case of slaughtering

3.5.Costs from treatment of animal products (milk, eggs, hatching eggs, etc.)
3.5.
Costs from treatment of animal products (milk, eggs, hatching eggs, etc.)

3.5.
Costs from treatment of animal products (milk, eggs, hatching eggs, etc.)

4.Cleaning and disinfection
4.
Cleaning and disinfection

4.
Cleaning and disinfection

5.Salaries (staff contracted for the programme only)
5.
Salaries (staff contracted for the programme only)

5.
Salaries (staff contracted for the programme only)

6.Consumables and specific equipment
6.
Consumables and specific equipment

6.
Consumables and specific equipment

7.Other costs
7.
Other costs

7.
Other costs

Total

1.
Testing

1.1.
Cost of the analysis

1.2.
Cost of sampling

1.3.
Other costs

2.
Vaccination or treatment of animal products

2.1.
Purchase of vaccine/treatment of animal products

2.2.
Distribution costs

2.3.
Administering costs

2.4.
Control costs

3.
Slaughter and destruction

3.1.
Compensation of animals

3.2.
Transport costs

3.3.
Destruction costs

3.4.
Loss in case of slaughtering

3.5.
Costs from treatment of animal products (milk, eggs, hatching eggs, etc.)

4.
Cleaning and disinfection

5.
Salaries (staff contracted for the programme only)

6.
Consumables and specific equipment

7.
Other costs

(a1)
Region as defined in the approved control and eradication programme of the Member State.

(a1)
Region as defined in the approved control and eradication programme of the Member State.

4.1.
Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme:

4.2.
Description and delimitation of the geographical and administrative areas in which the programme is to be applied:

4.3.
System in place for the registration of holdings:

4.4.
System in place for the identification of animals:

4.5.
Measures in place as regards the notification of the disease:

Estimated number of tests

Animals referred to in Annex III, Chapter A, Part I, points 2.1, 3 and 4 of Regulation (EC) No 999/2001 of the European Parliament and of the Council(3)

Animals referred to in Annex III, Chapter A, Part I, point 2.2 of Regulation (EC) No 999/2001

Others (specify)

Estimated number of tests

Ovine animals referred to in Annex III, Chapter A, Part II, point 2 of Regulation (EC) No 999/2001

Ovine animals referred to in Annex III, Chapter A, Part II, point 3 of Regulation (EC) No 999/2001

Ovine animals referred to in Annex III, Chapter A, Part II, point 5 of Regulation (EC) No 999/2001

Ovine animals referred to in Annex VII, Chapter A, point 3.4(d) of Regulation (EC) No 999/2001

Ovine animals referred to in Annex VII, Chapter A, point 5(b)(ii) of Regulation (EC) No 999/2001

Others (specify other animal species referred to in Annex III, Chapter A, Part III of Regulation (EC) No 999/2001

Estimated number of tests

Caprine animals referred to in Annex III, Chapter A, Part II, point 2 of Regulation (EC) No 999/2001

Caprine animals referred to in Annex III, Chapter A, Part II, point 3 of Regulation (EC) No 999/2001

Caprine animals referred to in Annex III, Chapter A, Part II, point 5 of Regulation (EC) No 999/2001

Caprine animals referred to in Annex VII, Chapter A, point 3.3(c) of Regulation (EC) No 999/2001

Caprine animals referred to in Annex VII, Chapter A, point 5(b)(ii) of Regulation (EC) No 999/2001

Others (specify)

Estimated number of tests

Primary molecular testing referred to in Annex X, Chapter C, point 3.2(c)(i) of Regulation (EC) No 999/2001

Estimated number of tests

Animals referred to in Annex III, Chapter A, Part II, point 8.1 of Regulation (EC) No 999/2001

Animals referred to in Annex III, Chapter A, Part II, point 8.2 of Regulation (EC) No 999/2001

Estimated number

Animals to be killed under the requirements of Annex VII, Chapter A, point 2.1 of Regulation (EC) No 999/2001:

4.7.2.1.
Description:

Estimated number

Animals to be killed under the requirements of Annex VII, Chapter A, point 2.3 of Regulation (EC) No 999/2001:

Animals to be genotyped under the requirements of Annex VII, Chapter A, point 2.3 of Regulation (EC) No 999/2001:

4.7.3.1.
General description(4):

Estimated number

Ewes to be genotyped under the framework of a breeding programme referred to in Article 6a of Regulation (EC) No 999/2001

Rams to be genotyped under the framework of a breeding programme referred to in Article 6a of Regulation (EC) No 999/2001

5.1.
Detailed analysis of the costs:

Costs related to
Specification
Number of units
Unitary cost in EUR
Total amount in EUR
Community funding requested (yes/no)

1.
BSE testing(5)

1.1.
Rapid tests
Test:

Test:

Test:

Test:

2.
Scrapie testing(6)

2.1.
Rapid tests
Test:

Test:

Test:

3.
Discriminatory testing(7)

3.1.
Primary molecular tests
Test:

Test:

4.
Genotyping

4.1.
Determination of genotype of animals in the framework of the monitoring and eradication measures laid down by Regulation (EC) No 999/2001(8)
Method

4.2.
Determination of genotype of animals in the framework of a breeding programme(9)
Method

5.
Compulsory slaughter

5.1.
Compensation for bovine animals to be killed/slaughtered under the requirements of Annex VII, Chapter A, point 2.1 of Regulation (EC) No 999/2001

5.2.
Compensation for ovine and caprine animals to be killed/slaughtered under the requirements of Annex VII, Chapter A, point 2.3 of Regulation (EC)No 999/2001

Total

NUTS (2) code(2)
Total number of holdings(3)
Total number of holdings to be sampled
Number of samples per holding
Total number of tests to be performed per method
Methods of laboratory analysis

Total

NUTS 2 code(5)
Total number of duck and geese holdings
Total number of duck and geese holdings to be sampled
Number of samples per holding
Total number of tests to be performed per method
Methods of laboratory analysis

Total

NUTS (2) code/region(6)
Wild birds to be sampled(7)
Total number of birds to be sampled
Estimated total number of samples to be taken for active surveillance
Estimated total number of samples to be taken for passive surveillance

Total

4.1.1.
Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme

4.1.2.
System in place for the registration of holdings

4.1.3.
Data on vaccination carried out

5.1.1.
Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme

5.1.2.
Description and delimitation of the geographical and administrative areas in which the programme is to be applied

5.1.3.
Estimation of the local and/or migratory wildlife population

7.1.1.
Poultry

7.1.2.
Wild birds

Measures eligible for co-financing surveillance in poultry

Methods of laboratory analysis
Number of tests to perform per method
Unitary test cost (per method)
Total cost

Serological pre-screening(2)

Haemagglutination-inhibition-test (HI) for H5/H7(3)

Virus isolation test

PCR test

Other measures to be covered
Specify activities

Sampling

Others

Total

Measures eligible for co-financing surveillance wild birds

Methods of laboratory analysis
Number tests to perform per method
Unitary test cost (per method)
Total cost

Serological pre-screening

Haemagglutination-inhibition-test (HI) for H5/H7

Virus isolation test

PCR test

Other measures to be covered
Specify activities

Sampling

Others

Total

Requirements/information needed
Information/further explanation and justification

1.
Identification of the programme

1.1.
Declaring Member State

1.2.
Competent authority (address, fax, e-mail)

1.3.
Reference of this document

1.4.
Date sent to the Commission

2.
Type of communication

2.1.
Application for eradication programme

Application for eradication programme


Application for eradication programme

3.
National legislation(1)

4.
Request for co-finance

4.1.
Indicate the year(s) for which co-finance is requested

4.2.
Agreement of the managing authority of the operational programme(2)(signature and stamp)

5.
Diseases

5.1.
Fish
VHSIHNSVCISAKHV

VHS

IHN

SVC

ISA

KHV


VHS


IHN


SVC


ISA


KHV

5.2.
Molluscs
Marteilia refringensBonamia ostrae

Marteilia refringens

Bonamia ostrae


Marteilia refringens


Bonamia ostrae

5.3.
Crustaceans
White spot disease

White spot disease


White spot disease

6.
General information on the programmes

6.1.
Competent Authority(3)

6.2.
Organisation, supervision of all stakeholders involved in the programme(4)

6.3.
An overview of the structure of the aquaculture industry in the area in question including types of production, species kept etc.

6.4.
Notification to the competent authority of suspicion and confirmation of the disease(s) in question has been compulsory since when?

6.5.
Early detection system in place throughout the Member States, enabling the competent authority to undertake effective disease investigation and reporting since when?(5)

6.6.
Source of aquaculture animals of susceptible species to the disease in question entering in the Member State, zone or compartments for farming

6.7.
Guidelines on good hygiene practice(6)

6.8.
Epidemiological situation of the disease in at least the previous four years before the commencement of the programme(7)

6.9.
Estimated costs and the anticipated benefits of the programme.(8)

6.10.
Description of the submitted programme(9)

6.11.
Duration of the programme

7.
Area covered(10)

7.1.
Member State

Member State


Member State

7.2.
Zone (entire water catchment area)(11)

Zone (entire water catchment area)(11)


Zone (entire water catchment area)(11)

7.3.
Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area.

Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area.


Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area.

7.4.
Zone (more than one water catchment area)(13)

Zone (more than one water catchment area)(13)


Zone (more than one water catchment area)(13)

7.5.
Compartment independent on the surrounding health status(14)

Compartment independent on the surrounding health status(14)


Compartment independent on the surrounding health status(14)

Identify and describe for each farm the water supply(15)
Well, borehole or springWater treatment plant inactivating the relevant pathogen(16)

Well, borehole or spring

Water treatment plant inactivating the relevant pathogen(16)


Well, borehole or spring


Water treatment plant inactivating the relevant pathogen(16)

Identify and describe for each farm natural or artificial barriers and justify its capability to prevent that aquatic animals enter each farm in a compartment from the surrounding watercourses.

Identify and describe for each farm the protection against flooding and infiltration of water form the surrounding

7.6.
Compartment dependent on the surrounding health status(17)

Compartment dependent on the surrounding health status(17)


Compartment dependent on the surrounding health status(17)

One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18)

One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18)


One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18)

All farms comprising the compartment fall within a common biosecurity system.(19)

All farms comprising the compartment fall within a common biosecurity system.(19)


All farms comprising the compartment fall within a common biosecurity system.(19)

Any additional requirements(20)

Any additional requirements(20)


Any additional requirements(20)

7.7.
Farms or mollusc farming areas covered by the programme (registration numbers and geographical situation)

8.
Measures of the submitted programme

8.1.
Summary of the measures under the programme

First yearTestingHarvesting for human consumption or further processingImmediateDelayedRemoval and disposalImmediateDelayedVaccinationOther measures (specify)

Testing

Harvesting for human consumption or further processingImmediateDelayed

Immediate

Delayed

Removal and disposalImmediateDelayed

Immediate

Delayed

Vaccination

Other measures (specify)
Last yearTestingHarvesting for human consumption or further processingImmediateDelayedRemoval and disposalImmediateDelayedOther measures (specify)

Testing

Harvesting for human consumption or further processingImmediateDelayed

Immediate

Delayed

Removal and disposalImmediateDelayed

Immediate

Delayed

Other measures (specify)


Testing


Harvesting for human consumption or further processingImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Removal and disposalImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Vaccination


Other measures (specify)


Testing


Harvesting for human consumption or further processingImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Removal and disposalImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Other measures (specify)

8.2.
Description of the measures of the programme(21)

Target population/species

Used tests and sampling schemes. Laboratories involved in the programme(22).

Rules on movements of animals

Used vaccines and vaccination schemes

Measures in case of a positive result(23)

Compensation scheme for owners

Control and supervision on the implementation of the programme and reporting


Application for eradication programme


VHS


IHN


SVC


ISA


KHV


Marteilia refringens


Bonamia ostrae


White spot disease


Member State


Zone (entire water catchment area)(11)


Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area.


Zone (more than one water catchment area)(13)


Compartment independent on the surrounding health status(14)


Well, borehole or spring


Water treatment plant inactivating the relevant pathogen(16)


Compartment dependent on the surrounding health status(17)


One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18)


All farms comprising the compartment fall within a common biosecurity system.(19)


Any additional requirements(20)


Testing


Harvesting for human consumption or further processingImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Immediate


Delayed


Removal and disposalImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Immediate


Delayed


Vaccination


Other measures (specify)


Testing


Harvesting for human consumption or further processingImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Immediate


Delayed


Removal and disposalImmediateDelayed

Immediate

Delayed


Immediate


Delayed


Immediate


Delayed


Other measures (specify)

Disease:
Year

Farm or mollusc farming area
Number of samplings
Number of clinical inspections
Water temperature at sampling/inspection
Species at sampling
Species sampled
Number of animals sampled (total and by species)
Number of tests
Positive results of laboratorial examination
Positive results of clinical inspections

Total

Disease:
Year

Member State, zone or compartment(2)
Total number of farms or mollusc farming areas(3)
Total number farms or mollusc farming areas under the programme
Number of farms or mollusc farming areas checked(4)
Number of positive farms or mollusc farming areas(5)
Number of new positive farms or mollusc farming areas(6)
Number of farms or mollusc farming areas depopulated
% positive farms or mollusc farming areas depopulated
Animals removed and disposed of(7)
Target indicators

% farms or mollusc farming areas coverage
% positive farms or mollusc farming areasperiod farms or mollusc farming areas prevalence
% new positive farms or mollusc farming areasfarms or mollusc farming areas incidence

1
2
3
4
5
6
7
8 =
9
10 =
11 = (5/4)×100
12 = (6/4)×100

Total

Disease:
Year

Farm or mollusc farming area
Number of samplings
Number of clinical inspections
Water temperature at sampling/Inspection
Species at sampling
Species sampled
Number of animals sampled (total and by species)
Number of tests

Total

Disease:
Year

Member State, zone or compartment(9)
Total number of farms or mollusc farming areas(10)
Total number farms or mollusc farming areas under the programme
Number of farms or mollusc farming areas expected to be checked(11)
Number of expected positive farms or mollusc farming areas(12)
Number of expected new positive farms or mollusc farming areas(13)
Number of farms or mollusc farming areas expected to be depopulated
% positive farms or mollusc farming areas expected to be depopulated
Target indicators

Expected % farms or mollusc farming areas coverage
% positive farms or mollusc farming areasExpected period farms or mollusc farming areas prevalence
% new positive farms or mollusc farming areasExpected farms or mollusc farming areas incidence

1
2
3
4
5
6
7
8 = (7/5)×100
9 = (4/3)×100
10 = (5/4)×100
11 = (6/4)×100

Total

Costs related to
Specification
Number of units
Unitary cost in EUR
Total amount in EUR
Community(24)funding requested (yes/no)

1.
Testing

1.1.
Cost of the analysis
Test:

Test:

Test:

1.2.
Cost of sampling

1.3.
Other costs

2.
Vaccination or treatment

2.1.
Purchase of vaccine/treatment

2.2.
Distribution costs

2.3.
Administering costs

2.4.
Control costs

3.
Removal and disposal of the aquaculture animals

3.1.
Compensation of animals

3.2.
Transport costs

3.3.
Disposal costs

3.4.
Loss in case of removal

3.5.
Costs from treatment of products

4.
Cleansing and disinfection

5.
Salaries (staff contracted for the programme only)

6.
Consumables and specific equipment

7.
Other costs

Total

(a)
broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians of aquatic animals health specialists in detecting and reporting unusual disease occurrence;

(b)
veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence;

(c)
access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.

(a)
through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or

(b)
directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(1), and in particular Article 24(10) thereof,

(1) Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards the programmes for the eradication, control and monitoring of animal diseases and zoonoses. Pursuant to that Decision, a Community financial measure is to be introduced to reimburse the expenditure incurred by the Member States for the financing of national programmes for the eradication, control and monitoring of the animal diseases and zoonoses listed in the Annex to that Decision.

(2) Decision 90/424/EEC provides that each year, by 30 April at the latest, Member States are to submit to the Commission the annual or multi-annual programmes starting in the following year for which they wish to receive a financial contribution from the Community.

(3) Based on Article 3 of Decision 90/424/EEC, as amended by Decision 2006/965/EC, programmes for Enzootic bovine leucosis (EBL) and Aujeszky’s disease may be funded until 31 December 2010.

(4) Commission Decision 2004/450/EC of 29 April 2004 laying down standard requirements for the content of applications for Community financing for programmes for the eradication, monitoring and control of animal diseases(2)provides that Member States seeking a financial contribution from the Community for programmes for the eradication, monitoring and control of certain animal diseases are to submit applications containing certain information set out in that Decision.

(5) Commission Decision 2008/341/EC of 25 April 2008 laying down Community criteria for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses(3)lays down criteria to be fulfilled by the national programmes in order to be approved by the Commission under the Community financial measure provided for in Article 24(1) of Decision 90/424/EEC.

(6) Following the adoption of Decision 2008/341/EC and in order to further improve the process of submission, approval and assessment of progress during the implementation of the programmes, the standard requirements for the applications by Member States for Community financing for national programmes should be updated and made consistent with those criteria. For the sake of clarity, Decision 2004/450/EC should be repealed and replaced by this Decision.

(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1

Member States seeking a financial contribution from the Community for national programmes for the eradication, control and monitoring of animal diseases and zoonoses listed in the Annex to Decision 90/424/EEC shall submit applications containing at least the information set out in:

(a)

—

bovine tuberculosis,

—

bovine brucellosis,

—

ovine and caprine brucellosis (B. melitensis),

—

bluetongue in endemic or high risk areas,

—

African swine fever,

—

swine vesicular disease,

—

classical swine fever,

—

anthrax,

—

contagious bovine pleuropneumonia,

—

rabies,

—

echinococcosis,

—

trichinellosis,

—

verotoxigenicE. coli,

—

enzootic bovine leucosis (EBL) and Aujeszky’s disease;

(b)

Annex II to this Decision in respect of salmonellosis (zoonotic salmonella);

(c)

Annex III to this Decision in respect of transmissible spongiform encephalopathies (TSE) (bovine spongiform encephalopathy (BSE), scrapie and chronic waste disease (CWD);

(d)

Annex IV to this Decision in respect of avian influenza in poultry and wild birds;

(e)

—

infectious haematopoietic necrosis,

—

infectious salmon anaemia,

—

spring viraemia of carp (SVC),

—

viral haemorrhagic septicæmia (VHS),

—

koi herpes virus infection (KHV),

—

infection withBonamia ostreae,

—

infection withMarteilia refringens,

—

white spot disease in crustaceans.
Article 2

Decision 2004/450/EC is repealed.
Article 3

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(1), and in particular Article 24(10) thereof,

(1) Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards the programmes for the eradication, control and monitoring of animal diseases and zoonoses. Pursuant to that Decision, a Community financial measure is to be introduced to reimburse the expenditure incurred by the Member States for the financing of national programmes for the eradication, control and monitoring of the animal diseases and zoonoses listed in the Annex to that Decision.

(2) Decision 90/424/EEC provides that each year, by 30 April at the latest, Member States are to submit to the Commission the annual or multi-annual programmes starting in the following year for which they wish to receive a financial contribution from the Community.

(3) Based on Article 3 of Decision 90/424/EEC, as amended by Decision 2006/965/EC, programmes for Enzootic bovine leucosis (EBL) and Aujeszky’s disease may be funded until 31 December 2010.

(4) Commission Decision 2004/450/EC of 29 April 2004 laying down standard requirements for the content of applications for Community financing for programmes for the eradication, monitoring and control of animal diseases(2)provides that Member States seeking a financial contribution from the Community for programmes for the eradication, monitoring and control of certain animal diseases are to submit applications containing certain information set out in that Decision.

(5) Commission Decision 2008/341/EC of 25 April 2008 laying down Community criteria for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses(3)lays down criteria to be fulfilled by the national programmes in order to be approved by the Commission under the Community financial measure provided for in Article 24(1) of Decision 90/424/EEC.

(6) Following the adoption of Decision 2008/341/EC and in order to further improve the process of submission, approval and assessment of progress during the implementation of the programmes, the standard requirements for the applications by Member States for Community financing for national programmes should be updated and made consistent with those criteria. For the sake of clarity, Decision 2004/450/EC should be repealed and replaced by this Decision.

