Council Implementing Decision (CFSP) 2025/1349 of 8 July 2025 implementing Decision (CFSP) 2015/740 concerning restrictive measures in view of the situation in South Sudan

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1349
9.7.2025

(1)
On 7 May 2015, the Council adopted Decision (CFSP) 2015/740.

(2)
In accordance with Article 12(2) of Decision (CFSP) 2015/740, the Council has reviewed the list of persons subject to restrictive measures set out in Annex II to that Decision.

(3)
The Council has concluded that restrictive measures against one person listed in Annex II to Decision (CFSP) 2015/740 should be maintained and that the entry for that person should be updated.

(4)
Decision (CFSP) 2015/740 should therefore be amended accordingly,

Name
Identifying information
Statement of Reasons
Date of listing

‘1.
Michael MAKUEI LUETH
DOB: 1947POB: Bor, South Sudan; Bor, SudanGender: male
Michael Makuei Lueth has held the position of Minister for Information and Broadcasting since 2013 and continues to hold that position in the Revitalised Transitional Government of National Unity in South Sudan. He was also the public spokesman for the government delegation to the Intergovernmental Authority on Development peace talks from 2014 to 2015 and from 2016 to 2018.Michael Makuei Lueth has obstructed, in particular through inflammatory public statements, the implementation of the Agreement on the Resolution of the Conflict in South Sudan (ARCSS) of August 2015 (replaced in September 2018 by the “Revitalised ARCSS” (R-ARCSS)), the work of the ARCSS Joint Monitoring and Evaluation Commission (JMEC, renamed “Reconstituted JMEC” under R-ARCSS), the establishment of the ARCSS Transitional Justice Institutions (also provided for in R-ARCSS), and the operations of the United Nations’ Regional Protection Force.In addition, Michael Makuei Lueth is involved in the systematic curtailment of political and democratic space and in the repression of media, including through regular threats against journalists and support to media censorship, which hinders democratisation and sustainable peace in South Sudan.Since the beginning of 2025, Michael Makuei Lueth has publicly dismissed calls for dialogue, using confrontational and inflammatory rhetoric in an increasingly tense environment. Michael Makuei Lueth has also defended the arrests against First Vice-President Riek Machar and his allies, hampering efforts to deescalate the situation.Therefore, Michael Makuei Lueth has been obstructing the political process in South Sudan and is responsible for serious violations of human rights, in particular freedom of expression.
3.2.2018’

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 31(2) thereof,

Having regard to Council Decision (CFSP) 2015/740 of 7 May 2015 concerning restrictive measures in view of the situation in South Sudan and repealing Decision 2014/449/CFSP (1), and in particular Article 9(2) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1) On 7 May 2015, the Council adopted Decision (CFSP) 2015/740.

(2) In accordance with Article 12(2) of Decision (CFSP) 2015/740, the Council has reviewed the list of persons subject to restrictive measures set out in Annex II to that Decision.

(3) The Council has concluded that restrictive measures against one person listed in Annex II to Decision (CFSP) 2015/740 should be maintained and that the entry for that person should be updated.

(4) Decision (CFSP) 2015/740 should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:
Annex II to Decision (CFSP) 2015/740 is amended in accordance with the Annex to this Decision.
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
In Annex II to Decision (CFSP) 2015/740, entry No 1 is replaced by the following:

Name

Identifying information

Statement of Reasons

Date of listing

‘1. Michael MAKUEI LUETH

DOB: 1947

POB: Bor, South Sudan; Bor, Sudan

Gender: male

Michael Makuei Lueth has held the position of Minister for Information and Broadcasting since 2013 and continues to hold that position in the Revitalised Transitional Government of National Unity in South Sudan. He was also the public spokesman for the government delegation to the Intergovernmental Authority on Development peace talks from 2014 to 2015 and from 2016 to 2018. Michael Makuei Lueth has obstructed, in particular through inflammatory public statements, the implementation of the Agreement on the Resolution of the Conflict in South Sudan (ARCSS) of August 2015 (replaced in September 2018 by the “Revitalised ARCSS” (R-ARCSS)), the work of the ARCSS Joint Monitoring and Evaluation Commission (JMEC, renamed “Reconstituted JMEC” under R-ARCSS), the establishment of the ARCSS Transitional Justice Institutions (also provided for in R-ARCSS), and the operations of the United Nations’ Regional Protection Force.

In addition, Michael Makuei Lueth is involved in the systematic curtailment of political and democratic space and in the repression of media, including through regular threats against journalists and support to media censorship, which hinders democratisation and sustainable peace in South Sudan.

Since the beginning of 2025, Michael Makuei Lueth has publicly dismissed calls for dialogue, using confrontational and inflammatory rhetoric in an increasingly tense environment. Michael Makuei Lueth has also defended the arrests against First Vice-President Riek Machar and his allies, hampering efforts to deescalate the situation.

Therefore, Michael Makuei Lueth has been obstructing the political process in South Sudan and is responsible for serious violations of human rights, in particular freedom of expression.

3.2.2018’

Council Decision (EU) 2025/1348 of 27 January 2025 on the signing, on behalf of the Union, and provisional application of the Agreement between the European Union and Bosnia and Herzegovina on operational activities carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1348
11.7.2025

(1)
On 18 November 2022, the Council authorised the Commission to open negotiations with Bosnia and Herzegovina for an agreement on operational activities carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina (the ‘Agreement’). The negotiations were successfully concluded.

(2)
Pursuant to Article 73(3) of Regulation (EU) 2019/1896 of the European Parliament and of the Council(1), in circumstances requiring the deployment of border management teams from the standing corps of the European Border and Coast Guard to a third country where the members of the teams will exercise executive powers, a status agreement is to be concluded by the Union with the third country concerned on the basis of Article 218 of the Treaty on the Functioning of the European Union.

(3)
This Decision constitutes a development of the provisions of the Schengenacquisin which Ireland does not take part, in accordance with Council Decision 2002/192/EC(2); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(4)
In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengenacquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law.

(5)
The Agreement should be signed and the attached Declaration with regard to Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein be approved, on behalf of the Union.

(6)
With a view to ensuring the possibility of an urgent deployment of the European Border and Coast Guard standing corps on the territory of Bosnia and Herzegovina, the Agreement should be provisionally applied,

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2), points (b) and (d), and Article 79(2), point (c), in conjunction with Article 218(5) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) On 18 November 2022, the Council authorised the Commission to open negotiations with Bosnia and Herzegovina for an agreement on operational activities carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina (the ‘Agreement’). The negotiations were successfully concluded.

(2) Pursuant to Article 73(3) of Regulation (EU) 2019/1896 of the European Parliament and of the Council (1), in circumstances requiring the deployment of border management teams from the standing corps of the European Border and Coast Guard to a third country where the members of the teams will exercise executive powers, a status agreement is to be concluded by the Union with the third country concerned on the basis of Article 218 of the Treaty on the Functioning of the European Union.

(3) This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (2); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(4) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law.

(5) The Agreement should be signed and the attached Declaration with regard to Iceland, the Kingdom of Norway, the Swiss Confederation and the Principality of Liechtenstein be approved, on behalf of the Union.

(6) With a view to ensuring the possibility of an urgent deployment of the European Border and Coast Guard standing corps on the territory of Bosnia and Herzegovina, the Agreement should be provisionally applied,

HAS ADOPTED THIS DECISION:
The signing of the Agreement between the European Union and Bosnia and Herzegovina on operational activities carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina (the ‘Agreement’) is hereby authorised on behalf of the Union, subject to the conclusion of the said Agreement.
The Declaration attached to this Decision shall be approved on behalf of the Union.
The Agreement shall be applied provisionally, in accordance with Article 22(3) of the Agreement, as from the date of its signature, pending its entry into force.
This Decision shall enter into force on the date of its adoption.

Council Decision (CFSP) 2025/1341 of 8 July 2025 amending Decision (CFSP) 2016/610 on a European Union CSDP Military Training Mission in the Central African Republic (EUTM RCA)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1341
9.7.2025

(1)
On 19 April 2016, the Council adopted Decision (CFSP) 2016/610(1), which established a European Union CSDP Military Training Mission in the Central African Republic (EUTM RCA) with a mandate until 19 September 2018.

(2)
On 6 September 2024, the Council adopted Decision (CFSP) 2024/2396(2)which extended EUTM RCA until 19 September 2025.

(3)
On 30 April 2025, in the context of the Strategic Review of EUTM RCA, the Political and Security Committee agreed that the mandate of EUTM RCA should be extended until 19 September 2026 and that a Strategic Review in early 2026 should present options for the future of the Mission.

(4)
Decision (CFSP) 2016/610 should be amended accordingly,

(1)
In Article 10, the following paragraph is added:‘8.   The financial reference amount for the common costs of EUTM RCA for the period from 20 September 2025 until 19 September 2026 shall be EUR 11 400 000. The percentage of the reference amount referred to in Article 51(2) of Decision (CFSP) 2021/509 shall be 0 % in commitments and 0 % for payments.’;

(2)
in Article 13, paragraph 2 is replaced by the following:‘2.   Subject to a Strategic Review to be conducted in early 2026, the mandate of EUTM RCA shall end on 19 September 2026.’.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 42(4) and Article 43(2) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1) On 19 April 2016, the Council adopted Decision (CFSP) 2016/610 (1), which established a European Union CSDP Military Training Mission in the Central African Republic (EUTM RCA) with a mandate until 19 September 2018.

(2) On 6 September 2024, the Council adopted Decision (CFSP) 2024/2396 (2) which extended EUTM RCA until 19 September 2025.

(3) On 30 April 2025, in the context of the Strategic Review of EUTM RCA, the Political and Security Committee agreed that the mandate of EUTM RCA should be extended until 19 September 2026 and that a Strategic Review in early 2026 should present options for the future of the Mission.

(4) Decision (CFSP) 2016/610 should be amended accordingly,

HAS ADOPTED THIS DECISION:
Decision (CFSP) 2016/610 is amended as follows:
(1) In Article 10, the following paragraph is added:

‘8.   The financial reference amount for the common costs of EUTM RCA for the period from 20 September 2025 until 19 September 2026 shall be EUR 11 400 000. The percentage of the reference amount referred to in Article 51(2) of Decision (CFSP) 2021/509 shall be 0 % in commitments and 0 % for payments.’

;

(2) in Article 13, paragraph 2 is replaced by the following:

‘2.   Subject to a Strategic Review to be conducted in early 2026, the mandate of EUTM RCA shall end on 19 September 2026.’.
This Decision shall enter into force on the date of its adoption.

Council Decision (CFSP) 2025/1340 of 8 July 2025 on an assistance measure under the European Peace Facility to support the Armed Forces of Cabo Verde

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1340
9.7.2025

(1)
Council Decision (CFSP) 2021/509(1)establishes the European Peace Facility (EPF) for the financing by Member States of Union actions under the common foreign and security policy to preserve peace, prevent conflicts and strengthen international security pursuant to Article 21(2), point (c), of the Treaty. In particular, pursuant to Article 1(2) of Decision (CFSP) 2021/509, the EPF is to be used for the financing of assistance measures such as actions to strengthen the capacities of third States and regional and international organisations relating to military and defence matters.

(2)
The seas off West Africa continue to be a challenging environment in which piracy, armed robbery at sea, the kidnapping of seafarers, illegal, unreported, and unregulated (IUU) fishing, smuggling and trafficking of drugs and arms, as well as transnational organised crime pose a major and increasing threat to maritime security. This affects freedom of navigation, endangers major trade routes, jeopardises the sustainable development of the entire region and the economic livelihood of the population, and leads to the deterioration of the environment and biodiversity.

(3)
Cabo Verde remains particularly exposed to various threats, including maritime piracy, terrorism, drug trafficking, human trafficking, cybercrime and IUU fishing due to its vast Exclusive Economic Zone and its geostrategic location at the crossroads of the Atlantic, connecting Africa to Europe and the Americas. Strengthening the Armed Forces of Cabo Verde is an important element to enable and support maritime security efforts in Cabo Verde and within the Atlantic and Gulf of Guinea regions.

(4)
During the Thirteenth Ministerial Meeting under the European Union – Cabo Verde Special Partnership, held in Brussels on 31 January 2025, both partners reaffirmed their engagement to strengthen their mutual cooperation under the security and stability pillar, with the aim to define an intensified concept for security, in line with the Union’s Integrated Approach.

(5)
On 10 March 2025, the High Representative of the Union for Foreign Affairs and Security Policy received a request from Cabo Verde for the Union to assist the Armed Forces of Cabo Verde with the procurement of key equipment and services, to strengthen the capabilities of the Cabo Verde Coast Guard.

(6)
Assistance measures are to be implemented taking into account the principles and requirements set out in Decision (CFSP) 2021/509, in particular compliance with Council Common Position 2008/944/CFSP(2), and in line with the rules for the implementation of revenue and expenditure financed under the EPF.

(7)
The Council reaffirms its determination to protect, promote and fulfil human rights, fundamental freedoms and democratic principles and to strengthen the rule of law and good governance, in compliance with the Charter of the United Nations, with the Universal Declaration of Human Rights and with international law, in particular international human rights law and international humanitarian law,

(a)
to strengthen the cooperation on security and defence between the Union and Cabo Verde;

(b)
to contribute to enhancing the overall security and defence capacities of the Armed Forces of Cabo Verde to protect the sovereignty of Cabo Verde at sea and improve regional maritime security, and thereby better protect maritime vessels and resources, coastal populations and their livelihoods; and,

(c)
to strengthen Cabo Verde’s potential with respect to its participation in the Union’s common security and defence policy operations, and its contribution to joint actions in the framework of the Yaoundé Architecture.

(a)
an ocean patrol vessel; and,

(b)
training courses in piloting techniques and/or aircraft maintenance.

(a)
compliance of the units of the Armed Forces of Cabo Verde supported under the assistance measure with relevant international law, in particular international human rights law and international humanitarian law;

(b)
proper and efficient use of any assets provided under the assistance measure for the purposes for which they were provided;

(c)
sufficient maintenance of any assets provided under the assistance measure to ensure their usability and operational availability over their life cycle;

(d)
that any assets provided under the assistance measure are not lost or transferred to persons or entities other than those identified in those arrangements.

(a)
delivery verification, whereby EPF delivery certificates are to be signed by the end-user forces upon transfer of ownership;

(b)
reporting, whereby the beneficiary is to report annually on the activities conducted with the equipment, supplies and services provided under the assistance measure and on the inventory of designated items until such reporting is no longer deemed necessary by the Political and Security Committee (PSC);

(c)
on-site visits, whereby the beneficiary is to grant the High Representative and the EPF auditors access to conduct on-site checks and EPF audits, upon request.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 28(1) and Article 41(2) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1) Council Decision (CFSP) 2021/509 (1) establishes the European Peace Facility (EPF) for the financing by Member States of Union actions under the common foreign and security policy to preserve peace, prevent conflicts and strengthen international security pursuant to Article 21(2), point (c), of the Treaty. In particular, pursuant to Article 1(2) of Decision (CFSP) 2021/509, the EPF is to be used for the financing of assistance measures such as actions to strengthen the capacities of third States and regional and international organisations relating to military and defence matters.

