Pending: 32003L0053

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) The risks posed to the environment by nonylphenol (NP) and nonylphenol ethoxylate (NPE) have been assessed in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(4). The assessment identified a need to reduce those risks and, in its opinion of 6 and 7 March 2001, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) confirmed that conclusion.(2) NP is classified as a “priority hazardous substance” in Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(5). Pursuant to Article 16(6) of that Directive, the Commission is to submit proposals of control for the cessation or phasing-out of discharges, emissions and losses of such substances.(3) Commission Recommendation 2001/838/EC of 7 November 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-, branched; tert-butyl methyl ether(6), adopted within the framework of Regulation (EEC) No 793/93, proposed a risk limitation strategy for NP and NPE, recommending in particular that restrictions be placed on their marketing and use.(4) In order to protect the environment the Commission is invited to consider an amendment to Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture(7), with a view to establishing a concentration limit value for NP and NPE in sewage sludge that is to be spread on land.(5) In order further to protect the environment, the placing on the market and the use of NP and NPE should be restricted for specific uses which result in discharges, emissions or losses to the environment. However, the restriction concerning co-formulants in pesticides and biocides should be without prejudice to the validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, until they expire.(6) Scientific studies have also shown that cement preparations containing chromium VI may cause allergic reactions in certain circumstances, if there is direct and prolonged contact with the human skin. All uses of cement bear the risk of direct and prolonged contact with the human skin, with the exception of controlled closed and totally automated processes.(7) The CSTEE has confirmed the adverse health effects of chromium VI in cement.(8) Individual protection measures are necessary, but not sufficient to prevent skin contact with cement. Moreover, according to the hierarchy of protection provisions contained in Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (Fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8), the employer is to ensure as a priority that the level of exposure is reduced to as low a level as possible when substitution is impossible, and apply individual protection measures only where exposure cannot be prevented by other means.(9) In order to protect human health, it therefore appears necessary to restrict the placing on the market and the use of cement. In particular, the placing on the market and the use of cement or cement preparations containing more than 2 ppm chromium VI should be restricted in the case of activities where there is a possibility of contact with the skin. In controlled closed and totally automated processes this is not the case, and they should therefore be exempted. Reducing agents should be used at the earliest possible stage, i.e. at the point of cement production.(10) In order further to protect human health, the Commission is invited to consider an amendment to Annex I to Directive 98/24/EC so as to establish a binding occupational exposure limit value for dust.(11) The use of chromium VI has already been prohibited by Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles(9) and by Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment(10). Other uses of chromium VI are being examined in the framework of a risk assessment, and the Commission is invited to propose as soon as possible the appropriate legislation to address any risks identified.(12) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(11) should be amended accordingly.(13) The objective of this Directive is to introduce harmonised provisions with regard to NP, NPE and cement, thus preserving the internal market whilst ensuring a high level of protection for health and the environment, as required by Article 95 of the Treaty.(14) The adoption of a harmonised testing method is desirable for the application of this Directive as regards the content of chromium VI in cement but should not delay the entry into force of this Directive. Therefore, the Commission, in accordance with Article 2a of Directive 76/769/EEC, should establish such a method. The testing method should preferably be developed at European level, if appropriate by the European Committee for Standardisation (CEN).(15) This Directive does not affect the Community legislation laying down minimum requirements for the protection of workers, such as Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(12), and individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(13) and Directive 98/24/EC,HAVE ADOPTED THIS DIRECTIVE:Article 11. Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.2. The validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, shall not be affected by this Directive until they expire.Article 2A harmonised testing method for the application of point 47, cement, of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive.Article 3Before 17 July 2004 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply these provisions from 17 January 2005.Where these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.Article 4This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Luxembourg, 18 June 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) Proposal of 16 August 2002 (not yet published in the Official Journal).(2) OJ C 133, 6.6.2003, p. 13.(3) Opinion of the European Parliament of 27 March 2003 (not yet published in the Official Journal) and Council Decision of 19 May 2003.(4) OJ L 84, 5.4.1993, p. 1.(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).(6) OJ L 319, 4.12.2001, p. 30.(7) OJ L 181, 4.7.1986, p. 6. Directive as last amended by the 1994 Act of Accession.(8) OJ L 131, 5.5.1998, p. 11.(9) OJ L 269, 21.10.2000, p. 34. Directive as amended by Commission Decision 2002/525/EC (OJ L 170, 29.6.2002, p. 81).(10) OJ L 37, 13.2.2003, p. 19.(11) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/36/EC of the European Parliament and of the Council (OJ L 156, 25.6.2003, p. 26).(12) OJ L 183, 29.6.1989, p. 1.(13) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).ANNEXThe following points 46 and 47 shall be added to Annex I of Directive 76/769/EEC:”>TABLE>”

Article 1
1. Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.
2. The validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, shall not be affected by this Directive until they expire.

Article 2
A harmonised testing method for the application of point 47, cement, of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive.

Article 3
Before 17 July 2004 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply these provisions from 17 January 2005.
Where these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 5
This Directive is addressed to the Member States.
Done at Luxembourg, 18 June 2003.
For the European Parliament
The President
For the Council
(1) Proposal of 16 August 2002 (not yet published in the Official Journal).
(2) OJ C 133, 6.6.2003, p. 13.
(3) Opinion of the European Parliament of 27 March 2003 (not yet published in the Official Journal) and Council Decision of 19 May 2003.
(4) OJ L 84, 5.4.1993, p. 1.
(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(6) OJ L 319, 4.12.2001, p. 30.
(7) OJ L 181, 4.7.1986, p. 6. Directive as last amended by the 1994 Act of Accession.
(8) OJ L 131, 5.5.1998, p. 11.
(9) OJ L 269, 21.10.2000, p. 34. Directive as amended by Commission Decision 2002/525/EC (OJ L 170, 29.6.2002, p. 81).
(10) OJ L 37, 13.2.2003, p. 19.
(11) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/36/EC of the European Parliament and of the Council (OJ L 156, 25.6.2003, p. 26).
(12) OJ L 183, 29.6.1989, p. 1.
(13) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) The risks posed to the environment by nonylphenol (NP) and nonylphenol ethoxylate (NPE) have been assessed in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(4). The assessment identified a need to reduce those risks and, in its opinion of 6 and 7 March 2001, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) confirmed that conclusion.(2) NP is classified as a “priority hazardous substance” in Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(5). Pursuant to Article 16(6) of that Directive, the Commission is to submit proposals of control for the cessation or phasing-out of discharges, emissions and losses of such substances.(3) Commission Recommendation 2001/838/EC of 7 November 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-, branched; tert-butyl methyl ether(6), adopted within the framework of Regulation (EEC) No 793/93, proposed a risk limitation strategy for NP and NPE, recommending in particular that restrictions be placed on their marketing and use.(4) In order to protect the environment the Commission is invited to consider an amendment to Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture(7), with a view to establishing a concentration limit value for NP and NPE in sewage sludge that is to be spread on land.(5) In order further to protect the environment, the placing on the market and the use of NP and NPE should be restricted for specific uses which result in discharges, emissions or losses to the environment. However, the restriction concerning co-formulants in pesticides and biocides should be without prejudice to the validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, until they expire.(6) Scientific studies have also shown that cement preparations containing chromium VI may cause allergic reactions in certain circumstances, if there is direct and prolonged contact with the human skin. All uses of cement bear the risk of direct and prolonged contact with the human skin, with the exception of controlled closed and totally automated processes.(7) The CSTEE has confirmed the adverse health effects of chromium VI in cement.(8) Individual protection measures are necessary, but not sufficient to prevent skin contact with cement. Moreover, according to the hierarchy of protection provisions contained in Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (Fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8), the employer is to ensure as a priority that the level of exposure is reduced to as low a level as possible when substitution is impossible, and apply individual protection measures only where exposure cannot be prevented by other means.(9) In order to protect human health, it therefore appears necessary to restrict the placing on the market and the use of cement. In particular, the placing on the market and the use of cement or cement preparations containing more than 2 ppm chromium VI should be restricted in the case of activities where there is a possibility of contact with the skin. In controlled closed and totally automated processes this is not the case, and they should therefore be exempted. Reducing agents should be used at the earliest possible stage, i.e. at the point of cement production.(10) In order further to protect human health, the Commission is invited to consider an amendment to Annex I to Directive 98/24/EC so as to establish a binding occupational exposure limit value for dust.(11) The use of chromium VI has already been prohibited by Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles(9) and by Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment(10). Other uses of chromium VI are being examined in the framework of a risk assessment, and the Commission is invited to propose as soon as possible the appropriate legislation to address any risks identified.(12) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(11) should be amended accordingly.(13) The objective of this Directive is to introduce harmonised provisions with regard to NP, NPE and cement, thus preserving the internal market whilst ensuring a high level of protection for health and the environment, as required by Article 95 of the Treaty.(14) The adoption of a harmonised testing method is desirable for the application of this Directive as regards the content of chromium VI in cement but should not delay the entry into force of this Directive. Therefore, the Commission, in accordance with Article 2a of Directive 76/769/EEC, should establish such a method. The testing method should preferably be developed at European level, if appropriate by the European Committee for Standardisation (CEN).(15) This Directive does not affect the Community legislation laying down minimum requirements for the protection of workers, such as Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(12), and individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(13) and Directive 98/24/EC,HAVE ADOPTED THIS DIRECTIVE:Article 11. Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.2. The validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, shall not be affected by this Directive until they expire.Article 2A harmonised testing method for the application of point 47, cement, of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive.Article 3Before 17 July 2004 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply these provisions from 17 January 2005.Where these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.Article 4This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Luxembourg, 18 June 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) Proposal of 16 August 2002 (not yet published in the Official Journal).(2) OJ C 133, 6.6.2003, p. 13.(3) Opinion of the European Parliament of 27 March 2003 (not yet published in the Official Journal) and Council Decision of 19 May 2003.(4) OJ L 84, 5.4.1993, p. 1.(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).(6) OJ L 319, 4.12.2001, p. 30.(7) OJ L 181, 4.7.1986, p. 6. Directive as last amended by the 1994 Act of Accession.(8) OJ L 131, 5.5.1998, p. 11.(9) OJ L 269, 21.10.2000, p. 34. Directive as amended by Commission Decision 2002/525/EC (OJ L 170, 29.6.2002, p. 81).(10) OJ L 37, 13.2.2003, p. 19.(11) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/36/EC of the European Parliament and of the Council (OJ L 156, 25.6.2003, p. 26).(12) OJ L 183, 29.6.1989, p. 1.(13) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).ANNEXThe following points 46 and 47 shall be added to Annex I of Directive 76/769/EEC:”>TABLE>”
1. Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.
2. The validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, shall not be affected by this Directive until they expire.
A harmonised testing method for the application of point 47, cement, of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive.
Before 17 July 2004 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply these provisions from 17 January 2005.
Where these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Luxembourg, 18 June 2003.
For the European Parliament
The President
For the Council
(1) Proposal of 16 August 2002 (not yet published in the Official Journal).
(2) OJ C 133, 6.6.2003, p. 13.
(3) Opinion of the European Parliament of 27 March 2003 (not yet published in the Official Journal) and Council Decision of 19 May 2003.
(4) OJ L 84, 5.4.1993, p. 1.
(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(6) OJ L 319, 4.12.2001, p. 30.
(7) OJ L 181, 4.7.1986, p. 6. Directive as last amended by the 1994 Act of Accession.
(8) OJ L 131, 5.5.1998, p. 11.
(9) OJ L 269, 21.10.2000, p. 34. Directive as amended by Commission Decision 2002/525/EC (OJ L 170, 29.6.2002, p. 81).
(10) OJ L 37, 13.2.2003, p. 19.
(11) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/36/EC of the European Parliament and of the Council (OJ L 156, 25.6.2003, p. 26).
(12) OJ L 183, 29.6.1989, p. 1.
(13) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).
The following points 46 and 47 shall be added to Annex I of Directive 76/769/EEC:

Pending: 32003L0041

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) A genuine internal market for financial services is crucial for economic growth and job creation in the Community.(2) Major achievements have already been made in the establishment of this internal market, allowing financial institutions to operate in other Member States and ensuring a high level of protection for the consumers of financial services.(3) The communication from the Commission “Implementing the framework for financial markets: action plan” identifies a series of actions that are needed in order to complete the internal market for financial services, and the European Council, at its meeting in Lisbon on 23 and 24 March 2000, called for the implementation of this action plan by 2005.(4) The action plan for financial services stresses as an urgent priority the need to draw up a directive on the prudential supervision of institutions for occupational retirement provision, as these institutions are major financial institutions which have a key role to play in ensuring the integration, efficiency and liquidity of the financial markets, but they are not subject to a coherent Community legislative framework allowing them to benefit fully from the advantages of the internal market.(5) Since social-security systems are coming under increasing pressure, occupational retirement pensions will increasingly be relied on as a complement in future. Occupational retirement pensions should therefore be developed, without, however, calling into question the importance of social-security pension systems in terms of secure, durable and effective social protection, which should guarantee a decent standard of living in old age and should therefore be at the centre of the objective of strengthening the European social model.(6) This Directive thus represents a first step on the way to an internal market for occupational retirement provision organised on a European scale. By setting the “prudent person” rule as the underlying principle for capital investment and making it possible for institutions to operate across borders, the redirection of savings into the sector of occupational retirement provision is encouraged, thus contributing to economic and social progress.(7) The prudential rules laid down in this Directive are intended both to guarantee a high degree of security for future pensioners through the imposition of stringent supervisory standards, and to clear the way for the efficient management of occupational pension schemes.(8) Institutions which are completely separated from any sponsoring undertaking and which operate on a funded basis for the sole purpose of providing retirement benefits should have freedom to provide services and freedom of investment, subject only to coordinated prudential requirements, regardless of whether these institutions are considered as legal entities.(9) In accordance with the principle of subsidiarity, Member States should retain full responsibility for the organisation of their pension systems as well as for the decision on the role of each of the three “pillars” of the retirement system in individual Member States. In the context of the second pillar, they should also retain full responsibility for the role and functions of the various institutions providing occupational retirement benefits, such as industry-wide pension funds, company pension funds and life-assurance companies. This Directive is not intended to call this prerogative into question.(10) National rules concerning the participation of self-employed persons in institutions for occupational retirement provision differ. In some Member States, institutions for occupational retirement provision can operate on the basis of agreements with trade or trade groups whose members act in a self-employed capacity or directly with self-employed and employed persons. In some Member States a self-employed person can also become a member of an institution when the self-employed person acts as employer or provides his professional services to an undertaking. In some Member States self-employed persons cannot join an institution for occupational retirement provision unless certain requirements, including those imposed by social and labour law, are met.(11) Institutions managing social-security schemes, which are already coordinated at Community level, should be excluded from the scope of this Directive. Account should nevertheless be taken of the specificity of institutions which, in a single Member State, manage both social-security schemes and occupational pension schemes.(12) Financial institutions which already benefit from a Community legislative framework should in general be excluded from the scope of this Directive. However, as these institutions may also in some cases offer occupational pension services, it is important to ensure that this Directive does not lead to distortions of competition. Such distortions may be avoided by applying the prudential requirements of this Directive to the occupational pension business of life-assurance companies. The Commission should also carefully monitor the situation in the occupational pensions market and assess the possibility of extending the optional application of this Directive to other regulated financial institutions.(13) When aiming at ensuring financial security in retirement, the benefits paid by institutions for occupational retirement provision should generally provide for the payment of a lifelong pension. Payments for a temporary period or a lump sum should also be possible.(14) It is important to ensure that older and disabled people are not placed at risk of poverty and can enjoy a decent standard of living. Appropriate cover for biometrical risks in occupational pension arrangements is an important aspect of the fight against poverty and insecurity among elderly people. When setting up a pension scheme, employers and employees, or their respective representatives, should consider the possibility of the pension scheme including provisions for the coverage of the longevity risk and occupational disability risks as well as provision for surviving dependants.(15) Giving Member States the possibility to exclude from the scope of national implementing legislation institutions managing schemes which together have less than 100 members in total can facilitate supervision in some Member States, without undermining the proper functioning of the internal market in this field. However, this should not undermine the right of such institutions to appoint for the management of their investment portfolio and the custody of their assets investment managers and custodians established in another Member State and duly authorised.(16) Institutions such as “Unterstützungskassen” in Germany, where the members have no legal rights to benefits of a certain amount and where their interests are protected by a compulsory statutory insolvency insurance, should be excluded from the scope of the Directive.(17) In order to protect members and beneficiaries, institutions for occupational retirement provision should limit their activities to the activities, and those arising therefrom, referred to in this Directive.(18) In the event of the bankruptcy of a sponsoring undertaking, a member faces the risk of losing both his/her job and his/her acquired pension rights. This makes it necessary to ensure that there is a clear separation between that undertaking and the institution and that minimum prudential standards are laid down to protect members.(19) Institutions for occupational retirement provision operate and are supervised with significant differences in Member States. In some Member States, supervision can be exercised not only over the institution itself but also over the entities or companies which are authorised to manage these institutions. Member States should be able to take such specificity into account as long as all the requirements laid down in this Directive are effectively met. Member States should also be able to allow insurance entities and other financial entities to manage institutions for occupational retirement provision.(20) Institutions for occupational retirement provision are financial service providers which bear a heavy responsibility for the provision of occupational retirement benefits and therefore should meet certain minimum prudential standards with respect to their activities and conditions of operation.(21) The huge number of institutions in certain Member States means a pragmatic solution is necessary as regards prior authorisation of institutions. However, if an institution wishes to manage a scheme in another Member State, a prior authorisation granted by the competent authority of the home Member State should be required.(22) Each Member State should require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and annual reports, reflecting a true and fair view of the institution’s assets, liabilities and financial position, taking into account each pension scheme operated by an institution, and duly approved by an authorised person, are an essential source of information for members and beneficiaries of a scheme and the competent authorities. In particular, they enable the competent authorities to monitor the financial soundness of an institution and assess whether the institution is able to meet all its contractual obligations.(23) Proper information for members and beneficiaries of a pension scheme is crucial. This is of particular relevance for requests for information concerning the financial soundness of the institution, the contractual rules, the benefits and the actual financing of accrued pension entitlements, the investment policy and the management of risks and costs.(24) The investment policy of an institution is a decisive factor for both security and affordability of occupational pensions. The institutions should therefore draw up and, at least every three years, review a statement of investment principles. It should be made available to the competent authorities and on request also to members and beneficiaries of each pension scheme.(25) To fulfil their statutory function, the competent authorities should be provided with adequate rights to information and powers of intervention with respect to institutions and the persons who effectively run them. Where an institution for occupational retirement provision has transferred functions of material importance such as investment management, information technology or accounting to other companies (outsourcing), it should be possible for the rights to information and powers of intervention to be enlarged so as to cover these outsourced functions in order to check whether those activities are carried out in accordance with the supervisory rules.(26) A prudent calculation of technical provisions is an essential condition to ensure that obligations to pay retirement benefits can be met. Technical provisions should be calculated on the basis of recognised actuarial methods and certified by qualified persons. The maximum interest rates should be chosen prudently according to any relevant national rules. The minimum amount of technical provisions should both be sufficient for benefits already in payment to beneficiaries to continue to be paid and reflect the commitments that arise out of members’ accrued pension rights.(27) Risks covered by institutions vary significantly from one Member State to another. Home Member States should therefore have the possibility of making the calculation of technical provisions subject to additional and more detailed rules than those laid down in this Directive.(28) Sufficient and appropriate assets to cover the technical provisions protect the interests of members and beneficiaries of the pension scheme if the sponsoring undertaking becomes insolvent. In particular in cases of cross-border activity, the mutual recognition of supervisory principles applied in Member States requires that the technical provisions be fully funded at all times.(29) If the institution does not work on a cross-border basis, Member States should be able to permit underfunding provided that a proper plan is established to restore full funding and without prejudice to the requirements of Council Directive 80/987/EEC of 20 October 1980 on the approximation of the laws of the Member States relating to the protection of employees in the event of the insolvency of their employer(4).(30) In many cases, it could be the sponsoring undertaking and not the institution itself that either covers any biometric risk or guarantees certain benefits or investment performance. However, in some cases, it is the institution itself which provides such cover or guarantees and the sponsor’s obligations are generally exhausted by paying the necessary contributions. In these circumstances, the products offered are similar to those of life-assurance companies and the institutions concerned should hold at least the same additional own funds as life-assurance companies.(31) Institutions are very long-term investors. Redemption of the assets held by these institutions cannot, in general, be made for any purpose other than providing retirement benefits. Furthermore, in order to protect adequately the rights of members and beneficiaries, institutions should be able to opt for an asset allocation that suits the precise nature and duration of their liabilities. These aspects call for efficient supervision and an approach towards investment rules allowing institutions sufficient flexibility to decide on the most secure and efficient investment policy and obliging them to act prudently. Compliance with the “prudent person” rule therefore requires an investment policy geared to the membership structure of the individual institution for occupational retirement provision.(32) Supervisory methods and practices vary among Member States. Therefore, Member States should be given some discretion on the precise investment rules that they wish to impose on the institutions located in their territories. However, these rules must not restrict the free movement of capital, unless justified on prudential grounds.(33) As very long-term investors with low liquidity risks, institutions for occupational retirement provision are in a position to invest in non-liquid assets such as shares as well as in risk capital markets within prudent limits. They can also benefit from the advantages of international diversification. Investments in shares, risk capital markets and currencies other than those of the liabilities should therefore not be restricted except on prudential grounds.(34) However, if the institution works on a cross-border basis, it may be asked by the competent authorities of the host Member State to apply limits for investment in shares and similar assets not admitted to trading on a regulated market, in shares and other instruments issued by the same undertaking or in assets denominated in non-matching currencies provided such rules also apply to institutions located in the host Member State.(35) Restrictions regarding the free choice by institutions of approved asset managers and custodians limit competition in the internal market and should therefore be eliminated.(36) Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, institutions should have the possibility of providing their services in other Member States. They should be allowed to accept sponsorship from undertakings located in other Member States and to operate pension schemes with members in more than one Member State. This would potentially lead to significant economies of scale for these institutions, improve the competitiveness of the Community industry and facilitate labour mobility. This requires mutual recognition of prudential standards. Proper enforcement of these prudential standards should be supervised by the competent authorities of the home Member State, unless specified otherwise.(37) The exercise of the right of an institution in one Member State to manage an occupational pension scheme contracted in another Member State should fully respect the provisions of the social and labour law in force in the host Member State insofar as it is relevant to occupational pensions, for example the definition and payment of retirement benefits and the conditions for transferability of pension rights.(38) When a scheme is ring-fenced, the provisions of this Directive apply individually to that scheme.(39) It is important to make provision for cooperation between the competent authorities of the Member States for supervisory purposes and between those authorities and the Commission for other purposes. For the purposes of carrying out their duties and of contributing to the consistent and timely implementation of this Directive, competent authorities should provide each other with the information necessary to apply the provisions of the Directive. The Commission has indicated its intention to set up a committee of supervisors in order to encourage cooperation, coordination and exchanges of views between national competent authorities, and to promote the consistent implementation of this Directive.(40) Since the objective of the proposed action, namely to create a Community legal framework covering institutions for occupational retirement provision, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved by the Community, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,HAVE ADOPTED THE FOLLOWING DIRECTIVE:Article 1SubjectThis Directive lays down rules for the taking-up and pursuit of activities carried out by institutions for occupational retirement provision.Article 2Scope1. This Directive shall apply to institutions for occupational retirement provision. Where, in accordance with national law, institutions for occupational retirement provision do not have legal personality, Member States shall apply this Directive either to those institutions or, subject to paragraph 2, to those authorised entities responsible for managing them and acting on their behalf.2. This Directive shall not apply to:(a) institutions managing social-security schemes which are covered by Regulation (EEC) No 1408/71(5) and Regulation (EEC) No 574/72(6);(b) institutions which are covered by Directive 73/239/EEC(7), Directive 85/611/EEC(8), Directive 93/22/EEC(9), Directive 2000/12/EC(10) and Directive 2002/83/EC(11);(c) institutions which operate on a pay-as-you-go basis;(d) institutions where employees of the sponsoring undertakings have no legal rights to benefits and where the sponsoring undertaking can redeem the assets at any time and not necessarily meet its obligations for payment of retirement benefits;(e) companies using book-reserve schemes with a view to paying out retirement benefits to their employees.Article 3Application to institutions operating social-security schemesInstitutions for occupational retirement provision which also operate compulsory employment-related pension schemes which are considered to be social-security schemes covered by Regulations (EEC) No 1408/71 and (EEC) No 574/72 shall be covered by this Directive in respect of their non-compulsory occupational retirement provision business. In that case, the liabilities and the corresponding assets shall be ring-fenced and it shall not be possible to transfer them to the compulsory pension schemes which are considered as social-security schemes or vice versa.Article 4Optional application to institutions covered by Directive 2002/83/ECHome Member States may choose to apply the provisions of Articles 9 to 16 and Articles 18 to 20 of this Directive to the occupational-retirement-provision business of insurance undertakings which are covered by Directive 2002/83/EC. In that case, all assets and liabilities corresponding to the said business shall be ring-fenced, managed and organised separately from the other activities of the insurance undertakings, without any possibility of transfer.In such case, and only as far as their occupational retirement provision business is concerned, insurance undertakings shall not be subject to Articles 20 to 26, 31 and 36 of Directive 2002/83/EC.The home Member State shall ensure that either the competent authorities, or the authorities responsible for supervision of insurance undertakings covered by Directive 2002/83/EC, as part of their supervisory work, verify the strict separation of the relevant occupational retirement provision business.Article 5Small pension institutions and statutory schemesWith the exception of Article 19, Member States may choose not to apply this Directive, in whole or in part, to any institution located in their territories which operates pension schemes which together have less than 100 members in total. Subject to Article 2(2), such institutions should nevertheless be given the right to apply this Directive on a voluntary basis. Article 20 may be applied only if all the other provisions of this Directive apply.Member States may choose not to apply Articles 9 to 17 to institutions where occupational retirement provision is made under statute, pursuant to legislation, and is guaranteed by a public authority. Article 20 may be applied only if all the other provisions of this Directive apply.Article 6DefinitionsFor the purposes of this Directive:(a) “institution for occupational retirement provision”, or “institution”, means an institution, irrespective of its legal form, operating on a funded basis, established separately from any sponsoring undertaking or trade for the purpose of providing retirement benefits in the context of an occupational activity on the basis of an agreement or a contract agreed:- individually or collectively between the employer(s) and the employee(s) or their respective representatives, or- with self-employed persons, in compliance with the legislation of the home and host Member States,and which carries out activities directly arising therefrom;(b) “pension scheme” means a contract, an agreement, a trust deed or rules stipulating which retirement benefits are granted and under which conditions;(c) “sponsoring undertaking” means any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which pays contributions into an institution for occupational retirement provision;(d) “retirement benefits” means benefits paid by reference to reaching, or the expectation of reaching, retirement or, where they are supplementary to those benefits and provided on an ancillary basis, in the form of payments on death, disability, or cessation of employment or in the form of support payments or services in case of sickness, indigence or death. In order to facilitate financial security in retirement, these benefits usually take the form of payments for life. They may, however, also be payments made for a temporary period or as a lump sum.(e) “member” means a person whose occupational activities entitle or will entitle him/her to retirement benefits in accordance with the provisions of a pension scheme;(f) “beneficiary” means a person receiving retirement benefits;(g) “competent authorities” means the national authorities designated to carry out the duties provided for in this Directive;(h) “biometrical risks” mean risks linked to death, disability and longevity;(i) “home Member State” means the Member State in which the institution has its registered office and its main administration or, if it does not have a registered office, its main administration;(j) “host Member State” means the Member State whose social and labour law relevant to the field of occupational pension schemes is applicable to the relationship between the sponsoring undertaking and members.Article 7Activities of an institutionEach Member State shall require institutions located within its territory to limit their activities to retirement-benefit related operations and activities arising therefrom.When, in accordance with Article 4, an insurance undertaking manages its occupational retirement provision business by ring-fencing its assets and liabilities, the ring-fenced assets and liabilities shall be restricted to retirement-benefit related operations and activities directly arising therefrom.Article 8Legal separation between sponsoring undertakings and institutions for occupational retirement provisionEach Member State shall ensure that there is a legal separation between a sponsoring undertaking and an institution for occupational retirement provision in order that the assets of the institution are safeguarded in the interests of members and beneficiaries in the event of bankruptcy of the sponsoring undertaking.Article 9Conditions of operation1. Each Member State shall, in respect of every institution located in its territory, ensure that:(a) the institution is registered in a national register by the competent supervisory authority or authorised; in the case of cross-border activities referred to in Article 20, the register shall also indicate the Member States in which the institution is operating;(b) the institution is effectively run by persons of good repute who must themselves have appropriate professional qualifications and experience or employ advisers with appropriate professional qualifications and experience;(c) properly constituted rules regarding the functioning of any pension scheme operated by the institution have been implemented and members have been adequately informed of these rules;(d) all technical provisions are computed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State;(e) where the sponsoring undertaking guarantees the payment of the retirement benefits, it is committed to regular financing;(f) the members are sufficiently informed of the conditions of the pension scheme, in particular concerning:(i) the rights and obligations of the parties involved in the pension scheme;(ii) the financial, technical and other risks associated with the pension scheme;(iii) the nature and distribution of those risks.2. In accordance with the principle of subsidiarity and taking due account of the scale of pension benefits offered by the social-security regimes, Member States may provide that the option of longevity and disability cover, provision for surviving dependants and a guarantee of repayment of contributions as additional benefits be offered to members if employers and employees, or their respective representatives, so agree.3. A Member State may make the conditions of operation of an institution located in its territory subject to other requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.4. A Member State may permit or require institutions located in its territory to entrust management of these institutions, in whole or in part, to other entities operating on behalf of those institutions.5. In the case of cross-border activity as referred to in Article 20, the conditions of operation of the institution shall be subject to a prior authorisation by the competent authorities of the home Member State.Article 10Annual accounts and annual reportsEach Member State shall require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and the annual reports shall give a true and fair view of the institution’s assets, liabilities and financial position. The annual accounts and information in the reports shall be consistent, comprehensive, fairly presented and duly approved by authorised persons, according to national law.Article 11Information to be given to the members and beneficiaries1. Depending on the nature of the pension scheme established, each Member State shall ensure that every institution located in its territory provides at least the information set out in this Article.2. Members and beneficiaries and/or, where applicable, their representatives shall receive:(a) on request, the annual accounts and the annual reports referred to in Article 10, and, where an institution is responsible for more than one scheme, those relating to their particular pension scheme;(b) within a reasonable time, any relevant information regarding changes to the pension-scheme rules.3. The statement of investment policy principles, referred to in Article 12, shall be made available to members and beneficiaries and/or, where applicable, to their representatives on request.4. Each member shall also receive, on request, detailed and substantial information on:(a) the target level of the retirement benefits, if applicable;(b) the level of benefits in case of cessation of employment;(c) where the member bears the investment risk, the range of investment options, if applicable, and the actual investment portfolio as well as information on risk exposure and costs related to the investments;(d) the arrangements relating to the transfer of pension rights to another institution for occupational retirement provision in the event of termination of the employment relationship.Members shall receive every year brief particulars of the situation of the institution as well as the current level of financing of their accrued individual entitlements.5. Each beneficiary shall receive, on retirement or when other benefits become due, the appropriate information on the benefits which are due and the corresponding payment options.Article 12Statement of investment policy principlesEach Member State shall ensure that every institution located in its territory prepares and, at least every three years, reviews a written statement of investment-policy principles. This statement is to be revised without delay after any significant change in the investment policy. Member States shall provide that this statement contains, at least, such matters as the investment risk measurement methods, the risk-management processes implemented and the strategic asset allocation with respect to the nature and duration of pension liabilities.Article 13Information to be provided to the competent authoritiesEach Member State shall ensure that the competent authorities, in respect of any institution located in its territory, have the necessary powers and means:(a) to require the institution, the members of its board of directors and other managers or directors or persons controlling the institution to supply information about all business matters or forward all business documents;(b) to supervise relationships between the institution and other companies or between institutions, when institutions transfer functions to those other companies or institutions (outsourcing), influencing the financial situation of the institution or being in a material way relevant for effective supervision;(c) to obtain regularly the statement of investment-policy principles, the annual accounts and the annual reports, and all the documents necessary for the purposes of supervision. These may include documents such as:(i) internal interim reports;(ii) actuarial valuations and detailed assumptions;(iii) asset-liability studies;(iv) evidence of consistency with the investment-policy principles;(v) evidence that contributions have been paid in as planned;(vi) reports by the persons responsible for auditing the annual accounts referred to in Article 10;(d) to carry out on-site inspections at the institution’s premises and, where appropriate, on outsourced functions to check if activities are carried out in accordance with the supervisory rules.Article 14Powers of intervention and duties of the competent authorities1. The competent authorities shall require every institution located in their territories to have sound administrative and accounting procedures and adequate internal control mechanisms.2. The competent authorities shall have the power to take any measures including, where appropriate, those of an administrative or financial nature, either with regard to any institution located in their territories or against the persons running the institution, which are appropriate and necessary to prevent or remedy any irregularities prejudicial to the interests of the members and beneficiaries.They may also restrict or prohibit the free disposal of the institution’s assets when, in particular:(a) the institution has failed to establish sufficient technical provisions in respect of the entire business or has insufficient assets to cover the technical provisions;(b) the institution has failed to hold the regulatory own funds.3. In order to safeguard the interests of members and beneficiaries, the competent authorities may transfer the powers which the persons running an institution located in their territories hold in accordance with the law of the home Member State wholly or partly to a special representative who is fit to exercise these powers.4. The competent authorities may prohibit or restrict the activities of an institution located in their territories in particular if:(a) the institution fails to protect adequately the interests of members and beneficiaries;(b) the institution no longer fulfils the conditions of operation;(c) the institution fails seriously in its obligations under the rules to which it is subject;(d) in the case of cross-border activity, the institution does not respect the requirements of social and labour law of the host Member State relevant to the field of occupational pensions.Any decision to prohibit the activities of an institution shall be supported by precise reasons and notified to the institution in question.5. Member States shall ensure that decisions taken in respect of an institution under laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts.Article 15Technical provisions1. The home Member State shall ensure that institutions operating occupational pension schemes establish at all times in respect of the total range of their pension schemes an adequate amount of liabilities corresponding to the financial commitments which arise out of their portfolio of existing pension contracts.2. The home Member State shall ensure that institutions operating occupational pension schemes, where they provide cover against biometric risks and/or guarantee either an investment performance or a given level of benefits, establish sufficient technical provisions in respect of the total range of these schemes.3. The calculation of technical provisions shall take place every year. However, the home Member State may allow a calculation once every three years if the institution provides members and/or the competent authorities with a certification or a report of adjustments for the intervening years. The certification or the report shall reflect the adjusted development of the technical provisions and changes in risks covered.4. The calculation of the technical provisions shall be executed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State, according to the following principles:(a) the minimum amount of the technical provisions shall be calculated by a sufficiently prudent actuarial valuation, taking account of all commitments for benefits and for contributions in accordance with the pension arrangements of the institution. It must be sufficient both for pensions and benefits already in payment to beneficiaries to continue to be paid, and to reflect the commitments which arise out of members’ accrued pension rights. The economic and actuarial assumptions chosen for the valuation of the liabilities shall also be chosen prudently taking account, if applicable, of an appropriate margin for adverse deviation;(b) the maximum rates of interest used shall be chosen prudently and determined in accordance with any relevant rules of the home Member State. These prudent rates of interest shall be determined by taking into account:- the yield on the corresponding assets held by the institution and the future investment returns and/or- the market yields of high-quality or government bonds;(c) the biometric tables used for the calculation of technical provisions shall be based on prudent principles, having regard to the main characteristics of the group of members and the pension schemes, in particular the expected changes in the relevant risks;(d) the method and basis of calculation of technical provisions shall in general remain constant from one financial year to another. However, discontinuities may be justified by a change of legal, demographic or economic circumstances underlying the assumptions.5. The home Member State may make the calculation of technical provisions subject to additional and more detailed requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.6. With a view to further harmonisation of the rules regarding the calculation of technical provisions which may be justified – in particular the interest rates and other assumptions influencing the level of technical provisions – the Commission shall, every two years or at the request of a Member State, issue a report on the situation concerning the development in cross-border activities.The Commission shall propose any necessary measures to prevent possible distortions caused by different levels of interest rates and to protect the interest of beneficiaries and members of any scheme.Article 16Funding of technical provisions1. The home Member State shall require every institution to have at all times sufficient and appropriate assets to cover the technical provisions in respect of the total range of pension schemes operated.2. The home Member State may allow an institution, for a limited period of time, to have insufficient assets to cover the technical provisions. In this case the competent authorities shall require the institution to adopt a concrete and realisable recovery plan in order to ensure that the requirements of paragraph 1 are met again. The plan shall be subject to the following conditions:(a) the institution shall set up a concrete and realisable plan to re-establish the required amount of assets to cover fully the technical provisions in due time. The plan shall be made available to members or, where applicable, to their representatives and/or shall be subject to approval by the competent authorities of the home Member State;(b) in drawing up the plan, account shall be taken of the specific situation of the institution, in particular the asset/liability structure, risk profile, liquidity plan, the age profile of the members entitled to receive retirement benefits, start-up schemes and schemes changing from non-funding or partial funding to full funding;(c) in the event of termination of a pension scheme during the period referred to above in this paragraph, the institution shall inform the competent authorities of the home Member State. The institution shall establish a procedure in order to transfer the assets and the corresponding liabilities to another financial institution or a similar body. This procedure shall be disclosed to the competent authorities of the home Member State and a general outline of the procedure shall be made available to members or, where applicable, to their representatives in accordance with the principle of confidentiality.3. In the event of cross-border activity as referred to in Article 20, the technical provisions shall at all times be fully funded in respect of the total range of pension schemes operated. If these conditions are not met, the competent authorities of the home Member State shall intervene in accordance with Article 14. To comply with this requirement the home Member State may require ring-fencing of the assets and liabilities.Article 17Regulatory own funds1. The home Member State shall ensure that institutions operating pension schemes, where the institution itself, and not the sponsoring undertaking, underwrites the liability to cover against biometric risk, or guarantees a given investment performance or a given level of benefits, hold on a permanent basis additional assets above the technical provisions to serve as a buffer. The amount thereof shall reflect the type of risk and asset base in respect of the total range of schemes operated. These assets shall be free of all foreseeable liabilities and serve as a safety capital to absorb discrepancies between the anticipated and the actual expenses and profits.2. For the purposes of calculating the minimum amount of the additional assets, the rules laid down in Articles 27 and 28 of Directive 2002/83/EC shall apply.3. Paragraph 1 shall, however, not prevent Member States from requiring institutions located in their territory to hold regulatory own funds or from laying down more detailed rules provided that they are prudentially justified.Article 18Investment rules1. Member States shall require institutions located in their territories to invest in accordance with the “prudent person” rule and in particular in accordance with the following rules:(a) the assets shall be invested in the best interests of members and beneficiaries. In the case of a potential conflict of interest, the institution, or the entity which manages its portfolio, shall ensure that the investment is made in the sole interest of members and beneficiaries;(b) the assets shall be invested in such a manner as to ensure the security, quality, liquidity and profitability of the portfolio as a whole.Assets held to cover the technical provisions shall also be invested in a manner appropriate to the nature and duration of the expected future retirement benefits;(c) the assets shall be predominantly invested on regulated markets. Investment in assets which are not admitted to trading on a regulated financial market must in any event be kept to prudent levels;(d) investment in derivative instruments shall be possible insofar as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis, taking into account the underlying asset, and included in the valuation of the institution’s assets. The institution shall also avoid excessive risk exposure to a single counterparty and to other derivative operations;(e) the assets shall be properly diversified in such a way as to avoid excessive reliance on any particular asset, issuer or group of undertakings and accumulations of risk in the portfolio as a whole.Investments in assets issued by the same issuer or by issuers belonging to the same group shall not expose the institution to excessive risk concentration;(f) investment in the sponsoring undertaking shall be no more than 5 % of the portfolio as a whole and, when the sponsoring undertaking belongs to a group, investment in the undertakings belonging to the same group as the sponsoring undertaking shall not be more than 10 % of the portfolio.When the institution is sponsored by a number of undertakings, investment in these sponsoring undertakings shall be made prudently, taking into account the need for proper diversification.Member States may decide not to apply the requirements referred to in points (e) and (f) to investment in government bonds.2. The home Member State shall prohibit the institution from borrowing or acting as a guarantor on behalf of third parties. However, Member States may authorise institutions to carry out some borrowing only for liquidity purposes and on a temporary basis.3. Member States shall not require institutions located in their territory to invest in particular categories of assets.4. Without prejudice to Article 12, Member States shall not subject the investment decisions of an institution located in their territory or its investment manager to any kind of prior approval or systematic notification requirements.5. In accordance with the provisions of paragraphs 1 to 4, Member States may, for the institutions located in their territories, lay down more detailed rules, including quantitative rules, provided they are prudentially justified, to reflect the total range of pension schemes operated by these institutions.In particular, Member States may apply investment provisions similar to those of Directive 2002/83/EC.However, Member States shall not prevent institutions from:(a) investing up to 70 % of the assets covering the technical provisions or of the whole portfolio for schemes in which the members bear the investment risks in shares, negotiable securities treated as shares and corporate bonds admitted to trading on regulated markets and deciding on the relative weight of these securities in their investment portfolio. Provided it is prudentially justified, Member States may, however, apply a lower limit to institutions which provide retirement products with a long-term interest rate guarantee, bear the investment risk and themselves provide for the guarantee;(b) investing up to 30 % of the assets covering technical provisions in assets denominated in currencies other than those in which the liabilities are expressed;(c) investing in risk capital markets.6. Paragraph 5 shall not preclude the right for Member States to require the application to institutions located in their territory of more stringent investment rules also on an individual basis provided they are prudentially justified, in particular in the light of the liabilities entered into by the institution.7. In the event of cross-border activity as referred in Article 20, the competent authorities of each host Member State may require that the rules set out in the second subparagraph apply to the institution in the home Member State. In such case, these rules shall apply only to the part of the assets of the institution that corresponds to the activities carried out in the particular host Member State. Furthermore, they shall only be applied if the same or stricter rules also apply to institutions located in the host Member State.The rules referred to in the first subparagraph are as follows:(a) the institution shall not invest more than 30 % of these assets in shares, other securities treated as shares and debt securities which are not admitted to trading on a regulated market, or the institution shall invest at least 70 % of these assets in shares, other securities treated as shares, and debt securities which are admitted to trading on a regulated market;(b) the institution shall invest no more than 5 % of these assets in shares and other securities treated as shares, bonds, debt securities and other money and capital-market instruments issued by the same undertaking and no more than 10 % of these assets in shares and other securities treated as shares, bonds, debt securities and other money and capital market instruments issued by undertakings belonging to a single group;(c) the institution shall not invest more than 30 % of these assets in assets denominated in currencies other than those in which the liabilities are expressed.To comply with these requirements, the home Member State may require ring-fencing of the assets.Article 19Management and custody1. Member States shall not restrict institutions from appointing, for the management of the investment portfolio, investment managers established in another Member State and duly authorised for this activity, in accordance with Directives 85/611/EEC, 93/22/EEC, 2000/12/EC and 2002/83/EC, as well as those referred to in Article 2(1) of this Directive.2. Member States shall not restrict institutions from appointing, for the custody of their assets, custodians established in another Member State and duly authorised in accordance with Directive 93/22/EEC or Directive 2000/12/EC, or accepted as a depositary for the purposes of Directive 85/611/EEC.The provision referred to in this paragraph shall not prevent the home Member State from making the appointment of a depositary or a custodian compulsory.3. Each Member State shall take the necessary steps to enable it under its national law to prohibit, in accordance with Article 14, the free disposal of assets held by a depositary or custodian located within its territory at the request of the institution’s home Member State.Article 20Cross-border activities1. Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, Member States shall allow undertakings located within their territories to sponsor institutions for occupational retirement provision authorised in other Member States. They shall also allow institutions for occupational retirement provision authorised in their territories to accept sponsorship by undertakings located within the territories of other Member States.2. An institution wishing to accept sponsorship from a sponsoring undertaking located within the territory of another Member State shall be subject to a prior authorisation by the competent authorities of its home Member State, as referred to in Article 9(5). It shall notify its intention to accept sponsorship from a sponsoring undertaking located within the territory of another Member State to the competent authorities of the home Member State where it is authorised.3. Member States shall require institutions located within their territories and proposing to be sponsored by an undertaking located in the territory of another Member State to provide the following information when effecting a notification under paragraph 2:(a) the host Member State(s);(b) the name of the sponsoring undertaking;(c) the main characteristics of the pension scheme to be operated for the sponsoring undertaking.4. Where a competent authority of the home Member State is notified under paragraph 2, and unless it has reason to doubt that the administrative structure or the financial situation of the institution or the good repute and professional qualifications or experience of the persons running the institution are compatible with the operations proposed in the host Member State, it shall within three months of receiving all the information referred to in paragraph 3 communicate that information to the competent authorities of the host Member State and inform the institution accordingly.5. Before the institution starts to operate a pension scheme for a sponsoring undertaking in another Member State, the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 3, inform the competent authorities of the home Member State, if appropriate, of the requirements of social and labour law relevant to the field of occupational pensions under which the pension scheme sponsored by an undertaking in the host Member State must be operated and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. The competent authorities of the home Member State shall communicate this information to the institution.6. On receiving the communication referred to in paragraph 5, or if no communication is received from the competent authorities of the home Member State on expiry of the period provided for in paragraph 5, the institution may start to operate the pension scheme sponsored by an undertaking in the host Member State in accordance with the host Member State’s requirements of social and labour law relevant to the field of occupational pensions, and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.7. In particular, an institution sponsored by an undertaking located in another Member State shall also be subject, in respect of the corresponding members, to any information requirements imposed by the competent authorities of the host Member State on institutions located in that Member State, in accordance with Article 11.8. The competent authorities of the host Member State shall inform the competent authorities of the home Member State of any significant change in the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes which may affect the characteristics of the pension scheme insofar as it concerns the operation of the pension scheme sponsored by an undertaking in the host Member State and in any rules that have to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.9. The institution shall be subject to ongoing supervision by the competent authorities of the host Member State as to the compliance of its activities with the host Member State’s requirements of labour and social law relevant to the field of occupational pension schemes referred to in paragraph 5 and with the information requirements referred to in paragraph 7. Should this supervision bring irregularities to light, the competent authorities of the host Member State shall inform the competent authorities of the home Member State immediately. The competent authorities of the home Member State shall, in coordination with the competent authorities of the host Member State, take the necessary measures to ensure that the institution puts a stop to the detected breach of social and labour law.10. If, despite the measures taken by the competent authorities of the home Member State or because appropriate measures are lacking in the home Member State, the institution persists in breaching the applicable provisions of the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes, the competent authorities of the host Member State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalise further irregularities, including, insofar as is strictly necessary, preventing the institution from operating in the host Member State for the sponsoring undertaking.Article 21Cooperation between Member States and the Commission1. Member States shall ensure, in an appropriate manner, the uniform application of this Directive through regular exchanges of information and experience with a view to developing best practices in this sphere and closer cooperation, and by so doing, preventing distortions of competition and creating the conditions required for unproblematic cross-border membership.2. The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating supervision of the operations of institutions for occupational retirement provision.3. Each Member State shall inform the Commission of any major difficulties to which the application of this Directive gives rise.The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution.4. Four years after the entry into force of this Directive, the Commission shall issue a report reviewing:(a) the application of Article 18 and the progress achieved in the adaptation of national supervisory systems, and(b) the application of the second subparagraph of Article 19(2), in particular the situation prevailing in Member States regarding the use of depositaries and the role played by them where appropriate.5. The competent authorities of the host Member State may ask the competent authorities of the home Member State to decide on the ring-fencing of the institution’s assets and liabilities, as provided for in Article 16(3) and Article 18(7).Article 22Implementation1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 September 2005. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.3. Member States may postpone until 23 September 2010 the application of Article 17(1) and (2) to institutions located in their territory which at the date specified in paragraph 1 of this Article do not have the minimum level of regulatory own funds required pursuant to Article 17(1) and (2). However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.4. Member States may postpone until 23 September 2010 the application of Article 18(1)(f) to institutions located in their territory. However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.Article 23Entry in forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 24AddresseesThis Directive is addressed to the Member States.Done at Luxembourg, 3 June 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentN. Christodoulakis(1) OJ C 96 E, 27.3.2001, p. 136.(2) OJ C 155, 29.5.2001, p. 26.(3) Opinion of the European Parliament of 4 July 2001 (OJ C 65 E, 14.3.2002, p. 135), Council common position of 5 November 2002 (not yet published in the Official Journal) and decision of the European Parliament of 12 March 2003 (not yet published in the Official Journal) and decision of the Council of 13 May 2003.(4) OJ L 283, 28.10.1980, p. 23. Directive as last amended by Directive 2002/74/EC of the European Parliament and of the Council (OJ L 270, 8.10.2002, p. 10).(5) Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 149, 5.7.1971, p. 2). Regulation as last amended by Regulation (EC) No 1386/2001 of the European Parliament and of the Council (OJ L 187, 10.7.2001, p. 1).(6) Council Regulation (EEC) No 574/72 of 21 March 1972 fixing the procedure for implementing Regulation (EEC) No 1408/71 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 74, 27.3.1972, p. 1). Regulation as last amended by Commission Regulation (EC) No 410/2002 (OJ L 62, 5.3.2002, p. 17).(7) First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (OJ L 228, 16.8.1973, p. 3). Directive as last amended by Directive 2002/13/EC of the European Parliament and of the Council (OJ L 77, 20.3.2002, p. 17).(8) Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 375, 31.12.1985, p. 3). Directive as last amended by Directive 2001/108/EC of the European Parliament and of the Council (OJ L 41, 13.2.2002, p. 35).(9) Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (OJ L 141, 11.6.1993, p. 27). Directive as last amended by Directive 2000/64/EC of the European Parliament and of the Council (OJ L 290, 17.11.2000, p. 27).(10) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking-up and pursuit of the business of credit institutions (OJ L 126, 26.5.2000, p. 1). Directive as amended by Directive 2000/28/EC (OJ L 275, 27.10.2000, p. 37).(11) Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (OJ L 345, 19.12.2002, p. 1).