(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Member States seeking a financial contribution from the Community for national programmes for the eradication, control and monitoring of animal diseases and zoonoses listed in the Annex to Decision 90/424/EEC shall submit applications containing at least the information set out in:

(a)

—

bovine tuberculosis,

—

bovine brucellosis,

—

ovine and caprine brucellosis (B. melitensis),

—

bluetongue in endemic or high risk areas,

—

African swine fever,

—

swine vesicular disease,

—

classical swine fever,

—

anthrax,

—

contagious bovine pleuropneumonia,

—

rabies,

—

echinococcosis,

—

trichinellosis,

—

verotoxigenicE. coli,

—

enzootic bovine leucosis (EBL) and Aujeszky’s disease;

(b)

Annex II to this Decision in respect of salmonellosis (zoonotic salmonella);

(c)

Annex III to this Decision in respect of transmissible spongiform encephalopathies (TSE) (bovine spongiform encephalopathy (BSE), scrapie and chronic waste disease (CWD);

(d)

Annex IV to this Decision in respect of avian influenza in poultry and wild birds;

(e)

—

infectious haematopoietic necrosis,

—

infectious salmon anaemia,

—

spring viraemia of carp (SVC),

—

viral haemorrhagic septicæmia (VHS),

—

koi herpes virus infection (KHV),

—

infection withBonamia ostreae,

—

infection withMarteilia refringens,

—

white spot disease in crustaceans.
Decision 2004/450/EC is repealed.
This Decision is addressed to the Member States.
1.   Identification of the programmeANNEX IStandard requirements for the submission of national programmes for the eradication, control and monitoring of the animal diseases or zoonoses referred to in Article 1(a)                 (1) Member State:

Disease(s)(2):

Request of Community co-financing for(3):

Reference of this document:

Contact (name, phone, fax, e-mail):

Date sent to the Commission:
 | 2. | Historical data on the epidemiological evolution of the disease(s)(4):

 | 3. | Description of the submitted programme(5):4.   Measures of the submitted programme4.1.   Summary of measures under the programme

First year: | Last year:

Control |  | Control | Eradication |  | Eradication

 | Control

 | Eradication

Testing |  | Testing | Testing |  | Testing

 | Testing

 | Testing

Slaughter of animals tested positive |  | Slaughter of animals tested positive | Slaughter of positive animals tested |  | Slaughter of positive animals tested

 | Slaughter of animals tested positive

 | Slaughter of positive animals tested

Killing of animals tested positive |  | Killing of animals tested positive | Killing of animals tested positive |  | Killing of animals tested positive

 | Killing of animals tested positive

 | Killing of animals tested positive

Vaccination |  | Vaccination | Extended slaughter or killing |  | Extended slaughter or killing

 | Vaccination

 | Extended slaughter or killing

Treatment |  | Treatment | Disposal of products |  | Disposal of products

 | Treatment

 | Disposal of products

Disposal of products |  | Disposal of products | 

 | Disposal of products

Eradication, control or monitoring. |  | Eradication, control or monitoring. | Other measures(specify): |  | Other measures(specify):

 | Eradication, control or monitoring.

 | Other measures(specify):

 | 4.2. | Organisation, supervision and role of all stakeholders(6)involved in the programme:

 | 4.3. | Description and demarcation of the geographical and administrative areas in which the programme is to be implemented(7):4.4.   Description of the measures of the programme

                            (8) :

 | 4.4.1. | Notification of the disease:

 | 4.4.2. | Target animals and animal population:

 | 4.4.3. | Identification of animals and registration of holdings:

 | 4.4.4. | Qualifications of animals and herds(9):

 | 4.4.5. | Rules on the movement of animals:

 | 4.4.6. | Tests used and sampling schemes:

 | 4.4.7. | Vaccines used and vaccination schemes:

 | 4.4.8. | Information and assessment on bio-security measures management and infrastructure) in place in the holdings involved:

 | 4.4.9. | Measures in case of a positive result(10):

 | 4.4.10. | Compensation scheme for owners of slaughtered and killed animals:

 | 4.4.11. | Control on the implementation of the programme and reporting:

 | 5. | Benefits of the programme(11):6.   Data on the epidemiological evolution during the last five years

                         (12) 6.1.   Evolution of the disease

                            (13) 6.1.1.   Data on herds (1) (one table per year and per disease/species)

Year:Disease(2): |  | Situation on date:Animal species: |  |  |  | 

Region(3) | Total number of herds(4) | Total number of herds under the programme | Number of herds checked(5) | Number of positive herds(6) | Number of new positive herds(7) | Number of herds depopulated | % positive herds depopulated | Indicators

% herd coverage | % positive herdsPeriod herd prevalence | % new positive herdsHerd incidence

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5)×100 | 9 = (4/3)×100 | 10 = (5/4)×100 | 11 = (6/4)×100

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  | 6.1.2.   Data on animals (one table per year and per disease/species)

Year:Disease(8): |  | Situation on date:Animal species: |  |  | 

Region(9) | Total number of animals(10) | Number of animals(11)to be tested under the programme | Number of animals(11)tested | Number of animals tested individually(12) | Number of positive animals | Slaughtering | Indicators

Number of animals with positive result slaughtered or culled | Total number of animals slaughtered(13) | % coverage at animal level | % positive animalsAnimal prevalence

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9=(4/3)×100 | 10=(6/4)×100

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  | 6.2.   Stratified data on surveillance and laboratory tests6.2.1.   Stratified data on surveillance and laboratory tests (one table per year and per disease/species)

Year: | Disease(14): | Animal species/category: | 

Description of the used serological tests:Description of the used microbiological or virological tests:Description of the other used tests:

Region(15) | Serological tests | Microbiological or virological tests | Other tests

Number of samples tested(16) | Number of positive samples(17) | Number of samples tested(16) | Number of positive samples(17) | Number of samples tested(16) | Number of positive samples(17)

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total |  |  |  |  |  | 6.3.   Data on infection (one table per year and per disease/species)

Year: | Disease(18): | Animal species: | 

Region(19) | Number of herds infected(20) | Number of animals infected

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

Total |  | 6.4.   Data on the status of herds at the end of each year

                            (14) 

Year: | Disease(21): | Animal species: | 

Region(22) | Status of herds and animals under the programme(23)

Total number of herds and animals under the programme | Unknown(24) | Not free or not officially free from disease | Free or officially free from disease status suspended(27) | Free from disease(28) | Officially free from disease(29)

Last check positive(25) | Last check negative(26)

Herds | Animals(30) | Herds | Animals(30) | Herds | Animals(30) | Herds | Animals(30) | Herds | Animals(30) | Herds | Animals(30) | Herds | Animals(30)

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  |  |  |  |  | 6.5.   Data on vaccination or treatment programmes

                            (15) 

Year: | Disease(31): | Animal species: |  |  | 

Description of the used vaccination, therapeutic or other scheme:

Region(32) | Total number of herds(33) | Total number of animals | Information on vaccination or treatment programme

Number of herds(33)in vaccination or treatment programme | Number of herds(33)vaccinated or treated | Number of animals vaccinated or treated | Number of doses of vaccine or treatment administered | Number of adults(34)vaccinated | Number of young(34)animals vaccinated

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  | 6.6.   Data on wildlife

                            (16) 6.6.1.   Estimation of wildlife population

Year: | Method of estimation(35): |  |  | 

Regions(36) | Estimation of the population of the concerned wild species

Species: | Species: | Species: | Species:

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

Total |  |  |  | 6.6.2.   Monitoring of wildlife (one table per year and per disease/species)

Year: | Disease(37): | Animal species: | 

Description of the used serological tests:Description of the used microbiological or virological tests:Description of the other used tests:

Region(38) | Microbiological or virological tests | Serological tests | Other tests

Number of samples tested | Number of positive samples | Number of samples tested | Number of positive samples | Number of samples tested | Number of positive samples

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total |  |  |  |  |  | 6.6.3.   Data on vaccination or treatment of wildlife

Year: |  | Disease(39): |  | Animal species: |  | 

Description of the used vaccination, therapeutic or other scheme:

Region(40) | Square km | Vaccination or treatment programme

Number of doses of vaccine or treatment to be administered | Number of campaigns | Total number of doses of vaccine or treatment administered

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

Total |  |  |  | 7.   Targets7.1.   Targets related to testing (one table for each year of implementation)7.1.1.   Targets on diagnostic tests

Disease(41): | Animal species: |  |  |  | 

Region(42) | Type of the test(43) | Target population(44) | Type of sample(45) | Objective(46) | Number of planned tests

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Total | 7.1.2.   Targets on testing herds and animals (17) 7.1.2.1.   Targets on the testing of herds (47) 

Disease(48): |  | Animal species: |  |  |  |  | 

Region(49) | Total number of herds(50) | Total number of herds under the programme | Number of herds expected to be checked(51) | Number of expected positive herds(52) | Number of expected new positive herds(53) | Number of herds expected to be depopulated | % positive herds expected to be depopulated | Target indicators

Expected % herd coverage | % positive herdsExpected period herd prevalence | % new positive herdsExpected herd incidence

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5)×100 | 9 = (4/3)×100 | 10 = (5/4)×100 | 11 = (6/4)×100

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  | 7.1.2.2.   Targets on the testing of animals

Disease(54): |  | Animal species: |  |  |  | 

Region(55) | Total number of animals(56) | Number of animals(57)under the programme | Number of animals(57)expected to be tested | Number of animals to be tested individually(58) | Number of expected positive animals | Slaughtering | Target indicators

Number of animals with positive result expected to be slaughtered or culled | Total number of animals expected to be slaughtered(59) | Expected % coverage at animal level | % positive animals (Expected animal prevalence)

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9=(4/3)×100 | 10=(6/4)×100

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  | 7.2.   Targets on qualification of herds and animals

                            (18)  (one table for each year of implementation)

Disease(60): |  | Animal species: |  |  |  |  |  |  |  |  |  | 

Region(61) | Total number of herds and animals under the programme | Targets on the status of herds and animals under the programme(62)

Expected unknown(63) | Expected not free or not officially free from disease | Expected free or officially free from disease status suspended(66) | Expected free from disease(67) | Expected officially free from disease(68)

Last check positive(64) | Last check negative(65)

Herds | Animals(69) | Herds | Animals(69) | Herds | Animals(69) | Herds | Animals(69) | Herds | Animals(69) | Herds | Animals(69) | Herds | Animals(69)

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  |  |  |  |  | 7.3.   Targets on vaccination or treatment (one table for each year of implementation)7.3.1.   Targets on vaccination or treatment (19) 

Disease(70): |  | Animal species: |  |  |  |  | 

Region(71) | Total number of herds(72)in vaccination or treatment programme | Total number of animals in vaccination or treatment programme | Targets on vaccination or treatment programme

Number of herds(72)in vaccination or treatment programme | Number of herds(72)expected to be vaccinated or treated | Number of animals expected to be vaccinated or treated | Number of doses of vaccine or treatment expected to be administered | Number of adults(73)expected to be vaccinated | Number of young(73)animals expected to be vaccinated

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  | 7.3.2.   Targets on vaccination or treatment (20) of wildlife

Disease(74): | Animal species: | 

Region(75) | Square km | Targets on the vaccination or treatment programme

Number of doses of vaccine or treatments expected to be administered in the campaign | Expected number of campaigns | Total number of doses of vaccine or treatment expected to be administered

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

Total |  |  |  | 8.   Detailed analysis of the cost of the programme (one table per year of implementation)

Costs related to | Specification | Number of units | Unitary cost in EUR | Total amount in EUR | Community funding requested (yes/no)

1.Testing | 1. | Testing |  |  |  |  | 

1. | Testing

1.1.Cost of the analysis | 1.1. | Cost of the analysis | Test: |  |  |  | 

1.1. | Cost of the analysis

 | Test: |  |  |  | 

 | Test: |  |  |  | 

1.2.Cost of sampling | 1.2. | Cost of sampling |  |  |  |  | 

1.2. | Cost of sampling

1.3.Other costs | 1.3. | Other costs |  |  |  |  | 

1.3. | Other costs

2.Vaccination or treatment | 2. | Vaccination or treatment |  |  |  |  | 

2. | Vaccination or treatment

2.1.Purchase of vaccine/treatment | 2.1. | Purchase of vaccine/treatment |  |  |  |  | 

2.1. | Purchase of vaccine/treatment

2.2.Distribution costs | 2.2. | Distribution costs |  |  |  |  | 

2.2. | Distribution costs

2.3.Administering costs | 2.3. | Administering costs |  |  |  |  | 

2.3. | Administering costs

2.4.Control costs | 2.4. | Control costs |  |  |  |  | 

2.4. | Control costs

3.Slaughter and destruction | 3. | Slaughter and destruction |  |  |  |  | 

3. | Slaughter and destruction

3.1.Compensation of animals | 3.1. | Compensation of animals |  |  |  |  | 

3.1. | Compensation of animals

3.2.Transport costs | 3.2. | Transport costs |  |  |  |  | 

3.2. | Transport costs

3.3.Destruction costs | 3.3. | Destruction costs |  |  |  |  | 

3.3. | Destruction costs

3.4.Loss in case of slaughtering | 3.4. | Loss in case of slaughtering |  |  |  |  | 

3.4. | Loss in case of slaughtering

3.5.Costs from treatment of products (milk, eggs, hatching eggs, etc.) | 3.5. | Costs from treatment of products (milk, eggs, hatching eggs, etc.) |  |  |  |  | 

3.5. | Costs from treatment of products (milk, eggs, hatching eggs, etc.)

4.Cleaning and disinfection | 4. | Cleaning and disinfection |  |  |  |  | 

4. | Cleaning and disinfection

 |  |  |  |  | 

 |  |  |  |  | 

5.Salaries (staff contracted for the programme only) | 5. | Salaries (staff contracted for the programme only) |  |  |  |  | 

5. | Salaries (staff contracted for the programme only)

 |  |  |  |  | 

 |  |  |  |  | 

6.Consumables and specific equipment | 6. | Consumables and specific equipment |  |  |  |  | 

6. | Consumables and specific equipment

 |  |  |  |  | 

 |  |  |  |  | 

7.Other costs | 7. | Other costs |  |  |  |  | 

7. | Other costs

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Total |  | 

(1)  In the case of the second and subsequent years of a multi-annual programme that has already been approved by a Commission Decision, only section 1, section 7 and section 8 need to be completed.

(2)  One document per disease is used unless all measures of the programme on the target population are used for the monitoring, control and eradication of different diseases.

(3)  Indicate the year(s) for which co-financing is requested.

(4)  A concise description is given with data on the target population (species, number of herds and animals present and under the programme), the main measures (testing, testing and slaughter, testing and killing, qualification of herds and animals, vaccination) and the main results (incidence, prevalence, qualification of herds and animals). The information is given for distinct periods if the measures were substantially modified. The information is documented by relevant summary epidemiological tables, graphs or maps.

(5)  A concise description of the programme is given with the main objective(s) (monitoring, control, eradication, qualification of herds and/or regions, reducing prevalence and incidence), the main measures (testing, testing and slaughter, testing and killing, qualification of herds and animals, vaccination), the target animal population and the area(s) of implementation and the definition of a positive case.

(6)  Describe the authorities in charge of supervising and coordinating the departments responsible for implementing the programme and the different operators involved. Describe the responsibilities of all involved.

(7)  Describe the name and denomination, the administrative boundaries, and the surface of the administrative and geographical areas in which the programme is to be applied. Illustrate with maps.

(8)  A comprehensive description needs to be provided of all measures unless reference can be made to Community legislation. The national legislation in which the measures are laid down is mentioned.

(9)  To mention only if applicable.

(10)  A short description is provided of the measures as regards positive animals (slaughter, destination of carcasses, use or treatment of animal products, the destruction of all products which could transmit the disease or the treatment of such products to avoid any possible contamination, a procedure for the disinfection of infected holdings, the therapeutic or preventive treatment chosen, a procedure for the restocking with healthy animals of holdings which have been depopulated by slaughter and the creation of a surveillance zone around the infected holding,).

(11)  A description is provided of the benefits for farmers and society in general.

(12)  The data on the evolution of the disease are provided according to the tables below where appropriate.

(13)  No data to provide in case of rabies.

(1)  Herds or flocks or holdings as appropriate.

(2)  Disease and animal species if necessary.

(3)  Region as defined in the eradication programme of the Member State.

(4)  Total number of herds existing in the region including eligible herds and non-eligible herds for the programme.

(5)  Check means to perform a herd level test under the programme for the respective disease with the purpose of maintaining or upgrading, the health status of the herd. In this column a herd must not be counted twice even if has been checked more than once.

(6)  Herds with at least one positive animal during the period independent of the number of times the herd has been checked.

(7)  Herds which status in the previous period was Unknown, Not free-negative, Free, Officially Free or Suspended and have at least one animal tested positive in this period.

(8)  Disease and animal species if necessary.

(9)  Region as defined in the approved eradication programme of the Member State.

(10)  Total number of animals existing in the region including eligible herds and non-eligible herds for the programme.

(11)  Includes animals tested individually or under bulk level scheme.

(12)  Include only animals tested individually, do not include animals tested by bulk level samples (for instance: milk bulk tank tests).

(13)  Include all positive animal slaughtered and also the negative animals slaughtered under the programme.

(14)  Disease and animal species if necessary.

(15)  Region as defined in the approved eradication programme of the Member State.

(16)  Number of samples tested.

(17)  Number of positive samples.

(18)  Disease and animal species if necessary.

(19)  Region as defined in the eradication programme of the Member State.

(20)  Herds or flocks or holdings as appropriate.

(14)  Only data to provide for bovine tuberculosis, bovine brucellosis, ovine and caprine brucellosis (B. melitensis), enzootic bovine leucosis (EBL) and Aujesky’s disease.

(21)  Disease and species if necessary.

(22)  Region as defined in the approved eradication programme of the Member State.

(23)  At the end of the year.

(24)  Unknown: No previous checking results available.

(25)  Not free and last check positive: Herd checked with at least one positive result in the latest check.

(26)  Not free and last check negative: Herd checked with negative results in the latest check but not being Free or Officially Free.
(27)  Suspended as defined in Community or national legislation for the respective disease at the end of the reporting period.

(28)  Free herd as defined in Community or national legislation for the respective disease.

(29)  Officially free herd as defined in Community or national legislation for the respective disease.

(30)  Include animals under the programme in the herds with the referred status (left column).

(15)  Data to provide only if vaccination has been carried out.

(31)  Disease and species if necessary.

(32)  Region as defined in the approved eradication programme of the Member State.

(33)  Herds or flocks or holdings as appropriate.

(34)  Only for Bovine brucellosis, Ovine and Caprine brucellosis (B. melitensis) as defined in the programme.

(16)  Data only to provide in case the programme comprises measures as regards wildlife or if the data are epidemiologically relevant for the disease.

(35)  The hunting bag is considered to be the standard method of estimation. If other method is used, explain.

(36)  Region as defined in the approved eradication programme of the Member State.

(37)  Disease and species, if necessary.

(38)  Region as defined in the approved eradication programme of the Member State.

(39)  Disease and species if necessary.

(40)  Region as defined in the approved eradication programme of the Member State.

(41)  Disease and species if necessary.

(42)  Region as defined in the approved eradication programme of the Member State.

(43)  Description of the test (for instance SN-test, AB-Elisa, RBT, etc.).

(44)  Specification of the targeted species and the categories of targeted animals (for instance sex, age, breeding animal, slaughter animal, etc.).

(45)  Description of the sample (for instance blood, serum, milk, etc.).

(46)  Description of the objective (for instance qualification, surveillance, confirmation of suspected cases, monitoring of campaigns, seroconversion, control on deleted vaccines, testing of vaccine, control of vaccination, etc.).

(17)  Data not to provide in case of rabies.

(47)  Herds or flocks, or holdings as appropriate.

(48)  Disease and animal species if necessary.

(49)  Region as defined in the approved eradication programme of the Member State.

(50)  Total number of herds existing in the region including eligible herds and non-eligible herds for the programme.

(51)  Check means to perform a herd level test under the programme for the respective disease with the purpose of maintaining, upgrading, etc., the health status of the herd. In this column a herd must not be counted twice even if it has been checked more than once.

(52)  Herds with at least one positive animal during the period independent of the number of times the herd has been checked.

(53)  Herds which status in the previous period was Unknown, Not free-negative, Free, Officially Free or Suspended and have at least one positive animal in this period.

(54)  Disease and animal species if necessary.

(55)  Region as defined in the approved eradication programme of the Member State.

(56)  Total number of animals existing in the region including eligible herds and non-eligible herds for the programme.

(57)  Includes animals tested individually or under bulk level scheme.

(58)  Include only animals tested individually, do not include animals tested by bulk level samples (for instance milk bulk tank tests).

(59)  Include all positive animals slaughtered and also the negative animals slaughtered under the programme.

(18)  Data to provide only for bovine tuberculosis, bovine brucellosis, ovine and caprine brucellosis (B. melitensis), enzootic bovine leucosis (EBL) and Aujesky’s disease.

(60)  Disease and species if necessary.

(61)  Region as defined in the approved eradication programme of the Member State.

(62)  At the end of the year.

(63)  Unknown: No previous checking results available.

(64)  Not free and last check positive: Herd checked with at least one positive result in the latest check.

(65)  Not free and last check negative: Herd checked with negative results in the latest check but not being Free or Officially Free.
(66)  Suspended as defined for the respective disease in Community or national legislation where appropriate or according national legislation.

(67)  Free herd as defined for the respective disease where appropriate in Community or national legislation where appropriate or according national legislation.

(68)  Officially free herd as defined for the respective disease where appropriate in Community or national legislation where appropriate or according national legislation.

(69)  Include animals under the programme in the herds with the referred status (left column).

(19)  Data to provide only if appropriate.

(70)  Disease and species if necessary.

(71)  Region as defined in the approved eradication programme of the Member State.

(72)  Herds or flocks or holdings as appropriate.

(73)  Only for Bovine brucellosis and Ovine, Caprine brucellosis (B. melitensis) as defined in the programme.

(20)  Data to provide only if appropriate.

(74)  Disease and species if necessary.