(2) The seas off West Africa continue to be a challenging environment in which piracy, armed robbery at sea, the kidnapping of seafarers, illegal, unreported, and unregulated (IUU) fishing, smuggling and trafficking of drugs and arms, as well as transnational organised crime pose a major and increasing threat to maritime security. This affects freedom of navigation, endangers major trade routes, jeopardises the sustainable development of the entire region and the economic livelihood of the population, and leads to the deterioration of the environment and biodiversity.

(3) Cabo Verde remains particularly exposed to various threats, including maritime piracy, terrorism, drug trafficking, human trafficking, cybercrime and IUU fishing due to its vast Exclusive Economic Zone and its geostrategic location at the crossroads of the Atlantic, connecting Africa to Europe and the Americas. Strengthening the Armed Forces of Cabo Verde is an important element to enable and support maritime security efforts in Cabo Verde and within the Atlantic and Gulf of Guinea regions.

(4) During the Thirteenth Ministerial Meeting under the European Union – Cabo Verde Special Partnership, held in Brussels on 31 January 2025, both partners reaffirmed their engagement to strengthen their mutual cooperation under the security and stability pillar, with the aim to define an intensified concept for security, in line with the Union’s Integrated Approach.

(5) On 10 March 2025, the High Representative of the Union for Foreign Affairs and Security Policy received a request from Cabo Verde for the Union to assist the Armed Forces of Cabo Verde with the procurement of key equipment and services, to strengthen the capabilities of the Cabo Verde Coast Guard.

(6) Assistance measures are to be implemented taking into account the principles and requirements set out in Decision (CFSP) 2021/509, in particular compliance with Council Common Position 2008/944/CFSP (2), and in line with the rules for the implementation of revenue and expenditure financed under the EPF.

(7) The Council reaffirms its determination to protect, promote and fulfil human rights, fundamental freedoms and democratic principles and to strengthen the rule of law and good governance, in compliance with the Charter of the United Nations, with the Universal Declaration of Human Rights and with international law, in particular international human rights law and international humanitarian law,

HAS ADOPTED THIS DECISION:
Establishment, objectives, scope and duration 1.   An assistance measure benefiting Cabo Verde (the ‘beneficiary’) to be financed under the European Peace Facility (EPF) (the ‘assistance measure’) is hereby established.
 2.   The objectives of the assistance measure are the following:

(a) to strengthen the cooperation on security and defence between the Union and Cabo Verde;

(b) to contribute to enhancing the overall security and defence capacities of the Armed Forces of Cabo Verde to protect the sovereignty of Cabo Verde at sea and improve regional maritime security, and thereby better protect maritime vessels and resources, coastal populations and their livelihoods; and,

(c) to strengthen Cabo Verde’s potential with respect to its participation in the Union’s common security and defence policy operations, and its contribution to joint actions in the framework of the Yaoundé Architecture.
 3.   To achieve the objectives set out in paragraph 2, the assistance measure shall finance the following types of equipment not designed to deliver lethal force, and the following supplies and services:

(a) an ocean patrol vessel; and,

(b) training courses in piloting techniques and/or aircraft maintenance.

The assistance measure shall also finance related supplies and services, including technical training, where needed.
 4.   The duration of the assistance measure shall be 48 months from the date of adoption of this Decision.
Financial arrangements 1.   The financial reference amount intended to cover the expenditure related to the assistance measure shall be EUR 12 000 000. 

 2.   All expenditure shall be managed in accordance with Decision (CFSP) 2021/509 and in line with the rules for the implementation of revenue and expenditure financed under the EPF.
Arrangements with the beneficiary 1.   The High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’) shall make the necessary arrangements with the beneficiary to ensure its compliance with the requirements and conditions established by this Decision as a condition for the provision of support under the assistance measure.
 2.   The arrangements referred to in paragraph 1 shall include provisions obliging the beneficiary to ensure:

(a) compliance of the units of the Armed Forces of Cabo Verde supported under the assistance measure with relevant international law, in particular international human rights law and international humanitarian law;

(b) proper and efficient use of any assets provided under the assistance measure for the purposes for which they were provided;

(c) sufficient maintenance of any assets provided under the assistance measure to ensure their usability and operational availability over their life cycle;

(d) that any assets provided under the assistance measure are not lost or transferred to persons or entities other than those identified in those arrangements.
 3.   The arrangements referred to in paragraph 1 shall include provisions on the suspension and termination of support under the assistance measure in the event of the beneficiary being found in breach of the obligations set out in paragraph 2. 
Implementation 1.   The High Representative shall be responsible for ensuring the implementation of this Decision in accordance with Decision (CFSP) 2021/509, and in line with the rules for the implementation of revenue and expenditure financed under the EPF and with the Integrated Methodological Framework for assessing and identifying the required measures and controls for assistance measures under the EPF.
 2.   The implementation of the activities referred to in Article 1(3) of this Decision shall be carried out by the Ministry of National Defence of the Portuguese Republic.
Monitoring, control and evaluation 1.   The High Representative shall monitor the compliance by the beneficiary with the obligations set out in Article 3. That monitoring shall be used to provide awareness of the context and the risks of breaches of the obligations set out in Article 3, and to contribute to the prevention of such breaches, including violations of international human rights law and international humanitarian law by the units of the Armed Forces of Cabo Verde supported under the assistance measure.
 2.   The post-shipment control of equipment and supplies shall be organised as follows:

(a) delivery verification, whereby EPF delivery certificates are to be signed by the end-user forces upon transfer of ownership;

(b) reporting, whereby the beneficiary is to report annually on the activities conducted with the equipment, supplies and services provided under the assistance measure and on the inventory of designated items until such reporting is no longer deemed necessary by the Political and Security Committee (PSC);

(c) on-site visits, whereby the beneficiary is to grant the High Representative and the EPF auditors access to conduct on-site checks and EPF audits, upon request.
 3.   The High Representative shall conduct a final evaluation upon completion of the assistance measure to assess whether the assistance measure has contributed to reaching the objectives set out in Article 1(2).
ReportingDuring the period of implementation, the High Representative shall provide the PSC with six-monthly reports on the implementation of the assistance measure, in accordance with Article 63 of Decision (CFSP) 2021/509. The administrator for assistance measures shall regularly inform the Facility Committee established by Decision (CFSP) 2021/509 on the implementation of revenue and expenditure in accordance with Article 38 of that Decision, including by providing information on the suppliers and subcontractors involved.
Suspension and termination 1.   The PSC may decide to suspend wholly or partially the implementation of the assistance measure in accordance with Article 64 of Decision (CFSP) 2021/509. 

 2.   The PSC may recommend that the Council terminate the assistance measure.
Entry into forceThis Decision shall enter into force on the date of its adoption.

Commission Implementing Decision (EU) 2025/1336 of 3 July 2025 concerning certain interim emergency measures relating to infection with lumpy skin disease virus in France (notified under document C(2025) 4588)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1336
4.7.2025

(1)
Infection with lumpy skin disease virus is an infectious, vector-borne disease affecting bovine animals. Its occurrence can have a severe impact on the concerned animal population and on the profitability of farming, also causing disturbance to movements of consignments of those animals and products thereof within the Union and exports to third countries.

(2)
In the event of an outbreak of infection lumpy skin disease virus in bovine animals, there is a serious risk of the spread of that disease to other establishments of bovine animals particularly due its mode of transmission through vectors.

(3)
Commission Delegated Regulation (EU) 2020/687(2)supplements the rules for the control of the listed diseases referred to in Article 9(1), points (a), (b) and (c), of Regulation (EU) 2016/429, and defined as category A, B and C diseases in Commission Implementing Regulation (EU) 2018/1882(3). In particular, Articles 21 and 22 of Delegated Regulation (EU) 2020/687 provide for the establishment of a restricted zone in the event of an outbreak of a category A disease, including infection with lumpy skin disease virus, and for certain measures to be applied therein. In addition, Article 21(1) of that Delegated Regulation provides that the restricted zone is to comprise at least a protection zone, a surveillance zone, and, if necessary, further restricted zones around or adjacent to the protection and surveillance zones.

(4)
France has informed the Commission of the current situation, in its territory, as regards the infection of bovine animals with the lumpy skin disease virus, following an outbreak of that disease in kept bovine animals, in the commune of Chambéry, department of Savoie, region of Auvergne-Rhône-Alpes which was reported on 30 June 2025. Following that report, France has reportedly established a restricted zone in the sense of Delegated Regulation (EU) 2020/687; that comprises a protection zone and a surveillance zone, where the disease control measures foreseen in Delegated Regulation (EU) 2020/687 are also applied.

(5)
In order to control the spread of infection with lumpy skin disease virus, as well as to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade by third countries, it is necessary to rapidly identify at Union level the restricted zone for infection with lumpy skin disease virus, which comprises at least one protection zone and a surveillance zone.

(6)
The size of the protection zone and the surveillance zone, and the duration of the measures to be applied therein, are based on the criteria laid down in Article 64(1) of Regulation (EU) 2016/429, as well as on the rules laid down in Delegated Regulation (EU) 2020/687. The criteria applied for the choice of the size of the protection zone and the surveillance zone, as well as of the duration of the measures to be applied therein, include a consideration of not only the epidemiological situation as regards infection with lumpy skin disease virus in the areas affected by that disease, but also of other epidemiological factors, including geographical parameters and the risk for the further spread of the disease. The chosen duration of the measures foreseen in this Decision has also taken into account the international standards of the Terrestrial Animal Health Code of the World Organisation for Animal Health(4).

(7)
The areas identified as protection zone and as surveillance zone in France should therefore be set out in the Annex to this Decision accordingly, and the duration of that regionalisation should be established in Union law.

(8)
Given the urgency of the epidemiological situation in the Union as regards the spread of infection with lumpy skin disease virus and the need to prevent the disease from spreading from the affected establishment in France to other parts of that Member State or to other Member States, the measures laid down in this Implementing Decision should apply as soon as possible.

(9)
Accordingly, pending the opinion of the Standing Committee on Plants, Animals, Food and Feed, the protection zone and the surveillance zone in France should be established immediately and listed in the Annex to this Decision and the duration of that zoning fixed.

(10)
Taking into account the current epidemiological situation in the Union as regards infection with lumpy skin disease virus, this Decision should apply until 14 August 2025.

(11)
This Decision is to be reviewed at the next meeting of the Standing Committee on Plants, Animals, Food and Feed,

(a)
a restricted zone, which comprises a protection zone and a surveillance zone, is established immediately by the competent authorities of that Member State in accordance with Article 21 of Delegated Regulation (EU) 2020/687, and under the conditions laid down in that Article;

(b)
the protection zone and the surveillance zone referred to in point (a) comprise at least the areas listed in the Annex to this Decision;

(c)
the measures required to be applied in the protection zone and the surveillance zone are applied at least until the dates listed in the Annex to this Decision.

Administrative area and ADIS reference number of the outbreak
Areas established as protection and surveillance zones, part of the restricted zone in France, referred to in Article 1
Date until applicable

Region of Auvergne-Rhône-AlpesFR-LSD-2025-00001
Protection zone:Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 20 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001).
28.7.2025

Surveillance zone:Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 50 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001) excluding the areas included in the protection zone.
14.8.2025

Surveillance zone:Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 20 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001).
29.7.2025 – 14.8.2025

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 259(2) thereof,

Whereas:

(1) Infection with lumpy skin disease virus is an infectious, vector-borne disease affecting bovine animals. Its occurrence can have a severe impact on the concerned animal population and on the profitability of farming, also causing disturbance to movements of consignments of those animals and products thereof within the Union and exports to third countries.

(2) In the event of an outbreak of infection lumpy skin disease virus in bovine animals, there is a serious risk of the spread of that disease to other establishments of bovine animals particularly due its mode of transmission through vectors.

(3) Commission Delegated Regulation (EU) 2020/687 (2) supplements the rules for the control of the listed diseases referred to in Article 9(1), points (a), (b) and (c), of Regulation (EU) 2016/429, and defined as category A, B and C diseases in Commission Implementing Regulation (EU) 2018/1882 (3). In particular, Articles 21 and 22 of Delegated Regulation (EU) 2020/687 provide for the establishment of a restricted zone in the event of an outbreak of a category A disease, including infection with lumpy skin disease virus, and for certain measures to be applied therein. In addition, Article 21(1) of that Delegated Regulation provides that the restricted zone is to comprise at least a protection zone, a surveillance zone, and, if necessary, further restricted zones around or adjacent to the protection and surveillance zones.

(4) France has informed the Commission of the current situation, in its territory, as regards the infection of bovine animals with the lumpy skin disease virus, following an outbreak of that disease in kept bovine animals, in the commune of Chambéry, department of Savoie, region of Auvergne-Rhône-Alpes which was reported on 30 June 2025. Following that report, France has reportedly established a restricted zone in the sense of Delegated Regulation (EU) 2020/687; that comprises a protection zone and a surveillance zone, where the disease control measures foreseen in Delegated Regulation (EU) 2020/687 are also applied.

(5) In order to control the spread of infection with lumpy skin disease virus, as well as to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade by third countries, it is necessary to rapidly identify at Union level the restricted zone for infection with lumpy skin disease virus, which comprises at least one protection zone and a surveillance zone.

(6) The size of the protection zone and the surveillance zone, and the duration of the measures to be applied therein, are based on the criteria laid down in Article 64(1) of Regulation (EU) 2016/429, as well as on the rules laid down in Delegated Regulation (EU) 2020/687. The criteria applied for the choice of the size of the protection zone and the surveillance zone, as well as of the duration of the measures to be applied therein, include a consideration of not only the epidemiological situation as regards infection with lumpy skin disease virus in the areas affected by that disease, but also of other epidemiological factors, including geographical parameters and the risk for the further spread of the disease. The chosen duration of the measures foreseen in this Decision has also taken into account the international standards of the Terrestrial Animal Health Code of the World Organisation for Animal Health (4).

(7) The areas identified as protection zone and as surveillance zone in France should therefore be set out in the Annex to this Decision accordingly, and the duration of that regionalisation should be established in Union law.

(8) Given the urgency of the epidemiological situation in the Union as regards the spread of infection with lumpy skin disease virus and the need to prevent the disease from spreading from the affected establishment in France to other parts of that Member State or to other Member States, the measures laid down in this Implementing Decision should apply as soon as possible.

(9) Accordingly, pending the opinion of the Standing Committee on Plants, Animals, Food and Feed, the protection zone and the surveillance zone in France should be established immediately and listed in the Annex to this Decision and the duration of that zoning fixed.

(10) Taking into account the current epidemiological situation in the Union as regards infection with lumpy skin disease virus, this Decision should apply until 14 August 2025.

(11) This Decision is to be reviewed at the next meeting of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:
France shall ensure that:
(a) a restricted zone, which comprises a protection zone and a surveillance zone, is established immediately by the competent authorities of that Member State in accordance with Article 21 of Delegated Regulation (EU) 2020/687, and under the conditions laid down in that Article;

(b) the protection zone and the surveillance zone referred to in point (a) comprise at least the areas listed in the Annex to this Decision;

(c) the measures required to be applied in the protection zone and the surveillance zone are applied at least until the dates listed in the Annex to this Decision.
This Decision shall apply until 14 August 2025.
This Decision is addressed to the French Republic.
Administrative area and ADIS reference number of the outbreak

Areas established as protection and surveillance zones, part of the restricted zone in France, referred to in Article 1

Date until applicable

Region of Auvergne-Rhône-Alpes

FR-LSD-2025-00001

Protection zone:

Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 20 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001).

