Commission Delegated Regulation (EU) 2025/1535 of 29 July 2025 supplementing Regulation (EU) 2024/2847 of the European Parliament and of the Council with regard to an exclusion from the application of that Regulation for certain products with digital elements falling within the scope of Regulation (EU) No 168/2013 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/1535 29.10.2025
(1) Pursuant to Article (2) of Regulation (EU) 2024/2847, the application of that Regulation to products with digital elements covered by other Union rules laying down requirements that address all or some of the risks covered by the essential cybersecurity requirements set out in that Regulation may be limited or excluded where such limitation or exclusion is consistent with the overall regulatory framework applying to those products and where the sectoral rules achieve at least the same level of protection as the one provided for by that Regulation.
(2) Regulation (EU) No 168/2013 of the European Parliament and of the Council(2)establishes the administrative and technical requirements for the type-approval of two- or three-wheel vehicles and quadricycles as categorised in that Regulation (‘L-category vehicles’). Commission Delegated Regulation (EU) No 44/2014(3)establishes the detailed technical requirements and test procedures regarding vehicle construction and general requirements for the approval of L-category vehicles and the systems, components and separate technical units intended for such vehicles in accordance with Regulation (EU) No 168/2013 and sets out a list of UNECE regulations and amendments thereto. Pursuant to Article 4(1) of Delegated Regulation (EU) No 44/2014, the UNECE regulations and amendments thereto set out in Annex I to that Delegated Regulation are to apply to type approval of L-category vehicles.
(3) The scope of UN Regulation No 155(4)has been extended to include rules on cybersecurity for L-category vehicles. Therefore, Delegated Regulation (EU) No 44/2014 has been amended by Commission Delegated Regulation (EU) 2025/1455(5)amending Delegated Regulation (EU) No 44/2014 as regards laying down technical requirements and testing procedures regarding the protection of L-category vehicles against cyberattacks to include UN Regulation No 155 in the list of UNECE regulations applying on a compulsory basis set out in Annex I to that Delegated Regulation. L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 were however excluded from the compulsory application of UN Regulation No 155. Delegated Regulation (EU) 2025/1455 is to apply to new vehicle types from 11 December 2027 and to existing vehicle types from 11 June 2029.
(4) UN Regulation No 155 introduces certain cybersecurity requirements, including on the operation of a certified cybersecurity management system, on software updates, covering organisations’ policies and processes for cybersecurity risks related to the entire lifecycle of vehicles, equipment and services. It addresses cybersecurity risks in a manner that is comparable to Regulation (EU) 2024/2847 and achieves at least the same level of protection as that Regulation. In addition, UN Regulation No 155 ensures consistency with the overall type-approval framework applying to L-category vehicles. Consequently, Regulation (EU) 2024/2847 should not apply to products with digital elements falling within the scope of Regulation (EU) No 168/2013, with the exception of L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act)(1), and in particular Article 2(5), second subparagraph, thereof,
(1) Pursuant to Article (2) of Regulation (EU) 2024/2847, the application of that Regulation to products with digital elements covered by other Union rules laying down requirements that address all or some of the risks covered by the essential cybersecurity requirements set out in that Regulation may be limited or excluded where such limitation or exclusion is consistent with the overall regulatory framework applying to those products and where the sectoral rules achieve at least the same level of protection as the one provided for by that Regulation.
(2) Regulation (EU) No 168/2013 of the European Parliament and of the Council(2)establishes the administrative and technical requirements for the type-approval of two- or three-wheel vehicles and quadricycles as categorised in that Regulation (‘L-category vehicles’). Commission Delegated Regulation (EU) No 44/2014(3)establishes the detailed technical requirements and test procedures regarding vehicle construction and general requirements for the approval of L-category vehicles and the systems, components and separate technical units intended for such vehicles in accordance with Regulation (EU) No 168/2013 and sets out a list of UNECE regulations and amendments thereto. Pursuant to Article 4(1) of Delegated Regulation (EU) No 44/2014, the UNECE regulations and amendments thereto set out in Annex I to that Delegated Regulation are to apply to type approval of L-category vehicles.
(3) The scope of UN Regulation No 155(4)has been extended to include rules on cybersecurity for L-category vehicles. Therefore, Delegated Regulation (EU) No 44/2014 has been amended by Commission Delegated Regulation (EU) 2025/1455(5)amending Delegated Regulation (EU) No 44/2014 as regards laying down technical requirements and testing procedures regarding the protection of L-category vehicles against cyberattacks to include UN Regulation No 155 in the list of UNECE regulations applying on a compulsory basis set out in Annex I to that Delegated Regulation. L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 were however excluded from the compulsory application of UN Regulation No 155. Delegated Regulation (EU) 2025/1455 is to apply to new vehicle types from 11 December 2027 and to existing vehicle types from 11 June 2029.
(4) UN Regulation No 155 introduces certain cybersecurity requirements, including on the operation of a certified cybersecurity management system, on software updates, covering organisations’ policies and processes for cybersecurity risks related to the entire lifecycle of vehicles, equipment and services. It addresses cybersecurity risks in a manner that is comparable to Regulation (EU) 2024/2847 and achieves at least the same level of protection as that Regulation. In addition, UN Regulation No 155 ensures consistency with the overall type-approval framework applying to L-category vehicles. Consequently, Regulation (EU) 2024/2847 should not apply to products with digital elements falling within the scope of Regulation (EU) No 168/2013, with the exception of L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013,
HAS ADOPTED THIS REGULATION:

Article 1
The application of Regulation (EU) 2024/2847 shall be excluded for products with digital elements falling within the scope of Regulation (EU) No 168/2013.
However, that exclusion shall not apply to L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013.

Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act)(1), and in particular Article 2(5), second subparagraph, thereof,
(1) Pursuant to Article (2) of Regulation (EU) 2024/2847, the application of that Regulation to products with digital elements covered by other Union rules laying down requirements that address all or some of the risks covered by the essential cybersecurity requirements set out in that Regulation may be limited or excluded where such limitation or exclusion is consistent with the overall regulatory framework applying to those products and where the sectoral rules achieve at least the same level of protection as the one provided for by that Regulation.
(2) Regulation (EU) No 168/2013 of the European Parliament and of the Council(2)establishes the administrative and technical requirements for the type-approval of two- or three-wheel vehicles and quadricycles as categorised in that Regulation (‘L-category vehicles’). Commission Delegated Regulation (EU) No 44/2014(3)establishes the detailed technical requirements and test procedures regarding vehicle construction and general requirements for the approval of L-category vehicles and the systems, components and separate technical units intended for such vehicles in accordance with Regulation (EU) No 168/2013 and sets out a list of UNECE regulations and amendments thereto. Pursuant to Article 4(1) of Delegated Regulation (EU) No 44/2014, the UNECE regulations and amendments thereto set out in Annex I to that Delegated Regulation are to apply to type approval of L-category vehicles.
(3) The scope of UN Regulation No 155(4)has been extended to include rules on cybersecurity for L-category vehicles. Therefore, Delegated Regulation (EU) No 44/2014 has been amended by Commission Delegated Regulation (EU) 2025/1455(5)amending Delegated Regulation (EU) No 44/2014 as regards laying down technical requirements and testing procedures regarding the protection of L-category vehicles against cyberattacks to include UN Regulation No 155 in the list of UNECE regulations applying on a compulsory basis set out in Annex I to that Delegated Regulation. L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 were however excluded from the compulsory application of UN Regulation No 155. Delegated Regulation (EU) 2025/1455 is to apply to new vehicle types from 11 December 2027 and to existing vehicle types from 11 June 2029.
(4) UN Regulation No 155 introduces certain cybersecurity requirements, including on the operation of a certified cybersecurity management system, on software updates, covering organisations’ policies and processes for cybersecurity risks related to the entire lifecycle of vehicles, equipment and services. It addresses cybersecurity risks in a manner that is comparable to Regulation (EU) 2024/2847 and achieves at least the same level of protection as that Regulation. In addition, UN Regulation No 155 ensures consistency with the overall type-approval framework applying to L-category vehicles. Consequently, Regulation (EU) 2024/2847 should not apply to products with digital elements falling within the scope of Regulation (EU) No 168/2013, with the exception of L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013,
HAS ADOPTED THIS REGULATION:
The application of Regulation (EU) 2024/2847 shall be excluded for products with digital elements falling within the scope of Regulation (EU) No 168/2013.
However, that exclusion shall not apply to L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013.
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Commission Delegated Regulation (EU) 2025/1496 of 12 June 2025 amending Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to the date of application of the own funds requirements for market risk