(75)  Region as defined in the approved eradication programme of the Member State.
PART AANNEX IIStandard requirements for the submission of national programmes for the control of Salmonellosis (zoonotic Salmonella) as referred to in Article 1(b)General requirements for the national salmonella control programmes

(a) | State the aim of the programme

(b) | Demonstrate the evidence that it complies with the minimum sampling requirements laid down in part B of Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council(1)indicating the relevant animal population and phases of production which sampling must coverBreeding flocks ofGallus gallus:—rearing flocks—day-old chicks,—four-week-old birds—two weeks before moving to laying phase or laying unit—adult breeding flocks — every second week during the laying period,Laying hens:—rearing flocks—day-old chicks,—pullets two weeks before moving to laying phase or laying unit—laying flocks — every 15 weeks during the laying phase,Broilers — birds leaving for slaughterTurkeys — birds leaving for slaughterHerds of pigs:—breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse,—slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse; | —rearing flocks | — | rearing flocks | —day-old chicks, | — | day-old chicks, |  | —four-week-old birds | — | four-week-old birds |  | —two weeks before moving to laying phase or laying unit | — | two weeks before moving to laying phase or laying unit | — | adult breeding flocks — every second week during the laying period, | —rearing flocks | — | rearing flocks | —day-old chicks, | — | day-old chicks, |  | —pullets two weeks before moving to laying phase or laying unit | — | pullets two weeks before moving to laying phase or laying unit | — | laying flocks — every 15 weeks during the laying phase, | — | breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse, | — | slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse;

—rearing flocks | — | rearing flocks | —day-old chicks, | — | day-old chicks,

— | rearing flocks

— | day-old chicks,

 | —four-week-old birds | — | four-week-old birds

— | four-week-old birds

 | —two weeks before moving to laying phase or laying unit | — | two weeks before moving to laying phase or laying unit

— | two weeks before moving to laying phase or laying unit

— | adult breeding flocks — every second week during the laying period,

—rearing flocks | — | rearing flocks | —day-old chicks, | — | day-old chicks,

— | rearing flocks

— | day-old chicks,

 | —pullets two weeks before moving to laying phase or laying unit | — | pullets two weeks before moving to laying phase or laying unit

— | pullets two weeks before moving to laying phase or laying unit

— | laying flocks — every 15 weeks during the laying phase,

— | breeding pigs — animals leaving for slaughter or carcases at the slaughterhouse,

— | slaughter pigs — animals leaving for slaughter or carcases at the slaughterhouse;

(c) | demonstrate the evidence that it complies with the specific requirements laid down in Parts C, D and E of Annex II to Regulation (EC) No 2160/2003; and

(d) | specify the following points:1.General1.1.A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes.1.2.The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme.1.3.Approved laboratories where samples collected within the programme are analysed.1.4.Methods used in the examination of the samples in the framework of the programme.1.5.Official controls (including sampling schemes) at feed, flock and/or herd level.1.6.Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination.1.7.National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme.1.8.Any financial assistance provided to food and feed businesses in the context of the programme.2.Concerning food and feed businesses covered by the programme2.1.The structure of the production of the given species and products thereof.2.2.The structure of the production of feed.2.3.Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms.2.4.Routine veterinary supervision of farms.2.5.Registration of farms.2.6.Record-keeping at farms.2.7.Documents to accompany animals when dispatched.2.8.Other relevant measures to ensure the traceability of animals. | 1. | General | 1.1. | A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes. | 1.2. | The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme. | 1.3. | Approved laboratories where samples collected within the programme are analysed. | 1.4. | Methods used in the examination of the samples in the framework of the programme. | 1.5. | Official controls (including sampling schemes) at feed, flock and/or herd level. | 1.6. | Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination. | 1.7. | National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme. | 1.8. | Any financial assistance provided to food and feed businesses in the context of the programme. | 2. | Concerning food and feed businesses covered by the programme | 2.1. | The structure of the production of the given species and products thereof. | 2.2. | The structure of the production of feed. | 2.3. | Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms. | — | hygiene management at farms, | — | measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and | — | hygiene in transporting animals to and from farms. | 2.4. | Routine veterinary supervision of farms. | 2.5. | Registration of farms. | 2.6. | Record-keeping at farms. | 2.7. | Documents to accompany animals when dispatched. | 2.8. | Other relevant measures to ensure the traceability of animals.

1. | General

1.1. | A short summary referring to the occurrence of the salmonellosis [zoonotic salmonella] in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC of the European Parliament and of the Council(2), particularly highlighting the prevalence values of the salmonella serovars targeted in the salmonella control programmes.

1.2. | The structure and organization of the relevant competent authorities. Please refer to the information flow between bodies involved in the implementation of the programme.

1.3. | Approved laboratories where samples collected within the programme are analysed.

1.4. | Methods used in the examination of the samples in the framework of the programme.

1.5. | Official controls (including sampling schemes) at feed, flock and/or herd level.

1.6. | Measures taken by the competent authorities with regard to animals or products in which the presence ofSalmonella spp.have been detected, in particular to protect public health, and any preventive measures taken, such as vaccination.

1.7. | National legislation relevant to the implementation of the programmes, including any national provisions concerning the activities set out in the programme.

1.8. | Any financial assistance provided to food and feed businesses in the context of the programme.

2. | Concerning food and feed businesses covered by the programme

2.1. | The structure of the production of the given species and products thereof.

2.2. | The structure of the production of feed.

2.3. | Relevant guidelines for good animal husbandry practices or other guidelines (mandatory or voluntary) on biosecurity measures defining at least:—hygiene management at farms,—measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and—hygiene in transporting animals to and from farms. | — | hygiene management at farms, | — | measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and | — | hygiene in transporting animals to and from farms.

— | hygiene management at farms,

— | measures to prevent incoming infections carried by animals, feed, drinking water, people working at farms, and

— | hygiene in transporting animals to and from farms.

2.4. | Routine veterinary supervision of farms.

2.5. | Registration of farms.

2.6. | Record-keeping at farms.

2.7. | Documents to accompany animals when dispatched.

2.8. | Other relevant measures to ensure the traceability of animals.PART B1.   Identification of the programmeMember State:

Disease: infection of animals with zoonoticSalmonella spp

Animal population covered by the programme:

Year/s of implementation:

Reference of this document:

Contact (name, phone, fax, e-mail):

Date sent to the Commission:
 | 2. | Historical data on the epidemiological evolution of zoonotic salmonellosis specified in point 1(3):

 | 3. | Description of the submitted programme(4):4.   Measures of the submitted programme4.1.   Summary of measures under the programmeDuration of the programme:
First year: | Last year:

Control |  | Control | Control/eradication |  | Control/eradication

 | Control

 | Control/eradication

Testing |  | Testing | Testing |  | Testing

 | Testing

 | Testing

Slaughter of animals tested positive |  | Slaughter of animals tested positive | Slaughter of animals tested positive |  | Slaughter of animals tested positive

 | Slaughter of animals tested positive

 | Slaughter of animals tested positive

Killing of animals tested positive |  | Killing of animals tested positive | Killing of animals tested positive |  | Killing of animals tested positive

 | Killing of animals tested positive

 | Killing of animals tested positive

Vaccination |  | Vaccination | Extended slaughter or killing |  | Extended slaughter or killing

 | Vaccination

 | Extended slaughter or killing

Treatment of animal products |  | Treatment of animal products | Disposal of products |  | Disposal of products

 | Treatment of animal products

 | Disposal of products

Disposal of products |  | Disposal of products | 

 | Disposal of products

Monitoring or surveillance |  | Monitoring or surveillance | 

 | Monitoring or surveillance

Other measures(specify): |  | Other measures(specify): | 

 | Other measures(specify):

 | 4.2. | Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme(5):

 | 4.3. | Description and delimitation of the geographical and administrative areas in which the programme is to be implemented(6):

 | 4.4. | Measures implemented under the programme(7)

 | 4.4.1. | Measures and applicable legislation as regards the registration of holdings:

 | 4.4.2. | Measures and applicable legislation as regards the identification of animals(8):

 | 4.4.3. | Measures and applicable legislation as regards the notification of the disease:

 | 4.4.4. | Measures and applicable legislation as regards the measures in case of a positive result(9):

 | 4.4.5. | Measures and applicable legislation as regards the different qualifications of animals and herds:

 | 4.4.6. | Control procedures and in particular rules on the movement of animals liable to be affected or contaminated by a given disease and the regular inspection of the holdings or areas concerned(10):

 | 4.4.7. | Measures and applicable legislation as regards the control (testing, vaccination, etc.) of the disease:

 | 4.4.8. | Measures and applicable legislation as regards the compensation for owners of slaughtered and killed animals:

 | 4.4.9. | Information and assessment on bio-security measures management and infrastructure in place in the flocks/holdings involved.

 | 5. | General description of the costs and benefits(11):6.   Data on the epidemiological evolution during the last five years

                            (12) 6.1.   Evolution of zoonotic salmonellosis6.1.1.   Data on evolution of zoonotic salmonellosis

Year:Animal species: | Situation on date:Disease/infection(1): |  |  |  |  |  | 

Region(1) | Type of flock(2) | Total number of flocks(3) | Total number of animals | Total number of flocks under the programme | Total number of animals under the programme | Number of flocks checked(4) | Number of positive(5)flocks(1) | Number of flocks depopulated(1) | Total number of animals slaughtered or destroyed(1) | Quantity of eggs destroyed (number or kg)(1) | Quantity of eggs channelled to egg products (number or kg)(1)

(a1) | (a2) | (a3) | (a3) | (a4) | (a4) | (a3) | (a4) | (a3) | (a4) | (a3)

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 6.2.   Stratified data on surveillance and laboratory tests6.2.1.   Stratified data on surveillance and laboratory tests (one table per year and per disease/species)

Year: | Animal species(6): | Category(7): | 

Description of the used serological tests:Description of the used microbiological or virological tests:Description of the other used tests:

Region(8) | Serological tests | Microbiological or virological tests | Other tests

Number of samples tested(9) | Number of positive samples(10) | Number of samples tested(9) | Number of positive samples(10) | Number of samples tested(9) | Number of positive samples(10)

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total |  |  |  |  |  | 6.3.   Data on infection (one table per year and per species)
Year: | Animal species(11): |  | 

Region(12) | Number of herds infected(13) | Number of animals infected

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

 |  | 

Total |  | 6.4.   Data on vaccination programmes

                               (13) 

Year: |  | Animal species:(14): | 

Description of the used vaccination

Region(15) | Total number of herds(16) | Total number of animals | Information on vaccination programme

Number of herds(16)in vaccination programme | Number of herds(16)vaccinated | Number of animals vaccinated | Number of doses of vaccine administered

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total |  |  |  |  |  | 7.   Targets7.1.   Targets related to testing (one table for each year of implementation)

7.1.1.   Targets on diagnostic tests

 | Animal species:(17): |  |  |  | 

Region(18) | Type of the test(19) | Target population(20) | Type of sample(21) | Objective(22) | Number of planned tests

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Total | 7.1.2.   Targets on testing of flocks (14) 

Year:Animal species: |  | Situation on date:infection(23): |  |  |  |  |  | 

Region(2) | Type of flock(24) | Total number of flocks(25) | Total number of animals | Total number of flocks under the programme | Total number of animals under the programme | Expected number of flocks to be checked(26) | Number of flocks(27)expected to be positive(23) | Number of flocks expected to be depopulated(23) | Total number of animals expected to be slaughtered or destroyed(23) | Expected quantity of eggs to be destroyed (number or kg)(23) | Expected quantity of eggs channelled to egg products (number or kg)(23)

(a1) | (a2) | (a3) | (a4) | (a3) | (a4) | (a3) | (a4) | (a3) | (a4) | (a3)

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 7.2.   Targets on vaccination (one table for each year of implementation)7.2.1.   Targets on vaccination (15) 

 |  | Animal species:(28): | 

Region(29) | Total number of herds(30)in vaccination programme | Total number of animals in vaccination programme | Targets on vaccination programme

Number of herds(30)in vaccination programme | Number of herds(30)expected to be vaccinated | Number of animals expected to be vaccinated | Number of doses of vaccine expected to be administered

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total |  |  |  |  |  | 8.   Detailed analysis of the cost of the programme (one table per year of implementation)
Costs related to | Specification | Number of units | Unitary cost in EUR | Total amount in EUR | Community funding requested (yes/no)

1.Testing | 1. | Testing |  |  |  |  | 

1. | Testing

1.1.Cost of the analysis | 1.1. | Cost of the analysis | Test: Number of bacteriological tests (cultivation) planned to be carried out in the framework of official sampling |  |  |  | 

1.1. | Cost of the analysis

 | Test: Number of serotyping of relevant isolates tests planned to be carried out |  |  |  | 

 |  |  |  |  | 

1.2.Cost of sampling | 1.2. | Cost of sampling |  |  |  |  | 

1.2. | Cost of sampling

1.3.Other costs | 1.3. | Other costs |  |  |  |  | 

1.3. | Other costs

2.Vaccination or treatment of animal products | 2. | Vaccination or treatment of animal products |  |  |  |  | 

2. | Vaccination or treatment of animal products

2.1.Purchase of vaccine/treatment of animal products | 2.1. | Purchase of vaccine/treatment of animal products |  |  |  |  | 

2.1. | Purchase of vaccine/treatment of animal products

 | Number of purchase of vaccine doses planned if a vaccination policy is part of the programme as set out explicitly under point 4 of Annex II |  |  |  | 

2.2.Distribution costs | 2.2. | Distribution costs |  |  |  |  | 

2.2. | Distribution costs

2.3.Administering costs | 2.3. | Administering costs |  |  |  |  | 

2.3. | Administering costs

2.4.Control costs | 2.4. | Control costs |  |  |  |  | 

2.4. | Control costs

3.Slaughter and destruction | 3. | Slaughter and destruction |  |  |  |  | 

3. | Slaughter and destruction

3.1.Compensation of animals | 3.1. | Compensation of animals |  |  |  |  | 

3.1. | Compensation of animals

3.2.Transport costs | 3.2. | Transport costs |  |  |  |  | 

3.2. | Transport costs

3.3.Destruction costs | 3.3. | Destruction costs |  |  |  |  | 

3.3. | Destruction costs

3.4.Loss in case of slaughtering | 3.4. | Loss in case of slaughtering |  |  |  |  | 

3.4. | Loss in case of slaughtering

3.5.Costs from treatment of animal products (milk, eggs, hatching eggs, etc.) | 3.5. | Costs from treatment of animal products (milk, eggs, hatching eggs, etc.) |  |  |  |  | 

3.5. | Costs from treatment of animal products (milk, eggs, hatching eggs, etc.)

4.Cleaning and disinfection | 4. | Cleaning and disinfection |  |  |  |  | 

4. | Cleaning and disinfection

 |  |  |  |  | 

 |  |  |  |  | 

5.Salaries (staff contracted for the programme only) | 5. | Salaries (staff contracted for the programme only) |  |  |  |  | 

5. | Salaries (staff contracted for the programme only)

 |  |  |  |  | 

 |  |  |  |  | 

6.Consumables and specific equipment | 6. | Consumables and specific equipment |  |  |  |  | 

6. | Consumables and specific equipment

 |  |  |  |  | 

 |  |  |  |  | 

7.Other costs | 7. | Other costs |  |  |  |  | 

7. | Other costs

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Total |  | 

(1)  

            OJ L 325, 12.12.2003, p. 1.

(2)  

            OJ L 325, 12.12.2003, p. 31.

(3)  A concise description is given with data on the target population (species, number of flocks/herds and animals present and under the programme), the main measures (testing, testing and slaughter, testing and killing, qualification of flocks/herds and animals, vaccination) and the main results (incidence, prevalence, qualification of flocks/herds and animals). The information is given for distinct periods if the measures were substantially modified. The information is documented by relevant summary epidemiological tables, graphs or maps.

(4)  A concise description of the programme is given with the main objective(s) (monitoring, control, eradication, qualification of flocks/herds and/or regions, reducing prevalence and incidence), the main measures (testing, testing and slaughter, testing and killing, qualification of flocks/herds and animals, vaccination), the target animal population and the area(s) of implementation and the definition of a positive case.

(5)  Describe the authorities in charge of supervising and coordinating the departments responsible for implementing the programme and the different operators involved. Describe the responsibilities of all involved.

(6)  Describe the name and denomination, the administrative boundaries, and the surface of the administrative and geographical areas in which the programme is to be applied. Illustrate with maps.

(7)  Where appropriate Community legislation is mentioned. Otherwise the national legislation is mentioned.

(8)  Not applicable for poultry.

(9)  A short description is provided of the measures as regards positive animals (slaughter, destination of carcasses, use or treatment of animal products, the destruction of all products which could transmit the disease or the treatment of such products to avoid any possible contamination, a procedure for the disinfection of infected holdings, a procedure for the restocking with healthy animals of holdings which have been depopulated by slaughter.

(10)  A short description of the control procedures and in particular rules on the movement of animals liable to be affected or contaminated by a given disease and the regular inspection of the holdings or areas is provided.

(11)  A description is provided of all costs for the authorities and society and the benefits for farmers and society in general.

(12)  The data on the evolution of zoonotic salmonellosis are provided according to the tables where appropriate.

(1)  For zoonotic salmonellosis indicate the serotypes covered by the control programmes: (a1) for salmonella enteritidis, (a2) for salmonella typhimurium, (a3) for other serotypes-specify as appropriate, (a4) for salmonella enteritidis or salmonella typhimurium.

(1)  

(a1) | Region as defined in the approved control and eradication programme of the Member State.

(2)  For example, breeding flocks (rearing, adult flocks), production flocks, laying hen flocks, breeding turkeys, broiler turkeys, breeding pigs, slaughter pigs, etc. Flocks or herds or as appropriate.

(3)  Total number of flocks existing in the region including eligible flocks and non-eligible flocks for the programme.

(4)  Check means to perform a flock level test under the programme for the presence of salmonella. In this column a flock must not be counted twice even if it has been checked more than once.

(5)  If a flock has been checked, in accordance with footnote (d), more than once, a positive sample must be taken into account only once.

(6)  Animal species if necessary.

(7)  Category/further specifications such as breeders, laying hens, broilers, breeding turkeys, broiler turkeys, breeding pigs, slaughter pigs, etc., when appropriate.

(8)  Region as defined in the approved control and eradication programme of the Member State.

(9)  Number of samples tested.

(10)  Number of positive samples.

(11)  Animal species if necessary.

(12)  Region as defined in the control and eradication programme of the Member State.

(13)  Herds or flocks or holdings as appropriate.

(13)  Data to provide only if vaccination has been carried out.

(14)  Animal species if necessary.

(15)  Region as defined in the approved control and eradication programme of the Member State.

(16)  Herds or flocks or holdings as appropriate.

(17)  Species if necessary.

(18)  Region as defined in the approved control and eradication programme of the Member State.

(19)  Description of the test.

(20)  Specification of the targeted species and the categories of targeted animals if necessary.

(21)  Description of the sample (for instance faeces).

(22)  Description of the objective (for instance surveillance, monitoring, control of vaccination).

(14)  Specify types of flocks if appropriate (breeders, layers, broilers).

(23)  For zoonotic salmonellosis indicate the serotypes covered by the control programmes: (a1) for salmonella enteritidis, (a2) for salmonella typhimurium, (a3) for other serotypes-specify as appropriate, (a4) for salmonella enteritidis or salmonella typhimurium.

(2)  

(a1) | Region as defined in the approved control and eradication programme of the Member State.

(24)  For example, breeding flocks (rearing, adult flocks), production flocks, laying hen flocks, breeding turkeys, broiler turkeys, breeding pigs, slaughter pigs, etc. Flocks or herds or as appropriate.

(25)  Total number of flocks existing in the region including eligible flocks and non-eligible flocks for the programme.

(26)  Check means to perform a flock level test under the programme for the presence of salmonella. In this column a flock must not be counted twice even if it has been checked more than once.

(27)  If a flock has been checked, in accordance with footnote (d), more than once, a positive sample must be taken into account only once.

(15)  Data to provide only if appropriate.

(28)  Species if necessary.

(29)  Region as defined in the approved control and eradication programme of the Member State.