28.7.2025

Surveillance zone:

Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 50 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001) excluding the areas included in the protection zone.

14.8.2025

Surveillance zone:

Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 20 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001).

29.7.2025 – 14.8.2025

Council Decision (CFSP) 2025/1333 of 8 July 2025 on an assistance measure under the European Peace Facility to support the Armed Forces of Senegal

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1333
9.7.2025

(1)
Council Decision (CFSP) 2021/509(1)establishes the European Peace Facility (EPF) for the financing by Member States of Union actions under the common foreign and security policy to preserve peace, prevent conflicts and strengthen international security pursuant to Article 21(2), point (c), of the Treaty. In particular, pursuant to Article 1(2) of Decision (CFSP) 2021/509, the EPF is to be used for the financing of assistance measures such as actions to strengthen the capacities of third states and regional and international organisations relating to military and defence matters.

(2)
The persistent and growing strength of violent extremist organisations in the central Sahel threatens the stability of Senegal and the whole West Africa region.

(3)
In light of the deteriorating security environment, strengthening the Armed Forces of Senegal is an important element to support the efforts of Senegal against the spill-over of the terrorist threat coming from the Sahel, particularly on Senegal’s border with Mali. In that context, and fully cognisant of the fact that the situation requires an integrated response, ensuring long-term peace and security in Senegal is a key priority for the Union.

(4)
On 4 November 2024, the High Representative of the Union for Foreign Affairs and Security Policy received a request from Senegal for the Union to assist the Armed Forces of Senegal with the procurement of key equipment and operational infrastructure to strengthen their operational capabilities to secure land borders and to counter non-state armed groups which are destabilising the country and the whole West Africa region.

(5)
Assistance measures are to be implemented taking into account the principles and requirements set out in Decision (CFSP) 2021/509, in particular compliance with Council Common Position 2008/944/CFSP(2), and in line with the rules for the implementation of revenue and expenditure financed under the EPF.

(6)
The Council reaffirms its determination to protect, promote and fulfil human rights, fundamental freedoms and democratic principles and to strengthen the rule of law and good governance, in compliance with the Charter of the United Nations, with the Universal Declaration of Human Rights and with international law, in particular international human rights law and international humanitarian law,

(a)
day-and-night land and river surveillance and vision equipment;

(b)
intelligence-gathering equipment;

(c)
force protection equipment;

(d)
construction of a river base in Foundiougne and in Bakel;

(e)
construction of an outdoor assault course and an advanced obstacle course for the National Non-Commissioned Officer Academy in Kaolack.

(a)
compliance of the units of the Armed Forces of Senegal supported under the assistance measure with relevant international law, in particular international human rights law and international humanitarian law;

(b)
proper and efficient use of any assets provided under the assistance measure for the purposes for which they were provided;

(c)
sufficient maintenance of any assets provided under the assistance measure to ensure their usability and their operational availability over their life cycle;

(d)
that any assets provided under the assistance measure are not lost or transferred to persons or entities other than those identified in those arrangements.

(a)
delivery verification, whereby EPF delivery certificates are to be signed by the end-user forces upon transfer of ownership;

(b)
reporting, whereby the beneficiary is to report annually on the activities conducted with the equipment, supplies, services and infrastructure provided under the assistance measure and on the inventory of designated items until such reporting is no longer deemed necessary by the Political and Security Committee (PSC);

(c)
on-site visits, whereby the beneficiary is to grant the High Representative and the EPF auditors access to conduct on-site checks and EPF audits, upon request.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 28(1) and Article 41(2) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1) Council Decision (CFSP) 2021/509 (1) establishes the European Peace Facility (EPF) for the financing by Member States of Union actions under the common foreign and security policy to preserve peace, prevent conflicts and strengthen international security pursuant to Article 21(2), point (c), of the Treaty. In particular, pursuant to Article 1(2) of Decision (CFSP) 2021/509, the EPF is to be used for the financing of assistance measures such as actions to strengthen the capacities of third states and regional and international organisations relating to military and defence matters.

(2) The persistent and growing strength of violent extremist organisations in the central Sahel threatens the stability of Senegal and the whole West Africa region.

(3) In light of the deteriorating security environment, strengthening the Armed Forces of Senegal is an important element to support the efforts of Senegal against the spill-over of the terrorist threat coming from the Sahel, particularly on Senegal’s border with Mali. In that context, and fully cognisant of the fact that the situation requires an integrated response, ensuring long-term peace and security in Senegal is a key priority for the Union.

(4) On 4 November 2024, the High Representative of the Union for Foreign Affairs and Security Policy received a request from Senegal for the Union to assist the Armed Forces of Senegal with the procurement of key equipment and operational infrastructure to strengthen their operational capabilities to secure land borders and to counter non-state armed groups which are destabilising the country and the whole West Africa region.

(5) Assistance measures are to be implemented taking into account the principles and requirements set out in Decision (CFSP) 2021/509, in particular compliance with Council Common Position 2008/944/CFSP (2), and in line with the rules for the implementation of revenue and expenditure financed under the EPF.

(6) The Council reaffirms its determination to protect, promote and fulfil human rights, fundamental freedoms and democratic principles and to strengthen the rule of law and good governance, in compliance with the Charter of the United Nations, with the Universal Declaration of Human Rights and with international law, in particular international human rights law and international humanitarian law,

HAS ADOPTED THIS DECISION:
Establishment, objectives, scope and duration 1.   An assistance measure benefiting Senegal (the ‘beneficiary’) to be financed under the European Peace Facility (EPF) (the ‘assistance measure’) is hereby established.
 2.   The objective of the assistance measure is to support the Armed Forces of Senegal to defend the territorial integrity of Senegal and to protect its civilian population against internal and external threats.
 3.   To achieve the objective set out in paragraph 2, the assistance measure shall finance the following types of equipment not designed to deliver lethal force, and the following infrastructure works:

(a) day-and-night land and river surveillance and vision equipment;

(b) intelligence-gathering equipment;

(c) force protection equipment;

(d) construction of a river base in Foundiougne and in Bakel;

(e) construction of an outdoor assault course and an advanced obstacle course for the National Non-Commissioned Officer Academy in Kaolack.

The assistance measure shall also finance related supplies and services, including technical training, where needed.
 4.   The duration of the assistance measure shall be 36 months from the date of adoption of this Decision.
Financial arrangements 1.   The financial reference amount intended to cover the expenditure related to the assistance measure shall be EUR 10 000 000. 

 2.   All expenditure shall be managed in accordance with Decision (CFSP) 2021/509 and in line with the rules for the implementation of revenue and expenditure financed under the EPF.
Arrangements with the beneficiary 1.   The High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’) shall make the necessary arrangements with the beneficiary to ensure its compliance with the requirements and conditions established by this Decision as a condition for the provision of support under the assistance measure.
 2.   The arrangements referred to in paragraph 1 shall include provisions obliging the beneficiary to ensure:

(a) compliance of the units of the Armed Forces of Senegal supported under the assistance measure with relevant international law, in particular international human rights law and international humanitarian law;

(b) proper and efficient use of any assets provided under the assistance measure for the purposes for which they were provided;

(c) sufficient maintenance of any assets provided under the assistance measure to ensure their usability and their operational availability over their life cycle;

(d) that any assets provided under the assistance measure are not lost or transferred to persons or entities other than those identified in those arrangements.
 3.   The arrangements referred to in paragraph 1 shall include provisions on the suspension and termination of support under the assistance measure in the event of the beneficiary being found in breach of the obligations set out in paragraph 2. 
Implementation 1.   The High Representative shall be responsible for ensuring the implementation of this Decision in accordance with Decision (CFSP) 2021/509, and in line with the rules for the implementation of revenue and expenditure financed under the EPF and with the Integrated Methodological Framework for assessing and identifying the required measures and controls for assistance measures under the EPF.
 2.   The implementation of the activities referred to in Article 1(3) of this Decision shall be carried out by the administrator for assistance measures through an administrative arrangement with the Économat des Armées in accordance with Article 37 of Decision (CFSP) 2021/509. 
Monitoring, control and evaluation 1.   The High Representative shall monitor the compliance by the beneficiary with the obligations set out in Article 3. That monitoring shall be used to provide awareness of the context and the risks of breaches of the obligations set out in Article 3, and to contribute to the prevention of such breaches, including violations of international human rights law and international humanitarian law by the units of the Armed Forces of Senegal supported under the assistance measure.
 2.   The post-shipment control of equipment and supplies shall be organised as follows:

(a) delivery verification, whereby EPF delivery certificates are to be signed by the end-user forces upon transfer of ownership;

(b) reporting, whereby the beneficiary is to report annually on the activities conducted with the equipment, supplies, services and infrastructure provided under the assistance measure and on the inventory of designated items until such reporting is no longer deemed necessary by the Political and Security Committee (PSC);

(c) on-site visits, whereby the beneficiary is to grant the High Representative and the EPF auditors access to conduct on-site checks and EPF audits, upon request.
 3.   The High Representative shall conduct a final evaluation upon completion of the assistance measure to assess whether the assistance measure has contributed to reaching the objective set out in Article 1(2).
ReportingDuring the period of implementation, the High Representative shall provide the PSC with six-monthly reports on the implementation of the assistance measure, in accordance with Article 63 of Decision (CFSP) 2021/509. The administrator for assistance measures shall regularly inform the Facility Committee established by Decision (CFSP) 2021/509 on the implementation of revenue and expenditure in accordance with Article 38 of that Decision, including by providing information on the suppliers and subcontractors involved.
Suspension and termination 1.   The PSC may decide to suspend wholly or partially the implementation of the assistance measure in accordance with Article 64 of Decision (CFSP) 2021/509. 

 2.   The PSC may recommend that the Council terminate the assistance measure.
Entry into forceThis Decision shall enter into force on the date of its adoption.

Commission Implementing Decision (EU) 2025/1332 of 9 July 2025 on the implementation of the Rail Baltica cross-border project on the North Sea – Baltic European Transport Corridor and the Baltic Sea – Black Sea – Aegean Sea European Transport Corridor in application of Regulation (EU) 2024/1679 of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2018/1723 (notified under document C(2025) 3944)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1332
10.7.2025

(1)
The cross-border project Rail Baltica is expected to play a crucial role in ensuring the functioning of the North Sea – Baltic and the Baltic Sea – Black Sea – Aegean Sea European Transport Corridors. The Rail Baltica line will be an interoperable and efficient railway connection between Poland and the Baltic States and, indirectly, Finland. It will create connection points between rail, sea, air and road transport. As a major missing link on both corridors, the Rail Baltica line will also help connect the region to Ukraine and Moldova which are part of the North Sea – Baltic and the Baltic Sea – Black Sea – Aegean Sea corridors. It is expected to contribute to the promotion of zero-emission mobility in line with the relevant Union CO2reduction targets.

(2)
Given the current international context, the geostrategic value of the Rail Baltica line has increased significantly. Its contribution to defence, security and military mobility should be taken into account during its implementation.

(3)
The Rail Baltica project has faced extraordinary circumstances, such as the outbreak of the COVID pandemic and Russia’s full-scale war against Ukraine, causing major disruption to the implementation of the project. That necessitates a re-evaluation of the implementation timetable as set out in Commission Implementing Decision (EU) 2018/1723(2).

(4)
The Rail Baltica line is implemented as a fast conventional, mixed passenger and freight railway line. It should contribute to the ambition of connecting all European capitals by high-speed rail.

(5)
The Rail Baltica line should connect the three Baltic countries to the European railway network in 2030 and integrate them into the single European railway area.

(6)
The Rail Baltica line is the backbone of the European railway system based on the European standard nominal track gauge of 1 435 mm in Estonia, Latvia and Lithuania. In the future, that European gauge railway system should be gradually expanded in the region, in line with the national re-gauging plans.

(7)
In accordance with Article 6(1) of Regulation (EU) 2024/1679, without prejudice to Article 8(5) of that Regulation, Member States are to complete the core network by 31 December 2030. Furthermore, Article 8(5) provides that the implementation of projects of common interest depends on their degree of maturity, compliance with Union and national legal procedures, and the availability of financial resources, without prejudging the financial commitment of a Member State or of the Union.

(8)
Estonia, Latvia, Lithuania and Poland should make every effort to meet the target date of 2030 for the core network. However, because of technical and financial challenges of the project, the Rail Baltica project will not be completed before the end of 2030.

(9)
In view of, on the one hand, the time and the resources required to build the complete Rail Baltica line and, on the other hand, the strategic importance to connect Estonia, Latvia, and Lithuania to the European railway network as soon as possible, that line should be built in two phases.

(10)
During the first phase until the end of 2030, the basic Rail Baltica line should be built to connect Estonia, Latvia and Lithuania to the European railway network. During the second phase, further elements which are essential to use the full potential of the Rail Baltica line, should be implemented in accordance with Regulation (EU) 2024/1679.

(11)
In order for the line to be operational as early as possible, Estonia, Latvia and Lithuania should build the Rail Baltica line as a single track from Tallinn to Kaunas during the first phase. To start ramping up cross-border traffic on the Rail Baltica corridor during the first phase, Lithuania should be able to implement energy, control-command and signalling subsystem installations on the existing railway track in in the European standard nominal gauge of 1 435 mm on the section between Poland and Kaunas.

(12)
That phasing should give all involved partners the certainty that the basic cross-border connections will be built as a priority and by the end of 2030.

(13)
Estonia, Latvia, Lithuania, Poland and Finland should collaborate closely during the planning and construction of the Rail Baltica line to ensure a coordinated construction and a fully interoperable railway line. The Rail Baltica Task Force, chaired by the European Coordinator of the North Sea – Baltic corridor, should provide for steering between the ministries of Estonia, Latvia, Lithuania, Poland and Finland, and the Commission to support coordination, guide the project and foster a smooth implementation.

(14)
Estonia, Latvia, Lithuania and Poland have agreed to build the Rail Baltica line in close collaboration, and in close coordination with Finland.

(15)
The Baltic states should work with their joint venture RB Rail AS which continues performing as the project coordinator, and acts as the main interlocutor for the Rail Baltica partners, namely Estonia, Latvia and Lithuania and their national affiliated entities, in their exchanges with the Commission to ensure a coherent implementation. The joint venture RB Rail AS and the national affiliated entities should implement the cross-border project Rail Baltica, in line with the agreed project setup.

(16)
This Decision should set out the actions and the timetable for their completion in order to guide the work of the project partners and provide clarity to stakeholders involved in the project implementation. It should also reflect the updated implementation strategy based on geographical operational sections as outlined in the Project Management Agreement concluded between the joint venture RB Rail AS, the responsible ministries of Estonia, Latvia and Lithuania and the national affiliated entities of the Rail Baltica project on 28 February 2024.