Article 1
This Directive lays down rules for the taking-up and pursuit of activities carried out by institutions for occupational retirement provision.

Article 2
1. This Directive shall apply to institutions for occupational retirement provision. Where, in accordance with national law, institutions for occupational retirement provision do not have legal personality, Member States shall apply this Directive either to those institutions or, subject to paragraph 2, to those authorised entities responsible for managing them and acting on their behalf.
2. This Directive shall not apply to:
(a) institutions managing social-security schemes which are covered by Regulation (EEC) No 1408/71(5) and Regulation (EEC) No 574/72(6);
(b) institutions which are covered by Directive 73/239/EEC(7), Directive 85/611/EEC(8), Directive 93/22/EEC(9), Directive 2000/12/EC(10) and Directive 2002/83/EC(11);
(c) institutions which operate on a pay-as-you-go basis;
(d) institutions where employees of the sponsoring undertakings have no legal rights to benefits and where the sponsoring undertaking can redeem the assets at any time and not necessarily meet its obligations for payment of retirement benefits;
(e) companies using book-reserve schemes with a view to paying out retirement benefits to their employees.

Article 3
Application to institutions operating social-security schemes
Institutions for occupational retirement provision which also operate compulsory employment-related pension schemes which are considered to be social-security schemes covered by Regulations (EEC) No 1408/71 and (EEC) No 574/72 shall be covered by this Directive in respect of their non-compulsory occupational retirement provision business. In that case, the liabilities and the corresponding assets shall be ring-fenced and it shall not be possible to transfer them to the compulsory pension schemes which are considered as social-security schemes or vice versa.

Article 4
Optional application to institutions covered by Directive 2002/83/EC
Home Member States may choose to apply the provisions of Articles 9 to 16 and Articles 18 to 20 of this Directive to the occupational-retirement-provision business of insurance undertakings which are covered by Directive 2002/83/EC. In that case, all assets and liabilities corresponding to the said business shall be ring-fenced, managed and organised separately from the other activities of the insurance undertakings, without any possibility of transfer.
In such case, and only as far as their occupational retirement provision business is concerned, insurance undertakings shall not be subject to Articles 20 to 26, 31 and 36 of Directive 2002/83/EC.
The home Member State shall ensure that either the competent authorities, or the authorities responsible for supervision of insurance undertakings covered by Directive 2002/83/EC, as part of their supervisory work, verify the strict separation of the relevant occupational retirement provision business.

Article 5
Small pension institutions and statutory schemes
With the exception of Article 19, Member States may choose not to apply this Directive, in whole or in part, to any institution located in their territories which operates pension schemes which together have less than 100 members in total. Subject to Article 2(2), such institutions should nevertheless be given the right to apply this Directive on a voluntary basis. Article 20 may be applied only if all the other provisions of this Directive apply.
Member States may choose not to apply Articles 9 to 17 to institutions where occupational retirement provision is made under statute, pursuant to legislation, and is guaranteed by a public authority. Article 20 may be applied only if all the other provisions of this Directive apply.

Article 6
Definitions
For the purposes of this Directive:
(a) “institution for occupational retirement provision”, or “institution”, means an institution, irrespective of its legal form, operating on a funded basis, established separately from any sponsoring undertaking or trade for the purpose of providing retirement benefits in the context of an occupational activity on the basis of an agreement or a contract agreed:
– individually or collectively between the employer(s) and the employee(s) or their respective representatives, or
– with self-employed persons, in compliance with the legislation of the home and host Member States,
and which carries out activities directly arising therefrom;
(b) “pension scheme” means a contract, an agreement, a trust deed or rules stipulating which retirement benefits are granted and under which conditions;
(c) “sponsoring undertaking” means any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which pays contributions into an institution for occupational retirement provision;
(d) “retirement benefits” means benefits paid by reference to reaching, or the expectation of reaching, retirement or, where they are supplementary to those benefits and provided on an ancillary basis, in the form of payments on death, disability, or cessation of employment or in the form of support payments or services in case of sickness, indigence or death. In order to facilitate financial security in retirement, these benefits usually take the form of payments for life. They may, however, also be payments made for a temporary period or as a lump sum.
(e) “member” means a person whose occupational activities entitle or will entitle him/her to retirement benefits in accordance with the provisions of a pension scheme;
(f) “beneficiary” means a person receiving retirement benefits;
(g) “competent authorities” means the national authorities designated to carry out the duties provided for in this Directive;
(h) “biometrical risks” mean risks linked to death, disability and longevity;
(i) “home Member State” means the Member State in which the institution has its registered office and its main administration or, if it does not have a registered office, its main administration;
(j) “host Member State” means the Member State whose social and labour law relevant to the field of occupational pension schemes is applicable to the relationship between the sponsoring undertaking and members.

Article 7
Activities of an institution
Each Member State shall require institutions located within its territory to limit their activities to retirement-benefit related operations and activities arising therefrom.
When, in accordance with Article 4, an insurance undertaking manages its occupational retirement provision business by ring-fencing its assets and liabilities, the ring-fenced assets and liabilities shall be restricted to retirement-benefit related operations and activities directly arising therefrom.

Article 8
Legal separation between sponsoring undertakings and institutions for occupational retirement provision
Each Member State shall ensure that there is a legal separation between a sponsoring undertaking and an institution for occupational retirement provision in order that the assets of the institution are safeguarded in the interests of members and beneficiaries in the event of bankruptcy of the sponsoring undertaking.

Article 9
Conditions of operation
1. Each Member State shall, in respect of every institution located in its territory, ensure that:
(a) the institution is registered in a national register by the competent supervisory authority or authorised; in the case of cross-border activities referred to in Article 20, the register shall also indicate the Member States in which the institution is operating;
(b) the institution is effectively run by persons of good repute who must themselves have appropriate professional qualifications and experience or employ advisers with appropriate professional qualifications and experience;
(c) properly constituted rules regarding the functioning of any pension scheme operated by the institution have been implemented and members have been adequately informed of these rules;
(d) all technical provisions are computed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State;
(e) where the sponsoring undertaking guarantees the payment of the retirement benefits, it is committed to regular financing;
(f) the members are sufficiently informed of the conditions of the pension scheme, in particular concerning:
(i) the rights and obligations of the parties involved in the pension scheme;
(ii) the financial, technical and other risks associated with the pension scheme;
(iii) the nature and distribution of those risks.
2. In accordance with the principle of subsidiarity and taking due account of the scale of pension benefits offered by the social-security regimes, Member States may provide that the option of longevity and disability cover, provision for surviving dependants and a guarantee of repayment of contributions as additional benefits be offered to members if employers and employees, or their respective representatives, so agree.
3. A Member State may make the conditions of operation of an institution located in its territory subject to other requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.
4. A Member State may permit or require institutions located in its territory to entrust management of these institutions, in whole or in part, to other entities operating on behalf of those institutions.
5. In the case of cross-border activity as referred to in Article 20, the conditions of operation of the institution shall be subject to a prior authorisation by the competent authorities of the home Member State.

Article 10
Annual accounts and annual reports
Each Member State shall require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and the annual reports shall give a true and fair view of the institution’s assets, liabilities and financial position. The annual accounts and information in the reports shall be consistent, comprehensive, fairly presented and duly approved by authorised persons, according to national law.

Article 11
Information to be given to the members and beneficiaries
1. Depending on the nature of the pension scheme established, each Member State shall ensure that every institution located in its territory provides at least the information set out in this Article.
2. Members and beneficiaries and/or, where applicable, their representatives shall receive:
(a) on request, the annual accounts and the annual reports referred to in Article 10, and, where an institution is responsible for more than one scheme, those relating to their particular pension scheme;
(b) within a reasonable time, any relevant information regarding changes to the pension-scheme rules.
3. The statement of investment policy principles, referred to in Article 12, shall be made available to members and beneficiaries and/or, where applicable, to their representatives on request.
4. Each member shall also receive, on request, detailed and substantial information on:
(a) the target level of the retirement benefits, if applicable;
(b) the level of benefits in case of cessation of employment;
(c) where the member bears the investment risk, the range of investment options, if applicable, and the actual investment portfolio as well as information on risk exposure and costs related to the investments;
(d) the arrangements relating to the transfer of pension rights to another institution for occupational retirement provision in the event of termination of the employment relationship.
Members shall receive every year brief particulars of the situation of the institution as well as the current level of financing of their accrued individual entitlements.
5. Each beneficiary shall receive, on retirement or when other benefits become due, the appropriate information on the benefits which are due and the corresponding payment options.

Article 12
Statement of investment policy principles
Each Member State shall ensure that every institution located in its territory prepares and, at least every three years, reviews a written statement of investment-policy principles. This statement is to be revised without delay after any significant change in the investment policy. Member States shall provide that this statement contains, at least, such matters as the investment risk measurement methods, the risk-management processes implemented and the strategic asset allocation with respect to the nature and duration of pension liabilities.

Article 13
Information to be provided to the competent authorities
Each Member State shall ensure that the competent authorities, in respect of any institution located in its territory, have the necessary powers and means:
(a) to require the institution, the members of its board of directors and other managers or directors or persons controlling the institution to supply information about all business matters or forward all business documents;
(b) to supervise relationships between the institution and other companies or between institutions, when institutions transfer functions to those other companies or institutions (outsourcing), influencing the financial situation of the institution or being in a material way relevant for effective supervision;
(c) to obtain regularly the statement of investment-policy principles, the annual accounts and the annual reports, and all the documents necessary for the purposes of supervision. These may include documents such as:
(i) internal interim reports;
(ii) actuarial valuations and detailed assumptions;
(iii) asset-liability studies;
(iv) evidence of consistency with the investment-policy principles;
(v) evidence that contributions have been paid in as planned;
(vi) reports by the persons responsible for auditing the annual accounts referred to in Article 10;
(d) to carry out on-site inspections at the institution’s premises and, where appropriate, on outsourced functions to check if activities are carried out in accordance with the supervisory rules.

Article 14
Powers of intervention and duties of the competent authorities
1. The competent authorities shall require every institution located in their territories to have sound administrative and accounting procedures and adequate internal control mechanisms.
2. The competent authorities shall have the power to take any measures including, where appropriate, those of an administrative or financial nature, either with regard to any institution located in their territories or against the persons running the institution, which are appropriate and necessary to prevent or remedy any irregularities prejudicial to the interests of the members and beneficiaries.
They may also restrict or prohibit the free disposal of the institution’s assets when, in particular:
(a) the institution has failed to establish sufficient technical provisions in respect of the entire business or has insufficient assets to cover the technical provisions;
(b) the institution has failed to hold the regulatory own funds.
3. In order to safeguard the interests of members and beneficiaries, the competent authorities may transfer the powers which the persons running an institution located in their territories hold in accordance with the law of the home Member State wholly or partly to a special representative who is fit to exercise these powers.
4. The competent authorities may prohibit or restrict the activities of an institution located in their territories in particular if:
(a) the institution fails to protect adequately the interests of members and beneficiaries;
(b) the institution no longer fulfils the conditions of operation;
(c) the institution fails seriously in its obligations under the rules to which it is subject;
(d) in the case of cross-border activity, the institution does not respect the requirements of social and labour law of the host Member State relevant to the field of occupational pensions.
Any decision to prohibit the activities of an institution shall be supported by precise reasons and notified to the institution in question.
5. Member States shall ensure that decisions taken in respect of an institution under laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts.

Article 15
Technical provisions
1. The home Member State shall ensure that institutions operating occupational pension schemes establish at all times in respect of the total range of their pension schemes an adequate amount of liabilities corresponding to the financial commitments which arise out of their portfolio of existing pension contracts.
2. The home Member State shall ensure that institutions operating occupational pension schemes, where they provide cover against biometric risks and/or guarantee either an investment performance or a given level of benefits, establish sufficient technical provisions in respect of the total range of these schemes.
3. The calculation of technical provisions shall take place every year. However, the home Member State may allow a calculation once every three years if the institution provides members and/or the competent authorities with a certification or a report of adjustments for the intervening years. The certification or the report shall reflect the adjusted development of the technical provisions and changes in risks covered.
4. The calculation of the technical provisions shall be executed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State, according to the following principles:
(a) the minimum amount of the technical provisions shall be calculated by a sufficiently prudent actuarial valuation, taking account of all commitments for benefits and for contributions in accordance with the pension arrangements of the institution. It must be sufficient both for pensions and benefits already in payment to beneficiaries to continue to be paid, and to reflect the commitments which arise out of members’ accrued pension rights. The economic and actuarial assumptions chosen for the valuation of the liabilities shall also be chosen prudently taking account, if applicable, of an appropriate margin for adverse deviation;
(b) the maximum rates of interest used shall be chosen prudently and determined in accordance with any relevant rules of the home Member State. These prudent rates of interest shall be determined by taking into account:
– the yield on the corresponding assets held by the institution and the future investment returns and/or
– the market yields of high-quality or government bonds;
(c) the biometric tables used for the calculation of technical provisions shall be based on prudent principles, having regard to the main characteristics of the group of members and the pension schemes, in particular the expected changes in the relevant risks;
(d) the method and basis of calculation of technical provisions shall in general remain constant from one financial year to another. However, discontinuities may be justified by a change of legal, demographic or economic circumstances underlying the assumptions.
5. The home Member State may make the calculation of technical provisions subject to additional and more detailed requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.
6. With a view to further harmonisation of the rules regarding the calculation of technical provisions which may be justified – in particular the interest rates and other assumptions influencing the level of technical provisions – the Commission shall, every two years or at the request of a Member State, issue a report on the situation concerning the development in cross-border activities.
The Commission shall propose any necessary measures to prevent possible distortions caused by different levels of interest rates and to protect the interest of beneficiaries and members of any scheme.

Article 16
Funding of technical provisions
1. The home Member State shall require every institution to have at all times sufficient and appropriate assets to cover the technical provisions in respect of the total range of pension schemes operated.
2. The home Member State may allow an institution, for a limited period of time, to have insufficient assets to cover the technical provisions. In this case the competent authorities shall require the institution to adopt a concrete and realisable recovery plan in order to ensure that the requirements of paragraph 1 are met again. The plan shall be subject to the following conditions:
(a) the institution shall set up a concrete and realisable plan to re-establish the required amount of assets to cover fully the technical provisions in due time. The plan shall be made available to members or, where applicable, to their representatives and/or shall be subject to approval by the competent authorities of the home Member State;
(b) in drawing up the plan, account shall be taken of the specific situation of the institution, in particular the asset/liability structure, risk profile, liquidity plan, the age profile of the members entitled to receive retirement benefits, start-up schemes and schemes changing from non-funding or partial funding to full funding;
(c) in the event of termination of a pension scheme during the period referred to above in this paragraph, the institution shall inform the competent authorities of the home Member State. The institution shall establish a procedure in order to transfer the assets and the corresponding liabilities to another financial institution or a similar body. This procedure shall be disclosed to the competent authorities of the home Member State and a general outline of the procedure shall be made available to members or, where applicable, to their representatives in accordance with the principle of confidentiality.
3. In the event of cross-border activity as referred to in Article 20, the technical provisions shall at all times be fully funded in respect of the total range of pension schemes operated. If these conditions are not met, the competent authorities of the home Member State shall intervene in accordance with Article 14. To comply with this requirement the home Member State may require ring-fencing of the assets and liabilities.

Article 17
Regulatory own funds
1. The home Member State shall ensure that institutions operating pension schemes, where the institution itself, and not the sponsoring undertaking, underwrites the liability to cover against biometric risk, or guarantees a given investment performance or a given level of benefits, hold on a permanent basis additional assets above the technical provisions to serve as a buffer. The amount thereof shall reflect the type of risk and asset base in respect of the total range of schemes operated. These assets shall be free of all foreseeable liabilities and serve as a safety capital to absorb discrepancies between the anticipated and the actual expenses and profits.
2. For the purposes of calculating the minimum amount of the additional assets, the rules laid down in Articles 27 and 28 of Directive 2002/83/EC shall apply.
3. Paragraph 1 shall, however, not prevent Member States from requiring institutions located in their territory to hold regulatory own funds or from laying down more detailed rules provided that they are prudentially justified.

Article 18
Investment rules
1. Member States shall require institutions located in their territories to invest in accordance with the “prudent person” rule and in particular in accordance with the following rules:
(a) the assets shall be invested in the best interests of members and beneficiaries. In the case of a potential conflict of interest, the institution, or the entity which manages its portfolio, shall ensure that the investment is made in the sole interest of members and beneficiaries;
(b) the assets shall be invested in such a manner as to ensure the security, quality, liquidity and profitability of the portfolio as a whole.
Assets held to cover the technical provisions shall also be invested in a manner appropriate to the nature and duration of the expected future retirement benefits;
(c) the assets shall be predominantly invested on regulated markets. Investment in assets which are not admitted to trading on a regulated financial market must in any event be kept to prudent levels;
(d) investment in derivative instruments shall be possible insofar as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis, taking into account the underlying asset, and included in the valuation of the institution’s assets. The institution shall also avoid excessive risk exposure to a single counterparty and to other derivative operations;
(e) the assets shall be properly diversified in such a way as to avoid excessive reliance on any particular asset, issuer or group of undertakings and accumulations of risk in the portfolio as a whole.
Investments in assets issued by the same issuer or by issuers belonging to the same group shall not expose the institution to excessive risk concentration;
(f) investment in the sponsoring undertaking shall be no more than 5 % of the portfolio as a whole and, when the sponsoring undertaking belongs to a group, investment in the undertakings belonging to the same group as the sponsoring undertaking shall not be more than 10 % of the portfolio.
When the institution is sponsored by a number of undertakings, investment in these sponsoring undertakings shall be made prudently, taking into account the need for proper diversification.
Member States may decide not to apply the requirements referred to in points (e) and (f) to investment in government bonds.
2. The home Member State shall prohibit the institution from borrowing or acting as a guarantor on behalf of third parties. However, Member States may authorise institutions to carry out some borrowing only for liquidity purposes and on a temporary basis.
3. Member States shall not require institutions located in their territory to invest in particular categories of assets.
4. Without prejudice to Article 12, Member States shall not subject the investment decisions of an institution located in their territory or its investment manager to any kind of prior approval or systematic notification requirements.
5. In accordance with the provisions of paragraphs 1 to 4, Member States may, for the institutions located in their territories, lay down more detailed rules, including quantitative rules, provided they are prudentially justified, to reflect the total range of pension schemes operated by these institutions.
In particular, Member States may apply investment provisions similar to those of Directive 2002/83/EC.
However, Member States shall not prevent institutions from:
(a) investing up to 70 % of the assets covering the technical provisions or of the whole portfolio for schemes in which the members bear the investment risks in shares, negotiable securities treated as shares and corporate bonds admitted to trading on regulated markets and deciding on the relative weight of these securities in their investment portfolio. Provided it is prudentially justified, Member States may, however, apply a lower limit to institutions which provide retirement products with a long-term interest rate guarantee, bear the investment risk and themselves provide for the guarantee;
(b) investing up to 30 % of the assets covering technical provisions in assets denominated in currencies other than those in which the liabilities are expressed;

Article 19
Management and custody
1. Member States shall not restrict institutions from appointing, for the management of the investment portfolio, investment managers established in another Member State and duly authorised for this activity, in accordance with Directives 85/611/EEC, 93/22/EEC, 2000/12/EC and 2002/83/EC, as well as those referred to in Article 2(1) of this Directive.
2. Member States shall not restrict institutions from appointing, for the custody of their assets, custodians established in another Member State and duly authorised in accordance with Directive 93/22/EEC or Directive 2000/12/EC, or accepted as a depositary for the purposes of Directive 85/611/EEC.
The provision referred to in this paragraph shall not prevent the home Member State from making the appointment of a depositary or a custodian compulsory.
3. Each Member State shall take the necessary steps to enable it under its national law to prohibit, in accordance with Article 14, the free disposal of assets held by a depositary or custodian located within its territory at the request of the institution’s home Member State.

Article 20
Cross-border activities
1. Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, Member States shall allow undertakings located within their territories to sponsor institutions for occupational retirement provision authorised in other Member States. They shall also allow institutions for occupational retirement provision authorised in their territories to accept sponsorship by undertakings located within the territories of other Member States.
2. An institution wishing to accept sponsorship from a sponsoring undertaking located within the territory of another Member State shall be subject to a prior authorisation by the competent authorities of its home Member State, as referred to in Article 9(5). It shall notify its intention to accept sponsorship from a sponsoring undertaking located within the territory of another Member State to the competent authorities of the home Member State where it is authorised.
3. Member States shall require institutions located within their territories and proposing to be sponsored by an undertaking located in the territory of another Member State to provide the following information when effecting a notification under paragraph 2:
(a) the host Member State(s);
(b) the name of the sponsoring undertaking;
(c) the main characteristics of the pension scheme to be operated for the sponsoring undertaking.
4. Where a competent authority of the home Member State is notified under paragraph 2, and unless it has reason to doubt that the administrative structure or the financial situation of the institution or the good repute and professional qualifications or experience of the persons running the institution are compatible with the operations proposed in the host Member State, it shall within three months of receiving all the information referred to in paragraph 3 communicate that information to the competent authorities of the host Member State and inform the institution accordingly.
5. Before the institution starts to operate a pension scheme for a sponsoring undertaking in another Member State, the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 3, inform the competent authorities of the home Member State, if appropriate, of the requirements of social and labour law relevant to the field of occupational pensions under which the pension scheme sponsored by an undertaking in the host Member State must be operated and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. The competent authorities of the home Member State shall communicate this information to the institution.
6. On receiving the communication referred to in paragraph 5, or if no communication is received from the competent authorities of the home Member State on expiry of the period provided for in paragraph 5, the institution may start to operate the pension scheme sponsored by an undertaking in the host Member State in accordance with the host Member State’s requirements of social and labour law relevant to the field of occupational pensions, and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.
7. In particular, an institution sponsored by an undertaking located in another Member State shall also be subject, in respect of the corresponding members, to any information requirements imposed by the competent authorities of the host Member State on institutions located in that Member State, in accordance with Article 11.
8. The competent authorities of the host Member State shall inform the competent authorities of the home Member State of any significant change in the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes which may affect the characteristics of the pension scheme insofar as it concerns the operation of the pension scheme sponsored by an undertaking in the host Member State and in any rules that have to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.
9. The institution shall be subject to ongoing supervision by the competent authorities of the host Member State as to the compliance of its activities with the host Member State’s requirements of labour and social law relevant to the field of occupational pension schemes referred to in paragraph 5 and with the information requirements referred to in paragraph 7. Should this supervision bring irregularities to light, the competent authorities of the host Member State shall inform the competent authorities of the home Member State immediately. The competent authorities of the home Member State shall, in coordination with the competent authorities of the host Member State, take the necessary measures to ensure that the institution puts a stop to the detected breach of social and labour law.
10. If, despite the measures taken by the competent authorities of the home Member State or because appropriate measures are lacking in the home Member State, the institution persists in breaching the applicable provisions of the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes, the competent authorities of the host Member State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalise further irregularities, including, insofar as is strictly necessary, preventing the institution from operating in the host Member State for the sponsoring undertaking.

Article 21
Cooperation between Member States and the Commission
1. Member States shall ensure, in an appropriate manner, the uniform application of this Directive through regular exchanges of information and experience with a view to developing best practices in this sphere and closer cooperation, and by so doing, preventing distortions of competition and creating the conditions required for unproblematic cross-border membership.
2. The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating supervision of the operations of institutions for occupational retirement provision.
3. Each Member State shall inform the Commission of any major difficulties to which the application of this Directive gives rise.
The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution.
4. Four years after the entry into force of this Directive, the Commission shall issue a report reviewing:
(a) the application of Article 18 and the progress achieved in the adaptation of national supervisory systems, and
(b) the application of the second subparagraph of Article 19(2), in particular the situation prevailing in Member States regarding the use of depositaries and the role played by them where appropriate.
5. The competent authorities of the host Member State may ask the competent authorities of the home Member State to decide on the ring-fencing of the institution’s assets and liabilities, as provided for in Article 16(3) and Article 18(7).

Article 22
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 September 2005. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
3. Member States may postpone until 23 September 2010 the application of Article 17(1) and (2) to institutions located in their territory which at the date specified in paragraph 1 of this Article do not have the minimum level of regulatory own funds required pursuant to Article 17(1) and (2). However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.
4. Member States may postpone until 23 September 2010 the application of Article 18(1)(f) to institutions located in their territory. However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.

Article 23
Entry in force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 24
This Directive is addressed to the Member States.
Done at Luxembourg, 3 June 2003.
For the European Parliament
The President
For the Council
N. Christodoulakis
(1) OJ C 96 E, 27.3.2001, p. 136.
(2) OJ C 155, 29.5.2001, p. 26.
(3) Opinion of the European Parliament of 4 July 2001 (OJ C 65 E, 14.3.2002, p. 135), Council common position of 5 November 2002 (not yet published in the Official Journal) and decision of the European Parliament of 12 March 2003 (not yet published in the Official Journal) and decision of the Council of 13 May 2003.
(4) OJ L 283, 28.10.1980, p. 23. Directive as last amended by Directive 2002/74/EC of the European Parliament and of the Council (OJ L 270, 8.10.2002, p. 10).
(5) Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 149, 5.7.1971, p. 2). Regulation as last amended by Regulation (EC) No 1386/2001 of the European Parliament and of the Council (OJ L 187, 10.7.2001, p. 1).
(6) Council Regulation (EEC) No 574/72 of 21 March 1972 fixing the procedure for implementing Regulation (EEC) No 1408/71 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 74, 27.3.1972, p. 1). Regulation as last amended by Commission Regulation (EC) No 410/2002 (OJ L 62, 5.3.2002, p. 17).
(7) First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (OJ L 228, 16.8.1973, p. 3). Directive as last amended by Directive 2002/13/EC of the European Parliament and of the Council (OJ L 77, 20.3.2002, p. 17).
(8) Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 375, 31.12.1985, p. 3). Directive as last amended by Directive 2001/108/EC of the European Parliament and of the Council (OJ L 41, 13.2.2002, p. 35).
(9) Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (OJ L 141, 11.6.1993, p. 27). Directive as last amended by Directive 2000/64/EC of the European Parliament and of the Council (OJ L 290, 17.11.2000, p. 27).
(10) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking-up and pursuit of the business of credit institutions (OJ L 126, 26.5.2000, p. 1). Directive as amended by Directive 2000/28/EC (OJ L 275, 27.10.2000, p. 37).
(11) Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (OJ L 345, 19.12.2002, p. 1).