Official Journalof the European Union ENL series
2025/1496 19.9.2025
(1) Regulation (EU) 2019/876 of the European Parliament and of the Council(2)amended Regulation (EU) No 575/2013, inter alia, to introduce as a reporting requirement into that Regulation the Fundamental Review of the Trading Book (FRTB) standards, which is a comprehensive set of own funds requirements for market risk exposures developed by the Basel Committee on Banking Supervision (BCBS). Regulation (EU) 2024/1623 of the European Parliament and of the Council(3)amended Regulation (EU) No 575/2013 once more, inter alia, to transform the FRTB standards into binding requirements for the calculation of own funds requirements for market risk.
(2) Given the highly competitive nature of international trading activities, the FRTB standards were adopted on the premise that their implementation across jurisdictions, both in terms of substance and timelines, would ensure an international level playing field for institutions’ trading activities. The monitoring of the implementation of the FRTB standards in other BCBS member jurisdictions, and more specifically in those jurisdictions with many internationally active banks, during the last two years, has shown that, due to delays to the implementation of the FRTB standards in those jurisdictions, there is a significant risk of distortions to the international level playing field. To address that risk and to gather more information on other jurisdictions’ implementation timeline and actual rules, in July 2024, the Commission used the empowerment in Article 461a(2) of Regulation (EU) No 575/2013 to adopt Commission Delegated Regulation (EU) 2024/2795(4)to defer the application of the FRTB standards for the calculation of own funds requirements for market risk in the Union for 1 year, to 1 January 2026.
(3) In recent months, the monitoring of the implementation of the FRTB standards has shown that while a small number of jurisdictions have indeed progressed with their implementation, the uncertainty around implementation timelines in the jurisdictions with many internationally active banks remains very high and further delays are expected or have been confirmed. It is therefore necessary to defer the application of the FRTB standards for the calculation of own funds requirements for market risk in the Union by one additional year.
(4) The deferred application of the FRTB standards has as a consequence that until 1 January 2027, institutions should be required to continue to apply the market risk framework laid down in the version of Regulation (EU) No 575/2013 in force on 8 July 2024 (i.e. one day before Regulation (EU) 2024/1623 that amended Regulation (EU) No 575/2013 entered into force), while finalising the implementation of the FRTB approaches. To account for the operational complexities and costs that some institutions face for the maintenance of the current internal models for another year, in the uncertain international context of the FRTB implementation, and given the temporary short-dated nature of the deferral, competent authorities should use, in their ongoing assessment of the internal models during that one-year period, the necessary flexibility to avoid impacts on the own funds requirements that are not linked to increases in the underlying market risk.
(5) Competent authorities need information to monitor the impact of the FRTB, identify potential issues, and facilitate the implementation-related exchanges between them and institutions. Therefore, in accordance with the existing requirements and the regulatory and supervisory expectations that were communicated following the adoption of the Delegated Regulation (EU) 2024/2795, institutions should be required to continue to report the information related to their own funds requirements calculation for market risk under pre-FRTB approaches until the date of application of the FRTB for the calculation of own funds requirements for market risk in the Union. At the same time, institutions should also continue to report to their competent authorities their own funds requirements in accordance with Article 430b of Regulation (EU) No 575/2013 in the version in force on 8 July 2024.
(6) Regulation (EU) 2024/1623 introduces into Regulation (EU) No 575/2013 specific disclosure requirements for market risk, tailored to the requirements laid down in the FRTB for the calculation of own funds requirements for market risk. The date of application of the provisions in Regulation (EU) 2024/1623 concerning the calculation of own funds requirements for market risk is, however, to be deferred by one additional year. For reasons of consistency, the related specific disclosure requirements should also be deferred by one additional year. Given the importance of the disclosure of own funds requirements in preserving a robust market discipline and in informing the investment decisions of market participants, institutions should instead be required, during that period of deferral, to continue disclosing the information relevant for their exposure to market risk and related own funds requirements based on the pre-FRTB calculation approaches.
(7) Regulation (EU) 575/2013 should therefore be amended accordingly.
(8) Delegated Regulation (EU) 2024/2795 applies until 1 January 2026. It is therefore necessary to align the date of entry into force and date of application of this Regulation with that date to avoid conflicting requirements to institutions,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and amending Regulation (EU) No 648/2012(1), and in particular Article 461a(2) thereof,
(1) Regulation (EU) 2019/876 of the European Parliament and of the Council(2)amended Regulation (EU) No 575/2013, inter alia, to introduce as a reporting requirement into that Regulation the Fundamental Review of the Trading Book (FRTB) standards, which is a comprehensive set of own funds requirements for market risk exposures developed by the Basel Committee on Banking Supervision (BCBS). Regulation (EU) 2024/1623 of the European Parliament and of the Council(3)amended Regulation (EU) No 575/2013 once more, inter alia, to transform the FRTB standards into binding requirements for the calculation of own funds requirements for market risk.
(2) Given the highly competitive nature of international trading activities, the FRTB standards were adopted on the premise that their implementation across jurisdictions, both in terms of substance and timelines, would ensure an international level playing field for institutions’ trading activities. The monitoring of the implementation of the FRTB standards in other BCBS member jurisdictions, and more specifically in those jurisdictions with many internationally active banks, during the last two years, has shown that, due to delays to the implementation of the FRTB standards in those jurisdictions, there is a significant risk of distortions to the international level playing field. To address that risk and to gather more information on other jurisdictions’ implementation timeline and actual rules, in July 2024, the Commission used the empowerment in Article 461a(2) of Regulation (EU) No 575/2013 to adopt Commission Delegated Regulation (EU) 2024/2795(4)to defer the application of the FRTB standards for the calculation of own funds requirements for market risk in the Union for 1 year, to 1 January 2026.
(3) In recent months, the monitoring of the implementation of the FRTB standards has shown that while a small number of jurisdictions have indeed progressed with their implementation, the uncertainty around implementation timelines in the jurisdictions with many internationally active banks remains very high and further delays are expected or have been confirmed. It is therefore necessary to defer the application of the FRTB standards for the calculation of own funds requirements for market risk in the Union by one additional year.
(4) The deferred application of the FRTB standards has as a consequence that until 1 January 2027, institutions should be required to continue to apply the market risk framework laid down in the version of Regulation (EU) No 575/2013 in force on 8 July 2024 (i.e. one day before Regulation (EU) 2024/1623 that amended Regulation (EU) No 575/2013 entered into force), while finalising the implementation of the FRTB approaches. To account for the operational complexities and costs that some institutions face for the maintenance of the current internal models for another year, in the uncertain international context of the FRTB implementation, and given the temporary short-dated nature of the deferral, competent authorities should use, in their ongoing assessment of the internal models during that one-year period, the necessary flexibility to avoid impacts on the own funds requirements that are not linked to increases in the underlying market risk.
(5) Competent authorities need information to monitor the impact of the FRTB, identify potential issues, and facilitate the implementation-related exchanges between them and institutions. Therefore, in accordance with the existing requirements and the regulatory and supervisory expectations that were communicated following the adoption of the Delegated Regulation (EU) 2024/2795, institutions should be required to continue to report the information related to their own funds requirements calculation for market risk under pre-FRTB approaches until the date of application of the FRTB for the calculation of own funds requirements for market risk in the Union. At the same time, institutions should also continue to report to their competent authorities their own funds requirements in accordance with Article 430b of Regulation (EU) No 575/2013 in the version in force on 8 July 2024.
(6) Regulation (EU) 2024/1623 introduces into Regulation (EU) No 575/2013 specific disclosure requirements for market risk, tailored to the requirements laid down in the FRTB for the calculation of own funds requirements for market risk. The date of application of the provisions in Regulation (EU) 2024/1623 concerning the calculation of own funds requirements for market risk is, however, to be deferred by one additional year. For reasons of consistency, the related specific disclosure requirements should also be deferred by one additional year. Given the importance of the disclosure of own funds requirements in preserving a robust market discipline and in informing the investment decisions of market participants, institutions should instead be required, during that period of deferral, to continue disclosing the information relevant for their exposure to market risk and related own funds requirements based on the pre-FRTB calculation approaches.
(7) Regulation (EU) 575/2013 should therefore be amended accordingly.
(8) Delegated Regulation (EU) 2024/2795 applies until 1 January 2026. It is therefore necessary to align the date of entry into force and date of application of this Regulation with that date to avoid conflicting requirements to institutions,
HAS ADOPTED THIS REGULATION:

Amendment to Regulation (EU) No 575/2013
Article 1
In Regulation (EU) No 575/2013, Article 520a is replaced by the following:
Until 1 January 2027, institutions shall continue to apply Part Three, Title IV, and the market risk requirements of Articles 430, 430b, 445 and 455 of this Regulation in the version in force on 8 July 2024.’.

Entry into force and application
Article 2
This Regulation shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.
This Regulation shall apply from 1 January 2026.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and amending Regulation (EU) No 648/2012(1), and in particular Article 461a(2) thereof,
(1) Regulation (EU) 2019/876 of the European Parliament and of the Council(2)amended Regulation (EU) No 575/2013, inter alia, to introduce as a reporting requirement into that Regulation the Fundamental Review of the Trading Book (FRTB) standards, which is a comprehensive set of own funds requirements for market risk exposures developed by the Basel Committee on Banking Supervision (BCBS). Regulation (EU) 2024/1623 of the European Parliament and of the Council(3)amended Regulation (EU) No 575/2013 once more, inter alia, to transform the FRTB standards into binding requirements for the calculation of own funds requirements for market risk.
(2) Given the highly competitive nature of international trading activities, the FRTB standards were adopted on the premise that their implementation across jurisdictions, both in terms of substance and timelines, would ensure an international level playing field for institutions’ trading activities. The monitoring of the implementation of the FRTB standards in other BCBS member jurisdictions, and more specifically in those jurisdictions with many internationally active banks, during the last two years, has shown that, due to delays to the implementation of the FRTB standards in those jurisdictions, there is a significant risk of distortions to the international level playing field. To address that risk and to gather more information on other jurisdictions’ implementation timeline and actual rules, in July 2024, the Commission used the empowerment in Article 461a(2) of Regulation (EU) No 575/2013 to adopt Commission Delegated Regulation (EU) 2024/2795(4)to defer the application of the FRTB standards for the calculation of own funds requirements for market risk in the Union for 1 year, to 1 January 2026.
(3) In recent months, the monitoring of the implementation of the FRTB standards has shown that while a small number of jurisdictions have indeed progressed with their implementation, the uncertainty around implementation timelines in the jurisdictions with many internationally active banks remains very high and further delays are expected or have been confirmed. It is therefore necessary to defer the application of the FRTB standards for the calculation of own funds requirements for market risk in the Union by one additional year.
(4) The deferred application of the FRTB standards has as a consequence that until 1 January 2027, institutions should be required to continue to apply the market risk framework laid down in the version of Regulation (EU) No 575/2013 in force on 8 July 2024 (i.e. one day before Regulation (EU) 2024/1623 that amended Regulation (EU) No 575/2013 entered into force), while finalising the implementation of the FRTB approaches. To account for the operational complexities and costs that some institutions face for the maintenance of the current internal models for another year, in the uncertain international context of the FRTB implementation, and given the temporary short-dated nature of the deferral, competent authorities should use, in their ongoing assessment of the internal models during that one-year period, the necessary flexibility to avoid impacts on the own funds requirements that are not linked to increases in the underlying market risk.
(5) Competent authorities need information to monitor the impact of the FRTB, identify potential issues, and facilitate the implementation-related exchanges between them and institutions. Therefore, in accordance with the existing requirements and the regulatory and supervisory expectations that were communicated following the adoption of the Delegated Regulation (EU) 2024/2795, institutions should be required to continue to report the information related to their own funds requirements calculation for market risk under pre-FRTB approaches until the date of application of the FRTB for the calculation of own funds requirements for market risk in the Union. At the same time, institutions should also continue to report to their competent authorities their own funds requirements in accordance with Article 430b of Regulation (EU) No 575/2013 in the version in force on 8 July 2024.
(6) Regulation (EU) 2024/1623 introduces into Regulation (EU) No 575/2013 specific disclosure requirements for market risk, tailored to the requirements laid down in the FRTB for the calculation of own funds requirements for market risk. The date of application of the provisions in Regulation (EU) 2024/1623 concerning the calculation of own funds requirements for market risk is, however, to be deferred by one additional year. For reasons of consistency, the related specific disclosure requirements should also be deferred by one additional year. Given the importance of the disclosure of own funds requirements in preserving a robust market discipline and in informing the investment decisions of market participants, institutions should instead be required, during that period of deferral, to continue disclosing the information relevant for their exposure to market risk and related own funds requirements based on the pre-FRTB calculation approaches.
(7) Regulation (EU) 575/2013 should therefore be amended accordingly.
(8) Delegated Regulation (EU) 2024/2795 applies until 1 January 2026. It is therefore necessary to align the date of entry into force and date of application of this Regulation with that date to avoid conflicting requirements to institutions,
HAS ADOPTED THIS REGULATION:

Amendment to Regulation (EU) No 575/2013

In Regulation (EU) No 575/2013, Article 520a is replaced by the following:
Until 1 January 2027, institutions shall continue to apply Part Three, Title IV, and the market risk requirements of Articles 430, 430b, 445 and 455 of this Regulation in the version in force on 8 July 2024.’.

Entry into force and application

This Regulation shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.
This Regulation shall apply from 1 January 2026.

Commission Delegated Regulation (EU) 2025/1493 of 11 June 2025 amending Commission Delegated Regulation (EU) No 876/2013 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council as regards changes to the functioning and management of colleges for central counterparties