(17)
In accordance with Article 55(1) of Regulation (EU) 2024/1679, the Commission is to update this Decision every four years or upon request of a Member State involved.

(18)
As the timetable and the measures set out in Implementing Decision (EU) 2018/1723 are outdated and the geopolitical context has changed, that Implementing Decision should be repealed.

(19)
The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 61 of Regulation (EU) 2024/1679,

(a)
as regards the section Tallinn-Pärnu:(i)land acquisition shall be completed by 31 December 2026;(ii)the construction of the railway substructure shall begin by 31 December 2025;(iii)the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;
(i)
land acquisition shall be completed by 31 December 2026;
(ii)
the construction of the railway substructure shall begin by 31 December 2025;
(iii)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(i)
land acquisition shall be completed by 31 December 2026;

(ii)
the construction of the railway substructure shall begin by 31 December 2025;

(iii)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(i)
land acquisition shall be completed by 31 December 2026;

(ii)
the construction of the railway substructure shall begin by 31 December 2025;

(iii)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(b)
as regards the section Pärnu-border between Estonia and Latvia:(i)the design of the railway infrastructure sub-system shall be completed by 31 December 2026;(ii)land acquisition shall be completed by 31 December 2026;(iii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;(iv)the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;
(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2026;
(ii)
land acquisition shall be completed by 31 December 2026;
(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;
(iv)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2026;

(ii)
land acquisition shall be completed by 31 December 2026;

(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;

(iv)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2026;

(ii)
land acquisition shall be completed by 31 December 2026;

(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;

(iv)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(c)
as regards the section border between Estonia and Latvia-Salaspils:(i)the design of the railway infrastructure sub-system shall be completed by 31 December 2026;(ii)land acquisition shall be completed by 30 June 2027;(iii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;(iv)the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;
(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2026;
(ii)
land acquisition shall be completed by 30 June 2027;
(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;
(iv)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;

(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2026;

(ii)
land acquisition shall be completed by 30 June 2027;

(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;

(iv)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;

(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2026;

(ii)
land acquisition shall be completed by 30 June 2027;

(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;

(iv)
the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;

(d)
as regards the section Salaspils-border between Latvia and Lithuania:(i)the design of the railway infrastructure subsystem shall be completed by 31 December 2025;(ii)land acquisition shall be completed by 31 December 2026;(iii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;(iv)the construction of the railway infrastructure sub-system border shall be completed by mid-2029;
(i)
the design of the railway infrastructure subsystem shall be completed by 31 December 2025;
(ii)
land acquisition shall be completed by 31 December 2026;
(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;
(iv)
the construction of the railway infrastructure sub-system border shall be completed by mid-2029;

(i)
the design of the railway infrastructure subsystem shall be completed by 31 December 2025;

(ii)
land acquisition shall be completed by 31 December 2026;

(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;

(iv)
the construction of the railway infrastructure sub-system border shall be completed by mid-2029;

(i)
the design of the railway infrastructure subsystem shall be completed by 31 December 2025;

(ii)
land acquisition shall be completed by 31 December 2026;

(iii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;

(iv)
the construction of the railway infrastructure sub-system border shall be completed by mid-2029;

(e)
as regards the section border between Latvia and Lithuania-Panevėžys:(i)the design of the railway infrastructure sub-system shall be completed by 31 December 2027;(ii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;(iii)the construction of the railway infrastructure sub-system shall be underway by mid-2029;
(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2027;
(ii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;
(iii)
the construction of the railway infrastructure sub-system shall be underway by mid-2029;

(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2027;

(ii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;

(iii)
the construction of the railway infrastructure sub-system shall be underway by mid-2029;

(i)
the design of the railway infrastructure sub-system shall be completed by 31 December 2027;

(ii)
the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;

(iii)
the construction of the railway infrastructure sub-system shall be underway by mid-2029;

(f)
as regards the section Panevėžys-Kaunas:(i)the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025(ii)the construction of the railway substructure shall be completed by 31 December 2028;(iii)the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;
(i)
the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025
(ii)
the construction of the railway substructure shall be completed by 31 December 2028;
(iii)
the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;

(i)
the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025

(ii)
the construction of the railway substructure shall be completed by 31 December 2028;

(iii)
the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;

(i)
the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025

(ii)
the construction of the railway substructure shall be completed by 31 December 2028;

(iii)
the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;

(g)
as regards the section Kaunas-Warszawa (with a connection to Vilnius):(i)land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;(ii)land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;(iii)the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);(iv)the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;(v)the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;
(i)
land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;
(ii)
land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;
(iii)
the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);
(iv)
the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;
(v)
the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;

(i)
land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;

(ii)
land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;

(iii)
the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);

(iv)
the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;

(v)
the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;

(i)
land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;

(ii)
land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;

(iii)
the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);

(iv)
the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;

(v)
the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;

(h)
as regards the section Warszawa-border between Lithuania and Poland:(i)the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;(ii)the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;
(i)
the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;
(ii)
the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;

(i)
the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;

(ii)
the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;

(i)
the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;

(ii)
the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;

(i)
as regards all sections Tallinn-Pärnu-Salaspils-Misa-Panevėžys-Kaunas-Warszawa:(i)the design for the electrification sub-system shall be completed by 31 December 2027;(ii)the design for the control command and signalling sub-system shall be completed by mid 2028;(iii)installation works for the electrification sub-system shall begin in the first quarter of 2027;(iv)the installation works for the control command and signalling sub-system shall begin in the first quarter of 2028;(v)the railway infrastructure shall be completed as a mix of single- and double-track railway line on double-track embankment for mixed traffic, suitable for minimum 740-m-long freight trains, electrified, in European standard nominal track gauge by 31 December 2030;(vi)the European Rail Traffic Management System (ERTMS) shall be deployed to achieve full interoperability, in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council(3), by 31 December 2030;(vii)dynamic testing shall begin as from 2030.
(i)
the design for the electrification sub-system shall be completed by 31 December 2027;
(ii)
the design for the control command and signalling sub-system shall be completed by mid 2028;
(iii)
installation works for the electrification sub-system shall begin in the first quarter of 2027;
(iv)
the installation works for the control command and signalling sub-system shall begin in the first quarter of 2028;
(v)
the railway infrastructure shall be completed as a mix of single- and double-track railway line on double-track embankment for mixed traffic, suitable for minimum 740-m-long freight trains, electrified, in European standard nominal track gauge by 31 December 2030;
(vi)
the European Rail Traffic Management System (ERTMS) shall be deployed to achieve full interoperability, in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council(3), by 31 December 2030;
(vii)
dynamic testing shall begin as from 2030.

(i)
the design for the electrification sub-system shall be completed by 31 December 2027;

(ii)
the design for the control command and signalling sub-system shall be completed by mid 2028;

(iii)
installation works for the electrification sub-system shall begin in the first quarter of 2027;

(iv)
the installation works for the control command and signalling sub-system shall begin in the first quarter of 2028;

(v)
the railway infrastructure shall be completed as a mix of single- and double-track railway line on double-track embankment for mixed traffic, suitable for minimum 740-m-long freight trains, electrified, in European standard nominal track gauge by 31 December 2030;

(vi)
the European Rail Traffic Management System (ERTMS) shall be deployed to achieve full interoperability, in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council(3), by 31 December 2030;

(vii)
dynamic testing shall begin as from 2030.

(i)
the design for the electrification sub-system shall be completed by 31 December 2027;

(ii)
the design for the control command and signalling sub-system shall be completed by mid 2028;

(iii)
installation works for the electrification sub-system shall begin in the first quarter of 2027;

(iv)
the installation works for the control command and signalling sub-system shall begin in the first quarter of 2028;

(v)
the railway infrastructure shall be completed as a mix of single- and double-track railway line on double-track embankment for mixed traffic, suitable for minimum 740-m-long freight trains, electrified, in European standard nominal track gauge by 31 December 2030;

(vi)
the European Rail Traffic Management System (ERTMS) shall be deployed to achieve full interoperability, in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council(3), by 31 December 2030;

(vii)
dynamic testing shall begin as from 2030.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2024/1679 of the European Parliament and of the Council of 13 June 2024 on Union guidelines for the development of the trans-European transport network, amending Regulations (EU) 2021/1153 and (EU) No 913/2010 and repealing Regulation (EU) No 1315/2013 (1), and in particular Article 55(1) thereof,

Whereas:

(1) The cross-border project Rail Baltica is expected to play a crucial role in ensuring the functioning of the North Sea – Baltic and the Baltic Sea – Black Sea – Aegean Sea European Transport Corridors. The Rail Baltica line will be an interoperable and efficient railway connection between Poland and the Baltic States and, indirectly, Finland. It will create connection points between rail, sea, air and road transport. As a major missing link on both corridors, the Rail Baltica line will also help connect the region to Ukraine and Moldova which are part of the North Sea – Baltic and the Baltic Sea – Black Sea – Aegean Sea corridors. It is expected to contribute to the promotion of zero-emission mobility in line with the relevant Union CO2 reduction targets.

(2) Given the current international context, the geostrategic value of the Rail Baltica line has increased significantly. Its contribution to defence, security and military mobility should be taken into account during its implementation.

(3) The Rail Baltica project has faced extraordinary circumstances, such as the outbreak of the COVID pandemic and Russia’s full-scale war against Ukraine, causing major disruption to the implementation of the project. That necessitates a re-evaluation of the implementation timetable as set out in Commission Implementing Decision (EU) 2018/1723 (2).

(4) The Rail Baltica line is implemented as a fast conventional, mixed passenger and freight railway line. It should contribute to the ambition of connecting all European capitals by high-speed rail.

(5) The Rail Baltica line should connect the three Baltic countries to the European railway network in 2030 and integrate them into the single European railway area.

(6) The Rail Baltica line is the backbone of the European railway system based on the European standard nominal track gauge of 1 435 mm in Estonia, Latvia and Lithuania. In the future, that European gauge railway system should be gradually expanded in the region, in line with the national re-gauging plans.

(7) In accordance with Article 6(1) of Regulation (EU) 2024/1679, without prejudice to Article 8(5) of that Regulation, Member States are to complete the core network by 31 December 2030. Furthermore, Article 8(5) provides that the implementation of projects of common interest depends on their degree of maturity, compliance with Union and national legal procedures, and the availability of financial resources, without prejudging the financial commitment of a Member State or of the Union.

(8) Estonia, Latvia, Lithuania and Poland should make every effort to meet the target date of 2030 for the core network. However, because of technical and financial challenges of the project, the Rail Baltica project will not be completed before the end of 2030.

(9) In view of, on the one hand, the time and the resources required to build the complete Rail Baltica line and, on the other hand, the strategic importance to connect Estonia, Latvia, and Lithuania to the European railway network as soon as possible, that line should be built in two phases.

(10) During the first phase until the end of 2030, the basic Rail Baltica line should be built to connect Estonia, Latvia and Lithuania to the European railway network. During the second phase, further elements which are essential to use the full potential of the Rail Baltica line, should be implemented in accordance with Regulation (EU) 2024/1679.

(11) In order for the line to be operational as early as possible, Estonia, Latvia and Lithuania should build the Rail Baltica line as a single track from Tallinn to Kaunas during the first phase. To start ramping up cross-border traffic on the Rail Baltica corridor during the first phase, Lithuania should be able to implement energy, control-command and signalling subsystem installations on the existing railway track in in the European standard nominal gauge of 1 435 mm on the section between Poland and Kaunas.

(12) That phasing should give all involved partners the certainty that the basic cross-border connections will be built as a priority and by the end of 2030.

(13) Estonia, Latvia, Lithuania, Poland and Finland should collaborate closely during the planning and construction of the Rail Baltica line to ensure a coordinated construction and a fully interoperable railway line. The Rail Baltica Task Force, chaired by the European Coordinator of the North Sea – Baltic corridor, should provide for steering between the ministries of Estonia, Latvia, Lithuania, Poland and Finland, and the Commission to support coordination, guide the project and foster a smooth implementation.

(14) Estonia, Latvia, Lithuania and Poland have agreed to build the Rail Baltica line in close collaboration, and in close coordination with Finland.

(15) The Baltic states should work with their joint venture RB Rail AS which continues performing as the project coordinator, and acts as the main interlocutor for the Rail Baltica partners, namely Estonia, Latvia and Lithuania and their national affiliated entities, in their exchanges with the Commission to ensure a coherent implementation. The joint venture RB Rail AS and the national affiliated entities should implement the cross-border project Rail Baltica, in line with the agreed project setup.

(16) This Decision should set out the actions and the timetable for their completion in order to guide the work of the project partners and provide clarity to stakeholders involved in the project implementation. It should also reflect the updated implementation strategy based on geographical operational sections as outlined in the Project Management Agreement concluded between the joint venture RB Rail AS, the responsible ministries of Estonia, Latvia and Lithuania and the national affiliated entities of the Rail Baltica project on 28 February 2024.

(17) In accordance with Article 55(1) of Regulation (EU) 2024/1679, the Commission is to update this Decision every four years or upon request of a Member State involved.

(18) As the timetable and the measures set out in Implementing Decision (EU) 2018/1723 are outdated and the geopolitical context has changed, that Implementing Decision should be repealed.