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) A genuine internal market for financial services is crucial for economic growth and job creation in the Community.(2) Major achievements have already been made in the establishment of this internal market, allowing financial institutions to operate in other Member States and ensuring a high level of protection for the consumers of financial services.(3) The communication from the Commission “Implementing the framework for financial markets: action plan” identifies a series of actions that are needed in order to complete the internal market for financial services, and the European Council, at its meeting in Lisbon on 23 and 24 March 2000, called for the implementation of this action plan by 2005.(4) The action plan for financial services stresses as an urgent priority the need to draw up a directive on the prudential supervision of institutions for occupational retirement provision, as these institutions are major financial institutions which have a key role to play in ensuring the integration, efficiency and liquidity of the financial markets, but they are not subject to a coherent Community legislative framework allowing them to benefit fully from the advantages of the internal market.(5) Since social-security systems are coming under increasing pressure, occupational retirement pensions will increasingly be relied on as a complement in future. Occupational retirement pensions should therefore be developed, without, however, calling into question the importance of social-security pension systems in terms of secure, durable and effective social protection, which should guarantee a decent standard of living in old age and should therefore be at the centre of the objective of strengthening the European social model.(6) This Directive thus represents a first step on the way to an internal market for occupational retirement provision organised on a European scale. By setting the “prudent person” rule as the underlying principle for capital investment and making it possible for institutions to operate across borders, the redirection of savings into the sector of occupational retirement provision is encouraged, thus contributing to economic and social progress.(7) The prudential rules laid down in this Directive are intended both to guarantee a high degree of security for future pensioners through the imposition of stringent supervisory standards, and to clear the way for the efficient management of occupational pension schemes.(8) Institutions which are completely separated from any sponsoring undertaking and which operate on a funded basis for the sole purpose of providing retirement benefits should have freedom to provide services and freedom of investment, subject only to coordinated prudential requirements, regardless of whether these institutions are considered as legal entities.(9) In accordance with the principle of subsidiarity, Member States should retain full responsibility for the organisation of their pension systems as well as for the decision on the role of each of the three “pillars” of the retirement system in individual Member States. In the context of the second pillar, they should also retain full responsibility for the role and functions of the various institutions providing occupational retirement benefits, such as industry-wide pension funds, company pension funds and life-assurance companies. This Directive is not intended to call this prerogative into question.(10) National rules concerning the participation of self-employed persons in institutions for occupational retirement provision differ. In some Member States, institutions for occupational retirement provision can operate on the basis of agreements with trade or trade groups whose members act in a self-employed capacity or directly with self-employed and employed persons. In some Member States a self-employed person can also become a member of an institution when the self-employed person acts as employer or provides his professional services to an undertaking. In some Member States self-employed persons cannot join an institution for occupational retirement provision unless certain requirements, including those imposed by social and labour law, are met.(11) Institutions managing social-security schemes, which are already coordinated at Community level, should be excluded from the scope of this Directive. Account should nevertheless be taken of the specificity of institutions which, in a single Member State, manage both social-security schemes and occupational pension schemes.(12) Financial institutions which already benefit from a Community legislative framework should in general be excluded from the scope of this Directive. However, as these institutions may also in some cases offer occupational pension services, it is important to ensure that this Directive does not lead to distortions of competition. Such distortions may be avoided by applying the prudential requirements of this Directive to the occupational pension business of life-assurance companies. The Commission should also carefully monitor the situation in the occupational pensions market and assess the possibility of extending the optional application of this Directive to other regulated financial institutions.(13) When aiming at ensuring financial security in retirement, the benefits paid by institutions for occupational retirement provision should generally provide for the payment of a lifelong pension. Payments for a temporary period or a lump sum should also be possible.(14) It is important to ensure that older and disabled people are not placed at risk of poverty and can enjoy a decent standard of living. Appropriate cover for biometrical risks in occupational pension arrangements is an important aspect of the fight against poverty and insecurity among elderly people. When setting up a pension scheme, employers and employees, or their respective representatives, should consider the possibility of the pension scheme including provisions for the coverage of the longevity risk and occupational disability risks as well as provision for surviving dependants.(15) Giving Member States the possibility to exclude from the scope of national implementing legislation institutions managing schemes which together have less than 100 members in total can facilitate supervision in some Member States, without undermining the proper functioning of the internal market in this field. However, this should not undermine the right of such institutions to appoint for the management of their investment portfolio and the custody of their assets investment managers and custodians established in another Member State and duly authorised.(16) Institutions such as “Unterstützungskassen” in Germany, where the members have no legal rights to benefits of a certain amount and where their interests are protected by a compulsory statutory insolvency insurance, should be excluded from the scope of the Directive.(17) In order to protect members and beneficiaries, institutions for occupational retirement provision should limit their activities to the activities, and those arising therefrom, referred to in this Directive.(18) In the event of the bankruptcy of a sponsoring undertaking, a member faces the risk of losing both his/her job and his/her acquired pension rights. This makes it necessary to ensure that there is a clear separation between that undertaking and the institution and that minimum prudential standards are laid down to protect members.(19) Institutions for occupational retirement provision operate and are supervised with significant differences in Member States. In some Member States, supervision can be exercised not only over the institution itself but also over the entities or companies which are authorised to manage these institutions. Member States should be able to take such specificity into account as long as all the requirements laid down in this Directive are effectively met. Member States should also be able to allow insurance entities and other financial entities to manage institutions for occupational retirement provision.(20) Institutions for occupational retirement provision are financial service providers which bear a heavy responsibility for the provision of occupational retirement benefits and therefore should meet certain minimum prudential standards with respect to their activities and conditions of operation.(21) The huge number of institutions in certain Member States means a pragmatic solution is necessary as regards prior authorisation of institutions. However, if an institution wishes to manage a scheme in another Member State, a prior authorisation granted by the competent authority of the home Member State should be required.(22) Each Member State should require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and annual reports, reflecting a true and fair view of the institution’s assets, liabilities and financial position, taking into account each pension scheme operated by an institution, and duly approved by an authorised person, are an essential source of information for members and beneficiaries of a scheme and the competent authorities. In particular, they enable the competent authorities to monitor the financial soundness of an institution and assess whether the institution is able to meet all its contractual obligations.(23) Proper information for members and beneficiaries of a pension scheme is crucial. This is of particular relevance for requests for information concerning the financial soundness of the institution, the contractual rules, the benefits and the actual financing of accrued pension entitlements, the investment policy and the management of risks and costs.(24) The investment policy of an institution is a decisive factor for both security and affordability of occupational pensions. The institutions should therefore draw up and, at least every three years, review a statement of investment principles. It should be made available to the competent authorities and on request also to members and beneficiaries of each pension scheme.(25) To fulfil their statutory function, the competent authorities should be provided with adequate rights to information and powers of intervention with respect to institutions and the persons who effectively run them. Where an institution for occupational retirement provision has transferred functions of material importance such as investment management, information technology or accounting to other companies (outsourcing), it should be possible for the rights to information and powers of intervention to be enlarged so as to cover these outsourced functions in order to check whether those activities are carried out in accordance with the supervisory rules.(26) A prudent calculation of technical provisions is an essential condition to ensure that obligations to pay retirement benefits can be met. Technical provisions should be calculated on the basis of recognised actuarial methods and certified by qualified persons. The maximum interest rates should be chosen prudently according to any relevant national rules. The minimum amount of technical provisions should both be sufficient for benefits already in payment to beneficiaries to continue to be paid and reflect the commitments that arise out of members’ accrued pension rights.(27) Risks covered by institutions vary significantly from one Member State to another. Home Member States should therefore have the possibility of making the calculation of technical provisions subject to additional and more detailed rules than those laid down in this Directive.(28) Sufficient and appropriate assets to cover the technical provisions protect the interests of members and beneficiaries of the pension scheme if the sponsoring undertaking becomes insolvent. In particular in cases of cross-border activity, the mutual recognition of supervisory principles applied in Member States requires that the technical provisions be fully funded at all times.(29) If the institution does not work on a cross-border basis, Member States should be able to permit underfunding provided that a proper plan is established to restore full funding and without prejudice to the requirements of Council Directive 80/987/EEC of 20 October 1980 on the approximation of the laws of the Member States relating to the protection of employees in the event of the insolvency of their employer(4).(30) In many cases, it could be the sponsoring undertaking and not the institution itself that either covers any biometric risk or guarantees certain benefits or investment performance. However, in some cases, it is the institution itself which provides such cover or guarantees and the sponsor’s obligations are generally exhausted by paying the necessary contributions. In these circumstances, the products offered are similar to those of life-assurance companies and the institutions concerned should hold at least the same additional own funds as life-assurance companies.(31) Institutions are very long-term investors. Redemption of the assets held by these institutions cannot, in general, be made for any purpose other than providing retirement benefits. Furthermore, in order to protect adequately the rights of members and beneficiaries, institutions should be able to opt for an asset allocation that suits the precise nature and duration of their liabilities. These aspects call for efficient supervision and an approach towards investment rules allowing institutions sufficient flexibility to decide on the most secure and efficient investment policy and obliging them to act prudently. Compliance with the “prudent person” rule therefore requires an investment policy geared to the membership structure of the individual institution for occupational retirement provision.(32) Supervisory methods and practices vary among Member States. Therefore, Member States should be given some discretion on the precise investment rules that they wish to impose on the institutions located in their territories. However, these rules must not restrict the free movement of capital, unless justified on prudential grounds.(33) As very long-term investors with low liquidity risks, institutions for occupational retirement provision are in a position to invest in non-liquid assets such as shares as well as in risk capital markets within prudent limits. They can also benefit from the advantages of international diversification. Investments in shares, risk capital markets and currencies other than those of the liabilities should therefore not be restricted except on prudential grounds.(34) However, if the institution works on a cross-border basis, it may be asked by the competent authorities of the host Member State to apply limits for investment in shares and similar assets not admitted to trading on a regulated market, in shares and other instruments issued by the same undertaking or in assets denominated in non-matching currencies provided such rules also apply to institutions located in the host Member State.(35) Restrictions regarding the free choice by institutions of approved asset managers and custodians limit competition in the internal market and should therefore be eliminated.(36) Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, institutions should have the possibility of providing their services in other Member States. They should be allowed to accept sponsorship from undertakings located in other Member States and to operate pension schemes with members in more than one Member State. This would potentially lead to significant economies of scale for these institutions, improve the competitiveness of the Community industry and facilitate labour mobility. This requires mutual recognition of prudential standards. Proper enforcement of these prudential standards should be supervised by the competent authorities of the home Member State, unless specified otherwise.(37) The exercise of the right of an institution in one Member State to manage an occupational pension scheme contracted in another Member State should fully respect the provisions of the social and labour law in force in the host Member State insofar as it is relevant to occupational pensions, for example the definition and payment of retirement benefits and the conditions for transferability of pension rights.(38) When a scheme is ring-fenced, the provisions of this Directive apply individually to that scheme.(39) It is important to make provision for cooperation between the competent authorities of the Member States for supervisory purposes and between those authorities and the Commission for other purposes. For the purposes of carrying out their duties and of contributing to the consistent and timely implementation of this Directive, competent authorities should provide each other with the information necessary to apply the provisions of the Directive. The Commission has indicated its intention to set up a committee of supervisors in order to encourage cooperation, coordination and exchanges of views between national competent authorities, and to promote the consistent implementation of this Directive.(40) Since the objective of the proposed action, namely to create a Community legal framework covering institutions for occupational retirement provision, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved by the Community, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,HAVE ADOPTED THE FOLLOWING DIRECTIVE:Article 1SubjectThis Directive lays down rules for the taking-up and pursuit of activities carried out by institutions for occupational retirement provision.Article 2Scope1. This Directive shall apply to institutions for occupational retirement provision. Where, in accordance with national law, institutions for occupational retirement provision do not have legal personality, Member States shall apply this Directive either to those institutions or, subject to paragraph 2, to those authorised entities responsible for managing them and acting on their behalf.2. This Directive shall not apply to:(a) institutions managing social-security schemes which are covered by Regulation (EEC) No 1408/71(5) and Regulation (EEC) No 574/72(6);(b) institutions which are covered by Directive 73/239/EEC(7), Directive 85/611/EEC(8), Directive 93/22/EEC(9), Directive 2000/12/EC(10) and Directive 2002/83/EC(11);(c) institutions which operate on a pay-as-you-go basis;(d) institutions where employees of the sponsoring undertakings have no legal rights to benefits and where the sponsoring undertaking can redeem the assets at any time and not necessarily meet its obligations for payment of retirement benefits;(e) companies using book-reserve schemes with a view to paying out retirement benefits to their employees.Article 3Application to institutions operating social-security schemesInstitutions for occupational retirement provision which also operate compulsory employment-related pension schemes which are considered to be social-security schemes covered by Regulations (EEC) No 1408/71 and (EEC) No 574/72 shall be covered by this Directive in respect of their non-compulsory occupational retirement provision business. In that case, the liabilities and the corresponding assets shall be ring-fenced and it shall not be possible to transfer them to the compulsory pension schemes which are considered as social-security schemes or vice versa.Article 4Optional application to institutions covered by Directive 2002/83/ECHome Member States may choose to apply the provisions of Articles 9 to 16 and Articles 18 to 20 of this Directive to the occupational-retirement-provision business of insurance undertakings which are covered by Directive 2002/83/EC. In that case, all assets and liabilities corresponding to the said business shall be ring-fenced, managed and organised separately from the other activities of the insurance undertakings, without any possibility of transfer.In such case, and only as far as their occupational retirement provision business is concerned, insurance undertakings shall not be subject to Articles 20 to 26, 31 and 36 of Directive 2002/83/EC.The home Member State shall ensure that either the competent authorities, or the authorities responsible for supervision of insurance undertakings covered by Directive 2002/83/EC, as part of their supervisory work, verify the strict separation of the relevant occupational retirement provision business.Article 5Small pension institutions and statutory schemesWith the exception of Article 19, Member States may choose not to apply this Directive, in whole or in part, to any institution located in their territories which operates pension schemes which together have less than 100 members in total. Subject to Article 2(2), such institutions should nevertheless be given the right to apply this Directive on a voluntary basis. Article 20 may be applied only if all the other provisions of this Directive apply.Member States may choose not to apply Articles 9 to 17 to institutions where occupational retirement provision is made under statute, pursuant to legislation, and is guaranteed by a public authority. Article 20 may be applied only if all the other provisions of this Directive apply.Article 6DefinitionsFor the purposes of this Directive:(a) “institution for occupational retirement provision”, or “institution”, means an institution, irrespective of its legal form, operating on a funded basis, established separately from any sponsoring undertaking or trade for the purpose of providing retirement benefits in the context of an occupational activity on the basis of an agreement or a contract agreed:- individually or collectively between the employer(s) and the employee(s) or their respective representatives, or- with self-employed persons, in compliance with the legislation of the home and host Member States,and which carries out activities directly arising therefrom;(b) “pension scheme” means a contract, an agreement, a trust deed or rules stipulating which retirement benefits are granted and under which conditions;(c) “sponsoring undertaking” means any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which pays contributions into an institution for occupational retirement provision;(d) “retirement benefits” means benefits paid by reference to reaching, or the expectation of reaching, retirement or, where they are supplementary to those benefits and provided on an ancillary basis, in the form of payments on death, disability, or cessation of employment or in the form of support payments or services in case of sickness, indigence or death. In order to facilitate financial security in retirement, these benefits usually take the form of payments for life. They may, however, also be payments made for a temporary period or as a lump sum.(e) “member” means a person whose occupational activities entitle or will entitle him/her to retirement benefits in accordance with the provisions of a pension scheme;(f) “beneficiary” means a person receiving retirement benefits;(g) “competent authorities” means the national authorities designated to carry out the duties provided for in this Directive;(h) “biometrical risks” mean risks linked to death, disability and longevity;(i) “home Member State” means the Member State in which the institution has its registered office and its main administration or, if it does not have a registered office, its main administration;(j) “host Member State” means the Member State whose social and labour law relevant to the field of occupational pension schemes is applicable to the relationship between the sponsoring undertaking and members.Article 7Activities of an institutionEach Member State shall require institutions located within its territory to limit their activities to retirement-benefit related operations and activities arising therefrom.When, in accordance with Article 4, an insurance undertaking manages its occupational retirement provision business by ring-fencing its assets and liabilities, the ring-fenced assets and liabilities shall be restricted to retirement-benefit related operations and activities directly arising therefrom.Article 8Legal separation between sponsoring undertakings and institutions for occupational retirement provisionEach Member State shall ensure that there is a legal separation between a sponsoring undertaking and an institution for occupational retirement provision in order that the assets of the institution are safeguarded in the interests of members and beneficiaries in the event of bankruptcy of the sponsoring undertaking.Article 9Conditions of operation1. Each Member State shall, in respect of every institution located in its territory, ensure that:(a) the institution is registered in a national register by the competent supervisory authority or authorised; in the case of cross-border activities referred to in Article 20, the register shall also indicate the Member States in which the institution is operating;(b) the institution is effectively run by persons of good repute who must themselves have appropriate professional qualifications and experience or employ advisers with appropriate professional qualifications and experience;(c) properly constituted rules regarding the functioning of any pension scheme operated by the institution have been implemented and members have been adequately informed of these rules;(d) all technical provisions are computed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State;(e) where the sponsoring undertaking guarantees the payment of the retirement benefits, it is committed to regular financing;(f) the members are sufficiently informed of the conditions of the pension scheme, in particular concerning:(i) the rights and obligations of the parties involved in the pension scheme;(ii) the financial, technical and other risks associated with the pension scheme;(iii) the nature and distribution of those risks.2. In accordance with the principle of subsidiarity and taking due account of the scale of pension benefits offered by the social-security regimes, Member States may provide that the option of longevity and disability cover, provision for surviving dependants and a guarantee of repayment of contributions as additional benefits be offered to members if employers and employees, or their respective representatives, so agree.3. A Member State may make the conditions of operation of an institution located in its territory subject to other requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.4. A Member State may permit or require institutions located in its territory to entrust management of these institutions, in whole or in part, to other entities operating on behalf of those institutions.5. In the case of cross-border activity as referred to in Article 20, the conditions of operation of the institution shall be subject to a prior authorisation by the competent authorities of the home Member State.Article 10Annual accounts and annual reportsEach Member State shall require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and the annual reports shall give a true and fair view of the institution’s assets, liabilities and financial position. The annual accounts and information in the reports shall be consistent, comprehensive, fairly presented and duly approved by authorised persons, according to national law.Article 11Information to be given to the members and beneficiaries1. Depending on the nature of the pension scheme established, each Member State shall ensure that every institution located in its territory provides at least the information set out in this Article.2. Members and beneficiaries and/or, where applicable, their representatives shall receive:(a) on request, the annual accounts and the annual reports referred to in Article 10, and, where an institution is responsible for more than one scheme, those relating to their particular pension scheme;(b) within a reasonable time, any relevant information regarding changes to the pension-scheme rules.3. The statement of investment policy principles, referred to in Article 12, shall be made available to members and beneficiaries and/or, where applicable, to their representatives on request.4. Each member shall also receive, on request, detailed and substantial information on:(a) the target level of the retirement benefits, if applicable;(b) the level of benefits in case of cessation of employment;(c) where the member bears the investment risk, the range of investment options, if applicable, and the actual investment portfolio as well as information on risk exposure and costs related to the investments;(d) the arrangements relating to the transfer of pension rights to another institution for occupational retirement provision in the event of termination of the employment relationship.Members shall receive every year brief particulars of the situation of the institution as well as the current level of financing of their accrued individual entitlements.5. Each beneficiary shall receive, on retirement or when other benefits become due, the appropriate information on the benefits which are due and the corresponding payment options.Article 12Statement of investment policy principlesEach Member State shall ensure that every institution located in its territory prepares and, at least every three years, reviews a written statement of investment-policy principles. This statement is to be revised without delay after any significant change in the investment policy. Member States shall provide that this statement contains, at least, such matters as the investment risk measurement methods, the risk-management processes implemented and the strategic asset allocation with respect to the nature and duration of pension liabilities.Article 13Information to be provided to the competent authoritiesEach Member State shall ensure that the competent authorities, in respect of any institution located in its territory, have the necessary powers and means:(a) to require the institution, the members of its board of directors and other managers or directors or persons controlling the institution to supply information about all business matters or forward all business documents;(b) to supervise relationships between the institution and other companies or between institutions, when institutions transfer functions to those other companies or institutions (outsourcing), influencing the financial situation of the institution or being in a material way relevant for effective supervision;(c) to obtain regularly the statement of investment-policy principles, the annual accounts and the annual reports, and all the documents necessary for the purposes of supervision. These may include documents such as:(i) internal interim reports;(ii) actuarial valuations and detailed assumptions;(iii) asset-liability studies;(iv) evidence of consistency with the investment-policy principles;(v) evidence that contributions have been paid in as planned;(vi) reports by the persons responsible for auditing the annual accounts referred to in Article 10;(d) to carry out on-site inspections at the institution’s premises and, where appropriate, on outsourced functions to check if activities are carried out in accordance with the supervisory rules.Article 14Powers of intervention and duties of the competent authorities1. The competent authorities shall require every institution located in their territories to have sound administrative and accounting procedures and adequate internal control mechanisms.2. The competent authorities shall have the power to take any measures including, where appropriate, those of an administrative or financial nature, either with regard to any institution located in their territories or against the persons running the institution, which are appropriate and necessary to prevent or remedy any irregularities prejudicial to the interests of the members and beneficiaries.They may also restrict or prohibit the free disposal of the institution’s assets when, in particular:(a) the institution has failed to establish sufficient technical provisions in respect of the entire business or has insufficient assets to cover the technical provisions;(b) the institution has failed to hold the regulatory own funds.3. In order to safeguard the interests of members and beneficiaries, the competent authorities may transfer the powers which the persons running an institution located in their territories hold in accordance with the law of the home Member State wholly or partly to a special representative who is fit to exercise these powers.4. The competent authorities may prohibit or restrict the activities of an institution located in their territories in particular if:(a) the institution fails to protect adequately the interests of members and beneficiaries;(b) the institution no longer fulfils the conditions of operation;(c) the institution fails seriously in its obligations under the rules to which it is subject;(d) in the case of cross-border activity, the institution does not respect the requirements of social and labour law of the host Member State relevant to the field of occupational pensions.Any decision to prohibit the activities of an institution shall be supported by precise reasons and notified to the institution in question.5. Member States shall ensure that decisions taken in respect of an institution under laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts.Article 15Technical provisions1. The home Member State shall ensure that institutions operating occupational pension schemes establish at all times in respect of the total range of their pension schemes an adequate amount of liabilities corresponding to the financial commitments which arise out of their portfolio of existing pension contracts.2. The home Member State shall ensure that institutions operating occupational pension schemes, where they provide cover against biometric risks and/or guarantee either an investment performance or a given level of benefits, establish sufficient technical provisions in respect of the total range of these schemes.3. The calculation of technical provisions shall take place every year. However, the home Member State may allow a calculation once every three years if the institution provides members and/or the competent authorities with a certification or a report of adjustments for the intervening years. The certification or the report shall reflect the adjusted development of the technical provisions and changes in risks covered.4. The calculation of the technical provisions shall be executed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State, according to the following principles:(a) the minimum amount of the technical provisions shall be calculated by a sufficiently prudent actuarial valuation, taking account of all commitments for benefits and for contributions in accordance with the pension arrangements of the institution. It must be sufficient both for pensions and benefits already in payment to beneficiaries to continue to be paid, and to reflect the commitments which arise out of members’ accrued pension rights. The economic and actuarial assumptions chosen for the valuation of the liabilities shall also be chosen prudently taking account, if applicable, of an appropriate margin for adverse deviation;(b) the maximum rates of interest used shall be chosen prudently and determined in accordance with any relevant rules of the home Member State. These prudent rates of interest shall be determined by taking into account:- the yield on the corresponding assets held by the institution and the future investment returns and/or- the market yields of high-quality or government bonds;(c) the biometric tables used for the calculation of technical provisions shall be based on prudent principles, having regard to the main characteristics of the group of members and the pension schemes, in particular the expected changes in the relevant risks;(d) the method and basis of calculation of technical provisions shall in general remain constant from one financial year to another. However, discontinuities may be justified by a change of legal, demographic or economic circumstances underlying the assumptions.5. The home Member State may make the calculation of technical provisions subject to additional and more detailed requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.6. With a view to further harmonisation of the rules regarding the calculation of technical provisions which may be justified – in particular the interest rates and other assumptions influencing the level of technical provisions – the Commission shall, every two years or at the request of a Member State, issue a report on the situation concerning the development in cross-border activities.The Commission shall propose any necessary measures to prevent possible distortions caused by different levels of interest rates and to protect the interest of beneficiaries and members of any scheme.Article 16Funding of technical provisions1. The home Member State shall require every institution to have at all times sufficient and appropriate assets to cover the technical provisions in respect of the total range of pension schemes operated.2. The home Member State may allow an institution, for a limited period of time, to have insufficient assets to cover the technical provisions. In this case the competent authorities shall require the institution to adopt a concrete and realisable recovery plan in order to ensure that the requirements of paragraph 1 are met again. The plan shall be subject to the following conditions:(a) the institution shall set up a concrete and realisable plan to re-establish the required amount of assets to cover fully the technical provisions in due time. The plan shall be made available to members or, where applicable, to their representatives and/or shall be subject to approval by the competent authorities of the home Member State;(b) in drawing up the plan, account shall be taken of the specific situation of the institution, in particular the asset/liability structure, risk profile, liquidity plan, the age profile of the members entitled to receive retirement benefits, start-up schemes and schemes changing from non-funding or partial funding to full funding;(c) in the event of termination of a pension scheme during the period referred to above in this paragraph, the institution shall inform the competent authorities of the home Member State. The institution shall establish a procedure in order to transfer the assets and the corresponding liabilities to another financial institution or a similar body. This procedure shall be disclosed to the competent authorities of the home Member State and a general outline of the procedure shall be made available to members or, where applicable, to their representatives in accordance with the principle of confidentiality.3. In the event of cross-border activity as referred to in Article 20, the technical provisions shall at all times be fully funded in respect of the total range of pension schemes operated. If these conditions are not met, the competent authorities of the home Member State shall intervene in accordance with Article 14. To comply with this requirement the home Member State may require ring-fencing of the assets and liabilities.Article 17Regulatory own funds1. The home Member State shall ensure that institutions operating pension schemes, where the institution itself, and not the sponsoring undertaking, underwrites the liability to cover against biometric risk, or guarantees a given investment performance or a given level of benefits, hold on a permanent basis additional assets above the technical provisions to serve as a buffer. The amount thereof shall reflect the type of risk and asset base in respect of the total range of schemes operated. These assets shall be free of all foreseeable liabilities and serve as a safety capital to absorb discrepancies between the anticipated and the actual expenses and profits.2. For the purposes of calculating the minimum amount of the additional assets, the rules laid down in Articles 27 and 28 of Directive 2002/83/EC shall apply.3. Paragraph 1 shall, however, not prevent Member States from requiring institutions located in their territory to hold regulatory own funds or from laying down more detailed rules provided that they are prudentially justified.Article 18Investment rules1. Member States shall require institutions located in their territories to invest in accordance with the “prudent person” rule and in particular in accordance with the following rules:(a) the assets shall be invested in the best interests of members and beneficiaries. In the case of a potential conflict of interest, the institution, or the entity which manages its portfolio, shall ensure that the investment is made in the sole interest of members and beneficiaries;(b) the assets shall be invested in such a manner as to ensure the security, quality, liquidity and profitability of the portfolio as a whole.Assets held to cover the technical provisions shall also be invested in a manner appropriate to the nature and duration of the expected future retirement benefits;(c) the assets shall be predominantly invested on regulated markets. Investment in assets which are not admitted to trading on a regulated financial market must in any event be kept to prudent levels;(d) investment in derivative instruments shall be possible insofar as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis, taking into account the underlying asset, and included in the valuation of the institution’s assets. The institution shall also avoid excessive risk exposure to a single counterparty and to other derivative operations;(e) the assets shall be properly diversified in such a way as to avoid excessive reliance on any particular asset, issuer or group of undertakings and accumulations of risk in the portfolio as a whole.Investments in assets issued by the same issuer or by issuers belonging to the same group shall not expose the institution to excessive risk concentration;(f) investment in the sponsoring undertaking shall be no more than 5 % of the portfolio as a whole and, when the sponsoring undertaking belongs to a group, investment in the undertakings belonging to the same group as the sponsoring undertaking shall not be more than 10 % of the portfolio.When the institution is sponsored by a number of undertakings, investment in these sponsoring undertakings shall be made prudently, taking into account the need for proper diversification.Member States may decide not to apply the requirements referred to in points (e) and (f) to investment in government bonds.2. The home Member State shall prohibit the institution from borrowing or acting as a guarantor on behalf of third parties. However, Member States may authorise institutions to carry out some borrowing only for liquidity purposes and on a temporary basis.3. Member States shall not require institutions located in their territory to invest in particular categories of assets.4. Without prejudice to Article 12, Member States shall not subject the investment decisions of an institution located in their territory or its investment manager to any kind of prior approval or systematic notification requirements.5. In accordance with the provisions of paragraphs 1 to 4, Member States may, for the institutions located in their territories, lay down more detailed rules, including quantitative rules, provided they are prudentially justified, to reflect the total range of pension schemes operated by these institutions.In particular, Member States may apply investment provisions similar to those of Directive 2002/83/EC.However, Member States shall not prevent institutions from:(a) investing up to 70 % of the assets covering the technical provisions or of the whole portfolio for schemes in which the members bear the investment risks in shares, negotiable securities treated as shares and corporate bonds admitted to trading on regulated markets and deciding on the relative weight of these securities in their investment portfolio. Provided it is prudentially justified, Member States may, however, apply a lower limit to institutions which provide retirement products with a long-term interest rate guarantee, bear the investment risk and themselves provide for the guarantee;(b) investing up to 30 % of the assets covering technical provisions in assets denominated in currencies other than those in which the liabilities are expressed;(c) investing in risk capital markets.6. Paragraph 5 shall not preclude the right for Member States to require the application to institutions located in their territory of more stringent investment rules also on an individual basis provided they are prudentially justified, in particular in the light of the liabilities entered into by the institution.7. In the event of cross-border activity as referred in Article 20, the competent authorities of each host Member State may require that the rules set out in the second subparagraph apply to the institution in the home Member State. In such case, these rules shall apply only to the part of the assets of the institution that corresponds to the activities carried out in the particular host Member State. Furthermore, they shall only be applied if the same or stricter rules also apply to institutions located in the host Member State.The rules referred to in the first subparagraph are as follows:(a) the institution shall not invest more than 30 % of these assets in shares, other securities treated as shares and debt securities which are not admitted to trading on a regulated market, or the institution shall invest at least 70 % of these assets in shares, other securities treated as shares, and debt securities which are admitted to trading on a regulated market;(b) the institution shall invest no more than 5 % of these assets in shares and other securities treated as shares, bonds, debt securities and other money and capital-market instruments issued by the same undertaking and no more than 10 % of these assets in shares and other securities treated as shares, bonds, debt securities and other money and capital market instruments issued by undertakings belonging to a single group;(c) the institution shall not invest more than 30 % of these assets in assets denominated in currencies other than those in which the liabilities are expressed.To comply with these requirements, the home Member State may require ring-fencing of the assets.Article 19Management and custody1. Member States shall not restrict institutions from appointing, for the management of the investment portfolio, investment managers established in another Member State and duly authorised for this activity, in accordance with Directives 85/611/EEC, 93/22/EEC, 2000/12/EC and 2002/83/EC, as well as those referred to in Article 2(1) of this Directive.2. Member States shall not restrict institutions from appointing, for the custody of their assets, custodians established in another Member State and duly authorised in accordance with Directive 93/22/EEC or Directive 2000/12/EC, or accepted as a depositary for the purposes of Directive 85/611/EEC.The provision referred to in this paragraph shall not prevent the home Member State from making the appointment of a depositary or a custodian compulsory.3. Each Member State shall take the necessary steps to enable it under its national law to prohibit, in accordance with Article 14, the free disposal of assets held by a depositary or custodian located within its territory at the request of the institution’s home Member State.Article 20Cross-border activities1. Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, Member States shall allow undertakings located within their territories to sponsor institutions for occupational retirement provision authorised in other Member States. They shall also allow institutions for occupational retirement provision authorised in their territories to accept sponsorship by undertakings located within the territories of other Member States.2. An institution wishing to accept sponsorship from a sponsoring undertaking located within the territory of another Member State shall be subject to a prior authorisation by the competent authorities of its home Member State, as referred to in Article 9(5). It shall notify its intention to accept sponsorship from a sponsoring undertaking located within the territory of another Member State to the competent authorities of the home Member State where it is authorised.3. Member States shall require institutions located within their territories and proposing to be sponsored by an undertaking located in the territory of another Member State to provide the following information when effecting a notification under paragraph 2:(a) the host Member State(s);(b) the name of the sponsoring undertaking;(c) the main characteristics of the pension scheme to be operated for the sponsoring undertaking.4. Where a competent authority of the home Member State is notified under paragraph 2, and unless it has reason to doubt that the administrative structure or the financial situation of the institution or the good repute and professional qualifications or experience of the persons running the institution are compatible with the operations proposed in the host Member State, it shall within three months of receiving all the information referred to in paragraph 3 communicate that information to the competent authorities of the host Member State and inform the institution accordingly.5. Before the institution starts to operate a pension scheme for a sponsoring undertaking in another Member State, the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 3, inform the competent authorities of the home Member State, if appropriate, of the requirements of social and labour law relevant to the field of occupational pensions under which the pension scheme sponsored by an undertaking in the host Member State must be operated and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. The competent authorities of the home Member State shall communicate this information to the institution.6. On receiving the communication referred to in paragraph 5, or if no communication is received from the competent authorities of the home Member State on expiry of the period provided for in paragraph 5, the institution may start to operate the pension scheme sponsored by an undertaking in the host Member State in accordance with the host Member State’s requirements of social and labour law relevant to the field of occupational pensions, and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.7. In particular, an institution sponsored by an undertaking located in another Member State shall also be subject, in respect of the corresponding members, to any information requirements imposed by the competent authorities of the host Member State on institutions located in that Member State, in accordance with Article 11.8. The competent authorities of the host Member State shall inform the competent authorities of the home Member State of any significant change in the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes which may affect the characteristics of the pension scheme insofar as it concerns the operation of the pension scheme sponsored by an undertaking in the host Member State and in any rules that have to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.9. The institution shall be subject to ongoing supervision by the competent authorities of the host Member State as to the compliance of its activities with the host Member State’s requirements of labour and social law relevant to the field of occupational pension schemes referred to in paragraph 5 and with the information requirements referred to in paragraph 7. Should this supervision bring irregularities to light, the competent authorities of the host Member State shall inform the competent authorities of the home Member State immediately. The competent authorities of the home Member State shall, in coordination with the competent authorities of the host Member State, take the necessary measures to ensure that the institution puts a stop to the detected breach of social and labour law.10. If, despite the measures taken by the competent authorities of the home Member State or because appropriate measures are lacking in the home Member State, the institution persists in breaching the applicable provisions of the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes, the competent authorities of the host Member State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalise further irregularities, including, insofar as is strictly necessary, preventing the institution from operating in the host Member State for the sponsoring undertaking.Article 21Cooperation between Member States and the Commission1. Member States shall ensure, in an appropriate manner, the uniform application of this Directive through regular exchanges of information and experience with a view to developing best practices in this sphere and closer cooperation, and by so doing, preventing distortions of competition and creating the conditions required for unproblematic cross-border membership.2. The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating supervision of the operations of institutions for occupational retirement provision.3. Each Member State shall inform the Commission of any major difficulties to which the application of this Directive gives rise.The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution.4. Four years after the entry into force of this Directive, the Commission shall issue a report reviewing:(a) the application of Article 18 and the progress achieved in the adaptation of national supervisory systems, and(b) the application of the second subparagraph of Article 19(2), in particular the situation prevailing in Member States regarding the use of depositaries and the role played by them where appropriate.5. The competent authorities of the host Member State may ask the competent authorities of the home Member State to decide on the ring-fencing of the institution’s assets and liabilities, as provided for in Article 16(3) and Article 18(7).Article 22Implementation1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 September 2005. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.3. Member States may postpone until 23 September 2010 the application of Article 17(1) and (2) to institutions located in their territory which at the date specified in paragraph 1 of this Article do not have the minimum level of regulatory own funds required pursuant to Article 17(1) and (2). However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.4. Member States may postpone until 23 September 2010 the application of Article 18(1)(f) to institutions located in their territory. However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.Article 23Entry in forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 24AddresseesThis Directive is addressed to the Member States.Done at Luxembourg, 3 June 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentN. Christodoulakis(1) OJ C 96 E, 27.3.2001, p. 136.(2) OJ C 155, 29.5.2001, p. 26.(3) Opinion of the European Parliament of 4 July 2001 (OJ C 65 E, 14.3.2002, p. 135), Council common position of 5 November 2002 (not yet published in the Official Journal) and decision of the European Parliament of 12 March 2003 (not yet published in the Official Journal) and decision of the Council of 13 May 2003.(4) OJ L 283, 28.10.1980, p. 23. Directive as last amended by Directive 2002/74/EC of the European Parliament and of the Council (OJ L 270, 8.10.2002, p. 10).(5) Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 149, 5.7.1971, p. 2). Regulation as last amended by Regulation (EC) No 1386/2001 of the European Parliament and of the Council (OJ L 187, 10.7.2001, p. 1).(6) Council Regulation (EEC) No 574/72 of 21 March 1972 fixing the procedure for implementing Regulation (EEC) No 1408/71 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 74, 27.3.1972, p. 1). Regulation as last amended by Commission Regulation (EC) No 410/2002 (OJ L 62, 5.3.2002, p. 17).(7) First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (OJ L 228, 16.8.1973, p. 3). Directive as last amended by Directive 2002/13/EC of the European Parliament and of the Council (OJ L 77, 20.3.2002, p. 17).(8) Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 375, 31.12.1985, p. 3). Directive as last amended by Directive 2001/108/EC of the European Parliament and of the Council (OJ L 41, 13.2.2002, p. 35).(9) Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (OJ L 141, 11.6.1993, p. 27). Directive as last amended by Directive 2000/64/EC of the European Parliament and of the Council (OJ L 290, 17.11.2000, p. 27).(10) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking-up and pursuit of the business of credit institutions (OJ L 126, 26.5.2000, p. 1). Directive as amended by Directive 2000/28/EC (OJ L 275, 27.10.2000, p. 37).(11) Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (OJ L 345, 19.12.2002, p. 1).
This Directive lays down rules for the taking-up and pursuit of activities carried out by institutions for occupational retirement provision.
1. This Directive shall apply to institutions for occupational retirement provision. Where, in accordance with national law, institutions for occupational retirement provision do not have legal personality, Member States shall apply this Directive either to those institutions or, subject to paragraph 2, to those authorised entities responsible for managing them and acting on their behalf.
2. This Directive shall not apply to:
(a) institutions managing social-security schemes which are covered by Regulation (EEC) No 1408/71(5) and Regulation (EEC) No 574/72(6);
(b) institutions which are covered by Directive 73/239/EEC(7), Directive 85/611/EEC(8), Directive 93/22/EEC(9), Directive 2000/12/EC(10) and Directive 2002/83/EC(11);
(c) institutions which operate on a pay-as-you-go basis;
(d) institutions where employees of the sponsoring undertakings have no legal rights to benefits and where the sponsoring undertaking can redeem the assets at any time and not necessarily meet its obligations for payment of retirement benefits;
(e) companies using book-reserve schemes with a view to paying out retirement benefits to their employees.
Application to institutions operating social-security schemes
Institutions for occupational retirement provision which also operate compulsory employment-related pension schemes which are considered to be social-security schemes covered by Regulations (EEC) No 1408/71 and (EEC) No 574/72 shall be covered by this Directive in respect of their non-compulsory occupational retirement provision business. In that case, the liabilities and the corresponding assets shall be ring-fenced and it shall not be possible to transfer them to the compulsory pension schemes which are considered as social-security schemes or vice versa.
Optional application to institutions covered by Directive 2002/83/EC
Home Member States may choose to apply the provisions of Articles 9 to 16 and Articles 18 to 20 of this Directive to the occupational-retirement-provision business of insurance undertakings which are covered by Directive 2002/83/EC. In that case, all assets and liabilities corresponding to the said business shall be ring-fenced, managed and organised separately from the other activities of the insurance undertakings, without any possibility of transfer.
In such case, and only as far as their occupational retirement provision business is concerned, insurance undertakings shall not be subject to Articles 20 to 26, 31 and 36 of Directive 2002/83/EC.
The home Member State shall ensure that either the competent authorities, or the authorities responsible for supervision of insurance undertakings covered by Directive 2002/83/EC, as part of their supervisory work, verify the strict separation of the relevant occupational retirement provision business.
Small pension institutions and statutory schemes
With the exception of Article 19, Member States may choose not to apply this Directive, in whole or in part, to any institution located in their territories which operates pension schemes which together have less than 100 members in total. Subject to Article 2(2), such institutions should nevertheless be given the right to apply this Directive on a voluntary basis. Article 20 may be applied only if all the other provisions of this Directive apply.
Member States may choose not to apply Articles 9 to 17 to institutions where occupational retirement provision is made under statute, pursuant to legislation, and is guaranteed by a public authority. Article 20 may be applied only if all the other provisions of this Directive apply.
Definitions
For the purposes of this Directive:
(a) “institution for occupational retirement provision”, or “institution”, means an institution, irrespective of its legal form, operating on a funded basis, established separately from any sponsoring undertaking or trade for the purpose of providing retirement benefits in the context of an occupational activity on the basis of an agreement or a contract agreed:
– individually or collectively between the employer(s) and the employee(s) or their respective representatives, or
– with self-employed persons, in compliance with the legislation of the home and host Member States,
and which carries out activities directly arising therefrom;
(b) “pension scheme” means a contract, an agreement, a trust deed or rules stipulating which retirement benefits are granted and under which conditions;
(c) “sponsoring undertaking” means any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which pays contributions into an institution for occupational retirement provision;
(d) “retirement benefits” means benefits paid by reference to reaching, or the expectation of reaching, retirement or, where they are supplementary to those benefits and provided on an ancillary basis, in the form of payments on death, disability, or cessation of employment or in the form of support payments or services in case of sickness, indigence or death. In order to facilitate financial security in retirement, these benefits usually take the form of payments for life. They may, however, also be payments made for a temporary period or as a lump sum.
(e) “member” means a person whose occupational activities entitle or will entitle him/her to retirement benefits in accordance with the provisions of a pension scheme;
(f) “beneficiary” means a person receiving retirement benefits;
(g) “competent authorities” means the national authorities designated to carry out the duties provided for in this Directive;
(h) “biometrical risks” mean risks linked to death, disability and longevity;
(i) “home Member State” means the Member State in which the institution has its registered office and its main administration or, if it does not have a registered office, its main administration;
(j) “host Member State” means the Member State whose social and labour law relevant to the field of occupational pension schemes is applicable to the relationship between the sponsoring undertaking and members.
Activities of an institution
Each Member State shall require institutions located within its territory to limit their activities to retirement-benefit related operations and activities arising therefrom.
When, in accordance with Article 4, an insurance undertaking manages its occupational retirement provision business by ring-fencing its assets and liabilities, the ring-fenced assets and liabilities shall be restricted to retirement-benefit related operations and activities directly arising therefrom.
Legal separation between sponsoring undertakings and institutions for occupational retirement provision
Each Member State shall ensure that there is a legal separation between a sponsoring undertaking and an institution for occupational retirement provision in order that the assets of the institution are safeguarded in the interests of members and beneficiaries in the event of bankruptcy of the sponsoring undertaking.
Conditions of operation
1. Each Member State shall, in respect of every institution located in its territory, ensure that:
(a) the institution is registered in a national register by the competent supervisory authority or authorised; in the case of cross-border activities referred to in Article 20, the register shall also indicate the Member States in which the institution is operating;
(b) the institution is effectively run by persons of good repute who must themselves have appropriate professional qualifications and experience or employ advisers with appropriate professional qualifications and experience;
(c) properly constituted rules regarding the functioning of any pension scheme operated by the institution have been implemented and members have been adequately informed of these rules;
(d) all technical provisions are computed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State;
(e) where the sponsoring undertaking guarantees the payment of the retirement benefits, it is committed to regular financing;
(f) the members are sufficiently informed of the conditions of the pension scheme, in particular concerning:
(i) the rights and obligations of the parties involved in the pension scheme;
(ii) the financial, technical and other risks associated with the pension scheme;
(iii) the nature and distribution of those risks.
2. In accordance with the principle of subsidiarity and taking due account of the scale of pension benefits offered by the social-security regimes, Member States may provide that the option of longevity and disability cover, provision for surviving dependants and a guarantee of repayment of contributions as additional benefits be offered to members if employers and employees, or their respective representatives, so agree.
3. A Member State may make the conditions of operation of an institution located in its territory subject to other requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.
4. A Member State may permit or require institutions located in its territory to entrust management of these institutions, in whole or in part, to other entities operating on behalf of those institutions.
5. In the case of cross-border activity as referred to in Article 20, the conditions of operation of the institution shall be subject to a prior authorisation by the competent authorities of the home Member State.
Annual accounts and annual reports
Each Member State shall require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and the annual reports shall give a true and fair view of the institution’s assets, liabilities and financial position. The annual accounts and information in the reports shall be consistent, comprehensive, fairly presented and duly approved by authorised persons, according to national law.
Information to be given to the members and beneficiaries
1. Depending on the nature of the pension scheme established, each Member State shall ensure that every institution located in its territory provides at least the information set out in this Article.
2. Members and beneficiaries and/or, where applicable, their representatives shall receive:
(a) on request, the annual accounts and the annual reports referred to in Article 10, and, where an institution is responsible for more than one scheme, those relating to their particular pension scheme;
(b) within a reasonable time, any relevant information regarding changes to the pension-scheme rules.
3. The statement of investment policy principles, referred to in Article 12, shall be made available to members and beneficiaries and/or, where applicable, to their representatives on request.
4. Each member shall also receive, on request, detailed and substantial information on:
(a) the target level of the retirement benefits, if applicable;
(b) the level of benefits in case of cessation of employment;
(c) where the member bears the investment risk, the range of investment options, if applicable, and the actual investment portfolio as well as information on risk exposure and costs related to the investments;
(d) the arrangements relating to the transfer of pension rights to another institution for occupational retirement provision in the event of termination of the employment relationship.
Members shall receive every year brief particulars of the situation of the institution as well as the current level of financing of their accrued individual entitlements.
5. Each beneficiary shall receive, on retirement or when other benefits become due, the appropriate information on the benefits which are due and the corresponding payment options.
Statement of investment policy principles
Each Member State shall ensure that every institution located in its territory prepares and, at least every three years, reviews a written statement of investment-policy principles. This statement is to be revised without delay after any significant change in the investment policy. Member States shall provide that this statement contains, at least, such matters as the investment risk measurement methods, the risk-management processes implemented and the strategic asset allocation with respect to the nature and duration of pension liabilities.
Information to be provided to the competent authorities
Each Member State shall ensure that the competent authorities, in respect of any institution located in its territory, have the necessary powers and means:
(a) to require the institution, the members of its board of directors and other managers or directors or persons controlling the institution to supply information about all business matters or forward all business documents;
(b) to supervise relationships between the institution and other companies or between institutions, when institutions transfer functions to those other companies or institutions (outsourcing), influencing the financial situation of the institution or being in a material way relevant for effective supervision;
(c) to obtain regularly the statement of investment-policy principles, the annual accounts and the annual reports, and all the documents necessary for the purposes of supervision. These may include documents such as:
(i) internal interim reports;
(ii) actuarial valuations and detailed assumptions;
(iii) asset-liability studies;
(iv) evidence of consistency with the investment-policy principles;
(v) evidence that contributions have been paid in as planned;
(vi) reports by the persons responsible for auditing the annual accounts referred to in Article 10;
(d) to carry out on-site inspections at the institution’s premises and, where appropriate, on outsourced functions to check if activities are carried out in accordance with the supervisory rules.
Powers of intervention and duties of the competent authorities
1. The competent authorities shall require every institution located in their territories to have sound administrative and accounting procedures and adequate internal control mechanisms.
2. The competent authorities shall have the power to take any measures including, where appropriate, those of an administrative or financial nature, either with regard to any institution located in their territories or against the persons running the institution, which are appropriate and necessary to prevent or remedy any irregularities prejudicial to the interests of the members and beneficiaries.
They may also restrict or prohibit the free disposal of the institution’s assets when, in particular:
(a) the institution has failed to establish sufficient technical provisions in respect of the entire business or has insufficient assets to cover the technical provisions;
(b) the institution has failed to hold the regulatory own funds.
3. In order to safeguard the interests of members and beneficiaries, the competent authorities may transfer the powers which the persons running an institution located in their territories hold in accordance with the law of the home Member State wholly or partly to a special representative who is fit to exercise these powers.
4. The competent authorities may prohibit or restrict the activities of an institution located in their territories in particular if:
(a) the institution fails to protect adequately the interests of members and beneficiaries;
(b) the institution no longer fulfils the conditions of operation;
(c) the institution fails seriously in its obligations under the rules to which it is subject;
(d) in the case of cross-border activity, the institution does not respect the requirements of social and labour law of the host Member State relevant to the field of occupational pensions.
Any decision to prohibit the activities of an institution shall be supported by precise reasons and notified to the institution in question.
5. Member States shall ensure that decisions taken in respect of an institution under laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts.
Technical provisions
1. The home Member State shall ensure that institutions operating occupational pension schemes establish at all times in respect of the total range of their pension schemes an adequate amount of liabilities corresponding to the financial commitments which arise out of their portfolio of existing pension contracts.
2. The home Member State shall ensure that institutions operating occupational pension schemes, where they provide cover against biometric risks and/or guarantee either an investment performance or a given level of benefits, establish sufficient technical provisions in respect of the total range of these schemes.
3. The calculation of technical provisions shall take place every year. However, the home Member State may allow a calculation once every three years if the institution provides members and/or the competent authorities with a certification or a report of adjustments for the intervening years. The certification or the report shall reflect the adjusted development of the technical provisions and changes in risks covered.
4. The calculation of the technical provisions shall be executed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State, according to the following principles:
(a) the minimum amount of the technical provisions shall be calculated by a sufficiently prudent actuarial valuation, taking account of all commitments for benefits and for contributions in accordance with the pension arrangements of the institution. It must be sufficient both for pensions and benefits already in payment to beneficiaries to continue to be paid, and to reflect the commitments which arise out of members’ accrued pension rights. The economic and actuarial assumptions chosen for the valuation of the liabilities shall also be chosen prudently taking account, if applicable, of an appropriate margin for adverse deviation;
(b) the maximum rates of interest used shall be chosen prudently and determined in accordance with any relevant rules of the home Member State. These prudent rates of interest shall be determined by taking into account:
– the yield on the corresponding assets held by the institution and the future investment returns and/or
– the market yields of high-quality or government bonds;
(c) the biometric tables used for the calculation of technical provisions shall be based on prudent principles, having regard to the main characteristics of the group of members and the pension schemes, in particular the expected changes in the relevant risks;
(d) the method and basis of calculation of technical provisions shall in general remain constant from one financial year to another. However, discontinuities may be justified by a change of legal, demographic or economic circumstances underlying the assumptions.
5. The home Member State may make the calculation of technical provisions subject to additional and more detailed requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected.
6. With a view to further harmonisation of the rules regarding the calculation of technical provisions which may be justified – in particular the interest rates and other assumptions influencing the level of technical provisions – the Commission shall, every two years or at the request of a Member State, issue a report on the situation concerning the development in cross-border activities.
The Commission shall propose any necessary measures to prevent possible distortions caused by different levels of interest rates and to protect the interest of beneficiaries and members of any scheme.
Funding of technical provisions
1. The home Member State shall require every institution to have at all times sufficient and appropriate assets to cover the technical provisions in respect of the total range of pension schemes operated.
2. The home Member State may allow an institution, for a limited period of time, to have insufficient assets to cover the technical provisions. In this case the competent authorities shall require the institution to adopt a concrete and realisable recovery plan in order to ensure that the requirements of paragraph 1 are met again. The plan shall be subject to the following conditions:
(a) the institution shall set up a concrete and realisable plan to re-establish the required amount of assets to cover fully the technical provisions in due time. The plan shall be made available to members or, where applicable, to their representatives and/or shall be subject to approval by the competent authorities of the home Member State;
(b) in drawing up the plan, account shall be taken of the specific situation of the institution, in particular the asset/liability structure, risk profile, liquidity plan, the age profile of the members entitled to receive retirement benefits, start-up schemes and schemes changing from non-funding or partial funding to full funding;
(c) in the event of termination of a pension scheme during the period referred to above in this paragraph, the institution shall inform the competent authorities of the home Member State. The institution shall establish a procedure in order to transfer the assets and the corresponding liabilities to another financial institution or a similar body. This procedure shall be disclosed to the competent authorities of the home Member State and a general outline of the procedure shall be made available to members or, where applicable, to their representatives in accordance with the principle of confidentiality.
3. In the event of cross-border activity as referred to in Article 20, the technical provisions shall at all times be fully funded in respect of the total range of pension schemes operated. If these conditions are not met, the competent authorities of the home Member State shall intervene in accordance with Article 14. To comply with this requirement the home Member State may require ring-fencing of the assets and liabilities.
Regulatory own funds
1. The home Member State shall ensure that institutions operating pension schemes, where the institution itself, and not the sponsoring undertaking, underwrites the liability to cover against biometric risk, or guarantees a given investment performance or a given level of benefits, hold on a permanent basis additional assets above the technical provisions to serve as a buffer. The amount thereof shall reflect the type of risk and asset base in respect of the total range of schemes operated. These assets shall be free of all foreseeable liabilities and serve as a safety capital to absorb discrepancies between the anticipated and the actual expenses and profits.
2. For the purposes of calculating the minimum amount of the additional assets, the rules laid down in Articles 27 and 28 of Directive 2002/83/EC shall apply.
3. Paragraph 1 shall, however, not prevent Member States from requiring institutions located in their territory to hold regulatory own funds or from laying down more detailed rules provided that they are prudentially justified.
Investment rules
1. Member States shall require institutions located in their territories to invest in accordance with the “prudent person” rule and in particular in accordance with the following rules:
(a) the assets shall be invested in the best interests of members and beneficiaries. In the case of a potential conflict of interest, the institution, or the entity which manages its portfolio, shall ensure that the investment is made in the sole interest of members and beneficiaries;
(b) the assets shall be invested in such a manner as to ensure the security, quality, liquidity and profitability of the portfolio as a whole.
Assets held to cover the technical provisions shall also be invested in a manner appropriate to the nature and duration of the expected future retirement benefits;
(c) the assets shall be predominantly invested on regulated markets. Investment in assets which are not admitted to trading on a regulated financial market must in any event be kept to prudent levels;
(d) investment in derivative instruments shall be possible insofar as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis, taking into account the underlying asset, and included in the valuation of the institution’s assets. The institution shall also avoid excessive risk exposure to a single counterparty and to other derivative operations;
(e) the assets shall be properly diversified in such a way as to avoid excessive reliance on any particular asset, issuer or group of undertakings and accumulations of risk in the portfolio as a whole.
Investments in assets issued by the same issuer or by issuers belonging to the same group shall not expose the institution to excessive risk concentration;
(f) investment in the sponsoring undertaking shall be no more than 5 % of the portfolio as a whole and, when the sponsoring undertaking belongs to a group, investment in the undertakings belonging to the same group as the sponsoring undertaking shall not be more than 10 % of the portfolio.
When the institution is sponsored by a number of undertakings, investment in these sponsoring undertakings shall be made prudently, taking into account the need for proper diversification.
Member States may decide not to apply the requirements referred to in points (e) and (f) to investment in government bonds.
2. The home Member State shall prohibit the institution from borrowing or acting as a guarantor on behalf of third parties. However, Member States may authorise institutions to carry out some borrowing only for liquidity purposes and on a temporary basis.
3. Member States shall not require institutions located in their territory to invest in particular categories of assets.
4. Without prejudice to Article 12, Member States shall not subject the investment decisions of an institution located in their territory or its investment manager to any kind of prior approval or systematic notification requirements.
5. In accordance with the provisions of paragraphs 1 to 4, Member States may, for the institutions located in their territories, lay down more detailed rules, including quantitative rules, provided they are prudentially justified, to reflect the total range of pension schemes operated by these institutions.
In particular, Member States may apply investment provisions similar to those of Directive 2002/83/EC.
However, Member States shall not prevent institutions from:
(a) investing up to 70 % of the assets covering the technical provisions or of the whole portfolio for schemes in which the members bear the investment risks in shares, negotiable securities treated as shares and corporate bonds admitted to trading on regulated markets and deciding on the relative weight of these securities in their investment portfolio. Provided it is prudentially justified, Member States may, however, apply a lower limit to institutions which provide retirement products with a long-term interest rate guarantee, bear the investment risk and themselves provide for the guarantee;
(b) investing up to 30 % of the assets covering technical provisions in assets denominated in currencies other than those in which the liabilities are expressed;
Management and custody
1. Member States shall not restrict institutions from appointing, for the management of the investment portfolio, investment managers established in another Member State and duly authorised for this activity, in accordance with Directives 85/611/EEC, 93/22/EEC, 2000/12/EC and 2002/83/EC, as well as those referred to in Article 2(1) of this Directive.
2. Member States shall not restrict institutions from appointing, for the custody of their assets, custodians established in another Member State and duly authorised in accordance with Directive 93/22/EEC or Directive 2000/12/EC, or accepted as a depositary for the purposes of Directive 85/611/EEC.
The provision referred to in this paragraph shall not prevent the home Member State from making the appointment of a depositary or a custodian compulsory.
3. Each Member State shall take the necessary steps to enable it under its national law to prohibit, in accordance with Article 14, the free disposal of assets held by a depositary or custodian located within its territory at the request of the institution’s home Member State.
Cross-border activities
1. Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, Member States shall allow undertakings located within their territories to sponsor institutions for occupational retirement provision authorised in other Member States. They shall also allow institutions for occupational retirement provision authorised in their territories to accept sponsorship by undertakings located within the territories of other Member States.
2. An institution wishing to accept sponsorship from a sponsoring undertaking located within the territory of another Member State shall be subject to a prior authorisation by the competent authorities of its home Member State, as referred to in Article 9(5). It shall notify its intention to accept sponsorship from a sponsoring undertaking located within the territory of another Member State to the competent authorities of the home Member State where it is authorised.
3. Member States shall require institutions located within their territories and proposing to be sponsored by an undertaking located in the territory of another Member State to provide the following information when effecting a notification under paragraph 2:
(a) the host Member State(s);
(b) the name of the sponsoring undertaking;
(c) the main characteristics of the pension scheme to be operated for the sponsoring undertaking.
4. Where a competent authority of the home Member State is notified under paragraph 2, and unless it has reason to doubt that the administrative structure or the financial situation of the institution or the good repute and professional qualifications or experience of the persons running the institution are compatible with the operations proposed in the host Member State, it shall within three months of receiving all the information referred to in paragraph 3 communicate that information to the competent authorities of the host Member State and inform the institution accordingly.
5. Before the institution starts to operate a pension scheme for a sponsoring undertaking in another Member State, the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 3, inform the competent authorities of the home Member State, if appropriate, of the requirements of social and labour law relevant to the field of occupational pensions under which the pension scheme sponsored by an undertaking in the host Member State must be operated and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. The competent authorities of the home Member State shall communicate this information to the institution.
6. On receiving the communication referred to in paragraph 5, or if no communication is received from the competent authorities of the home Member State on expiry of the period provided for in paragraph 5, the institution may start to operate the pension scheme sponsored by an undertaking in the host Member State in accordance with the host Member State’s requirements of social and labour law relevant to the field of occupational pensions, and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.
7. In particular, an institution sponsored by an undertaking located in another Member State shall also be subject, in respect of the corresponding members, to any information requirements imposed by the competent authorities of the host Member State on institutions located in that Member State, in accordance with Article 11.
8. The competent authorities of the host Member State shall inform the competent authorities of the home Member State of any significant change in the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes which may affect the characteristics of the pension scheme insofar as it concerns the operation of the pension scheme sponsored by an undertaking in the host Member State and in any rules that have to be applied in accordance with Article 18(7) and with paragraph 7 of this Article.
9. The institution shall be subject to ongoing supervision by the competent authorities of the host Member State as to the compliance of its activities with the host Member State’s requirements of labour and social law relevant to the field of occupational pension schemes referred to in paragraph 5 and with the information requirements referred to in paragraph 7. Should this supervision bring irregularities to light, the competent authorities of the host Member State shall inform the competent authorities of the home Member State immediately. The competent authorities of the home Member State shall, in coordination with the competent authorities of the host Member State, take the necessary measures to ensure that the institution puts a stop to the detected breach of social and labour law.
10. If, despite the measures taken by the competent authorities of the home Member State or because appropriate measures are lacking in the home Member State, the institution persists in breaching the applicable provisions of the host Member State’s requirements of social and labour law relevant to the field of occupational pension schemes, the competent authorities of the host Member State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalise further irregularities, including, insofar as is strictly necessary, preventing the institution from operating in the host Member State for the sponsoring undertaking.
Cooperation between Member States and the Commission
1. Member States shall ensure, in an appropriate manner, the uniform application of this Directive through regular exchanges of information and experience with a view to developing best practices in this sphere and closer cooperation, and by so doing, preventing distortions of competition and creating the conditions required for unproblematic cross-border membership.
2. The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating supervision of the operations of institutions for occupational retirement provision.
3. Each Member State shall inform the Commission of any major difficulties to which the application of this Directive gives rise.
The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution.
4. Four years after the entry into force of this Directive, the Commission shall issue a report reviewing:
(a) the application of Article 18 and the progress achieved in the adaptation of national supervisory systems, and
(b) the application of the second subparagraph of Article 19(2), in particular the situation prevailing in Member States regarding the use of depositaries and the role played by them where appropriate.
5. The competent authorities of the host Member State may ask the competent authorities of the home Member State to decide on the ring-fencing of the institution’s assets and liabilities, as provided for in Article 16(3) and Article 18(7).
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 September 2005. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
3. Member States may postpone until 23 September 2010 the application of Article 17(1) and (2) to institutions located in their territory which at the date specified in paragraph 1 of this Article do not have the minimum level of regulatory own funds required pursuant to Article 17(1) and (2). However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.
4. Member States may postpone until 23 September 2010 the application of Article 18(1)(f) to institutions located in their territory. However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive.
Entry in force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Luxembourg, 3 June 2003.
For the European Parliament
The President
For the Council
N. Christodoulakis
(1) OJ C 96 E, 27.3.2001, p. 136.
(2) OJ C 155, 29.5.2001, p. 26.
(3) Opinion of the European Parliament of 4 July 2001 (OJ C 65 E, 14.3.2002, p. 135), Council common position of 5 November 2002 (not yet published in the Official Journal) and decision of the European Parliament of 12 March 2003 (not yet published in the Official Journal) and decision of the Council of 13 May 2003.
(4) OJ L 283, 28.10.1980, p. 23. Directive as last amended by Directive 2002/74/EC of the European Parliament and of the Council (OJ L 270, 8.10.2002, p. 10).
(5) Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 149, 5.7.1971, p. 2). Regulation as last amended by Regulation (EC) No 1386/2001 of the European Parliament and of the Council (OJ L 187, 10.7.2001, p. 1).
(6) Council Regulation (EEC) No 574/72 of 21 March 1972 fixing the procedure for implementing Regulation (EEC) No 1408/71 on the application of social-security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ L 74, 27.3.1972, p. 1). Regulation as last amended by Commission Regulation (EC) No 410/2002 (OJ L 62, 5.3.2002, p. 17).
(7) First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance (OJ L 228, 16.8.1973, p. 3). Directive as last amended by Directive 2002/13/EC of the European Parliament and of the Council (OJ L 77, 20.3.2002, p. 17).
(8) Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 375, 31.12.1985, p. 3). Directive as last amended by Directive 2001/108/EC of the European Parliament and of the Council (OJ L 41, 13.2.2002, p. 35).
(9) Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (OJ L 141, 11.6.1993, p. 27). Directive as last amended by Directive 2000/64/EC of the European Parliament and of the Council (OJ L 290, 17.11.2000, p. 27).
(10) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking-up and pursuit of the business of credit institutions (OJ L 126, 26.5.2000, p. 1). Directive as amended by Directive 2000/28/EC (OJ L 275, 27.10.2000, p. 37).
(11) Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (OJ L 345, 19.12.2002, p. 1).

Pending: 32003L0032

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1), as last amended by Directive 2001/104/EC of the European Parliament and of the Council(2), and in particular Article 14(b) thereof,Whereas:(1) On 5 March 2001 France adopted a national measure prohibiting the manufacture, placing on the market, distribution, import, export and use of medical devices manufactured from materials of animal origin, where these are used as dura mater substitutes.(2) France justified the measure by the uncertainties that exist with regard to the risk of transmission to humans of animal spongiform encephalopathies from such medical devices, and by the fact that alternatives are available, in the form of synthetic materials or autologous materials taken from the patient.(3) Other Member States have taken unilateral national measures on other legal bases in relation to the use of certain raw materials originating from animal tissues and presenting specific risks of transmitting animal spongiform encephalopathies.(4) All those national measures are related to the general protection of public health against the risks of transmitting the animal spongiform encephalopathies via medical devices.(5) With regard to the sourcing of materials used in medical devices the provisions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(3) apply.(6) In order to improve the level of safety and health protection, it is necessary to further reinforce the protective measures against the overall risk of transmitting animal spongiform encephalopathies via medical devices.(7) The Scientific Committee on Medicinal Products and Medical Devices has adopted an opinion on the use of Transmissible Spongiform Encephalopathies (TSE) risk materials for the manufacture of implantable medical devices, which recommends that manufacturers of these devices that utilise animal tissues or derivatives be required, as an essential part of the risk management, to fully justify the use of these tissues in the context of the benefits to patients and of the comparison with alternative materials.(8) The Scientific Steering Committee has adopted several opinions on specified risk materials and on the products derived from ruminant tissues, such as gelatine and collagen, which are of direct relevance to the safety of medical devices.(9) Medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable are Class III devices in accordance with the classification rules set out in Annex IX to Directive 93/42/EEC, except where such devices are intended to come into contact with intact skin only.(10) Prior to being placed on the market, medical devices, whether they originate in the Community or are imported from third countries, are subject to the conformity assessment procedures laid down in Directive 93/42/EEC.(11) Annex I to Directive 93/42/EEC sets out the essential requirements that medical devices must meet pursuant to that Directive. Points 8.1 and 8.2 of that Annex set out specific requirements intended to eliminate or reduce as far as possible the risk of infection for the patient, user and third parties due to tissues of animal origin and specifies that the solutions adopted by the manufacturer in the design and construction of the devices must conform to safety principles taking into account the generally acknowledged state of the art.(12) With regard to medical devices manufactured utilising tissues of animal origin it is necessary to adopt more detailed specifications in relation to the requirements of point 8.2 of Annex I to Directive 93/42/EEC and to specify certain aspects relating to the risk analysis and risk management in the framework of the conformity assessment procedures referred to in Article 11 of that Directive.(13) Some of the terms used in Directive 93/42/EEC should be further clarified in order to ensure a uniform implementation of this Directive.(14) It is necessary to provide for an adequate transitional period for medical devices already covered by an EC design-examination certificate or by an EC type examination certificate.(15) The measures provided for in this Directive are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Council Directive 90/385/EEC(4),HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.2. The animal tissues covered by this Directive are those originating from bovine, ovine and caprine species, as well as deer, elk, mink and cats.3. Collagen, gelatin and tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.4. This Directive does not apply to medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.Article 2For the purposes of this Directive, the following definitions shall apply in addition to the definitions set out in Directive 93/42/EEC:(a) “cell” means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;(b) “tissue” means an organisation of cells and/or extra-cellular constituents;(c) “derivative” means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;(d) “non-viable” means having no potential for metabolism or multiplication;(e) “transmissible agents” means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalophathies agents and scrapie agents;(f) “reduction, elimination or removal” means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;(g) “inactivation” means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;(h) “source country” means the country in which the animal was born, has been reared and/or has been slaughtered;(i) “starting materials” means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in

Article 1
1. This Directive lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
2. The animal tissues covered by this Directive are those originating from bovine, ovine and caprine species, as well as deer, elk, mink and cats.
3. Collagen, gelatin and tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.
4. This Directive does not apply to medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.