Official Journalof the European Union ENL series
2025/1493 25.9.2025
(1) Regulation (EU) 2024/2987 of the European Parliament and of the Council(2)introduced into Regulation (EU) No 648/2012 changes to the functioning and management of CCP colleges. In particular, a new co-chair has been introduced, in addition to the CCP’s competent authority, as being any of the independent members of the CCP Supervisory Committee. It is therefore necessary to reflect those changes in Commission Delegated Regulation (EU) No 876/2013(3).
(2) Without prejudice to the ultimate responsibility of the CCP’s competent authority and to further enhance supervisory convergence and the consistent functioning of all CCP colleges, the European Securities and Markets Authority (ESMA) should coordinate the functioning of the colleges and should ensure that each college performs its tasks and achieves its objectives in accordance with Regulation (EU) No 648/2012. To that aim, and with the objective of converging supervisory best practices, the co-chairs of the CCP college should discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012.
(3) In light of the amendments to Regulation (EU) No 648/2012, the non-exhaustive list of information items to be shared with the college should be updated.
(4) To allow for an efficient and timely flow of information between members of the college, the CCP’s competent authority and members of the college should circulate information through the central database provided by Article 17c of Regulation (EU) No 648/2012.
(5) Delegated Regulation (EU) No 876/2013 should therefore be amended accordingly.
(6) This Regulation is based on draft regulatory technical standards submitted to the Commission by ESMA following consultation of the European System of Central Banks (ESCB).
(7) Since the amendments are limited in scope and concern only CCP’s national competent authorities without imposing any additional requirements on market participants and to facilitate as soon as possible the adjustment of CCP colleges to the new provisions of Regulation (EU) No 648/2012, in accordance with Article 10(1) of Regulation (EU) No 1095/2010 of the European Parliament and of the Council(4), ESMA has considered that it is highly disproportionate to the scope and impact of the regulatory technical standards to conduct a public consultation. However, ESMA has consulted the Securities and Markets Stakeholder Group established in accordance with Article 37 of that Regulation, the relevant CCP’s national competent authorities and the ESCB,
(1) Article 2 is amended as follows:(a)paragraph 1 is replaced by the following:‘1.   Following the notification that an application contains the documents and information required as referred to in Article 17(2), first subparagraph, point (a), of Regulation (EU) No 648/2012, the CCP’s competent authority shall circulate a proposal for the written agreement under Article 18(5) of that Regulation to the members of the college determined in accordance with Article 18(2) of that Regulation. That written agreement shall include a process for the review of the composition of the college at least on an annual basis. It shall also include an amendment process whereby changes may be initiated at any time by the CCP’s competent authority or by other members of the college, subject to approval by the college in accordance with the procedure set out in this Article.’;(b)paragraph 3 is replaced by the following:‘3.   Where the members of the college express comments regarding the proposal for the written agreement circulated pursuant to paragraph 1, they shall submit those comments together with a thorough explanation to the co-chairs within 10 calendar days. Where relevant, the co-chairs shall agree on and prepare a revised proposal and convene a meeting to agree on, and adopt, the final written agreement taking into account the deadline referred to in Article 18(1) of Regulation (EU) No 648/2012.’;(c)paragraph 4a is replaced by the following:‘4a.   Competent authorities as referred to in Article 18(2), point (ca), of Regulation (EU) No 648/2012, and central banks of issue as referred to in Article 18(2), point (i), of that Regulation that wish to participate in the college shall submit a reasoned request to the CCP’s competent authority. The CCP’s competent authority shall, within 20 calendar days of the receipt of the request, either provide the requesting competent authority or central bank with a copy of the written agreement for review and approval, or substantiating in writing why the request has been rejected. The CCP’s competent authority shall inform the members of the college of any such requests and their respective outcome.’; (a) paragraph 1 is replaced by the following:‘1.   Following the notification that an application contains the documents and information required as referred to in Article 17(2), first subparagraph, point (a), of Regulation (EU) No 648/2012, the CCP’s competent authority shall circulate a proposal for the written agreement under Article 18(5) of that Regulation to the members of the college determined in accordance with Article 18(2) of that Regulation. That written agreement shall include a process for the review of the composition of the college at least on an annual basis. It shall also include an amendment process whereby changes may be initiated at any time by the CCP’s competent authority or by other members of the college, subject to approval by the college in accordance with the procedure set out in this Article.’; (b) paragraph 3 is replaced by the following:‘3.   Where the members of the college express comments regarding the proposal for the written agreement circulated pursuant to paragraph 1, they shall submit those comments together with a thorough explanation to the co-chairs within 10 calendar days. Where relevant, the co-chairs shall agree on and prepare a revised proposal and convene a meeting to agree on, and adopt, the final written agreement taking into account the deadline referred to in Article 18(1) of Regulation (EU) No 648/2012.’; (c) paragraph 4a is replaced by the following:‘4a.   Competent authorities as referred to in Article 18(2), point (ca), of Regulation (EU) No 648/2012, and central banks of issue as referred to in Article 18(2), point (i), of that Regulation that wish to participate in the college shall submit a reasoned request to the CCP’s competent authority. The CCP’s competent authority shall, within 20 calendar days of the receipt of the request, either provide the requesting competent authority or central bank with a copy of the written agreement for review and approval, or substantiating in writing why the request has been rejected. The CCP’s competent authority shall inform the members of the college of any such requests and their respective outcome.’;
(a) paragraph 1 is replaced by the following:‘1.   Following the notification that an application contains the documents and information required as referred to in Article 17(2), first subparagraph, point (a), of Regulation (EU) No 648/2012, the CCP’s competent authority shall circulate a proposal for the written agreement under Article 18(5) of that Regulation to the members of the college determined in accordance with Article 18(2) of that Regulation. That written agreement shall include a process for the review of the composition of the college at least on an annual basis. It shall also include an amendment process whereby changes may be initiated at any time by the CCP’s competent authority or by other members of the college, subject to approval by the college in accordance with the procedure set out in this Article.’;
(b) paragraph 3 is replaced by the following:‘3.   Where the members of the college express comments regarding the proposal for the written agreement circulated pursuant to paragraph 1, they shall submit those comments together with a thorough explanation to the co-chairs within 10 calendar days. Where relevant, the co-chairs shall agree on and prepare a revised proposal and convene a meeting to agree on, and adopt, the final written agreement taking into account the deadline referred to in Article 18(1) of Regulation (EU) No 648/2012.’;
(c) paragraph 4a is replaced by the following:‘4a.   Competent authorities as referred to in Article 18(2), point (ca), of Regulation (EU) No 648/2012, and central banks of issue as referred to in Article 18(2), point (i), of that Regulation that wish to participate in the college shall submit a reasoned request to the CCP’s competent authority. The CCP’s competent authority shall, within 20 calendar days of the receipt of the request, either provide the requesting competent authority or central bank with a copy of the written agreement for review and approval, or substantiating in writing why the request has been rejected. The CCP’s competent authority shall inform the members of the college of any such requests and their respective outcome.’;
(a) paragraph 1 is replaced by the following:‘1.   Following the notification that an application contains the documents and information required as referred to in Article 17(2), first subparagraph, point (a), of Regulation (EU) No 648/2012, the CCP’s competent authority shall circulate a proposal for the written agreement under Article 18(5) of that Regulation to the members of the college determined in accordance with Article 18(2) of that Regulation. That written agreement shall include a process for the review of the composition of the college at least on an annual basis. It shall also include an amendment process whereby changes may be initiated at any time by the CCP’s competent authority or by other members of the college, subject to approval by the college in accordance with the procedure set out in this Article.’;
(b) paragraph 3 is replaced by the following:‘3.   Where the members of the college express comments regarding the proposal for the written agreement circulated pursuant to paragraph 1, they shall submit those comments together with a thorough explanation to the co-chairs within 10 calendar days. Where relevant, the co-chairs shall agree on and prepare a revised proposal and convene a meeting to agree on, and adopt, the final written agreement taking into account the deadline referred to in Article 18(1) of Regulation (EU) No 648/2012.’;
(c) paragraph 4a is replaced by the following:‘4a.   Competent authorities as referred to in Article 18(2), point (ca), of Regulation (EU) No 648/2012, and central banks of issue as referred to in Article 18(2), point (i), of that Regulation that wish to participate in the college shall submit a reasoned request to the CCP’s competent authority. The CCP’s competent authority shall, within 20 calendar days of the receipt of the request, either provide the requesting competent authority or central bank with a copy of the written agreement for review and approval, or substantiating in writing why the request has been rejected. The CCP’s competent authority shall inform the members of the college of any such requests and their respective outcome.’;
(2) in Article 3 paragraphs 1 and 2 are replaced by the following:‘1.   Where a request for information is made to a college by a competent authority of a Member State which is not a member of the college in accordance with Article 18(3) of Regulation (EU) No 648/2012, the co-chairs, after having consulted the college, shall decide on the most appropriate way to provide and request information to and from the authorities that are not members of the college.2.   Each member of the college shall designate one participant to attend the meetings of the college and may designate one alternate, with the exception of the co-chairs which may require additional participants who shall have no voting rights.’;
(3) Article 4 is amended as follows:(a)paragraph 1 is replaced by the following:‘1.   The co-chairs shall ensure that the work of the college facilitates the tasks to be performed in accordance with Regulation (EU) No 648/2012.’;(b)the introductory wording of paragraph 3 is replaced by the following:‘The co-chairs shall at least ensure that:’;(c)paragraphs 4 and 5 are replaced by the following:‘4.   To ensure the efficiency and effectiveness of the college, the co-chairs shall act as a central point of contact for any matter related to the practical organisation of the college and keep each other informed. The co-chairs shall at least perform the following tasks:(a)draw-up, update and circulate the contact list of members of the college;(b)prepare and circulate the agenda and documentation for meetings or activities of the college;(ba)discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;(c)record minutes of the meetings and formalise action points;(d)manage the college website, if any;(e)where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;(f)share all information in a timely and appropriate manner among members of the college.For the purposes of point (b), the co-chairs shall circulate a draft agenda for each meeting of the college, other than for meetings called in emergency situations, well in advance of each meeting, in order to enable the members of the college to contribute to the setting of the agenda, in particular by adding points to the agenda.The agenda shall be finalised by the co-chairs and distributed to members of the college sufficiently in advance of a meeting of the college. The co-chairs and other members of the college shall distribute any information to be considered at a meeting of the college well in advance of the meeting.For the purposes of point (c), the CCP’s competent authority shall distribute the minutes of meetings to members of the college once those minutes are agreed by the co-chairs and as soon as practicable following the meetings and shall give members of the college sufficient time to comment.5.   The co-chairs shall determine the frequency of college meetings having regard to the CCP’s size, nature, scale and complexity, the systemic implications of the CCP across jurisdictions and currencies, the potential impacts of the activities of the CCP, external circumstances and potential requests by members of the college. There shall be at least an annual meeting of the college and if deemed necessary by the co-chairs, a meeting each time that a decision is to be taken under Regulation (EU) No 648/2012. The co-chairs shall organise, periodically, and at least annually, meetings between members of the college and the senior management of the CCP.Members of the college may request that the co-chairs hold a meeting of the college. The co-chairs shall duly provide reasons for any rejection of such request.’;(d)paragraphs 7 and 8 are replaced by the following:‘7.   The co-chairs shall endeavour to ensure that each college meeting has a valid quorum for decisions to be taken. Where a quorum is not met, the co-chairs shall ensure that any decisions that need to be taken are postponed until a quorum is present, taking into account the relevant time limits set out in Regulation (EU) No 648/2012.8.   The college may vote by written procedure, where proposed by the co-chairs or at the request of a member of the college.’; (a) paragraph 1 is replaced by the following:‘1.   The co-chairs shall ensure that the work of the college facilitates the tasks to be performed in accordance with Regulation (EU) No 648/2012.’; (b) the introductory wording of paragraph 3 is replaced by the following:‘The co-chairs shall at least ensure that:’; (c) paragraphs 4 and 5 are replaced by the following:‘4.   To ensure the efficiency and effectiveness of the college, the co-chairs shall act as a central point of contact for any matter related to the practical organisation of the college and keep each other informed. The co-chairs shall at least perform the following tasks:(a)draw-up, update and circulate the contact list of members of the college;(b)prepare and circulate the agenda and documentation for meetings or activities of the college;(ba)discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;(c)record minutes of the meetings and formalise action points;(d)manage the college website, if any;(e)where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;(f)share all information in a timely and appropriate manner among members of the college.For the purposes of point (b), the co-chairs shall circulate a draft agenda for each meeting of the college, other than for meetings called in emergency situations, well in advance of each meeting, in order to enable the members of the college to contribute to the setting of the agenda, in particular by adding points to the agenda.The agenda shall be finalised by the co-chairs and distributed to members of the college sufficiently in advance of a meeting of the college. The co-chairs and other members of the college shall distribute any information to be considered at a meeting of the college well in advance of the meeting.For the purposes of point (c), the CCP’s competent authority shall distribute the minutes of meetings to members of the college once those minutes are agreed by the co-chairs and as soon as practicable following the meetings and shall give members of the college sufficient time to comment.5.   The co-chairs shall determine the frequency of college meetings having regard to the CCP’s size, nature, scale and complexity, the systemic implications of the CCP across jurisdictions and currencies, the potential impacts of the activities of the CCP, external circumstances and potential requests by members of the college. There shall be at least an annual meeting of the college and if deemed necessary by the co-chairs, a meeting each time that a decision is to be taken under Regulation (EU) No 648/2012. The co-chairs shall organise, periodically, and at least annually, meetings between members of the college and the senior management of the CCP.Members of the college may request that the co-chairs hold a meeting of the college. The co-chairs shall duly provide reasons for any rejection of such request.’; (a) draw-up, update and circulate the contact list of members of the college; (b) prepare and circulate the agenda and documentation for meetings or activities of the college; (ba) discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012; (c) record minutes of the meetings and formalise action points; (d) manage the college website, if any; (e) where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks; (f) share all information in a timely and appropriate manner among members of the college. (d) paragraphs 7 and 8 are replaced by the following:‘7.   The co-chairs shall endeavour to ensure that each college meeting has a valid quorum for decisions to be taken. Where a quorum is not met, the co-chairs shall ensure that any decisions that need to be taken are postponed until a quorum is present, taking into account the relevant time limits set out in Regulation (EU) No 648/2012.8.   The college may vote by written procedure, where proposed by the co-chairs or at the request of a member of the college.’;
(a) paragraph 1 is replaced by the following:‘1.   The co-chairs shall ensure that the work of the college facilitates the tasks to be performed in accordance with Regulation (EU) No 648/2012.’;
(b) the introductory wording of paragraph 3 is replaced by the following:‘The co-chairs shall at least ensure that:’;
(c) paragraphs 4 and 5 are replaced by the following:‘4.   To ensure the efficiency and effectiveness of the college, the co-chairs shall act as a central point of contact for any matter related to the practical organisation of the college and keep each other informed. The co-chairs shall at least perform the following tasks:(a)draw-up, update and circulate the contact list of members of the college;(b)prepare and circulate the agenda and documentation for meetings or activities of the college;(ba)discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;(c)record minutes of the meetings and formalise action points;(d)manage the college website, if any;(e)where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;(f)share all information in a timely and appropriate manner among members of the college.For the purposes of point (b), the co-chairs shall circulate a draft agenda for each meeting of the college, other than for meetings called in emergency situations, well in advance of each meeting, in order to enable the members of the college to contribute to the setting of the agenda, in particular by adding points to the agenda.The agenda shall be finalised by the co-chairs and distributed to members of the college sufficiently in advance of a meeting of the college. The co-chairs and other members of the college shall distribute any information to be considered at a meeting of the college well in advance of the meeting.For the purposes of point (c), the CCP’s competent authority shall distribute the minutes of meetings to members of the college once those minutes are agreed by the co-chairs and as soon as practicable following the meetings and shall give members of the college sufficient time to comment.5.   The co-chairs shall determine the frequency of college meetings having regard to the CCP’s size, nature, scale and complexity, the systemic implications of the CCP across jurisdictions and currencies, the potential impacts of the activities of the CCP, external circumstances and potential requests by members of the college. There shall be at least an annual meeting of the college and if deemed necessary by the co-chairs, a meeting each time that a decision is to be taken under Regulation (EU) No 648/2012. The co-chairs shall organise, periodically, and at least annually, meetings between members of the college and the senior management of the CCP.Members of the college may request that the co-chairs hold a meeting of the college. The co-chairs shall duly provide reasons for any rejection of such request.’; (a) draw-up, update and circulate the contact list of members of the college; (b) prepare and circulate the agenda and documentation for meetings or activities of the college; (ba) discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012; (c) record minutes of the meetings and formalise action points; (d) manage the college website, if any; (e) where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks; (f) share all information in a timely and appropriate manner among members of the college.
(a) draw-up, update and circulate the contact list of members of the college;
(b) prepare and circulate the agenda and documentation for meetings or activities of the college;
(ba) discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;
(c) record minutes of the meetings and formalise action points;
(d) manage the college website, if any;
(e) where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;
(f) share all information in a timely and appropriate manner among members of the college.
(d) paragraphs 7 and 8 are replaced by the following:‘7.   The co-chairs shall endeavour to ensure that each college meeting has a valid quorum for decisions to be taken. Where a quorum is not met, the co-chairs shall ensure that any decisions that need to be taken are postponed until a quorum is present, taking into account the relevant time limits set out in Regulation (EU) No 648/2012.8.   The college may vote by written procedure, where proposed by the co-chairs or at the request of a member of the college.’;
(a) paragraph 1 is replaced by the following:‘1.   The co-chairs shall ensure that the work of the college facilitates the tasks to be performed in accordance with Regulation (EU) No 648/2012.’;
(b) the introductory wording of paragraph 3 is replaced by the following:‘The co-chairs shall at least ensure that:’;
(c) paragraphs 4 and 5 are replaced by the following:‘4.   To ensure the efficiency and effectiveness of the college, the co-chairs shall act as a central point of contact for any matter related to the practical organisation of the college and keep each other informed. The co-chairs shall at least perform the following tasks:(a)draw-up, update and circulate the contact list of members of the college;(b)prepare and circulate the agenda and documentation for meetings or activities of the college;(ba)discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;(c)record minutes of the meetings and formalise action points;(d)manage the college website, if any;(e)where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;(f)share all information in a timely and appropriate manner among members of the college.For the purposes of point (b), the co-chairs shall circulate a draft agenda for each meeting of the college, other than for meetings called in emergency situations, well in advance of each meeting, in order to enable the members of the college to contribute to the setting of the agenda, in particular by adding points to the agenda.The agenda shall be finalised by the co-chairs and distributed to members of the college sufficiently in advance of a meeting of the college. The co-chairs and other members of the college shall distribute any information to be considered at a meeting of the college well in advance of the meeting.For the purposes of point (c), the CCP’s competent authority shall distribute the minutes of meetings to members of the college once those minutes are agreed by the co-chairs and as soon as practicable following the meetings and shall give members of the college sufficient time to comment.5.   The co-chairs shall determine the frequency of college meetings having regard to the CCP’s size, nature, scale and complexity, the systemic implications of the CCP across jurisdictions and currencies, the potential impacts of the activities of the CCP, external circumstances and potential requests by members of the college. There shall be at least an annual meeting of the college and if deemed necessary by the co-chairs, a meeting each time that a decision is to be taken under Regulation (EU) No 648/2012. The co-chairs shall organise, periodically, and at least annually, meetings between members of the college and the senior management of the CCP.Members of the college may request that the co-chairs hold a meeting of the college. The co-chairs shall duly provide reasons for any rejection of such request.’; (a) draw-up, update and circulate the contact list of members of the college; (b) prepare and circulate the agenda and documentation for meetings or activities of the college; (ba) discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012; (c) record minutes of the meetings and formalise action points; (d) manage the college website, if any; (e) where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks; (f) share all information in a timely and appropriate manner among members of the college.
(a) draw-up, update and circulate the contact list of members of the college;
(b) prepare and circulate the agenda and documentation for meetings or activities of the college;
(ba) discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;
(c) record minutes of the meetings and formalise action points;
(d) manage the college website, if any;
(e) where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;
(f) share all information in a timely and appropriate manner among members of the college.
(a) draw-up, update and circulate the contact list of members of the college;
(b) prepare and circulate the agenda and documentation for meetings or activities of the college;
(ba) discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;
(c) record minutes of the meetings and formalise action points;
(d) manage the college website, if any;
(e) where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;
(f) share all information in a timely and appropriate manner among members of the college.
(d) paragraphs 7 and 8 are replaced by the following:‘7.   The co-chairs shall endeavour to ensure that each college meeting has a valid quorum for decisions to be taken. Where a quorum is not met, the co-chairs shall ensure that any decisions that need to be taken are postponed until a quorum is present, taking into account the relevant time limits set out in Regulation (EU) No 648/2012.8.   The college may vote by written procedure, where proposed by the co-chairs or at the request of a member of the college.’;
(4) Article 5 is amended as follows:(a)paragraph 1 is replaced by the following:‘1.   Each member of a college shall provide, in a timely manner, the co-chairs with all information necessary for the operational functioning of the college and for the performance of the key activities in which that member participates. The co-chairs shall provide the members of the college with similar information in a timely manner.’;(b)paragraph 2 is amended as follows:(i)point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;(ii)points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;(iii)point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;(iv)point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’;(v)the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;(c)paragraphs 4 and 5 are replaced by the following:‘4.   The CCP’s competent authority’s draft decisions, reports or other measures referred to in Article 17(3), Article 17b(2) and Article 49(1d) of Regulation (EU) No 648/2012 shall be submitted to the college within an appropriate timescale to ensure that members of the college are able to review it and contribute to the college opinion.5.   Members of the college shall exchange all information through the central database provided by Article 17c of Regulation (EU) No 648/2012.’;(d)paragraph 6 is deleted; (a) paragraph 1 is replaced by the following:‘1.   Each member of a college shall provide, in a timely manner, the co-chairs with all information necessary for the operational functioning of the college and for the performance of the key activities in which that member participates. The co-chairs shall provide the members of the college with similar information in a timely manner.’; (b) paragraph 2 is amended as follows:(i)point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;(ii)points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;(iii)point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;(iv)point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’;(v)the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; (i) point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; ‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; (ii) points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; ‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business; (p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; (iii) point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; ‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; (iv) point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’; ‘(u) changes in the payment and settlement arrangements of the CCP;’; (v) the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; ‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out; (w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations; (x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012; (y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; (c) paragraphs 4 and 5 are replaced by the following:‘4.   The CCP’s competent authority’s draft decisions, reports or other measures referred to in Article 17(3), Article 17b(2) and Article 49(1d) of Regulation (EU) No 648/2012 shall be submitted to the college within an appropriate timescale to ensure that members of the college are able to review it and contribute to the college opinion.5.   Members of the college shall exchange all information through the central database provided by Article 17c of Regulation (EU) No 648/2012.’; (d) paragraph 6 is deleted;
(a) paragraph 1 is replaced by the following:‘1.   Each member of a college shall provide, in a timely manner, the co-chairs with all information necessary for the operational functioning of the college and for the performance of the key activities in which that member participates. The co-chairs shall provide the members of the college with similar information in a timely manner.’;
(b) paragraph 2 is amended as follows:(i)point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;(ii)points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;(iii)point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;(iv)point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’;(v)the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; (i) point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; ‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; (ii) points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; ‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business; (p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; (iii) point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; ‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; (iv) point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’; ‘(u) changes in the payment and settlement arrangements of the CCP;’; (v) the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; ‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out; (w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations; (x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012; (y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(i) point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; ‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
(ii) points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; ‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business; (p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;
(p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
(iii) point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; ‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
(iv) point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’; ‘(u) changes in the payment and settlement arrangements of the CCP;’;
‘(u) changes in the payment and settlement arrangements of the CCP;’;
(v) the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; ‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out; (w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations; (x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012; (y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;
(w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;
(x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;
(y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(c) paragraphs 4 and 5 are replaced by the following:‘4.   The CCP’s competent authority’s draft decisions, reports or other measures referred to in Article 17(3), Article 17b(2) and Article 49(1d) of Regulation (EU) No 648/2012 shall be submitted to the college within an appropriate timescale to ensure that members of the college are able to review it and contribute to the college opinion.5.   Members of the college shall exchange all information through the central database provided by Article 17c of Regulation (EU) No 648/2012.’;
(d) paragraph 6 is deleted;
(a) paragraph 1 is replaced by the following:‘1.   Each member of a college shall provide, in a timely manner, the co-chairs with all information necessary for the operational functioning of the college and for the performance of the key activities in which that member participates. The co-chairs shall provide the members of the college with similar information in a timely manner.’;
(b) paragraph 2 is amended as follows:(i)point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;(ii)points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;(iii)point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;(iv)point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’;(v)the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; (i) point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; ‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; (ii) points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; ‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business; (p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; (iii) point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; ‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; (iv) point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’; ‘(u) changes in the payment and settlement arrangements of the CCP;’; (v) the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; ‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out; (w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations; (x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012; (y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(i) point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; ‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
(ii) points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; ‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business; (p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;
(p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
(iii) point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; ‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
(iv) point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’; ‘(u) changes in the payment and settlement arrangements of the CCP;’;
‘(u) changes in the payment and settlement arrangements of the CCP;’;
(v) the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; ‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out; (w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations; (x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012; (y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;
(w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;
(x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;
(y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(i) point (m) is replaced by the following:‘(m)reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’; ‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
‘(m) reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
(ii) points (o) and (p) are replaced by the following:‘(o)overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;(p)changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’; ‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business; (p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;
(p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
‘(o) overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;
(p) changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
(iii) point (r) is replaced by the following:‘(r)changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’; ‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
‘(r) changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
(iv) point (u) is replaced by the following:‘(u)changes in the payment and settlement arrangements of the CCP;’; ‘(u) changes in the payment and settlement arrangements of the CCP;’;
‘(u) changes in the payment and settlement arrangements of the CCP;’;
‘(u) changes in the payment and settlement arrangements of the CCP;’;
(v) the following points (v) to (y) are added:‘(v)any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;(w)any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;(x)any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;(y)a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’; ‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out; (w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations; (x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012; (y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;
(w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;
(x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;
(y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
‘(v) any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;
(w) any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;
(x) any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;
(y) a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(c) paragraphs 4 and 5 are replaced by the following:‘4.   The CCP’s competent authority’s draft decisions, reports or other measures referred to in Article 17(3), Article 17b(2) and Article 49(1d) of Regulation (EU) No 648/2012 shall be submitted to the college within an appropriate timescale to ensure that members of the college are able to review it and contribute to the college opinion.5.   Members of the college shall exchange all information through the central database provided by Article 17c of Regulation (EU) No 648/2012.’;
(d) paragraph 6 is deleted;
(5) Article 5a is deleted.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories(1), and in particular Article 18(6) thereof,
(1) Regulation (EU) 2024/2987 of the European Parliament and of the Council(2)introduced into Regulation (EU) No 648/2012 changes to the functioning and management of CCP colleges. In particular, a new co-chair has been introduced, in addition to the CCP’s competent authority, as being any of the independent members of the CCP Supervisory Committee. It is therefore necessary to reflect those changes in Commission Delegated Regulation (EU) No 876/2013(3).
(2) Without prejudice to the ultimate responsibility of the CCP’s competent authority and to further enhance supervisory convergence and the consistent functioning of all CCP colleges, the European Securities and Markets Authority (ESMA) should coordinate the functioning of the colleges and should ensure that each college performs its tasks and achieves its objectives in accordance with Regulation (EU) No 648/2012. To that aim, and with the objective of converging supervisory best practices, the co-chairs of the CCP college should discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012.
(3) In light of the amendments to Regulation (EU) No 648/2012, the non-exhaustive list of information items to be shared with the college should be updated.
(4) To allow for an efficient and timely flow of information between members of the college, the CCP’s competent authority and members of the college should circulate information through the central database provided by Article 17c of Regulation (EU) No 648/2012.
(5) Delegated Regulation (EU) No 876/2013 should therefore be amended accordingly.
(6) This Regulation is based on draft regulatory technical standards submitted to the Commission by ESMA following consultation of the European System of Central Banks (ESCB).
(7) Since the amendments are limited in scope and concern only CCP’s national competent authorities without imposing any additional requirements on market participants and to facilitate as soon as possible the adjustment of CCP colleges to the new provisions of Regulation (EU) No 648/2012, in accordance with Article 10(1) of Regulation (EU) No 1095/2010 of the European Parliament and of the Council(4), ESMA has considered that it is highly disproportionate to the scope and impact of the regulatory technical standards to conduct a public consultation. However, ESMA has consulted the Securities and Markets Stakeholder Group established in accordance with Article 37 of that Regulation, the relevant CCP’s national competent authorities and the ESCB,
HAS ADOPTED THIS REGULATION:

Amendments to Delegated Regulation (EU) No 876/2013
Article 1
Delegated Regulation (EU) No 876/2013 is amended as follows:
(1)
Article 2 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. Following the notification that an application contains the documents and information required as referred to in Article 17(2), first subparagraph, point (a), of Regulation (EU) No 648/2012, the CCP’s competent authority shall circulate a proposal for the written agreement under Article 18(5) of that Regulation to the members of the college determined in accordance with Article 18(2) of that Regulation. That written agreement shall include a process for the review of the composition of the college at least on an annual basis. It shall also include an amendment process whereby changes may be initiated at any time by the CCP’s competent authority or by other members of the college, subject to approval by the college in accordance with the procedure set out in this Article.’
(b)
paragraph 3 is replaced by the following:
‘3. Where the members of the college express comments regarding the proposal for the written agreement circulated pursuant to paragraph 1, they shall submit those comments together with a thorough explanation to the co-chairs within 10 calendar days. Where relevant, the co-chairs shall agree on and prepare a revised proposal and convene a meeting to agree on, and adopt, the final written agreement taking into account the deadline referred to in Article 18(1) of Regulation (EU) No 648/2012.’
(c)
paragraph 4a is replaced by the following:
‘4a. Competent authorities as referred to in Article 18(2), point (ca), of Regulation (EU) No 648/2012, and central banks of issue as referred to in Article 18(2), point (i), of that Regulation that wish to participate in the college shall submit a reasoned request to the CCP’s competent authority. The CCP’s competent authority shall, within 20 calendar days of the receipt of the request, either provide the requesting competent authority or central bank with a copy of the written agreement for review and approval, or substantiating in writing why the request has been rejected. The CCP’s competent authority shall inform the members of the college of any such requests and their respective outcome.’
(2)
in Article 3 paragraphs 1 and 2 are replaced by the following:
‘1. Where a request for information is made to a college by a competent authority of a Member State which is not a member of the college in accordance with Article 18(3) of Regulation (EU) No 648/2012, the co-chairs, after having consulted the college, shall decide on the most appropriate way to provide and request information to and from the authorities that are not members of the college.
2. Each member of the college shall designate one participant to attend the meetings of the college and may designate one alternate, with the exception of the co-chairs which may require additional participants who shall have no voting rights.’
(3)
Article 4 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. The co-chairs shall ensure that the work of the college facilitates the tasks to be performed in accordance with Regulation (EU) No 648/2012.’
(b)
the introductory wording of paragraph 3 is replaced by the following:
‘The co-chairs shall at least ensure that:’;
(c)
paragraphs 4 and 5 are replaced by the following:
‘4. To ensure the efficiency and effectiveness of the college, the co-chairs shall act as a central point of contact for any matter related to the practical organisation of the college and keep each other informed. The co-chairs shall at least perform the following tasks:
(a)
draw-up, update and circulate the contact list of members of the college;
(b)
prepare and circulate the agenda and documentation for meetings or activities of the college;
(ba)
discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;
(c)
record minutes of the meetings and formalise action points;
(d)
manage the college website, if any;
(e)
where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;
(f)
share all information in a timely and appropriate manner among members of the college.
For the purposes of point (b), the co-chairs shall circulate a draft agenda for each meeting of the college, other than for meetings called in emergency situations, well in advance of each meeting, in order to enable the members of the college to contribute to the setting of the agenda, in particular by adding points to the agenda.
The agenda shall be finalised by the co-chairs and distributed to members of the college sufficiently in advance of a meeting of the college. The co-chairs and other members of the college shall distribute any information to be considered at a meeting of the college well in advance of the meeting.
For the purposes of point (c), the CCP’s competent authority shall distribute the minutes of meetings to members of the college once those minutes are agreed by the co-chairs and as soon as practicable following the meetings and shall give members of the college sufficient time to comment.
5. The co-chairs shall determine the frequency of college meetings having regard to the CCP’s size, nature, scale and complexity, the systemic implications of the CCP across jurisdictions and currencies, the potential impacts of the activities of the CCP, external circumstances and potential requests by members of the college. There shall be at least an annual meeting of the college and if deemed necessary by the co-chairs, a meeting each time that a decision is to be taken under Regulation (EU) No 648/2012. The co-chairs shall organise, periodically, and at least annually, meetings between members of the college and the senior management of the CCP.
Members of the college may request that the co-chairs hold a meeting of the college. The co-chairs shall duly provide reasons for any rejection of such request.’
(d)
paragraphs 7 and 8 are replaced by the following:
‘7. The co-chairs shall endeavour to ensure that each college meeting has a valid quorum for decisions to be taken. Where a quorum is not met, the co-chairs shall ensure that any decisions that need to be taken are postponed until a quorum is present, taking into account the relevant time limits set out in Regulation (EU) No 648/2012.
8. The college may vote by written procedure, where proposed by the co-chairs or at the request of a member of the college.’
(4)
Article 5 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. Each member of a college shall provide, in a timely manner, the co-chairs with all information necessary for the operational functioning of the college and for the performance of the key activities in which that member participates. The co-chairs shall provide the members of the college with similar information in a timely manner.’
(b)
paragraph 2 is amended as follows:
(i)
point (m) is replaced by the following:
‘(m)
reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
(ii)
points (o) and (p) are replaced by the following:
‘(o)
overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;
(p)
changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
(iii)
point (r) is replaced by the following:
‘(r)
changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
(iv)
point (u) is replaced by the following:
‘(u)
changes in the payment and settlement arrangements of the CCP;’;
(v)
the following points (v) to (y) are added:
‘(v)
any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;
(w)
any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;
(x)
any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;
(y)
a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(c)
paragraphs 4 and 5 are replaced by the following:
‘4. The CCP’s competent authority’s draft decisions, reports or other measures referred to in Article 17(3), Article 17b(2) and Article 49(1d) of Regulation (EU) No 648/2012 shall be submitted to the college within an appropriate timescale to ensure that members of the college are able to review it and contribute to the college opinion.
5. Members of the college shall exchange all information through the central database provided by Article 17c of Regulation (EU) No 648/2012.’
(d)
paragraph 6 is deleted;
(5)
Article 5a is deleted.