(19) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 61 of Regulation (EU) 2024/1679,

HAS ADOPTED THIS DECISION:
Subject matterThis Decision lays down the priorities, actions and in order timetable for the implementation of the cross-border project Rail Baltica (Tallinn-Pärnu-Riga-Panevėžys-Kaunas-Warszawa, with a connection to Vilnius), as well as related governance and reporting provisions.
Priorities for the first phase 1.   During the first phase, until 31 December 2030, Estonia, Latvia, Lithuania and Poland shall prioritise the construction of the sections Tallinn-Pärnu-Salaspils-Misa-Panevėžys-Kaunas-Warszawa and work to the completion of those sections. During that phase, the connection to the Rail Baltica line of Riga and Vilnius respectively shall be ensured through the existing rail network.
 2.   As regards the first phase, Estonia, Latvia and Lithuania may build the Rail Baltica line as a single track from Tallinn to Kaunas, provided that a double-track embankment and enough passing loops for a smooth operation are built.
 3.   In parallel to the actions of the first phase referred to in paragraphs 1 and 2, Lithuania may implement energy, control-command and signalling subsystem installations on the existing European railway track in the section between Poland and Kaunas.
 4.   Estonia, Latvia, and Lithuania may start undertaking actions from the second phase prior to the completion of the first phase, where that does not delay directly or indirectly the completion of the activities of the first phase.
Priorities for the second phaseThe Rail Baltica project shall not be considered complete before Tallinn, Riga, Vilnius and Warszawa are connected via the railway in European standard nominal track gauge of 1 435 mm built in double track on the entire route.
Actions and timetable 1.   Estonia, Latvia, Lithuania and Poland shall ensure the implementation of the following actions for completing the first phase of the Rail Baltica project in a timely manner:

(a) as regards the section Tallinn-Pärnu:

(i) land acquisition shall be completed by 31 December 2026;

(ii) the construction of the railway substructure shall begin by 31 December 2025;

(iii) the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(b) as regards the section Pärnu-border between Estonia and Latvia:

(i) the design of the railway infrastructure sub-system shall be completed by 31 December 2026;

(ii) land acquisition shall be completed by 31 December 2026;

(iii) the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;

(iv) the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(c) as regards the section border between Estonia and Latvia-Salaspils:

(i) the design of the railway infrastructure sub-system shall be completed by 31 December 2026;

(ii) land acquisition shall be completed by 30 June 2027;

(iii) the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;

(iv) the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;

(d) as regards the section Salaspils-border between Latvia and Lithuania:

(i) the design of the railway infrastructure subsystem shall be completed by 31 December 2025;

(ii) land acquisition shall be completed by 31 December 2026;

(iii) the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;

(iv) the construction of the railway infrastructure sub-system border shall be completed by mid-2029;

(e) as regards the section border between Latvia and Lithuania-Panevėžys:

(i) the design of the railway infrastructure sub-system shall be completed by 31 December 2027;

(ii) the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;

(iii) the construction of the railway infrastructure sub-system shall be underway by mid-2029;

(f) as regards the section Panevėžys-Kaunas:

(i) the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025

(ii) the construction of the railway substructure shall be completed by 31 December 2028;

(iii) the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;

(g) as regards the section Kaunas-Warszawa (with a connection to Vilnius):

(i) land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;

(ii) land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;

(iii) the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);

(iv) the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;

(v) the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;

(h) as regards the section Warszawa-border between Lithuania and Poland:

(i) the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;

(ii) the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;

(i) as regards all sections Tallinn-Pärnu-Salaspils-Misa-Panevėžys-Kaunas-Warszawa:

(i) the design for the electrification sub-system shall be completed by 31 December 2027;

(ii) the design for the control command and signalling sub-system shall be completed by mid 2028;

(iii) installation works for the electrification sub-system shall begin in the first quarter of 2027;

(iv) the installation works for the control command and signalling sub-system shall begin in the first quarter of 2028;

(v) the railway infrastructure shall be completed as a mix of single- and double-track railway line on double-track embankment for mixed traffic, suitable for minimum 740-m-long freight trains, electrified, in European standard nominal track gauge by 31 December 2030;

(vi) the European Rail Traffic Management System (ERTMS) shall be deployed to achieve full interoperability, in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council (3), by 31 December 2030;

(vii) dynamic testing shall begin as from 2030. 

 2.   The actions under the second phase of Rail Baltica project consist of the remaining actions that are necessary to ensure that the Rail Baltica line is fully compliant with Regulation (EU) 2024/1679. 
Governance and reporting 1.   The European Coordinator for the North Sea-Baltic European Transport Corridor, representatives of the Commission and nominated representatives of Poland and Finland shall be invited to participate as observers in the meetings of the Supervisory Board of RB Rail AS. RB Rail AS may also decide to invite the European Coordinator or the Commission to strategic meetings of the project partners.
 2.   The Rail Baltica Task Force shall meet upon invitation of the European Coordinator for the North Sea – Baltic European Transport Corridor at least twice per year. It shall be consulted about strategic decisions for the project. The European Coordinator of the North Sea – Baltic corridor shall keep the European Coordinator of the Baltic Sea – Black Sea – Aegean Sea informed about significant developments related to the Rail Baltica project and relevant for the two corridors.
 3.   After consulting Estonia, Latvia, Lithuania and Poland, RB Rail AS shall provide updated information to the European Coordinator for the North Sea – Baltic corridor in writing at least once per year about the progress in implementing the actions referred to in Article 2 and shall where relevant notify any delay encountered, specifying the reasons for the delay and indicating the corrective measures taken.
 4.   If force majeure has an impact on the implementation programme and its financing, the project partners and the European Coordinator for the North Sea – Baltic corridor shall consult each other to define corrective measures.
RepealImplementing Decision (EU) 2018/1723 is repealed.
AddresseesThis Decision is addressed to the Republic of Estonia, the Republic of Latvia, the Republic of Lithuania, the Republic of Poland and the Republic of Finland.

Political and Security Committee Decision (CFSP) 2025/1326 of 25 June 2025 extending the mandate of the Head of Mission of the European Union Integrated Border Management Assistance Mission in Libya (EUBAM Libya) (EUBAM Libya/1/2025)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1326
4.7.2025

(1)
Pursuant to Article 9(1) of Decision 2013/233/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with Article 38, third paragraph, of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of the European Union Integrated Border Management Assistance Mission in Libya (EUBAM Libya), including the decision to appoint a Head of Mission upon a proposal of the High Representative of the Union for Foreign Affairs and Security policy (the ‘High Representative’).

(2)
On 8 December 2023, the PSC adopted Decision (CFSP) 2023/2784(2), appointing Mr Jan VYČÍTAL as Head of Mission of EUBAM Libya from 1 January 2024 to 30 June 2025.

(3)
On 24 April 2025, the High Representative proposed to extend the mandate of Mr Jan VYČÍTAL as Head of Mission of EUBAM Libya from 1 July 2025 to 31 December 2025.

(4)
The mandate of the current Head of Mission of EUBAM Libya should therefore be extended for a further period of six months,

THE POLITICAL AND SECURITY COMMITTEE,

Having regard to the Treaty on European Union, and in particular Article 38, third paragraph, thereof,

Having regard to Council Decision 2013/233/CFSP of 22 May 2013 on the European Union Integrated Border Management Assistance Mission in Libya (EUBAM Libya) (1), and in particular Article 9(1) thereof,

Whereas:

(1) Pursuant to Article 9(1) of Decision 2013/233/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with Article 38, third paragraph, of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of the European Union Integrated Border Management Assistance Mission in Libya (EUBAM Libya), including the decision to appoint a Head of Mission upon a proposal of the High Representative of the Union for Foreign Affairs and Security policy (the ‘High Representative’).

(2) On 8 December 2023, the PSC adopted Decision (CFSP) 2023/2784 (2), appointing Mr Jan VYČÍTAL as Head of Mission of EUBAM Libya from 1 January 2024 to 30 June 2025.

(3) On 24 April 2025, the High Representative proposed to extend the mandate of Mr Jan VYČÍTAL as Head of Mission of EUBAM Libya from 1 July 2025 to 31 December 2025.

(4) The mandate of the current Head of Mission of EUBAM Libya should therefore be extended for a further period of six months,

HAS ADOPTED THIS DECISION:
The mandate of Mr Jan VYČÍTAL as Head of Mission of the European Union Integrated Border Management Assistance Mission in Libya (EUBAM Libya) is extended from 1 July 2025 to 31 December 2025.
This Decision shall enter into force on the date of its adoption.

It shall apply subject to the adoption of a decision by the Council extending the mandate of EUBAM LIBYA as from 1 July 2025.

Commission Implementing Decision (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices

                                January 13, 2026                            

Official Journalof the European Union
ENL series




2025/1324
8.7.2025



(1)
Article 1 of Commission Implementing Decision (EU) 2019/1396(2)designates expert panels in several medical areas. The tasks of those expert panels are set out in Article 106(9) and (10) of Regulation (EU) 2017/745.



(2)
In order to provide scientific and clinical advice in relation to medical devices andin vitrodiagnostics intended for small size patient populations, such as for patients with a rare disease or for children, an additional expert panel should be designated in that field.



(3)
Since 1 March 2022, pursuant to Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council(3), the European Medicines Agency, on behalf of the Commission, provides the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745. Implementing Decision (EU) 2019/1396 should therefore be amended to reflect that change.



(4)
Experience with the application of Implementing Decision (EU) 2019/1396 has demonstrated the need to adapt some of its technical or administrative aspects, such as the timing of the publication of scientific opinions and the remuneration of experts for the development and review of guidance, common specifications and standards.



(5)
The Medical Device Coordination Group has been consulted.



(6)
Implementing Decision (EU) 2019/1396 should therefore be amended accordingly,



(1)
Article 1(1) is amended as follows:(a)point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;(b)the following point (12) is added:‘(12)Paediatrics and rare diseases.’;
(a)
point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;
‘(11)
In vitrodiagnostic medical devices (IVD);’;
(b)
the following point (12) is added:‘(12)Paediatrics and rare diseases.’;
‘(12)
Paediatrics and rare diseases.’;

(a)
point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;
‘(11)
In vitrodiagnostic medical devices (IVD);’;

‘(11)
In vitrodiagnostic medical devices (IVD);’;

(b)
the following point (12) is added:‘(12)Paediatrics and rare diseases.’;
‘(12)
Paediatrics and rare diseases.’;

‘(12)
Paediatrics and rare diseases.’;



(a)
point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;
‘(11)
In vitrodiagnostic medical devices (IVD);’;

‘(11)
In vitrodiagnostic medical devices (IVD);’;



‘(11)
In vitrodiagnostic medical devices (IVD);’;



(b)
the following point (12) is added:‘(12)Paediatrics and rare diseases.’;
‘(12)
Paediatrics and rare diseases.’;

‘(12)
Paediatrics and rare diseases.’;



‘(12)
Paediatrics and rare diseases.’;



(2)
Article 2(6) is replaced by the following:‘6.   Where it is necessary due to the workload of a certain expert panel or the need to provide the required expertise to a certain expert panel, advisors on the central list or in another expert panel may be assigned to that expert panel for a specific role or task and for a limited period of time.’;



(3)
Article 3(1) is replaced by the following:‘1.   An expert panel may, in agreement with the Secretariat referred to in Article 10, establish permanent or ad hoc sub-groups entrusted with specific tasks and composed of a certain number of its members.’;



(4)
Article 8 is amended as follows:(a)the title is replaced by the following:‘Preparation of opinions, views or advice’;(b)paragraph 1 is replaced by the following:‘1.   For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;
(a)
the title is replaced by the following:‘Preparation of opinions, views or advice’;
(b)
paragraph 1 is replaced by the following:‘1.   For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;

(a)
the title is replaced by the following:‘Preparation of opinions, views or advice’;

(b)
paragraph 1 is replaced by the following:‘1.   For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;



(a)
the title is replaced by the following:‘Preparation of opinions, views or advice’;



(b)
paragraph 1 is replaced by the following:‘1.   For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;



(5)
Article 9 is amended as follows:(a)in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;(b)paragraph 3 is replaced by the following:‘3.   The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;(c)paragraph 4 is replaced by the following:‘4.   The common rules of procedure shall be publicly available on a dedicated website.’;
(a)
in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;
(b)
paragraph 3 is replaced by the following:‘3.   The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;
(c)
paragraph 4 is replaced by the following:‘4.   The common rules of procedure shall be publicly available on a dedicated website.’;

(a)
in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;

(b)
paragraph 3 is replaced by the following:‘3.   The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;

(c)
paragraph 4 is replaced by the following:‘4.   The common rules of procedure shall be publicly available on a dedicated website.’;



(a)
in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;



(b)
paragraph 3 is replaced by the following:‘3.   The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;



(c)
paragraph 4 is replaced by the following:‘4.   The common rules of procedure shall be publicly available on a dedicated website.’;



(6)
in Article 10, paragraphs 1 and 2 are replaced by the following:‘The European Medicines Agency, acting as secretariat for the expert panels in accordance with Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council(*1), shall also provide the secretariat for the Committee referred to in Article 7 of this Decision (the “Secretariat”).(*1)Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI:http://data.europa.eu/eli/reg/2022/123/oj).’;"



(7)
in Article 11, paragraph 2 is replaced by the following:‘2.   Travel and, where appropriate, subsistence expenses of advisors in connection with the activities of the expert panels governed by this Decision shall be reimbursed by the Secretariat in accordance with the provisions in force at the European Medicines Agency. Those expenses shall be reimbursed within the limits of the available appropriations allocated to the European Medicines Agency under the annual procedure for the allocation of resources.’;



(8)
Article 12(5) is replaced by the following:‘5.   Where the obligations referred to in paragraphs 1 to 4 are not met, the Commission or the Secretariat may take all appropriate measures.’;



(9)
Article 14 is amended as follows:(a)in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;(b)point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;
(a)
in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;
(b)
point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;
‘(d)
opinions, views and advice in accordance with Article 8.’;

(a)
in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;

(b)
point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;
‘(d)
opinions, views and advice in accordance with Article 8.’;

‘(d)
opinions, views and advice in accordance with Article 8.’;



(a)
in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;



(b)
point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;
‘(d)
opinions, views and advice in accordance with Article 8.’;

‘(d)
opinions, views and advice in accordance with Article 8.’;



‘(d)
opinions, views and advice in accordance with Article 8.’;



(10)
Article 15(3) is replaced by the following:‘3.   Where the obligations referred to in paragraphs 1 and 2 are not met, the Commission or the Secretariat may take all appropriate measures.’;



(11)
the Annex is amended in accordance with the Annex to this Decision.



(1)
Table 1 is replaced by the following:‘Table 1Maximum number of working days for which experts may be remunerated for tasks referred to in Article 54(1) of Regulation (EU) 2017/745 and Article 48(6) of Regulation (EU) 2017/746Regulation (EU) 2017/745Article 54(1)Regulation (EU) 2017/746Article 48(6)Decision on whether a scientific opinion should be developed (Yes/No)Development and provision of a scientific opinionProvision of a view of the performance of anin vitrodiagnostic medical deviceChair/Vice-ChairN/A33Rapporteur155Co-rapporteur155ReviewerN/A11Advisor assigned for a specific taskN/A11 ’

Regulation (EU) 2017/745Article 54(1)
Regulation (EU) 2017/746Article 48(6)

Decision on whether a scientific opinion should be developed (Yes/No)
Development and provision of a scientific opinion
Provision of a view of the performance of anin vitrodiagnostic medical device
Chair/Vice-Chair
N/A
3
3
Rapporteur
1
5
5
Co-rapporteur
1
5
5
Reviewer
N/A
1
1
Advisor assigned for a specific task
N/A
1
1 ’


Regulation (EU) 2017/745Article 54(1)
Regulation (EU) 2017/746Article 48(6)


Decision on whether a scientific opinion should be developed (Yes/No)
Development and provision of a scientific opinion
Provision of a view of the performance of anin vitrodiagnostic medical device

Chair/Vice-Chair
N/A
3
3

Rapporteur
1
5
5

Co-rapporteur
1
5
5

Reviewer
N/A
1
1

Advisor assigned for a specific task
N/A
1
1 ’




Regulation (EU) 2017/745Article 54(1)
Regulation (EU) 2017/746Article 48(6)


Decision on whether a scientific opinion should be developed (Yes/No)
Development and provision of a scientific opinion
Provision of a view of the performance of anin vitrodiagnostic medical device

Chair/Vice-Chair
N/A
3
3

Rapporteur
1
5
5

Co-rapporteur
1
5
5

Reviewer
N/A
1
1

Advisor assigned for a specific task
N/A
1
1 ’