Article 2
For the purposes of this Directive, the following definitions shall apply in addition to the definitions set out in Directive 93/42/EEC:
(a) “cell” means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;
(b) “tissue” means an organisation of cells and/or extra-cellular constituents;
(c) “derivative” means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;
(d) “non-viable” means having no potential for metabolism or multiplication;
(e) “transmissible agents” means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalophathies agents and scrapie agents;
(f) “reduction, elimination or removal” means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;
(g) “inactivation” means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;
(h) “source country” means the country in which the animal was born, has been reared and/or has been slaughtered;
(i) “starting materials” means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.

Article 3
Before lodging an application for a conformity assessment pursuant to Article 11(1) of Directive 93/42/EEC, the manufacturer of medical devices referred to in Article 1(1), shall carry out the risk analysis and the risk management scheme set out in the Annex to this Directive.

Article 4
Member States shall verify that bodies notified under Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices referred to in Article 1(1) with the provisions of Directive 93/42/EEC and with the specifications laid down in the Annex to this Directive.
If, on the basis of that verification, it is necessary for a Member State to amend the tasks of a notified body, that Member State shall notify the Commission and the other Member States accordingly.

Article 5
1. Conformity assessment procedures for medical devices referred to in Article 1(1), shall include the evaluation of their compliance with the essential requirements of Directive 93/42/EEC and the specifications laid down in the Annex to this Directive.
2. Notified bodies shall evaluate the manufacturer’s risk analysis and risk management strategy, and in particular:
(a) the information provided by the manufacturer;
(b) the justification for the use of animal tissues or derivatives;
(c) the results of elimination and/or inactivation studies or of literature search;
(d) the manufacturer’s control of the sources of raw materials, finished products and subcontractors;
(e) the need to audit matters related to sourcing, including third party supplies.
3. Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter “TSE certificate”, for starting materials, where available.
4. Except for medical devices using starting materials for which a TSE certificate has been issued as referred to in paragraph 3, national bodies shall, through their competent authority, seek the opinion of the competent authorities of the other Member States on their evaluation of and conclusions on the risk analysis and risk management of the tissues or the derivatives intended to be incorporated in the medical device as established by the manufacturer.
Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within 12 weeks from the date on which the opinion of the national competent authorities was sought.

Article 6
Member States shall take all necessary steps to ensure that medical devices referred to in Article 1(1) are placed on the market and put into service only if they comply with the provisions of Directive 93/42/EEC and the specifications laid down in the Annex to this Directive.

Article 7
1. Holders of EC design-examination certificates or EC type-examination certificates issued before 1 April 2004 for medical devices referred to in Article 1(1) shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in the Annex to this Directive.
2. Until 30 September 2004, Member States shall accept the placing on the market and the putting into service of medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1 April 2004.

Article 8
1. Member States shall adopt and publish before 1 January 2004 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply those provisions with effect from 1 April 2004.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference at the time of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.

Article 9
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Article 10
This Directive is addressed to the Member States.
Done at Brussels, 23 April 2003.
For the Commission
Erkki Liikanen
Member of the Commission
(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 6, 10.1.2002, p. 50.
(3) OJ L 273, 10.10.2002, p. 1.
(4) OJ L 189, 20.7.1990, p. 17.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1), as last amended by Directive 2001/104/EC of the European Parliament and of the Council(2), and in particular Article 14(b) thereof,Whereas:(1) On 5 March 2001 France adopted a national measure prohibiting the manufacture, placing on the market, distribution, import, export and use of medical devices manufactured from materials of animal origin, where these are used as dura mater substitutes.(2) France justified the measure by the uncertainties that exist with regard to the risk of transmission to humans of animal spongiform encephalopathies from such medical devices, and by the fact that alternatives are available, in the form of synthetic materials or autologous materials taken from the patient.(3) Other Member States have taken unilateral national measures on other legal bases in relation to the use of certain raw materials originating from animal tissues and presenting specific risks of transmitting animal spongiform encephalopathies.(4) All those national measures are related to the general protection of public health against the risks of transmitting the animal spongiform encephalopathies via medical devices.(5) With regard to the sourcing of materials used in medical devices the provisions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(3) apply.(6) In order to improve the level of safety and health protection, it is necessary to further reinforce the protective measures against the overall risk of transmitting animal spongiform encephalopathies via medical devices.(7) The Scientific Committee on Medicinal Products and Medical Devices has adopted an opinion on the use of Transmissible Spongiform Encephalopathies (TSE) risk materials for the manufacture of implantable medical devices, which recommends that manufacturers of these devices that utilise animal tissues or derivatives be required, as an essential part of the risk management, to fully justify the use of these tissues in the context of the benefits to patients and of the comparison with alternative materials.(8) The Scientific Steering Committee has adopted several opinions on specified risk materials and on the products derived from ruminant tissues, such as gelatine and collagen, which are of direct relevance to the safety of medical devices.(9) Medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable are Class III devices in accordance with the classification rules set out in Annex IX to Directive 93/42/EEC, except where such devices are intended to come into contact with intact skin only.(10) Prior to being placed on the market, medical devices, whether they originate in the Community or are imported from third countries, are subject to the conformity assessment procedures laid down in Directive 93/42/EEC.(11) Annex I to Directive 93/42/EEC sets out the essential requirements that medical devices must meet pursuant to that Directive. Points 8.1 and 8.2 of that Annex set out specific requirements intended to eliminate or reduce as far as possible the risk of infection for the patient, user and third parties due to tissues of animal origin and specifies that the solutions adopted by the manufacturer in the design and construction of the devices must conform to safety principles taking into account the generally acknowledged state of the art.(12) With regard to medical devices manufactured utilising tissues of animal origin it is necessary to adopt more detailed specifications in relation to the requirements of point 8.2 of Annex I to Directive 93/42/EEC and to specify certain aspects relating to the risk analysis and risk management in the framework of the conformity assessment procedures referred to in Article 11 of that Directive.(13) Some of the terms used in Directive 93/42/EEC should be further clarified in order to ensure a uniform implementation of this Directive.(14) It is necessary to provide for an adequate transitional period for medical devices already covered by an EC design-examination certificate or by an EC type examination certificate.(15) The measures provided for in this Directive are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Council Directive 90/385/EEC(4),HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.2. The animal tissues covered by this Directive are those originating from bovine, ovine and caprine species, as well as deer, elk, mink and cats.3. Collagen, gelatin and tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.4. This Directive does not apply to medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.Article 2For the purposes of this Directive, the following definitions shall apply in addition to the definitions set out in Directive 93/42/EEC:(a) “cell” means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;(b) “tissue” means an organisation of cells and/or extra-cellular constituents;(c) “derivative” means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;(d) “non-viable” means having no potential for metabolism or multiplication;(e) “transmissible agents” means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalophathies agents and scrapie agents;(f) “reduction, elimination or removal” means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;(g) “inactivation” means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;(h) “source country” means the country in which the animal was born, has been reared and/or has been slaughtered;(i) “starting materials” means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in
1. This Directive lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
2. The animal tissues covered by this Directive are those originating from bovine, ovine and caprine species, as well as deer, elk, mink and cats.
3. Collagen, gelatin and tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.
4. This Directive does not apply to medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.
For the purposes of this Directive, the following definitions shall apply in addition to the definitions set out in Directive 93/42/EEC:
(a) “cell” means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;
(b) “tissue” means an organisation of cells and/or extra-cellular constituents;
(c) “derivative” means a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies;
(d) “non-viable” means having no potential for metabolism or multiplication;
(e) “transmissible agents” means unclassified pathogenic entities, prions and such entities as bovine spongiform encephalophathies agents and scrapie agents;
(f) “reduction, elimination or removal” means a process by which the number of transmissible agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;
(g) “inactivation” means a process by which the ability to cause infection or pathogenic reaction by transmissible agents is reduced;
(h) “source country” means the country in which the animal was born, has been reared and/or has been slaughtered;
(i) “starting materials” means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.
Before lodging an application for a conformity assessment pursuant to Article 11(1) of Directive 93/42/EEC, the manufacturer of medical devices referred to in Article 1(1), shall carry out the risk analysis and the risk management scheme set out in the Annex to this Directive.
Member States shall verify that bodies notified under Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices referred to in Article 1(1) with the provisions of Directive 93/42/EEC and with the specifications laid down in the Annex to this Directive.
If, on the basis of that verification, it is necessary for a Member State to amend the tasks of a notified body, that Member State shall notify the Commission and the other Member States accordingly.
1. Conformity assessment procedures for medical devices referred to in Article 1(1), shall include the evaluation of their compliance with the essential requirements of Directive 93/42/EEC and the specifications laid down in the Annex to this Directive.
2. Notified bodies shall evaluate the manufacturer’s risk analysis and risk management strategy, and in particular:
(a) the information provided by the manufacturer;
(b) the justification for the use of animal tissues or derivatives;
(c) the results of elimination and/or inactivation studies or of literature search;
(d) the manufacturer’s control of the sources of raw materials, finished products and subcontractors;
(e) the need to audit matters related to sourcing, including third party supplies.
3. Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter “TSE certificate”, for starting materials, where available.
4. Except for medical devices using starting materials for which a TSE certificate has been issued as referred to in paragraph 3, national bodies shall, through their competent authority, seek the opinion of the competent authorities of the other Member States on their evaluation of and conclusions on the risk analysis and risk management of the tissues or the derivatives intended to be incorporated in the medical device as established by the manufacturer.
Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within 12 weeks from the date on which the opinion of the national competent authorities was sought.
Member States shall take all necessary steps to ensure that medical devices referred to in Article 1(1) are placed on the market and put into service only if they comply with the provisions of Directive 93/42/EEC and the specifications laid down in the Annex to this Directive.
1. Holders of EC design-examination certificates or EC type-examination certificates issued before 1 April 2004 for medical devices referred to in Article 1(1) shall apply for a complementary EC design-examination certificate or EC type-examination certificate attesting to compliance with the specifications laid down in the Annex to this Directive.
2. Until 30 September 2004, Member States shall accept the placing on the market and the putting into service of medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 1 April 2004.
1. Member States shall adopt and publish before 1 January 2004 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply those provisions with effect from 1 April 2004.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference at the time of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 23 April 2003.
For the Commission
Erkki Liikanen
Member of the Commission
(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 6, 10.1.2002, p. 50.
(3) OJ L 273, 10.10.2002, p. 1.
(4) OJ L 189, 20.7.1990, p. 17.
1. RISK ANALYSIS AND RISK MANAGEMENT
1.1. Justification for the use of animal tissues or derivatives
The manufacturer must justify, on the basis of his overall risk analysis and risk management strategy for a specific medical device, the decision to use animal tissues or derivatives, referred to in Article 1, (specifying animal species and tissues) taking into account the expected clinical benefit, potential residual risk and suitable alternatives.
1.2. Assessment procedure
In order to ensure a high level of protection for patients or users, the manufacturer of devices utilising animal tissues or derivatives referred to in point 1.1 must implement an appropriate and well documented risk analysis and risk management strategy, to address all relevant relating aspects to TSE. He must identify the hazards associated with those tissues or derivatives, establish documentation on measures taken to minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the device utilising such tissues or derivatives, taking into account the intended use and the benefit of the device.
The safety of a device, in terms of its potential for passing on a transmissible agent, is dependent on all the factors described in points 1.2.1 to 1.2.7, which must be analysed, evaluated and managed. These measures in combination determine the device safety.
There are two key steps that must be considered.
– selecting starting materials (tissues or derivatives) considered appropriate regarding their potential contamination with transmissible agents (see 1.2.1, 1.2.2 and 1.2.3) taking into account further processing,
– applying a production process to remove or inactivate transmissible agents on controlled sourced tissues or derivatives (see 1.2.4).
Furthermore, the characteristics of the device and its intended use must be taken into account (see 1.2.5, 1.2.6 and 1.2.7).
In performing the risk analysis and risk management strategy, due consideration must be given to opinions adopted by the relevant scientific committees, and where appropriate to the opinions of the Committee for Proprietary Medicinal Products CPMP, the references of which have been published in the Official Journal of the European Union.
1.2.1. Animals as a source of material
The TSE risk is related to the source species, strains and nature of the starting tissue. As the accumulation of TSE infectivity occurs over an incubation period of several years, sourcing from young healthy animals is considered to be a factor reducing the risk. Risk animals such as fallen stock, emergency slaughtered and TSE suspected animals must be excluded.
1.2.2. Geographical sourcing
Pending the classification of countries according to the BSE status in Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(1), the Geographical BSE risk (GBR) is used when assessing the risk of the source country. The GBR is a qualitative indicator of the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, at a given point in time, in a country. Where presence is confirmed, the GBR gives an indication of the level of infection as specified in the table below.
Certain factors influence the geographical risk of BSE infection associated with the use of raw tissues or derivatives from individual countries. These factors are defined in Article 2.3.13.2, point 1) of the International Animal Health Code of the OIE (Office International des Épizooties), which is available at web-site www.oie.int/eng/normes/Mcode/A_00067.htm
The Scientific Steering Committee has made an assessment of Geographical BSE Risk (GBR) of several third countries and Member States, and will continue to do so for all the countries, which applied for BSE status categorisation, taking the main OIE factors into account.
1.2.3. Nature of starting tissue
The manufacturer must take into account the classification of the hazards relating to different type of starting tissue. Sourcing of animal tissue must be subject to control and individual inspection by a veterinarian and the animal carcass must be certified as fit for human consumption.
The manufacturer must ensure that no risk of cross-contamination occurs at the time of slaughtering.
The manufacturer must not source animal tissue or derivatives classified as potentially high TSE infectivity, unless sourcing of these materials is necessary in exceptional circumstances, taking into account the important benefit for the patient and the absence of an alternative starting tissue.
In addition, the provisions in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption must be applied.
1.2.3.1. Sheep and goats
A classification of infectivity in tissues for sheep and goats has been established based on actual knowledge on the basis of the titres of transmissible agents in tissues and body fluids from naturally infected sheep and goats with clinical scrapie. A table was presented in the Scientific Steering Committee (SSC) opinion of 22-23 July 1999 on “The policy of breeding and genotyping of sheep”, (as an annex)(2) and further updated in the opinion of the SSC – TSE infectivity distributed in ruminant tissues state of knowledge December 2001 – adopted 10-11 January 2002(3).
The classification may be reviewed in the light of new scientific evidence (for example using relevant opinions from the Scientific Committees, the Committee for Proprietary Medicinal Products CPMP and Commission Measures regulating the use of material presenting risks as regards TSE). A review of the references to relevant documents/opinions will be published in the Official Journal of the European Union and will be listed after a Commission Decision has been taken.
1.2.3.2. Cattle
The list of specified risk material (SRM) laid down in Regulation (EC) No 999/2001 shall be considered as potentially high TSE infective.
1.2.4. Inactivation or removal of transmissible agents
1.2.4.1. For devices which cannot withstand an inactivation/elimination process without undergoing unacceptable degradation, the manufacturer must rely principally on the control of sourcing.
1.2.4.2. For other devices, if claims are made by the manufacturer for the ability of manufacturing processes to remove or inactivate transmissible agents, these will have to be substantiated by appropriate documentation.
Relevant information from an appropriate scientific literature search and analysis can be used to support inactivation/elimination factors, where the specific processes referred to the literature are comparable to those used for the device. This search and analysis should also cover the available scientific opinions that may have been adopted by a EU Scientific Committee. These opinions shall serve as a reference, in cases where there are conflicting opinions.
When the literature search failed to substantiate the claims, the manufacturer must set up a specific inactivation and/or elimination study on a scientific basis and the following need to be considered:
– the identified hazard associated with the tissue,
– identification of the relevant model agents,
– rationale for the choice of the particular combinations of model agents,
– identification of stage chosen to eliminate and/or inactivate the transmissible agents,
– calculation of the reduction factors.
A final report must identify manufacturing parameters and limits that are critical to the effectiveness of the inactivation or elimination process.
Appropriate documented procedures must be applied to ensure that the validated processing parameters are applied during routine manufacture.
1.2.5. Quantities of animal starting tissues or derivatives required to produce one unit of the medical device
The manufacturer must evaluate the quantity of raw tissues or derivatives of animal origin required to produce a single unit of the medical device. Where a purification process is involved, the manufacturer must assess whether it may have the potential to concentrate levels of transmissible agents present in the animal starting tissues or derivatives.
1.2.6. Tissues or derivatives of animal origin coming into contact with the patients and users
The manufacturer must consider:
(i) the quantity of animal tissues or derivatives;
(ii) the contact area: its surface, type (e.g. skin, mucous tissue, brain) and condition (e.g. healthy or damaged);
(iii) the type of the tissues or derivatives coming into contact with the patients and/or users; and
(iv) how long the device is intended to remain in contact with the body (including bioresorption effect).
The number of medical devices that could be used in a given procedure shall be taken into account.
1.2.7. Route of administration
The manufacturer must take into account the route of administration recommended in the product information, from the highest risk down to the lowest.

Pending: 32003L0011

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposals from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 8 November 2002,Whereas:(1) Under Article 14 of the Treaty, an area without internal frontiers is to be established, in which the free movement of goods, persons, services and capital is ensured.(2) The risks to the environment of pentabromodiphenyl ether (pentaBDE) and octabromo-diphenyl ether (octaBDE) have been assessed under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(4). The risk assessments on pentaBDE and octaBDE identified a need for reducing risks from these substances to the environment. In its opinions of 4 February 2000 and 31 October 2002, the Scientific Committee on toxicity, ecotoxicity and the environment (CSTEE) confirmed the conclusions of these assessments of pentaBDE and octaBDE on the need to reduce risks to protect the environment. Furthermore, the CSTEE confirmed, in its opinion of 19 June 2000, the concern about exposure of breast-fed children to pentaBDE and that the increasing levels of pentaBDE in breast milk might be the result of a use not yet identified.(3) The Commission has adopted Recommendations in the framework of Regulation (EEC) No 793/93 on a risk reduction strategy for pentaBDE(5) and octaBDE(6) providing for restrictions on marketing and use to control risks to the environment. They also recommended that any measures should take account of the concerns about infants exposed via milk.(4) In order to protect health and the environment the placing on the market and the use of pentaBDE and octaBDE and the placing on the market of articles containing one or both of these substances should be prohibited.(5) The presence of pentaBDE or octaBDE in concentrations higher than 0,1 % can be identified using standard analytical techniques such as GC-MS (gas chromatography-mass spectrometry).(6) The risk assessment on decaBDE was concluded in August 2002 and has revealed a number of uncertainties concerning possible effects on the environment of this substance. Risk reduction measures should be taken by the Community without delay and a risk reduction strategy has therefore to be established immediately. The Commission expects the results of the risk reduction strategy not later than 30 June 2003. It should then immediately assess these results and propose appropriate and strict measures to address risks identified. The European Parliament and the Council should consider this proposal without delay. Restrictions approved by the Community on the marketing and use of decaBDE are to enter into force without further delay, unless the further testing provided for in the above risk assessment resolves the current uncertainties by concluding that decaBDE gives no cause for concern.(7) This Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(7), and in individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8) and Council Directive 98/24/EC of 7 April 1998 on protection of health and safety of workers from the risks related to chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(9),HAVE ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 15 February 2004. They shall forthwith inform the Commission thereof.They shall apply those measures from 15 August 2004.When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 6 February 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentP. Efthymiou(1) OJ C 154 E, 29.5.2001, p. 112 and OJ C 25, 29.1.2002, p. 472.(2) OJ C 193, 10.7.2001, p. 27.(3) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 235), Council Common Position of 6 December 2001 (OJ C 110 E, 7.5.2002, p. 23) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal).(4) OJ L 84, 5.4.1993, p. 1.(5) OJ L 69, 10.3.2001, p. 30.(6) OJ L 249, 17.9.2002, p. 27.(7) OJ L 183, 29.6.1989, p. 1.(8) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).(9) OJ L 131, 5.5.1998, p. 11.ANNEXThe following point [XX] shall be added to Annex I of Directive 76/769/EEC:”>TABLE>”The following point [XXa] shall be added to Annex I of Directive 76/769/EEC:”>TABLE>”

Article 2
Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 15 February 2004. They shall forthwith inform the Commission thereof.
They shall apply those measures from 15 August 2004.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 4
This Directive is addressed to the Member States.
Done at Brussels, 6 February 2003.
For the European Parliament
The President
For the Council
P. Efthymiou
(1) OJ C 154 E, 29.5.2001, p. 112 and OJ C 25, 29.1.2002, p. 472.
(2) OJ C 193, 10.7.2001, p. 27.
(3) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 235), Council Common Position of 6 December 2001 (OJ C 110 E, 7.5.2002, p. 23) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal).
(4) OJ L 84, 5.4.1993, p. 1.
(5) OJ L 69, 10.3.2001, p. 30.
(6) OJ L 249, 17.9.2002, p. 27.
(7) OJ L 183, 29.6.1989, p. 1.
(8) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).
(9) OJ L 131, 5.5.1998, p. 11.

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposals from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 8 November 2002,Whereas:(1) Under Article 14 of the Treaty, an area without internal frontiers is to be established, in which the free movement of goods, persons, services and capital is ensured.(2) The risks to the environment of pentabromodiphenyl ether (pentaBDE) and octabromo-diphenyl ether (octaBDE) have been assessed under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(4). The risk assessments on pentaBDE and octaBDE identified a need for reducing risks from these substances to the environment. In its opinions of 4 February 2000 and 31 October 2002, the Scientific Committee on toxicity, ecotoxicity and the environment (CSTEE) confirmed the conclusions of these assessments of pentaBDE and octaBDE on the need to reduce risks to protect the environment. Furthermore, the CSTEE confirmed, in its opinion of 19 June 2000, the concern about exposure of breast-fed children to pentaBDE and that the increasing levels of pentaBDE in breast milk might be the result of a use not yet identified.(3) The Commission has adopted Recommendations in the framework of Regulation (EEC) No 793/93 on a risk reduction strategy for pentaBDE(5) and octaBDE(6) providing for restrictions on marketing and use to control risks to the environment. They also recommended that any measures should take account of the concerns about infants exposed via milk.(4) In order to protect health and the environment the placing on the market and the use of pentaBDE and octaBDE and the placing on the market of articles containing one or both of these substances should be prohibited.(5) The presence of pentaBDE or octaBDE in concentrations higher than 0,1 % can be identified using standard analytical techniques such as GC-MS (gas chromatography-mass spectrometry).(6) The risk assessment on decaBDE was concluded in August 2002 and has revealed a number of uncertainties concerning possible effects on the environment of this substance. Risk reduction measures should be taken by the Community without delay and a risk reduction strategy has therefore to be established immediately. The Commission expects the results of the risk reduction strategy not later than 30 June 2003. It should then immediately assess these results and propose appropriate and strict measures to address risks identified. The European Parliament and the Council should consider this proposal without delay. Restrictions approved by the Community on the marketing and use of decaBDE are to enter into force without further delay, unless the further testing provided for in the above risk assessment resolves the current uncertainties by concluding that decaBDE gives no cause for concern.(7) This Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(7), and in individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8) and Council Directive 98/24/EC of 7 April 1998 on protection of health and safety of workers from the risks related to chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(9),HAVE ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 15 February 2004. They shall forthwith inform the Commission thereof.They shall apply those measures from 15 August 2004.When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 6 February 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentP. Efthymiou(1) OJ C 154 E, 29.5.2001, p. 112 and OJ C 25, 29.1.2002, p. 472.(2) OJ C 193, 10.7.2001, p. 27.(3) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 235), Council Common Position of 6 December 2001 (OJ C 110 E, 7.5.2002, p. 23) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal).(4) OJ L 84, 5.4.1993, p. 1.(5) OJ L 69, 10.3.2001, p. 30.(6) OJ L 249, 17.9.2002, p. 27.(7) OJ L 183, 29.6.1989, p. 1.(8) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).(9) OJ L 131, 5.5.1998, p. 11.ANNEXThe following point [XX] shall be added to Annex I of Directive 76/769/EEC:”>TABLE>”The following point [XXa] shall be added to Annex I of Directive 76/769/EEC:”>TABLE>”
Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 15 February 2004. They shall forthwith inform the Commission thereof.
They shall apply those measures from 15 August 2004.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 6 February 2003.
For the European Parliament
The President
For the Council
P. Efthymiou
(1) OJ C 154 E, 29.5.2001, p. 112 and OJ C 25, 29.1.2002, p. 472.
(2) OJ C 193, 10.7.2001, p. 27.
(3) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 235), Council Common Position of 6 December 2001 (OJ C 110 E, 7.5.2002, p. 23) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal).
(4) OJ L 84, 5.4.1993, p. 1.
(5) OJ L 69, 10.3.2001, p. 30.
(6) OJ L 249, 17.9.2002, p. 27.
(7) OJ L 183, 29.6.1989, p. 1.
(8) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ L 138, 1.6.1999, p. 66).
(9) OJ L 131, 5.5.1998, p. 11.
The following point [XX] shall be added to Annex I of Directive 76/769/EEC:
The following point [XXa] shall be added to Annex I of Directive 76/769/EEC:

Pending: 32003L0009

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular point (1)(b) of the first subparagraph of Article 63 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Parliament(2),Having regard to the opinion of the Economic and Social Committee(3),Having regard to the opinion of the Committee of the Regions(4),Whereas:(1) A common policy on asylum, including a Common European Asylum System, is a constituent part of the European Union’s objective of progressively establishing an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the Community.(2) At its special meeting in Tampere on 15 and 16 October 1999, the European Council agreed to work towards establishing a Common European Asylum System, based on the full and inclusive application of the Geneva Convention relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967, thus maintaining the principle of non-refoulement.(3) The Tampere Conclusions provide that a Common European Asylum System should include, in the short term, common minimum conditions of reception of asylum seekers.(4) The establishment of minimum standards for the reception of asylum seekers is a further step towards a European asylum policy.(5) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, this Directive seeks to ensure full respect for human dignity and to promote the application of Articles 1 and 18 of the said Charter.(6) With respect to the treatment of persons falling within the scope of this Directive, Member States are bound by obligations under instruments of international law to which they are party and which prohibit discrimination.(7) Minimum standards for the reception of asylum seekers that will normally suffice to ensure them a dignified standard of living and comparable living conditions in all Member States should be laid down.(8) The harmonisation of conditions for the reception of asylum seekers should help to limit the secondary movements of asylum seekers influenced by the variety of conditions for their reception.(9) Reception of groups with special needs should be specifically designed to meet those needs.(10) Reception of applicants who are in detention should be specifically designed to meet their needs in that situation.(11) In order to ensure compliance with the minimum procedural guarantees consisting in the opportunity to contact organisations or groups of persons that provide legal assistance, information should be provided on such organisations and groups of persons.(12) The possibility of abuse of the reception system should be restricted by laying down cases for the reduction or withdrawal of reception conditions for asylum seekers.(13) The efficiency of national reception systems and cooperation among Member States in the field of reception of asylum seekers should be secured.(14) Appropriate coordination should be encouraged between the competent authorities as regards the reception of asylum seekers, and harmonious relationships between local communities and accommodation centres should therefore be promoted.(15) It is in the very nature of minimum standards that Member States have the power to introduce or maintain more favourable provisions for third-country nationals and stateless persons who ask for international protection from a Member State.(16) In this spirit, Member States are also invited to apply the provisions of this Directive in connection with procedures for deciding on applications for forms of protection other than that emanating from the Geneva Convention for third country nationals and stateless persons.(17) The implementation of this Directive should be evaluated at regular intervals.(18) Since the objectives of the proposed action, namely to establish minimum standards on the reception of asylum seekers in Member States, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the proposed action, be better achieved by the Community, the Community may adopt measures in accordance with the principles of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.(19) 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 gave notice, by letter of 18 August 2001, of its wish to take part in the adoption and application of this Directive.(20) In accordance with

Article 1
The purpose of this Directive is to lay down minimum standards for the reception of asylum seekers in Member States.

Article 2
Definitions
For the purposes of this Directive:
(a) “Geneva Convention” shall mean the Convention of 28 July 1951 relating to the status of refugees, as amended by the New York Protocol of 31 January 1967;
(b) “application for asylum” shall mean the application made by a third-country national or a stateless person which can be understood as a request for international protection from a Member State, under the Geneva Convention. Any application for international protection is presumed to be an application for asylum unless a third-country national or a stateless person explicitly requests another kind of protection that can be applied for separately;
(c) “applicant” or “asylum seeker” shall mean a third country national or a stateless person who has made an application for asylum in respect of which a final decision has not yet been taken;
(d) “family members” shall mean, in so far as the family already existed in the country of origin, the following members of the applicant’s family who are present in the same Member State in relation to the application for asylum:
(i) the spouse of the asylum seeker or his or her unmarried partner in a stable relationship, where the legislation or practice of the Member State concerned treats unmarried couples in a way comparable to married couples under its law relating to aliens;
(ii) the minor children of the couple referred to in point (i) or of the applicant, on condition that they are unmarried and dependent and regardless of whether they were born in or out of wedlock or adopted as defined under the national law;
(e) “refugee” shall mean a person who fulfils the requirements of Article 1(A) of the Geneva Convention;
(f) “refugee status” shall mean the status granted by a Member State to a person who is a refugee and is admitted as such to the territory of that Member State;
(g) “procedures” and “appeals”, shall mean the procedures and appeals established by Member States in their national law;
(h) “unaccompanied minors” shall mean persons below the age of eighteen who arrive in the territory of the Member States unaccompanied by an adult responsible for them whether by law or by custom, and for as long as they are not effectively taken into the care of such a person; it shall include minors who are left unaccompanied after they have entered the territory of Member States;
(i) “reception conditions” shall mean the full set of measures that Member States grant to asylum seekers in accordance with this Directive;
(j) “material reception conditions” shall mean the reception conditions that include housing, food and clothing, provided in kind, or as financial allowances or in vouchers, and a daily expenses allowance;
(k) “detention” shall mean confinement of an asylum seeker by a Member State within a particular place, where the applicant is deprived of his or her freedom of movement;
(l) “accommodation centre” shall mean any place used for collective housing of asylum seekers.

Article 3
1. This Directive shall apply to all third country nationals and stateless persons who make an application for asylum at the border or in the territory of a Member State as long as they are allowed to remain on the territory as asylum seekers, as well as to family members, if they are covered by such application for asylum according to the national law.
2. This Directive shall not apply in cases of requests for diplomatic or territorial asylum submitted to representations of Member States.
3. This Directive shall not apply when the provisions of Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof(5) are applied.
4. Member States may decide to apply this Directive in connection with procedures for deciding on applications for kinds of protection other than that emanating from the Geneva Convention for third-country nationals or stateless persons who are found not to be refugees.

Article 4
More favourable provisions
Member States may introduce or retain more favourable provisions in the field of reception conditions for asylum seekers and other close relatives of the applicant who are present in the same Member State when they are dependent on him or for humanitarian reasons insofar as these provisions are compatible with this Directive.

Article 5
Information
1. Member States shall inform asylum seekers, within a reasonable time not exceeding fifteen days after they have lodged their application for asylum with the competent authority, of at least any established benefits and of the obligations with which they must comply relating to reception conditions.
Member States shall ensure that applicants are provided with information on organisations or groups of persons that provide specific legal assistance and organisations that might be able to help or inform them concerning the available reception conditions, including health care.
2. Member States shall ensure that the information referred to in paragraph 1 is in writing and, as far as possible, in a language that the applicants may reasonably be supposed to understand. Where appropriate, this information may also be supplied orally.

Article 6
Documentation
1. Member States shall ensure that, within three days after an application is lodged with the competent authority, the applicant is provided with a document issued in his or her own name certifying his or her status as an asylum seeker or testifying that he or she is allowed to stay in the territory of the Member State while his or her application is pending or being examined.
If the holder is not free to move within all or a part of the territory of the Member State, the document shall also certify this fact.
2. Member States may exclude application of this Article when the asylum seeker is in detention and during the examination of an application for asylum made at the border or within the context of a procedure to decide on the right of the applicant legally to enter the territory of a Member State. In specific cases, during the examination of an application for asylum, Member States may provide applicants with other evidence equivalent to the document referred to in paragraph 1.
3. The document referred to in paragraph 1 need not certify the identity of the asylum seeker.
4. Member States shall adopt the necessary measures to provide asylum seekers with the document referred to in paragraph 1, which must be valid for as long as they are authorised to remain in the territory of the Member State concerned or at the border thereof.
5. Member States may provide asylum seekers with a travel document when serious humanitarian reasons arise that require their presence in another State.

Article 7
Residence and freedom of movement
1. Asylum seekers may move freely within the territory of the host Member State or within an area assigned to them by that Member State. The assigned area shall not affect the unalienable sphere of private life and shall allow sufficient scope for guaranteeing access to all benefits under this Directive.
2. Member States may decide on the residence of the asylum seeker for reasons of public interest, public order or, when necessary, for the swift processing and effective monitoring of his or her application.
3. When it proves necessary, for example for legal reasons or reasons of public order, Member States may confine an applicant to a particular place in accordance with their national law.
4. Member States may make provision of the material reception conditions subject to actual residence by the applicants in a specific place, to be determined by the Member States. Such a decision, which may be of a general nature, shall be taken individually and established by national legislation.
5. Member States shall provide for the possibility of granting applicants temporary permission to leave the place of residence mentioned in paragraphs 2 and 4 and/or the assigned area mentioned in paragraph 1. Decisions shall be taken individually, objectively and impartially and reasons shall be given if they are negative.
The applicant shall not require permission to keep appointments with authorities and courts if his or her appearance is necessary.
6. Member States shall require applicants to inform the competent authorities of their current address and notify any change of address to such authorities as soon as possible.

Article 8
Member States shall take appropriate measures to maintain as far as possible family unity as present within their territory, if applicants are provided with housing by the Member State concerned. Such measures shall be implemented with the asylum seeker’s agreement.

Article 9
Medical screening
Member States may require medical screening for applicants on public health grounds.

Article 10
Schooling and education of minors
1. Member States shall grant to minor children of asylum seekers and to asylum seekers who are minors access to the education system under similar conditions as nationals of the host Member State for so long as an expulsion measure against them or their parents is not actually enforced. Such education may be provided in accommodation centres.
The Member State concerned may stipulate that such access must be confined to the State education system.
Minors shall be younger than the age of legal majority in the Member State in which the application for asylum was lodged or is being examined. Member States shall not withdraw secondary education for the sole reason that the minor has reached the age of majority.
2. Access to the education system shall not be postponed for more than three months from the date the application for asylum was lodged by the minor or the minor’s parents. This period may be extended to one year where specific education is provided in order to facilitate access to the education system.
3. Where access to the education system as set out in paragraph 1 is not possible due to the specific situation of the minor, the Member State may offer other education arrangements.

Article 11
1. Member States shall determine a period of time, starting from the date on which an application for asylum was lodged, during which an applicant shall not have access to the labour market.
2. If a decision at first instance has not been taken within one year of the presentation of an application for asylum and this delay cannot be attributed to the applicant, Member States shall decide the conditions for granting access to the labour market for the applicant.
3. Access to the labour market shall not be withdrawn during appeals procedures, where an appeal against a negative decision in a regular procedure has suspensive effect, until such time as a negative decision on the appeal is notified.
4. For reasons of labour market policies, Member States may give priority to EU citizens and nationals of States parties to the Agreement on the European Economic Area and also to legally resident third-country nationals.

Article 12
Vocational training
Member States may allow asylum seekers access to vocational training irrespective of whether they have access to the labour market.
Access to vocational training relating to an employment contract shall depend on the extent to which the applicant has access to the labour market in accordance with Article 11.

Article 13
General rules on material reception conditions and health care
1. Member States shall ensure that material reception conditions are available to applicants when they make their application for asylum.
2. Member States shall make provisions on material reception conditions to ensure a standard of living adequate for the health of applicants and capable of ensuring their subsistence.
Member States shall ensure that that standard of living is met in the specific situation of persons who have special needs, in accordance with Article 17, as well as in relation to the situation of persons who are in detention.
3. Member States may make the provision of all or some of the material reception conditions and health care subject to the condition that applicants do not have sufficient means to have a standard of living adequate for their health and to enable their subsistence.
4. Member States may require applicants to cover or contribute to the cost of the material reception conditions and of the health care provided for in this Directive, pursuant to the provision of paragraph 3, if the applicants have sufficient resources, for example if they have been working for a reasonable period of time.
If it transpires that an applicant had sufficient means to cover material reception conditions and health care at the time when these basic needs were being covered, Member States may ask the asylum seeker for a refund.
5. Material reception conditions may be provided in kind, or in the form of financial allowances or vouchers or in a combination of these provisions.
Where Member States provide material reception conditions in the form of financial allowances or vouchers, the amount thereof shall be determined in accordance with the principles set out in this Article.

Article 14
Modalities for material reception conditions
1. Where housing is provided in kind, it should take one or a combination of the following forms:
(a) premises used for the purpose of housing applicants during the examination of an application for asylum lodged at the border;
(b) accommodation centres which guarantee an adequate standard of living;
(c) private houses, flats, hotels or other premises adapted for housing applicants.
2. Member States shall ensure that applicants provided with the housing referred to in paragraph 1(a), (b) and (c) are assured:
(a) protection of their family life;
(b) the possibility of communicating with relatives, legal advisers and representatives of the United Nations High Commissioner for Refugees (UNHCR) and non-governmental organisations (NGOs) recognised by Member States.
Member States shall pay particular attention to the prevention of assault within the premises and accommodation centres referred to in paragraph 1(a) and (b).
3. Member States shall ensure, if appropriate, that minor children of applicants or applicants who are minors are lodged with their parents or with the adult family member responsible for them whether by law or by custom.
4. Member States shall ensure that transfers of applicants from one housing facility to another take place only when necessary. Member States shall provide for the possibility for applicants to inform their legal advisers of the transfer and of their new address.
5. Persons working in accommodation centres shall be adequately trained and shall be bound by the confidentiality principle as defined in the national law in relation to any information they obtain in the course of their work.
6. Member States may involve applicants in managing the material resources and non-material aspects of life in the centre through an advisory board or council representing residents.
7. Legal advisors or counsellors of asylum seekers and representatives of the United Nations High Commissioner for Refugees or non-governmental organisations designated by the latter and recognised by the Member State concerned shall be granted access to accommodation centres and other housing facilities in order to assist the said asylum seekers. Limits on such access may be imposed only on grounds relating to the security of the centres and facilities and of the asylum seekers.
8. Member States may exceptionally set modalities for material reception conditions different from those provided for in this Article, for a reasonable period which shall be as short as possible, when:
– an initial assessment of the specific needs of the applicant is required,
– material reception conditions, as provided for in this Article, are not available in a certain geographical area,
– housing capacities normally available are temporarily exhausted,
– the asylum seeker is in detention or confined to border posts.
These different conditions shall cover in any case basic needs.

Article 15
Health care
1. Member States shall ensure that applicants receive the necessary health care which shall include, at least, emergency care and essential treatment of illness.
2. Member States shall provide necessary medical or other assistance to applicants who have special needs.

Article 16
Reduction or withdrawal of reception conditions
1. Member States may reduce or withdraw reception conditions in the following cases:
(a) where an asylum seeker:
– abandons the place of residence determined by the competent authority without informing it or, if requested, without permission, or
– does not comply with reporting duties or with requests to provide information or to appear for personal interviews concerning the asylum procedure during a reasonable period laid down in national law, or
– has already lodged an application in the same Member State.
When the applicant is traced or voluntarily reports to the competent authority, a duly motivated decision, based on the reasons for the disappearance, shall be taken on the reinstallation of the grant of some or all of the reception conditions;
(b) where an applicant has concealed financial resources and has therefore unduly benefited from material reception conditions.
If it transpires that an applicant had sufficient means to cover material reception conditions and health care at the time when these basic needs were being covered, Member States may ask the asylum seeker for a refund.
2. Member States may refuse conditions in cases where an asylum seeker has failed to demonstrate that the asylum claim was made as soon as reasonably practicable after arrival in that Member State.
3. Member States may determine sanctions applicable to serious breaching of the rules of the accommodation centres as well as to seriously violent behaviour.
4. Decisions for reduction, withdrawal or refusal of reception conditions or sanctions referred to in paragraphs 1, 2 and 3 shall be taken individually, objectively and impartially and reasons shall be given. Decisions shall be based on the particular situation of the person concerned, especially with regard to persons covered by Article 17, taking into account the principle of proportionality. Member States shall under all circumstances ensure access to emergency health care.
5. Member States shall ensure that material reception conditions are not withdrawn or reduced before a negative decision is taken.

Article 17
General principle
1. Member States shall take into account the specific situation of vulnerable persons such as minors, unaccompanied minors, disabled people, elderly people, pregnant women, single parents with minor children and persons who have been subjected to torture, rape or other serious forms of psychological, physical or sexual violence, in the national legislation implementing the provisions of Chapter II relating to material reception conditions and health care.
2. Paragraph 1 shall apply only to persons found to have special needs after an individual evaluation of their situation.

Article 18
1. The best interests of the child shall be a primary consideration for Member States when implementing the provisions of this Directive that involve minors.
2. Member States shall ensure access to rehabilitation services for minors who have been victims of any form of abuse, neglect, exploitation, torture or cruel, inhuman and degrading treatment, or who have suffered from armed conflicts, and ensure that appropriate mental health care is developed and qualified counselling is provided when needed.

Article 19
Unaccompanied minors
1. Member States shall as soon as possible take measures to ensure the necessary representation of unaccompanied minors by legal guardianship or, where necessary, representation by an organisation which is responsible for the care and well-being of minors, or by any other appropriate representation. Regular assessments shall be made by the appropriate authorities.
2. Unaccompanied minors who make an application for asylum shall, from the moment they are admitted to the territory to the moment they are obliged to leave the host Member State in which the application for asylum was made or is being examined, be placed:
(a) with adult relatives;
(b) with a foster-family;
(c) in accommodation centres with special provisions for minors;
(d) in other accommodation suitable for minors.
Member States may place unaccompanied minors aged 16 or over in accommodation centres for adult asylum seekers.
As far as possible, siblings shall be kept together, taking into account the best interests of the minor concerned and, in particular, his or her age and degree of maturity. Changes of residence of unaccompanied minors shall be limited to a minimum.
3. Member States, protecting the unaccompanied minor’s best interests, shall endeavour to trace the members of his or her family as soon as possible. In cases where there may be a threat to the life or integrity of the minor or his or her close relatives, particularly if they have remained in the country of origin, care must be taken to ensure that the collection, processing and circulation of information concerning those persons is undertaken on a confidential basis, so as to avoid jeopardising their safety.
4. Those working with unaccompanied minors shall have had or receive appropriate training concerning their needs, and shall be bound by the confidentiality principle as defined in the national law, in relation to any information they obtain in the course of their work.

Article 20
Victims of torture and violence
Member States shall ensure that, if necessary, persons who have been subjected to torture, rape or other serious acts of violence receive the necessary treatment of damages caused by the aforementioned acts.

Article 21
1. Member States shall ensure that negative decisions relating to the granting of benefits under this Directive or decisions taken under Article 7 which individually affect asylum seekers may be the subject of an appeal within the procedures laid down in the national law. At least in the last instance the possibility of an appeal or a review before a judicial body shall be granted.
2. Procedures for access to legal assistance in such cases shall be laid down in national law.

Article 22
Cooperation
Member States shall regularly inform the Commission on the data concerning the number of persons, broken down by sex and age, covered by reception conditions and provide full information on the type, name and format of the documents provided for by Article 6.

Article 23
Guidance, monitoring and control system
Member States shall, with due respect to their constitutional structure, ensure that appropriate guidance, monitoring and control of the level of reception conditions are established.

Article 24
Staff and resources
1. Member States shall take appropriate measures to ensure that authorities and other organisations implementing this Directive have received the necessary basic training with respect to the needs of both male and female applicants.
2. Member States shall allocate the necessary resources in connection with the national provisions enacted to implement this Directive.

Article 25
By 6 August 2006, the Commission shall report to the European Parliament and the Council on the application of this Directive and shall propose any amendments that are necessary.
Member States shall send the Commission all the information that is appropriate for drawing up the report, including the statistical data provided for by Article 22 by 6 February 2006.
After presenting the report, the Commission shall report to the European Parliament and the Council on the application of this Directive at least every five years.

Article 26
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 February 2005. They shall forthwith inform the Commission thereof.
When the Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made.
2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field relating to the enforcement of this Directive.

Article 27
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 28
This Directive is addressed to the Member States in accordance with the Treaty establishing the European Union.
Done at Brussels, 27 January 2003.
For the Council
The President
G. Papandreou
(1) OJ C 213 E, 31.7.2001, p. 286.
(2) Opinion delivered on 25 April 2002 (not yet published in the Official Journal).
(3) OJ C 48, 21.2.2002, p. 63.
(4) OJ C 107, 3.5.2002, p. 85.
(5) OJ L 212, 7.8.2001, p. 12.