Entry into force
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories(1), and in particular Article 18(6) thereof,
(1) Regulation (EU) 2024/2987 of the European Parliament and of the Council(2)introduced into Regulation (EU) No 648/2012 changes to the functioning and management of CCP colleges. In particular, a new co-chair has been introduced, in addition to the CCP’s competent authority, as being any of the independent members of the CCP Supervisory Committee. It is therefore necessary to reflect those changes in Commission Delegated Regulation (EU) No 876/2013(3).
(2) Without prejudice to the ultimate responsibility of the CCP’s competent authority and to further enhance supervisory convergence and the consistent functioning of all CCP colleges, the European Securities and Markets Authority (ESMA) should coordinate the functioning of the colleges and should ensure that each college performs its tasks and achieves its objectives in accordance with Regulation (EU) No 648/2012. To that aim, and with the objective of converging supervisory best practices, the co-chairs of the CCP college should discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012.
(3) In light of the amendments to Regulation (EU) No 648/2012, the non-exhaustive list of information items to be shared with the college should be updated.
(4) To allow for an efficient and timely flow of information between members of the college, the CCP’s competent authority and members of the college should circulate information through the central database provided by Article 17c of Regulation (EU) No 648/2012.
(5) Delegated Regulation (EU) No 876/2013 should therefore be amended accordingly.
(6) This Regulation is based on draft regulatory technical standards submitted to the Commission by ESMA following consultation of the European System of Central Banks (ESCB).
(7) Since the amendments are limited in scope and concern only CCP’s national competent authorities without imposing any additional requirements on market participants and to facilitate as soon as possible the adjustment of CCP colleges to the new provisions of Regulation (EU) No 648/2012, in accordance with Article 10(1) of Regulation (EU) No 1095/2010 of the European Parliament and of the Council(4), ESMA has considered that it is highly disproportionate to the scope and impact of the regulatory technical standards to conduct a public consultation. However, ESMA has consulted the Securities and Markets Stakeholder Group established in accordance with Article 37 of that Regulation, the relevant CCP’s national competent authorities and the ESCB,
HAS ADOPTED THIS REGULATION:

Amendments to Delegated Regulation (EU) No 876/2013

Delegated Regulation (EU) No 876/2013 is amended as follows:
(1)
Article 2 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. Following the notification that an application contains the documents and information required as referred to in Article 17(2), first subparagraph, point (a), of Regulation (EU) No 648/2012, the CCP’s competent authority shall circulate a proposal for the written agreement under Article 18(5) of that Regulation to the members of the college determined in accordance with Article 18(2) of that Regulation. That written agreement shall include a process for the review of the composition of the college at least on an annual basis. It shall also include an amendment process whereby changes may be initiated at any time by the CCP’s competent authority or by other members of the college, subject to approval by the college in accordance with the procedure set out in this Article.’
(b)
paragraph 3 is replaced by the following:
‘3. Where the members of the college express comments regarding the proposal for the written agreement circulated pursuant to paragraph 1, they shall submit those comments together with a thorough explanation to the co-chairs within 10 calendar days. Where relevant, the co-chairs shall agree on and prepare a revised proposal and convene a meeting to agree on, and adopt, the final written agreement taking into account the deadline referred to in Article 18(1) of Regulation (EU) No 648/2012.’
(c)
paragraph 4a is replaced by the following:
‘4a. Competent authorities as referred to in Article 18(2), point (ca), of Regulation (EU) No 648/2012, and central banks of issue as referred to in Article 18(2), point (i), of that Regulation that wish to participate in the college shall submit a reasoned request to the CCP’s competent authority. The CCP’s competent authority shall, within 20 calendar days of the receipt of the request, either provide the requesting competent authority or central bank with a copy of the written agreement for review and approval, or substantiating in writing why the request has been rejected. The CCP’s competent authority shall inform the members of the college of any such requests and their respective outcome.’
(2)
in Article 3 paragraphs 1 and 2 are replaced by the following:
‘1. Where a request for information is made to a college by a competent authority of a Member State which is not a member of the college in accordance with Article 18(3) of Regulation (EU) No 648/2012, the co-chairs, after having consulted the college, shall decide on the most appropriate way to provide and request information to and from the authorities that are not members of the college.
2. Each member of the college shall designate one participant to attend the meetings of the college and may designate one alternate, with the exception of the co-chairs which may require additional participants who shall have no voting rights.’
(3)
Article 4 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. The co-chairs shall ensure that the work of the college facilitates the tasks to be performed in accordance with Regulation (EU) No 648/2012.’
(b)
the introductory wording of paragraph 3 is replaced by the following:
‘The co-chairs shall at least ensure that:’;
(c)
paragraphs 4 and 5 are replaced by the following:
‘4. To ensure the efficiency and effectiveness of the college, the co-chairs shall act as a central point of contact for any matter related to the practical organisation of the college and keep each other informed. The co-chairs shall at least perform the following tasks:
(a)
draw-up, update and circulate the contact list of members of the college;
(b)
prepare and circulate the agenda and documentation for meetings or activities of the college;
(ba)
discuss the implementation of the annual supervisory priorities referred to in Article 24a(7), point (ba), of Regulation (EU) No 648/2012;
(c)
record minutes of the meetings and formalise action points;
(d)
manage the college website, if any;
(e)
where necessary, provide information and specialised teams where appropriate, to assist the college in its tasks;
(f)
share all information in a timely and appropriate manner among members of the college.
For the purposes of point (b), the co-chairs shall circulate a draft agenda for each meeting of the college, other than for meetings called in emergency situations, well in advance of each meeting, in order to enable the members of the college to contribute to the setting of the agenda, in particular by adding points to the agenda.
The agenda shall be finalised by the co-chairs and distributed to members of the college sufficiently in advance of a meeting of the college. The co-chairs and other members of the college shall distribute any information to be considered at a meeting of the college well in advance of the meeting.
For the purposes of point (c), the CCP’s competent authority shall distribute the minutes of meetings to members of the college once those minutes are agreed by the co-chairs and as soon as practicable following the meetings and shall give members of the college sufficient time to comment.
5. The co-chairs shall determine the frequency of college meetings having regard to the CCP’s size, nature, scale and complexity, the systemic implications of the CCP across jurisdictions and currencies, the potential impacts of the activities of the CCP, external circumstances and potential requests by members of the college. There shall be at least an annual meeting of the college and if deemed necessary by the co-chairs, a meeting each time that a decision is to be taken under Regulation (EU) No 648/2012. The co-chairs shall organise, periodically, and at least annually, meetings between members of the college and the senior management of the CCP.
Members of the college may request that the co-chairs hold a meeting of the college. The co-chairs shall duly provide reasons for any rejection of such request.’
(d)
paragraphs 7 and 8 are replaced by the following:
‘7. The co-chairs shall endeavour to ensure that each college meeting has a valid quorum for decisions to be taken. Where a quorum is not met, the co-chairs shall ensure that any decisions that need to be taken are postponed until a quorum is present, taking into account the relevant time limits set out in Regulation (EU) No 648/2012.
8. The college may vote by written procedure, where proposed by the co-chairs or at the request of a member of the college.’
(4)
Article 5 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. Each member of a college shall provide, in a timely manner, the co-chairs with all information necessary for the operational functioning of the college and for the performance of the key activities in which that member participates. The co-chairs shall provide the members of the college with similar information in a timely manner.’
(b)
paragraph 2 is amended as follows:
(i)
point (m) is replaced by the following:
‘(m)
reports on performance problems or incidents occurred, including ICT and cyber-related incidents, and remedial actions taken;’;
(ii)
points (o) and (p) are replaced by the following:
‘(o)
overview of major commercial proposals, new products or services to be offered including any extensions of activities or services to be implemented by the CCP in accordance with Article 15a of Regulation (EU) No 648/2012, and any information on changes to the CCP’s business;
(p)
changes in the CCP’s risk models and parameters, including changes to parameters referred to in Article 49(1h) of Regulation (EU) No 648/2012, stress testing and back testing;’;
(iii)
point (r) is replaced by the following:
‘(r)
changes in any outsourcing arrangements of the CCP for major activities linked to risk management, including any changes to the list of critical third-party service providers of the CCP;’;
(iv)
point (u) is replaced by the following:
‘(u)
changes in the payment and settlement arrangements of the CCP;’;
(v)
the following points (v) to (y) are added:
‘(v)
any information relevant to ad hoc meetings between ESMA, the CCP’s competent authority and the CCP and any relevant information received in relation to on-site inspections planned, ongoing or already carried out;
(w)
any information relevant to the implementation status of recommendations or conditions included in ESMA or college opinions or ESMA validations;
(x)
any information regarding the competent authority’s decision to follow or not follow the input from ESMA and the college pursuant to Article 17a(3) of Regulation (EU) No 648/2012;
(y)
a presentation of the CCP’s competent authority’s annual supervisory programme and of its implementation;’;
(c)
paragraphs 4 and 5 are replaced by the following:
‘4. The CCP’s competent authority’s draft decisions, reports or other measures referred to in Article 17(3), Article 17b(2) and Article 49(1d) of Regulation (EU) No 648/2012 shall be submitted to the college within an appropriate timescale to ensure that members of the college are able to review it and contribute to the college opinion.
5. Members of the college shall exchange all information through the central database provided by Article 17c of Regulation (EU) No 648/2012.’
(d)
paragraph 6 is deleted;
(5)
Article 5a is deleted.

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Commission Delegated Regulation (EU) 2025/1484 of 24 July 2025 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards the derogation from the minimum conservation reference size of Venus shells (Venus spp.) in certain Italian territorial waters

Official Journalof the European Union ENL series
2025/1484 23.12.2025
(1) Commission Delegated Regulation (EU) 2016/2376(2)granted a derogation from the minimum conservation reference size (MCRS) concerning Venus shells for a total length of 22 mm, in the Italian territorial waters of General Fisheries Commission for the Mediterranean Geographical Sub-Areas 9, 10, 17 and 18. That derogation followed a joint recommendation submitted by Italy, which is the single Member State with a direct management interest in its territorial waters.
(2) The derogation was granted several times by Commission Delegated Regulations (EU) 2020/3(3), (EU) 2020/2237(4)and (EU) 2022/2587(5), last until 31 December 2025.
(3) On 10 March 2025(6), Italy submitted to the Commission, in accordance with the procedure of Article 15(3) of Regulation (EU) 2019/1241, a new joint recommendation requesting to extend that derogation as regards the MCRS for Venus shells in the same Italian territorial waters. The Mediterranean Advisory Council (MEDAC)(7)has been duly consulted and supports the joint recommendation. In the Joint Recommendation, the Italian authorities committed to take a series of measures to help the sustainable exploitation of the Venus shells stock, including a maximum four days harvesting per week, a maximum 400 kg daily catch per vessel with no tolerance, exclusively designated landing points, a screening system at these landing points, compliant with the regulatory requirements (DM 22/12/2000), ensuring that only commercially sized clams (equal to or above 22 mm) are selected, fishing activities stopped for three (non-consecutive) months between February and November instead of two as in the current plan and designated restocking areas for clams below the minimum conservation reference size.
(4) The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the joint recommendation, and the supporting scientific evidence submitted by Italy at its plenary session from 24 to 28 March 2025 (STECF 25-01)(8). STECF commended the comprehensive information presented in support of the joint recommendation for derogation to the MCRS of Venus shells, which updated the information submitted to STECF for the 2022 March plenary. The information submitted addressed the key elements necessary to assess the Joint Recommendation. STECF noted that the surveys that were conducted in the different districts over a six, seven- or eight-year period, depending on the district, show stable length frequency distributions (LFDs), with good annual recruitments, and that the commercial clams (equal to or above 22 mm) represent a small fraction of the total in all cases. Moreover, STECF observed that selectivity has improved since the MCRS of 22 mm was implemented for the first time in 2017, in such a way that there are now not enough clams retained on board to support meaningful seeding operations for restocking purposes and restocking areas have been used only marginally. Also, STECF noted that after the first derogation of the MCRS via Delegated Regulation (EU) 2016/2376 and the implementation of the management measures in that regulation, Venus shells (Venusspp.) landings appear to have stabilised around 20 000 tonnes while biomass has increased in several districts. According to the assessment results, catches have generally remained around maximum sustainable yield, which would suggest, overall, that current management practices have helped prevent overexploitation of Venus clams. Also, STECF further concluded that despite the reduction of MCRS to 22 mm in 2017, the spawning stock biomass level appears to be healthy as good recruitment was observed in most of the maritime districts and within the commercial catch, provided that the management measures continue being implemented as in previous years and that there are no major environmental disturbances, it is reasonable to assume that in the next five years the impacts on the Venus shells (Venusspp.) stock in the Adriatic on exploitation rates and stock biomass will follow trends similar to those observed since the implementation of the 22 mm MCRS. STEFC also recommended an assessment of the results of the implementation of the 22 mm MCRS in 2030 to allow for any potential modification of the Management Plan and to track the evolution of the stock in the different maritime districts.
(5) STECF also concluded that the studies reported in the joint recommendation seem to show that the impacts on the habitats are not major or irreversible. STECF reiterated that Italy’s 2019 management plan(9)includes measures which are likely to be more effective than the previous conditions prevailing before 2017.
(6) The Commission considers that, on the basis of the information gathered at this stage in the joint recommendation, the MEDAC opinion, the STECF 25-01 assessment and the Italian administration commitments contained in Annex B to the Joint Recommendation, the derogation to the MCRS comply with the requirements established for technical measures in Articles 15 and 18 of Regulation (EU) 2019/1241.
(7) Regulation (EU) 2019/1241 should therefore be amended accordingly.
(8) The Italian management plan specifies that Italy will closely monitor the Venus shell stocks through reports which will be sent to the Commission annually.
(9) The measures suggested in the joint recommendation are in line with Article 18(3) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council(10)and with Article 15(4) of Regulation (EU) 2019/1241.
(10) As the measures provided for in this Regulation have a direct impact on the economic activities linked to fisheries and the planning of the fishing season for Union vessels, it should enter into force immediately after its publication,
‘Venus shells (Venusspp.) 25 mm(*1)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005(1), and in particular Article 15(2) thereof,
(1) Commission Delegated Regulation (EU) 2016/2376(2)granted a derogation from the minimum conservation reference size (MCRS) concerning Venus shells for a total length of 22 mm, in the Italian territorial waters of General Fisheries Commission for the Mediterranean Geographical Sub-Areas 9, 10, 17 and 18. That derogation followed a joint recommendation submitted by Italy, which is the single Member State with a direct management interest in its territorial waters.
(2) The derogation was granted several times by Commission Delegated Regulations (EU) 2020/3(3), (EU) 2020/2237(4)and (EU) 2022/2587(5), last until 31 December 2025.
(3) On 10 March 2025(6), Italy submitted to the Commission, in accordance with the procedure of Article 15(3) of Regulation (EU) 2019/1241, a new joint recommendation requesting to extend that derogation as regards the MCRS for Venus shells in the same Italian territorial waters. The Mediterranean Advisory Council (MEDAC)(7)has been duly consulted and supports the joint recommendation. In the Joint Recommendation, the Italian authorities committed to take a series of measures to help the sustainable exploitation of the Venus shells stock, including a maximum four days harvesting per week, a maximum 400 kg daily catch per vessel with no tolerance, exclusively designated landing points, a screening system at these landing points, compliant with the regulatory requirements (DM 22/12/2000), ensuring that only commercially sized clams (equal to or above 22 mm) are selected, fishing activities stopped for three (non-consecutive) months between February and November instead of two as in the current plan and designated restocking areas for clams below the minimum conservation reference size.
(4) The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the joint recommendation, and the supporting scientific evidence submitted by Italy at its plenary session from 24 to 28 March 2025 (STECF 25-01)(8). STECF commended the comprehensive information presented in support of the joint recommendation for derogation to the MCRS of Venus shells, which updated the information submitted to STECF for the 2022 March plenary. The information submitted addressed the key elements necessary to assess the Joint Recommendation. STECF noted that the surveys that were conducted in the different districts over a six, seven- or eight-year period, depending on the district, show stable length frequency distributions (LFDs), with good annual recruitments, and that the commercial clams (equal to or above 22 mm) represent a small fraction of the total in all cases. Moreover, STECF observed that selectivity has improved since the MCRS of 22 mm was implemented for the first time in 2017, in such a way that there are now not enough clams retained on board to support meaningful seeding operations for restocking purposes and restocking areas have been used only marginally. Also, STECF noted that after the first derogation of the MCRS via Delegated Regulation (EU) 2016/2376 and the implementation of the management measures in that regulation, Venus shells (Venusspp.) landings appear to have stabilised around 20 000 tonnes while biomass has increased in several districts. According to the assessment results, catches have generally remained around maximum sustainable yield, which would suggest, overall, that current management practices have helped prevent overexploitation of Venus clams. Also, STECF further concluded that despite the reduction of MCRS to 22 mm in 2017, the spawning stock biomass level appears to be healthy as good recruitment was observed in most of the maritime districts and within the commercial catch, provided that the management measures continue being implemented as in previous years and that there are no major environmental disturbances, it is reasonable to assume that in the next five years the impacts on the Venus shells (Venusspp.) stock in the Adriatic on exploitation rates and stock biomass will follow trends similar to those observed since the implementation of the 22 mm MCRS. STEFC also recommended an assessment of the results of the implementation of the 22 mm MCRS in 2030 to allow for any potential modification of the Management Plan and to track the evolution of the stock in the different maritime districts.
(5) STECF also concluded that the studies reported in the joint recommendation seem to show that the impacts on the habitats are not major or irreversible. STECF reiterated that Italy’s 2019 management plan(9)includes measures which are likely to be more effective than the previous conditions prevailing before 2017.
(6) The Commission considers that, on the basis of the information gathered at this stage in the joint recommendation, the MEDAC opinion, the STECF 25-01 assessment and the Italian administration commitments contained in Annex B to the Joint Recommendation, the derogation to the MCRS comply with the requirements established for technical measures in Articles 15 and 18 of Regulation (EU) 2019/1241.
(7) Regulation (EU) 2019/1241 should therefore be amended accordingly.
(8) The Italian management plan specifies that Italy will closely monitor the Venus shell stocks through reports which will be sent to the Commission annually.
(9) The measures suggested in the joint recommendation are in line with Article 18(3) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council(10)and with Article 15(4) of Regulation (EU) 2019/1241.
(10) As the measures provided for in this Regulation have a direct impact on the economic activities linked to fisheries and the planning of the fishing season for Union vessels, it should enter into force immediately after its publication,
HAS ADOPTED THIS REGULATION:

Amendments to Regulation (EU) 2019/1241
Article 1
Annex IX to Regulation (EU) 2019/1241 is amended in accordance with the Annex to this Regulation.