(2)
Table 2 is replaced by the following:‘Table 2Maximum number of working days for which experts may be remunerated for tasks under Article 55(3), Article 61(2), Article 106(10), points (a) to (f), and Article 106(11) of Regulation (EU) 2017/745 and Article 50(3) of Regulation (EU) 2017/746Complexity of task (indicative criteria(*1))Acting asRemuneration in in full-day equivalentsCategory I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish taskChair/Vice-Chair2Rapporteur3Co-rapporteur3Reviewer0,5Advisor assigned for a specific task0,5Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish taskChair/Vice-Chair3Rapporteur5Co-rapporteur5Reviewer1Advisor assigned for a specific task1Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish taskChair/Vice-Chair4Rapporteur7Co-rapporteur7Reviewer2Advisor assigned for a specific task2Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish taskChair/Vice-Chair8Rapporteur21Co-rapporteur21Reviewer4Advisor assigned for a specific task4
Complexity of task (indicative criteria(*1))
Acting as
Remuneration in in full-day equivalents
Category I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish task
—
opinion based on examination of a low volume of data, documents and literature
—
no consultation of other scientific bodies
—
no information available from stakeholders including patient organisations and healthcare professionals
—
indicatively, less than three months to accomplish task
Chair/Vice-Chair
2
Rapporteur
3
Co-rapporteur
3
Reviewer
0,5
Advisor assigned for a specific task
0,5
Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish task
—
opinion based on a significant volume of data, documents and literature
—
feedback following consultation, if any, of other scientific bodies to be examined
—
information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, three to six months to accomplish task
Chair/Vice-Chair
3
Rapporteur
5
Co-rapporteur
5
Reviewer
1
Advisor assigned for a specific task
1
Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish task
—
opinion based on a significant volume of data, documents and literature
—
high volume of feedback following consultation, if any, of other scientific bodies to be examined
—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, more than six months to accomplish task
Chair/Vice-Chair
4
Rapporteur
7
Co-rapporteur
7
Reviewer
2
Advisor assigned for a specific task
2
Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish task
—
contributions based on a significant volume of data, documents and literature
—
high volume of feedback following consultation, if any, of other scientific bodies to be examined
—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, more than 12 months to accomplish task
Chair/Vice-Chair
8
Rapporteur
21
Co-rapporteur
21
Reviewer
4
Advisor assigned for a specific task
4

Complexity of task (indicative criteria(*1))
Acting as
Remuneration in in full-day equivalents

Category I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish task
—
opinion based on examination of a low volume of data, documents and literature
—
no consultation of other scientific bodies
—
no information available from stakeholders including patient organisations and healthcare professionals
—
indicatively, less than three months to accomplish task
Chair/Vice-Chair
2

—
opinion based on examination of a low volume of data, documents and literature

—
no consultation of other scientific bodies

—
no information available from stakeholders including patient organisations and healthcare professionals

—
indicatively, less than three months to accomplish task

Rapporteur
3

Co-rapporteur
3

Reviewer
0,5

Advisor assigned for a specific task
0,5

Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish task
—
opinion based on a significant volume of data, documents and literature
—
feedback following consultation, if any, of other scientific bodies to be examined
—
information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, three to six months to accomplish task
Chair/Vice-Chair
3

—
opinion based on a significant volume of data, documents and literature

—
feedback following consultation, if any, of other scientific bodies to be examined

—
information available from stakeholders including patient organisations and healthcare professionals, to be examined

—
indicatively, three to six months to accomplish task

Rapporteur
5

Co-rapporteur
5

Reviewer
1

Advisor assigned for a specific task
1

Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish task
—
opinion based on a significant volume of data, documents and literature
—
high volume of feedback following consultation, if any, of other scientific bodies to be examined
—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, more than six months to accomplish task
Chair/Vice-Chair
4

—
opinion based on a significant volume of data, documents and literature

—
high volume of feedback following consultation, if any, of other scientific bodies to be examined

—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

—
indicatively, more than six months to accomplish task

Rapporteur
7

Co-rapporteur
7

Reviewer
2

Advisor assigned for a specific task
2

Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish task
—
contributions based on a significant volume of data, documents and literature
—
high volume of feedback following consultation, if any, of other scientific bodies to be examined
—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, more than 12 months to accomplish task
Chair/Vice-Chair
8

—
contributions based on a significant volume of data, documents and literature

—
high volume of feedback following consultation, if any, of other scientific bodies to be examined

—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

—
indicatively, more than 12 months to accomplish task

Rapporteur
21

Co-rapporteur
21

Reviewer
4

Advisor assigned for a specific task
4



Complexity of task (indicative criteria(*1))
Acting as
Remuneration in in full-day equivalents

Category I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish task
—
opinion based on examination of a low volume of data, documents and literature
—
no consultation of other scientific bodies
—
no information available from stakeholders including patient organisations and healthcare professionals
—
indicatively, less than three months to accomplish task
Chair/Vice-Chair
2

—
opinion based on examination of a low volume of data, documents and literature

—
no consultation of other scientific bodies

—
no information available from stakeholders including patient organisations and healthcare professionals

—
indicatively, less than three months to accomplish task

Rapporteur
3

Co-rapporteur
3

Reviewer
0,5

Advisor assigned for a specific task
0,5

Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish task
—
opinion based on a significant volume of data, documents and literature
—
feedback following consultation, if any, of other scientific bodies to be examined
—
information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, three to six months to accomplish task
Chair/Vice-Chair
3

—
opinion based on a significant volume of data, documents and literature

—
feedback following consultation, if any, of other scientific bodies to be examined

—
information available from stakeholders including patient organisations and healthcare professionals, to be examined

—
indicatively, three to six months to accomplish task

Rapporteur
5

Co-rapporteur
5

Reviewer
1

Advisor assigned for a specific task
1

Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish task
—
opinion based on a significant volume of data, documents and literature
—
high volume of feedback following consultation, if any, of other scientific bodies to be examined
—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, more than six months to accomplish task
Chair/Vice-Chair
4

—
opinion based on a significant volume of data, documents and literature

—
high volume of feedback following consultation, if any, of other scientific bodies to be examined

—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

—
indicatively, more than six months to accomplish task

Rapporteur
7

Co-rapporteur
7

Reviewer
2

Advisor assigned for a specific task
2

Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish task
—
contributions based on a significant volume of data, documents and literature
—
high volume of feedback following consultation, if any, of other scientific bodies to be examined
—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—
indicatively, more than 12 months to accomplish task
Chair/Vice-Chair
8

—
contributions based on a significant volume of data, documents and literature

—
high volume of feedback following consultation, if any, of other scientific bodies to be examined

—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

—
indicatively, more than 12 months to accomplish task

Rapporteur
21

Co-rapporteur
21

Reviewer
4

Advisor assigned for a specific task
4



—
opinion based on examination of a low volume of data, documents and literature



—
no consultation of other scientific bodies



—
no information available from stakeholders including patient organisations and healthcare professionals



—
indicatively, less than three months to accomplish task



—
opinion based on a significant volume of data, documents and literature



—
feedback following consultation, if any, of other scientific bodies to be examined



—
information available from stakeholders including patient organisations and healthcare professionals, to be examined



—
indicatively, three to six months to accomplish task



—
opinion based on a significant volume of data, documents and literature



—
high volume of feedback following consultation, if any, of other scientific bodies to be examined



—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined



—
indicatively, more than six months to accomplish task



—
contributions based on a significant volume of data, documents and literature



—
high volume of feedback following consultation, if any, of other scientific bodies to be examined



—
large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined



—
indicatively, more than 12 months to accomplish task

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), and in particular Article 106(1) thereof,

Whereas:

(1) Article 1 of Commission Implementing Decision (EU) 2019/1396 (2) designates expert panels in several medical areas. The tasks of those expert panels are set out in Article 106(9) and (10) of Regulation (EU) 2017/745.

(2) In order to provide scientific and clinical advice in relation to medical devices and in vitro diagnostics intended for small size patient populations, such as for patients with a rare disease or for children, an additional expert panel should be designated in that field.

(3) Since 1 March 2022, pursuant to Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council (3), the European Medicines Agency, on behalf of the Commission, provides the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745. Implementing Decision (EU) 2019/1396 should therefore be amended to reflect that change.

(4) Experience with the application of Implementing Decision (EU) 2019/1396 has demonstrated the need to adapt some of its technical or administrative aspects, such as the timing of the publication of scientific opinions and the remuneration of experts for the development and review of guidance, common specifications and standards.

(5) The Medical Device Coordination Group has been consulted.

(6) Implementing Decision (EU) 2019/1396 should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:
Implementing Decision (EU) 2019/1396 is amended as follows:
(1) Article 1(1) is amended as follows:

(a) point (11) is replaced by the following:

‘(11) In vitro diagnostic medical devices (IVD);’;

(b) the following point (12) is added:

‘(12) Paediatrics and rare diseases.’;

(2) Article 2(6) is replaced by the following:

‘6.   Where it is necessary due to the workload of a certain expert panel or the need to provide the required expertise to a certain expert panel, advisors on the central list or in another expert panel may be assigned to that expert panel for a specific role or task and for a limited period of time.’

;

(3) Article 3(1) is replaced by the following:

‘1.   An expert panel may, in agreement with the Secretariat referred to in Article 10, establish permanent or ad hoc sub-groups entrusted with specific tasks and composed of a certain number of its members.’

;

(4) Article 8 is amended as follows:

(a) the title is replaced by the following:

                                          ‘Preparation of opinions, views or advice’;

(b) paragraph 1 is replaced by the following:

‘1.   For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’

;

(5) Article 9 is amended as follows:

(a) in paragraph 1, the first subparagraph is replaced by the following:

                                          ‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;

(b) paragraph 3 is replaced by the following:

‘3.   The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’

;

(c) paragraph 4 is replaced by the following:

‘4.   The common rules of procedure shall be publicly available on a dedicated website.’

;

(6) in Article 10, paragraphs 1 and 2 are replaced by the following:

                              ‘The European Medicines Agency, acting as secretariat for the expert panels in accordance with Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council (*1), shall also provide the secretariat for the Committee referred to in Article 7 of this Decision (the “Secretariat”).

(*1)  Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).’;”
(7) in Article 11, paragraph 2 is replaced by the following:

‘2.   Travel and, where appropriate, subsistence expenses of advisors in connection with the activities of the expert panels governed by this Decision shall be reimbursed by the Secretariat in accordance with the provisions in force at the European Medicines Agency. Those expenses shall be reimbursed within the limits of the available appropriations allocated to the European Medicines Agency under the annual procedure for the allocation of resources.’

;

(8) Article 12(5) is replaced by the following:

‘5.   Where the obligations referred to in paragraphs 1 to 4 are not met, the Commission or the Secretariat may take all appropriate measures.’

;

(9) Article 14 is amended as follows:

(a) in introductory part, the second sentence is replaced by the following:

                                          ‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;

(b) point (d) is replaced by the following:

‘(d) opinions, views and advice in accordance with Article 8.’;

(10) Article 15(3) is replaced by the following:

‘3.   Where the obligations referred to in paragraphs 1 and 2 are not met, the Commission or the Secretariat may take all appropriate measures.’

;

(11) the Annex is amended in accordance with the Annex to this Decision.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
The Annex to Implementing Decision (EU) 2019/1396 is amended as follows:
(1) Table 1 is replaced by the following:

‘Table 1

Maximum number of working days for which experts may be remunerated for tasks referred to in Article 54(1) of Regulation (EU) 2017/745 and Article 48(6) of Regulation (EU) 2017/746
Regulation (EU) 2017/745

Article 54(1) Regulation (EU) 2017/746

Article 48(6)  

Decision on whether a scientific opinion should be developed (Yes/No)

Development and provision of a scientific opinion

Provision of a view of the performance of an in vitro diagnostic medical device

Chair/Vice-Chair

N/A

3 

3 

Rapporteur

1

5 

5 

Co-rapporteur

1

5 

5 

Reviewer

N/A

1 

1 

Advisor assigned for a specific task

N/A

1 

1 ’

(2) Table 2 is replaced by the following:

‘Table 2

Maximum number of working days for which experts may be remunerated for tasks under Article 55(3), Article 61(2), Article 106(10), points (a) to (f), and Article 106(11) of Regulation (EU) 2017/745 and Article 50(3) of Regulation (EU) 2017/746

Complexity of task (indicative criteria (*1))

Acting as

Remuneration in in full-day equivalents

Category I

—

opinion based on examination of a low volume of data, documents and literature

—

no consultation of other scientific bodies

—

no information available from stakeholders including patient organisations and healthcare professionals

—

indicatively, less than three months to accomplish task

Chair/Vice-Chair

2 

Rapporteur

3 

Co-rapporteur

3 

Reviewer

0,5 

Advisor assigned for a specific task

0,5 

Category II

—

opinion based on a significant volume of data, documents and literature

—

feedback following consultation, if any, of other scientific bodies to be examined

—

information available from stakeholders including patient organisations and healthcare professionals, to be examined

—

indicatively, three to six months to accomplish task

Chair/Vice-Chair

3 

Rapporteur

5 

Co-rapporteur

5 

Reviewer

1 

Advisor assigned for a specific task

1 

Category III

—

opinion based on a significant volume of data, documents and literature

—

high volume of feedback following consultation, if any, of other scientific bodies to be examined

—

large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

—

indicatively, more than six months to accomplish task

Chair/Vice-Chair

4 

Rapporteur

7 

Co-rapporteur

7 

Reviewer

2 

Advisor assigned for a specific task

2 

Category IV

—

contributions based on a significant volume of data, documents and literature

—

high volume of feedback following consultation, if any, of other scientific bodies to be examined

—

large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

—

indicatively, more than 12 months to accomplish task

Chair/Vice-Chair

8 

Rapporteur

21 

Co-rapporteur

21 

Reviewer

4 

Advisor assigned for a specific task

4 
(*1)  Each of these criteria may be applied independently’
			

Commission Implementing Decision (EU) 2025/1321 of 4 July 2025 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2025) 4349)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2025/1321
7.7.2025

(1)
On 11 September 2015, Monsanto Europe S.A./N.V. on behalf of Monsanto Company, based in the United States, submitted to the national competent authority of the Netherlands an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application also covered the placing on the market of products containing or consisting of genetically modified soybean MON 87705 × MON 87708 × MON 89788 for uses other than food and feed, with the exception of cultivation.

(2)
In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council(2). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(3)
By a letter dated 27 August 2018, Monsanto Europe S.A./N.V. informed the Commission that, as of 23 August 2018, it converted its legal form and changed its name to Bayer Agriculture BVBA.

(4)
By a letter dated 28 July 2020, Bayer Agriculture BVBA informed the Commission that, as of 1 August 2020, it changed its name to Bayer Agriculture BV.

(5)
By a letter dated 28 July 2020, Bayer Agriculture BVBA, representing Monsanto Company, based in the United States, informed the Commission that, as of 1 August 2020, Monsanto Company, based in the United States, converted its legal form and changed its name to Bayer CropScience LP.

(6)
On 18 May 2020, the European Food Safety Authority (‘the Authority’) issued a scientific opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 on genetically modified soybean MON 87705 × MON 87708 × MON 89788. The Authority had considered all the questions and concerns raised by the Member States in the context of the consultation with the national competent authorities, as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(7)
The Authority also concluded that the monitoring plan for environmental effects submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products.

(8)
However, the Authority was not able to finalise the risk assessment and to conclude on the safety of genetically modified soybean MON 87705 × MON 87708 × MON 89788 because of the absence of a 90-day study on genetically modified soybean MON 87705 and of the absence a post-market monitoring plan taking into consideration the altered fatty acid profile of this soybean stack.