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular point (1)(b) of the first subparagraph of Article 63 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Parliament(2),Having regard to the opinion of the Economic and Social Committee(3),Having regard to the opinion of the Committee of the Regions(4),Whereas:(1) A common policy on asylum, including a Common European Asylum System, is a constituent part of the European Union’s objective of progressively establishing an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the Community.(2) At its special meeting in Tampere on 15 and 16 October 1999, the European Council agreed to work towards establishing a Common European Asylum System, based on the full and inclusive application of the Geneva Convention relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967, thus maintaining the principle of non-refoulement.(3) The Tampere Conclusions provide that a Common European Asylum System should include, in the short term, common minimum conditions of reception of asylum seekers.(4) The establishment of minimum standards for the reception of asylum seekers is a further step towards a European asylum policy.(5) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, this Directive seeks to ensure full respect for human dignity and to promote the application of Articles 1 and 18 of the said Charter.(6) With respect to the treatment of persons falling within the scope of this Directive, Member States are bound by obligations under instruments of international law to which they are party and which prohibit discrimination.(7) Minimum standards for the reception of asylum seekers that will normally suffice to ensure them a dignified standard of living and comparable living conditions in all Member States should be laid down.(8) The harmonisation of conditions for the reception of asylum seekers should help to limit the secondary movements of asylum seekers influenced by the variety of conditions for their reception.(9) Reception of groups with special needs should be specifically designed to meet those needs.(10) Reception of applicants who are in detention should be specifically designed to meet their needs in that situation.(11) In order to ensure compliance with the minimum procedural guarantees consisting in the opportunity to contact organisations or groups of persons that provide legal assistance, information should be provided on such organisations and groups of persons.(12) The possibility of abuse of the reception system should be restricted by laying down cases for the reduction or withdrawal of reception conditions for asylum seekers.(13) The efficiency of national reception systems and cooperation among Member States in the field of reception of asylum seekers should be secured.(14) Appropriate coordination should be encouraged between the competent authorities as regards the reception of asylum seekers, and harmonious relationships between local communities and accommodation centres should therefore be promoted.(15) It is in the very nature of minimum standards that Member States have the power to introduce or maintain more favourable provisions for third-country nationals and stateless persons who ask for international protection from a Member State.(16) In this spirit, Member States are also invited to apply the provisions of this Directive in connection with procedures for deciding on applications for forms of protection other than that emanating from the Geneva Convention for third country nationals and stateless persons.(17) The implementation of this Directive should be evaluated at regular intervals.(18) Since the objectives of the proposed action, namely to establish minimum standards on the reception of asylum seekers in Member States, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the proposed action, be better achieved by the Community, the Community may adopt measures in accordance with the principles of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.(19) 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 gave notice, by letter of 18 August 2001, of its wish to take part in the adoption and application of this Directive.(20) In accordance with
The purpose of this Directive is to lay down minimum standards for the reception of asylum seekers in Member States.
Definitions
For the purposes of this Directive:
(a) “Geneva Convention” shall mean the Convention of 28 July 1951 relating to the status of refugees, as amended by the New York Protocol of 31 January 1967;
(b) “application for asylum” shall mean the application made by a third-country national or a stateless person which can be understood as a request for international protection from a Member State, under the Geneva Convention. Any application for international protection is presumed to be an application for asylum unless a third-country national or a stateless person explicitly requests another kind of protection that can be applied for separately;
(c) “applicant” or “asylum seeker” shall mean a third country national or a stateless person who has made an application for asylum in respect of which a final decision has not yet been taken;
(d) “family members” shall mean, in so far as the family already existed in the country of origin, the following members of the applicant’s family who are present in the same Member State in relation to the application for asylum:
(i) the spouse of the asylum seeker or his or her unmarried partner in a stable relationship, where the legislation or practice of the Member State concerned treats unmarried couples in a way comparable to married couples under its law relating to aliens;
(ii) the minor children of the couple referred to in point (i) or of the applicant, on condition that they are unmarried and dependent and regardless of whether they were born in or out of wedlock or adopted as defined under the national law;
(e) “refugee” shall mean a person who fulfils the requirements of Article 1(A) of the Geneva Convention;
(f) “refugee status” shall mean the status granted by a Member State to a person who is a refugee and is admitted as such to the territory of that Member State;
(g) “procedures” and “appeals”, shall mean the procedures and appeals established by Member States in their national law;
(h) “unaccompanied minors” shall mean persons below the age of eighteen who arrive in the territory of the Member States unaccompanied by an adult responsible for them whether by law or by custom, and for as long as they are not effectively taken into the care of such a person; it shall include minors who are left unaccompanied after they have entered the territory of Member States;
(i) “reception conditions” shall mean the full set of measures that Member States grant to asylum seekers in accordance with this Directive;
(j) “material reception conditions” shall mean the reception conditions that include housing, food and clothing, provided in kind, or as financial allowances or in vouchers, and a daily expenses allowance;
(k) “detention” shall mean confinement of an asylum seeker by a Member State within a particular place, where the applicant is deprived of his or her freedom of movement;
(l) “accommodation centre” shall mean any place used for collective housing of asylum seekers.
1. This Directive shall apply to all third country nationals and stateless persons who make an application for asylum at the border or in the territory of a Member State as long as they are allowed to remain on the territory as asylum seekers, as well as to family members, if they are covered by such application for asylum according to the national law.
2. This Directive shall not apply in cases of requests for diplomatic or territorial asylum submitted to representations of Member States.
3. This Directive shall not apply when the provisions of Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof(5) are applied.
4. Member States may decide to apply this Directive in connection with procedures for deciding on applications for kinds of protection other than that emanating from the Geneva Convention for third-country nationals or stateless persons who are found not to be refugees.
More favourable provisions
Member States may introduce or retain more favourable provisions in the field of reception conditions for asylum seekers and other close relatives of the applicant who are present in the same Member State when they are dependent on him or for humanitarian reasons insofar as these provisions are compatible with this Directive.
Information
1. Member States shall inform asylum seekers, within a reasonable time not exceeding fifteen days after they have lodged their application for asylum with the competent authority, of at least any established benefits and of the obligations with which they must comply relating to reception conditions.
Member States shall ensure that applicants are provided with information on organisations or groups of persons that provide specific legal assistance and organisations that might be able to help or inform them concerning the available reception conditions, including health care.
2. Member States shall ensure that the information referred to in paragraph 1 is in writing and, as far as possible, in a language that the applicants may reasonably be supposed to understand. Where appropriate, this information may also be supplied orally.
Documentation
1. Member States shall ensure that, within three days after an application is lodged with the competent authority, the applicant is provided with a document issued in his or her own name certifying his or her status as an asylum seeker or testifying that he or she is allowed to stay in the territory of the Member State while his or her application is pending or being examined.
If the holder is not free to move within all or a part of the territory of the Member State, the document shall also certify this fact.
2. Member States may exclude application of this Article when the asylum seeker is in detention and during the examination of an application for asylum made at the border or within the context of a procedure to decide on the right of the applicant legally to enter the territory of a Member State. In specific cases, during the examination of an application for asylum, Member States may provide applicants with other evidence equivalent to the document referred to in paragraph 1.
3. The document referred to in paragraph 1 need not certify the identity of the asylum seeker.
4. Member States shall adopt the necessary measures to provide asylum seekers with the document referred to in paragraph 1, which must be valid for as long as they are authorised to remain in the territory of the Member State concerned or at the border thereof.
5. Member States may provide asylum seekers with a travel document when serious humanitarian reasons arise that require their presence in another State.
Residence and freedom of movement
1. Asylum seekers may move freely within the territory of the host Member State or within an area assigned to them by that Member State. The assigned area shall not affect the unalienable sphere of private life and shall allow sufficient scope for guaranteeing access to all benefits under this Directive.
2. Member States may decide on the residence of the asylum seeker for reasons of public interest, public order or, when necessary, for the swift processing and effective monitoring of his or her application.
3. When it proves necessary, for example for legal reasons or reasons of public order, Member States may confine an applicant to a particular place in accordance with their national law.
4. Member States may make provision of the material reception conditions subject to actual residence by the applicants in a specific place, to be determined by the Member States. Such a decision, which may be of a general nature, shall be taken individually and established by national legislation.
5. Member States shall provide for the possibility of granting applicants temporary permission to leave the place of residence mentioned in paragraphs 2 and 4 and/or the assigned area mentioned in paragraph 1. Decisions shall be taken individually, objectively and impartially and reasons shall be given if they are negative.
The applicant shall not require permission to keep appointments with authorities and courts if his or her appearance is necessary.
6. Member States shall require applicants to inform the competent authorities of their current address and notify any change of address to such authorities as soon as possible.
Member States shall take appropriate measures to maintain as far as possible family unity as present within their territory, if applicants are provided with housing by the Member State concerned. Such measures shall be implemented with the asylum seeker’s agreement.
Medical screening
Member States may require medical screening for applicants on public health grounds.
Schooling and education of minors
1. Member States shall grant to minor children of asylum seekers and to asylum seekers who are minors access to the education system under similar conditions as nationals of the host Member State for so long as an expulsion measure against them or their parents is not actually enforced. Such education may be provided in accommodation centres.
The Member State concerned may stipulate that such access must be confined to the State education system.
Minors shall be younger than the age of legal majority in the Member State in which the application for asylum was lodged or is being examined. Member States shall not withdraw secondary education for the sole reason that the minor has reached the age of majority.
2. Access to the education system shall not be postponed for more than three months from the date the application for asylum was lodged by the minor or the minor’s parents. This period may be extended to one year where specific education is provided in order to facilitate access to the education system.
3. Where access to the education system as set out in paragraph 1 is not possible due to the specific situation of the minor, the Member State may offer other education arrangements.
1. Member States shall determine a period of time, starting from the date on which an application for asylum was lodged, during which an applicant shall not have access to the labour market.
2. If a decision at first instance has not been taken within one year of the presentation of an application for asylum and this delay cannot be attributed to the applicant, Member States shall decide the conditions for granting access to the labour market for the applicant.
3. Access to the labour market shall not be withdrawn during appeals procedures, where an appeal against a negative decision in a regular procedure has suspensive effect, until such time as a negative decision on the appeal is notified.
4. For reasons of labour market policies, Member States may give priority to EU citizens and nationals of States parties to the Agreement on the European Economic Area and also to legally resident third-country nationals.
Vocational training
Member States may allow asylum seekers access to vocational training irrespective of whether they have access to the labour market.
Access to vocational training relating to an employment contract shall depend on the extent to which the applicant has access to the labour market in accordance with Article 11.
General rules on material reception conditions and health care
1. Member States shall ensure that material reception conditions are available to applicants when they make their application for asylum.
2. Member States shall make provisions on material reception conditions to ensure a standard of living adequate for the health of applicants and capable of ensuring their subsistence.
Member States shall ensure that that standard of living is met in the specific situation of persons who have special needs, in accordance with Article 17, as well as in relation to the situation of persons who are in detention.
3. Member States may make the provision of all or some of the material reception conditions and health care subject to the condition that applicants do not have sufficient means to have a standard of living adequate for their health and to enable their subsistence.
4. Member States may require applicants to cover or contribute to the cost of the material reception conditions and of the health care provided for in this Directive, pursuant to the provision of paragraph 3, if the applicants have sufficient resources, for example if they have been working for a reasonable period of time.
If it transpires that an applicant had sufficient means to cover material reception conditions and health care at the time when these basic needs were being covered, Member States may ask the asylum seeker for a refund.
5. Material reception conditions may be provided in kind, or in the form of financial allowances or vouchers or in a combination of these provisions.
Where Member States provide material reception conditions in the form of financial allowances or vouchers, the amount thereof shall be determined in accordance with the principles set out in this Article.
Modalities for material reception conditions
1. Where housing is provided in kind, it should take one or a combination of the following forms:
(a) premises used for the purpose of housing applicants during the examination of an application for asylum lodged at the border;
(b) accommodation centres which guarantee an adequate standard of living;
(c) private houses, flats, hotels or other premises adapted for housing applicants.
2. Member States shall ensure that applicants provided with the housing referred to in paragraph 1(a), (b) and (c) are assured:
(a) protection of their family life;
(b) the possibility of communicating with relatives, legal advisers and representatives of the United Nations High Commissioner for Refugees (UNHCR) and non-governmental organisations (NGOs) recognised by Member States.
Member States shall pay particular attention to the prevention of assault within the premises and accommodation centres referred to in paragraph 1(a) and (b).
3. Member States shall ensure, if appropriate, that minor children of applicants or applicants who are minors are lodged with their parents or with the adult family member responsible for them whether by law or by custom.
4. Member States shall ensure that transfers of applicants from one housing facility to another take place only when necessary. Member States shall provide for the possibility for applicants to inform their legal advisers of the transfer and of their new address.
5. Persons working in accommodation centres shall be adequately trained and shall be bound by the confidentiality principle as defined in the national law in relation to any information they obtain in the course of their work.
6. Member States may involve applicants in managing the material resources and non-material aspects of life in the centre through an advisory board or council representing residents.
7. Legal advisors or counsellors of asylum seekers and representatives of the United Nations High Commissioner for Refugees or non-governmental organisations designated by the latter and recognised by the Member State concerned shall be granted access to accommodation centres and other housing facilities in order to assist the said asylum seekers. Limits on such access may be imposed only on grounds relating to the security of the centres and facilities and of the asylum seekers.
8. Member States may exceptionally set modalities for material reception conditions different from those provided for in this Article, for a reasonable period which shall be as short as possible, when:
– an initial assessment of the specific needs of the applicant is required,
– material reception conditions, as provided for in this Article, are not available in a certain geographical area,
– housing capacities normally available are temporarily exhausted,
– the asylum seeker is in detention or confined to border posts.
These different conditions shall cover in any case basic needs.
Health care
1. Member States shall ensure that applicants receive the necessary health care which shall include, at least, emergency care and essential treatment of illness.
2. Member States shall provide necessary medical or other assistance to applicants who have special needs.
Reduction or withdrawal of reception conditions
1. Member States may reduce or withdraw reception conditions in the following cases:
(a) where an asylum seeker:
– abandons the place of residence determined by the competent authority without informing it or, if requested, without permission, or
– does not comply with reporting duties or with requests to provide information or to appear for personal interviews concerning the asylum procedure during a reasonable period laid down in national law, or
– has already lodged an application in the same Member State.
When the applicant is traced or voluntarily reports to the competent authority, a duly motivated decision, based on the reasons for the disappearance, shall be taken on the reinstallation of the grant of some or all of the reception conditions;
(b) where an applicant has concealed financial resources and has therefore unduly benefited from material reception conditions.
If it transpires that an applicant had sufficient means to cover material reception conditions and health care at the time when these basic needs were being covered, Member States may ask the asylum seeker for a refund.
2. Member States may refuse conditions in cases where an asylum seeker has failed to demonstrate that the asylum claim was made as soon as reasonably practicable after arrival in that Member State.
3. Member States may determine sanctions applicable to serious breaching of the rules of the accommodation centres as well as to seriously violent behaviour.
4. Decisions for reduction, withdrawal or refusal of reception conditions or sanctions referred to in paragraphs 1, 2 and 3 shall be taken individually, objectively and impartially and reasons shall be given. Decisions shall be based on the particular situation of the person concerned, especially with regard to persons covered by Article 17, taking into account the principle of proportionality. Member States shall under all circumstances ensure access to emergency health care.
5. Member States shall ensure that material reception conditions are not withdrawn or reduced before a negative decision is taken.
General principle
1. Member States shall take into account the specific situation of vulnerable persons such as minors, unaccompanied minors, disabled people, elderly people, pregnant women, single parents with minor children and persons who have been subjected to torture, rape or other serious forms of psychological, physical or sexual violence, in the national legislation implementing the provisions of Chapter II relating to material reception conditions and health care.
2. Paragraph 1 shall apply only to persons found to have special needs after an individual evaluation of their situation.
1. The best interests of the child shall be a primary consideration for Member States when implementing the provisions of this Directive that involve minors.
2. Member States shall ensure access to rehabilitation services for minors who have been victims of any form of abuse, neglect, exploitation, torture or cruel, inhuman and degrading treatment, or who have suffered from armed conflicts, and ensure that appropriate mental health care is developed and qualified counselling is provided when needed.
Unaccompanied minors
1. Member States shall as soon as possible take measures to ensure the necessary representation of unaccompanied minors by legal guardianship or, where necessary, representation by an organisation which is responsible for the care and well-being of minors, or by any other appropriate representation. Regular assessments shall be made by the appropriate authorities.
2. Unaccompanied minors who make an application for asylum shall, from the moment they are admitted to the territory to the moment they are obliged to leave the host Member State in which the application for asylum was made or is being examined, be placed:
(a) with adult relatives;
(b) with a foster-family;
(c) in accommodation centres with special provisions for minors;
(d) in other accommodation suitable for minors.
Member States may place unaccompanied minors aged 16 or over in accommodation centres for adult asylum seekers.
As far as possible, siblings shall be kept together, taking into account the best interests of the minor concerned and, in particular, his or her age and degree of maturity. Changes of residence of unaccompanied minors shall be limited to a minimum.
3. Member States, protecting the unaccompanied minor’s best interests, shall endeavour to trace the members of his or her family as soon as possible. In cases where there may be a threat to the life or integrity of the minor or his or her close relatives, particularly if they have remained in the country of origin, care must be taken to ensure that the collection, processing and circulation of information concerning those persons is undertaken on a confidential basis, so as to avoid jeopardising their safety.
4. Those working with unaccompanied minors shall have had or receive appropriate training concerning their needs, and shall be bound by the confidentiality principle as defined in the national law, in relation to any information they obtain in the course of their work.
Victims of torture and violence
Member States shall ensure that, if necessary, persons who have been subjected to torture, rape or other serious acts of violence receive the necessary treatment of damages caused by the aforementioned acts.
1. Member States shall ensure that negative decisions relating to the granting of benefits under this Directive or decisions taken under Article 7 which individually affect asylum seekers may be the subject of an appeal within the procedures laid down in the national law. At least in the last instance the possibility of an appeal or a review before a judicial body shall be granted.
2. Procedures for access to legal assistance in such cases shall be laid down in national law.
Cooperation
Member States shall regularly inform the Commission on the data concerning the number of persons, broken down by sex and age, covered by reception conditions and provide full information on the type, name and format of the documents provided for by Article 6.
Guidance, monitoring and control system
Member States shall, with due respect to their constitutional structure, ensure that appropriate guidance, monitoring and control of the level of reception conditions are established.
Staff and resources
1. Member States shall take appropriate measures to ensure that authorities and other organisations implementing this Directive have received the necessary basic training with respect to the needs of both male and female applicants.
2. Member States shall allocate the necessary resources in connection with the national provisions enacted to implement this Directive.
By 6 August 2006, the Commission shall report to the European Parliament and the Council on the application of this Directive and shall propose any amendments that are necessary.
Member States shall send the Commission all the information that is appropriate for drawing up the report, including the statistical data provided for by Article 22 by 6 February 2006.
After presenting the report, the Commission shall report to the European Parliament and the Council on the application of this Directive at least every five years.
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 February 2005. They shall forthwith inform the Commission thereof.
When the Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made.
2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field relating to the enforcement of this Directive.
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States in accordance with the Treaty establishing the European Union.
Done at Brussels, 27 January 2003.
For the Council
The President
G. Papandreou
(1) OJ C 213 E, 31.7.2001, p. 286.
(2) Opinion delivered on 25 April 2002 (not yet published in the Official Journal).
(3) OJ C 48, 21.2.2002, p. 63.
(4) OJ C 107, 3.5.2002, p. 85.
(5) OJ L 212, 7.8.2001, p. 12.

Pending: 32003L0006

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Having regard to the opinion of the European Central Bank(3),Acting in accordance with the procedure laid down in Article 251(4),Whereas:(1) A genuine Single Market for financial services is crucial for economic growth and job creation in the Community.(2) An integrated and efficient financial market requires market integrity. The smooth functioning of securities markets and public confidence in markets are prerequisites for economic growth and wealth. Market abuse harms the integrity of financial markets and public confidence in securities and derivatives.(3) The Commission Communication of 11 May 1999 entitled “Implementing the framework for financial markets: action plan” identifies a series of actions that are needed in order to complete the single market for financial services. The Lisbon European Council of April 2000 called for the implementation of that action plan by 2005. The action plan stresses the need to draw up a Directive against market manipulation.(4) At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European Securities Markets. In its final report, the Committee of Wise Men proposed the introduction of new legislative techniques based on a four-level approach, namely framework principles, implementing measures, cooperation and enforcement. Level 1, the Directive, should confine itself to broad general “framework” principles while Level 2 should contain technical implementing measures to be adopted by the Commission with the assistance of a committee.(5) The Resolution adopted by the Stockholm European Council of March 2001 endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent.(6) The Resolution of the European Parliament of 5 February 2002 on the implementation of financial services legislation also endorsed the Committee of Wise Men’s report, on the basis of the solemn declaration made before Parliament the same day by the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the chairman of Parliament’s Committee on Economic and Monetary Affairs with regard to the safeguards for the European Parliament’s role in this process.(7) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).(8) According to the Stockholm European Council, Level 2 implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of Level 2 work.(9) The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, this period may be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission should re-examine the draft measures.(10) New financial and technical developments enhance the incentives, means and opportunities for market abuse: through new products, new technologies, increasing cross-border activities and the Internet.(11) The existing Community legal framework to protect market integrity is incomplete. Legal requirements vary from one Member State to another, leaving economic actors often uncertain over concepts, definitions and enforcement. In some Member States there is no legislation addressing the issues of price manipulation and the dissemination of misleading information.(12) Market abuse consists of insider dealing and market manipulation. The objective of legislation against insider dealing is the same as that of legislation against market manipulation: to ensure the integrity of Community financial markets and to enhance investor confidence in those markets. It is therefore advisable to adopt combined rules to combat both insider dealing and market manipulation. A single Directive will ensure throughout the Community the same framework for allocation of responsibilities, enforcement and cooperation.(13) Given the changes in financial markets and in Community legislation since the adoption of Council Directive 89/592/EEC of 13 November 1989 coordinating regulations on insider dealing(6), that Directive should now be replaced, to ensure consistency with legislation against market manipulation. A new Directive is also needed to avoid loopholes in Community legislation which could be used for wrongful conduct and which would undermine public confidence and therefore prejudice the smooth functioning of the markets.(14) This Directive meets the concerns expressed by the Member States following the terrorist attacks on 11 September 2001 as regards the fight against financing terrorist activities.(15) Insider dealing and market manipulation prevent full and proper market transparency, which is a prerequisite for trading for all economic actors in integrated financial markets.(16) Inside information is any information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments. Information which could have a significant effect on the evolution and forming of the prices of a regulated market as such could be considered as information which indirectly relates to one or more issuers of financial instruments or to one or more related derivative financial instruments.(17) As regards insider dealing, account should be taken of cases where inside information originates not from a profession or function but from criminal activities, the preparation or execution of which could have a significant effect on the prices of one or more financial instruments or on price formation in the regulated market as such.(18) Use of inside information can consist in the acquisition or disposal of financial instruments by a person who knows, or ought to have known, that the information possessed is inside information. In this respect, the competent authorities should consider what a normal and reasonable person would know or should have known in the circumstances. Moreover, the mere fact that market-makers, bodies authorised to act as counterparties, or persons authorised to execute orders on behalf of third parties with inside information confine themselves, in the first two cases, to pursuing their legitimate business of buying or selling financial instruments or, in the last case, to carrying out an order dutifully, should not in itself be deemed to constitute use of such inside information.(19) Member States should tackle the practice known as “front running”, including “front running” in commodity derivatives, where it constitutes market abuse under the definitions contained in this Directive.(20) A person who enters into transactions or issues orders to trade which are constitutive of market manipulation may be able to establish that his reasons for entering into such transactions or issuing orders to trade were legitimate and that the transactions and orders to trade were in conformity with accepted practice on the regulated market concerned. A sanction could still be imposed if the competent authority established that there was another, illegitimate, reason behind these transactions or orders to trade.(21) The competent authority may issue guidance on matters covered by this Directive, e.g. definition of inside information in relation to derivatives on commodities or implementation of the definition of accepted market practices relating to the definition of market manipulation. This guidance should be in conformity with the provisions of the Directive and the implementing measures adopted in accordance with the comitology procedure.(22) Member States should be able to choose the most appropriate way to regulate persons producing or disseminating research concerning financial instruments or issuers of financial instruments or persons producing or disseminating other information recommending or suggesting investment strategy, including appropriate mechanisms for self-regulation, which should be notified to the Commission.(23) Posting of inside information by issuers on their internet sites should be in accordance with the rules on transfer of personal data to third countries as laid down in 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 movement of such data(7).(24) Prompt and fair disclosure of information to the public enhances market integrity, whereas selective disclosure by issuers can lead to a loss of investor confidence in the integrity of financial markets. Professional economic actors should contribute to market integrity by various means. Such measures could include, for instance, the creation of “grey lists”, the application of “window trading” to sensitive categories of personnel, the application of internal codes of conduct and the establishment of “Chinese walls”. Such preventive measures may contribute to combating market abuse only if they are enforced with determination and are dutifully controlled. Adequate enforcement control would imply for instance the designation of compliance officers within the bodies concerned and periodic checks conducted by independent auditors.(25) Modern communication methods make it possible for financial market professionals and private investors to have more equal access to financial information, but also increase the risk of the spread of false or misleading information.(26) Greater transparency of transactions conducted by persons discharging managerial responsibilities within issuers and, where applicable, persons closely associated with them, constitutes a preventive measure against market abuse. The publication of those transactions on at least an individual basis can also be a highly valuable source of information to investors.(27) Market operators should contribute to the prevention of market abuse and adopt structural provisions aimed at preventing and detecting market manipulation practices. Such provisions may include requirements concerning transparency of transactions concluded, total disclosure of price-regularisation agreements, a fair system of order pairing, introduction of an effective atypical-order detection scheme, sufficiently robust financial instrument reference price-fixing schemes and clarity of rules on the suspension of transactions.(28) This Directive should be interpreted, and implemented by Member States, in a manner consistent with the requirements for effective regulation in order to protect the interests of holders of transferable securities carrying voting rights in a company (or which may carry such rights as a consequence of the exercise of rights or conversion) when the company is subject to a public take-over bid or other proposed change of control. In particular, this Directive does not in any way prevent a Member State from putting or having in place such measures as it sees fit for these purposes.(29) Having access to inside information relating to another company and using it in the context of a public take-over bid for the purpose of gaining control of that company or proposing a merger with that company should not in itself be deemed to constitute insider dealing.(30) Since the acquisition or disposal of financial instruments necessarily involves a prior decision to acquire or dispose taken by the person who undertakes one or other of these operations, the carrying out of this acquisition or disposal should not be deemed in itself to constitute the use of inside information.(31) Research and estimates developed from publicly available data should not be regarded as inside information and, therefore, any transaction carried out on the basis of such research or estimates should not be deemed in itself to constitute insider dealing within the meaning of this Directive.(32) Member States and the European System of Central Banks, national central banks or any other officially designated body, or any person acting on their behalf, should not be restricted in carrying out monetary, exchange-rate or public debt management policy.(33) Stabilisation of financial instruments or trading in own shares in buy-back programmes can be legitimate, in certain circumstances, for economic reasons and should not, therefore, in themselves be regarded as market abuse. Common standards should be developed to provide practical guidance.(34) The widening scope of financial markets, the rapid change and the range of new products and developments require a wide application of this Directive to financial instruments and techniques involved, in order to guarantee the integrity of Community financial markets.(35) Establishing a level playing field in Community financial markets requires wide geographical application of the provisions covered by this Directive. As regards derivative instruments not admitted to trading but falling within the scope of this Directive, each Member State should be competent to sanction actions carried out on its territory or abroad which concern underlying financial instruments admitted to trading on a regulated market situated or operating within its territory or for which a request for admission to trading on such a regulated market has been made. Each Member State should also be competent to sanction actions carried out on its territory which concern underlying financial instruments admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such a market has been made.(36) A variety of competent authorities in Member States, having different responsibilities, may create confusion among economic actors. A single competent authority should be designated in each Member State to assume at least final responsibility for supervising compliance with the provisions adopted pursuant to this Directive, as well as international collaboration. Such an authority should be of an administrative nature guaranteeing its independence of economic actors and avoiding conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. That authority should have adequate arrangements for consultation concerning possible changes in national legislation such as a consultative committee composed of representatives of issuers, financial services providers and consumers, so as to be fully informed of their views and concerns.(37) A common minimum set of effective tools and powers for the competent authority of each Member State will guarantee supervisory effectiveness. Market undertakings and all economic actors should also contribute at their level to market integrity. In this sense, the designation of a single competent authority for market abuse does not exclude collaboration links or delegation under the responsibility of the competent authority, between that authority and market undertakings with a view to guaranteeing efficient supervision of compliance with the provisions adopted pursuant to this Directive.(38) In order to ensure that a Community framework against market abuse is sufficient, any infringement of the prohibitions or requirements laid down pursuant to this Directive will have to be promptly detected and sanctioned. To this end, sanctions should be sufficiently dissuasive and proportionate to the gravity of the infringement and to the gains realised and should be consistently applied.(39) Member States should remain alert, in determining the administrative measures and sanctions, to the need to ensure a degree of uniformity of regulation from one Member State to another.(40) Increasing cross-border activities require improved cooperation and a comprehensive set of provisions for the exchange of information between national competent authorities. The organisation of supervision and of investigatory powers in each Member State should not hinder cooperation between the competent national authorities.(41) Since the objective of the proposed action, namely to prevent market abuse in the form of insider dealing and market manipulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the measures, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.(42) Technical guidance and implementing measures for the rules laid down in this Directive may from time to time be necessary to take account of new developments on financial markets. The Commission should accordingly be empowered to adopt implementing measures, provided that these do not modify the essential elements of this Directive and the Commission acts according to the principles set out in this Directive, after consulting the European Securities Committee established by Commission Decision 2001/528/EC(8).(43) In exercising its implementing powers in accordance with this Directive, the Commission should respect the following principles:- the need to ensure confidence in financial markets among investors by promoting high standards of transparency in financial markets,- the need to provide investors with a wide range of competing investments and a level of disclosure and protection tailored to their circumstances,- the need to ensure that independent regulatory authorities enforce the rules consistently, especially as regards the fight against economic crime,- the need for high levels of transparency and consultation with all market participants and with the European Parliament and the Council,- the need to encourage innovation in financial markets if they are to be dynamic and efficient,- the need to ensure market integrity by close and reactive monitoring of financial innovation,- the importance of reducing the cost of, and increasing access to, capital,- the balance of costs and benefits to market participants on a long-term basis (including small and medium-sized businesses and small investors) in any implementing measures,- the need to foster the international competitiveness of EU financial markets without prejudice to a much-needed extension of international cooperation,- the need to achieve a level playing field for all market participants by establishing EU-wide regulations every time it is appropriate,- the need to respect differences in national markets where these do not unduly impinge on the coherence of the single market,- the need to ensure coherence with other Community legislation in this area, as imbalances in information and a lack of transparency may jeopardise the operation of the markets and above all harm consumers and small investors.(44) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular by Article 11 thereof and Article 10 of the European Convention on Human Rights. In this regard, this Directive does not in any way prevent Member States from applying their constitutional rules relating to freedom of the press and freedom of expression in the media,HAVE ADOPTED THIS DIRECTIVE:Article 1For the purposes of this Directive:1. “Inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.In relation to derivatives on commodities, “inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more such derivatives and which users of markets on which such derivatives are traded would expect to receive in accordance with accepted market practices on those markets.For persons charged with the execution of orders concerning financial instruments, “inside information” shall also mean information conveyed by a client and related to the client’s pending orders, which is of a precise nature, which relates directly or indirectly to one or more issuers of financial instruments or to one or more financial instruments, and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.2. “Market manipulation” shall mean:(a) transactions or orders to trade:- which give, or are likely to give, false or misleading signals as to the supply of, demand for or price of financial instruments, or- which secure, by a person, or persons acting in collaboration, the price of one or several financial instruments at an abnormal or artificial level,unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for so doing are legitimate and that these transactions or orders to trade conform to accepted market practices on the regulated market concerned;(b) transactions or orders to trade which employ fictitious devices or any other form of deception or contrivance;(c) dissemination of information through the media, including the Internet, or by any other means, which gives, or is likely to give, false or misleading signals as to financial instruments, including the dissemination of rumours and false or misleading news, where the person who made the dissemination knew, or ought to have known, that the information was false or misleading. In respect of journalists when they act in their professional capacity such dissemination of information is to be assessed, without prejudice to Article 11, taking into account the rules governing their profession, unless those persons derive, directly or indirectly, an advantage or profits from the dissemination of the information in question.In particular, the following instances are derived from the core definition given in points (a), (b) and (c) above:- conduct by a person, or persons acting in collaboration, to secure a dominant position over the supply of or demand for a financial instrument which has the effect of fixing, directly or indirectly, purchase or sale prices or creating other unfair trading conditions,- the buying or selling of financial instruments at the close of the market with the effect of misleading investors acting on the basis of closing prices,- taking advantage of occasional or regular access to the traditional or electronic media by voicing an opinion about a financial instrument (or indirectly about its issuer) while having previously taken positions on that financial instrument and profiting subsequently from the impact of the opinions voiced on the price of that instrument, without having simultaneously disclosed that conflict of interest to the public in a proper and effective way.The definitions of market manipulation shall be adapted so as to ensure that new patterns of activity that in practice constitute market manipulation can be included.3. “Financial instrument” shall mean:- transferable securities as defined in Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(9),- units in collective investment undertakings,- money-market instruments,- financial-futures contracts, including equivalent cash-settled instruments,- forward interest-rate agreements,- interest-rate, currency and equity swaps,- options to acquire or dispose of any instrument falling into these categories, including equivalent cash-settled instruments. This category includes in particular options on currency and on interest rates,- derivatives on commodities,- any other instrument admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such a market has been made.4. “Regulated market” shall mean a market as defined by

Article 1
For the purposes of this Directive:
1. “Inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.
In relation to derivatives on commodities, “inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more such derivatives and which users of markets on which such derivatives are traded would expect to receive in accordance with accepted market practices on those markets.
For persons charged with the execution of orders concerning financial instruments, “inside information” shall also mean information conveyed by a client and related to the client’s pending orders, which is of a precise nature, which relates directly or indirectly to one or more issuers of financial instruments or to one or more financial instruments, and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.
2. “Market manipulation” shall mean:
(a) transactions or orders to trade:
– which give, or are likely to give, false or misleading signals as to the supply of, demand for or price of financial instruments, or
– which secure, by a person, or persons acting in collaboration, the price of one or several financial instruments at an abnormal or artificial level,
unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for so doing are legitimate and that these transactions or orders to trade conform to accepted market practices on the regulated market concerned;
(b) transactions or orders to trade which employ fictitious devices or any other form of deception or contrivance;
(c) dissemination of information through the media, including the Internet, or by any other means, which gives, or is likely to give, false or misleading signals as to financial instruments, including the dissemination of rumours and false or misleading news, where the person who made the dissemination knew, or ought to have known, that the information was false or misleading. In respect of journalists when they act in their professional capacity such dissemination of information is to be assessed, without prejudice to Article 11, taking into account the rules governing their profession, unless those persons derive, directly or indirectly, an advantage or profits from the dissemination of the information in question.
In particular, the following instances are derived from the core definition given in points (a), (b) and (c) above:
– conduct by a person, or persons acting in collaboration, to secure a dominant position over the supply of or demand for a financial instrument which has the effect of fixing, directly or indirectly, purchase or sale prices or creating other unfair trading conditions,
– the buying or selling of financial instruments at the close of the market with the effect of misleading investors acting on the basis of closing prices,
– taking advantage of occasional or regular access to the traditional or electronic media by voicing an opinion about a financial instrument (or indirectly about its issuer) while having previously taken positions on that financial instrument and profiting subsequently from the impact of the opinions voiced on the price of that instrument, without having simultaneously disclosed that conflict of interest to the public in a proper and effective way.
The definitions of market manipulation shall be adapted so as to ensure that new patterns of activity that in practice constitute market manipulation can be included.
3. “Financial instrument” shall mean:
– transferable securities as defined in Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(9),
– units in collective investment undertakings,
– money-market instruments,

Article 2
1. Member States shall prohibit any person referred to in the second subparagraph who possesses inside information from using that information by acquiring or disposing of, or by trying to acquire or dispose of, for his own account or for the account of a third party, either directly or indirectly, financial instruments to which that information relates.
The first subparagraph shall apply to any person who possesses that information:
(a) by virtue of his membership of the administrative, management or supervisory bodies of the issuer; or
(b) by virtue of his holding in the capital of the issuer; or
(c) by virtue of his having access to the information through the exercise of his employment, profession or duties; or
(d) by virtue of his criminal activities.
2. Where the person referred to in paragraph 1 is a legal person, the prohibition laid down in that paragraph shall also apply to the natural persons who take part in the decision to carry out the transaction for the account of the legal person concerned.
3. This Article shall not apply to transactions conducted in the discharge of an obligation that has become due to acquire or dispose of financial instruments where that obligation results from an agreement concluded before the person concerned possessed inside information.

Article 3
Member States shall prohibit any person subject to the prohibition laid down in Article 2 from:
(a) disclosing inside information to any other person unless such disclosure is made in the normal course of the exercise of his employment, profession or duties;
(b) recommending or inducing another person, on the basis of inside information, to acquire or dispose of financial instruments to which that information relates.

Article 4
Member States shall ensure that Articles 2 and 3 also apply to any person, other than the persons referred to in those Articles, who possesses inside information while that person knows, or ought to have known, that it is inside information.

Article 5
Member States shall prohibit any person from engaging in market manipulation.

Article 6
1. Member States shall ensure that issuers of financial instruments inform the public as soon as possible of inside information which directly concerns the said issuers.
Without prejudice to any measures taken to comply with the provisions of the first subparagraph, Member States shall ensure that issuers, for an appropriate period, post on their Internet sites all inside information that they are required to disclose publicly.
2. An issuer may under his own responsibility delay the public disclosure of inside information, as referred to in paragraph 1, such as not to prejudice his legitimate interests provided that such omission would not be likely to mislead the public and provided that the issuer is able to ensure the confidentiality of that information. Member States may require that an issuer shall without delay inform the competent authority of the decision to delay the public disclosure of inside information.
3. Member States shall require that, whenever an issuer, or a person acting on his behalf or for his account, discloses any inside information to any third party in the normal exercise of his employment, profession or duties, as referred to in Article 3(a), he must make complete and effective public disclosure of that information, simultaneously in the case of an intentional disclosure and promptly in the case of a non-intentional disclosure.
The provisions of the first subparagraph shall not apply if the person receiving the information owes a duty of confidentiality, regardless of whether such duty is based on a law, on regulations, on articles of association or on a contract.
Member States shall require that issuers, or persons acting on their behalf or for their account, draw up a list of those persons working for them, under a contract of employment or otherwise, who have access to inside information. Issuers and persons acting on their behalf or for their account shall regularly update this list and transmit it to the competent authority whenever the latter requests it.
4. Persons discharging managerial responsibilities within an issuer of financial instruments and, where applicable, persons closely associated with them, shall, at least, notify to the competent authority the existence of transactions conducted on their own account relating to shares of the said issuer, or to derivatives or other financial instruments linked to them. Member States shall ensure that public access to information concerning such transactions, on at least an individual basis, is readily available as soon as possible.
5. Member States shall ensure that there is appropriate regulation in place to ensure that persons who produce or disseminate research concerning financial instruments or issuers of financial instruments and persons who produce or disseminate other information recommending or suggesting investment strategy, intended for distribution channels or for the public, take reasonable care to ensure that such information is fairly presented and disclose their interests or indicate conflicts of interest concerning the financial instruments to which that information relates. Details of such regulation shall be notified to the Commission.
6. Member States shall ensure that market operators adopt structural provisions aimed at preventing and detecting market manipulation practices.
7. With a view to ensuring compliance with paragraphs 1 to 5, the competent authority may take all necessary measures to ensure that the public is correctly informed.
8. Public institutions disseminating statistics liable to have a significant effect on financial markets shall disseminate them in a fair and transparent way.
9. Member States shall require that any person professionally arranging transactions in financial instruments who reasonably suspects that a transaction might constitute insider dealing or market manipulation shall notify the competent authority without delay.
10. In order to take account of technical developments on financial markets and to ensure uniform application of this Directive, the Commission shall adopt, in accordance with the procedure referred to in Article 17(2), implementing measures concerning:
– the technical modalities for appropriate public disclosure of inside information as referred to in paragraphs 1 and 3,
– the technical modalities for delaying the public disclosure of inside information as referred to in paragraph 2,
– the technical modalities designed to favour a common approach in the implementation of the second sentence of paragraph 2,
– the conditions under which issuers, or entities acting on their behalf, are to draw up a list of those persons working for them and having access to inside information, as referred to in paragraph 3, together with the conditions under which such lists are to be updated,
– the categories of persons who are subject to a duty of disclosure as referred to in paragraph 4 and the characteristics of a transaction, including its size, which trigger that duty, and the technical arrangements for disclosure to the competent authority,
– technical arrangements, for the various categories of person referred to in paragraph 5, for fair presentation of research and other information recommending investment strategy and for disclosure of particular interests or conflicts of interest as referred to in paragraph 5. Such arrangements shall take into account the rules, including self-regulation, governing the profession of journalist,
– technical arrangements governing notification to the competent authority by the persons referred to in paragraph 9.

Article 7
This Directive shall not apply to transactions carried out in pursuit of monetary, exchange-rate or public debt-management policy by a Member State, by the European System of Central Banks, by a national central bank or by any other officially designated body, or by any person acting on their behalf. Member States may extend this exemption to their federated States or similar local authorities in respect of the management of their public debt.

Article 8
The prohibitions provided for in this Directive shall not apply to trading in own shares in “buy-back” programmes or to the stabilisation of a financial instrument provided such trading is carried out in accordance with implementing measures adopted in accordance with the procedure laid down in Article 17(2).

Article 9
This Directive shall apply to any financial instrument admitted to trading on a regulated market in at least one Member State, or for which a request for admission to trading on such a market has been made, irrespective of whether or not the transaction itself actually takes place on that market.
Articles 2, 3 and 4 shall also apply to any financial instrument not admitted to trading on a regulated market in a Member State, but whose value depends on a financial instrument as referred to in paragraph 1.

Article 10
Each Member State shall apply the prohibitions and requirements provided for in this Directive to:
(a) actions carried out on its territory or abroad concerning financial instruments that are admitted to trading on a regulated market situated or operating within its territory or for which a request for admission to trading on such market has been made;
(b) actions carried out on its territory concerning financial instruments that are admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such market has been made.

Article 11
Without prejudice to the competences of the judicial authorities, each Member State shall designate a single administrative authority competent to ensure that the provisions adopted pursuant to this Directive are applied.
Member States shall establish effective consultative arrangements and procedures with market participants concerning possible changes in national legislation. These arrangements may include consultative committees within each competent authority, the membership of which should reflect as far as possible the diversity of market participants, be they issuers, providers of financial services or consumers.

Article 12
1. The competent authority shall be given all supervisory and investigatory powers that are necessary for the exercise of its functions. It shall exercise such powers:
(a) directly; or
(b) in collaboration with other authorities or with the market undertakings; or
(c) under its responsibility by delegation to such authorities or to the market undertakings; or
(d) by application to the competent judicial authorities.
2. Without prejudice to Article 6(7), the powers referred to in paragraph 1 of this Article shall be exercised in conformity with national law and shall include at least the right to:
(a) have access to any document in any form whatsoever, and to receive a copy of it;
(b) demand information from any person, including those who are successively involved in the transmission of orders or conduct of the operations concerned, as well as their principals, and if necessary, to summon and hear any such person;
(c) carry out on-site inspections;
(d) require existing telephone and existing data traffic records;
(e) require the cessation of any practice that is contrary to the provisions adopted in the implementation of this Directive;
(f) suspend trading of the financial instruments concerned;
(g) request the freezing and/or sequestration of assets;
(h) request temporary prohibition of professional activity.
3. This Article shall be without prejudice to national legal provisions on professional secrecy.

Article 13
The obligation of professional secrecy shall apply to all persons who work or who have worked for the competent authority or for any authority or market undertaking to whom the competent authority has delegated its powers, including auditors and experts instructed by the competent authority. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of provisions laid down by law.

Article 14
1. Without prejudice to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that the appropriate administrative measures can be taken or administrative sanctions be imposed against the persons responsible where the provisions adopted in the implementation of this Directive have not been complied with. Member States shall ensure that these measures are effective, proportionate and dissuasive.
2. In accordance with the procedure laid down in Article 17(2), the Commission shall, for information, draw up a list of the administrative measures and sanctions referred to in paragraph 1.
3. Member States shall determine the sanctions to be applied for failure to cooperate in an investigation covered by Article 12.
4. Member States shall provide that the competent authority may disclose to the public every measure or sanction that will be imposed for infringement of the provisions adopted in the implementation of this Directive, unless such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved.

Article 15
Member States shall ensure that an appeal may be brought before a court against the decisions taken by the competent authority.

Article 16
1. Competent authorities shall cooperate with each other whenever necessary for the purpose of carrying out their duties, making use of their powers whether set out in this Directive or in national law. Competent authorities shall render assistance to competent authorities of other Member States. In particular, they shall exchange information and cooperate in investigation activities.
2. Competent authorities shall, on request, immediately supply any information required for the purpose referred to in paragraph 1. Where necessary, the competent authorities receiving any such request shall immediately take the necessary measures in order to gather the required information. If the requested competent authority is not able to supply the required information immediately, it shall notify the requesting competent authority of the reasons. Information thus supplied shall be covered by the obligation of professional secrecy to which the persons employed or formerly employed by the competent authorities receiving the information are subject.
The competent authorities may refuse to act on a request for information where:
– communication might adversely affect the sovereignty, security or public policy of the Member State addressed,
– judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the Member State addressed, or
– where a final judgment has already been delivered in relation to such persons for the same actions in the Member State addressed.
In any such case, they shall notify the requesting competent authority accordingly, providing as detailed information as possible on those proceedings or the judgment.
Without prejudice to Article 226 of the Treaty, a competent authority whose request for information is not acted upon within a reasonable time or whose request for information is rejected may bring that non-compliance to the attention of the Committee of European Securities Regulators, where discussion will take place in order to reach a rapid and effective solution.
Without prejudice to the obligations to which they are subject in judicial proceedings under criminal law, the competent authorities which receive information pursuant to paragraph 1 may use it only for the exercise of their functions within the scope of this Directive and in the context of administrative or judicial proceedings specifically related to the exercise of those functions. However, where the competent authority communicating information consents thereto, the authority receiving the information may use it for other purposes or forward it to other States’ competent authorities.
3. Where a competent authority is convinced that acts contrary to the provisions of this Directive are being, or have been, carried out on the territory of another Member State or that acts are affecting financial instruments traded on a regulated market situated in another Member State, it shall give notice of that fact in as specific a manner as possible to the competent authority of the other Member State. The competent authority of the other Member State shall take appropriate action. It shall inform the notifying competent authority of the outcome and, so far as possible, of significant interim developments. This paragraph shall not prejudice the competences of the competent authority that has forwarded the information. The competent authorities of the various Member States that are competent for the purposes of Article 10 shall consult each other on the proposed follow-up to their action.
4. A competent authority of one Member State may request that an investigation be carried out by the competent authority of another Member State, on the latter’s territory.
It may further request that members of its own personnel be allowed to accompany the personnel of the competent authority of that other Member State during the course of the investigation.
The investigation shall, however, be subject throughout to the overall control of the Member State on whose territory it is conducted.
The competent authorities may refuse to act on a request for an investigation to be conducted as provided for in the first subparagraph, or on a request for its personnel to be accompanied by personnel of the competent authority of another Member State as provided for in the second subparagraph, where such an investigation might adversely affect the sovereignty, security or public policy of the State addressed, or where judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the State addressed or where a final judgment has already been delivered in relation to such persons for the same actions in the State addressed. In such case, they shall notify the requesting competent authority accordingly, providing information, as detailed as possible, on those proceedings or judgment.
Without prejudice to the provisions of Article 226 of the Treaty, a competent authority whose application to open an inquiry or whose request for authorisation for its officials to accompany those of the other Member State’s competent authority is not acted upon within a reasonable time or is rejected may bring that non-compliance to the attention of the Committee of European Securities Regulators, where discussion will take place in order to reach a rapid and effective solution.
5. In accordance with the procedure laid down in Article 17(2), the Commission shall adopt implementing measures on the procedures for exchange of information and cross-border inspections as referred to in this Article.

Article 17
1. The Commission shall be assisted by the European Securities Committee instituted by Decision 2001/528/EC (hereinafter referred to as the “Committee”).
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof, provided that the implementing measures adopted according to this procedure do not modify the essential provisions of this Directive.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
4. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following the entry into force of this Directive, the application of its provisions requiring the adoption of technical rules and decisions in accordance with paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the period referred to above.

Article 18
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 October 2004. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 20
Directive 89/592/EEC and Article 68(1) and Article 81(1) of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities(10) shall be repealed with effect from the date of entry into force of this Directive.

Article 21
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 22
This Directive is addressed to the Member States.
Done at Brussels, 28 January 2003.
For the Parliament
The President
For the Council
G. Papandreou
(1) OJ C 240 E, 28.8.2001, p. 265.
(2) OJ C 80, 3.4.2002, p. 61.
(3) OJ C 24, 26.1.2002, p. 8.
(4) Opinion of the European Parliament of 14 March 2002 (not yet published in the Official Journal), Council Common Position of 19 July 2002 (OJ C 228 E, 25.9.2002, p. 19) and Decision of the European Parliament of 24 October 2002 (not yet published in the Official Journal).
(5) OJ L 184, 17.7.1999, p. 23.
(6) OJ L 334, 18.11.1989, p. 30.
(7) OJ L 281, 23.11.1995, p. 31.
(8) OJ L 191, 13.7.2001, p. 45.
(9) OJ L 141, 11.6.1993, p. 27. Directive as last amended by European Parliament and Council Directive 2000/64/EC (OJ L 290, 17.11.2000, p. 27).
(10) OJ L 184, 6.7.2001, p. 1.