(30)  Herds or flocks or holdings as appropriate.
1.   Identification of the programmeANNEX IIIStandard requirements for the submission of national programmes of eradication and monitoring of TSEs (1) as referred to in Article 1(c)Member State:

Disease(s)(2):

Year of implementation:

Reference of this document:

Contact (name, phone, fax, e-mail):

Date sent to the Commission:

2.   Description of the programme3.   Description of the epidemiological situation of the disease4.   Measures included in the programme

 | 4.1. | Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme:

 | 4.2. | Description and delimitation of the geographical and administrative areas in which the programme is to be applied:

 | 4.3. | System in place for the registration of holdings:

 | 4.4. | System in place for the identification of animals:

 | 4.5. | Measures in place as regards the notification of the disease:4.6.   Monitoring4.6.1.   Monitoring in bovine animals

 | Estimated number of tests

Animals referred to in Annex III, Chapter A, Part I, points 2.1, 3 and 4 of Regulation (EC) No 999/2001 of the European Parliament and of the Council(3) | 

Animals referred to in Annex III, Chapter A, Part I, point 2.2 of Regulation (EC) No 999/2001 | 

Others (specify) | 4.6.2.   Monitoring in ovine animals

 | Estimated number of tests

Ovine animals referred to in Annex III, Chapter A, Part II, point 2 of Regulation (EC) No 999/2001 | 

Ovine animals referred to in Annex III, Chapter A, Part II, point 3 of Regulation (EC) No 999/2001 | 

Ovine animals referred to in Annex III, Chapter A, Part II, point 5 of Regulation (EC) No 999/2001 | 

Ovine animals referred to in Annex VII, Chapter A, point 3.4(d) of Regulation (EC) No 999/2001 | 

Ovine animals referred to in Annex VII, Chapter A, point 5(b)(ii) of Regulation (EC) No 999/2001 | 

Others (specify other animal species referred to in Annex III, Chapter A, Part III of Regulation (EC) No 999/2001 | 4.6.3.   Monitoring in caprine animals

 | Estimated number of tests

Caprine animals referred to in Annex III, Chapter A, Part II, point 2 of Regulation (EC) No 999/2001 | 

Caprine animals referred to in Annex III, Chapter A, Part II, point 3 of Regulation (EC) No 999/2001 | 

Caprine animals referred to in Annex III, Chapter A, Part II, point 5 of Regulation (EC) No 999/2001 | 

Caprine animals referred to in Annex VII, Chapter A, point 3.3(c) of Regulation (EC) No 999/2001 | 

Caprine animals referred to in Annex VII, Chapter A, point 5(b)(ii) of Regulation (EC) No 999/2001 | 

Others (specify) | 4.6.4.   Discriminatory tests

 | Estimated number of tests

Primary molecular testing referred to in Annex X, Chapter C, point 3.2(c)(i) of Regulation (EC) No 999/2001 | 4.6.5.   Genotyping of positive and randomly selected animals

 | Estimated number of tests

Animals referred to in Annex III, Chapter A, Part II, point 8.1 of Regulation (EC) No 999/2001 | 

Animals referred to in Annex III, Chapter A, Part II, point 8.2 of Regulation (EC) No 999/2001 | 4.7.   Eradication4.7.1.   Measures following confirmation of a BSE case:4.7.1.1.   Description:4.7.1.2.   Summary table

 | Estimated number

Animals to be killed under the requirements of Annex VII, Chapter A, point 2.1 of Regulation (EC) No 999/2001: | 4.7.2.   Measures following confirmation of a scrapie case:
 | 4.7.2.1. | Description:4.7.2.2.   Summary table

 | Estimated number

Animals to be killed under the requirements of Annex VII, Chapter A, point 2.3 of Regulation (EC) No 999/2001: | 

Animals to be genotyped under the requirements of Annex VII, Chapter A, point 2.3 of Regulation (EC) No 999/2001: | 4.7.3.   Breeding programme for resistance to TSEs in sheep
 | 4.7.3.1. | General description(4):4.7.3.2.   Summary table

 | Estimated number

Ewes to be genotyped under the framework of a breeding programme referred to in Article 6a of Regulation (EC) No 999/2001 | 

Rams to be genotyped under the framework of a breeding programme referred to in Article 6a of Regulation (EC) No 999/2001 | 5.   Costs

 | 5.1. | Detailed analysis of the costs:5.2.   Summary of the costs

Costs related to | Specification | Number of units | Unitary cost in EUR | Total amount in EUR | Community funding requested (yes/no)

1. | BSE testing(5)

1.1. | Rapid tests | Test: |  |  |  | 

 |  | Test: |  |  |  | 

 |  | Test: |  |  |  | 

 |  | Test: |  |  |  | 

2. | Scrapie testing(6)

2.1. | Rapid tests | Test: |  |  |  | 

 |  | Test: |  |  |  | 

 |  | Test: |  |  |  | 

3. | Discriminatory testing(7)

3.1. | Primary molecular tests | Test: |  |  |  | 

 |  | Test: |  |  |  | 

4. | Genotyping

4.1. | Determination of genotype of animals in the framework of the monitoring and eradication measures laid down by Regulation (EC) No 999/2001(8) | Method |  |  |  | 

4.2. | Determination of genotype of animals in the framework of a breeding programme(9) | Method |  |  |  | 

5. | Compulsory slaughter

5.1. | Compensation for bovine animals to be killed/slaughtered under the requirements of Annex VII, Chapter A, point 2.1 of Regulation (EC) No 999/2001 |  |  |  |  | 

5.2. | Compensation for ovine and caprine animals to be killed/slaughtered under the requirements of Annex VII, Chapter A, point 2.3 of Regulation (EC)No 999/2001 |  |  |  |  | 

Total |  | 

(1)  Bovine spongiform encephalopathy (BSE), scrapie and chronic waste disease (CWD).

(2)  One document per disease is used unless all measures of the programme on the target population are used for the control and eradication of different diseases.

(3)  

            OJ L 147, 31.5.2001, p. 1.

(4)  Description of the programme according to the minimum requirements set out in Annex VII, Chapter B of Regulation (EC) No 999/2001.

(5)  As referred to in point 4.6.1.

(6)  As referred to in points 4.6.2 and 4.6.3.

(7)  As referred to in point 4.6.4.

(8)  As referred to in points 4.6.5 and 4.7.2.2.

(9)  As referred to in point 4.7.3.2.
1.   Identification of the programmeANNEX IVStandard requirements for the submission of national surveillance programmes for avian influenza in poultry and wild birds as referred to in Article 1(d)Member State:

Disease:

Year of implementation:

Reference of this document:

Contact (name, phone, fax, e-mail):

Date sent to the Commission:

2.   Description of the surveillance programme in poultry2.1.   Objectives, general requirements and criteria2.2.   Design and implementationTable 2.2.1Poultry holdings (1) (except ducks and geese) to be sampledSerological investigation according to point B of Annex I to Commission Decision 2007/268/EC (1) on holdings of broilers(only when at risk)/fattening turkeys/chicken breeders/turkey breeders/laying hens/free range laying hens/ratites/farmed feathered game (pheasants, partridges, quails…)/‘backyard flocks‘/others [delete as appropriate]

PLEASE USE ONE FORM PER POULTRY CATEGORY
NUTS (2) code(2) | Total number of holdings(3) | Total number of holdings to be sampled | Number of samples per holding | Total number of tests to be performed per method | Methods of laboratory analysis

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Total |  |  |  |  | 

Table 2.2.2.Duck and geese holdings to be sampled (4) according to point C of Annex I to Decision 2007/268/ECSerological investigation

NUTS 2 code(5) | Total number of duck and geese holdings | Total number of duck and geese holdings to be sampled | Number of samples per holding | Total number of tests to be performed per method | Methods of laboratory analysis

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

 |  |  |  |  | 

Total |  |  |  |  | 2.3.   Laboratory testing: description of the laboratory tests used3.   Description of the surveillance programme in wild birds:3.1.   Objectives, general requirements and criteria3.2.   Design and implementationTable 3.2.1.WILD BIRDS — investigation according to the surveillance programme for avian influenza in wild birds set out in Annex II to Decision 2007/268/EC

NUTS (2) code/region(6) | Wild birds to be sampled(7) | Total number of birds to be sampled | Estimated total number of samples to be taken for active surveillance | Estimated total number of samples to be taken for passive surveillance

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

 |  |  |  | 

Total |  |  |  | 3.3.   Laboratory testing: description of the laboratory tests used4.   Description of the epidemiological situation of the disease in poultry during the last five years4.1.   Measures included in the programme for surveillance in poultry

 | 4.1.1. | Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme

 | 4.1.2. | System in place for the registration of holdings

 | 4.1.3. | Data on vaccination carried out5.   Description of the epidemiological situation of the disease in wild birds during the last five years5.1.   Measures included in the programme for surveillance in wild birds

 | 5.1.1. | Designation of the central authority in charge of supervising and coordinating the departments responsible for implementing the programme

 | 5.1.2. | Description and delimitation of the geographical and administrative areas in which the programme is to be applied

 | 5.1.3. | Estimation of the local and/or migratory wildlife population6.   Measures in place as regards the notification of the disease7.   Costs7.1.   Detailed analysis of the costs:

 | 7.1.1. | Poultry

 | 7.1.2. | Wild birds7.2.   Summary of the costs7.2.1.   Poultry surveillance

Measures eligible for co-financing surveillance in poultry

Methods of laboratory analysis | Number of tests to perform per method | Unitary test cost (per method) | Total cost

Serological pre-screening(2) |  |  | 

Haemagglutination-inhibition-test (HI) for H5/H7(3) |  |  | 

Virus isolation test |  |  | 

PCR test |  |  | 

Other measures to be covered | Specify activities |  | 

Sampling |  |  | 

Others |  |  | 

Total |  |  | 7.2.2.   Wild bird surveillance

Measures eligible for co-financing surveillance wild birds

Methods of laboratory analysis | Number tests to perform per method | Unitary test cost (per method) | Total cost

Serological pre-screening |  |  | 

Haemagglutination-inhibition-test (HI) for H5/H7 |  |  | 

Virus isolation test |  |  | 

PCR test |  |  | 

Other measures to be covered | Specify activities |  | 

Sampling |  |  | 

Others |  |  | 

Total |  |  | 

(1)  Holdings or herds or flocks or establishments as appropriate.

(2)  Refers to the location of the holding of origin. In case NUTS (Nomenclature of Territorial Units for Statistics) 2 can not be used, coordinates (long/lat- to write out) are requested.

(3)  Total number of holdings of one category of poultry in concerned NUTS 2 region.

(1)  

            OJ L 115, 3.5.2007, p. 3.

(4)  Holdings or herds or flocks or establishments as appropriate.

(5)  Refers to the location of the holding of origin. In case NUTS 2 code can not be used, coordinates (long/lat — to write out) are requested.

(6)  Refers to the place of collection of birds/samples. In case NUTS 2 code can not be used, region as defined in the programme by the Member State is requested.

(7)  General description of the wild birds are intended to be sampled in the framework of the active and passive surveillance.

(2)  Specify the laboratory test to be used.

(3)  Specify number of tests for H5 and for H7.
10.   Data on the epidemiological situation/evolution of the disease in the last four years (one table for each year of implementation)ANNEX VStandard requirements for the submission of national programmes for the eradication of the aquacultures animal diseases referred to in Article 1(e)

Requirements/information needed | Information/further explanation and justification

1. | Identification of the programme | 

1.1. | Declaring Member State | 

1.2. | Competent authority (address, fax, e-mail) | 

1.3. | Reference of this document | 

1.4. | Date sent to the Commission | 

2. | Type of communication | 

2.1. | Application for eradication programme |  | Application for eradication programme | 

 | Application for eradication programme

3. | National legislation(1) | 

4. | Request for co-finance | 

4.1. | Indicate the year(s) for which co-finance is requested | 

4.2. | Agreement of the managing authority of the operational programme(2)(signature and stamp) | 

5. | Diseases | 

5.1. | Fish | VHSIHNSVCISAKHV |  | VHS |  | IHN |  | SVC |  | ISA |  | KHV

 | VHS

 | IHN

 | SVC

 | ISA

 | KHV

5.2. | Molluscs | Marteilia refringensBonamia ostrae |  | Marteilia refringens |  | Bonamia ostrae

 | Marteilia refringens

 | Bonamia ostrae

5.3. | Crustaceans | White spot disease |  | White spot disease

 | White spot disease

6. | General information on the programmes | 

6.1. | Competent Authority(3) | 

6.2. | Organisation, supervision of all stakeholders involved in the programme(4) | 

6.3. | An overview of the structure of the aquaculture industry in the area in question including types of production, species kept etc. | 

6.4. | Notification to the competent authority of suspicion and confirmation of the disease(s) in question has been compulsory since when? | 

6.5. | Early detection system in place throughout the Member States, enabling the competent authority to undertake effective disease investigation and reporting since when?(5) | 

6.6. | Source of aquaculture animals of susceptible species to the disease in question entering in the Member State, zone or compartments for farming | 

6.7. | Guidelines on good hygiene practice(6) | 

6.8. | Epidemiological situation of the disease in at least the previous four years before the commencement of the programme(7) | 

6.9. | Estimated costs and the anticipated benefits of the programme.(8) | 

6.10. | Description of the submitted programme(9) | 

6.11. | Duration of the programme | 

7. | Area covered(10) | 

7.1. | Member State |  | Member State | 

 | Member State

7.2. | Zone (entire water catchment area)(11) |  | Zone (entire water catchment area)(11) | 

 | Zone (entire water catchment area)(11)

7.3. | Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area. |  | Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area. | 

 | Zone (part of water catchment area)(12)Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area.

7.4. | Zone (more than one water catchment area)(13) |  | Zone (more than one water catchment area)(13) | 

 | Zone (more than one water catchment area)(13)

7.5. | Compartment independent on the surrounding health status(14) |  | Compartment independent on the surrounding health status(14) | 

 | Compartment independent on the surrounding health status(14)

 | Identify and describe for each farm the water supply(15) | Well, borehole or springWater treatment plant inactivating the relevant pathogen(16) |  | Well, borehole or spring |  | Water treatment plant inactivating the relevant pathogen(16)

 | Well, borehole or spring

 | Water treatment plant inactivating the relevant pathogen(16)

 | Identify and describe for each farm natural or artificial barriers and justify its capability to prevent that aquatic animals enter each farm in a compartment from the surrounding watercourses. | 

 | Identify and describe for each farm the protection against flooding and infiltration of water form the surrounding | 

7.6. | Compartment dependent on the surrounding health status(17) |  | Compartment dependent on the surrounding health status(17) | 

 | Compartment dependent on the surrounding health status(17)

 | One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18) |  | One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18) | 

 | One epidemiological unit due to geographical localisation and distance from other farms/farming areas(18)

 | All farms comprising the compartment fall within a common biosecurity system.(19) |  | All farms comprising the compartment fall within a common biosecurity system.(19) | 

 | All farms comprising the compartment fall within a common biosecurity system.(19)

 | Any additional requirements(20) |  | Any additional requirements(20) | 

 | Any additional requirements(20)

7.7. | Farms or mollusc farming areas covered by the programme (registration numbers and geographical situation) | 

8. | Measures of the submitted programme | 

8.1. | Summary of the measures under the programme | 

 | First yearTestingHarvesting for human consumption or further processingImmediateDelayedRemoval and disposalImmediateDelayedVaccinationOther measures (specify) |  | Testing |  | Harvesting for human consumption or further processingImmediateDelayed |  | Immediate |  | Delayed |  | Removal and disposalImmediateDelayed |  | Immediate |  | Delayed |  | Vaccination |  | Other measures (specify) | Last yearTestingHarvesting for human consumption or further processingImmediateDelayedRemoval and disposalImmediateDelayedOther measures (specify) |  | Testing |  | Harvesting for human consumption or further processingImmediateDelayed |  | Immediate |  | Delayed |  | Removal and disposalImmediateDelayed |  | Immediate |  | Delayed |  | Other measures (specify)

 | Testing

 | Harvesting for human consumption or further processingImmediateDelayed |  | Immediate |  | Delayed

 | Immediate

 | Delayed

 | Removal and disposalImmediateDelayed |  | Immediate |  | Delayed

 | Immediate

 | Delayed

 | Vaccination

 | Other measures (specify)

 | Testing

 | Harvesting for human consumption or further processingImmediateDelayed |  | Immediate |  | Delayed

 | Immediate

 | Delayed

 | Removal and disposalImmediateDelayed |  | Immediate |  | Delayed

 | Immediate

 | Delayed

 | Other measures (specify)

8.2. | Description of the measures of the programme(21) | 

 | Target population/species | 

 | Used tests and sampling schemes. Laboratories involved in the programme(22). | 

 | Rules on movements of animals | 

 | Used vaccines and vaccination schemes | 

 | Measures in case of a positive result(23) | 

 | Compensation scheme for owners | 

 | Control and supervision on the implementation of the programme and reporting | 10.1.   Data on testing animalsMember State, zone or compartment (1) 

Disease: | Year |  |  |  |  |  | 

Farm or mollusc farming area | Number of samplings | Number of clinical inspections | Water temperature at sampling/inspection | Species at sampling | Species sampled | Number of animals sampled (total and by species) | Number of tests | Positive results of laboratorial examination | Positive results of clinical inspections

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  | 

Total |  |  |  | 10.2.   Data on testing farms or farming areas

Disease: | Year |  |  |  |  |  | 

Member State, zone or compartment(2) | Total number of farms or mollusc farming areas(3) | Total number farms or mollusc farming areas under the programme | Number of farms or mollusc farming areas checked(4) | Number of positive farms or mollusc farming areas(5) | Number of new positive farms or mollusc farming areas(6) | Number of farms or mollusc farming areas depopulated | % positive farms or mollusc farming areas depopulated | Animals removed and disposed of(7) | Target indicators

% farms or mollusc farming areas coverage | % positive farms or mollusc farming areasperiod farms or mollusc farming areas prevalence | % new positive farms or mollusc farming areasfarms or mollusc farming areas incidence

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = | 9 | 10 = | 11 = (5/4)×100 | 12 = (6/4)×100

 |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  |  | 11.   Targets (one table for each year of implementation)11.1.   Targets related to testing animalsMember State, zone or compartment (8) 

Disease: | Year |  |  |  | 

Farm or mollusc farming area | Number of samplings | Number of clinical inspections | Water temperature at sampling/Inspection | Species at sampling | Species sampled | Number of animals sampled (total and by species) | Number of tests

 |  |  |  |  |  |  | 

 |  |  |  |  |  |  | 

 |  |  |  |  |  |  | 

 |  |  |  |  |  |  | 

 |  |  |  |  |  |  | 

 |  |  |  |  |  |  | 

Total | 11.2.   Targets on testing farms or farming areas

Disease: | Year |  |  |  |  | 

Member State, zone or compartment(9) | Total number of farms or mollusc farming areas(10) | Total number farms or mollusc farming areas under the programme | Number of farms or mollusc farming areas expected to be checked(11) | Number of expected positive farms or mollusc farming areas(12) | Number of expected new positive farms or mollusc farming areas(13) | Number of farms or mollusc farming areas expected to be depopulated | % positive farms or mollusc farming areas expected to be depopulated | Target indicators

Expected % farms or mollusc farming areas coverage | % positive farms or mollusc farming areasExpected period farms or mollusc farming areas prevalence | % new positive farms or mollusc farming areasExpected farms or mollusc farming areas incidence

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 = (7/5)×100 | 9 = (4/3)×100 | 10 = (5/4)×100 | 11 = (6/4)×100

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

 |  |  |  |  |  |  |  |  |  | 

Total |  |  |  |  |  |  |  |  |  | 12.   Detailed analysis of the cost of the programme (one table per year of implementation)

Costs related to | Specification | Number of units | Unitary cost in EUR | Total amount in EUR | Community(24)funding requested (yes/no)

1. | Testing |  |  |  |  | 

1.1. | Cost of the analysis | Test: |  |  |  | 

 |  | Test: |  |  |  | 

 |  | Test: |  |  |  | 

1.2. | Cost of sampling |  |  |  |  | 

1.3. | Other costs |  |  |  |  | 

2. | Vaccination or treatment |  |  |  |  | 

2.1. | Purchase of vaccine/treatment |  |  |  |  | 

2.2. | Distribution costs |  |  |  |  | 

2.3. | Administering costs |  |  |  |  | 

2.4. | Control costs |  |  |  |  | 

3. | Removal and disposal of the aquaculture animals |  |  |  |  | 

3.1. | Compensation of animals |  |  |  |  | 

3.2. | Transport costs |  |  |  |  | 

3.3. | Disposal costs |  |  |  |  | 

3.4. | Loss in case of removal |  |  |  |  | 

3.5. | Costs from treatment of products |  |  |  |  | 

4. | Cleansing and disinfection |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

5. | Salaries (staff contracted for the programme only) |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

6. | Consumables and specific equipment |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

7. | Other costs |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

 |  |  |  |  |  | 

Total |  | 

(1)  National legislation in force applicable to the application for eradication programme.

(2)  In accordance with Article 12 of Commission Regulation (EC) N 498/2007 of 26 March 2007 laying down detailed rules for the implementation of Council Regulation (EC) No 1198/2006 on the European Fisheries Fund (OJ L 120, 10.5.2007, p. 1).

(3)  A description shall be provided of the structure, competencies, duties and powers of the Competent Authority or Competent Authorities involved.

(4)  A description shall be provided of the authorities in charge of the supervision and coordination of the programme and the different operators involved.

(5)  The early detection systems shall in particular ensure the rapid recognition of any clinical sings consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or molluscs farming areas, and in the wild, and the rapid communication of the event to the competent authority with the aim to activating diagnostic investigation with minimum delay. The early detection system shall include at least the following:

(a) | broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians of aquatic animals health specialists in detecting and reporting unusual disease occurrence;

(b) | veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence;

(c) | access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.

(6)  A description shall be provided in accordance with Article 9 of Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14).

(7)  Information shall be given using the table laid down in Part 10 of Annex V to this Decision.

(8)  A description shall be provided of the benefits for farmers and society in general.

(9)  A concise description of the programme shall be given with the main objectives, the main measures, the target population, the areas of implementation and the definition of a positive case.

(10)  The area covered shall be clearly identified and described in a map, which should be attached as an Annex to the application.

(11)  An entire water catchment area from its sources to its estuary.

(12)  Part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from the lower stretches of the water catchment area.

(13)  More than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.

(14)  Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is independent on the health status regarding that disease of surrounding natural waters.

(15)  An compartment which is independent of the health status of surrounding waters, shall be supplied with water:

(a) | through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or

(b) | directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe.

(16)  Technical information shall be provided to demonstrate that the relevant pathogen is inactivated in order to reduce the risk of the introduction of the disease to an acceptable level.

(17)  Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status regarding that disease of surrounding natural waters.

(18)  A description shall be provided of the geographical localisation and the distance from other farms/farming areas that make possible to consider the compartment as one epidemiological unit.