(9)
On 20 March 2024, Bayer Agriculture BV provided a 90-day study on genetically modified soybean MON 87705 and the post-market monitoring plan, which considered the altered fatty acid profile of genetically modified soybean MON 87705 × MON 87708 × MON 89788.

(10)
On 28 October 2024, the Authority issued a statement(4)complementing its scientific opinion of 18 May 2020, based on the additional data provided by the applicant. The Authority concluded that genetically modified soybean MON 87705 × MON 87708 × MON 89788, as described in the application, is as safe as its conventional counterpart and the tested non-genetically modified soybean reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of genetically modified soybean MON 87705 × MON 87708 × MON 89788 does not represent any nutritional concern.

(11)
In addition, the Authority recommended implementing a post-market monitoring plan, focusing on the collection of data of imports entering into the Union of genetically modified soybean MON 87705 × MON 87708 × MON 89788 and products derived from it for food, and on the collection of consumption data for humans, to verify that the conditions of use of genetically modified soybean MON 87705 × MON 87708 × MON 89788 are those considered during the pre-marketing risk assessment.

(12)
Taking into account the conclusions contained in the statement of the Authority of 28 October 2024, the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788 should be authorised for the uses listed in the application.

(13)
A unique identifier should be assigned to genetically modified soybean MON 87705 × MON 87708 × MON 89788 in accordance with Commission Regulation (EC) No 65/2004(5).

(14)
Food, food ingredients and feed containing, consisting of, or produced genetically modified soybean MON 87705 × MON 87708 × MON 89788 should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

(15)
On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of genetically modified soybean MON 87705 × MON 87708 × MON 89788 and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

(16)
Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(17)
In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products should be complemented by a clear indication that the products in question must not be used for cultivation.

(18)
The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC(7).

(19)
The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(20)
The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling of genetically modified soybean MON 87705 × MON 87708 × MON 89788 or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

(21)
All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(22)
This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).

(23)
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)
foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(b)
feed containing, consisting of or produced from genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(c)
products containing or consisting of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

(a)
Applicant and authorisation holder:Name:Bayer CropScience LP;Address:800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;Represented in the Union by: Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, Belgium.
Name
:
Bayer CropScience LP;
Address
:
800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;

Name
:
Bayer CropScience LP;

Address
:
800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;

Name
:
Bayer CropScience LP;

Address
:
800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;

(b)
Designation and specification of the products:(1)foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);(2)feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);(3)products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.The genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, as described in the application, is produced by crosses between soybean containing MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 events. MON-877Ø5-6 produces dsRNAs which downregulate endogenous fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes; MON-877Ø8-9 expresses the DMO protein and MON-89788-1 expresses the CP4 EPSPS protein. This combination confers an altered fatty acid profile (increased oleic acid and reduced linoleic acid content), and tolerance to herbicides containing glyphosate and to herbicides containing dicamba.
(1)
foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);
(2)
feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);
(3)
products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(2)
feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(3)
products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(2)
feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(3)
products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(c)
Labelling:(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;(2)For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;(3)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).
(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;
(2)
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;
(3)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

(2)
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;

(3)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

(2)
For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;

(3)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).

(d)
Method for detection:(1)The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.(3)Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.
(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.
(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.
(3)
Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.

(3)
Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.

(3)
Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

(e)
Unique identifier:MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.

(f)
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:[Biosafety Clearing-House, Record ID number:published in the Community register of genetically modified food and feed when notified].

(g)
Conditions or restrictions on the placing on the market, use or handling of the products:Not required.

(h)
Monitoring plan for environmental effects:Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.[Link:plan published in the Community register of genetically modified food and feed]

(i)
Post-market monitoring plan:1.The authorisation holder shall collect the following information:(i)quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.2.The authorisation holder shall, based on the information collected and reported:(i)review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;(ii)verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.
1.
The authorisation holder shall collect the following information:(i)quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i)
quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii)
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
2.
The authorisation holder shall, based on the information collected and reported:(i)review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;(ii)verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.
(i)
review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;
(ii)
verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

1.
The authorisation holder shall collect the following information:(i)quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i)
quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii)
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

(i)
quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;

(ii)
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

2.
The authorisation holder shall, based on the information collected and reported:(i)review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;(ii)verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.
(i)
review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;
(ii)
verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

(i)
review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(ii)
verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

1.
The authorisation holder shall collect the following information:(i)quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i)
quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii)
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

(i)
quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;

(ii)
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

(i)
quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;

(ii)
In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

2.
The authorisation holder shall, based on the information collected and reported:(i)review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;(ii)verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.
(i)
review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;
(ii)
verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

(i)
review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(ii)
verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

(i)
review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(ii)
verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

Note:
links to relevant documents may need to be modified over time. Those modifications will be made available to the public through the update of the Community register of genetically modified food and feed.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 7(3) and Article 19(3) thereof,

Whereas:

(1) On 11 September 2015, Monsanto Europe S.A./N.V. on behalf of Monsanto Company, based in the United States, submitted to the national competent authority of the Netherlands an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application also covered the placing on the market of products containing or consisting of genetically modified soybean MON 87705 × MON 87708 × MON 89788 for uses other than food and feed, with the exception of cultivation.

(2) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (2). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(3) By a letter dated 27 August 2018, Monsanto Europe S.A./N.V. informed the Commission that, as of 23 August 2018, it converted its legal form and changed its name to Bayer Agriculture BVBA.

(4) By a letter dated 28 July 2020, Bayer Agriculture BVBA informed the Commission that, as of 1 August 2020, it changed its name to Bayer Agriculture BV.

(5) By a letter dated 28 July 2020, Bayer Agriculture BVBA, representing Monsanto Company, based in the United States, informed the Commission that, as of 1 August 2020, Monsanto Company, based in the United States, converted its legal form and changed its name to Bayer CropScience LP.

(6) On 18 May 2020, the European Food Safety Authority (‘the Authority’) issued a scientific opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 on genetically modified soybean MON 87705 × MON 87708 × MON 89788. The Authority had considered all the questions and concerns raised by the Member States in the context of the consultation with the national competent authorities, as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(7) The Authority also concluded that the monitoring plan for environmental effects submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products.

(8) However, the Authority was not able to finalise the risk assessment and to conclude on the safety of genetically modified soybean MON 87705 × MON 87708 × MON 89788 because of the absence of a 90-day study on genetically modified soybean MON 87705 and of the absence a post-market monitoring plan taking into consideration the altered fatty acid profile of this soybean stack.

(9) On 20 March 2024, Bayer Agriculture BV provided a 90-day study on genetically modified soybean MON 87705 and the post-market monitoring plan, which considered the altered fatty acid profile of genetically modified soybean MON 87705 × MON 87708 × MON 89788.

(10) On 28 October 2024, the Authority issued a statement (4) complementing its scientific opinion of 18 May 2020, based on the additional data provided by the applicant. The Authority concluded that genetically modified soybean MON 87705 × MON 87708 × MON 89788, as described in the application, is as safe as its conventional counterpart and the tested non-genetically modified soybean reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of genetically modified soybean MON 87705 × MON 87708 × MON 89788 does not represent any nutritional concern.

(11) In addition, the Authority recommended implementing a post-market monitoring plan, focusing on the collection of data of imports entering into the Union of genetically modified soybean MON 87705 × MON 87708 × MON 89788 and products derived from it for food, and on the collection of consumption data for humans, to verify that the conditions of use of genetically modified soybean MON 87705 × MON 87708 × MON 89788 are those considered during the pre-marketing risk assessment.

(12) Taking into account the conclusions contained in the statement of the Authority of 28 October 2024, the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788 should be authorised for the uses listed in the application.

(13) A unique identifier should be assigned to genetically modified soybean MON 87705 × MON 87708 × MON 89788 in accordance with Commission Regulation (EC) No 65/2004 (5).

(14) Food, food ingredients and feed containing, consisting of, or produced genetically modified soybean MON 87705 × MON 87708 × MON 89788 should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

(15) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of genetically modified soybean MON 87705 × MON 87708 × MON 89788 and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

(16) Regulation (EC) No 1830/2003 of the European Parliament and of the Council (6) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(17) In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products should be complemented by a clear indication that the products in question must not be used for cultivation.

(18) The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (7).

(19) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(20) The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling of genetically modified soybean MON 87705 × MON 87708 × MON 89788 or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

(21) All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(22) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (8).

(23) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:
Genetically modified organism and unique identifierGenetically modified soybean (Glycine max (L.) Merr.) MON 87705 × MON 87708 × MON 89788, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, in accordance with Regulation (EC) No 65/2004.
AuthorisationThe following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a) foods and food ingredients containing, consisting of or produced from genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(b) feed containing, consisting of or produced from genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(c) products containing or consisting of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for uses other than those provided for in points (a) and (b), with the exception of cultivation.
Labelling 1.   For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘soybean’.
 2.   For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
 3.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).
Method for detectionThe method set out in point (d) of the Annex shall apply for the detection of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.
Monitoring plan for environmental effects 1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
 2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
Post-market monitoring 1.   The authorisation holder shall ensure that the post-market monitoring plan for genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, as set out in point (i) of the Annex, is put in place and implemented.
 2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
Community registerThe information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.
Authorisation holderThe authorisation holder shall be Bayer CropScience LP, represented in the Union by Bayer Agriculture BV.
ValidityThis Decision shall apply for a period of 10 years from the date of its notification.
AddresseeThis Decision is addressed to Bayer CropScience LP, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States, represented in the Union by Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, Belgium.

(a) Applicant and authorisation holder:

Name

:

Bayer CropScience LP;

Address

:

800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;

Represented in the Union by: Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, Belgium.

(b) Designation and specification of the products:

(1) foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(2) feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);

(3) products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, as described in the application, is produced by crosses between soybean containing MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 events. MON-877Ø5-6 produces dsRNAs which downregulate endogenous fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes; MON-877Ø8-9 expresses the DMO protein and MON-89788-1 expresses the CP4 EPSPS protein. This combination confers an altered fatty acid profile (increased oleic acid and reduced linoleic acid content), and tolerance to herbicides containing glyphosate and to herbicides containing dicamba.

(c) Labelling:

(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

(2) For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;

(3) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).

(d) Method for detection:

(1) The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1. (2) Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.

(3) Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

(e) Unique identifier:

MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1. 
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan for environmental effects:

Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.

[Link: plan published in the Community register of genetically modified food and feed]

(i) Post-market monitoring plan: 1. The authorisation holder shall collect the following information:

(i) quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;

(ii) In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed. 2. The authorisation holder shall, based on the information collected and reported:

(i) review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;

(ii) verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.

Note:

links to relevant documents may need to be modified over time. Those modifications will be made available to the public through the update of the Community register of genetically modified food and feed.

	Name	Identifying information	Statement of Reasons	Date of listing
‘1.	Michael MAKUEI LUETH	DOB: 1947POB: Bor, South Sudan; Bor, SudanGender: male	Michael Makuei Lueth has held the position of Minister for Information and Broadcasting since 2013 and continues to hold that position in the Revitalised Transitional Government of National Unity in South Sudan. He was also the public spokesman for the government delegation to the Intergovernmental Authority on Development peace talks from 2014 to 2015 and from 2016 to 2018.Michael Makuei Lueth has obstructed, in particular through inflammatory public statements, the implementation of the Agreement on the Resolution of the Conflict in South Sudan (ARCSS) of August 2015 (replaced in September 2018 by the “Revitalised ARCSS” (R-ARCSS)), the work of the ARCSS Joint Monitoring and Evaluation Commission (JMEC, renamed “Reconstituted JMEC” under R-ARCSS), the establishment of the ARCSS Transitional Justice Institutions (also provided for in R-ARCSS), and the operations of the United Nations’ Regional Protection Force.In addition, Michael Makuei Lueth is involved in the systematic curtailment of political and democratic space and in the repression of media, including through regular threats against journalists and support to media censorship, which hinders democratisation and sustainable peace in South Sudan.Since the beginning of 2025, Michael Makuei Lueth has publicly dismissed calls for dialogue, using confrontational and inflammatory rhetoric in an increasingly tense environment. Michael Makuei Lueth has also defended the arrests against First Vice-President Riek Machar and his allies, hampering efforts to deescalate the situation.Therefore, Michael Makuei Lueth has been obstructing the political process in South Sudan and is responsible for serious violations of human rights, in particular freedom of expression.	3.2.2018’

Administrative area and ADIS reference number of the outbreak	Areas established as protection and surveillance zones, part of the restricted zone in France, referred to in Article 1	Date until applicable
Region of Auvergne-Rhône-AlpesFR-LSD-2025-00001	Protection zone:Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 20 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001).	28.7.2025
Surveillance zone:Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 50 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001) excluding the areas included in the protection zone.	14.8.2025
Surveillance zone:Those parts of the region of Auvergne-Rhône-Alpes, contained within a circle of a radius of 20 kilometres, centred on UTM 30, ETRS89 coordinates Lat. 45.79778582, Long. 5.89422132 (FR-LSD-2025-00001).	29.7.2025 – 14.8.2025

(a)	as regards the section Tallinn-Pärnu:(i)land acquisition shall be completed by 31 December 2026;(ii)the construction of the railway substructure shall begin by 31 December 2025;(iii)the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;	(i)	land acquisition shall be completed by 31 December 2026;	(ii)	the construction of the railway substructure shall begin by 31 December 2025;	(iii)	the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;
(i)	land acquisition shall be completed by 31 December 2026;
(ii)	the construction of the railway substructure shall begin by 31 December 2025;
(iii)	the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(b)	as regards the section Pärnu-border between Estonia and Latvia:(i)the design of the railway infrastructure sub-system shall be completed by 31 December 2026;(ii)land acquisition shall be completed by 31 December 2026;(iii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;(iv)the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;	(i)	the design of the railway infrastructure sub-system shall be completed by 31 December 2026;	(ii)	land acquisition shall be completed by 31 December 2026;	(iii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;	(iv)	the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;
(i)	the design of the railway infrastructure sub-system shall be completed by 31 December 2026;
(ii)	land acquisition shall be completed by 31 December 2026;
(iii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;
(iv)	the construction of the railway infrastructure sub-system shall be completed by 31 December 2028;

(c)	as regards the section border between Estonia and Latvia-Salaspils:(i)the design of the railway infrastructure sub-system shall be completed by 31 December 2026;(ii)land acquisition shall be completed by 30 June 2027;(iii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;(iv)the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;	(i)	the design of the railway infrastructure sub-system shall be completed by 31 December 2026;	(ii)	land acquisition shall be completed by 30 June 2027;	(iii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;	(iv)	the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;
(i)	the design of the railway infrastructure sub-system shall be completed by 31 December 2026;
(ii)	land acquisition shall be completed by 30 June 2027;
(iii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2026;
(iv)	the construction of the railway infrastructure sub-system shall be completed by 31 December 2029;