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Having regard to the opinion of the European Central Bank(3),Acting in accordance with the procedure laid down in Article 251(4),Whereas:(1) A genuine Single Market for financial services is crucial for economic growth and job creation in the Community.(2) An integrated and efficient financial market requires market integrity. The smooth functioning of securities markets and public confidence in markets are prerequisites for economic growth and wealth. Market abuse harms the integrity of financial markets and public confidence in securities and derivatives.(3) The Commission Communication of 11 May 1999 entitled “Implementing the framework for financial markets: action plan” identifies a series of actions that are needed in order to complete the single market for financial services. The Lisbon European Council of April 2000 called for the implementation of that action plan by 2005. The action plan stresses the need to draw up a Directive against market manipulation.(4) At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European Securities Markets. In its final report, the Committee of Wise Men proposed the introduction of new legislative techniques based on a four-level approach, namely framework principles, implementing measures, cooperation and enforcement. Level 1, the Directive, should confine itself to broad general “framework” principles while Level 2 should contain technical implementing measures to be adopted by the Commission with the assistance of a committee.(5) The Resolution adopted by the Stockholm European Council of March 2001 endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent.(6) The Resolution of the European Parliament of 5 February 2002 on the implementation of financial services legislation also endorsed the Committee of Wise Men’s report, on the basis of the solemn declaration made before Parliament the same day by the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the chairman of Parliament’s Committee on Economic and Monetary Affairs with regard to the safeguards for the European Parliament’s role in this process.(7) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).(8) According to the Stockholm European Council, Level 2 implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of Level 2 work.(9) The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, this period may be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission should re-examine the draft measures.(10) New financial and technical developments enhance the incentives, means and opportunities for market abuse: through new products, new technologies, increasing cross-border activities and the Internet.(11) The existing Community legal framework to protect market integrity is incomplete. Legal requirements vary from one Member State to another, leaving economic actors often uncertain over concepts, definitions and enforcement. In some Member States there is no legislation addressing the issues of price manipulation and the dissemination of misleading information.(12) Market abuse consists of insider dealing and market manipulation. The objective of legislation against insider dealing is the same as that of legislation against market manipulation: to ensure the integrity of Community financial markets and to enhance investor confidence in those markets. It is therefore advisable to adopt combined rules to combat both insider dealing and market manipulation. A single Directive will ensure throughout the Community the same framework for allocation of responsibilities, enforcement and cooperation.(13) Given the changes in financial markets and in Community legislation since the adoption of Council Directive 89/592/EEC of 13 November 1989 coordinating regulations on insider dealing(6), that Directive should now be replaced, to ensure consistency with legislation against market manipulation. A new Directive is also needed to avoid loopholes in Community legislation which could be used for wrongful conduct and which would undermine public confidence and therefore prejudice the smooth functioning of the markets.(14) This Directive meets the concerns expressed by the Member States following the terrorist attacks on 11 September 2001 as regards the fight against financing terrorist activities.(15) Insider dealing and market manipulation prevent full and proper market transparency, which is a prerequisite for trading for all economic actors in integrated financial markets.(16) Inside information is any information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments. Information which could have a significant effect on the evolution and forming of the prices of a regulated market as such could be considered as information which indirectly relates to one or more issuers of financial instruments or to one or more related derivative financial instruments.(17) As regards insider dealing, account should be taken of cases where inside information originates not from a profession or function but from criminal activities, the preparation or execution of which could have a significant effect on the prices of one or more financial instruments or on price formation in the regulated market as such.(18) Use of inside information can consist in the acquisition or disposal of financial instruments by a person who knows, or ought to have known, that the information possessed is inside information. In this respect, the competent authorities should consider what a normal and reasonable person would know or should have known in the circumstances. Moreover, the mere fact that market-makers, bodies authorised to act as counterparties, or persons authorised to execute orders on behalf of third parties with inside information confine themselves, in the first two cases, to pursuing their legitimate business of buying or selling financial instruments or, in the last case, to carrying out an order dutifully, should not in itself be deemed to constitute use of such inside information.(19) Member States should tackle the practice known as “front running”, including “front running” in commodity derivatives, where it constitutes market abuse under the definitions contained in this Directive.(20) A person who enters into transactions or issues orders to trade which are constitutive of market manipulation may be able to establish that his reasons for entering into such transactions or issuing orders to trade were legitimate and that the transactions and orders to trade were in conformity with accepted practice on the regulated market concerned. A sanction could still be imposed if the competent authority established that there was another, illegitimate, reason behind these transactions or orders to trade.(21) The competent authority may issue guidance on matters covered by this Directive, e.g. definition of inside information in relation to derivatives on commodities or implementation of the definition of accepted market practices relating to the definition of market manipulation. This guidance should be in conformity with the provisions of the Directive and the implementing measures adopted in accordance with the comitology procedure.(22) Member States should be able to choose the most appropriate way to regulate persons producing or disseminating research concerning financial instruments or issuers of financial instruments or persons producing or disseminating other information recommending or suggesting investment strategy, including appropriate mechanisms for self-regulation, which should be notified to the Commission.(23) Posting of inside information by issuers on their internet sites should be in accordance with the rules on transfer of personal data to third countries as laid down in 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 movement of such data(7).(24) Prompt and fair disclosure of information to the public enhances market integrity, whereas selective disclosure by issuers can lead to a loss of investor confidence in the integrity of financial markets. Professional economic actors should contribute to market integrity by various means. Such measures could include, for instance, the creation of “grey lists”, the application of “window trading” to sensitive categories of personnel, the application of internal codes of conduct and the establishment of “Chinese walls”. Such preventive measures may contribute to combating market abuse only if they are enforced with determination and are dutifully controlled. Adequate enforcement control would imply for instance the designation of compliance officers within the bodies concerned and periodic checks conducted by independent auditors.(25) Modern communication methods make it possible for financial market professionals and private investors to have more equal access to financial information, but also increase the risk of the spread of false or misleading information.(26) Greater transparency of transactions conducted by persons discharging managerial responsibilities within issuers and, where applicable, persons closely associated with them, constitutes a preventive measure against market abuse. The publication of those transactions on at least an individual basis can also be a highly valuable source of information to investors.(27) Market operators should contribute to the prevention of market abuse and adopt structural provisions aimed at preventing and detecting market manipulation practices. Such provisions may include requirements concerning transparency of transactions concluded, total disclosure of price-regularisation agreements, a fair system of order pairing, introduction of an effective atypical-order detection scheme, sufficiently robust financial instrument reference price-fixing schemes and clarity of rules on the suspension of transactions.(28) This Directive should be interpreted, and implemented by Member States, in a manner consistent with the requirements for effective regulation in order to protect the interests of holders of transferable securities carrying voting rights in a company (or which may carry such rights as a consequence of the exercise of rights or conversion) when the company is subject to a public take-over bid or other proposed change of control. In particular, this Directive does not in any way prevent a Member State from putting or having in place such measures as it sees fit for these purposes.(29) Having access to inside information relating to another company and using it in the context of a public take-over bid for the purpose of gaining control of that company or proposing a merger with that company should not in itself be deemed to constitute insider dealing.(30) Since the acquisition or disposal of financial instruments necessarily involves a prior decision to acquire or dispose taken by the person who undertakes one or other of these operations, the carrying out of this acquisition or disposal should not be deemed in itself to constitute the use of inside information.(31) Research and estimates developed from publicly available data should not be regarded as inside information and, therefore, any transaction carried out on the basis of such research or estimates should not be deemed in itself to constitute insider dealing within the meaning of this Directive.(32) Member States and the European System of Central Banks, national central banks or any other officially designated body, or any person acting on their behalf, should not be restricted in carrying out monetary, exchange-rate or public debt management policy.(33) Stabilisation of financial instruments or trading in own shares in buy-back programmes can be legitimate, in certain circumstances, for economic reasons and should not, therefore, in themselves be regarded as market abuse. Common standards should be developed to provide practical guidance.(34) The widening scope of financial markets, the rapid change and the range of new products and developments require a wide application of this Directive to financial instruments and techniques involved, in order to guarantee the integrity of Community financial markets.(35) Establishing a level playing field in Community financial markets requires wide geographical application of the provisions covered by this Directive. As regards derivative instruments not admitted to trading but falling within the scope of this Directive, each Member State should be competent to sanction actions carried out on its territory or abroad which concern underlying financial instruments admitted to trading on a regulated market situated or operating within its territory or for which a request for admission to trading on such a regulated market has been made. Each Member State should also be competent to sanction actions carried out on its territory which concern underlying financial instruments admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such a market has been made.(36) A variety of competent authorities in Member States, having different responsibilities, may create confusion among economic actors. A single competent authority should be designated in each Member State to assume at least final responsibility for supervising compliance with the provisions adopted pursuant to this Directive, as well as international collaboration. Such an authority should be of an administrative nature guaranteeing its independence of economic actors and avoiding conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. That authority should have adequate arrangements for consultation concerning possible changes in national legislation such as a consultative committee composed of representatives of issuers, financial services providers and consumers, so as to be fully informed of their views and concerns.(37) A common minimum set of effective tools and powers for the competent authority of each Member State will guarantee supervisory effectiveness. Market undertakings and all economic actors should also contribute at their level to market integrity. In this sense, the designation of a single competent authority for market abuse does not exclude collaboration links or delegation under the responsibility of the competent authority, between that authority and market undertakings with a view to guaranteeing efficient supervision of compliance with the provisions adopted pursuant to this Directive.(38) In order to ensure that a Community framework against market abuse is sufficient, any infringement of the prohibitions or requirements laid down pursuant to this Directive will have to be promptly detected and sanctioned. To this end, sanctions should be sufficiently dissuasive and proportionate to the gravity of the infringement and to the gains realised and should be consistently applied.(39) Member States should remain alert, in determining the administrative measures and sanctions, to the need to ensure a degree of uniformity of regulation from one Member State to another.(40) Increasing cross-border activities require improved cooperation and a comprehensive set of provisions for the exchange of information between national competent authorities. The organisation of supervision and of investigatory powers in each Member State should not hinder cooperation between the competent national authorities.(41) Since the objective of the proposed action, namely to prevent market abuse in the form of insider dealing and market manipulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the measures, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.(42) Technical guidance and implementing measures for the rules laid down in this Directive may from time to time be necessary to take account of new developments on financial markets. The Commission should accordingly be empowered to adopt implementing measures, provided that these do not modify the essential elements of this Directive and the Commission acts according to the principles set out in this Directive, after consulting the European Securities Committee established by Commission Decision 2001/528/EC(8).(43) In exercising its implementing powers in accordance with this Directive, the Commission should respect the following principles:- the need to ensure confidence in financial markets among investors by promoting high standards of transparency in financial markets,- the need to provide investors with a wide range of competing investments and a level of disclosure and protection tailored to their circumstances,- the need to ensure that independent regulatory authorities enforce the rules consistently, especially as regards the fight against economic crime,- the need for high levels of transparency and consultation with all market participants and with the European Parliament and the Council,- the need to encourage innovation in financial markets if they are to be dynamic and efficient,- the need to ensure market integrity by close and reactive monitoring of financial innovation,- the importance of reducing the cost of, and increasing access to, capital,- the balance of costs and benefits to market participants on a long-term basis (including small and medium-sized businesses and small investors) in any implementing measures,- the need to foster the international competitiveness of EU financial markets without prejudice to a much-needed extension of international cooperation,- the need to achieve a level playing field for all market participants by establishing EU-wide regulations every time it is appropriate,- the need to respect differences in national markets where these do not unduly impinge on the coherence of the single market,- the need to ensure coherence with other Community legislation in this area, as imbalances in information and a lack of transparency may jeopardise the operation of the markets and above all harm consumers and small investors.(44) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular by Article 11 thereof and Article 10 of the European Convention on Human Rights. In this regard, this Directive does not in any way prevent Member States from applying their constitutional rules relating to freedom of the press and freedom of expression in the media,HAVE ADOPTED THIS DIRECTIVE:Article 1For the purposes of this Directive:1. “Inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.In relation to derivatives on commodities, “inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more such derivatives and which users of markets on which such derivatives are traded would expect to receive in accordance with accepted market practices on those markets.For persons charged with the execution of orders concerning financial instruments, “inside information” shall also mean information conveyed by a client and related to the client’s pending orders, which is of a precise nature, which relates directly or indirectly to one or more issuers of financial instruments or to one or more financial instruments, and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.2. “Market manipulation” shall mean:(a) transactions or orders to trade:- which give, or are likely to give, false or misleading signals as to the supply of, demand for or price of financial instruments, or- which secure, by a person, or persons acting in collaboration, the price of one or several financial instruments at an abnormal or artificial level,unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for so doing are legitimate and that these transactions or orders to trade conform to accepted market practices on the regulated market concerned;(b) transactions or orders to trade which employ fictitious devices or any other form of deception or contrivance;(c) dissemination of information through the media, including the Internet, or by any other means, which gives, or is likely to give, false or misleading signals as to financial instruments, including the dissemination of rumours and false or misleading news, where the person who made the dissemination knew, or ought to have known, that the information was false or misleading. In respect of journalists when they act in their professional capacity such dissemination of information is to be assessed, without prejudice to Article 11, taking into account the rules governing their profession, unless those persons derive, directly or indirectly, an advantage or profits from the dissemination of the information in question.In particular, the following instances are derived from the core definition given in points (a), (b) and (c) above:- conduct by a person, or persons acting in collaboration, to secure a dominant position over the supply of or demand for a financial instrument which has the effect of fixing, directly or indirectly, purchase or sale prices or creating other unfair trading conditions,- the buying or selling of financial instruments at the close of the market with the effect of misleading investors acting on the basis of closing prices,- taking advantage of occasional or regular access to the traditional or electronic media by voicing an opinion about a financial instrument (or indirectly about its issuer) while having previously taken positions on that financial instrument and profiting subsequently from the impact of the opinions voiced on the price of that instrument, without having simultaneously disclosed that conflict of interest to the public in a proper and effective way.The definitions of market manipulation shall be adapted so as to ensure that new patterns of activity that in practice constitute market manipulation can be included.3. “Financial instrument” shall mean:- transferable securities as defined in Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(9),- units in collective investment undertakings,- money-market instruments,- financial-futures contracts, including equivalent cash-settled instruments,- forward interest-rate agreements,- interest-rate, currency and equity swaps,- options to acquire or dispose of any instrument falling into these categories, including equivalent cash-settled instruments. This category includes in particular options on currency and on interest rates,- derivatives on commodities,- any other instrument admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such a market has been made.4. “Regulated market” shall mean a market as defined by
For the purposes of this Directive:
1. “Inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.
In relation to derivatives on commodities, “inside information” shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more such derivatives and which users of markets on which such derivatives are traded would expect to receive in accordance with accepted market practices on those markets.
For persons charged with the execution of orders concerning financial instruments, “inside information” shall also mean information conveyed by a client and related to the client’s pending orders, which is of a precise nature, which relates directly or indirectly to one or more issuers of financial instruments or to one or more financial instruments, and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments.
2. “Market manipulation” shall mean:
(a) transactions or orders to trade:
– which give, or are likely to give, false or misleading signals as to the supply of, demand for or price of financial instruments, or
– which secure, by a person, or persons acting in collaboration, the price of one or several financial instruments at an abnormal or artificial level,
unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for so doing are legitimate and that these transactions or orders to trade conform to accepted market practices on the regulated market concerned;
(b) transactions or orders to trade which employ fictitious devices or any other form of deception or contrivance;
(c) dissemination of information through the media, including the Internet, or by any other means, which gives, or is likely to give, false or misleading signals as to financial instruments, including the dissemination of rumours and false or misleading news, where the person who made the dissemination knew, or ought to have known, that the information was false or misleading. In respect of journalists when they act in their professional capacity such dissemination of information is to be assessed, without prejudice to Article 11, taking into account the rules governing their profession, unless those persons derive, directly or indirectly, an advantage or profits from the dissemination of the information in question.
In particular, the following instances are derived from the core definition given in points (a), (b) and (c) above:
– conduct by a person, or persons acting in collaboration, to secure a dominant position over the supply of or demand for a financial instrument which has the effect of fixing, directly or indirectly, purchase or sale prices or creating other unfair trading conditions,
– the buying or selling of financial instruments at the close of the market with the effect of misleading investors acting on the basis of closing prices,
– taking advantage of occasional or regular access to the traditional or electronic media by voicing an opinion about a financial instrument (or indirectly about its issuer) while having previously taken positions on that financial instrument and profiting subsequently from the impact of the opinions voiced on the price of that instrument, without having simultaneously disclosed that conflict of interest to the public in a proper and effective way.
The definitions of market manipulation shall be adapted so as to ensure that new patterns of activity that in practice constitute market manipulation can be included.
3. “Financial instrument” shall mean:
– transferable securities as defined in Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(9),
– units in collective investment undertakings,
– money-market instruments,
1. Member States shall prohibit any person referred to in the second subparagraph who possesses inside information from using that information by acquiring or disposing of, or by trying to acquire or dispose of, for his own account or for the account of a third party, either directly or indirectly, financial instruments to which that information relates.
The first subparagraph shall apply to any person who possesses that information:
(a) by virtue of his membership of the administrative, management or supervisory bodies of the issuer; or
(b) by virtue of his holding in the capital of the issuer; or
(c) by virtue of his having access to the information through the exercise of his employment, profession or duties; or
(d) by virtue of his criminal activities.
2. Where the person referred to in paragraph 1 is a legal person, the prohibition laid down in that paragraph shall also apply to the natural persons who take part in the decision to carry out the transaction for the account of the legal person concerned.
3. This Article shall not apply to transactions conducted in the discharge of an obligation that has become due to acquire or dispose of financial instruments where that obligation results from an agreement concluded before the person concerned possessed inside information.
Member States shall prohibit any person subject to the prohibition laid down in Article 2 from:
(a) disclosing inside information to any other person unless such disclosure is made in the normal course of the exercise of his employment, profession or duties;
(b) recommending or inducing another person, on the basis of inside information, to acquire or dispose of financial instruments to which that information relates.
Member States shall ensure that Articles 2 and 3 also apply to any person, other than the persons referred to in those Articles, who possesses inside information while that person knows, or ought to have known, that it is inside information.
Member States shall prohibit any person from engaging in market manipulation.
1. Member States shall ensure that issuers of financial instruments inform the public as soon as possible of inside information which directly concerns the said issuers.
Without prejudice to any measures taken to comply with the provisions of the first subparagraph, Member States shall ensure that issuers, for an appropriate period, post on their Internet sites all inside information that they are required to disclose publicly.
2. An issuer may under his own responsibility delay the public disclosure of inside information, as referred to in paragraph 1, such as not to prejudice his legitimate interests provided that such omission would not be likely to mislead the public and provided that the issuer is able to ensure the confidentiality of that information. Member States may require that an issuer shall without delay inform the competent authority of the decision to delay the public disclosure of inside information.
3. Member States shall require that, whenever an issuer, or a person acting on his behalf or for his account, discloses any inside information to any third party in the normal exercise of his employment, profession or duties, as referred to in Article 3(a), he must make complete and effective public disclosure of that information, simultaneously in the case of an intentional disclosure and promptly in the case of a non-intentional disclosure.
The provisions of the first subparagraph shall not apply if the person receiving the information owes a duty of confidentiality, regardless of whether such duty is based on a law, on regulations, on articles of association or on a contract.
Member States shall require that issuers, or persons acting on their behalf or for their account, draw up a list of those persons working for them, under a contract of employment or otherwise, who have access to inside information. Issuers and persons acting on their behalf or for their account shall regularly update this list and transmit it to the competent authority whenever the latter requests it.
4. Persons discharging managerial responsibilities within an issuer of financial instruments and, where applicable, persons closely associated with them, shall, at least, notify to the competent authority the existence of transactions conducted on their own account relating to shares of the said issuer, or to derivatives or other financial instruments linked to them. Member States shall ensure that public access to information concerning such transactions, on at least an individual basis, is readily available as soon as possible.
5. Member States shall ensure that there is appropriate regulation in place to ensure that persons who produce or disseminate research concerning financial instruments or issuers of financial instruments and persons who produce or disseminate other information recommending or suggesting investment strategy, intended for distribution channels or for the public, take reasonable care to ensure that such information is fairly presented and disclose their interests or indicate conflicts of interest concerning the financial instruments to which that information relates. Details of such regulation shall be notified to the Commission.
6. Member States shall ensure that market operators adopt structural provisions aimed at preventing and detecting market manipulation practices.
7. With a view to ensuring compliance with paragraphs 1 to 5, the competent authority may take all necessary measures to ensure that the public is correctly informed.
8. Public institutions disseminating statistics liable to have a significant effect on financial markets shall disseminate them in a fair and transparent way.
9. Member States shall require that any person professionally arranging transactions in financial instruments who reasonably suspects that a transaction might constitute insider dealing or market manipulation shall notify the competent authority without delay.
10. In order to take account of technical developments on financial markets and to ensure uniform application of this Directive, the Commission shall adopt, in accordance with the procedure referred to in Article 17(2), implementing measures concerning:
– the technical modalities for appropriate public disclosure of inside information as referred to in paragraphs 1 and 3,
– the technical modalities for delaying the public disclosure of inside information as referred to in paragraph 2,
– the technical modalities designed to favour a common approach in the implementation of the second sentence of paragraph 2,
– the conditions under which issuers, or entities acting on their behalf, are to draw up a list of those persons working for them and having access to inside information, as referred to in paragraph 3, together with the conditions under which such lists are to be updated,
– the categories of persons who are subject to a duty of disclosure as referred to in paragraph 4 and the characteristics of a transaction, including its size, which trigger that duty, and the technical arrangements for disclosure to the competent authority,
– technical arrangements, for the various categories of person referred to in paragraph 5, for fair presentation of research and other information recommending investment strategy and for disclosure of particular interests or conflicts of interest as referred to in paragraph 5. Such arrangements shall take into account the rules, including self-regulation, governing the profession of journalist,
– technical arrangements governing notification to the competent authority by the persons referred to in paragraph 9.
This Directive shall not apply to transactions carried out in pursuit of monetary, exchange-rate or public debt-management policy by a Member State, by the European System of Central Banks, by a national central bank or by any other officially designated body, or by any person acting on their behalf. Member States may extend this exemption to their federated States or similar local authorities in respect of the management of their public debt.
The prohibitions provided for in this Directive shall not apply to trading in own shares in “buy-back” programmes or to the stabilisation of a financial instrument provided such trading is carried out in accordance with implementing measures adopted in accordance with the procedure laid down in Article 17(2).
This Directive shall apply to any financial instrument admitted to trading on a regulated market in at least one Member State, or for which a request for admission to trading on such a market has been made, irrespective of whether or not the transaction itself actually takes place on that market.
Articles 2, 3 and 4 shall also apply to any financial instrument not admitted to trading on a regulated market in a Member State, but whose value depends on a financial instrument as referred to in paragraph 1.
Each Member State shall apply the prohibitions and requirements provided for in this Directive to:
(a) actions carried out on its territory or abroad concerning financial instruments that are admitted to trading on a regulated market situated or operating within its territory or for which a request for admission to trading on such market has been made;
(b) actions carried out on its territory concerning financial instruments that are admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such market has been made.
Without prejudice to the competences of the judicial authorities, each Member State shall designate a single administrative authority competent to ensure that the provisions adopted pursuant to this Directive are applied.
Member States shall establish effective consultative arrangements and procedures with market participants concerning possible changes in national legislation. These arrangements may include consultative committees within each competent authority, the membership of which should reflect as far as possible the diversity of market participants, be they issuers, providers of financial services or consumers.
1. The competent authority shall be given all supervisory and investigatory powers that are necessary for the exercise of its functions. It shall exercise such powers:
(a) directly; or
(b) in collaboration with other authorities or with the market undertakings; or
(c) under its responsibility by delegation to such authorities or to the market undertakings; or
(d) by application to the competent judicial authorities.
2. Without prejudice to Article 6(7), the powers referred to in paragraph 1 of this Article shall be exercised in conformity with national law and shall include at least the right to:
(a) have access to any document in any form whatsoever, and to receive a copy of it;
(b) demand information from any person, including those who are successively involved in the transmission of orders or conduct of the operations concerned, as well as their principals, and if necessary, to summon and hear any such person;
(c) carry out on-site inspections;
(d) require existing telephone and existing data traffic records;
(e) require the cessation of any practice that is contrary to the provisions adopted in the implementation of this Directive;
(f) suspend trading of the financial instruments concerned;
(g) request the freezing and/or sequestration of assets;
(h) request temporary prohibition of professional activity.
3. This Article shall be without prejudice to national legal provisions on professional secrecy.
The obligation of professional secrecy shall apply to all persons who work or who have worked for the competent authority or for any authority or market undertaking to whom the competent authority has delegated its powers, including auditors and experts instructed by the competent authority. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of provisions laid down by law.
1. Without prejudice to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that the appropriate administrative measures can be taken or administrative sanctions be imposed against the persons responsible where the provisions adopted in the implementation of this Directive have not been complied with. Member States shall ensure that these measures are effective, proportionate and dissuasive.
2. In accordance with the procedure laid down in Article 17(2), the Commission shall, for information, draw up a list of the administrative measures and sanctions referred to in paragraph 1.
3. Member States shall determine the sanctions to be applied for failure to cooperate in an investigation covered by Article 12.
4. Member States shall provide that the competent authority may disclose to the public every measure or sanction that will be imposed for infringement of the provisions adopted in the implementation of this Directive, unless such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved.
Member States shall ensure that an appeal may be brought before a court against the decisions taken by the competent authority.
1. Competent authorities shall cooperate with each other whenever necessary for the purpose of carrying out their duties, making use of their powers whether set out in this Directive or in national law. Competent authorities shall render assistance to competent authorities of other Member States. In particular, they shall exchange information and cooperate in investigation activities.
2. Competent authorities shall, on request, immediately supply any information required for the purpose referred to in paragraph 1. Where necessary, the competent authorities receiving any such request shall immediately take the necessary measures in order to gather the required information. If the requested competent authority is not able to supply the required information immediately, it shall notify the requesting competent authority of the reasons. Information thus supplied shall be covered by the obligation of professional secrecy to which the persons employed or formerly employed by the competent authorities receiving the information are subject.
The competent authorities may refuse to act on a request for information where:
– communication might adversely affect the sovereignty, security or public policy of the Member State addressed,
– judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the Member State addressed, or
– where a final judgment has already been delivered in relation to such persons for the same actions in the Member State addressed.
In any such case, they shall notify the requesting competent authority accordingly, providing as detailed information as possible on those proceedings or the judgment.
Without prejudice to Article 226 of the Treaty, a competent authority whose request for information is not acted upon within a reasonable time or whose request for information is rejected may bring that non-compliance to the attention of the Committee of European Securities Regulators, where discussion will take place in order to reach a rapid and effective solution.
Without prejudice to the obligations to which they are subject in judicial proceedings under criminal law, the competent authorities which receive information pursuant to paragraph 1 may use it only for the exercise of their functions within the scope of this Directive and in the context of administrative or judicial proceedings specifically related to the exercise of those functions. However, where the competent authority communicating information consents thereto, the authority receiving the information may use it for other purposes or forward it to other States’ competent authorities.
3. Where a competent authority is convinced that acts contrary to the provisions of this Directive are being, or have been, carried out on the territory of another Member State or that acts are affecting financial instruments traded on a regulated market situated in another Member State, it shall give notice of that fact in as specific a manner as possible to the competent authority of the other Member State. The competent authority of the other Member State shall take appropriate action. It shall inform the notifying competent authority of the outcome and, so far as possible, of significant interim developments. This paragraph shall not prejudice the competences of the competent authority that has forwarded the information. The competent authorities of the various Member States that are competent for the purposes of Article 10 shall consult each other on the proposed follow-up to their action.
4. A competent authority of one Member State may request that an investigation be carried out by the competent authority of another Member State, on the latter’s territory.
It may further request that members of its own personnel be allowed to accompany the personnel of the competent authority of that other Member State during the course of the investigation.
The investigation shall, however, be subject throughout to the overall control of the Member State on whose territory it is conducted.
The competent authorities may refuse to act on a request for an investigation to be conducted as provided for in the first subparagraph, or on a request for its personnel to be accompanied by personnel of the competent authority of another Member State as provided for in the second subparagraph, where such an investigation might adversely affect the sovereignty, security or public policy of the State addressed, or where judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the State addressed or where a final judgment has already been delivered in relation to such persons for the same actions in the State addressed. In such case, they shall notify the requesting competent authority accordingly, providing information, as detailed as possible, on those proceedings or judgment.
Without prejudice to the provisions of Article 226 of the Treaty, a competent authority whose application to open an inquiry or whose request for authorisation for its officials to accompany those of the other Member State’s competent authority is not acted upon within a reasonable time or is rejected may bring that non-compliance to the attention of the Committee of European Securities Regulators, where discussion will take place in order to reach a rapid and effective solution.
5. In accordance with the procedure laid down in Article 17(2), the Commission shall adopt implementing measures on the procedures for exchange of information and cross-border inspections as referred to in this Article.
1. The Commission shall be assisted by the European Securities Committee instituted by Decision 2001/528/EC (hereinafter referred to as the “Committee”).
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof, provided that the implementing measures adopted according to this procedure do not modify the essential provisions of this Directive.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
4. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following the entry into force of this Directive, the application of its provisions requiring the adoption of technical rules and decisions in accordance with paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the period referred to above.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 October 2004. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Directive 89/592/EEC and Article 68(1) and Article 81(1) of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities(10) shall be repealed with effect from the date of entry into force of this Directive.
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 28 January 2003.
For the Parliament
The President
For the Council
G. Papandreou
(1) OJ C 240 E, 28.8.2001, p. 265.
(2) OJ C 80, 3.4.2002, p. 61.
(3) OJ C 24, 26.1.2002, p. 8.
(4) Opinion of the European Parliament of 14 March 2002 (not yet published in the Official Journal), Council Common Position of 19 July 2002 (OJ C 228 E, 25.9.2002, p. 19) and Decision of the European Parliament of 24 October 2002 (not yet published in the Official Journal).
(5) OJ L 184, 17.7.1999, p. 23.
(6) OJ L 334, 18.11.1989, p. 30.
(7) OJ L 281, 23.11.1995, p. 31.
(8) OJ L 191, 13.7.2001, p. 45.
(9) OJ L 141, 11.6.1993, p. 27. Directive as last amended by European Parliament and Council Directive 2000/64/EC (OJ L 290, 17.11.2000, p. 27).
(10) OJ L 184, 6.7.2001, p. 1.

Pending: 32002L0099

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Parliament(2),Having regard to the opinion of the European Economic and Social Committee(3),Whereas:(1) In the context of the single market, specific animal health rules have been laid down to govern intra-Community trade in the production, processing, distribution and introduction from third countries of products of animal origin for human consumption included in Annex I to the Treaty.(2) Those rules have allowed the removal of obstacles to trade in the products concerned, thereby contributing to the creation of the internal market whilst ensuring a high level of animal health protection.(3) The aim of those rules is to prevent the introduction or spread of animal diseases resulting from the placing on the market of products of animal origin. They also contain common provisions concerning in particular the restrictions applicable to the placing on the market of products coming from a holding or area infected by epizootic diseases and the obligation to subject products coming from restricted areas to treatment to destroy the disease agent.(4) Those common provisions should be harmonised in order to remove possible inconsistencies introduced when the specific animal health rules were adopted. Such harmonisation will also ensure uniform implementation of animal health rules throughout the Community and introduce greater transparency in the structure of Community legislation.(5) Veterinary checks on products of animal origin intended for trade must be carried out in accordance with Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(4). Directive 89/662/EEC contains safeguard measures that may be implemented in the event of a serious hazard to animal health.(6) Products imported from third countries must not present an animal health hazard for Community livestock.(7) To that end, procedures should be introduced to prevent the introduction of epizootic diseases. Such procedures include a regular evaluation of the animal health situation in the third countries concerned.(8) Procedures must also be introduced for establishing general or specific rules or criteria to be applied to imports of products of animal origin.(9) Provisions concerning the importation of meat of domestic ungulates and meat products prepared from or with such meat are already contained in Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries(5).(10) The procedures applicable to the importation of meat and meat products can be used as a model for the importation of other products of animal origin.(11) Veterinary checks on products of animal origin imported into the Community from third countries must be carried out in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(6); Directive 97/78/EC contains safeguard measures that may be implemented in case of a serious hazard to animal health.(12) Account must be taken of the guidelines laid down by the World Organisation for Animal Health (OIE) when adopting rules for international trade.(13) Community audits and inspections must be organised in order to ensure the uniform application of the animal health provisions.(14) The products covered by this Directive are listed in Annex I to the Treaty.(15) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7),HAS ADOPTED THIS DIRECTIVE:Article 1ScopeThis Directive lays down the general animal health rules governing all stages of the production, processing and distribution within the Community and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption.These rules do not affect the provisions laid down in Directives 89/662/EEC and 97/78/EC and the Directives listed in Annex I.Article 2DefinitionsFor the purposes of this Directive, the definitions in 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(8) and Directive 97/78/EC shall apply as necessary. The following definitions shall also apply:1. “all stages of the production, processing and distribution” means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer;2. “introduction” means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(9);3. “official veterinarian” means a veterinarian qualified to act in that capacity appointed by the competent authority;4. “products of animal origin” means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use.CHAPTER IANIMAL HEALTH REQUIREMENTS APPLICABLE TO ALL STAGES OF THE PRODUCTION, PROCESSING AND DISTRIBUTION OF PRODUCTS OF ANIMAL ORIGIN WITHIN THE COMMUNITYArticle 3General animal health requirements1. Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions.2. Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation.3. Products of animal origin shall be obtained from animals:(a) which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions applicable to the animals and products concerned, under the rules set out in Annex I;(b) which, in the case of meat and meat products, were not slaughtered in an establishment in which animals infected or suspected of being infected with one of the diseases covered by the rules referred to in (a), or carcasses or parts thereof of such animals, were present during the slaughtering or production process, unless such suspicion has been ruled out;(c) which, in the case of aquaculture animals and products, comply with Directive 91/67/EEC(10).Article 4Derogations1. Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that:(i) before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority;(ii) the products which are to undergo treatment are clearly identified;(iii) the products undergo treatment enabling the animal health problem concerned to be eliminated, and(iv) the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred.The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2).2. The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2).3. Furthermore, where the health situation so permits, derogations from Article 3 may be granted in certain situations, in accordance with the procedure referred to in Article 12(2). In such cases, particular account shall be taken of:(a) the specific characteristics of the disease in the species concerned, and(b) any tests or measures to which the animals must be subjected.Where such derogations are granted, steps must be taken to ensure that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure.Article 5Veterinary certificates1. Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where:- provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or- a derogation has been granted under Article 4(3).2. Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation.Article 6Official veterinary controls1. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC.2. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC.3. Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof.4. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2).CHAPTER IIIMPORTS FROM THIRD COUNTRIESArticle 7General provisionsMember States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of

Article 1
This Directive lays down the general animal health rules governing all stages of the production, processing and distribution within the Community and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption.
These rules do not affect the provisions laid down in Directives 89/662/EEC and 97/78/EC and the Directives listed in Annex I.

Article 2
Definitions
For the purposes of this Directive, the definitions in 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(8) and Directive 97/78/EC shall apply as necessary. The following definitions shall also apply:
1. “all stages of the production, processing and distribution” means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer;
2. “introduction” means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(9);
3. “official veterinarian” means a veterinarian qualified to act in that capacity appointed by the competent authority;
4. “products of animal origin” means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use.

Article 3
General animal health requirements
1. Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions.
2. Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation.
3. Products of animal origin shall be obtained from animals:
(a) which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions applicable to the animals and products concerned, under the rules set out in Annex I;
(b) which, in the case of meat and meat products, were not slaughtered in an establishment in which animals infected or suspected of being infected with one of the diseases covered by the rules referred to in (a), or carcasses or parts thereof of such animals, were present during the slaughtering or production process, unless such suspicion has been ruled out;
(c) which, in the case of aquaculture animals and products, comply with Directive 91/67/EEC(10).

Article 4
Derogations
1. Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that:
(i) before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority;
(ii) the products which are to undergo treatment are clearly identified;
(iii) the products undergo treatment enabling the animal health problem concerned to be eliminated, and
(iv) the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred.
The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2).
2. The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2).
3. Furthermore, where the health situation so permits, derogations from Article 3 may be granted in certain situations, in accordance with the procedure referred to in Article 12(2). In such cases, particular account shall be taken of:
(a) the specific characteristics of the disease in the species concerned, and
(b) any tests or measures to which the animals must be subjected.
Where such derogations are granted, steps must be taken to ensure that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure.

Article 5
Veterinary certificates
1. Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where:
– provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or
– a derogation has been granted under Article 4(3).
2. Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation.

Article 6
Official veterinary controls
1. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC.
2. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC.
3. Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.
If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof.
4. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2).

Article 7
General provisions
Member States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of Chapter I applicable to all stages of the production, processing and distribution of such products in the Community or if they offer equivalent animal health guarantees.

Article 8
Compliance with Community rules
In order to ensure compliance with the general obligation laid down in Article 7, the following shall be established in accordance with the procedure referred to in Article 12(2):
1. Lists of the third countries or regions of third countries from which imports of specified products of animal origin are permitted. A third country shall appear on such lists only if a Community audit of that country has taken place and demonstrates that the competent veterinary authority provides appropriate guarantees as regards compliance with Community legislation.
When drawing up or updating those lists, particular account shall be taken of:
(a) the legislation of the third country;
(b) the organisation of the competent veterinary authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively;
(c) the actual animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community;
(d) the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions;
(e) any experience of marketing the product from the third country and the results of any import controls carried out;
(f) the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities of the third country on the inspections which they have carried out;
(g) the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;
(h) the regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases in its territory, particularly the notifiable diseases listed by the World Organisation for Animal Health (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases listed in the Aquatic Animal Health Code of the OIE;
(i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries.
2. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public. Lists drawn up in accordance with this Article may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates.
3. Rules of origin for products of animal origin and the animals from which such products are obtained shall be established in accordance with the procedure referred to in Article 12(2).
4. Special import conditions for each third country or group of third countries, having regard to the animal health situation of the third country or countries concerned shall be established in accordance with the procedure referred to in Article 12(2).
5. Where necessary:
– the detailed rules for the application of this Article,
– criteria for classifying third countries and regions thereof with regard to animal diseases, and
– specific rules concerning types of introduction or particular products, such as the introduction of products by travellers or the introduction of commercial samples,

Article 9
1. A veterinary certificate meeting the requirements set out in Annex IV shall be presented with consignments of products of animal origin upon their entry into the Community.
2. The veterinary certificate shall certify that the products satisfy:
(a) the requirements laid down for such products under this Directive and under the Community legislation laying down animal health requirements or provisions that are equivalent to those requirements; and
(b) any special import conditions established in accordance with the procedure referred to in Article 12(2).
3. Documents may include details required under other provisions of Community public and animal health legislation.
4. In accordance with the procedure referred to in Article 12(2):
(a) provision may be made for the use of electronic documents,
(b) model documents may be drawn up,
(c) rules and certification for transit may be established.

Article 10
Community inspections and audits
1. Community inspections and/or audits at all stages covered by this Directive may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules. The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out these inspections and/or audits.
2. The inspections and/or audits in third countries referred to in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred.
3. The procedure for carrying out the inspections and/or audits in third countries referred to in paragraph 1 may be established or modified in accordance with the procedure referred to in Article 12(2).
4. If a serious animal health risk is identified during a Community inspection or audit, the Commission shall immediately take the measures necessary to safeguard animal health, in accordance with Article 22 of Directive 97/78/EC, and inform the Member States thereof.

Article 11
Update of technical annexes
The annexes hereto may be amended in accordance with the procedure referred to in Article 12(2) in order to take account in particular of:
(i) scientific opinions and scientific knowledge, particularly concerning new risk assessments;
(ii) technical developments; and
(iii) the setting of safety targets for animal health.

Article 12
Committee procedure
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.

Article 13
Transitional provisions
1. As from the date referred to in Article 14(1), the animal health rules laid down by the Directives listed in Annex V shall no longer apply.
2. Implementing rules adopted on the basis of such provisions shall remain in force until they are replaced by rules having the same effect adopted on the basis of this Directive.
3. Transitional measures may be laid down in accordance with the procedure referred to in Article 12(2).

Article 14
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2005. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.

Article 15
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

Article 16
This Directive is addressed to the Member States.
Done at Brussels, 16 December 2002.
For the Council
The President
M. Fischer Boel
(1) OJ C 365 E, 19.12.2000.
(2) Opinion of the European Parliament delivered on 15 May 2002.
(3) Opinion of the Economic and Social Committee delivered on 28 March 2001.
(4) OJ L 395, 30.12.1989, p. 13. Directive as last amended by Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).
(5) OJ L 302, 31.12.1972, p. 28. Directive as last amended by Regulation (EC) No 1452/2001 (OJ L 198, 21.7.2001, p. 11).
(6) OJ L 24, 30.1.1998, p. 9.
(7) OJ L 184, 17.7.1999, p. 23.
(8) OJ L 31, 1.2.2002, p. 1.
(9) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 2700/2000 (OJ L 311, 12.12.2000, p. 17).
(10) OJ L 46, 19.2.1991, p. 1.

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Parliament(2),Having regard to the opinion of the European Economic and Social Committee(3),Whereas:(1) In the context of the single market, specific animal health rules have been laid down to govern intra-Community trade in the production, processing, distribution and introduction from third countries of products of animal origin for human consumption included in Annex I to the Treaty.(2) Those rules have allowed the removal of obstacles to trade in the products concerned, thereby contributing to the creation of the internal market whilst ensuring a high level of animal health protection.(3) The aim of those rules is to prevent the introduction or spread of animal diseases resulting from the placing on the market of products of animal origin. They also contain common provisions concerning in particular the restrictions applicable to the placing on the market of products coming from a holding or area infected by epizootic diseases and the obligation to subject products coming from restricted areas to treatment to destroy the disease agent.(4) Those common provisions should be harmonised in order to remove possible inconsistencies introduced when the specific animal health rules were adopted. Such harmonisation will also ensure uniform implementation of animal health rules throughout the Community and introduce greater transparency in the structure of Community legislation.(5) Veterinary checks on products of animal origin intended for trade must be carried out in accordance with Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(4). Directive 89/662/EEC contains safeguard measures that may be implemented in the event of a serious hazard to animal health.(6) Products imported from third countries must not present an animal health hazard for Community livestock.(7) To that end, procedures should be introduced to prevent the introduction of epizootic diseases. Such procedures include a regular evaluation of the animal health situation in the third countries concerned.(8) Procedures must also be introduced for establishing general or specific rules or criteria to be applied to imports of products of animal origin.(9) Provisions concerning the importation of meat of domestic ungulates and meat products prepared from or with such meat are already contained in Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries(5).(10) The procedures applicable to the importation of meat and meat products can be used as a model for the importation of other products of animal origin.(11) Veterinary checks on products of animal origin imported into the Community from third countries must be carried out in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(6); Directive 97/78/EC contains safeguard measures that may be implemented in case of a serious hazard to animal health.(12) Account must be taken of the guidelines laid down by the World Organisation for Animal Health (OIE) when adopting rules for international trade.(13) Community audits and inspections must be organised in order to ensure the uniform application of the animal health provisions.(14) The products covered by this Directive are listed in Annex I to the Treaty.(15) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7),HAS ADOPTED THIS DIRECTIVE:Article 1ScopeThis Directive lays down the general animal health rules governing all stages of the production, processing and distribution within the Community and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption.These rules do not affect the provisions laid down in Directives 89/662/EEC and 97/78/EC and the Directives listed in Annex I.Article 2DefinitionsFor the purposes of this Directive, the definitions in 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(8) and Directive 97/78/EC shall apply as necessary. The following definitions shall also apply:1. “all stages of the production, processing and distribution” means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer;2. “introduction” means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(9);3. “official veterinarian” means a veterinarian qualified to act in that capacity appointed by the competent authority;4. “products of animal origin” means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use.CHAPTER IANIMAL HEALTH REQUIREMENTS APPLICABLE TO ALL STAGES OF THE PRODUCTION, PROCESSING AND DISTRIBUTION OF PRODUCTS OF ANIMAL ORIGIN WITHIN THE COMMUNITYArticle 3General animal health requirements1. Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions.2. Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation.3. Products of animal origin shall be obtained from animals:(a) which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions applicable to the animals and products concerned, under the rules set out in Annex I;(b) which, in the case of meat and meat products, were not slaughtered in an establishment in which animals infected or suspected of being infected with one of the diseases covered by the rules referred to in (a), or carcasses or parts thereof of such animals, were present during the slaughtering or production process, unless such suspicion has been ruled out;(c) which, in the case of aquaculture animals and products, comply with Directive 91/67/EEC(10).Article 4Derogations1. Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that:(i) before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority;(ii) the products which are to undergo treatment are clearly identified;(iii) the products undergo treatment enabling the animal health problem concerned to be eliminated, and(iv) the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred.The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2).2. The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2).3. Furthermore, where the health situation so permits, derogations from Article 3 may be granted in certain situations, in accordance with the procedure referred to in Article 12(2). In such cases, particular account shall be taken of:(a) the specific characteristics of the disease in the species concerned, and(b) any tests or measures to which the animals must be subjected.Where such derogations are granted, steps must be taken to ensure that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure.Article 5Veterinary certificates1. Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where:- provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or- a derogation has been granted under Article 4(3).2. Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation.Article 6Official veterinary controls1. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC.2. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC.3. Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof.4. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2).CHAPTER IIIMPORTS FROM THIRD COUNTRIESArticle 7General provisionsMember States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of
This Directive lays down the general animal health rules governing all stages of the production, processing and distribution within the Community and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption.
These rules do not affect the provisions laid down in Directives 89/662/EEC and 97/78/EC and the Directives listed in Annex I.
Definitions
For the purposes of this Directive, the definitions in 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(8) and Directive 97/78/EC shall apply as necessary. The following definitions shall also apply:
1. “all stages of the production, processing and distribution” means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer;
2. “introduction” means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(9);
3. “official veterinarian” means a veterinarian qualified to act in that capacity appointed by the competent authority;
4. “products of animal origin” means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use.
General animal health requirements
1. Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions.
2. Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation.
3. Products of animal origin shall be obtained from animals:
(a) which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions applicable to the animals and products concerned, under the rules set out in Annex I;
(b) which, in the case of meat and meat products, were not slaughtered in an establishment in which animals infected or suspected of being infected with one of the diseases covered by the rules referred to in (a), or carcasses or parts thereof of such animals, were present during the slaughtering or production process, unless such suspicion has been ruled out;
(c) which, in the case of aquaculture animals and products, comply with Directive 91/67/EEC(10).
Derogations
1. Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that:
(i) before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority;
(ii) the products which are to undergo treatment are clearly identified;
(iii) the products undergo treatment enabling the animal health problem concerned to be eliminated, and
(iv) the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred.
The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2).
2. The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2).
3. Furthermore, where the health situation so permits, derogations from Article 3 may be granted in certain situations, in accordance with the procedure referred to in Article 12(2). In such cases, particular account shall be taken of:
(a) the specific characteristics of the disease in the species concerned, and
(b) any tests or measures to which the animals must be subjected.
Where such derogations are granted, steps must be taken to ensure that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure.
Veterinary certificates
1. Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where:
– provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or
– a derogation has been granted under Article 4(3).
2. Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation.
Official veterinary controls
1. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC.
2. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC.
3. Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.
If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof.
4. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2).
General provisions
Member States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of Chapter I applicable to all stages of the production, processing and distribution of such products in the Community or if they offer equivalent animal health guarantees.
Compliance with Community rules
In order to ensure compliance with the general obligation laid down in Article 7, the following shall be established in accordance with the procedure referred to in Article 12(2):
1. Lists of the third countries or regions of third countries from which imports of specified products of animal origin are permitted. A third country shall appear on such lists only if a Community audit of that country has taken place and demonstrates that the competent veterinary authority provides appropriate guarantees as regards compliance with Community legislation.
When drawing up or updating those lists, particular account shall be taken of:
(a) the legislation of the third country;
(b) the organisation of the competent veterinary authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively;
(c) the actual animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community;
(d) the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions;
(e) any experience of marketing the product from the third country and the results of any import controls carried out;
(f) the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities of the third country on the inspections which they have carried out;
(g) the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;
(h) the regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases in its territory, particularly the notifiable diseases listed by the World Organisation for Animal Health (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases listed in the Aquatic Animal Health Code of the OIE;
(i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries.
2. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public. Lists drawn up in accordance with this Article may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates.
3. Rules of origin for products of animal origin and the animals from which such products are obtained shall be established in accordance with the procedure referred to in Article 12(2).
4. Special import conditions for each third country or group of third countries, having regard to the animal health situation of the third country or countries concerned shall be established in accordance with the procedure referred to in Article 12(2).
5. Where necessary:
– the detailed rules for the application of this Article,
– criteria for classifying third countries and regions thereof with regard to animal diseases, and
– specific rules concerning types of introduction or particular products, such as the introduction of products by travellers or the introduction of commercial samples,
1. A veterinary certificate meeting the requirements set out in Annex IV shall be presented with consignments of products of animal origin upon their entry into the Community.
2. The veterinary certificate shall certify that the products satisfy:
(a) the requirements laid down for such products under this Directive and under the Community legislation laying down animal health requirements or provisions that are equivalent to those requirements; and
(b) any special import conditions established in accordance with the procedure referred to in Article 12(2).
3. Documents may include details required under other provisions of Community public and animal health legislation.
4. In accordance with the procedure referred to in Article 12(2):
(a) provision may be made for the use of electronic documents,
(b) model documents may be drawn up,
(c) rules and certification for transit may be established.
Community inspections and audits
1. Community inspections and/or audits at all stages covered by this Directive may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules. The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out these inspections and/or audits.
2. The inspections and/or audits in third countries referred to in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred.
3. The procedure for carrying out the inspections and/or audits in third countries referred to in paragraph 1 may be established or modified in accordance with the procedure referred to in Article 12(2).
4. If a serious animal health risk is identified during a Community inspection or audit, the Commission shall immediately take the measures necessary to safeguard animal health, in accordance with Article 22 of Directive 97/78/EC, and inform the Member States thereof.
Update of technical annexes
The annexes hereto may be amended in accordance with the procedure referred to in Article 12(2) in order to take account in particular of:
(i) scientific opinions and scientific knowledge, particularly concerning new risk assessments;
(ii) technical developments; and
(iii) the setting of safety targets for animal health.
Committee procedure
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Transitional provisions
1. As from the date referred to in Article 14(1), the animal health rules laid down by the Directives listed in Annex V shall no longer apply.
2. Implementing rules adopted on the basis of such provisions shall remain in force until they are replaced by rules having the same effect adopted on the basis of this Directive.
3. Transitional measures may be laid down in accordance with the procedure referred to in Article 12(2).
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2005. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
This Directive is addressed to the Member States.
Done at Brussels, 16 December 2002.
For the Council
The President
M. Fischer Boel
(1) OJ C 365 E, 19.12.2000.
(2) Opinion of the European Parliament delivered on 15 May 2002.
(3) Opinion of the Economic and Social Committee delivered on 28 March 2001.
(4) OJ L 395, 30.12.1989, p. 13. Directive as last amended by Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).
(5) OJ L 302, 31.12.1972, p. 28. Directive as last amended by Regulation (EC) No 1452/2001 (OJ L 198, 21.7.2001, p. 11).
(6) OJ L 24, 30.1.1998, p. 9.
(7) OJ L 184, 17.7.1999, p. 23.
(8) OJ L 31, 1.2.2002, p. 1.
(9) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 2700/2000 (OJ L 311, 12.12.2000, p. 17).
(10) OJ L 46, 19.2.1991, p. 1.
Diseases of relevance to trade in products of animal origin and for which control measures have been introduced under Community legislation
Special identification mark for meat from a territory or a part of a territory
1. The health mark for fresh meat must bear a diagonal cross consisting of two straight lines intersecting at the centre of the stamp and enabling the information thereon to remain legible.
2. The mark mentioned in paragraph 1 may also be applied using a single oval stamp, 6,5 cm wide by 4,5 cm high; the following information must appear on the mark in perfectly legible characters:
– on the upper part, the name or ISO code of the Member State in capitals: AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK,
– in the centre, the veterinary approval number of the slaughterhouse,
– on the lower part, one of the following sets of initials CE, EC, EF, EG, EK or EY,
– two straight lines crossing at the centre of the stamp in such a way that the information is not obscured.
The letters must be at least 0,8 cm high and the figures at least 1 cm high.
The stamp must also carry information whereby the veterinarian who inspected the meat can be identified.
The mark must be applied under the direct supervision of the official veterinarian controlling the implementation of the animal health requirements.
1. Treatments to eliminate certain animal health risks linked to meat and milk
+: Effectiveness recognised.
0: Effectiveness not recognised.
General principles of certification
1. The representative of the competent authority of dispatch issuing a certificate to accompany a consignment of products of animal origin must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one.
2. Certificates must be drawn up in the official language or languages of the Member State of destination and those of the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or those languages. However, a Member State may consent to the use of an official Community language other than its own.
3. The original version of the certificate must accompany consignments on entry into the Community.
4. Certificates must consist of:
(a) a single sheet of paper; or
(b) two or more pages that are part of a single and indivisible sheet of paper; or
(c) a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, “page 2 of 4 pages”).
5. Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number.
6. The certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the country of dispatch.
1. Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat(1), as last amended by the Act of Accession of Austria, Finland and Sweden.
2. Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products(2), as last amended by the Act of Accession of Austria, Finland and Sweden.
3. Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat(3), as last amended by Directive 93/121/EC.
4. Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat(4), as last amended by the Act of Accession of Austria, Finland and Sweden.
5. Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat(5), as last amended by Directive 97/79/EC.
6. Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products(6).
7. Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations(7).
(1) OJ L 302, 31.12.1972, p. 24.
(2) OJ L 47, 21.2.1980, p. 4.
(3) OJ L 268, 24.9.1991, p. 35.
(4) OJ L 268, 24.9.1991, p. 41.
(5) OJ L 268, 14.9.1992, p. 35.
(6) OJ L 268, 14.9.1992, p. 1.
(7) OJ L 368, 31.12.1994, p. 10.