(19)  A description shall be provided of the common biosecurity system.

(20)  Each farm or mollusc farming area in a compartment which is dependent on the health status of surrounding waters shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors.

(21)  A comprehensive description needs to be provided unless reference can be made to Community legislation. The national legislation in which the measures are laid down shall be mentioned.

(22)  Describe diagnostic methods and sampling schemes. When OIE or EU standards are applied, refer to them. If not, describe them. Name the laboratories involved in the programme (National Reference Laboratory or designated laboratories).

(23)  A description is provided of the measures as regards positive animals (immediate or delayed harvesting for human consumption, immediate or delayed removal and disposal, measures to avoid the spread of the pathogen when harvesting, further processing or removal and disposal takes place, a procedure for the disinfection of the infected farms or mollusc farming areas, a procedure for restocking with healthy animals in farms or farming areas which have been depopulated and creation of surveillance zone around the infected farm or farming area, etc.).

(1)  Member State, zone or compartment as defined in Point 7 of Annex V.

(2)  Member State, zone or compartment as defined in Point 7 of Annex V.

(3)  Total number of farms or mollusc farming areas existing in the Member State, Zone or Compartment as defined in Point 7 of Annex V.

(4)  Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area should not be counted twice even if has been checked more than once.

(5)  Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas has been checked.

(6)  Farms or mollusc farming areas which health status in the previous period was, in accordance with Part A of Annex III to Directive 2006/88/EC, category I, category II, category III or category IV and have at least one positive animal in this period.In the case of programmes submitted before 1 August 2008, Farms or mollusc farming areas which were not positive to the disease in question in the previous period and have at least one positive animal in this period.

(7)  Animals × 1 000 or total weight of animals removed and disposed of.

(8)  Member State, zone or compartment as defined in Point 7 of Annex V.

(9)  Member State, zone or compartment as defined in Point 7 of Annex V.

(10)  Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 7 of Annex V.

(11)  Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading, the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area should not be counted twice even if has been checked more than once.

(12)  Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas has been checked.

(13)  Farms or mollusc farming areas which health status in the previous period was, in accordance with Part A of Annex III to Directive 2006/88/EC, category I, category II, category III or category IV and have at least one positive animal in this period.

(24)  Referred either to Veterinary funds either to European Fishery Fund (Council Regulation (EC) No 1198/2006).

Pending: 32008D0359

                                January 16, 2026                            

7.5.2008
EN
Official Journal of the European Union
L 120/15

(1)
Article 157(1) of the Treaty assigned the Community and the Member States the task of ensuring that the conditions necessary for the competitiveness of the Community’s industry exist. Article 157(2) in particular calls upon the Member States to consult each other in liaison with the Commission and, where necessary, to coordinate their actions. The Commission may take any useful initiative to promote such coordination.

(2)
In its Communication ‘Mid-term review of Industrial Policy A contribution to the EU’s Growth and Jobs Strategy’(1), the Commission announced the intention to launch a food initiative concerned with the competitiveness of the Community agro-food industry.

(3)
It is therefore necessary to set up a High Level Group composed mainly of experts in the field of competitiveness of the Community agro-food industry, and related challenges such as food safety, health, environment and to define its tasks and structure.

(4)
The group should address issues that determine and will determine in the future the competitiveness of the Community agro-food industry. Based on the outcome of its discussions the group should formulate a set of sector-specific policy recommendations with a view of enhancing the competitiveness of the agro-food industry in accordance with the Community policies, in particular the objectives of food safety and health, agricultural policy and sustainable development.

(5)
The group should be composed of representatives of the Commission, the Member States and relevant stakeholders, in particular from the agro-food industry upstream producers and downstream users, consumers as well as civil society.

(6)
Rules on disclosure of information by members of the group should be provided for, without prejudice to the Commission’s rules on security as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom(2).

(7)
Personal data relating to members of the group should be processed in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data(3),

1.
to address issues that determine and will determine in the future the competitiveness of the Community agro-food industry and related challenges;

2.
to identify the factors that influence the competitive position and sustainability of the Community agro-food industry, including future challenges and trends with an impact on competitiveness;

3.
to formulate a set of sector-specific recommendations addressed to policy makers at the Community level.

(a)
8 representatives of the Member States;

(b)
13 representatives of the agro-food industry;

(c)
6 representatives of civil society and professional associations.

(a)
where they resign;

(b)
where the member is no longer capable of contributing effectively to the group’s deliberations;

(c)
where the member does not comply with Article 287 of the Treaty.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

(1) Article 157(1) of the Treaty assigned the Community and the Member States the task of ensuring that the conditions necessary for the competitiveness of the Community’s industry exist. Article 157(2) in particular calls upon the Member States to consult each other in liaison with the Commission and, where necessary, to coordinate their actions. The Commission may take any useful initiative to promote such coordination.

(2) In its Communication ‘Mid-term review of Industrial Policy A contribution to the EU’s Growth and Jobs Strategy’(1), the Commission announced the intention to launch a food initiative concerned with the competitiveness of the Community agro-food industry.

(3) It is therefore necessary to set up a High Level Group composed mainly of experts in the field of competitiveness of the Community agro-food industry, and related challenges such as food safety, health, environment and to define its tasks and structure.

(4) The group should address issues that determine and will determine in the future the competitiveness of the Community agro-food industry. Based on the outcome of its discussions the group should formulate a set of sector-specific policy recommendations with a view of enhancing the competitiveness of the agro-food industry in accordance with the Community policies, in particular the objectives of food safety and health, agricultural policy and sustainable development.

(5) The group should be composed of representatives of the Commission, the Member States and relevant stakeholders, in particular from the agro-food industry upstream producers and downstream users, consumers as well as civil society.

(6) Rules on disclosure of information by members of the group should be provided for, without prejudice to the Commission’s rules on security as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom(2).

(7) Personal data relating to members of the group should be processed in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data(3),

HAS DECIDED AS FOLLOWS:
High Level Group on the Competitiveness of the Agro-Food Industry

Article 1

A High Level Group on the Competitiveness of the Agro-Food Industry, hereinafter referred to as the ‘group’, is set up.
Task

Article 2

The group’s task shall be the following:

1.

to address issues that determine and will determine in the future the competitiveness of the Community agro-food industry and related challenges;

2.

to identify the factors that influence the competitive position and sustainability of the Community agro-food industry, including future challenges and trends with an impact on competitiveness;

3.

to formulate a set of sector-specific recommendations addressed to policy makers at the Community level.
Consultation

Article 3

The Commission may consult the group on any matter relating to the competitiveness of the Community agro-food industry.
Membership — appointment

Article 4

1.   The members of the group shall be appointed by the Commission from high level specialists with competence and responsibility in areas which are related to the competitiveness and related challenges of the Community agro-food industry.

2.   The group shall comprise up to 27 members composed as follows:

(a)

8 representatives of the Member States;

(b)

13 representatives of the agro-food industry;

(c)

6 representatives of civil society and professional associations.

3.   Members of the group shall be appointed for their expertise in a personal capacity and shall advise the Commission independently of any outside influence.

4.   Each member of the group shall nominate a personal representative to the preparatory sub-group set up in Article 5(2).

5.   Members shall be appointed for a 1-year renewable term of office and shall remain in office until such time as they are replaced in accordance with paragraph 6 of this article or their term of office ends.

6.   Members may be replaced for the remaining period of their term of office in any of the following cases:

(a)

where they resign;

(b)

where the member is no longer capable of contributing effectively to the group’s deliberations;

(c)

where the member does not comply with Article 287 of the Treaty.

7.   Members shall make a written declaration of commitment to act in the public interest, together with a declaration as to whether there is any interest which would prejudice their independence.

8.   The names of the members shall be published on the Internet site of Directorate-General for Enterprise and Industry and in the Commission’s Register of Expert Groups. The names of the members shall be collected, processed and published in accordance with Regulation (EC) No 45/2001.
Operation

Article 5

1.   The group shall be chaired by the Commission.

2.   A sub-group, hereinafter referred to as the ‘sherpa’ sub-group shall prepare the discussions, position papers and advice for actions and/or policy measures to be recommended by the group. It shall work in close contact with the Commission services in order to prepare the work for the group meetings.

3.   The group may, with the agreement of the Commission, set up sub-groups to examine specific questions under terms of reference established by the group. Such subgroups shall be dissolved as soon as their mandates are fulfilled.

4.   The Commission’s representative may ask experts or observers with specific competence on a subject on the agenda to participate in the work of the group, or in the deliberations or work of sub-groups and ad hoc groups.

5.   Information obtained by participating in deliberations or work of the group or ad hoc groups or sub-groups shall not be divulged if, the Commission considers that information to be confidential.

6.   The group, the ‘sherpa’ sub-group, and other sub-groups shall normally meet on Commission premises in accordance with the procedures and schedule established by the Commission. The Commission shall provide secretarial services. Other Commission officials with an interest in the proceedings may attend meetings of the group and its sub-groups.

7.   The group shall adopt its rules of procedure on the basis of the standard rules of procedure adopted by the Commission.

8.   The Commission may publish, or place on the Internet on a dedicated website, in the original language of the document concerned, any summary, conclusion, part of a conclusion or working document of the group, proceedings and reports.
Expiry

Article 6

The Decision shall be applicable until 1st November 2009. The Commission shall decide on a possible extension before that date.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

(1) Article 157(1) of the Treaty assigned the Community and the Member States the task of ensuring that the conditions necessary for the competitiveness of the Community’s industry exist. Article 157(2) in particular calls upon the Member States to consult each other in liaison with the Commission and, where necessary, to coordinate their actions. The Commission may take any useful initiative to promote such coordination.

(2) In its Communication ‘Mid-term review of Industrial Policy A contribution to the EU’s Growth and Jobs Strategy’(1), the Commission announced the intention to launch a food initiative concerned with the competitiveness of the Community agro-food industry.

(3) It is therefore necessary to set up a High Level Group composed mainly of experts in the field of competitiveness of the Community agro-food industry, and related challenges such as food safety, health, environment and to define its tasks and structure.

(4) The group should address issues that determine and will determine in the future the competitiveness of the Community agro-food industry. Based on the outcome of its discussions the group should formulate a set of sector-specific policy recommendations with a view of enhancing the competitiveness of the agro-food industry in accordance with the Community policies, in particular the objectives of food safety and health, agricultural policy and sustainable development.

(5) The group should be composed of representatives of the Commission, the Member States and relevant stakeholders, in particular from the agro-food industry upstream producers and downstream users, consumers as well as civil society.

(6) Rules on disclosure of information by members of the group should be provided for, without prejudice to the Commission’s rules on security as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom(2).

(7) Personal data relating to members of the group should be processed in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data(3),

HAS DECIDED AS FOLLOWS:
High Level Group on the Competitiveness of the Agro-Food IndustryA High Level Group on the Competitiveness of the Agro-Food Industry, hereinafter referred to as the ‘group’, is set up.
TaskThe group’s task shall be the following:

1.

to address issues that determine and will determine in the future the competitiveness of the Community agro-food industry and related challenges;

2.

to identify the factors that influence the competitive position and sustainability of the Community agro-food industry, including future challenges and trends with an impact on competitiveness;

3.

to formulate a set of sector-specific recommendations addressed to policy makers at the Community level.
ConsultationThe Commission may consult the group on any matter relating to the competitiveness of the Community agro-food industry.
Membership — appointment1.   The members of the group shall be appointed by the Commission from high level specialists with competence and responsibility in areas which are related to the competitiveness and related challenges of the Community agro-food industry.

2.   The group shall comprise up to 27 members composed as follows:

(a)

8 representatives of the Member States;

(b)

13 representatives of the agro-food industry;

(c)

6 representatives of civil society and professional associations.

3.   Members of the group shall be appointed for their expertise in a personal capacity and shall advise the Commission independently of any outside influence.

4.   Each member of the group shall nominate a personal representative to the preparatory sub-group set up in Article 5(2).

5.   Members shall be appointed for a 1-year renewable term of office and shall remain in office until such time as they are replaced in accordance with paragraph 6 of this article or their term of office ends.

6.   Members may be replaced for the remaining period of their term of office in any of the following cases:

(a)

where they resign;

(b)

where the member is no longer capable of contributing effectively to the group’s deliberations;

(c)

where the member does not comply with Article 287 of the Treaty.

7.   Members shall make a written declaration of commitment to act in the public interest, together with a declaration as to whether there is any interest which would prejudice their independence.

8.   The names of the members shall be published on the Internet site of Directorate-General for Enterprise and Industry and in the Commission’s Register of Expert Groups. The names of the members shall be collected, processed and published in accordance with Regulation (EC) No 45/2001.
Operation1.   The group shall be chaired by the Commission.

2.   A sub-group, hereinafter referred to as the ‘sherpa’ sub-group shall prepare the discussions, position papers and advice for actions and/or policy measures to be recommended by the group. It shall work in close contact with the Commission services in order to prepare the work for the group meetings.

3.   The group may, with the agreement of the Commission, set up sub-groups to examine specific questions under terms of reference established by the group. Such subgroups shall be dissolved as soon as their mandates are fulfilled.

4.   The Commission’s representative may ask experts or observers with specific competence on a subject on the agenda to participate in the work of the group, or in the deliberations or work of sub-groups and ad hoc groups.

5.   Information obtained by participating in deliberations or work of the group or ad hoc groups or sub-groups shall not be divulged if, the Commission considers that information to be confidential.

6.   The group, the ‘sherpa’ sub-group, and other sub-groups shall normally meet on Commission premises in accordance with the procedures and schedule established by the Commission. The Commission shall provide secretarial services. Other Commission officials with an interest in the proceedings may attend meetings of the group and its sub-groups.

7.   The group shall adopt its rules of procedure on the basis of the standard rules of procedure adopted by the Commission.

8.   The Commission may publish, or place on the Internet on a dedicated website, in the original language of the document concerned, any summary, conclusion, part of a conclusion or working document of the group, proceedings and reports.
ExpiryThe Decision shall be applicable until 1st November 2009. The Commission shall decide on a possible extension before that date.

Pending: 32008D0351

                                January 16, 2026                            

1.5.2008
EN
Official Journal of the European Union
L 117/40

(1)
Annex I to Decision 2000/57/EC of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council(2)lays down events to be reported by the competent public health authorities of each Member State within that system.

(2)
The early warning and response system of the Community network should be reserved for events defined in Annex I to Commission Decision 2000/96/EC(3)or for any other communicable diseases pursuant to Article 7 of that Decision, which, by themselves or in association with other similar events, are or have potential to become public health threats.

(3)
In its conclusions of 30 November and 1 December 2006 the Council of the European Union considered that the World Health Organization and the Community network under Decision No 2119/98/EC should be notified of potential public-health emergencies of international concern at the same time as the Community network, in order to prevent any delay.

(4)
Under the International Health Regulations (2005), which entered into force on 15 June 2007, the competent authorities of the Member States must notify or consult the World Health Organization on certain public health events, in particular those which may constitute a public health emergency of international concern, as well as on any health measure implemented in response to those events.

(5)
Those notifications and consultations concerning communicable diseases pursuant to Annex of Decision No 2119/98/EC should be transmitted through the early warning and response system set up by Decision 2000/57/EC at the same time as to the World Health Organization, in order to ensure that the Commission and the other Member States are informed without delay.

(6)
Annex I to Decision 2000/57/EC should therefore be amended accordingly.

(7)
The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 7 of Decision No 2119/98/EC,

‘5.
Manifestation of a disease or an occurrence that creates a potential for a disease pursuant to Article 1 of the International Health Regulations (2005) which is a communicable disease pursuant to Annex to Decision No 2119/98/EC and related measures to be notified to the World Health Organization under Article 6 of the International Health Regulations (2005).’

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(1), and in particular Articles 1 and 7 thereof,

(1) Annex I to Decision 2000/57/EC of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council(2)lays down events to be reported by the competent public health authorities of each Member State within that system.

(2) The early warning and response system of the Community network should be reserved for events defined in Annex I to Commission Decision 2000/96/EC(3)or for any other communicable diseases pursuant to Article 7 of that Decision, which, by themselves or in association with other similar events, are or have potential to become public health threats.

(3) In its conclusions of 30 November and 1 December 2006 the Council of the European Union considered that the World Health Organization and the Community network under Decision No 2119/98/EC should be notified of potential public-health emergencies of international concern at the same time as the Community network, in order to prevent any delay.

(4) Under the International Health Regulations (2005), which entered into force on 15 June 2007, the competent authorities of the Member States must notify or consult the World Health Organization on certain public health events, in particular those which may constitute a public health emergency of international concern, as well as on any health measure implemented in response to those events.

(5) Those notifications and consultations concerning communicable diseases pursuant to Annex of Decision No 2119/98/EC should be transmitted through the early warning and response system set up by Decision 2000/57/EC at the same time as to the World Health Organization, in order to ensure that the Commission and the other Member States are informed without delay.

(6) Annex I to Decision 2000/57/EC should therefore be amended accordingly.

(7) The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 7 of Decision No 2119/98/EC,

HAS ADOPTED THIS DECISION:
Article 1

Annex I to Decision 2000/57/EC is amended in accordance with the Annex to this Decision.
Article 2

This Decision shall apply from 1 May 2008.
Article 3

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(1), and in particular Articles 1 and 7 thereof,

(1) Annex I to Decision 2000/57/EC of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council(2)lays down events to be reported by the competent public health authorities of each Member State within that system.

(2) The early warning and response system of the Community network should be reserved for events defined in Annex I to Commission Decision 2000/96/EC(3)or for any other communicable diseases pursuant to Article 7 of that Decision, which, by themselves or in association with other similar events, are or have potential to become public health threats.

(3) In its conclusions of 30 November and 1 December 2006 the Council of the European Union considered that the World Health Organization and the Community network under Decision No 2119/98/EC should be notified of potential public-health emergencies of international concern at the same time as the Community network, in order to prevent any delay.

(4) Under the International Health Regulations (2005), which entered into force on 15 June 2007, the competent authorities of the Member States must notify or consult the World Health Organization on certain public health events, in particular those which may constitute a public health emergency of international concern, as well as on any health measure implemented in response to those events.

(5) Those notifications and consultations concerning communicable diseases pursuant to Annex of Decision No 2119/98/EC should be transmitted through the early warning and response system set up by Decision 2000/57/EC at the same time as to the World Health Organization, in order to ensure that the Commission and the other Member States are informed without delay.

(6) Annex I to Decision 2000/57/EC should therefore be amended accordingly.

(7) The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Article 7 of Decision No 2119/98/EC,

HAS ADOPTED THIS DECISION:
Annex I to Decision 2000/57/EC is amended in accordance with the Annex to this Decision.
This Decision shall apply from 1 May 2008.
This Decision is addressed to the Member States.
ANNEXIn Annex I to Decision 2000/57/EC, the following point 5 is added:
‘5. Manifestation of a disease or an occurrence that creates a potential for a disease pursuant to Article 1 of the International Health Regulations (2005) which is a communicable disease pursuant to Annex to Decision No 2119/98/EC and related measures to be notified to the World Health Organization under Article 6 of the International Health Regulations (2005).’

Pending: 32008D0173

                                January 16, 2026                            

1.3.2008
EN
Official Journal of the European Union
L 57/14

(1)
The development of the second generation Schengen Information System (SIS II) has been entrusted to the Commission pursuant to Council Regulation (EC) No 2424/2001 of 6 December 2001 on the development of the second generation Schengen Information System (SIS II)(2)and Decision 2001/886/JHA. The network requirements for SIS II development are established by Commission Decision 2007/170/EC of 16 March 2007 laying down the network requirements for the Schengen Information System II (first pillar)(3)and by Commission Decision 2007/171/EC of 16 March 2007 laying down the network requirements for the Schengen Information System II (third pillar)(4).

(2)
The second generation Schengen Information System (SIS II) was established by Regulation (EC) No 1987/2006 of the European Parliament and of the Council(5)and by Council Decision 2007/533/JHA(6)on the establishment, operation and use of the second generation Schengen Information System. This Decision is without prejudice to those texts, including their final provisions.

(3)
Those final provisions define the conditions that will allow the Council, acting by the unanimity of its Members representing the Governments of the Member States participating in SIS 1+, to fix the date of application of those texts. They provide,inter alia, that the Commission declares the successful completion of a comprehensive test of SIS II, as referred to in Article 55(3)(c) of Regulation (EC) No 1987/2006 and Article 71(3)(c) of Decision 2007/533/JHA, which shall be conducted by the Commission together with the Member States, and the preparatory bodies of the Council validate the proposed test result and confirm that the level of performance of SIS II is at least equivalent to that achieved with SIS 1+.

(4)
It is understood that this Decision should be complemented by the adoption in the future of the appropriate legislation to regulate, in detail, the organisation and coordination of a SIS II comprehensive test, which should be executed in full cooperation between the Member States and the Commission. The CS-SIS should remain the sole responsibility of the Commission.

(5)
It is necessary to conduct tests in order to assess whether SIS II can work in accordance with the technical and functional requirements as defined in the SIS II legal instruments.

(6)
Tests should also assess non-functional requirements such as robustness, availability and performance.

(7)
It is necessary for the Commission to test that the Central SIS II can be connected to the national systems of the Member States, whereas Member States participating in SIS 1+ should make the necessary technical arrangements to process SIS II data and exchange supplementary information.

(8)
It is necessary to clarify further the tasks to be performed by the Commission and the Member States with regard to the completion of certain SIS II tests.