(d)	as regards the section Salaspils-border between Latvia and Lithuania:(i)the design of the railway infrastructure subsystem shall be completed by 31 December 2025;(ii)land acquisition shall be completed by 31 December 2026;(iii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;(iv)the construction of the railway infrastructure sub-system border shall be completed by mid-2029;	(i)	the design of the railway infrastructure subsystem shall be completed by 31 December 2025;	(ii)	land acquisition shall be completed by 31 December 2026;	(iii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;	(iv)	the construction of the railway infrastructure sub-system border shall be completed by mid-2029;
(i)	the design of the railway infrastructure subsystem shall be completed by 31 December 2025;
(ii)	land acquisition shall be completed by 31 December 2026;
(iii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2025;
(iv)	the construction of the railway infrastructure sub-system border shall be completed by mid-2029;

(e)	as regards the section border between Latvia and Lithuania-Panevėžys:(i)the design of the railway infrastructure sub-system shall be completed by 31 December 2027;(ii)the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;(iii)the construction of the railway infrastructure sub-system shall be underway by mid-2029;	(i)	the design of the railway infrastructure sub-system shall be completed by 31 December 2027;	(ii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;	(iii)	the construction of the railway infrastructure sub-system shall be underway by mid-2029;
(i)	the design of the railway infrastructure sub-system shall be completed by 31 December 2027;
(ii)	the construction of the railway substructure shall begin and make sufficient progress by 31 December 2027;
(iii)	the construction of the railway infrastructure sub-system shall be underway by mid-2029;

(f)	as regards the section Panevėžys-Kaunas:(i)the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025(ii)the construction of the railway substructure shall be completed by 31 December 2028;(iii)the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;	(i)	the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025	(ii)	the construction of the railway substructure shall be completed by 31 December 2028;	(iii)	the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;
(i)	the construction of the railway infrastructure sub-system (railway superstructure) shall begin and make sufficient progress by 31 December 2025
(ii)	the construction of the railway substructure shall be completed by 31 December 2028;
(iii)	the railway infrastructure sub-system (railway superstructure) shall be completed by mid-2029;

(g)	as regards the section Kaunas-Warszawa (with a connection to Vilnius):(i)land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;(ii)land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;(iii)the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);(iv)the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;(v)the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;	(i)	land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;	(ii)	land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;	(iii)	the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);	(iv)	the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;	(v)	the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;
(i)	land acquisition shall be completed by 31 December 2026, except for the section between Kaunas to Vilnius;
(ii)	land acquisition shall be completed by 31 December 2027 for the section from Kaunas to Vilnius;
(iii)	the design of the railway infrastructure sub-system shall be completed by mid-2029 (including the connection to Vilnius);
(iv)	the railway infrastructure shall be completed by 31 December 2028 from the Lithuanian-Polish border to Marijampole to ensure a connection to the existing railway line consisting of the European standard nominal track gauge of 1 435 mm;
(v)	the railway infrastructure from Marijampole to Kaunas shall be completed by 31 December 2029;

(h)	as regards the section Warszawa-border between Lithuania and Poland:(i)the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;(ii)the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;	(i)	the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;	(ii)	the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;
(i)	the rail infrastructure upgrade works on the section Warszawa-Ełk shall be completed by 31 December 2029;
(ii)	the section Ełk-border border between Lithuania and Poland shall be completed by 31 December 2030;

(1)	Article 1(1) is amended as follows:(a)point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;(b)the following point (12) is added:‘(12)Paediatrics and rare diseases.’;	(a)	point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;	‘(11)	In vitrodiagnostic medical devices (IVD);’;	(b)	the following point (12) is added:‘(12)Paediatrics and rare diseases.’;	‘(12)	Paediatrics and rare diseases.’;
(a)	point (11) is replaced by the following:‘(11)In vitrodiagnostic medical devices (IVD);’;	‘(11)	In vitrodiagnostic medical devices (IVD);’;
‘(11)	In vitrodiagnostic medical devices (IVD);’;
(b)	the following point (12) is added:‘(12)Paediatrics and rare diseases.’;	‘(12)	Paediatrics and rare diseases.’;
‘(12)	Paediatrics and rare diseases.’;

(4)	Article 8 is amended as follows:(a)the title is replaced by the following:‘Preparation of opinions, views or advice’;(b)paragraph 1 is replaced by the following:‘1. For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;	(a)	the title is replaced by the following:‘Preparation of opinions, views or advice’;	(b)	paragraph 1 is replaced by the following:‘1. For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;
(a)	the title is replaced by the following:‘Preparation of opinions, views or advice’;
(b)	paragraph 1 is replaced by the following:‘1. For each opinion, view or advice under preparation, the Chair of the expert panel or of the sub-group may appoint a rapporteur, a co-rapporteur and reviewers.’;

(5)	Article 9 is amended as follows:(a)in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;(b)paragraph 3 is replaced by the following:‘3. The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;(c)paragraph 4 is replaced by the following:‘4. The common rules of procedure shall be publicly available on a dedicated website.’;	(a)	in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;	(b)	paragraph 3 is replaced by the following:‘3. The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;	(c)	paragraph 4 is replaced by the following:‘4. The common rules of procedure shall be publicly available on a dedicated website.’;
(a)	in paragraph 1, the first subparagraph is replaced by the following:‘On a proposal by the Secretariat referred to in Article 10 and in agreement with the Commission services, the Committee shall adopt common rules of procedure for all expert panels by simple majority of its members.’;
(b)	paragraph 3 is replaced by the following:‘3. The Committee shall, in agreement with the Secretariat referred to in Article 10 and the Commission services, update the common rules of procedure when needed.’;
(c)	paragraph 4 is replaced by the following:‘4. The common rules of procedure shall be publicly available on a dedicated website.’;

(9)	Article 14 is amended as follows:(a)in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;(b)point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;	(a)	in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;	(b)	point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;	‘(d)	opinions, views and advice in accordance with Article 8.’;
(a)	in introductory part, the second sentence is replaced by the following:‘The Secretariat shall, in particular, make the following information available to the public on a dedicated website:’;
(b)	point (d) is replaced by the following:‘(d)opinions, views and advice in accordance with Article 8.’;	‘(d)	opinions, views and advice in accordance with Article 8.’;
‘(d)	opinions, views and advice in accordance with Article 8.’;

(1)	Table 1 is replaced by the following:‘Table 1Maximum number of working days for which experts may be remunerated for tasks referred to in Article 54(1) of Regulation (EU) 2017/745 and Article 48(6) of Regulation (EU) 2017/746Regulation (EU) 2017/745Article 54(1)Regulation (EU) 2017/746Article 48(6)Decision on whether a scientific opinion should be developed (Yes/No)Development and provision of a scientific opinionProvision of a view of the performance of anin vitrodiagnostic medical deviceChair/Vice-ChairN/A33Rapporteur155Co-rapporteur155ReviewerN/A11Advisor assigned for a specific taskN/A11 ’		Regulation (EU) 2017/745Article 54(1)	Regulation (EU) 2017/746Article 48(6)	Decision on whether a scientific opinion should be developed (Yes/No)	Development and provision of a scientific opinion	Provision of a view of the performance of anin vitrodiagnostic medical device	Chair/Vice-Chair	N/A	3	3	Rapporteur	1	5	5	Co-rapporteur	1	5	5	Reviewer	N/A	1	1	Advisor assigned for a specific task	N/A	1	1 ’
	Regulation (EU) 2017/745Article 54(1)	Regulation (EU) 2017/746Article 48(6)
	Decision on whether a scientific opinion should be developed (Yes/No)	Development and provision of a scientific opinion	Provision of a view of the performance of anin vitrodiagnostic medical device
Chair/Vice-Chair	N/A	3	3
Rapporteur	1	5	5
Co-rapporteur	1	5	5
Reviewer	N/A	1	1
Advisor assigned for a specific task	N/A	1	1 ’

(2)	Table 2 is replaced by the following:‘Table 2Maximum number of working days for which experts may be remunerated for tasks under Article 55(3), Article 61(2), Article 106(10), points (a) to (f), and Article 106(11) of Regulation (EU) 2017/745 and Article 50(3) of Regulation (EU) 2017/746Complexity of task (indicative criteria(*1))Acting asRemuneration in in full-day equivalentsCategory I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish taskChair/Vice-Chair2Rapporteur3Co-rapporteur3Reviewer0,5Advisor assigned for a specific task0,5Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish taskChair/Vice-Chair3Rapporteur5Co-rapporteur5Reviewer1Advisor assigned for a specific task1Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish taskChair/Vice-Chair4Rapporteur7Co-rapporteur7Reviewer2Advisor assigned for a specific task2Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish taskChair/Vice-Chair8Rapporteur21Co-rapporteur21Reviewer4Advisor assigned for a specific task4	Complexity of task (indicative criteria(*1))	Acting as	Remuneration in in full-day equivalents	Category I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish task	—	opinion based on examination of a low volume of data, documents and literature	—	no consultation of other scientific bodies	—	no information available from stakeholders including patient organisations and healthcare professionals	—	indicatively, less than three months to accomplish task	Chair/Vice-Chair	2	Rapporteur	3	Co-rapporteur	3	Reviewer	0,5	Advisor assigned for a specific task	0,5	Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish task	—	opinion based on a significant volume of data, documents and literature	—	feedback following consultation, if any, of other scientific bodies to be examined	—	information available from stakeholders including patient organisations and healthcare professionals, to be examined	—	indicatively, three to six months to accomplish task	Chair/Vice-Chair	3	Rapporteur	5	Co-rapporteur	5	Reviewer	1	Advisor assigned for a specific task	1	Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish task	—	opinion based on a significant volume of data, documents and literature	—	high volume of feedback following consultation, if any, of other scientific bodies to be examined	—	large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined	—	indicatively, more than six months to accomplish task	Chair/Vice-Chair	4	Rapporteur	7	Co-rapporteur	7	Reviewer	2	Advisor assigned for a specific task	2	Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish task	—	contributions based on a significant volume of data, documents and literature	—	high volume of feedback following consultation, if any, of other scientific bodies to be examined	—	large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined	—	indicatively, more than 12 months to accomplish task	Chair/Vice-Chair	8	Rapporteur	21	Co-rapporteur	21	Reviewer	4	Advisor assigned for a specific task	4
Complexity of task (indicative criteria(*1))	Acting as	Remuneration in in full-day equivalents
Category I—opinion based on examination of a low volume of data, documents and literature—no consultation of other scientific bodies—no information available from stakeholders including patient organisations and healthcare professionals—indicatively, less than three months to accomplish task	—	opinion based on examination of a low volume of data, documents and literature	—	no consultation of other scientific bodies	—	no information available from stakeholders including patient organisations and healthcare professionals	—	indicatively, less than three months to accomplish task	Chair/Vice-Chair	2
—	opinion based on examination of a low volume of data, documents and literature
—	no consultation of other scientific bodies
—	no information available from stakeholders including patient organisations and healthcare professionals
—	indicatively, less than three months to accomplish task
Rapporteur	3
Co-rapporteur	3
Reviewer	0,5
Advisor assigned for a specific task	0,5
Category II—opinion based on a significant volume of data, documents and literature—feedback following consultation, if any, of other scientific bodies to be examined—information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, three to six months to accomplish task	—	opinion based on a significant volume of data, documents and literature	—	feedback following consultation, if any, of other scientific bodies to be examined	—	information available from stakeholders including patient organisations and healthcare professionals, to be examined	—	indicatively, three to six months to accomplish task	Chair/Vice-Chair	3
—	opinion based on a significant volume of data, documents and literature
—	feedback following consultation, if any, of other scientific bodies to be examined
—	information available from stakeholders including patient organisations and healthcare professionals, to be examined
—	indicatively, three to six months to accomplish task
Rapporteur	5
Co-rapporteur	5
Reviewer	1
Advisor assigned for a specific task	1
Category III—opinion based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than six months to accomplish task	—	opinion based on a significant volume of data, documents and literature	—	high volume of feedback following consultation, if any, of other scientific bodies to be examined	—	large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined	—	indicatively, more than six months to accomplish task	Chair/Vice-Chair	4
—	opinion based on a significant volume of data, documents and literature
—	high volume of feedback following consultation, if any, of other scientific bodies to be examined
—	large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—	indicatively, more than six months to accomplish task
Rapporteur	7
Co-rapporteur	7
Reviewer	2
Advisor assigned for a specific task	2
Category IV—contributions based on a significant volume of data, documents and literature—high volume of feedback following consultation, if any, of other scientific bodies to be examined—large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined—indicatively, more than 12 months to accomplish task	—	contributions based on a significant volume of data, documents and literature	—	high volume of feedback following consultation, if any, of other scientific bodies to be examined	—	large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined	—	indicatively, more than 12 months to accomplish task	Chair/Vice-Chair	8
—	contributions based on a significant volume of data, documents and literature
—	high volume of feedback following consultation, if any, of other scientific bodies to be examined
—	large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined
—	indicatively, more than 12 months to accomplish task
Rapporteur	21
Co-rapporteur	21
Reviewer	4
Advisor assigned for a specific task	4

(a)	Applicant and authorisation holder:Name:Bayer CropScience LP;Address:800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;Represented in the Union by: Bayer Agriculture BV, Haven 627, Scheldelaan 460, 2040 Antwerp, Belgium.	Name	:	Bayer CropScience LP;	Address	:	800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;
Name	:	Bayer CropScience LP;
Address	:	800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States;

(b)	Designation and specification of the products:(1)foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);(2)feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);(3)products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.The genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1, as described in the application, is produced by crosses between soybean containing MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 events. MON-877Ø5-6 produces dsRNAs which downregulate endogenous fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes; MON-877Ø8-9 expresses the DMO protein and MON-89788-1 expresses the CP4 EPSPS protein. This combination confers an altered fatty acid profile (increased oleic acid and reduced linoleic acid content), and tolerance to herbicides containing glyphosate and to herbicides containing dicamba.	(1)	foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);	(2)	feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);	(3)	products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.
(1)	foods and food ingredients containing, consisting of or produced from genetically modified soybean as referred to in point (e);
(2)	feed containing, consisting of or produced from genetically modified soybean as referred to in point (e);
(3)	products containing or consisting of genetically modified soybean as referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(c)	Labelling:(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;(2)For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;(3)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).	(1)	For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;	(2)	For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;	(3)	The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).
(1)	For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;
(2)	For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;
(3)	The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified soybean referred to in point (e), with the exception of the products referred to in point (b)(1).

(d)	Method for detection:(1)The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.(3)Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.	(1)	The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.	(2)	Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.	(3)	Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.
(1)	The quantitative event-specific PCR detection methods are those individually validated for genetically modified soybean MON-877Ø5-6, MON-877Ø8-9 and MON-89788-1 and further verified on soybean stack MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1.
(2)	Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.
(3)	Reference Material: AOCS 0210-A (for MON87705), AOCS 0311-A (for MON87708) and AOCS 0906-B (for MON 89788) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

1.	The authorisation holder shall collect the following information:(i)quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.	(i)	quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;	(ii)	In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.
(i)	quantities of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii)	In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

2.	The authorisation holder shall, based on the information collected and reported:(i)review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;(ii)verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.	(i)	review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;	(ii)	verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.
(i)	review the predicted consumption data of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1;
(ii)	verify that the conditions of use of genetically modified soybean MON-877Ø5-6 × MON-877Ø8-9 × MON-89788-1 are those considered during the pre-market risk assessment.