Pending: 32002L0096

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the Opinion of the Economic and Social Committee(2),Having regard to the Opinion of the Committee of Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4),Whereas:(1) The objectives of the Community’s environment policy are, in particular, to preserve, protect and improve the quality of the environment, protect human health and utilise natural resources prudently and rationally. That policy is based on the precautionary principle and principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.(2) The Community programme of policy and action in relation to the environment and sustainable development (Fifth Environmental Action Programme)(5) states that the achievement of sustainable development calls for significant changes in current patterns of development, production, consumption and behaviour and advocates, inter alia, the reduction of wasteful consumption of natural resources and the prevention of pollution. It mentions waste electrical and electronic equipment (WEEE) as one of the target areas to be regulated, in view of the application of the principles of prevention, recovery and safe disposal of waste.(3) The Commission Communication of 30 July 1996 on review of the Community strategy for waste management states that, where the generation of waste cannot be avoided, it should be reused or recovered for its material or energy.(4) The Council in its Resolution of 24 February 1997 on a Community strategy for waste management(6) insisted on the need for promoting waste recovery with a view to reducing the quantity of waste for disposal and saving natural resources, in particular by reuse, recycling, composting and recovering energy from waste and recognised that the choice of options in any particular case must have regard to environmental and economic effects but that until scientific and technological progress is made and life-cycle analyses are further developed, reuse and material recovery should be considered preferable where and in so far as they are the best environmental options. The Council also invited the Commission to develop, as soon as possible, an appropriate follow-up to the projects of the priority waste streams programme, including WEEE.(5) The European Parliament, in its Resolution of 14 November 1996(7), asked the Commission to present proposals for Directives on a number of priority waste streams, including electrical and electronic waste, and to base such proposals on the principle of producer responsibility. The European Parliament, in the same Resolution, requests the Council and the Commission to put forward proposals for cutting the volume of waste.(6) Council Directive 75/442/EEC of 15 July 1975 on waste(8) provides that specific rules for particular instances or supplementing those of Directive 75/442/EEC on the management of particular categories of waste may be laid down by means of individual Directives.(7) The amount of WEEE generated in the Community is growing rapidly. The content of hazardous components in electrical and electronic equipment (EEE) is a major concern during the waste management phase and recycling of WEEE is not undertaken to a sufficient extent.(8) The objective of improving the management of WEEE cannot be achieved effectively by Member States acting individually. In particular, different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators. Having different national policies on the management of WEEE hampers the effectiveness of recycling policies. For that reason the essential criteria should be laid down at Community level.(9) The provisions of this Directive should apply to products and producers irrespective of the selling technique, including distance and electronic selling. In this connection the obligations of producers and distributors using distance and electronic selling channels should, as far as is practicable, take the same form and should be enforced in the same way in order to avoid other distribution channels having to bear the costs of the provisions of this Directive concerning WEEE for which the equipment was sold by distant or electronic selling.(10) This Directive should cover all electrical and electronic equipment used by consumers and electrical and electronic equipment intended for professional use. This Directive should apply without prejudice to Community legislation on safety and health requirements protecting all actors in contact with WEEE as well as specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(9).(11) Directive 91/157/EEC needs to be revised as soon as possible, particularly in the light of this Directive.(12) The establishment, by this Directive, of producer responsibility is one of the means of encouraging the design and production of electrical and electronic equipment which take into full account and facilitate their repair, possible upgrading, reuse, disassembly and recycling.(13) In order to guarantee the safety and health of distributors’ personnel involved in the take-back and handling of WEEE, Member States should, in accordance with national and Community legislation on safety and health requirements, determine the conditions under which take-back may be refused by distributors.(14) Member States should encourage the design and production of electrical and electronic equipment which take into account and facilitate dismantling and recovery, in particular the re-use and recycling of WEEE, their components and materials. Producers should not prevent, through specific design features or manufacturing processes, WEEE from being reused, unless such specific design features or manufacturing processes present overriding advantages, for example with regard to the protection of the environment and/or safety requirements.(15) Separate collection is the precondition to ensure specific treatment and recycling of WEEE and is necessary to achieve the chosen level of protection of human health and the environment in the Community. Consumers have to actively contribute to the success of such collection and should be encouraged to return WEEE. For this purpose, convenient facilities should be set up for the return of WEEE, including public collection points, where private households should be able to return their waste at least free of charge.(16) In order to attain the chosen level of protection and harmonised environmental objectives of the Community, Member States should adopt appropriate measures to minimise the disposal of WEEE as unsorted municipal waste and to achieve a high level of separate collection of WEEE. In order to ensure that Member States strive to set up efficient collection schemes, they should be required to achieve a high level of collection of WEEE from private households.(17) Specific treatment for WEEE is indispensable in order to avoid the dispersion of pollutants into the recycled material or the waste stream. Such treatment is the most effective means of ensuring compliance with the chosen level of protection of the environment of the Community. Any establishment or undertakings carrying out recycling and treatment operations should comply with minimum standards to prevent negative environmental impacts associated with the treatment of WEEE. Best available treatment, recovery and recycling techniques should be used provided that they ensure human health and high environmental protection. Best available treatment, recovery and recycling techniques may be further defined in accordance with the procedures of Directive 96/61/EC.(18) Where appropriate, priority should be given to the reuse of WEEE and its components, subassemblies and consumables. Where reuse is not preferable, all WEEE collected separately should be sent for recovery, in the course of which a high level of recycling and recovery should be achieved. In addition, producers should be encouraged to integrate recycled material in new equipment.(19) Basic principles with regard to the financing of WEEE management have to be set at Community level and financing schemes have to contribute to high collection rates as well as to the implementation of the principle of producer responsibility.(20) Users of electrical and electronic equipment from private households should have the possibility of returning WEEE at least free of charge. Producers should therefore finance collection from collection facilities, and the treatment, recovery and disposal of WEEE. In order to give maximum effect to the concept of producer responsibility, each producer should be responsible for financing the management of the waste from his own products. The producer should be able to choose to fulfil this obligation either individually or by joining a collective scheme. Each producer should, when placing a product on the market, provide a financial guarantee to prevent costs for the management of WEEE from orphan products from falling on society or the remaining producers. The responsibility for the financing of the management of historical waste should be shared by all existing producers in collective financing schemes to which all producers, existing on the market when the costs occur, contribute proportionately. Collective financing schemes should not have the effect of excluding niche and low-volume producers, importers and new entrants. For a transitional period, producers should be allowed to show purchasers, on a voluntary basis at the time of sale of new products, the costs of collecting, treating and disposing in an environmentally sound way of historical waste. Producers making use of this provision should ensure that the costs mentioned do not exceed the actual costs incurred.(21) Information to users about the requirement not to dispose of WEEE as unsorted municipal waste and to collect WEEE separately, and about the collection systems and their role in the management of WEEE, is indispensable for the success of WEEE collection. Such information implies the proper marking of electrical and electronic equipment which could end up in rubbish bins or similar means of municipal waste collection.(22) Information on component and material identification to be provided by producers is important to facilitate the management, and in particular the treatment and recovery/recycling, of WEEE.(23) Member States should ensure that inspection and monitoring infrastructure enable the proper implementation of this Directive to be verified, having regard, inter alia, to Recommendation 2001/331/EC of the European Parliament and the Council of 4 April 2001 providing for minimum criteria for environmental inspections in the Member States(10).(24) Information about the weight or, if this is not possible, the numbers of items of electrical and electronic equipment put on the market in the Community and the rates of collection, reuse (including as far as possible reuse of whole appliances), recovery/recycling and export of WEEE collected in accordance with this Directive is necessary to monitor the achievement of the objectives of this Directive.(25) Member States may choose to implement certain provisions of this Directive by means of agreements between the competent authorities and the economic sectors concerned provided that particular requirements are met.(26) The adaptation to scientific and technical progress of certain provisions of the Directive, the list of products falling under the categories set out in Annex IA, the selective treatment for materials and components of WEEE, the technical requirements for storage and treatment of WEEE and the symbol for the marking of EEE should be effected by the Commission under a committee procedure.(27) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11),HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe purpose of this Directive is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. It also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment, e.g. producers, distributors and consumers and in particular those operators directly involved in the treatment of waste electrical and electronic equipment.Article 2Scope1. This Directive shall apply to electrical and electronic equipment falling under the categories set out in Annex IA provided that the equipment concerned is not part of another type of equipment that does not fall within the scope of this Directive. Annex IB contains a list of products which fall under the categories set out in Annex IA.2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.3. Equipment which is connected with the protection of the essential interests of the security of Member States, arms, munitions and war material shall be excluded from this Directive. This does not, however, apply to products which are not intended for specifically military purposes.Article 3DefinitionsFor the purposes of this Directive, the following definitions shall apply:(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA and designed for use with a voltage rating not exceeding 1000 Volt for alternating current and 1500 Volt for direct current;(b) “waste electrical and electronic equipment” or “WEEE” means electrical or electronic equipment which is waste within the meaning of

Article 1
The purpose of this Directive is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. It also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment, e.g. producers, distributors and consumers and in particular those operators directly involved in the treatment of waste electrical and electronic equipment.

Article 2
1. This Directive shall apply to electrical and electronic equipment falling under the categories set out in Annex IA provided that the equipment concerned is not part of another type of equipment that does not fall within the scope of this Directive. Annex IB contains a list of products which fall under the categories set out in Annex IA.
2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.
3. Equipment which is connected with the protection of the essential interests of the security of Member States, arms, munitions and war material shall be excluded from this Directive. This does not, however, apply to products which are not intended for specifically military purposes.

Article 3
Definitions
For the purposes of this Directive, the following definitions shall apply:
(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA and designed for use with a voltage rating not exceeding 1000 Volt for alternating current and 1500 Volt for direct current;
(b) “waste electrical and electronic equipment” or “WEEE” means electrical or electronic equipment which is waste within the meaning of Article 1(a) of Directive 75/442/EEC, including all components, subassemblies and consumables which are part of the product at the time of discarding;
(c) “prevention” means measures aimed at reducing the quantity and the harmfulness to the environment of WEEE and materials and substances contained therein;
(d) “reuse” means any operation by which WEEE or components thereof are used for the same purpose for which they were conceived, including the continued use of the equipment or components thereof which are returned to collection points, distributors, recyclers or manufacturers;
(e) “recycling” means the reprocessing in a production process of the waste materials for the original purpose or for other purposes, but excluding energy recovery which means the use of combustible waste as a means of generating energy through direct incineration with or without other waste but with recovery of the heat;
(f) “recovery” means any of the applicable operations provided for in Annex IIB to Directive 75/442/EEC;
(g) “disposal” means any of the applicable operations provided for in Annex IIA to Directive 75/442/EEC;
(h) “treatment” means any activity after the WEEE has been handed over to a facility for depollution, disassembly, shredding, recovery or preparation for disposal and any other operation carried out for the recovery and/or the disposal of the WEEE;
(i) “producer” means any person who, irrespective of the selling technique used, including by means of distance communication in accordance with Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(12):
(i) manufactures and sells electrical and electronic equipment under his own brand,
(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the “producer” if the brand of the producer appears on the equipment, as provided for in subpoint (i), or
(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.
Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a “producer” unless he also acts as a producer within the meaning of subpoints (i) to (iii);
(j) “distributor” means any person who provides electrical or electronic equipment on a commercial basis to the party who is going to use it;
(k) “WEEE from private households” means WEEE which comes from private households and from commercial, industrial, institutional and other sources which, because of its nature and quantity, is similar to that from private households;
(l) “dangerous substance or preparation” means any substance or preparation which has to be considered dangerous under Council Directive 67/548/EEC(13) or Directive 1999/45/EC of the European Parliament and of the Council(14).
(m) “finance agreement” means any loan, lease, hiring or deferred sale agreement or arrangement relating to any equipment whether or not the terms of that agreement or arrangement or any collateral agreement or arrangement provide that a transfer of ownership of that equipment will or may take place.

Article 4
Product design
Member States shall encourage the design and production of electrical and electronic equipment which take into account and facilitate dismantling and recovery, in particular the reuse and recycling of WEEE, their components and materials. In this context, Member States shall take appropriate measures so that producers do not prevent, through specific design features or manufacturing processes, WEEE from being reused, unless such specific design features or manufacturing processes present overriding advantages, for example, with regard to the protection of the environment and/or safety requirements.

Article 5
Separate collection
1. Member States shall adopt appropriate measures in order to minimise the disposal of WEEE as unsorted municipal waste and to achieve a high level of separate collection of WEEE.
2. For WEEE from private households, Member States shall ensure that by the 13 August 2005:
(a) systems are set up allowing final holders and distributors to return such waste at least free of charge. Member States shall ensure the availability and accessibility of the necessary collection facilities, taking into account in particular the population density;
(b) when supplying a new product, distributors shall be responsible for ensuring that such waste can be returned to the distributor at least free of charge on a one-to-one basis as long as the equipment is of equivalent type and has fulfilled the same functions as the supplied equipment. Member States may depart from this provision provided they ensure that returning the WEEE is not thereby made more difficult for the final holder and provided that these systems remain free of charge for the final holder. Member States making use of this provision shall inform the Commission thereof;
(c) without prejudice to the provisions of (a) and (b), producers are allowed to set up and operate individual and/or collective take-back systems for WEEE from private households provided that these are in line with the objectives of this Directive;
(d) having regard to national and Community health and safety standards, WEEE that presents a health and safety risk to personnel because of contamination may be refused for return under (a) and (b). Member States shall make specific arrangements for such WEEE.
Member States may provide for specific arrangements for the return of WEEE as under (a) and (b) if the equipment does not contain the essential components or if the equipment contains waste other than WEEE.
3. In the case of WEEE other than WEEE from private households, and without prejudice to Article 9, Member States shall ensure that producers or third parties acting on their behalf provide for the collection of such waste.
4. Member States shall ensure that all WEEE collected under paragraphs 1, 2 and 3 above is transported to treatment facilities authorised under Article 6 unless the appliances are reused as a whole. Member States shall ensure that the envisaged reuse does not lead to a circumvention of this Directive, in particular as regards Articles 6 and 7. The collection and transport of separately collected WEEE shall be carried out in a way which optimises reuse and recycling of those components or whole appliances capable of being reused or recycled.
5. Without prejudice to paragraph 1, Member States shall ensure that by 31 December 2006 at the latest a rate of separate collection of at least four kilograms on average per inhabitant per year of WEEE from private households is achieved.
The European Parliament and the Council, acting on a proposal from the Commission and taking account of technical and economic experience in the Member States, shall establish a new mandatory target by 31 December 2008. This may take the form of a percentage of the quantities of electrical and electronic equipment sold to private households in the preceding years.

Article 6
1. Member States shall ensure that producers or third parties acting on their behalf, in accordance with Community legislation, set up systems to provide for the treatment of WEEE using best available treatment, recovery and recycling techniques. The systems may be set up by producers individually and/or collectively. To ensure compliance with Article 4 of Directive 75/442/EEC, the treatment shall, as a minimum, include the removal of all fluids and a selective treatment in accordance with Annex II to this Directive.
Other treatment technologies ensuring at least the same level of protection for human health and the environment may be introduced in Annex II under the procedure referred to in Article 14(2).
For the purposes of environmental protection, Member States may set up minimum quality standards for the treatment of collected WEEE. Member States which opt for such quality standards shall inform the Commission thereof, which shall publish these standards.
2. Member States shall ensure that any establishment or undertaking carrying out treatment operations obtains a permit from the competent authorities, in compliance with Articles 9 and 10 of Directive 75/442/EEC.
The derogation from the permit requirement referred to in Article 11(1)(b) of Directive 75/442/EEC may apply to recovery operations concerning WEEE if an inspection is carried out by the competent authorities before the registration in order to ensure compliance with Article 4 of Directive 75/442/EEC.
The inspection shall verify:
(a) the type and quantities of waste to be treated;
(b) the general technical requirements to be complied with;
(c) the safety precautions to be taken.
The inspection shall be carried out at least once a year and the results shall be communicated by the Member States to the Commission.
3. Member States shall ensure that any establishment or undertaking carrying out treatment operations stores and treats WEEE in compliance with the technical requirements set out in Annex III.
4. Member States shall ensure that the permit or the registration referred to in paragraph 2 includes all conditions necessary for compliance with the requirements of paragraphs 1 and 3 and for the achievement of the recovery targets set out in Article 7.
5. The treatment operation may also be undertaken outside the respective Member State or the Community provided that the shipment of WEEE is in compliance with Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community(15).
WEEE exported out of the Community in line with Council Regulation (EEC) No 259/93, Council Regulation (EC) No 1420/1999(16) of 29 April 1999 establishing common rules and procedures to apply to shipments to certain non-OECD countries of certain types of waste and Commission Regulation (EC) No 1547/1999(17) of 12 July 1999 determining the control procedures under Council Regulation (EEC) No 259/93 to apply to shipments of certain types of waste to certain countries to which OECD Decision C(92)39 final does not apply, shall only count for the fulfilment of obligations and targets of Article 7(1) and (2) of this Directive if the exporter can prove that the recovery, reuse and/or recycling operation took place under conditions that are equivalent to the requirements of this Directive.
6. Member States shall encourage establishments or undertakings which carry out treatment operations to introduce certified environmental management systems in accordance with Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS)(18).

Article 7
1. Member States shall ensure that producers or third parties acting on their behalf set up systems either on an individual or on a collective basis, in accordance with Community legislation, to provide for the recovery of WEEE collected separately in accordance with Article 5. Member States shall give priority to the reuse of whole appliances. Until the date referred to in paragraph 4, such appliances shall not be taken into account for the calculation of the targets set out in paragraph 2.
2. Regarding WEEE sent for treatment in accordance with Article 6, Member States shall ensure that, by 31 December 2006, producers meet the following targets:
(a) for WEEE falling under categories 1 and 10 of Annex IA,
– the rate of recovery shall be increased to a minimum of 80 % by an average weight per appliance, and
– component, material and substance reuse and recycling shall be increased to a minimum of 75 % by an average weight per appliance;
(b) for WEEE falling under categories 3 and 4 of Annex IA,
– the rate of recovery shall be increased to a minimum of 75 % by an average weight per appliance, and
– component, material and substance reuse and recycling shall be increased to a minimum of 65 % by an average weight per appliance;
(c) for WEEE falling under categories 2, 5, 6, 7 and 9 of Annex IA,
– the rate of recovery shall be increased to a minimum of 70 % by an average weight per appliance, and
– component, material and substance reuse and recycling shall be increased to a minimum of 50 % by an average weight per appliance;
(d) for gas discharge lamps, the rate of component, material and substance reuse and recycling shall reach a minimum of 80 % by weight of the lamps.
3. Member States shall ensure that, for the purpose of calculating these targets, producers or third parties acting on their behalf keep records on the mass of WEEE, their components, materials or substances when entering (input) and leaving (output) the treatment facility and/or when entering (input) the recovery or recycling facility.
The Commission shall, in accordance with the procedure laid down in Article 14(2), establish the detailed rules for monitoring compliance, including specifications for materials, of Member States with the targets set out in paragraph 2. The Commission shall submit this measure by 13 August 2004.
4. The European Parliament and the Council, acting on a proposal from the Commission, shall establish new targets for recovery and reuse/recycling, including for the reuse of whole appliances as appropriate, and for the products falling under category 8 of Annex IA, by 31 December 2008. This shall be done with account being taken of the environmental benefits of electrical and electronic equipment in use, such as improved resource efficiency resulting from developments in the areas of materials and technology. Technical progress in reuse, recovery and recycling, products and materials, and the experience gained by the Member States and the industry, shall also be taken into account.
5. Member States shall encourage the development of new recovery, recycling and treatment technologies.

Article 8
Financing in respect of WEEE from private households
1. Member States shall ensure that, by 13 August 2005, producers provide at least for the financing of the collection, treatment, recovery and environmentally sound disposal of WEEE from private households deposited at collection facilities, set up under Article 5(2).
2. For products put on the market later than 13 August 2005, each producer shall be responsible for financing the operations referred to in paragraph 1 relating to the waste from his own products. The producer can choose to fulfil this obligation either individually or by joining a collective scheme.
Member States shall ensure that each producer provides a guarantee when placing a product on the market showing that the management of all WEEE will be financed and that producers clearly mark their products in accordance with Article 11(2). This guarantee shall ensure that the operations referred to in paragraph 1 relating to this product will be financed. The guarantee may take the form of participation by the producer in appropriate schemes for the financing of the management of WEEE, a recycling insurance or a blocked bank account.
The costs of collection, treatment and environmentally sound disposal shall not be shown separately to purchasers at the time of sale of new products.
3. The responsibility for the financing of the costs of the management of WEEE from products put on the market before the date referred to in paragraph 1 (historical waste) shall be provided by one or more systems to which all producers, existing on the market when the respective costs occur, contribute proportionately, e.g. in proportion to their respective share of the market by type of equipment.
Member States shall ensure that for a transitional period of eight years (10 years for category 1 of Annex IA) after entry into force of this Directive, producers are allowed to show purchasers, at the time of sale of new products, the costs of collection, treatment and disposal in an environmentally sound way. The costs mentioned shall not exceed the actual costs incurred.
4. Member States shall ensure that producers supplying electrical or electronic equipment by means of distance communication also comply with the requirements set out in this Article for the equipment supplied in the Member State where the purchaser of that equipment resides.

Article 9
Financing in respect of WEEE from users other than private households
Member States shall ensure that, by 13 August 2005, the financing of the costs for the collection, treatment, recovery and environmentally sound disposal of WEEE from users other than private households from products put on the market after 13 August 2005 is to be provided for by producers.
For WEEE from products put on the market before 13 August 2005 (historical waste), the financing of the costs of management shall be provided for by producers. Member States may, as an alternative, provide that users other than private households also be made, partly or totally, responsible for this financing.
Producers and users other than private households may, without prejudice to this Directive, conclude agreements stipulating other financing methods.

Article 10
Information for users
1. Member States shall ensure that users of electrical and electronic equipment in private households are given the necessary information about:
(a) the requirement not to dispose of WEEE as unsorted municipal waste and to collect such WEEE separately;
(b) the return and collection systems available to them;
(c) their role in contributing to reuse, recycling and other forms of recovery of WEEE;
(d) the potential effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment;
(e) the meaning of the symbol shown in Annex IV.
2. Member States shall adopt appropriate measures so that consumers participate in the collection of WEEE and to encourage them to facilitate the process of reuse, treatment and recovery.
3. With a view to minimising the disposal of WEEE as unsorted municipal waste and to facilitating its separate collection, Member States shall ensure that producers appropriately mark electrical and electronic equipment put on the market after 13 August 2005 with the symbol shown in Annex IV. In exceptional cases, where this is necessary because of the size or the function of the product, the symbol shall be printed on the packaging, on the instructions for use and on the warranty of the electrical and electronic equipment.
4. Member States may require that some or all of the information referred to in paragraphs 1 to 3 shall be provided by producers and/or distributors, e.g. in the instructions for use or at the point of sale.

Article 11
Information for treatment facilities
1. In order to facilitate the reuse and the correct and environmentally sound treatment of WEEE, including maintenance, upgrade, refurbishment and recycling, Member States shall take the necessary measures to ensure that producers provide reuse and treatment information for each type of new EEE put on the market within one year after the equipment is put on the market. This information shall identify, as far as it is needed by reuse centres, treatment and recycling facilities in order to comply with the provisions of this Directive, the different EEE components and materials, as well as the location of dangerous substances and preparations in EEE. It shall be made available to reuse centres, treatment and recycling facilities by producers of EEE in the form of manuals or by means of electronic media (e.g. CD-ROM, online services).
2. Member States shall ensure that any producer of an electrical or electronic appliance put on the market after 13 August 2005 is clearly identifiable by a mark on the appliance. Furthermore, in order to enable the date upon which the appliance was put on the market to be determined unequivocally, a mark on the appliance shall specify that the latter was put on the market after 13 August 2005 The Commission shall promote the preparation of European standards for this purpose.

Article 12
Information and reporting
1. Member States shall draw up a register of producers and collect information, including substantiated estimates, on an annual basis on the quantities and categories of electrical and electronic equipment put on their market, collected through all routes, reused, recycled and recovered within the Member States, and on collected waste exported, by weight or, if this is not possible, by numbers.
Member States shall ensure that producers supplying electrical and electronic equipment by means of distance communication provide information on the compliance with the requirements of Article 8(4) and on the quantities and categories of electrical and electronic equipment put on the market of the Member State where the purchaser of that equipment resides.
Member States shall ensure that the information required is transmitted to the Commission on a two-yearly basis within 18 months after the end of the period covered. The first set of information shall cover the years 2005 and 2006. The information shall be provided in a format which shall be established within one year after the entry into force of this Directive in accordance with the procedure referred to in Article 14(2) with a view to establishing databases on WEEE and its treatment.
Member States shall provide for adequate information exchange in order to comply with this paragraph, in particular for treatment operations as referred to in Article 6(5).
2. Without prejudice to the requirements of paragraph 1, Member States shall send a report to the Commission on the implementation of this Directive at three-year intervals. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(19). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be made available to the Commission within nine months of the end of the three-year period covered by it.
The first three-year report shall cover the period from 2004 to 2006.
The Commission shall publish a report on the implementation of this Directive within nine months after receiving the reports from the Member States.

Article 13
Adaptation to scientific and technical progress
Any amendments which are necessary in order to adapt Article 7(3), Annex IB, (in particular with a view to possibly adding luminaires in households, filament bulbs and photovoltaic products, i.e. solar panels), Annex II (in particular taking into account new technical developments for the treatment of WEEE), and Annexes III and IV to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 14(2).
Before the Annexes are amended the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators and environmental organisations and employees’ and consumer associations.

Article 14
1. The Commission shall be assisted by the Committee set up by Article 18 of Directive 75/442/EEC.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.

Article 15
Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.

Article 16
Inspection and monitoring
Member States shall ensure that inspection and monitoring enable the proper implementation of this Directive to be verified.

Article 17
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 August 2004. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.
3. Provided that the objectives set out in this Directive are achieved, Member States may transpose the provisions set out in Articles 6(6), 10(1) and 11 by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements:
(a) agreements shall be enforceable;
(b) agreements shall specify objectives with the corresponding deadlines;
(c) agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission;
(d) the results achieved shall be monitored regularly, reported to the competent authorities and the Commission and made available to the public under the conditions set out in the agreement;
(e) the competent authorities shall ensure that the progress reached under the agreement is examined;
(f) in case of non-compliance with the agreement Member States must implement the relevant provisions of this Directive by legislative, regulatory or administrative measures.
4. (a) Greece and Ireland which, because of their overall:
– recycling infrastructure deficit,
– geographical circumstances such as the large number of small islands and the presence of rural and mountain areas,
– low population density, and
– low level of EEE consumption,
are unable to reach either the collection target mentioned in the first subparagraph of Article 5(5) or the recovery targets mentioned in Article 7(2) and which, under the third subparagraph of Article 5(2) of Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(20), may apply for an extension of the deadline mentioned in that Article,
may extend the periods referred to in Articles 5(5) and 7(2) of this Directive by up to 24 months.
These Member States shall inform the Commission of their Decisions at the latest at the time of transposition of this Directive.
(b) The Commission shall inform other Member States and the European Parliament of these decisions.

Article 18
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 19
This Directive is addressed to the Member States.
Done at Brussels, 27 January 2003.
For the European Parliament
The President
For the Council
(1) OJ C 365 E, 19.12.2000, p. 184 and OJ C 240 E, 28.8.2001, p. 298.
(2) OJ C 116, 20.4.2001, p. 38.
(3) OJ C 148, 18.5.2001, p. 1.
(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 115), Council Common Position of 4 December 2001 (OJ C 110 E, 7.5.2002, p. 1) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.
(5) OJ C 138, 17.5.1993, p. 5.
(6) OJ C 76, 11.3.1997, p. 1.
(7) OJ C 362, 2.12.1996, p. 241.
(8) OJ L 194, 25.7.1975, p. 47. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).
(9) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).
(10) OJ L 118, 27.4.2001, p. 41.
(11) OJ L 184, 17.7.1999, p. 23.
(12) OJ L 144, 4.6.1997, p. 19.
(13) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).
(14) OJ L 200, 30.7.1999, p. 1. Directive as amended by Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p. 5).