(9)
It is necessary to set out the requirements for the definition, development and application of the test specifications and how the tests should be validated.

(10)
SIS II can become operational only when all Member States fully participating in SIS 1+ have made the necessary arrangements to process SIS II data. Cases where a Member State considers that tests could not be successfully completed should therefore be documented.

(11)
The Committee assisting the Commission during the development of SIS II, and referred to in Article 6 of Decision 2001/886/JHA, has not delivered a favourable opinion on the draft measures of the Commission. The Commission therefore submitted to the Council a proposal relating to the measures to be taken and informed the European Parliament in accordance with Article 6(5) of Decision 2001/886/JHA.

(12)
The United Kingdom is taking part in this Decision, in accordance with Article 5 of the Protocol integrating the Schengenacquisinto the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 8(2) of Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengenacquis(7).

(13)
Ireland is taking part in this Decision in accordance with Article 5 of the Protocol integrating the Schengenacquisinto the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 6(2) of Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengenacquis(8).

(14)
As regards Iceland and Norway, this Decision constitutes a development of provisions of the Schengenacquiswithin the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengenacquis(9), which fall within the area referred to in Article 1, point G, of Council Decision 1999/437/EC(10)on certain arrangements for the application of that Agreement.

(15)
As regards Switzerland, this Decision constitutes a development of the provisions of the Schengenacquiswithin the meaning of the Agreement concluded between the European Union, the European Community and the Swiss Confederation concerning the association of the Swiss Confederation with the implementation, application and development of the Schengenacquis(11), which falls within the area referred to in Article 1, point G, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decisions 2008/149/JHA(12)and 2008/146/EC(13)on the conclusion of that Agreement on behalf of the European Union and on behalf of the European Community,

The first phase of tests shall address testing of the connectivity and resilience of the SIS II communication infrastructure.

The second phase of tests shall address testing of the Central SIS II without N.SIS II.

The third phase of tests shall address testing of the Central SIS II with some N.SIS II and testing of the compliance of each national system with the specifications described in the reference version of the Interface Control Document (ICD).

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union,

Having regard to Council Decision 2001/886/JHA of 6 December 2001 on the development of the second generation Schengen Information System (SIS II)(1), and in particular Article 4(c) and Article 6(6) thereof,

Having regard to the proposal from the Commission,

(1) The development of the second generation Schengen Information System (SIS II) has been entrusted to the Commission pursuant to Council Regulation (EC) No 2424/2001 of 6 December 2001 on the development of the second generation Schengen Information System (SIS II)(2)and Decision 2001/886/JHA. The network requirements for SIS II development are established by Commission Decision 2007/170/EC of 16 March 2007 laying down the network requirements for the Schengen Information System II (first pillar)(3)and by Commission Decision 2007/171/EC of 16 March 2007 laying down the network requirements for the Schengen Information System II (third pillar)(4).

(2) The second generation Schengen Information System (SIS II) was established by Regulation (EC) No 1987/2006 of the European Parliament and of the Council(5)and by Council Decision 2007/533/JHA(6)on the establishment, operation and use of the second generation Schengen Information System. This Decision is without prejudice to those texts, including their final provisions.

(3) Those final provisions define the conditions that will allow the Council, acting by the unanimity of its Members representing the Governments of the Member States participating in SIS 1+, to fix the date of application of those texts. They provide,inter alia, that the Commission declares the successful completion of a comprehensive test of SIS II, as referred to in Article 55(3)(c) of Regulation (EC) No 1987/2006 and Article 71(3)(c) of Decision 2007/533/JHA, which shall be conducted by the Commission together with the Member States, and the preparatory bodies of the Council validate the proposed test result and confirm that the level of performance of SIS II is at least equivalent to that achieved with SIS 1+.

(4) It is understood that this Decision should be complemented by the adoption in the future of the appropriate legislation to regulate, in detail, the organisation and coordination of a SIS II comprehensive test, which should be executed in full cooperation between the Member States and the Commission. The CS-SIS should remain the sole responsibility of the Commission.

(5) It is necessary to conduct tests in order to assess whether SIS II can work in accordance with the technical and functional requirements as defined in the SIS II legal instruments.

(6) Tests should also assess non-functional requirements such as robustness, availability and performance.

(7) It is necessary for the Commission to test that the Central SIS II can be connected to the national systems of the Member States, whereas Member States participating in SIS 1+ should make the necessary technical arrangements to process SIS II data and exchange supplementary information.

(8) It is necessary to clarify further the tasks to be performed by the Commission and the Member States with regard to the completion of certain SIS II tests.

(9) It is necessary to set out the requirements for the definition, development and application of the test specifications and how the tests should be validated.

(10) SIS II can become operational only when all Member States fully participating in SIS 1+ have made the necessary arrangements to process SIS II data. Cases where a Member State considers that tests could not be successfully completed should therefore be documented.

(11) The Committee assisting the Commission during the development of SIS II, and referred to in Article 6 of Decision 2001/886/JHA, has not delivered a favourable opinion on the draft measures of the Commission. The Commission therefore submitted to the Council a proposal relating to the measures to be taken and informed the European Parliament in accordance with Article 6(5) of Decision 2001/886/JHA.

(12) The United Kingdom is taking part in this Decision, in accordance with Article 5 of the Protocol integrating the Schengenacquisinto the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 8(2) of Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengenacquis(7).

(13) Ireland is taking part in this Decision in accordance with Article 5 of the Protocol integrating the Schengenacquisinto the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 6(2) of Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengenacquis(8).

(14) As regards Iceland and Norway, this Decision constitutes a development of provisions of the Schengenacquiswithin the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengenacquis(9), which fall within the area referred to in Article 1, point G, of Council Decision 1999/437/EC(10)on certain arrangements for the application of that Agreement.

(15) As regards Switzerland, this Decision constitutes a development of the provisions of the Schengenacquiswithin the meaning of the Agreement concluded between the European Union, the European Community and the Swiss Confederation concerning the association of the Swiss Confederation with the implementation, application and development of the Schengenacquis(11), which falls within the area referred to in Article 1, point G, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decisions 2008/149/JHA(12)and 2008/146/EC(13)on the conclusion of that Agreement on behalf of the European Union and on behalf of the European Community,

HAS DECIDED AS FOLLOWS:
Article 1

The specifications relevant to certain SIS II tests related to the Central SIS II, the communication infrastructure and the interactions between Central SIS II and the national systems (N.SIS II), in particular their scope and objectives, their requirements and their process shall be as set out in the Annex.
Article 2

This Decision shall take effect on the third day following its publication in theOfficial Journal of the European Union.
THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union,

Having regard to Council Decision 2001/886/JHA of 6 December 2001 on the development of the second generation Schengen Information System (SIS II)(1), and in particular Article 4(c) and Article 6(6) thereof,

Having regard to the proposal from the Commission,

(1) The development of the second generation Schengen Information System (SIS II) has been entrusted to the Commission pursuant to Council Regulation (EC) No 2424/2001 of 6 December 2001 on the development of the second generation Schengen Information System (SIS II)(2)and Decision 2001/886/JHA. The network requirements for SIS II development are established by Commission Decision 2007/170/EC of 16 March 2007 laying down the network requirements for the Schengen Information System II (first pillar)(3)and by Commission Decision 2007/171/EC of 16 March 2007 laying down the network requirements for the Schengen Information System II (third pillar)(4).

(2) The second generation Schengen Information System (SIS II) was established by Regulation (EC) No 1987/2006 of the European Parliament and of the Council(5)and by Council Decision 2007/533/JHA(6)on the establishment, operation and use of the second generation Schengen Information System. This Decision is without prejudice to those texts, including their final provisions.

(3) Those final provisions define the conditions that will allow the Council, acting by the unanimity of its Members representing the Governments of the Member States participating in SIS 1+, to fix the date of application of those texts. They provide,inter alia, that the Commission declares the successful completion of a comprehensive test of SIS II, as referred to in Article 55(3)(c) of Regulation (EC) No 1987/2006 and Article 71(3)(c) of Decision 2007/533/JHA, which shall be conducted by the Commission together with the Member States, and the preparatory bodies of the Council validate the proposed test result and confirm that the level of performance of SIS II is at least equivalent to that achieved with SIS 1+.

(4) It is understood that this Decision should be complemented by the adoption in the future of the appropriate legislation to regulate, in detail, the organisation and coordination of a SIS II comprehensive test, which should be executed in full cooperation between the Member States and the Commission. The CS-SIS should remain the sole responsibility of the Commission.

(5) It is necessary to conduct tests in order to assess whether SIS II can work in accordance with the technical and functional requirements as defined in the SIS II legal instruments.

(6) Tests should also assess non-functional requirements such as robustness, availability and performance.

(7) It is necessary for the Commission to test that the Central SIS II can be connected to the national systems of the Member States, whereas Member States participating in SIS 1+ should make the necessary technical arrangements to process SIS II data and exchange supplementary information.

(8) It is necessary to clarify further the tasks to be performed by the Commission and the Member States with regard to the completion of certain SIS II tests.

(9) It is necessary to set out the requirements for the definition, development and application of the test specifications and how the tests should be validated.

(10) SIS II can become operational only when all Member States fully participating in SIS 1+ have made the necessary arrangements to process SIS II data. Cases where a Member State considers that tests could not be successfully completed should therefore be documented.

(11) The Committee assisting the Commission during the development of SIS II, and referred to in Article 6 of Decision 2001/886/JHA, has not delivered a favourable opinion on the draft measures of the Commission. The Commission therefore submitted to the Council a proposal relating to the measures to be taken and informed the European Parliament in accordance with Article 6(5) of Decision 2001/886/JHA.

(12) The United Kingdom is taking part in this Decision, in accordance with Article 5 of the Protocol integrating the Schengenacquisinto the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 8(2) of Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengenacquis(7).

(13) Ireland is taking part in this Decision in accordance with Article 5 of the Protocol integrating the Schengenacquisinto the framework of the European Union annexed to the Treaty on European Union and to the Treaty establishing the European Community, and Article 6(2) of Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengenacquis(8).

(14) As regards Iceland and Norway, this Decision constitutes a development of provisions of the Schengenacquiswithin the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengenacquis(9), which fall within the area referred to in Article 1, point G, of Council Decision 1999/437/EC(10)on certain arrangements for the application of that Agreement.

(15) As regards Switzerland, this Decision constitutes a development of the provisions of the Schengenacquiswithin the meaning of the Agreement concluded between the European Union, the European Community and the Swiss Confederation concerning the association of the Swiss Confederation with the implementation, application and development of the Schengenacquis(11), which falls within the area referred to in Article 1, point G, of Decision 1999/437/EC read in conjunction with Article 3 of Council Decisions 2008/149/JHA(12)and 2008/146/EC(13)on the conclusion of that Agreement on behalf of the European Union and on behalf of the European Community,

HAS DECIDED AS FOLLOWS:
The specifications relevant to certain SIS II tests related to the Central SIS II, the communication infrastructure and the interactions between Central SIS II and the national systems (N.SIS II), in particular their scope and objectives, their requirements and their process shall be as set out in the Annex.
This Decision shall take effect on the third day following its publication in theOfficial Journal of the European Union.
1.   SCOPE OF SIS II TESTSANNEXCertain SIS II tests referred to in this Decision shall demonstrate that Central SIS II, the communication infrastructure and the interactions between Central SIS II and the national systems (N.SIS II) (except those of Bulgaria and Romania)(1)work in accordance with the technical and functional requirements set out in the SIS II legal instruments.

These SIS II tests shall also demonstrate that Central SIS II, the communication infrastructure and the interactions between Central SIS II and the national systems (N.SIS II) can work in accordance with non-functional requirements such as robustness, availability and performance.

2.   PROCESS DETAILED SCOPE AND ORGANISATION OF SIS II TESTSThe sequence of tests, their objective, scope and organisation shall be articulated as follows:
 | The first phase of tests shall address testing of the connectivity and resilience of the SIS II communication infrastructure.

 | The second phase of tests shall address testing of the Central SIS II without N.SIS II.

 | The third phase of tests shall address testing of the Central SIS II with some N.SIS II and testing of the compliance of each national system with the specifications described in the reference version of the Interface Control Document (ICD).The Test Advisory Group(2)established by the SIS II Committee is competent to report on the results of the tests to the SIS II Committee. The Test Advisory Group shall identify, categorise and describe any issue it detects and propose options for solutions. The Commission services and the Member States’ experts shall provide all necessary information for the Test Advisory Group to perform its task.

2.1.   Test documentationThe Commission shall define the detailed specifications of the tests. The Commission shall make available to the Member States involved the draft and finalised test specifications and the provisions for the management and coordination of the tests within a schedule agreed with the Member States’ experts.

2.2.   Coordination of the testsAll tests set out in the test documentation shall be coordinated by the Commission. For doing so the Commission shall work in close cooperation with the Test Advisory Group.

2.3.   Running the testsThe Commission shall execute the tests, together with the Member States involved on the basis of the test specifications and in accordance with the schedule agreed by the Commission together with Member States’ experts, and demonstrate that the test results are as foreseen in the test specifications.

For the N.SIS II compliance tests, each Member State, with the support of the Commission, shall be responsible for running and ensuring the smooth performance of the tests within the agreed schedule.

2.4.   Acceptance of the testsThe Test Advisory Group shall report on the results of certain SIS II tests to the SIS II Committee. The Test Advisory Group shall identify, categorise and describe any issue it detects and propose options for solutions. The Commission services and the Member States experts shall provide all necessary information for the Test Advisory Group to perform its task.

The Commission will decide on the successful completion of certain SIS II tests taking into account the views expressed by Member States experts within the framework of SIS II Committee.

Where the tests documentation divides the tests into separate phases the Commission shall inform Member States of the results of each phase before the start of the following phase.

The acceptance of the N.SIS II compliance tests will be based on a report, prepared by an expert appointed by the Member States, containing a detailed analysis of the test results and conclusions as to the validation of the Member States’ national systems.

If a Member State considers that tests could not be successfully completed, this should be noted in the report.

2.5.   Tests of the communication infrastructureThe objective of this test exercise shall be to demonstrate that the communication infrastructure of SIS II up to the uniform national interface (NI-SIS) can work in accordance with the requirements laid down in Decisions 2007/170/EC and 2007/171/EC. The scope of this test exercise includes testing the connectivity and the resilience of the SIS II communication infrastructure between CS-SIS and each NI-SIS, between the CS-SIS and backup CS-SIS as well as the resilience of the Local National Interfaces (LNI) and, where applicable, the Back-up Local National Interfaces (BLNI).

2.6.   Central SIS II and national compliance testsThe objective of the whole set of Central SIS II tests shall be to test that the Central SIS II meets the functional and non-functional specifications defined in the reference version of the ICD (Interface Control Document) and the DTS (Detailed Technical Specifications).

The objective of the N.SIS II Compliance test shall be to ensure the compatibility of each N.SIS II with the CS-SIS and to verify the compliance of the National Systems with the reference version of the Interface Control Document. The compliance tests for the N.SIS II may run in parallel with the tests of the Central SIS II.

After the successful completion of certain SIS II tests, the Commission shall inform Member States’ experts within the framework of the SIS II Committee that the test results of the communication infrastructure and of the Central SIS II tests are as foreseen in the test specifications.

After the successful completion of certain SIS II tests, the Commission shall set up a migration environment for the Central SIS II. This environment shall be stable and suitable to be used for migration.

3.   REFERENCE VERSIONS OF THE INTERFACE CONTROL DOCUMENT (ICD) AND DETAILED TECHNICAL SPECIFICATION (DTS) FOR TESTINGThe Central SIS II and the national systems (N.SIS II) in each of the Member States shall be tested against the same specifications.

The DTS prepared by the Commission shall define the functional and non-functional specifications of the Central SIS II.

The ICD prepared by the Commission shall define the interface between the Central SIS II and the national systems. It shall contain the technical specifications of the system-to-system interactions in terms of data items and messages passed, protocols used as well as timing and sequencing of events.

Specifications, as provided in the ICD and DTS, shall be stable for a given period and the timing of the update of both systems shall be laid down in a release plan that shall define the reference version for a given test phase. Issues found during the test campaigns shall be reported, analysed and solved in accordance with a release management plan and associated change management plan. The release management plan and associated change management plan shall be made available by the Commission, taking into account the opinion of Member States’ experts.

4.   INTERIM AND FINAL REPORT ON THE RESULTS OF THE TEST PHASESThe Commission shall draw up, on a regular basis, reports on the status of the tests. The reports shall note which test phase is currently being dealt with and which Member States have completed, begun or not yet begun that phase. If any repercussions for the project timetable are noticeable, they and their cause should be recorded.

On conclusion of each test phase the Commission shall draw up a report on the results, any issue it detects and options for solutions. In cases where a Member State considers that tests could not be successfully completed it shall record this fact, stating the reasons, in a note for the minutes.
(1)  As regards other Member States not participating in SIS 1 + like Cyprus, their participation in the SIS II tests referred to in this Decision is without prejudice to any future Council Decision on the full application of the SIS II.

(2)  The Test Advisory Group created on 27 April 2007 according to Article 7 of the Rules of Procedure of the SIS II Committee, reports to the SIS II Committee. It reports after the completion of each test part to help preparing the acceptance of SIS II tests.

Pending: 32008D0097

                                January 16, 2026                            

6.2.2008
EN
Official Journal of the European Union
L 32/25



(1)
Commission Decision 93/52/EEC of 21 December 1992 recording the compliance by certain Member States or regions with the requirements relating to brucellosis (B. melitensis) and according them the status of a Member State or region officially free of the disease(3)lists the Member States and regions thereof which are recognised as officially free of brucellosis (B. melitensis) in accordance with Directive 91/68/EEC.



(2)
Italy has submitted to the Commission documentation demonstrating compliance with the conditions provided for in Section II(1)(b) of Chapter 1 of Annex A to Directive 91/68/EEC as regards the provinces of Latina and Roma in the Region of Lazio and the Region of Veneto. Those provinces and that region should therefore be recognised as officially free of brucellosis (B. melitensis).



(3)
Directive 64/432/EEC provides that Member States or parts or regions thereof may be declared officially free of tuberculosis, brucellosis and enzootic bovine leucosis as regards bovine herds subject to compliance with certain conditions set out in that Directive.



(4)
The lists of regions of Member States declared free of bovine tuberculosis, bovine brucellosis and enzootic bovine leucosis are set out in Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis and enzootic-bovine-leucosis-free status of certain Member States and regions of Member States as regards bovine herds(4).



(5)
Italy has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards the province of Vercelli in the Region of Piemonte and the provinces of Pisa and Pistoia in the Region of Toscana in order that those provinces may be declared officially tuberculosis-free regions of Italy.



(6)
Italy has also submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards the province of Brindisi in the Region of Puglia and the Region of Toscana in order that that province and that region may be declared officially brucellosis-free regions of Italy.



(7)
Following evaluation of the documentation submitted by Italy, the provinces and the region concerned should therefore be declared officially tuberculosis-free and brucellosis-free regions of Italy respectively as regards bovine animals.



(8)
Poland has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards that certain powiaty may be considered officially enzootic-bovine-leucosis-free regions of Poland.



(9)
Following evaluation of the documentation submitted by Poland, those powiaty in Poland should therefore be recognised as officially enzootic-bovine-leucosis-free regions of that Member State.



(10)
Decisions 93/52/EEC and 2003/467/EC should therefore be amended accordingly.



(11)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,



—
Region Abruzzo: Province of Pescara.



—
Region Friuli Venezia Giulia.



—
Region Lazio: Provinces of Latina, Roma.



—
Region Liguria: Province of Savona.



—
Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.



—
Region Marche: Provinces of Ancona, Ascoli Piceno, Macerata, Pesaro, Urbino.



—
Region Molise: Province of Isernia.



—
Region Piemonte: Provinces of Alessandria, Asti, Biella, Cuneo, Novara, Torino, Verbania, Vercelli.



—
Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.



—
Region Trentino-Alto Adige: Provinces of Bolzano, Trento.



—
Region Toscana: Provinces of Arezzo, Firenze, Grosseto, Livorno, Lucca, Massa-Carrara, Pisa, Pistoia, Prato, Siena.



—
Region Umbria: Provinces of Perugia, Terni.



—
Region of Veneto.’



(1)
in Annex I, Chapter 2 is replaced by the following:‘CHAPTER 2Officially tuberculosis-free regions of Member StatesIn Italy:—Region Abruzzo: Province of Pescara.—Region Emilia-Romagna.—Region Friuli-Venezia Giulia.—Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio.—Region Marche: Province of Ascoli Piceno.—Region Piemonte: Provinces of Novara, Verbania, Vercelli.—Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena.—Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.—Region Veneto: Provinces of Belluno, Padova.’;
—
Region Abruzzo: Province of Pescara.
—
Region Emilia-Romagna.
—
Region Friuli-Venezia Giulia.
—
Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio.
—
Region Marche: Province of Ascoli Piceno.
—
Region Piemonte: Provinces of Novara, Verbania, Vercelli.
—
Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena.
—
Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.
—
Region Veneto: Provinces of Belluno, Padova.’;

—
Region Abruzzo: Province of Pescara.

—
Region Emilia-Romagna.

—
Region Friuli-Venezia Giulia.

—
Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio.

—
Region Marche: Province of Ascoli Piceno.

—
Region Piemonte: Provinces of Novara, Verbania, Vercelli.

—
Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena.

—
Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.

—
Region Veneto: Provinces of Belluno, Padova.’;



—
Region Abruzzo: Province of Pescara.



—
Region Emilia-Romagna.



—
Region Friuli-Venezia Giulia.



—
Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio.



—
Region Marche: Province of Ascoli Piceno.



—
Region Piemonte: Provinces of Novara, Verbania, Vercelli.



—
Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena.



—
Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.



—
Region Veneto: Provinces of Belluno, Padova.’;



(2)
in Annex II, Chapter 2 is replaced by the following:‘CHAPTER 2Officially brucellosis-free regions of Member StatesIn Italy:—Region Abruzzo: Province of Pescara.—Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini.—Region Friuli Venezia Giulia.—Region Lazio: Province of Rieti.—Region Liguria: Provinces of Imperia, Savona.—Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.—Region Marche: Province of Ascoli Piceno.—Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli.—Region Puglia: Province of Brindisi.—Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.—Region Toscana.—Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.—Region Umbria: Provinces of Perugia, Terni.—Region Veneto.’;
—
Region Abruzzo: Province of Pescara.
—
Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini.
—
Region Friuli Venezia Giulia.
—
Region Lazio: Province of Rieti.
—
Region Liguria: Provinces of Imperia, Savona.
—
Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.
—
Region Marche: Province of Ascoli Piceno.
—
Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli.
—
Region Puglia: Province of Brindisi.
—
Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.
—
Region Toscana.
—
Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.
—
Region Umbria: Provinces of Perugia, Terni.
—
Region Veneto.’;

—
Region Abruzzo: Province of Pescara.

—
Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini.

—
Region Friuli Venezia Giulia.

—
Region Lazio: Province of Rieti.

—
Region Liguria: Provinces of Imperia, Savona.

—
Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.

—
Region Marche: Province of Ascoli Piceno.

—
Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli.

—
Region Puglia: Province of Brindisi.

—
Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.

—
Region Toscana.

—
Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.

—
Region Umbria: Provinces of Perugia, Terni.

—
Region Veneto.’;



—
Region Abruzzo: Province of Pescara.



—
Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini.



—
Region Friuli Venezia Giulia.



—
Region Lazio: Province of Rieti.



—
Region Liguria: Provinces of Imperia, Savona.



—
Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.



—
Region Marche: Province of Ascoli Piceno.



—
Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli.



—
Region Puglia: Province of Brindisi.



—
Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.



—
Region Toscana.



—
Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.



—
Region Umbria: Provinces of Perugia, Terni.



—
Region Veneto.’;



(3)
in Chapter 2 of Annex III, the second paragraph concerning Poland is replaced by the following:‘In Poland:—Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.—Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.—Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.—Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.—Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.—Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.—Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.—Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.—Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’
—
Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.
Powiaty
:
Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.
—
Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.
Powiaty
:
Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.
—
Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.
Powiaty
:
Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.
—
Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.
Powiaty
:
Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.
—
Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.
Powiaty
:
Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.
—
Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.
Powiaty
:
Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.
—
Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.
Powiaty
:
Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.
—
Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.
Powiaty
:
Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.
—
Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’
Powiaty
:
Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’

—
Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.
Powiaty
:
Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.

Powiaty
:
Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.

—
Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.
Powiaty
:
Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.

Powiaty
:
Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.

—
Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.
Powiaty
:
Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.

Powiaty
:
Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.

—
Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.
Powiaty
:
Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.

Powiaty
:
Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.

—
Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.
Powiaty
:
Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.

Powiaty
:
Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.

—
Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.
Powiaty
:
Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.

Powiaty
:
Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.

—
Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.
Powiaty
:
Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.

Powiaty
:
Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.

—
Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.
Powiaty
:
Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.

Powiaty
:
Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.

—
Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’
Powiaty
:
Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’

Powiaty
:
Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’



—
Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.
Powiaty
:
Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.

Powiaty
:
Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.



Powiaty
:
Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.



—
Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.
Powiaty
:
Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.

Powiaty
:
Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.



Powiaty
:
Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.



—
Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.
Powiaty
:
Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.

Powiaty
:
Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.



Powiaty
:
Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.



—
Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.
Powiaty
:
Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.

Powiaty
:
Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.



Powiaty
:
Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.



—
Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.
Powiaty
:
Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.

Powiaty
:
Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.



Powiaty
:
Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.



—
Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.
Powiaty
:
Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.

Powiaty
:
Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.



Powiaty
:
Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.



—
Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.
Powiaty
:
Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.

Powiaty
:
Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.



Powiaty
:
Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.



—
Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.
Powiaty
:
Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.

Powiaty
:
Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.



Powiaty
:
Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.



—
Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’
Powiaty
:
Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’

Powiaty
:
Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’



Powiaty
:
Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine(1), and in particular Annex A(I)(4), Annex A(II)(7) and Annex D(I)(E) thereto,

Having regard to Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals(2), and in particular Section II of Chapter 1 of Annex A thereto,

(1) Commission Decision 93/52/EEC of 21 December 1992 recording the compliance by certain Member States or regions with the requirements relating to brucellosis (B. melitensis) and according them the status of a Member State or region officially free of the disease(3)lists the Member States and regions thereof which are recognised as officially free of brucellosis (B. melitensis) in accordance with Directive 91/68/EEC.

(2) Italy has submitted to the Commission documentation demonstrating compliance with the conditions provided for in Section II(1)(b) of Chapter 1 of Annex A to Directive 91/68/EEC as regards the provinces of Latina and Roma in the Region of Lazio and the Region of Veneto. Those provinces and that region should therefore be recognised as officially free of brucellosis (B. melitensis).

(3) Directive 64/432/EEC provides that Member States or parts or regions thereof may be declared officially free of tuberculosis, brucellosis and enzootic bovine leucosis as regards bovine herds subject to compliance with certain conditions set out in that Directive.

(4) The lists of regions of Member States declared free of bovine tuberculosis, bovine brucellosis and enzootic bovine leucosis are set out in Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis and enzootic-bovine-leucosis-free status of certain Member States and regions of Member States as regards bovine herds(4).

(5) Italy has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards the province of Vercelli in the Region of Piemonte and the provinces of Pisa and Pistoia in the Region of Toscana in order that those provinces may be declared officially tuberculosis-free regions of Italy.

(6) Italy has also submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards the province of Brindisi in the Region of Puglia and the Region of Toscana in order that that province and that region may be declared officially brucellosis-free regions of Italy.

(7) Following evaluation of the documentation submitted by Italy, the provinces and the region concerned should therefore be declared officially tuberculosis-free and brucellosis-free regions of Italy respectively as regards bovine animals.

(8) Poland has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards that certain powiaty may be considered officially enzootic-bovine-leucosis-free regions of Poland.

(9) Following evaluation of the documentation submitted by Poland, those powiaty in Poland should therefore be recognised as officially enzootic-bovine-leucosis-free regions of that Member State.

(10) Decisions 93/52/EEC and 2003/467/EC should therefore be amended accordingly.

(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1

Annex II to Decision 93/52/EEC is amended in accordance with Annex I to this Decision.
Article 2

Annexes I, II and III to Decision 2003/467/EC are amended in accordance with Annex II to this Decision.
Article 3

This Decision is addressed to the Member States.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine(1), and in particular Annex A(I)(4), Annex A(II)(7) and Annex D(I)(E) thereto,

Having regard to Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals(2), and in particular Section II of Chapter 1 of Annex A thereto,

(1) Commission Decision 93/52/EEC of 21 December 1992 recording the compliance by certain Member States or regions with the requirements relating to brucellosis (B. melitensis) and according them the status of a Member State or region officially free of the disease(3)lists the Member States and regions thereof which are recognised as officially free of brucellosis (B. melitensis) in accordance with Directive 91/68/EEC.

(2) Italy has submitted to the Commission documentation demonstrating compliance with the conditions provided for in Section II(1)(b) of Chapter 1 of Annex A to Directive 91/68/EEC as regards the provinces of Latina and Roma in the Region of Lazio and the Region of Veneto. Those provinces and that region should therefore be recognised as officially free of brucellosis (B. melitensis).

(3) Directive 64/432/EEC provides that Member States or parts or regions thereof may be declared officially free of tuberculosis, brucellosis and enzootic bovine leucosis as regards bovine herds subject to compliance with certain conditions set out in that Directive.

(4) The lists of regions of Member States declared free of bovine tuberculosis, bovine brucellosis and enzootic bovine leucosis are set out in Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis and enzootic-bovine-leucosis-free status of certain Member States and regions of Member States as regards bovine herds(4).

(5) Italy has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards the province of Vercelli in the Region of Piemonte and the provinces of Pisa and Pistoia in the Region of Toscana in order that those provinces may be declared officially tuberculosis-free regions of Italy.

(6) Italy has also submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards the province of Brindisi in the Region of Puglia and the Region of Toscana in order that that province and that region may be declared officially brucellosis-free regions of Italy.

(7) Following evaluation of the documentation submitted by Italy, the provinces and the region concerned should therefore be declared officially tuberculosis-free and brucellosis-free regions of Italy respectively as regards bovine animals.

(8) Poland has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards that certain powiaty may be considered officially enzootic-bovine-leucosis-free regions of Poland.

(9) Following evaluation of the documentation submitted by Poland, those powiaty in Poland should therefore be recognised as officially enzootic-bovine-leucosis-free regions of that Member State.

(10) Decisions 93/52/EEC and 2003/467/EC should therefore be amended accordingly.

(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Annex II to Decision 93/52/EEC is amended in accordance with Annex I to this Decision.
Annexes I, II and III to Decision 2003/467/EC are amended in accordance with Annex II to this Decision.
This Decision is addressed to the Member States.
ANNEX IIn Annex II to Decision 93/52/EEC, the second paragraph as regards Italy is replaced by the following:

‘In Italy:
— | Region Abruzzo: Province of Pescara.

— | Region Friuli Venezia Giulia.

— | Region Lazio: Provinces of Latina, Roma.

— | Region Liguria: Province of Savona.

— | Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.

— | Region Marche: Provinces of Ancona, Ascoli Piceno, Macerata, Pesaro, Urbino.

— | Region Molise: Province of Isernia.

— | Region Piemonte: Provinces of Alessandria, Asti, Biella, Cuneo, Novara, Torino, Verbania, Vercelli.

— | Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.

— | Region Trentino-Alto Adige: Provinces of Bolzano, Trento.

— | Region Toscana: Provinces of Arezzo, Firenze, Grosseto, Livorno, Lucca, Massa-Carrara, Pisa, Pistoia, Prato, Siena.

— | Region Umbria: Provinces of Perugia, Terni.

— | Region of Veneto.’
ANNEX IIAnnexes I, II and III to Decision 2003/467/EC are amended as follows:
(1) | in Annex I, Chapter 2 is replaced by the following:‘CHAPTER 2Officially tuberculosis-free regions of Member StatesIn Italy:—Region Abruzzo: Province of Pescara.—Region Emilia-Romagna.—Region Friuli-Venezia Giulia.—Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio.—Region Marche: Province of Ascoli Piceno.—Region Piemonte: Provinces of Novara, Verbania, Vercelli.—Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena.—Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.—Region Veneto: Provinces of Belluno, Padova.’; | — | Region Abruzzo: Province of Pescara. | — | Region Emilia-Romagna. | — | Region Friuli-Venezia Giulia. | — | Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio. | — | Region Marche: Province of Ascoli Piceno. | — | Region Piemonte: Provinces of Novara, Verbania, Vercelli. | — | Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena. | — | Region Trentino-Alto Aldige: Provinces of Bolzano, Trento. | — | Region Veneto: Provinces of Belluno, Padova.’;

— | Region Abruzzo: Province of Pescara.

— | Region Emilia-Romagna.

— | Region Friuli-Venezia Giulia.

— | Region Lombardia: Provinces of Bergamo, Como, Lecco, Sondrio.

— | Region Marche: Province of Ascoli Piceno.

— | Region Piemonte: Provinces of Novara, Verbania, Vercelli.

— | Region Toscana: Provinces of Grossetto, Livorno, Lucca, Prato, Pisa, Pistoia, Siena.

— | Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.

— | Region Veneto: Provinces of Belluno, Padova.’;

(2) | in Annex II, Chapter 2 is replaced by the following:‘CHAPTER 2Officially brucellosis-free regions of Member StatesIn Italy:—Region Abruzzo: Province of Pescara.—Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini.—Region Friuli Venezia Giulia.—Region Lazio: Province of Rieti.—Region Liguria: Provinces of Imperia, Savona.—Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.—Region Marche: Province of Ascoli Piceno.—Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli.—Region Puglia: Province of Brindisi.—Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.—Region Toscana.—Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.—Region Umbria: Provinces of Perugia, Terni.—Region Veneto.’; | — | Region Abruzzo: Province of Pescara. | — | Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini. | — | Region Friuli Venezia Giulia. | — | Region Lazio: Province of Rieti. | — | Region Liguria: Provinces of Imperia, Savona. | — | Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese. | — | Region Marche: Province of Ascoli Piceno. | — | Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli. | — | Region Puglia: Province of Brindisi. | — | Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari. | — | Region Toscana. | — | Region Trentino-Alto Aldige: Provinces of Bolzano, Trento. | — | Region Umbria: Provinces of Perugia, Terni. | — | Region Veneto.’;

— | Region Abruzzo: Province of Pescara.

— | Region Emilia-Romagna: Provinces of Bologna, Ferrara, Forli-Cesena, Modena, Parma, Piacenza, Ravenna, Reggio Emilia, Rimini.

— | Region Friuli Venezia Giulia.

— | Region Lazio: Province of Rieti.

— | Region Liguria: Provinces of Imperia, Savona.

— | Region Lombardia: Provinces of Bergamo, Brescia, Como, Cremona, Lecco, Lodi, Mantova, Milano, Pavia, Sondrio, Varese.

— | Region Marche: Province of Ascoli Piceno.

— | Region Piemonte: Provinces of Alessandria, Asti, Biella, Novara, Torino, Verbania, Vercelli.

— | Region Puglia: Province of Brindisi.

— | Region Sardinia: Provinces of Cagliari, Nuoro, Oristano, Sassari.

— | Region Toscana.

— | Region Trentino-Alto Aldige: Provinces of Bolzano, Trento.

— | Region Umbria: Provinces of Perugia, Terni.

— | Region Veneto.’;

(3) | in Chapter 2 of Annex III, the second paragraph concerning Poland is replaced by the following:‘In Poland:—Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.—Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.—Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.—Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.—Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.—Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.—Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.—Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.—Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’ | — | Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski. | Powiaty | : | Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski. | — | Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość. | Powiaty | : | Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość. | — | Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski. | Powiaty | : | Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski. | — | Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki. | Powiaty | : | Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki. | — | Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki. | Powiaty | : | Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki. | — | Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski. | Powiaty | : | Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski. | — | Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki. | Powiaty | : | Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki. | — | Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski. | Powiaty | : | Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski. | — | Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’ | Powiaty | : | Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’

— | Voivodship DolnośląskiePowiaty:Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski. | Powiaty | : | Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.

Powiaty | : | Bolesławiecki, Dzierżoniowski, Głogowski, Górowski, Jaworski, Jeleniogórski, Jelenia Góra, Kamiennogórski, Kłodzki, Legnicki, Legnica, Lubański, Lubiński, Lwówecki, Milicki, Oleśnicki, Oławski, Polkowicki, Strzeliński, Średzki, Świdnicki, Trzebnicki, Wałbrzyski, Wałbrzych, Wołowski, Wrocławski, Wrocław, Ząbkowicki, Zgorzelecki, Złotoryjski.

— | Voivodship LubelskiePowiaty:Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość. | Powiaty | : | Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.

Powiaty | : | Bialski, Biała Podlaska, Biłgorajski, Chełmski, Chełm, Hrubieszowski, Janowski, Krasnostawski, Kraśnicki, Lubartowski, Lubelski, Lublin, Łęczyński, Łukowski, Opolski, Parczewski, Puławski, Radzyński, Rycki, Świdnicki, Tomaszowski, Włodawski, Zamojski, Zamość.

— | Voivodship ŁódzkiePowiaty:Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski. | Powiaty | : | Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.

Powiaty | : | Bełchatowski, Brzeziński, Kutnowski, Łaski, Łęczycki, Łódzki, Łódź, Opoczyński, Pabianicki, Pajęczański, Piotrkowski, Piotrków Trybunalski, Poddębicki, Radomszczański, Rawski, Skierniewicki, Skierniewice, Tomaszowski, Wieluński, Zduńskowolski, Zgierski.

— | Voivodship MałopolskiePowiaty:Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki. | Powiaty | : | Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.

Powiaty | : | Brzeski, Bocheński, Chrzanowski, Dąbrowski, Gorlicki, Krakowski, Kraków, Limanowski, Miechowski, Myślenicki, Nowosądecki, Nowy Sącz, Oświęcimski, Olkuski, Tarnowski, Tarnów, Wielicki.

— | Voivodship OpolskiePowiaty:Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki. | Powiaty | : | Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.

Powiaty | : | Brzeski, Głubczycki, Kędzierzyńsko-Kozielski, Kluczborski, Krapkowicki, Namysłowski, Nyski, Olecki, Opolski, Opole, Prudnicki, Strzelecki.

— | Voivodship PodkarpackiePowiaty:Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski. | Powiaty | : | Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.

Powiaty | : | Bieszczadzki, Brzozowski, Jasielski, Krośnieński, Krosno, Leski, Leżajski, Łańcucki, Rzeszowski, Rzeszów, Sanocki, Strzyżowski.

— | Voivodship ŚląskiePowiaty:Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki. | Powiaty | : | Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.

Powiaty | : | Będziński, Bielski, Bielsko-Biała, Bytom, Chorzów, Cieszyński, Częstochowski, Częstochowa, Dąbrowa, Gliwicki, Gliwice, Jastrzębie Zdrój, Jaworzno, Katowice, Kłobucki, Lubliniecki, Mikołowski, Mysłowice, Myszkowski, Piekary Śląskie, Pszczyński, Raciborski, Ruda Śląska, Rybnicki, Rybnik, Siemianowice, Sosnowiec, Świętochłowice, Tarnogórski, Tychy, Tyski, Wodzisławski, Zabrze, Zawierciański, Żory, Żywiecki.

— | Voivodship ŚwiętokrzyskiePowiaty:Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski. | Powiaty | : | Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.

Powiaty | : | Buski, Jędrzejowski, Kazimierski, Kielecki, Kielce, Konecki, Opatowski, Ostrowiecki, Pińczowski, Sandomierski, Skarżyski, Starachowicki, Staszowski, Włoszczowski.

— | Voivodship WielkopolskiePowiaty:Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’ | Powiaty | : | Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’

Powiaty | : | Jarociński, Kaliski, Kalisz, Kępiński, Kolski, Koniński, Konin, Krotoszyński, Ostrzeszowski, Słupecki, Turecki, Wrzesiński.’
			