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the Opinion of the Economic and Social Committee(2),Having regard to the Opinion of the Committee of Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4),Whereas:(1) The objectives of the Community’s environment policy are, in particular, to preserve, protect and improve the quality of the environment, protect human health and utilise natural resources prudently and rationally. That policy is based on the precautionary principle and principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.(2) The Community programme of policy and action in relation to the environment and sustainable development (Fifth Environmental Action Programme)(5) states that the achievement of sustainable development calls for significant changes in current patterns of development, production, consumption and behaviour and advocates, inter alia, the reduction of wasteful consumption of natural resources and the prevention of pollution. It mentions waste electrical and electronic equipment (WEEE) as one of the target areas to be regulated, in view of the application of the principles of prevention, recovery and safe disposal of waste.(3) The Commission Communication of 30 July 1996 on review of the Community strategy for waste management states that, where the generation of waste cannot be avoided, it should be reused or recovered for its material or energy.(4) The Council in its Resolution of 24 February 1997 on a Community strategy for waste management(6) insisted on the need for promoting waste recovery with a view to reducing the quantity of waste for disposal and saving natural resources, in particular by reuse, recycling, composting and recovering energy from waste and recognised that the choice of options in any particular case must have regard to environmental and economic effects but that until scientific and technological progress is made and life-cycle analyses are further developed, reuse and material recovery should be considered preferable where and in so far as they are the best environmental options. The Council also invited the Commission to develop, as soon as possible, an appropriate follow-up to the projects of the priority waste streams programme, including WEEE.(5) The European Parliament, in its Resolution of 14 November 1996(7), asked the Commission to present proposals for Directives on a number of priority waste streams, including electrical and electronic waste, and to base such proposals on the principle of producer responsibility. The European Parliament, in the same Resolution, requests the Council and the Commission to put forward proposals for cutting the volume of waste.(6) Council Directive 75/442/EEC of 15 July 1975 on waste(8) provides that specific rules for particular instances or supplementing those of Directive 75/442/EEC on the management of particular categories of waste may be laid down by means of individual Directives.(7) The amount of WEEE generated in the Community is growing rapidly. The content of hazardous components in electrical and electronic equipment (EEE) is a major concern during the waste management phase and recycling of WEEE is not undertaken to a sufficient extent.(8) The objective of improving the management of WEEE cannot be achieved effectively by Member States acting individually. In particular, different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators. Having different national policies on the management of WEEE hampers the effectiveness of recycling policies. For that reason the essential criteria should be laid down at Community level.(9) The provisions of this Directive should apply to products and producers irrespective of the selling technique, including distance and electronic selling. In this connection the obligations of producers and distributors using distance and electronic selling channels should, as far as is practicable, take the same form and should be enforced in the same way in order to avoid other distribution channels having to bear the costs of the provisions of this Directive concerning WEEE for which the equipment was sold by distant or electronic selling.(10) This Directive should cover all electrical and electronic equipment used by consumers and electrical and electronic equipment intended for professional use. This Directive should apply without prejudice to Community legislation on safety and health requirements protecting all actors in contact with WEEE as well as specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(9).(11) Directive 91/157/EEC needs to be revised as soon as possible, particularly in the light of this Directive.(12) The establishment, by this Directive, of producer responsibility is one of the means of encouraging the design and production of electrical and electronic equipment which take into full account and facilitate their repair, possible upgrading, reuse, disassembly and recycling.(13) In order to guarantee the safety and health of distributors’ personnel involved in the take-back and handling of WEEE, Member States should, in accordance with national and Community legislation on safety and health requirements, determine the conditions under which take-back may be refused by distributors.(14) Member States should encourage the design and production of electrical and electronic equipment which take into account and facilitate dismantling and recovery, in particular the re-use and recycling of WEEE, their components and materials. Producers should not prevent, through specific design features or manufacturing processes, WEEE from being reused, unless such specific design features or manufacturing processes present overriding advantages, for example with regard to the protection of the environment and/or safety requirements.(15) Separate collection is the precondition to ensure specific treatment and recycling of WEEE and is necessary to achieve the chosen level of protection of human health and the environment in the Community. Consumers have to actively contribute to the success of such collection and should be encouraged to return WEEE. For this purpose, convenient facilities should be set up for the return of WEEE, including public collection points, where private households should be able to return their waste at least free of charge.(16) In order to attain the chosen level of protection and harmonised environmental objectives of the Community, Member States should adopt appropriate measures to minimise the disposal of WEEE as unsorted municipal waste and to achieve a high level of separate collection of WEEE. In order to ensure that Member States strive to set up efficient collection schemes, they should be required to achieve a high level of collection of WEEE from private households.(17) Specific treatment for WEEE is indispensable in order to avoid the dispersion of pollutants into the recycled material or the waste stream. Such treatment is the most effective means of ensuring compliance with the chosen level of protection of the environment of the Community. Any establishment or undertakings carrying out recycling and treatment operations should comply with minimum standards to prevent negative environmental impacts associated with the treatment of WEEE. Best available treatment, recovery and recycling techniques should be used provided that they ensure human health and high environmental protection. Best available treatment, recovery and recycling techniques may be further defined in accordance with the procedures of Directive 96/61/EC.(18) Where appropriate, priority should be given to the reuse of WEEE and its components, subassemblies and consumables. Where reuse is not preferable, all WEEE collected separately should be sent for recovery, in the course of which a high level of recycling and recovery should be achieved. In addition, producers should be encouraged to integrate recycled material in new equipment.(19) Basic principles with regard to the financing of WEEE management have to be set at Community level and financing schemes have to contribute to high collection rates as well as to the implementation of the principle of producer responsibility.(20) Users of electrical and electronic equipment from private households should have the possibility of returning WEEE at least free of charge. Producers should therefore finance collection from collection facilities, and the treatment, recovery and disposal of WEEE. In order to give maximum effect to the concept of producer responsibility, each producer should be responsible for financing the management of the waste from his own products. The producer should be able to choose to fulfil this obligation either individually or by joining a collective scheme. Each producer should, when placing a product on the market, provide a financial guarantee to prevent costs for the management of WEEE from orphan products from falling on society or the remaining producers. The responsibility for the financing of the management of historical waste should be shared by all existing producers in collective financing schemes to which all producers, existing on the market when the costs occur, contribute proportionately. Collective financing schemes should not have the effect of excluding niche and low-volume producers, importers and new entrants. For a transitional period, producers should be allowed to show purchasers, on a voluntary basis at the time of sale of new products, the costs of collecting, treating and disposing in an environmentally sound way of historical waste. Producers making use of this provision should ensure that the costs mentioned do not exceed the actual costs incurred.(21) Information to users about the requirement not to dispose of WEEE as unsorted municipal waste and to collect WEEE separately, and about the collection systems and their role in the management of WEEE, is indispensable for the success of WEEE collection. Such information implies the proper marking of electrical and electronic equipment which could end up in rubbish bins or similar means of municipal waste collection.(22) Information on component and material identification to be provided by producers is important to facilitate the management, and in particular the treatment and recovery/recycling, of WEEE.(23) Member States should ensure that inspection and monitoring infrastructure enable the proper implementation of this Directive to be verified, having regard, inter alia, to Recommendation 2001/331/EC of the European Parliament and the Council of 4 April 2001 providing for minimum criteria for environmental inspections in the Member States(10).(24) Information about the weight or, if this is not possible, the numbers of items of electrical and electronic equipment put on the market in the Community and the rates of collection, reuse (including as far as possible reuse of whole appliances), recovery/recycling and export of WEEE collected in accordance with this Directive is necessary to monitor the achievement of the objectives of this Directive.(25) Member States may choose to implement certain provisions of this Directive by means of agreements between the competent authorities and the economic sectors concerned provided that particular requirements are met.(26) The adaptation to scientific and technical progress of certain provisions of the Directive, the list of products falling under the categories set out in Annex IA, the selective treatment for materials and components of WEEE, the technical requirements for storage and treatment of WEEE and the symbol for the marking of EEE should be effected by the Commission under a committee procedure.(27) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11),HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe purpose of this Directive is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. It also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment, e.g. producers, distributors and consumers and in particular those operators directly involved in the treatment of waste electrical and electronic equipment.Article 2Scope1. This Directive shall apply to electrical and electronic equipment falling under the categories set out in Annex IA provided that the equipment concerned is not part of another type of equipment that does not fall within the scope of this Directive. Annex IB contains a list of products which fall under the categories set out in Annex IA.2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.3. Equipment which is connected with the protection of the essential interests of the security of Member States, arms, munitions and war material shall be excluded from this Directive. This does not, however, apply to products which are not intended for specifically military purposes.Article 3DefinitionsFor the purposes of this Directive, the following definitions shall apply:(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA and designed for use with a voltage rating not exceeding 1000 Volt for alternating current and 1500 Volt for direct current;(b) “waste electrical and electronic equipment” or “WEEE” means electrical or electronic equipment which is waste within the meaning of
The purpose of this Directive is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. It also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment, e.g. producers, distributors and consumers and in particular those operators directly involved in the treatment of waste electrical and electronic equipment.
1. This Directive shall apply to electrical and electronic equipment falling under the categories set out in Annex IA provided that the equipment concerned is not part of another type of equipment that does not fall within the scope of this Directive. Annex IB contains a list of products which fall under the categories set out in Annex IA.
2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.
3. Equipment which is connected with the protection of the essential interests of the security of Member States, arms, munitions and war material shall be excluded from this Directive. This does not, however, apply to products which are not intended for specifically military purposes.
Definitions
For the purposes of this Directive, the following definitions shall apply:
(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA and designed for use with a voltage rating not exceeding 1000 Volt for alternating current and 1500 Volt for direct current;
(b) “waste electrical and electronic equipment” or “WEEE” means electrical or electronic equipment which is waste within the meaning of Article 1(a) of Directive 75/442/EEC, including all components, subassemblies and consumables which are part of the product at the time of discarding;
(c) “prevention” means measures aimed at reducing the quantity and the harmfulness to the environment of WEEE and materials and substances contained therein;
(d) “reuse” means any operation by which WEEE or components thereof are used for the same purpose for which they were conceived, including the continued use of the equipment or components thereof which are returned to collection points, distributors, recyclers or manufacturers;
(e) “recycling” means the reprocessing in a production process of the waste materials for the original purpose or for other purposes, but excluding energy recovery which means the use of combustible waste as a means of generating energy through direct incineration with or without other waste but with recovery of the heat;
(f) “recovery” means any of the applicable operations provided for in Annex IIB to Directive 75/442/EEC;
(g) “disposal” means any of the applicable operations provided for in Annex IIA to Directive 75/442/EEC;
(h) “treatment” means any activity after the WEEE has been handed over to a facility for depollution, disassembly, shredding, recovery or preparation for disposal and any other operation carried out for the recovery and/or the disposal of the WEEE;
(i) “producer” means any person who, irrespective of the selling technique used, including by means of distance communication in accordance with Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(12):
(i) manufactures and sells electrical and electronic equipment under his own brand,
(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the “producer” if the brand of the producer appears on the equipment, as provided for in subpoint (i), or
(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.
Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a “producer” unless he also acts as a producer within the meaning of subpoints (i) to (iii);
(j) “distributor” means any person who provides electrical or electronic equipment on a commercial basis to the party who is going to use it;
(k) “WEEE from private households” means WEEE which comes from private households and from commercial, industrial, institutional and other sources which, because of its nature and quantity, is similar to that from private households;
(l) “dangerous substance or preparation” means any substance or preparation which has to be considered dangerous under Council Directive 67/548/EEC(13) or Directive 1999/45/EC of the European Parliament and of the Council(14).
(m) “finance agreement” means any loan, lease, hiring or deferred sale agreement or arrangement relating to any equipment whether or not the terms of that agreement or arrangement or any collateral agreement or arrangement provide that a transfer of ownership of that equipment will or may take place.
Product design
Member States shall encourage the design and production of electrical and electronic equipment which take into account and facilitate dismantling and recovery, in particular the reuse and recycling of WEEE, their components and materials. In this context, Member States shall take appropriate measures so that producers do not prevent, through specific design features or manufacturing processes, WEEE from being reused, unless such specific design features or manufacturing processes present overriding advantages, for example, with regard to the protection of the environment and/or safety requirements.
Separate collection
1. Member States shall adopt appropriate measures in order to minimise the disposal of WEEE as unsorted municipal waste and to achieve a high level of separate collection of WEEE.
2. For WEEE from private households, Member States shall ensure that by the 13 August 2005:
(a) systems are set up allowing final holders and distributors to return such waste at least free of charge. Member States shall ensure the availability and accessibility of the necessary collection facilities, taking into account in particular the population density;
(b) when supplying a new product, distributors shall be responsible for ensuring that such waste can be returned to the distributor at least free of charge on a one-to-one basis as long as the equipment is of equivalent type and has fulfilled the same functions as the supplied equipment. Member States may depart from this provision provided they ensure that returning the WEEE is not thereby made more difficult for the final holder and provided that these systems remain free of charge for the final holder. Member States making use of this provision shall inform the Commission thereof;
(c) without prejudice to the provisions of (a) and (b), producers are allowed to set up and operate individual and/or collective take-back systems for WEEE from private households provided that these are in line with the objectives of this Directive;
(d) having regard to national and Community health and safety standards, WEEE that presents a health and safety risk to personnel because of contamination may be refused for return under (a) and (b). Member States shall make specific arrangements for such WEEE.
Member States may provide for specific arrangements for the return of WEEE as under (a) and (b) if the equipment does not contain the essential components or if the equipment contains waste other than WEEE.
3. In the case of WEEE other than WEEE from private households, and without prejudice to Article 9, Member States shall ensure that producers or third parties acting on their behalf provide for the collection of such waste.
4. Member States shall ensure that all WEEE collected under paragraphs 1, 2 and 3 above is transported to treatment facilities authorised under Article 6 unless the appliances are reused as a whole. Member States shall ensure that the envisaged reuse does not lead to a circumvention of this Directive, in particular as regards Articles 6 and 7. The collection and transport of separately collected WEEE shall be carried out in a way which optimises reuse and recycling of those components or whole appliances capable of being reused or recycled.
5. Without prejudice to paragraph 1, Member States shall ensure that by 31 December 2006 at the latest a rate of separate collection of at least four kilograms on average per inhabitant per year of WEEE from private households is achieved.
The European Parliament and the Council, acting on a proposal from the Commission and taking account of technical and economic experience in the Member States, shall establish a new mandatory target by 31 December 2008. This may take the form of a percentage of the quantities of electrical and electronic equipment sold to private households in the preceding years.
1. Member States shall ensure that producers or third parties acting on their behalf, in accordance with Community legislation, set up systems to provide for the treatment of WEEE using best available treatment, recovery and recycling techniques. The systems may be set up by producers individually and/or collectively. To ensure compliance with Article 4 of Directive 75/442/EEC, the treatment shall, as a minimum, include the removal of all fluids and a selective treatment in accordance with Annex II to this Directive.
Other treatment technologies ensuring at least the same level of protection for human health and the environment may be introduced in Annex II under the procedure referred to in Article 14(2).
For the purposes of environmental protection, Member States may set up minimum quality standards for the treatment of collected WEEE. Member States which opt for such quality standards shall inform the Commission thereof, which shall publish these standards.
2. Member States shall ensure that any establishment or undertaking carrying out treatment operations obtains a permit from the competent authorities, in compliance with Articles 9 and 10 of Directive 75/442/EEC.
The derogation from the permit requirement referred to in Article 11(1)(b) of Directive 75/442/EEC may apply to recovery operations concerning WEEE if an inspection is carried out by the competent authorities before the registration in order to ensure compliance with Article 4 of Directive 75/442/EEC.
The inspection shall verify:
(a) the type and quantities of waste to be treated;
(b) the general technical requirements to be complied with;
(c) the safety precautions to be taken.
The inspection shall be carried out at least once a year and the results shall be communicated by the Member States to the Commission.
3. Member States shall ensure that any establishment or undertaking carrying out treatment operations stores and treats WEEE in compliance with the technical requirements set out in Annex III.
4. Member States shall ensure that the permit or the registration referred to in paragraph 2 includes all conditions necessary for compliance with the requirements of paragraphs 1 and 3 and for the achievement of the recovery targets set out in Article 7.
5. The treatment operation may also be undertaken outside the respective Member State or the Community provided that the shipment of WEEE is in compliance with Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community(15).
WEEE exported out of the Community in line with Council Regulation (EEC) No 259/93, Council Regulation (EC) No 1420/1999(16) of 29 April 1999 establishing common rules and procedures to apply to shipments to certain non-OECD countries of certain types of waste and Commission Regulation (EC) No 1547/1999(17) of 12 July 1999 determining the control procedures under Council Regulation (EEC) No 259/93 to apply to shipments of certain types of waste to certain countries to which OECD Decision C(92)39 final does not apply, shall only count for the fulfilment of obligations and targets of Article 7(1) and (2) of this Directive if the exporter can prove that the recovery, reuse and/or recycling operation took place under conditions that are equivalent to the requirements of this Directive.
6. Member States shall encourage establishments or undertakings which carry out treatment operations to introduce certified environmental management systems in accordance with Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS)(18).
1. Member States shall ensure that producers or third parties acting on their behalf set up systems either on an individual or on a collective basis, in accordance with Community legislation, to provide for the recovery of WEEE collected separately in accordance with Article 5. Member States shall give priority to the reuse of whole appliances. Until the date referred to in paragraph 4, such appliances shall not be taken into account for the calculation of the targets set out in paragraph 2.
2. Regarding WEEE sent for treatment in accordance with Article 6, Member States shall ensure that, by 31 December 2006, producers meet the following targets:
(a) for WEEE falling under categories 1 and 10 of Annex IA,
– the rate of recovery shall be increased to a minimum of 80 % by an average weight per appliance, and
– component, material and substance reuse and recycling shall be increased to a minimum of 75 % by an average weight per appliance;
(b) for WEEE falling under categories 3 and 4 of Annex IA,
– the rate of recovery shall be increased to a minimum of 75 % by an average weight per appliance, and
– component, material and substance reuse and recycling shall be increased to a minimum of 65 % by an average weight per appliance;
(c) for WEEE falling under categories 2, 5, 6, 7 and 9 of Annex IA,
– the rate of recovery shall be increased to a minimum of 70 % by an average weight per appliance, and
– component, material and substance reuse and recycling shall be increased to a minimum of 50 % by an average weight per appliance;
(d) for gas discharge lamps, the rate of component, material and substance reuse and recycling shall reach a minimum of 80 % by weight of the lamps.
3. Member States shall ensure that, for the purpose of calculating these targets, producers or third parties acting on their behalf keep records on the mass of WEEE, their components, materials or substances when entering (input) and leaving (output) the treatment facility and/or when entering (input) the recovery or recycling facility.
The Commission shall, in accordance with the procedure laid down in Article 14(2), establish the detailed rules for monitoring compliance, including specifications for materials, of Member States with the targets set out in paragraph 2. The Commission shall submit this measure by 13 August 2004.
4. The European Parliament and the Council, acting on a proposal from the Commission, shall establish new targets for recovery and reuse/recycling, including for the reuse of whole appliances as appropriate, and for the products falling under category 8 of Annex IA, by 31 December 2008. This shall be done with account being taken of the environmental benefits of electrical and electronic equipment in use, such as improved resource efficiency resulting from developments in the areas of materials and technology. Technical progress in reuse, recovery and recycling, products and materials, and the experience gained by the Member States and the industry, shall also be taken into account.
5. Member States shall encourage the development of new recovery, recycling and treatment technologies.
Financing in respect of WEEE from private households
1. Member States shall ensure that, by 13 August 2005, producers provide at least for the financing of the collection, treatment, recovery and environmentally sound disposal of WEEE from private households deposited at collection facilities, set up under Article 5(2).
2. For products put on the market later than 13 August 2005, each producer shall be responsible for financing the operations referred to in paragraph 1 relating to the waste from his own products. The producer can choose to fulfil this obligation either individually or by joining a collective scheme.
Member States shall ensure that each producer provides a guarantee when placing a product on the market showing that the management of all WEEE will be financed and that producers clearly mark their products in accordance with Article 11(2). This guarantee shall ensure that the operations referred to in paragraph 1 relating to this product will be financed. The guarantee may take the form of participation by the producer in appropriate schemes for the financing of the management of WEEE, a recycling insurance or a blocked bank account.
The costs of collection, treatment and environmentally sound disposal shall not be shown separately to purchasers at the time of sale of new products.
3. The responsibility for the financing of the costs of the management of WEEE from products put on the market before the date referred to in paragraph 1 (historical waste) shall be provided by one or more systems to which all producers, existing on the market when the respective costs occur, contribute proportionately, e.g. in proportion to their respective share of the market by type of equipment.
Member States shall ensure that for a transitional period of eight years (10 years for category 1 of Annex IA) after entry into force of this Directive, producers are allowed to show purchasers, at the time of sale of new products, the costs of collection, treatment and disposal in an environmentally sound way. The costs mentioned shall not exceed the actual costs incurred.
4. Member States shall ensure that producers supplying electrical or electronic equipment by means of distance communication also comply with the requirements set out in this Article for the equipment supplied in the Member State where the purchaser of that equipment resides.
Financing in respect of WEEE from users other than private households
Member States shall ensure that, by 13 August 2005, the financing of the costs for the collection, treatment, recovery and environmentally sound disposal of WEEE from users other than private households from products put on the market after 13 August 2005 is to be provided for by producers.
For WEEE from products put on the market before 13 August 2005 (historical waste), the financing of the costs of management shall be provided for by producers. Member States may, as an alternative, provide that users other than private households also be made, partly or totally, responsible for this financing.
Producers and users other than private households may, without prejudice to this Directive, conclude agreements stipulating other financing methods.
Information for users
1. Member States shall ensure that users of electrical and electronic equipment in private households are given the necessary information about:
(a) the requirement not to dispose of WEEE as unsorted municipal waste and to collect such WEEE separately;
(b) the return and collection systems available to them;
(c) their role in contributing to reuse, recycling and other forms of recovery of WEEE;
(d) the potential effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment;
(e) the meaning of the symbol shown in Annex IV.
2. Member States shall adopt appropriate measures so that consumers participate in the collection of WEEE and to encourage them to facilitate the process of reuse, treatment and recovery.
3. With a view to minimising the disposal of WEEE as unsorted municipal waste and to facilitating its separate collection, Member States shall ensure that producers appropriately mark electrical and electronic equipment put on the market after 13 August 2005 with the symbol shown in Annex IV. In exceptional cases, where this is necessary because of the size or the function of the product, the symbol shall be printed on the packaging, on the instructions for use and on the warranty of the electrical and electronic equipment.
4. Member States may require that some or all of the information referred to in paragraphs 1 to 3 shall be provided by producers and/or distributors, e.g. in the instructions for use or at the point of sale.
Information for treatment facilities
1. In order to facilitate the reuse and the correct and environmentally sound treatment of WEEE, including maintenance, upgrade, refurbishment and recycling, Member States shall take the necessary measures to ensure that producers provide reuse and treatment information for each type of new EEE put on the market within one year after the equipment is put on the market. This information shall identify, as far as it is needed by reuse centres, treatment and recycling facilities in order to comply with the provisions of this Directive, the different EEE components and materials, as well as the location of dangerous substances and preparations in EEE. It shall be made available to reuse centres, treatment and recycling facilities by producers of EEE in the form of manuals or by means of electronic media (e.g. CD-ROM, online services).
2. Member States shall ensure that any producer of an electrical or electronic appliance put on the market after 13 August 2005 is clearly identifiable by a mark on the appliance. Furthermore, in order to enable the date upon which the appliance was put on the market to be determined unequivocally, a mark on the appliance shall specify that the latter was put on the market after 13 August 2005 The Commission shall promote the preparation of European standards for this purpose.
Information and reporting
1. Member States shall draw up a register of producers and collect information, including substantiated estimates, on an annual basis on the quantities and categories of electrical and electronic equipment put on their market, collected through all routes, reused, recycled and recovered within the Member States, and on collected waste exported, by weight or, if this is not possible, by numbers.
Member States shall ensure that producers supplying electrical and electronic equipment by means of distance communication provide information on the compliance with the requirements of Article 8(4) and on the quantities and categories of electrical and electronic equipment put on the market of the Member State where the purchaser of that equipment resides.
Member States shall ensure that the information required is transmitted to the Commission on a two-yearly basis within 18 months after the end of the period covered. The first set of information shall cover the years 2005 and 2006. The information shall be provided in a format which shall be established within one year after the entry into force of this Directive in accordance with the procedure referred to in Article 14(2) with a view to establishing databases on WEEE and its treatment.
Member States shall provide for adequate information exchange in order to comply with this paragraph, in particular for treatment operations as referred to in Article 6(5).
2. Without prejudice to the requirements of paragraph 1, Member States shall send a report to the Commission on the implementation of this Directive at three-year intervals. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(19). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be made available to the Commission within nine months of the end of the three-year period covered by it.
The first three-year report shall cover the period from 2004 to 2006.
The Commission shall publish a report on the implementation of this Directive within nine months after receiving the reports from the Member States.
Adaptation to scientific and technical progress
Any amendments which are necessary in order to adapt Article 7(3), Annex IB, (in particular with a view to possibly adding luminaires in households, filament bulbs and photovoltaic products, i.e. solar panels), Annex II (in particular taking into account new technical developments for the treatment of WEEE), and Annexes III and IV to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 14(2).
Before the Annexes are amended the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators and environmental organisations and employees’ and consumer associations.
1. The Commission shall be assisted by the Committee set up by Article 18 of Directive 75/442/EEC.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.
Inspection and monitoring
Member States shall ensure that inspection and monitoring enable the proper implementation of this Directive to be verified.
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 August 2004. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.
3. Provided that the objectives set out in this Directive are achieved, Member States may transpose the provisions set out in Articles 6(6), 10(1) and 11 by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements:
(a) agreements shall be enforceable;
(b) agreements shall specify objectives with the corresponding deadlines;
(c) agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission;
(d) the results achieved shall be monitored regularly, reported to the competent authorities and the Commission and made available to the public under the conditions set out in the agreement;
(e) the competent authorities shall ensure that the progress reached under the agreement is examined;
(f) in case of non-compliance with the agreement Member States must implement the relevant provisions of this Directive by legislative, regulatory or administrative measures.
4. (a) Greece and Ireland which, because of their overall:
– recycling infrastructure deficit,
– geographical circumstances such as the large number of small islands and the presence of rural and mountain areas,
– low population density, and
– low level of EEE consumption,
are unable to reach either the collection target mentioned in the first subparagraph of Article 5(5) or the recovery targets mentioned in Article 7(2) and which, under the third subparagraph of Article 5(2) of Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(20), may apply for an extension of the deadline mentioned in that Article,
may extend the periods referred to in Articles 5(5) and 7(2) of this Directive by up to 24 months.
These Member States shall inform the Commission of their Decisions at the latest at the time of transposition of this Directive.
(b) The Commission shall inform other Member States and the European Parliament of these decisions.
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 27 January 2003.
For the European Parliament
The President
For the Council
(1) OJ C 365 E, 19.12.2000, p. 184 and OJ C 240 E, 28.8.2001, p. 298.
(2) OJ C 116, 20.4.2001, p. 38.
(3) OJ C 148, 18.5.2001, p. 1.
(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 115), Council Common Position of 4 December 2001 (OJ C 110 E, 7.5.2002, p. 1) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.
(5) OJ C 138, 17.5.1993, p. 5.
(6) OJ C 76, 11.3.1997, p. 1.
(7) OJ C 362, 2.12.1996, p. 241.
(8) OJ L 194, 25.7.1975, p. 47. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).
(9) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).
(10) OJ L 118, 27.4.2001, p. 41.
(11) OJ L 184, 17.7.1999, p. 23.
(12) OJ L 144, 4.6.1997, p. 19.
(13) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).
(14) OJ L 200, 30.7.1999, p. 1. Directive as amended by Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p. 5).
Categories of electrical and electronic equipment covered by this Directive
1. Large household appliances
2. Small household appliances
3. IT and telecommunications equipment
4. Consumer equipment
5. Lighting equipment
6. Electrical and electronic tools (with the exception of large-scale stationary industrial tools)
7. Toys, leisure and sports equipment
8. Medical devices (with the exception of all implanted and infected products)
9. Monitoring and control instruments
10. Automatic dispensers
List of products which shall be taken into account for the purpose of this Directive and which fall under the categories of Annex IA
1. Large household appliances
Large cooling appliances
Refrigerators
Other large appliances used for refrigeration, conservation and storage of food
Washing machines
Clothes dryers
Dish washing machines
Electric stoves
Electric hot plates
Other large appliances used for cooking and other processing of food
Electric heating appliances
Electric radiators
Other large appliances for heating rooms, beds, seating furniture
Electric fans
Air conditioner appliances
Other fanning, exhaust ventilation and conditioning equipment
2. Small household appliances
Vacuum cleaners
Carpet sweepers
Other appliances for cleaning
Appliances used for sewing, knitting, weaving and other processing for textiles
Irons and other appliances for ironing, mangling and other care of clothing
Grinders, coffee machines and equipment for opening or sealing containers or packages
Electric knives
Appliances for hair-cutting, hair drying, tooth brushing, shaving, massage and other body care appliances
Clocks, watches and equipment for the purpose of measuring, indicating or registering time
3. IT and telecommunications equipment
Centralised data processing:
Minicomputers
Printer units
Personal computing:
Personal computers (CPU, mouse, screen and keyboard included)
Laptop computers (CPU, mouse, screen and keyboard included)
Notebook computers
Notepad computers
Copying equipment
Electrical and electronic typewriters
Pocket and desk calculators
and other products and equipment for the collection, storage, processing, presentation or communication of information by electronic means
User terminals and systems
Pay telephones
Cordless telephones
Cellular telephones
Answering systems
and other products or equipment of transmitting sound, images or other information by telecommunications
4. Consumer equipment
Television sets
Videocameras
Video recorders
Selective treatment for materials and components of waste electrical and electronic equipment in accordance with Article 6(1)
1. As a minimum the following substances, preparations and components have to be removed from any separately collected WEEE:
– polychlorinated biphenyls (PCB) containing capacitors in accordance with Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT)(1),
– mercury containing components, such as switches or backlighting lamps,
– batteries,
– printed circuit boards of mobile phones generally, and of other devices if the surface of the printed circuit board is greater than 10 square centimetres,
– toner cartridges, liquid and pasty, as well as colour toner,
– plastic containing brominated flame retardants,
– asbestos waste and components which contain asbestos,
– cathode ray tubes,
– chlorofluorocarbons (CFC), hydrochlorofluorocarbons (HCFC) or hydrofluorocarbons (HFC), hydrocarbons (HC),
– gas discharge lamps,
– liquid crystal displays (together with their casing where appropriate) of a surface greater than 100 square centimetres and all those back-lighted with gas discharge lamps,
– external electric cables,
– components containing refractory ceramic fibres as described in Commission Directive 97/69/EC of 5 December 1997 adapting to technical progress Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances(2),
– components containing radioactive substances with the exception of components that are below the exemption thresholds set in Article 3 of and Annex I to Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(3),
– electrolyte capacitors containing substances of concern (height > 25 mm, diameter > 25 mm or proportionately similar volume)
These substances, preparations and components shall be disposed of or recovered in compliance with Article 4 of Council Directive 75/442/EEC.
2. The following components of WEEE that is separately collected have to be treated as indicated:
– cathode ray tubes: The fluorescent coating has to be removed,
– equipment containing gases that are ozone depleting or have a global warming potential (GWP) above 15, such as those contained in foams and refrigeration circuits: the gases must be properly extracted and properly treated. Ozone-depleting gases must be treated in accordance with Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer(4).
– gas discharge lamps: The mercury shall be removed.
3. Taking into account environmental considerations and the desirability of reuse and recycling, paragraphs 1 and 2 shall be applied in such a way that environmentally-sound reuse and recycling of components or whole appliances is not hindered.
4. Within the procedure referred to in Article 14(2), the Commission shall evaluate as a matter of priority whether the entries regarding:
– printed circuit boards for mobile phones, and
– liquid crystal displays
are to be amended.
(1) OJ L 243, 24.9.1996, p. 31.
(2) OJ L 343, 13.12.1997, p. 19.
(3) OJ L 159, 29.6.1996, p. 1.
(4) OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Regulation (EC) No 2039/2000 (OJ L 244, 29.9.2000, p. 26).
Technical requirements in accordance with Article 6(3)
1. Sites for storage (including temporary storage) of WEEE prior to their treatment (without prejudice to the requirements of Council Directive 1999/31/EC):
– impermeable surfaces for appropriate areas with the provision of spillage collection facilities and, where appropriate, decanters and cleanser-degreasers,
– weatherproof covering for appropriate areas.
2. Sites for treatment of WEEE:
– balances to measure the weight of the treated waste,
– impermeable surfaces and waterproof covering for appropriate areas with the provision of spillage collection facilities and, where appropriate, decanters and cleanser-degreasers,
– appropriate storage for disassembled spare parts,
– appropriate containers for storage of batteries, PCBs/PCTs containing capacitors and other hazardous waste such as radioactive waste,
– equipment for the treatment of water in compliance with health and environmental regulations.
Symbol for the marking of electrical and electronic equipment
The symbol indicating separate collection for electrical and electronic equipment consists of the crossed-out wheeled bin, as shown below. The symbol must be printed visibly, legibly and indelibly.
>PIC FILE= “L_2003037EN.003803.TIF”>
Joint declaration of the European Parliament, the Council and the Commission
relating to

Pending: 32002L0095

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having regard to the opinion of the Committee of Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4),Whereas:(1) The disparities between the laws or administrative measures adopted by the Member States as regards the restriction of the use of hazardous substances in electrical and electronic equipment could create barriers to trade and distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market. It therefore appears necessary to approximate the laws of the Member States in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.(2) The European Council at its meeting in Nice on 7, 8 and 9 December 2000 endorsed the Council Resolution of 4 December 2000 on the precautionary principle.(3) The Commission Communication of 30 July 1996 on the review of the Community strategy for waste management stresses the need to reduce the content of hazardous substances in waste and points out the potential benefits of Community-wide rules limiting the presence of such substances in products and in production processes.(4) The Council Resolution of 25 January 1988 on a Community action programme to combat environmental pollution by cadmium(5) invites the Commission to pursue without delay the development of specific measures for such a programme. Human health also has to be protected and an overall strategy that in particular restricts the use of cadmium and stimulates research into substitutes should therefore be implemented. The Resolution stresses that the use of cadmium should be limited to cases where suitable and safer alternatives do not exist.(5) The available evidence indicates that measures on the collection, treatment, recycling and disposal of waste electrical and electronic equipment (WEEE) as set out in Directive 2002/96/EC of 27 January 2003 of the European Parliament and of the Council on waste electrical and electronic equipment(6) are necessary to reduce the waste management problems linked to the heavy metals concerned and the flame retardants concerned. In spite of those measures, however, significant parts of WEEE will continue to be found in the current disposal routes. Even if WEEE were collected separately and submitted to recycling processes, its content of mercury, cadmium, lead, chromium VI, PBB and PBDE would be likely to pose risks to health or the environment.(6) Taking into account technical and economic feasibility, the most effective way of ensuring the significant reduction of risks to health and the environment relating to those substances which can achieve the chosen level of protection in the Community is the substitution of those substances in electrical and electronic equipment by safe or safer materials. Restricting the use of these hazardous substances is likely to enhance the possibilities and economic profitability of recycling of WEEE and decrease the negative health impact on workers in recycling plants.(7) The substances covered by this Directive are scientifically well researched and evaluated and have been subject to different measures both at Community and at national level.(8) The measures provided for in this Directive take into account existing international guidelines and recommendations and are based on an assessment of available scientific and technical information. The measures are necessary to achieve the chosen level of protection of human and animal health and the environment, having regard to the risks which the absence of measures would be likely to create in the Community. The measures should be kept under review and, if necessary, adjusted to take account of available technical and scientific information.(9) This Directive should apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(7).(10) The technical development of electrical and electronic equipment without heavy metals, PBDE and PBB should be taken into account. As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined.(11) Exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view or if the negative environmental or health impacts caused by substitution are likely to outweigh the human and environmental benefits of the substitution. Substitution of the hazardous substances in electrical and electronic equipment should also be carried out in a way so as to be compatible with the health and safety of users of electrical and electronic equipment (EEE).(12) As product reuse, refurbishment and extension of lifetime are beneficial, spare parts need to be available.(13) The adaptation to scientific and technical progress of the exemptions from the requirements concerning phasing out and prohibition of hazardous substances should be effected by the Commission under a committee procedure.(14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8),HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe purpose of this Directive is to approximate the laws of the Member States on the restrictions of the use of hazardous substances in electrical and electronic equipment and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.Article 2Scope1. Without prejudice to Article 6, this Directive shall apply to electrical and electronic equipment falling under the categories 1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive No 2002/96/EC (WEEE) and to electric light bulbs, and luminaires in households.2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.3. This Directive does not apply to spare parts for the repair, or to the reuse, of electrical and electronic equipment put on the market before 1 July 2006.Article 3DefinitionsFor the purposes of this Directive, the following definitions shall apply:(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE) and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;(b) “producer” means any person who, irrespective of the selling technique used, including by means of distance communication according to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(9):(i) manufactures and sells electrical and electronic equipment under his own brand;(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the “producer” if the brand of the producer appears on the equipment, as provided for in subpoint (i); or(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a “producer” unless he also acts as a producer within the meaning of subpoints (i) to (iii).Article 4Prevention1. Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). National measures restricting or prohibiting the use of these substances in electrical and electronic equipment which were adopted in line with Community legislation before the adoption of this Directive may be maintained until 1 July 2006.2. Paragraph 1 shall not apply to the applications listed in the Annex.3. On the basis of a proposal from the Commission, the European Parliament and the Council shall decide, as soon as scientific evidence is available, and in accordance with the principles on chemicals policy as laid down in the Sixth Community Environment Action Programme, on the prohibition of other hazardous substances and the substitution thereof by more environment-friendly alternatives which ensure at least the same level of protection for consumers.Article 5Adaptation to scientific and technical progress1. Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted in accordance with the procedure referred to in Article 7(2):(a) establishing, as necessary, maximum concentration values up to which the presence of the substances referred to in Article 4(1) in specific materials and components of electrical and electronic equipment shall be tolerated;(b) exempting materials and components of electrical and electronic equipment from Article 4(1) if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to therein is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits thereof;(c) carrying out a review of each exemption in the Annex at least every four years or four years after an item is added to the list with the aim of considering deletion of materials and components of electrical and electronic equipment from the Annex if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is technically or scientifically possible, provided that the negative environmental, health and/or consumer safety impacts caused by substitution do not outweigh the possible environmental, health and/or consumer safety benefits thereof.2. Before the Annex is amended pursuant to paragraph 1, the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. Comments shall be forwarded to the Committee referred to in Article 7(1). The Commission shall provide an account of the information it receives.Article 6ReviewBefore 13 February 2005, the Commission shall review the measures provided for in this Directive to take into account, as necessary, new scientific evidence.In particular the Commission shall, by that date, present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).The Commission shall also study the need to adapt the list of substances of Article 4(1), on the basis of scientific facts and taking the precautionary principle into account, and present proposals to the European Parliament and Council for such adaptations, if appropriate.Particular attention shall be paid during the review to the impact on the environment and on human health of other hazardous substances and materials used in electrical and electronic equipment. The Commission shall examine the feasibility of replacing such substances and materials and shall present proposals to the European Parliament and to the Council in order to extend the scope of Article 4, as appropriate.Article 7Committee1. The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC(10).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 8PenaltiesMember States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.Article 9Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 August 2004. They shall immediately inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.Article 10Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 11AddresseesThis Directive is addressed to the Member States.Done at Brussels, 27 January 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 365 E, 19.12.2000, p. 195 and OJ C 240 E, 28.8.2001, p. 303.(2) OJ C 116, 20.4.2001, p. 38.(3) OJ C 148, 18.5.2001, p. 1.(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 109), Council Common Position of 4 December 2001 (OJ C 90 E, 16.4.2002, p. 12) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.(5) OJ C 30, 4.2.1988, p. 1.(6) See page 24 of this Official Journal.(7) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).(8) OJ L 184, 17.7.1999, p. 23.(9) OJ L 144, 4.6.1997, p. 19. Directive as amended by Directive 2002/65/EC (L 271, 9.10.2002, p. 16).(10) OJ L 194, 25.7.1975, p. 39.ANNEXApplications of lead, mercury, cadmium and hexavalent chromium, which are exempted from the requirements of Article 4(1)1. Mercury in compact fluorescent lamps not exceeding 5 mg per lamp.2. Mercury in straight fluorescent lamps for general purposes not exceeding:>TABLE>.3. Mercury in straight fluorescent lamps for special purposes.4. Mercury in other lamps not specifically mentioned in this Annex.5. Lead in glass of cathode ray tubes, electronic components and fluorescent tubes.6. Lead as an alloying element in steel containing up to 0,35 % lead by weight, aluminium containing up to 0,4 % lead by weight and as a copper alloy containing up to 4 % lead by weight.7. – Lead in high melting temperature type solders (i.e. tin-lead solder alloys containing more than 85 % lead),- lead in solders for servers, storage and storage array systems (exemption granted until 2010),- lead in solders for network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunication,- lead in electronic ceramic parts (e.g. piezoelectronic devices).8. Cadmium plating except for applications banned under Directive 91/338/EEC(1) amending Directive 76/769/EEC(2) relating to restrictions on the marketing and use of certain dangerous substances and preparations.9. Hexavalent chromium as an anti-corrosion of the carbon steel cooling system in absorption refrigerators.10. Within the procedure referred to in Article 7(2), the Commission shall evaluate the applications for:- Deca BDE,- mercury in straight fluorescent lamps for special purposes,- lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunications (with a view to setting a specific time limit for this exemption), and- light bulbs,as a matter of priority in order to establish as soon as possible whether these items are to be amended accordingly.(1) OJ L 186, 12.7.1991, p. 59.(2) OJ L 262, 27.9.1976, p. 201.

Article 1
The purpose of this Directive is to approximate the laws of the Member States on the restrictions of the use of hazardous substances in electrical and electronic equipment and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.

Article 2
1. Without prejudice to Article 6, this Directive shall apply to electrical and electronic equipment falling under the categories 1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive No 2002/96/EC (WEEE) and to electric light bulbs, and luminaires in households.
2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.
3. This Directive does not apply to spare parts for the repair, or to the reuse, of electrical and electronic equipment put on the market before 1 July 2006.

Article 3
Definitions
For the purposes of this Directive, the following definitions shall apply:
(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE) and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;
(b) “producer” means any person who, irrespective of the selling technique used, including by means of distance communication according to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(9):
(i) manufactures and sells electrical and electronic equipment under his own brand;
(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the “producer” if the brand of the producer appears on the equipment, as provided for in subpoint (i); or
(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.
Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a “producer” unless he also acts as a producer within the meaning of subpoints (i) to (iii).

Article 4
1. Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). National measures restricting or prohibiting the use of these substances in electrical and electronic equipment which were adopted in line with Community legislation before the adoption of this Directive may be maintained until 1 July 2006.
2. Paragraph 1 shall not apply to the applications listed in the Annex.
3. On the basis of a proposal from the Commission, the European Parliament and the Council shall decide, as soon as scientific evidence is available, and in accordance with the principles on chemicals policy as laid down in the Sixth Community Environment Action Programme, on the prohibition of other hazardous substances and the substitution thereof by more environment-friendly alternatives which ensure at least the same level of protection for consumers.

Article 5
Adaptation to scientific and technical progress
1. Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted in accordance with the procedure referred to in Article 7(2):
(a) establishing, as necessary, maximum concentration values up to which the presence of the substances referred to in Article 4(1) in specific materials and components of electrical and electronic equipment shall be tolerated;
(b) exempting materials and components of electrical and electronic equipment from Article 4(1) if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to therein is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits thereof;
(c) carrying out a review of each exemption in the Annex at least every four years or four years after an item is added to the list with the aim of considering deletion of materials and components of electrical and electronic equipment from the Annex if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is technically or scientifically possible, provided that the negative environmental, health and/or consumer safety impacts caused by substitution do not outweigh the possible environmental, health and/or consumer safety benefits thereof.
2. Before the Annex is amended pursuant to paragraph 1, the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. Comments shall be forwarded to the Committee referred to in Article 7(1). The Commission shall provide an account of the information it receives.

Article 6
Before 13 February 2005, the Commission shall review the measures provided for in this Directive to take into account, as necessary, new scientific evidence.
In particular the Commission shall, by that date, present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).
The Commission shall also study the need to adapt the list of substances of Article 4(1), on the basis of scientific facts and taking the precautionary principle into account, and present proposals to the European Parliament and Council for such adaptations, if appropriate.
Particular attention shall be paid during the review to the impact on the environment and on human health of other hazardous substances and materials used in electrical and electronic equipment. The Commission shall examine the feasibility of replacing such substances and materials and shall present proposals to the European Parliament and to the Council in order to extend the scope of Article 4, as appropriate.

Article 7
1. The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC(10).
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.
The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.

Article 8
Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.

Article 9
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 August 2004. They shall immediately inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.

Article 10
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 11
This Directive is addressed to the Member States.
Done at Brussels, 27 January 2003.
For the European Parliament
The President
For the Council
(1) OJ C 365 E, 19.12.2000, p. 195 and OJ C 240 E, 28.8.2001, p. 303.
(2) OJ C 116, 20.4.2001, p. 38.
(3) OJ C 148, 18.5.2001, p. 1.
(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 109), Council Common Position of 4 December 2001 (OJ C 90 E, 16.4.2002, p. 12) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.
(5) OJ C 30, 4.2.1988, p. 1.
(6) See page 24 of this Official Journal.
(7) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).
(8) OJ L 184, 17.7.1999, p. 23.
(9) OJ L 144, 4.6.1997, p. 19. Directive as amended by Directive 2002/65/EC (L 271, 9.10.2002, p. 16).
(10) OJ L 194, 25.7.1975, p. 39.

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having regard to the opinion of the Committee of Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4),Whereas:(1) The disparities between the laws or administrative measures adopted by the Member States as regards the restriction of the use of hazardous substances in electrical and electronic equipment could create barriers to trade and distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market. It therefore appears necessary to approximate the laws of the Member States in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.(2) The European Council at its meeting in Nice on 7, 8 and 9 December 2000 endorsed the Council Resolution of 4 December 2000 on the precautionary principle.(3) The Commission Communication of 30 July 1996 on the review of the Community strategy for waste management stresses the need to reduce the content of hazardous substances in waste and points out the potential benefits of Community-wide rules limiting the presence of such substances in products and in production processes.(4) The Council Resolution of 25 January 1988 on a Community action programme to combat environmental pollution by cadmium(5) invites the Commission to pursue without delay the development of specific measures for such a programme. Human health also has to be protected and an overall strategy that in particular restricts the use of cadmium and stimulates research into substitutes should therefore be implemented. The Resolution stresses that the use of cadmium should be limited to cases where suitable and safer alternatives do not exist.(5) The available evidence indicates that measures on the collection, treatment, recycling and disposal of waste electrical and electronic equipment (WEEE) as set out in Directive 2002/96/EC of 27 January 2003 of the European Parliament and of the Council on waste electrical and electronic equipment(6) are necessary to reduce the waste management problems linked to the heavy metals concerned and the flame retardants concerned. In spite of those measures, however, significant parts of WEEE will continue to be found in the current disposal routes. Even if WEEE were collected separately and submitted to recycling processes, its content of mercury, cadmium, lead, chromium VI, PBB and PBDE would be likely to pose risks to health or the environment.(6) Taking into account technical and economic feasibility, the most effective way of ensuring the significant reduction of risks to health and the environment relating to those substances which can achieve the chosen level of protection in the Community is the substitution of those substances in electrical and electronic equipment by safe or safer materials. Restricting the use of these hazardous substances is likely to enhance the possibilities and economic profitability of recycling of WEEE and decrease the negative health impact on workers in recycling plants.(7) The substances covered by this Directive are scientifically well researched and evaluated and have been subject to different measures both at Community and at national level.(8) The measures provided for in this Directive take into account existing international guidelines and recommendations and are based on an assessment of available scientific and technical information. The measures are necessary to achieve the chosen level of protection of human and animal health and the environment, having regard to the risks which the absence of measures would be likely to create in the Community. The measures should be kept under review and, if necessary, adjusted to take account of available technical and scientific information.(9) This Directive should apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(7).(10) The technical development of electrical and electronic equipment without heavy metals, PBDE and PBB should be taken into account. As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined.(11) Exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view or if the negative environmental or health impacts caused by substitution are likely to outweigh the human and environmental benefits of the substitution. Substitution of the hazardous substances in electrical and electronic equipment should also be carried out in a way so as to be compatible with the health and safety of users of electrical and electronic equipment (EEE).(12) As product reuse, refurbishment and extension of lifetime are beneficial, spare parts need to be available.(13) The adaptation to scientific and technical progress of the exemptions from the requirements concerning phasing out and prohibition of hazardous substances should be effected by the Commission under a committee procedure.(14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8),HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe purpose of this Directive is to approximate the laws of the Member States on the restrictions of the use of hazardous substances in electrical and electronic equipment and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.Article 2Scope1. Without prejudice to Article 6, this Directive shall apply to electrical and electronic equipment falling under the categories 1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive No 2002/96/EC (WEEE) and to electric light bulbs, and luminaires in households.2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.3. This Directive does not apply to spare parts for the repair, or to the reuse, of electrical and electronic equipment put on the market before 1 July 2006.Article 3DefinitionsFor the purposes of this Directive, the following definitions shall apply:(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE) and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;(b) “producer” means any person who, irrespective of the selling technique used, including by means of distance communication according to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(9):(i) manufactures and sells electrical and electronic equipment under his own brand;(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the “producer” if the brand of the producer appears on the equipment, as provided for in subpoint (i); or(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a “producer” unless he also acts as a producer within the meaning of subpoints (i) to (iii).Article 4Prevention1. Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). National measures restricting or prohibiting the use of these substances in electrical and electronic equipment which were adopted in line with Community legislation before the adoption of this Directive may be maintained until 1 July 2006.2. Paragraph 1 shall not apply to the applications listed in the Annex.3. On the basis of a proposal from the Commission, the European Parliament and the Council shall decide, as soon as scientific evidence is available, and in accordance with the principles on chemicals policy as laid down in the Sixth Community Environment Action Programme, on the prohibition of other hazardous substances and the substitution thereof by more environment-friendly alternatives which ensure at least the same level of protection for consumers.Article 5Adaptation to scientific and technical progress1. Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted in accordance with the procedure referred to in Article 7(2):(a) establishing, as necessary, maximum concentration values up to which the presence of the substances referred to in Article 4(1) in specific materials and components of electrical and electronic equipment shall be tolerated;(b) exempting materials and components of electrical and electronic equipment from Article 4(1) if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to therein is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits thereof;(c) carrying out a review of each exemption in the Annex at least every four years or four years after an item is added to the list with the aim of considering deletion of materials and components of electrical and electronic equipment from the Annex if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is technically or scientifically possible, provided that the negative environmental, health and/or consumer safety impacts caused by substitution do not outweigh the possible environmental, health and/or consumer safety benefits thereof.2. Before the Annex is amended pursuant to paragraph 1, the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. Comments shall be forwarded to the Committee referred to in Article 7(1). The Commission shall provide an account of the information it receives.Article 6ReviewBefore 13 February 2005, the Commission shall review the measures provided for in this Directive to take into account, as necessary, new scientific evidence.In particular the Commission shall, by that date, present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).The Commission shall also study the need to adapt the list of substances of Article 4(1), on the basis of scientific facts and taking the precautionary principle into account, and present proposals to the European Parliament and Council for such adaptations, if appropriate.Particular attention shall be paid during the review to the impact on the environment and on human health of other hazardous substances and materials used in electrical and electronic equipment. The Commission shall examine the feasibility of replacing such substances and materials and shall present proposals to the European Parliament and to the Council in order to extend the scope of Article 4, as appropriate.Article 7Committee1. The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC(10).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 8PenaltiesMember States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.Article 9Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 August 2004. They shall immediately inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.Article 10Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 11AddresseesThis Directive is addressed to the Member States.Done at Brussels, 27 January 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 365 E, 19.12.2000, p. 195 and OJ C 240 E, 28.8.2001, p. 303.(2) OJ C 116, 20.4.2001, p. 38.(3) OJ C 148, 18.5.2001, p. 1.(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 109), Council Common Position of 4 December 2001 (OJ C 90 E, 16.4.2002, p. 12) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.(5) OJ C 30, 4.2.1988, p. 1.(6) See page 24 of this Official Journal.(7) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).(8) OJ L 184, 17.7.1999, p. 23.(9) OJ L 144, 4.6.1997, p. 19. Directive as amended by Directive 2002/65/EC (L 271, 9.10.2002, p. 16).(10) OJ L 194, 25.7.1975, p. 39.ANNEXApplications of lead, mercury, cadmium and hexavalent chromium, which are exempted from the requirements of Article 4(1)1. Mercury in compact fluorescent lamps not exceeding 5 mg per lamp.2. Mercury in straight fluorescent lamps for general purposes not exceeding:>TABLE>.3. Mercury in straight fluorescent lamps for special purposes.4. Mercury in other lamps not specifically mentioned in this Annex.5. Lead in glass of cathode ray tubes, electronic components and fluorescent tubes.6. Lead as an alloying element in steel containing up to 0,35 % lead by weight, aluminium containing up to 0,4 % lead by weight and as a copper alloy containing up to 4 % lead by weight.7. – Lead in high melting temperature type solders (i.e. tin-lead solder alloys containing more than 85 % lead),- lead in solders for servers, storage and storage array systems (exemption granted until 2010),- lead in solders for network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunication,- lead in electronic ceramic parts (e.g. piezoelectronic devices).8. Cadmium plating except for applications banned under Directive 91/338/EEC(1) amending Directive 76/769/EEC(2) relating to restrictions on the marketing and use of certain dangerous substances and preparations.9. Hexavalent chromium as an anti-corrosion of the carbon steel cooling system in absorption refrigerators.10. Within the procedure referred to in Article 7(2), the Commission shall evaluate the applications for:- Deca BDE,- mercury in straight fluorescent lamps for special purposes,- lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunications (with a view to setting a specific time limit for this exemption), and- light bulbs,as a matter of priority in order to establish as soon as possible whether these items are to be amended accordingly.(1) OJ L 186, 12.7.1991, p. 59.(2) OJ L 262, 27.9.1976, p. 201.
The purpose of this Directive is to approximate the laws of the Member States on the restrictions of the use of hazardous substances in electrical and electronic equipment and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.
1. Without prejudice to Article 6, this Directive shall apply to electrical and electronic equipment falling under the categories 1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive No 2002/96/EC (WEEE) and to electric light bulbs, and luminaires in households.
2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.
3. This Directive does not apply to spare parts for the repair, or to the reuse, of electrical and electronic equipment put on the market before 1 July 2006.
Definitions
For the purposes of this Directive, the following definitions shall apply:
(a) “electrical and electronic equipment” or “EEE” means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE) and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;
(b) “producer” means any person who, irrespective of the selling technique used, including by means of distance communication according to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(9):
(i) manufactures and sells electrical and electronic equipment under his own brand;
(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the “producer” if the brand of the producer appears on the equipment, as provided for in subpoint (i); or
(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.
Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a “producer” unless he also acts as a producer within the meaning of subpoints (i) to (iii).
1. Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). National measures restricting or prohibiting the use of these substances in electrical and electronic equipment which were adopted in line with Community legislation before the adoption of this Directive may be maintained until 1 July 2006.
2. Paragraph 1 shall not apply to the applications listed in the Annex.
3. On the basis of a proposal from the Commission, the European Parliament and the Council shall decide, as soon as scientific evidence is available, and in accordance with the principles on chemicals policy as laid down in the Sixth Community Environment Action Programme, on the prohibition of other hazardous substances and the substitution thereof by more environment-friendly alternatives which ensure at least the same level of protection for consumers.
Adaptation to scientific and technical progress
1. Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted in accordance with the procedure referred to in Article 7(2):
(a) establishing, as necessary, maximum concentration values up to which the presence of the substances referred to in Article 4(1) in specific materials and components of electrical and electronic equipment shall be tolerated;
(b) exempting materials and components of electrical and electronic equipment from Article 4(1) if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to therein is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits thereof;
(c) carrying out a review of each exemption in the Annex at least every four years or four years after an item is added to the list with the aim of considering deletion of materials and components of electrical and electronic equipment from the Annex if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is technically or scientifically possible, provided that the negative environmental, health and/or consumer safety impacts caused by substitution do not outweigh the possible environmental, health and/or consumer safety benefits thereof.
2. Before the Annex is amended pursuant to paragraph 1, the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. Comments shall be forwarded to the Committee referred to in Article 7(1). The Commission shall provide an account of the information it receives.
Before 13 February 2005, the Commission shall review the measures provided for in this Directive to take into account, as necessary, new scientific evidence.
In particular the Commission shall, by that date, present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).
The Commission shall also study the need to adapt the list of substances of Article 4(1), on the basis of scientific facts and taking the precautionary principle into account, and present proposals to the European Parliament and Council for such adaptations, if appropriate.
Particular attention shall be paid during the review to the impact on the environment and on human health of other hazardous substances and materials used in electrical and electronic equipment. The Commission shall examine the feasibility of replacing such substances and materials and shall present proposals to the European Parliament and to the Council in order to extend the scope of Article 4, as appropriate.
1. The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC(10).
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.
The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 August 2004. They shall immediately inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 27 January 2003.
For the European Parliament
The President
For the Council
(1) OJ C 365 E, 19.12.2000, p. 195 and OJ C 240 E, 28.8.2001, p. 303.
(2) OJ C 116, 20.4.2001, p. 38.
(3) OJ C 148, 18.5.2001, p. 1.
(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 109), Council Common Position of 4 December 2001 (OJ C 90 E, 16.4.2002, p. 12) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.
(5) OJ C 30, 4.2.1988, p. 1.
(6) See page 24 of this Official Journal.
(7) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).
(8) OJ L 184, 17.7.1999, p. 23.
(9) OJ L 144, 4.6.1997, p. 19. Directive as amended by Directive 2002/65/EC (L 271, 9.10.2002, p. 16).
(10) OJ L 194, 25.7.1975, p. 39.
Applications of lead, mercury, cadmium and hexavalent chromium, which are exempted from the requirements of Article 4(1)
1. Mercury in compact fluorescent lamps not exceeding 5 mg per lamp.
2. Mercury in straight fluorescent lamps for general purposes not exceeding:
3. Mercury in straight fluorescent lamps for special purposes.
4. Mercury in other lamps not specifically mentioned in this Annex.
5. Lead in glass of cathode ray tubes, electronic components and fluorescent tubes.
6. Lead as an alloying element in steel containing up to 0,35 % lead by weight, aluminium containing up to 0,4 % lead by weight and as a copper alloy containing up to 4 % lead by weight.
7. – Lead in high melting temperature type solders (i.e. tin-lead solder alloys containing more than 85 % lead),
– lead in solders for servers, storage and storage array systems (exemption granted until 2010),
– lead in solders for network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunication,
– lead in electronic ceramic parts (e.g. piezoelectronic devices).
8. Cadmium plating except for applications banned under Directive 91/338/EEC(1) amending Directive 76/769/EEC(2) relating to restrictions on the marketing and use of certain dangerous substances and preparations.
9. Hexavalent chromium as an anti-corrosion of the carbon steel cooling system in absorption refrigerators.
10. Within the procedure referred to in Article 7(2), the Commission shall evaluate the applications for:
– Deca BDE,
– mercury in straight fluorescent lamps for special purposes,
– lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunications (with a view to setting a specific time limit for this exemption), and
– light bulbs,
as a matter of priority in order to establish as soon as possible whether these items are to be amended accordingly.
(1) OJ L 186, 12.7.1991, p. 59.
(2) OJ L 262, 27.9.1976, p. 201.

Pending: 32002L0086

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1), as amended by Commission Directive 2001/101/EC(2), and in particular the first indent of the second subparagraph of Article 6(6) thereof,Whereas:(1) The provisions of Directive 2001/101/EC concerning the labelling of products containing meat are not applicable until the day following the final deadline for transposition of that Directive by the Member States.(2) Following the adoption of a definition of the term “meat” for labelling purposes, the operators concerned will have to make considerable changes to the labelling of their products, in particular in respect of the list of ingredients and, where applicable, the meat content.(3) Because of the large number of such products on the market and the number of small and medium-sized enterprises affected, an adequate transitional period is needed to enable the labelling of these products to be brought into line with Directive 2001/101/EC.(4) Provision must also be made to enable operators to sell on the market products labelled prior to expiry of the transitional period whose labelling does not comply with the abovementioned provisions.(5) Directive 2001/101/EC should therefore be amended accordingly.(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

Article 2
of Directive 2001/101/EC is replaced by the following: “Article 2
1. Member States shall authorise trade in products that are in conformity with Directive 2000/13/EC from 1 January 2003.
2. Member States shall prohibit, with effect from 1 July 2003, trade in products which are not in conformity with Directive 2000/13/EC.
However, products which are not in conformity with Directive 2000/13/EC and which were labelled before 1 July 2003 shall be authorised while stocks last.”

Article 3
This Directive is addressed to the Member States.
Done at Brussels, 6 November 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 310, 28.11.2001, p. 19.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1), as amended by Commission Directive 2001/101/EC(2), and in particular the first indent of the second subparagraph of Article 6(6) thereof,Whereas:(1) The provisions of Directive 2001/101/EC concerning the labelling of products containing meat are not applicable until the day following the final deadline for transposition of that Directive by the Member States.(2) Following the adoption of a definition of the term “meat” for labelling purposes, the operators concerned will have to make considerable changes to the labelling of their products, in particular in respect of the list of ingredients and, where applicable, the meat content.(3) Because of the large number of such products on the market and the number of small and medium-sized enterprises affected, an adequate transitional period is needed to enable the labelling of these products to be brought into line with Directive 2001/101/EC.(4) Provision must also be made to enable operators to sell on the market products labelled prior to expiry of the transitional period whose labelling does not comply with the abovementioned provisions.(5) Directive 2001/101/EC should therefore be amended accordingly.(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
of Directive 2001/101/EC is replaced by the following: “Article 2
1. Member States shall authorise trade in products that are in conformity with Directive 2000/13/EC from 1 January 2003.
2. Member States shall prohibit, with effect from 1 July 2003, trade in products which are not in conformity with Directive 2000/13/EC.
However, products which are not in conformity with Directive 2000/13/EC and which were labelled before 1 July 2003 shall be authorised while stocks last.”
This Directive is addressed to the Member States.
Done at Brussels, 6 November 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 310, 28.11.2001, p. 19.