Order No	CN code	Description of goods	Period	Quantities
09.1668	1604 14 11 , 1604 14 18 , 1604 20 70	Preserved tuna(1)	1.1.2008 to 31.12.2008	3 000 tonnes
09.1669	1604 14 16	Tuna loins	1.1.2008 to 31.12.2008	600 tonnes

2.1.Designation and supervision of the designated authorities	2.1.	Designation and supervision of the designated authorities
2.1.	Designation and supervision of the designated authorities
Short description of the process of setting up each of the designated authorities[The description should include all authorities]
	Key targets	Achieved?	Comments
1	Rules governing the relations of the Member State with the designated authorities identify the respective responsibilities	Y/N
2	Member State have provided guidance to the designated authorities to ensure sound financial management (through training and/or manuals)	Y/N
3	Each authority will inform their staff of the mission statement of the organisation as well as their job description and expected results	Y/N
4	Steps have been taken to ensure that the different authorities are adequately staffed in terms of numbers, seniority and experience in order to carry out their functions	Y/N

2.2.Separation of functions	2.2.	Separation of functions
2.2.	Separation of functions
Short description of the arrangements defined to ensure a proper separation of functions[The description should include all authorities]
	Key targets	Achieved?	Comments
1	Rules are defined to ensure a proper separation of functions between actors within the responsible authority for the signature of contracts/grant agreements	Y/N
2	Rules are defined to ensure a proper separation of functions between actors within the responsible authority for the initiation, verification and approval of financial transactions	Y/N
3	The audit authority will be functionally independent of the responsible authority and the certifying authority.	Y/N
4	The certifying authority will not be involved in the selection, implementation and financial transactions related to Community resources	Y/N

2.3.Monitoring of delegated authority(ies) — if applicable	2.3.	Monitoring of delegated authority(ies) — if applicable
2.3.	Monitoring of delegated authority(ies) — if applicable
Short description of the process[This description should include the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	The tasks to be delegated are clearly defined	Y/N
2	Procedures are established concerning the delegated tasks and their compliance with the rules defined in the basic act/implementing rules has been checked	Y/N
3	Supervisory controls will take place to ensure that the tasks are carried out according to established procedures	Y/N

2.4.Monitoring of other tasks not carried out by the authorities themselves — if applicable	2.4.	Monitoring of other tasks not carried out by the authorities themselves — if applicable
2.4.	Monitoring of other tasks not carried out by the authorities themselves — if applicable
Short description of the process[This description should include all authorities]
	Key targets	Achieved?	Comments
1	In case of bodies acting under the responsibility of the responsible authority (and not considered as delegated authorities), supervisory mechanisms are in place to ensure sound financial management	Y/N
2	In case of outsourcing of audit activities and in case of bodies acting under the responsibility of the audit authority, supervisory mechanisms are in place to ensure a common audit methodology and consistency of the audit work	Y/N
3	In case of outsourcing of certifying activities and in case of bodies acting under the responsibility of the certifying authority, supervisory mechanisms are in place to ensure a common approach to certification	Y/N
4	In case of outsourcing to private bodies without a public-service mission, mechanisms are defined to ensure that the tasks which may be entrusted do not include the exercise of public authority or require the use of discretionary powers of judgment	Y/N

3.1.Establishing multi-annual programmes	3.1.	Establishing multi-annual programmes
3.1.	Establishing multi-annual programmes
Short description of the process[This description should include the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	Arrangements are foreseen to ensure the implementation of the principle of partnership in accordance with current national rules and practices	Y/N
2	Procedures are defined to check that the multi-annual programme is consistent with the strategic guidelines and complies with Community law, in particular with Community law aiming at ensuring the free movement of persons in conjunction with the directly related flanking measures with respect to external border controls, asylum and immigration	Y/N
3	The multi-annual programme will be approved by a duly authorised person	Y/N

3.3.Establishing the audit strategy and the annual audit plans	3.3.	Establishing the audit strategy and the annual audit plans
3.3.	Establishing the audit strategy and the annual audit plans
Short description of the process[This description concerns the audit authority]
	Key targets	Achieved?	Comments
1	Rules are defined to ensure a transparent and appropriate communication from the responsible authority to the audit authority on management procedures implemented and on projects prior to and throughout the programming period	Y/N
2	Procedures are established to define annual audit plans (to be annexed each year to the audit strategy) and to send them to the Commission in time (if applicable)	Y/N
3	The audit strategy and the annual audit plans are approved by a duly authorised person	Y/N

3.4.Responsible authority acting as an executing body — if applicable	3.4.	Responsible authority acting as an executing body — if applicable
3.4.	Responsible authority acting as an executing body — if applicable
Short description of the reasons leading the responsible authority to implement projects directly and the specific arrangements foreseen to strengthen the management and control systems[This description should include all authorities]
	Key targets	Achieved?	Comments
1	The justification of the need for the responsible authority to implement projects will be documented and endorsed at the appropriate level	Y/N
2	Specific arrangements are put in place to ensure that the nature and the objectives of the projects comply with the provisions defined for the Fund
3	Specific arrangements are put in place in order to prevent conflict of interest for the projects implemented by the responsible authority	Y/N
4	Specific arrangements are put in place to ensure the principle of value for money is respected in the implementation of projects by the responsible authority	Y/N
5	Procedures are defined to ensure that the contractual terms governing these projects are clear and complete in particular with regard to the financing conditions, the payment terms, the eligibility rules and the obligations regarding operational and financial reporting	Y/N
6	Specific arrangements are put in place in order to ensure that the main functions of the responsible authority as provided for in the basic act are not affected in relation to the projects implemented by the responsible authority	Y/N
7	When the responsible authority acts as an executing body, the audit authority is located in another body than the responsible authority (if not, please describe the additional guarantees put in place to ensure the proper independence of the audit authority)	Y/N
8	The audit strategy will cover the specific risks which may be related to the implementation of projects by the responsible authority	Y/N

3.5.Selection and implementation of the projects (Responsible authority acting as an awarding body)	3.5.	Selection and implementation of the projects (Responsible authority acting as an awarding body)
3.5.	Selection and implementation of the projects (Responsible authority acting as an awarding body)
Short description of the process[This description should include the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	In the case of call for proposals (or tenders), rules are defined to ensure open competition and adequate publicity	Y/N
2	Selection criteria will comply with the minimum criteria defined in the basic act	Y/N
3	Procedures are defined for the receipt of proposals (or tenders)	Y/N
4	Procedures are defined to ensure that the proposals (or tenders) are assessed against the predefined rules and criteria in a transparent and non-discriminatory manner	Y/N
5	The award decisions and the contracts/grant agreements will be approved by a duly authorised person	Y/N
6	Procedures are defined to ensure adequate ex-post information on the results of the selection process to the applicants	Y/N
7	Procedures are defined to ensure the monitoring of the implementation of grant agreements/contracts according to the contractual terms	Y/N

3.6.Monitoring of the projects implemented by the final beneficiaries	3.6.	Monitoring of the projects implemented by the final beneficiaries
3.6.	Monitoring of the projects implemented by the final beneficiaries
Short description of the process[This description should include the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	Key operational and financial indicators will be established, monitored and communicated to the responsible authority for each project	Y/N
2	On-the-spot verifications by the responsible authority are foreseen to allow monitoring (of both the operational and financial aspects) of the projects	Y/N
3	The responsible authority will ensure that final beneficiaries make use of an appropriate accounting system in computerised form	Y/N
4	The responsible authority will ensure that final beneficiaries implement the provisions on the visibility of the EU funding	Y/N

3.7.Financial management of the project	3.7.	Financial management of the project
3.7.	Financial management of the project
Short description of the process[involves the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	Financial transactions will be approved by duly authorised persons	Y/N
2	Prior to making any payments/recoveries, verifications will be carried out in particular in order to monitor:—the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)—that products and/or services co-financed by the project have actually been delivered—the accuracy, completeness and effective payment of other contributions received from public or private resources—that the results of any audit activity have been taken into account	—	the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)	—	that products and/or services co-financed by the project have actually been delivered	—	the accuracy, completeness and effective payment of other contributions received from public or private resources	—	that the results of any audit activity have been taken into account	Y/N
—	the accuracy and the regularity of the payment request, with regard to the eligibility rules for the Fund(s)
—	that products and/or services co-financed by the project have actually been delivered
—	the accuracy, completeness and effective payment of other contributions received from public or private resources
—	that the results of any audit activity have been taken into account
3	Verifications will be carried out in order to have a reasonable assurance of the legality and regularity of the underlying transactions	Y/N
4	Supervisory controls will be carried out throughout the programming period to ensure that the established financial procedures are respected.	Y/N
5	Verifications will be performed on the complementarity with other Community financial programmes in order to avoid double funding	Y/N

3.8.Irregularities, corrections and recoveries	3.8.	Irregularities, corrections and recoveries
3.8.	Irregularities, corrections and recoveries
Short description of the process[This description should include the responsible authority, the delegated authority(ies) and the certifying authority]
	Key targets	Achieved?	Comments
1	Definitions of irregularities are established and comply with the Community requirements	Y/N
2	Mechanisms are in place to ensure that irregularities can be detected in due time and immediate corrective measures are taken	Y/N
3	Procedures are in place to ensure that the Commission is kept informed of irregularities detected, and if appropriate, of any corrective measure taken in accordance with the obligations set out in this decision	Y/N
4	Procedures are in place to ensure a proper follow-up of recovery orders issued and, if applicable, of default interest	Y/N
5	In case recovery orders cannot be cashed in, causes will be identified to evaluate whether Member States should reimburse the funds to the Community Budget or not	Y/N

3.9.Preparation and implementation of audit missions	3.9.	Preparation and implementation of audit missions
3.9.	Preparation and implementation of audit missions
Short description of the process[This description should include the audit authority and, as potential auditees, the responsible authority and the delegated authority(ies) and, as recipient of the conclusions, the certifying authority]
	Key targets	Achieved?	Comments
1	The audit practice is in line with internationally accepted standards	Y/N
2	An audit manual is established for use by the auditors on the basis of the requirements defined in the basic act	Y/N
3	Audits will be carried out to verify the effective functioning of the management and control systems	Y/N
4	The checks to be carried on the eligible expenditure will be based on an appropriate sample, and will consist of at least 10 % of eligible expenses	Y/N
5	The verifications on eligible expenses will verify at least the compliance, effectiveness and efficiency of the following elements: selection procedure, objectives of the project, reality of the achievements, eligibility of the expenses, valid supporting documents for the expenses, national co-financing, audit trail	Y/N
6	A follow-up of earlier recommendations will take place on a regular basis	Y/N
7	The projects implemented by the responsible authority will be subject to robust scrutiny	Y/N

3.10.Audit report on annual programmes and related declarations	3.10.	Audit report on annual programmes and related declarations
3.10.	Audit report on annual programmes and related declarations
Short description of the process[This description should involved the audit authority]
	Key targets	Achieved?	Comments
1	Procedures are established to consolidate the conclusions of the systems audit and the audit of projects for each annual programme	Y/N
2	Checks will be performed to assess the validity of the requests for payment	Y/N
3	Further examination will be launched in case of systemic errors or errors over the materiality threshold are detected	Y/N
4	The report and the related declarations will be approved by a duly authorised person	Y/N

3.11.Certification of expenditure	3.11.	Certification of expenditure
3.11.	Certification of expenditure
Short description of the process[involves primarily the certifying authority but also the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	Procedures are established to ensure that the necessary information is received from the responsible authority for the purpose of certification	Y/N
2	Procedures are established to ensure that the audit report on each annual programme and the related declarations are received from the audit authority	Y/N
3	Procedures are established to ensure that recoveries are taken into account for the final declaration of expenditure and to follow on-going legal proceedings or administrative appeals with suspensive effect regarding recoveries	Y/N
4	Verifications will be performed to ensure the accuracy and completeness of the declaration of expenditure (in particular, on any interest generated by the pre-financing received from the Commission as well as its effective use as national contribution)	Y/N
5	In case of local currency, the methods used for the calculation in EUR comply with the rules defined by the Commission	Y/N

3.12.Evaluation of the programme	3.12.	Evaluation of the programme
3.12.	Evaluation of the programme
Short description of the process[involves the responsible authority and the delegated authority(ies)]
	Key targets	Achieved?	Comments
1	The guidance documents from the Commission on evaluations are disseminated widely and made available to all potential final beneficiaries and other interested parties	Y/N
2	The key operational and financial indicators provided by the final beneficiaries to measure the achievements of the project will be recorded	Y/N
3	The responsible authority (and/or delegated authorities) will ensure that the indicators provided are appropriate to measure the outcome and results of each project	Y/N
4	Procedures are in place to ensure that the necessary evaluation will be carried out as required by the basic act	Y/N

4.1.Documentation on the procedures	4.1.	Documentation on the procedures
4.1.	Documentation on the procedures
Short description of the process[involves all authorities]
	Key targets	Achieved?	Comments
1	The authorities will ensure that the established procedures referred to in Article 7 of this decision comply with national and Community law (e.g. public procurement, accounting rules, etc.)	Y/N
2	The procedures are approved by a duly authorised person	Y/N
3	The established procedures set out clear instructions concerning each of the main operations and explain the decision-making circuits concerning the performance of functions	Y/N
4	Arrangements are in place to ensure that all relevant staff is informed of the established procedures	Y/N
5	Where appropriate, these procedures include the use of check-lists summarising the key controls to be performed	Y/N
6	Arrangements are in place to ensure the protection of personal data	Y/N

4.2.Accounting and book keeping	4.2.	Accounting and book keeping
4.2.	Accounting and book keeping
Short description of the process[involves the responsible authority, the delegated authority(ies) and the certifying authority]
	Key targets	Achieved?	Comments
1	Arrangements are in place to ensure that accounting data is complete, reliable and correct. In particular, the accounting system will allow:—a full traceability of the Community resources at the level of the final beneficiaries and projects—the identification of any interest generated by the pre-financing received from the Commission—the identification of recovery orders issued and if applicable, whether they have been cashed	—	a full traceability of the Community resources at the level of the final beneficiaries and projects	—	the identification of any interest generated by the pre-financing received from the Commission	—	the identification of recovery orders issued and if applicable, whether they have been cashed	Y/N
—	a full traceability of the Community resources at the level of the final beneficiaries and projects
—	the identification of any interest generated by the pre-financing received from the Commission
—	the identification of recovery orders issued and if applicable, whether they have been cashed
2	The accounting and financial reporting system complies with the national data protection legislation	Y/N
3	The accounting and financial reporting system to be used will be in computerised form	Y/N
4	A back-up system exists to guarantee the continuity of operations should the need arise	Y/N
5	In case of local currency, the methods used for the calculation in Euro comply with the rules defined by the Commission	Y/N

4.3.Reporting to the Commission	4.3.	Reporting to the Commission
4.3.	Reporting to the Commission
Short description of the process[involves all authorities]
	Key targets	Achieved?	Comments
1	Reporting obligations have been identified as well as the implications for resources	Y/N
2	The established procedures allow proper, timely and complete input by the designated authorities	Y/N
3	Reports are approved by a duly authorised person	Y/N

4.4.Audit trail	4.4.	Audit trail
4.4.	Audit trail
Short description of the process[involves all authorities]
Where are the following documents kept?	Body/Unit in charge	How long for?
Description of the management and control systems including manual(s) of procedures
Audit strategy
National multi-annual programme and possible revisions
National annual programmes and possible revisions
European Commission Decisions on multi-annual and annual programmes
Calls for proposals/Calls for tender
Applicant files/Contract files
Administrative, technical and financial analysis of proposals/tenders received (evaluation grids) and evaluation committee reports
Funding decisions or rejections
Project funding agreements
Financial commitment decisions for each of the projects
Progress reports and final reports submitted by funding recipients
Financial reports and payment applications submitted by funded Project
Supporting documents for expenditure and revenue for funded Project
Payments/recovery authorisations for funding (proof of verifications performed)
Payments/recovery orders for funding
Proof of payments/recovery of funding
Documentation related to the sampling methodology for the audit activity
Reports on audits carried out on projects
Reports on audits carried out at national level on management and control systems
Audit reports on annual programmes
Audit opinions on the management and control systems
Audit declarations on the validity of the requests for payment
Requests for payment sent to the European Commission
Certification of expenditure sent to the European Commission
Progress implementation reports sent to the European Commission
Final implementation reports sent to the European Commission
Proof of payment received from the European Commission
Evaluation reports sent to the European Commission

Guidelines for annual reports on the implementation of Member States national control plans

Subject matter

Definitions

Common authorities

Delegated authority

Outsourcing of tasks

Manual of procedures

Implementation of the Fund by the responsible authority

Conditions under which the responsible authority acts as executing body

Selection and award procedure when the responsible authority acts as awarding body

Grant agreements with final beneficiaries when the responsible authority acts as awarding body

Implementation contracts

Determination of the final Community contribution

Technical assistance

Technical assistance expenditure in the case of a common authority

Verifications by the responsible authority

Audit trail

Audits of systems and audits of projects

Verifications by the certifying authority

Principle of proportionality

Description of management and control systems

Revision of the description of management and control systems

Programming documents

Revision of financial breakdown in annual programmes

Progress and final reports on implementation of annual programmes

Documents established by the audit authority

Documents established by the certifying authority

Initial reporting — derogations

Reporting of follow-up — Non-recovery

Contacts with Member States

Use of information

Information for potential final beneficiaries

Information for final beneficiaries

Responsibilities of the responsible authority relating to information and publicity for the general public

Responsibilities of final beneficiaries relating to information and publicity for the general public

Technical characteristics of information and publicity for the operation

Protection of personal data

Electronic exchange of documents

Computer system for the exchange of documents

Eligibility rules

Addressees

1. IDENTIFICATION OF THE DESIGNATED AUTHORITIES

1. SITUATION IN THE MEMBER STATE

3. ACTIONS TO BE SUPPORTED BY THE PROGRAMME UNDER THE PRIORITIES CHOSEN

A. Technical report

A. Technical report

1. THE AUDIT UNIVERSE

A. Annual audit report

Symbolic description

I. General principles

Clinical criteria

1. Identification of the programme

PART A

1. Identification of the programme

1. Identification of the programme

10. Data on the epidemiological situation/evolution of the disease in the last four years (one table for each year of implementation)

High Level Group on the Competitiveness of the Agro-Food Industry

Task

Consultation

Membership — appointment

Operation

Expiry

1. SCOPE OF SIS II TESTS

Authority	Declaration	Date and signature
Responsible Authority	I certify the accuracy and completeness of the information about the identification and internal control systems of the Responsible Authority	Name:Function:Date:
		signature
Certifying Authority	I certify the accuracy and completeness of the information about the identification and internal control systems of the Certifying Authority	Name:Function:Date:
		signature
Audit Authority	I certify the accuracy and completeness of the information about the identification and internal control systems of the Audit AuthorityandI can confirm that what has been described provides a reliable picture of all the management and control systems	Name:Function:Date:
		signature

	3.3.	Etc.Breakdown when presenting the information on the priorities chosena)The objective(s) of the strategy and examples of key actionsb)Description of target(s) concerned and the indicator(s) usedc)If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority	a)	The objective(s) of the strategy and examples of key actions	b)	Description of target(s) concerned and the indicator(s) used	c)	If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority
a)	The objective(s) of the strategy and examples of key actions
b)	Description of target(s) concerned and the indicator(s) used
c)	If appropriate, an indication of which key actions are considered as implementing specific priorities under the chosen priority

	6.1.1.	TableMultiannual Programme — Draft Financial PlanTable 1Community ContributionMember State: […]Fund: […](in 000’ EUR — current prices)200820092010201120122013TotalPriority 1: […]0Priority 2: […]0Priority 3: […]0Priority …: […]0Technical Assistance0Total0000000	Multiannual Programme — Draft Financial Plan	Table 1Community Contribution	Member State: […]	Fund: […]	(in 000’ EUR — current prices)	2008	2009	2010	2011	2012	2013	Total	Priority 1: […]	0	Priority 2: […]	0	Priority 3: […]	0	Priority …: […]	0	Technical Assistance	0	Total	0	0	0	0	0	0	0
Multiannual Programme — Draft Financial Plan
Table 1Community Contribution
Member State: […]
Fund: […]
(in 000’ EUR — current prices)	2008	2009	2010	2011	2012	2013	Total
Priority 1: […]							0
Priority 2: […]							0
Priority 3: […]							0
Priority …: […]							0
Technical Assistance							0
Total	0	0	0	0	0	0	0

	6.2.1.	TableMultiannual Programme — Draft Financial PlanTable 2Overall Financing PlanMember State: […]Fund: […](in 000’ EUR — current prices)200820092010201120122013TotalCommunity ContributionPublic cofinancingPrivate cofinancingTotal0000000% Community Contribution%%%%%%%	Multiannual Programme — Draft Financial Plan	Table 2Overall Financing Plan	Member State: […]	Fund: […]	(in 000’ EUR — current prices)	2008	2009	2010	2011	2012	2013	Total	Community Contribution	Public cofinancing	Private cofinancing	Total	0	0	0	0	0	0	0	% Community Contribution	%	%	%	%	%	%	%
Multiannual Programme — Draft Financial Plan
Table 2Overall Financing Plan
Member State: […]
Fund: […]
(in 000’ EUR — current prices)	2008	2009	2010	2011	2012	2013	Total
Community Contribution
Public cofinancing
Private cofinancing
Total	0	0	0	0	0	0	0
% Community Contribution	%	%	%	%	%	%	%

Annual Programme — Draft Financial Plan
Table 1Overview table
Member State: […]
Annual programme concerned: […]
Fund: […]
	Ref. priority	Ref. specific priority(1)	Community Contribution	Public Allocation	Private Allocation	Total	% CE	Share of total
(all figures in EUR)			(a)	(b)	(c)	(d = a + b + c)	(e = a/d)	(d/total d)
Action 1: […]						0
Action 2: […]						0
Action 3: […]						0
Action 4: […]						0
Action 5: […]						0
Action …: […]						0
Action N: […]						0
Technical assistance						0
Other operations(2)						0
Total			0	0	0	0	%	100 %

Progress report on the implementation of the annual programme
Table 1Financial report
Member State: […]
Annual programme concerned: […]
Situation at: [day/month/year]
Pre-financing payment(s) received from EC: [amount]
(all figures in EUR)	Ref. priority	Ref. specificpriority(1)	Programmed MS	Committed at the level of the MS	EC contributionpaid by MS to final beneficiaries	Total eligible costs incurred to date by final beneficiaries
Total programmed costs	EC contribution	% EC contribution	Total eligible costs	EC contribution	% EC contribution
			(a)	(b)	(c = b/a)	(d)	(e)	(f = e/d)
Action 1: […]
Action 2: […]
Action 3: […]
Action 4: […]
Action 5: […]
Action N: […]
Technical assistance
Other operations(2)
Total			0	0	0	0	0	0	0	0

									↓	↓
									> 60 % of pre-financing payment(s) received?
									Yes/No	Yes/No

Notification of new irregularities(3)?	No	Yes (if Yes, fill in table 2)
Progress report on the implementation of the annual programme
Table 2Initial reporting on irregularity
Member State: […]
Situation at: [day/month/year]
Fund: […]
Reference	Annual Programme	Project	Provision infringed	Type of irregularity	Date/Source of first information	Method of detection	Possibility of fraud (Y/N)	Amount concerned in EUR (Community contribution)

Follow-up of previous irregularities?	No	Yes (if Yes, fill in table 3)
Progress report on the implementation of the annual programme
Table 3Reporting of follow-up of irregularities
Member State: […]
Situation at: [day/month/year]
Fund: […]
Reference	Annual Programme	Project	Provision infringed	Amount concerned (EC contrib.) in EUR	Follow-up actions	Recovery order (amounts in EUR)	Cancellation of EC contrib.
Issued	Paid	Default interest	Waived

Authority responsible for receiving payments
Bank
Bank account No
Account holder (if not the same as the authority responsible for receiving payments)

Final report on the implementation of the annual programme
Table 2List of pending recovery orders
Member State: […]
Fund: […]
Situation at: [day/month/year]
Reference	Annual Programme	Project	Total amount to be recovered	EC contribution to be recovered	Deduced from the related financial report (Y/N)	Reasons for recovery