List of vessels
Article 2
By 15 January 2026, Member State authorities shall submit to the Commission, using the secure Union control website, the list of all vessels authorised to fish Venus shells (Venusspp.) using hydraulic dredges in Italian territorial waters of General Fisheries Commission for the Mediterranean Geographical Sub-Areas 9, 10, 17 and 18.
Member State authorities shall keep that list updated at all times and inform the Commission about the updating, in accordance with the first subparagraph.

Entry into force
Article 3
This Regulation shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.
It shall apply from 1 January 2026 until 31 December 2030.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005(1), and in particular Article 15(2) thereof,
(1) Commission Delegated Regulation (EU) 2016/2376(2)granted a derogation from the minimum conservation reference size (MCRS) concerning Venus shells for a total length of 22 mm, in the Italian territorial waters of General Fisheries Commission for the Mediterranean Geographical Sub-Areas 9, 10, 17 and 18. That derogation followed a joint recommendation submitted by Italy, which is the single Member State with a direct management interest in its territorial waters.
(2) The derogation was granted several times by Commission Delegated Regulations (EU) 2020/3(3), (EU) 2020/2237(4)and (EU) 2022/2587(5), last until 31 December 2025.
(3) On 10 March 2025(6), Italy submitted to the Commission, in accordance with the procedure of Article 15(3) of Regulation (EU) 2019/1241, a new joint recommendation requesting to extend that derogation as regards the MCRS for Venus shells in the same Italian territorial waters. The Mediterranean Advisory Council (MEDAC)(7)has been duly consulted and supports the joint recommendation. In the Joint Recommendation, the Italian authorities committed to take a series of measures to help the sustainable exploitation of the Venus shells stock, including a maximum four days harvesting per week, a maximum 400 kg daily catch per vessel with no tolerance, exclusively designated landing points, a screening system at these landing points, compliant with the regulatory requirements (DM 22/12/2000), ensuring that only commercially sized clams (equal to or above 22 mm) are selected, fishing activities stopped for three (non-consecutive) months between February and November instead of two as in the current plan and designated restocking areas for clams below the minimum conservation reference size.
(4) The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the joint recommendation, and the supporting scientific evidence submitted by Italy at its plenary session from 24 to 28 March 2025 (STECF 25-01)(8). STECF commended the comprehensive information presented in support of the joint recommendation for derogation to the MCRS of Venus shells, which updated the information submitted to STECF for the 2022 March plenary. The information submitted addressed the key elements necessary to assess the Joint Recommendation. STECF noted that the surveys that were conducted in the different districts over a six, seven- or eight-year period, depending on the district, show stable length frequency distributions (LFDs), with good annual recruitments, and that the commercial clams (equal to or above 22 mm) represent a small fraction of the total in all cases. Moreover, STECF observed that selectivity has improved since the MCRS of 22 mm was implemented for the first time in 2017, in such a way that there are now not enough clams retained on board to support meaningful seeding operations for restocking purposes and restocking areas have been used only marginally. Also, STECF noted that after the first derogation of the MCRS via Delegated Regulation (EU) 2016/2376 and the implementation of the management measures in that regulation, Venus shells (Venusspp.) landings appear to have stabilised around 20 000 tonnes while biomass has increased in several districts. According to the assessment results, catches have generally remained around maximum sustainable yield, which would suggest, overall, that current management practices have helped prevent overexploitation of Venus clams. Also, STECF further concluded that despite the reduction of MCRS to 22 mm in 2017, the spawning stock biomass level appears to be healthy as good recruitment was observed in most of the maritime districts and within the commercial catch, provided that the management measures continue being implemented as in previous years and that there are no major environmental disturbances, it is reasonable to assume that in the next five years the impacts on the Venus shells (Venusspp.) stock in the Adriatic on exploitation rates and stock biomass will follow trends similar to those observed since the implementation of the 22 mm MCRS. STEFC also recommended an assessment of the results of the implementation of the 22 mm MCRS in 2030 to allow for any potential modification of the Management Plan and to track the evolution of the stock in the different maritime districts.
(5) STECF also concluded that the studies reported in the joint recommendation seem to show that the impacts on the habitats are not major or irreversible. STECF reiterated that Italy’s 2019 management plan(9)includes measures which are likely to be more effective than the previous conditions prevailing before 2017.
(6) The Commission considers that, on the basis of the information gathered at this stage in the joint recommendation, the MEDAC opinion, the STECF 25-01 assessment and the Italian administration commitments contained in Annex B to the Joint Recommendation, the derogation to the MCRS comply with the requirements established for technical measures in Articles 15 and 18 of Regulation (EU) 2019/1241.
(7) Regulation (EU) 2019/1241 should therefore be amended accordingly.
(8) The Italian management plan specifies that Italy will closely monitor the Venus shell stocks through reports which will be sent to the Commission annually.
(9) The measures suggested in the joint recommendation are in line with Article 18(3) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council(10)and with Article 15(4) of Regulation (EU) 2019/1241.
(10) As the measures provided for in this Regulation have a direct impact on the economic activities linked to fisheries and the planning of the fishing season for Union vessels, it should enter into force immediately after its publication,
HAS ADOPTED THIS REGULATION:

Amendments to Regulation (EU) 2019/1241

Annex IX to Regulation (EU) 2019/1241 is amended in accordance with the Annex to this Regulation.

List of vessels

By 15 January 2026, Member State authorities shall submit to the Commission, using the secure Union control website, the list of all vessels authorised to fish Venus shells (Venusspp.) using hydraulic dredges in Italian territorial waters of General Fisheries Commission for the Mediterranean Geographical Sub-Areas 9, 10, 17 and 18.
Member State authorities shall keep that list updated at all times and inform the Commission about the updating, in accordance with the first subparagraph.

Entry into force

This Regulation shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.
It shall apply from 1 January 2026 until 31 December 2030.
ANNEXThe twenty-seventh entry of the table in Part A of Annex IX to Regulation (EU) 2019/1241 is replaced by the following:

‘Venus shells (Venus spp.)
25 mm (*1)

(*1) By way of derogation, from 1 January 2026 to 31 December 2030, the minimum conservation reference size of Venus shells (Venus spp.) shall be 22 mm in the Italian territorial waters of the General Fisheries Commission for the Mediterranean (GFCM) geographical sub-areas 9, 10, 17 and 18 as defined in Annex I to Regulation (EU) 2023/2124 of the European Parliament and of the Council of 4 October 2023 on certain provisions for fishing in the General Fisheries Commission for the Mediterranean (GFCM) Agreement area (OJ L, 2023/2124, 12.10.2023, ELI: http://data.europa.eu/eli/reg/2023/2124/oj).’

Commission Delegated Regulation (EU) 2025/1482 of 24 July 2025 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the persistent organic pollutants tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether

Official Journalof the European Union ENL series
2025/1482 28.10.2025
(1) Regulation (EU) 2019/1021 implements the commitments of the Union under the Stockholm Convention on Persistent Organic Pollutants(2)(‘the Convention’) and under the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants(3).
(2) Pursuant to Article 3(1) of Regulation (EU) 2019/1021, the manufacturing, placing on the market and use, whether on their own, in mixtures or in articles, of substances listed in Annex I to that Regulation are prohibited, subject to Article 4 of that Regulation.
(3) Tetrabromodiphenyl ether (tetraBDE), pentabromodiphenyl ether (pentaBDE), hexabromodiphenyl ether (hexaBDE), heptabromodiphenyl ether (heptaBDE) and decabromodiphenyl ether (decaBDE) (together ‘listed polybrominated diphenyl ethers’, ‘listed PBDE’) are listed in Annex I to Regulation (EU) 2019/1021 with an unintentional trace contaminant (UTC) limit value of 500 mg/kg for the sum of the concentrations of the five substances where they are present in mixtures or articles. That UTC limit value is subject to review by the Commission.
(4) Regulation (EU) 2022/2400 of the European Parliament and of the Council(4)reduces the concentration limit in waste for the sum of tetraBDE, pentaBDE, hexaBDE, heptaBDE and decaBDE to 500 mg/kg as of 10 June 2023, to 350 mg/kg from 30 December 2025 and to 200 mg/kg from 30 December 2027.
(5) The manufacturing, placing on the market and use of PBDE in the Union have been largely phased out. However, due to past and current recycling activities the substances occur in products made from recovered materials, including products for the general public.
(6) Particular attention should be given to childcare products and toys in view of potential exposure to listed PBDE contained in them. To address the situation where listed PBDE may be present unintentionally in childcare products and toys manufactured from recovered material, it is justified to set an unintentional trace contaminant limit value for them.
(7) Taking into account the objective of Regulation (EU) 2019/1021 to protect human health and the environment from persistent organic pollutants by prohibiting, phasing out as soon as possible, or restricting their manufacturing, placing on the market and use, the fact that listed PBDE occur mainly in products from recovered materials, and the limit of detection of relevant determination methods, different UTC limit values should be set for mixtures and articles made from or containing listed PBDE-containing recovered material and other mixtures and articles. Food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(5)should be excluded from this Regulation as listed PBDE should in principle not be present in food contact materials in accordance with Commission Regulations (EU) No 10/2011(6)and (EU) 2022/1616(7).
(8) Regulation (EU) 2019/1021 should therefore be amended accordingly,
(1) in Part A, in the table, in the entry ‘Tetrabromodiphenyl ether C12H6Br4O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.(*1)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI:http://data.europa.eu/eli/reg/2004/1935/oj)."(*2)Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, ELI:http://data.europa.eu/eli/dir/2009/48/oj).’;" ‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004. (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1); (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004. (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1); (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004. (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1); (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
(2) in Part A, in the table, in the entry ‘Pentabromodiphenyl ether C12H5Br5O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; ‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(3) in Part A, in the table, in the entry ‘Hexabromodiphenyl ether C12H4Br6O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; ‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(4) in Part A, in the table, in the entry ‘Heptabromodiphenyl ether C12H3Br7O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; ‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(5) in Part A, in the table, in the entry ‘Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE)’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. ‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
‘2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. (a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; (b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; (c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
(a) 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants(1), and in particular Article 15(1) thereof,
(1) Regulation (EU) 2019/1021 implements the commitments of the Union under the Stockholm Convention on Persistent Organic Pollutants(2)(‘the Convention’) and under the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants(3).
(2) Pursuant to Article 3(1) of Regulation (EU) 2019/1021, the manufacturing, placing on the market and use, whether on their own, in mixtures or in articles, of substances listed in Annex I to that Regulation are prohibited, subject to Article 4 of that Regulation.
(3) Tetrabromodiphenyl ether (tetraBDE), pentabromodiphenyl ether (pentaBDE), hexabromodiphenyl ether (hexaBDE), heptabromodiphenyl ether (heptaBDE) and decabromodiphenyl ether (decaBDE) (together ‘listed polybrominated diphenyl ethers’, ‘listed PBDE’) are listed in Annex I to Regulation (EU) 2019/1021 with an unintentional trace contaminant (UTC) limit value of 500 mg/kg for the sum of the concentrations of the five substances where they are present in mixtures or articles. That UTC limit value is subject to review by the Commission.
(4) Regulation (EU) 2022/2400 of the European Parliament and of the Council(4)reduces the concentration limit in waste for the sum of tetraBDE, pentaBDE, hexaBDE, heptaBDE and decaBDE to 500 mg/kg as of 10 June 2023, to 350 mg/kg from 30 December 2025 and to 200 mg/kg from 30 December 2027.
(5) The manufacturing, placing on the market and use of PBDE in the Union have been largely phased out. However, due to past and current recycling activities the substances occur in products made from recovered materials, including products for the general public.
(6) Particular attention should be given to childcare products and toys in view of potential exposure to listed PBDE contained in them. To address the situation where listed PBDE may be present unintentionally in childcare products and toys manufactured from recovered material, it is justified to set an unintentional trace contaminant limit value for them.
(7) Taking into account the objective of Regulation (EU) 2019/1021 to protect human health and the environment from persistent organic pollutants by prohibiting, phasing out as soon as possible, or restricting their manufacturing, placing on the market and use, the fact that listed PBDE occur mainly in products from recovered materials, and the limit of detection of relevant determination methods, different UTC limit values should be set for mixtures and articles made from or containing listed PBDE-containing recovered material and other mixtures and articles. Food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(5)should be excluded from this Regulation as listed PBDE should in principle not be present in food contact materials in accordance with Commission Regulations (EU) No 10/2011(6)and (EU) 2022/1616(7).
(8) Regulation (EU) 2019/1021 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:

Article 1
Annex I to Regulation (EU) 2019/1021 is amended in accordance with the Annex to this Regulation.

Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants(1), and in particular Article 15(1) thereof,
(1) Regulation (EU) 2019/1021 implements the commitments of the Union under the Stockholm Convention on Persistent Organic Pollutants(2)(‘the Convention’) and under the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants(3).
(2) Pursuant to Article 3(1) of Regulation (EU) 2019/1021, the manufacturing, placing on the market and use, whether on their own, in mixtures or in articles, of substances listed in Annex I to that Regulation are prohibited, subject to Article 4 of that Regulation.
(3) Tetrabromodiphenyl ether (tetraBDE), pentabromodiphenyl ether (pentaBDE), hexabromodiphenyl ether (hexaBDE), heptabromodiphenyl ether (heptaBDE) and decabromodiphenyl ether (decaBDE) (together ‘listed polybrominated diphenyl ethers’, ‘listed PBDE’) are listed in Annex I to Regulation (EU) 2019/1021 with an unintentional trace contaminant (UTC) limit value of 500 mg/kg for the sum of the concentrations of the five substances where they are present in mixtures or articles. That UTC limit value is subject to review by the Commission.
(4) Regulation (EU) 2022/2400 of the European Parliament and of the Council(4)reduces the concentration limit in waste for the sum of tetraBDE, pentaBDE, hexaBDE, heptaBDE and decaBDE to 500 mg/kg as of 10 June 2023, to 350 mg/kg from 30 December 2025 and to 200 mg/kg from 30 December 2027.
(5) The manufacturing, placing on the market and use of PBDE in the Union have been largely phased out. However, due to past and current recycling activities the substances occur in products made from recovered materials, including products for the general public.
(6) Particular attention should be given to childcare products and toys in view of potential exposure to listed PBDE contained in them. To address the situation where listed PBDE may be present unintentionally in childcare products and toys manufactured from recovered material, it is justified to set an unintentional trace contaminant limit value for them.
(7) Taking into account the objective of Regulation (EU) 2019/1021 to protect human health and the environment from persistent organic pollutants by prohibiting, phasing out as soon as possible, or restricting their manufacturing, placing on the market and use, the fact that listed PBDE occur mainly in products from recovered materials, and the limit of detection of relevant determination methods, different UTC limit values should be set for mixtures and articles made from or containing listed PBDE-containing recovered material and other mixtures and articles. Food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(5)should be excluded from this Regulation as listed PBDE should in principle not be present in food contact materials in accordance with Commission Regulations (EU) No 10/2011(6)and (EU) 2022/1616(7).
(8) Regulation (EU) 2019/1021 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Annex I to Regulation (EU) 2019/1021 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
ANNEXAnnex I to Regulation (EU) 2019/1021 is amended as follows:

(1) | in Part A, in the table, in the entry ‘Tetrabromodiphenyl ether C12H6Br4O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.(*1)Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI:http://data.europa.eu/eli/reg/2004/1935/oj).”(*2)Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, ELI:http://data.europa.eu/eli/dir/2009/48/oj).’;” | ‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004. | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1); | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004. | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1); | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
(a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council(*1);
(b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC of the European Parliament and of the Council(*2), or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.
(2) | in Part A, in the table, in the entry ‘Pentabromodiphenyl ether C12H5Br5O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | ‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(3) | in Part A, in the table, in the entry ‘Hexabromodiphenyl ether C12H4Br6O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | ‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(4) | in Part A, in the table, in the entry ‘Heptabromodiphenyl ether C12H3Br7O’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | ‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’; | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027, where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’;
(5) | in Part A, in the table, in the entry ‘Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE)’, point 2 in the fourth column is replaced by the following:‘2.For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. | ‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
‘2. | For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the following sum of the concentrations of those substances:(a)10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;(b)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;(c)by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’. | (a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004; | (b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004; | (c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
(a) | 10 mg/kg upon entry into force of this Regulation where they are present in mixtures or articles, except for food contact materials subject to Regulation (EC) No 1935/2004;
(b) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 200 mg/kg as of 30 December 2027 where they are present in mixtures or articles containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004;
(c) | by way of derogation from point (a), 500 mg/kg upon entry into force of this Regulation, 350 mg/kg as of 30 December 2025 and 10 mg/kg as of 17 May 2027 where they are present in toys subject to Directive 2009/48/EC, or in any product facilitating children’s seating, sleep, relaxation, hygiene, changing and general body care, feeding, sucking, transportation and protection, containing or made of recovered material containing tetra-, penta-, hexa-, hepta- or decaBDE, except for food contact materials subject to Regulation (EC) No 1935/2004.’.
(*1) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4, ELI: http://data.europa.eu/eli/reg/2004/1935/oj).
(*2) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, ELI: http://data.europa.eu/eli/dir/2009/48/oj).’;’

Commission Delegated Regulation (EU) 2025/1455 of 23 July 2025 amending Delegated Regulation (EU) No 44/2014 as regards laying down technical requirements and testing procedures regarding the protection of L-category vehicles against cyberattacks

Official Journalof the European Union ENL series
2025/1455 29.10.2025
(1) The scope of UN Regulation No 155(2)on cyber security and cyber security management system has been extended to include rules on cybersecurity for L-category vehicles (two- and three-wheel vehicles and quadricycles). To make UN Regulation No 155 applicable to L-category vehicles within the Union, it is necessary to include a reference to it in Commission Delegated Regulation (EU) No 44/2014(3).
(2) L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 and pedal cycles with pedal assistance exempted from the application of Regulation (EU) No 168/2013 under its Article 2(2), point (h), are not technically different from a cybersecurity perspective. The latter cycles, representing the vast majority (97 % on average) of the product offer of the majority of bicycle manufacturers, would be subject to the cybersecurity requirements laid down in Regulation (EU) 2024/2847 of the European Parliament and of the Council(4), whereas the former cycles, representing only a minority (3 % on average) of the product offer of most bicycle manufacturers, would be subject to the cybersecurity requirements of the UN Regulation No 155. Bicycle manufacturers producing electrically assisted bicycles with digital elements are often involved in the production of both pedal cycles with pedal assistance as defined under the exception clause of Article 2(2), point (h), of Regulation (EU) No 168/2013 and L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013. Developing the compliance with a different set of cybersecurity requirements for only a minority segment of the total production would create a disproportionate administrative burden for bicycle manufacturers. For those reasons, it is appropriate to exclude L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 from the scope of Delegated Regulation (EU) No 44/2014 as regards cyber security requirements set out therein.
(3) As L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 are subject to the requirements of Regulation (EU) 2024/2847 under Commission Delegated Regulation (EU) 2025/1535(5), it is appropriate to align the applicability of the requirements of UN Regulation No 155 with the date of application of Regulation (EU) 2024/2847.
(4) Besides ensuring the compliance of new vehicle types, national authorities and manufacturers need additional time sufficient to ensure that also all existing vehicle types become compliant with the cybersecurity rules under UN Regulation No 155.
(5) Delegated Regulation (EU) No 44/2014 should therefore be amended accordingly,
(1) Annex I is amended in accordance with Annex I to this Regulation;
(2) the text set out in Annex II to this Regulation is added as Annex XVIII.
‘155 Cyber security and cyber security management system Supplement 3 to the 00 series of amendments OJ L, 2025/5, 10.1.2025, ELI: http://data.europa.eu/eli/reg/2025/5/oj L1e, L2e, L3e, L4e, L5e, L6e and L7e, except L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013’
1.1. “Type of vehicle with regard to cybersecurity” means a category of vehicles which do not differ in the following respects:(a)the manufacturer’s designation of the vehicle type;(b)essential aspects of the electric/electronic architecture and external interfaces with respect to cyber security. (a) the manufacturer’s designation of the vehicle type; (b) essential aspects of the electric/electronic architecture and external interfaces with respect to cyber security.
(a) the manufacturer’s designation of the vehicle type;
(b) essential aspects of the electric/electronic architecture and external interfaces with respect to cyber security.
(a) the manufacturer’s designation of the vehicle type;
(b) essential aspects of the electric/electronic architecture and external interfaces with respect to cyber security.
1.2. Vehicles of categories L1e, L2e, L3e, L4e, L5e, L6e and L7e, except L1e vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013, shall meet all the relevant requirements of UN regulation No 155.
1.3. Points 1.1 and 1.2 shall apply as follows:(a)to new vehicle types from 11 December 2027;(b)to existing vehicle types from 11 June 2029. (a) to new vehicle types from 11 December 2027; (b) to existing vehicle types from 11 June 2029.
(a) to new vehicle types from 11 December 2027;
(b) to existing vehicle types from 11 June 2029.
(a) to new vehicle types from 11 December 2027;
(b) to existing vehicle types from 11 June 2029.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles(1), and in particular Article 18(3) thereof,
(1) The scope of UN Regulation No 155(2)on cyber security and cyber security management system has been extended to include rules on cybersecurity for L-category vehicles (two- and three-wheel vehicles and quadricycles). To make UN Regulation No 155 applicable to L-category vehicles within the Union, it is necessary to include a reference to it in Commission Delegated Regulation (EU) No 44/2014(3).
(2) L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 and pedal cycles with pedal assistance exempted from the application of Regulation (EU) No 168/2013 under its Article 2(2), point (h), are not technically different from a cybersecurity perspective. The latter cycles, representing the vast majority (97 % on average) of the product offer of the majority of bicycle manufacturers, would be subject to the cybersecurity requirements laid down in Regulation (EU) 2024/2847 of the European Parliament and of the Council(4), whereas the former cycles, representing only a minority (3 % on average) of the product offer of most bicycle manufacturers, would be subject to the cybersecurity requirements of the UN Regulation No 155. Bicycle manufacturers producing electrically assisted bicycles with digital elements are often involved in the production of both pedal cycles with pedal assistance as defined under the exception clause of Article 2(2), point (h), of Regulation (EU) No 168/2013 and L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013. Developing the compliance with a different set of cybersecurity requirements for only a minority segment of the total production would create a disproportionate administrative burden for bicycle manufacturers. For those reasons, it is appropriate to exclude L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 from the scope of Delegated Regulation (EU) No 44/2014 as regards cyber security requirements set out therein.
(3) As L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 are subject to the requirements of Regulation (EU) 2024/2847 under Commission Delegated Regulation (EU) 2025/1535(5), it is appropriate to align the applicability of the requirements of UN Regulation No 155 with the date of application of Regulation (EU) 2024/2847.
(4) Besides ensuring the compliance of new vehicle types, national authorities and manufacturers need additional time sufficient to ensure that also all existing vehicle types become compliant with the cybersecurity rules under UN Regulation No 155.
(5) Delegated Regulation (EU) No 44/2014 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:

Amendments to Delegated Regulation (EU) No 44/2014
Article 1
Delegated Regulation (EU) No 44/2014 is amended as follows:
(1)
Annex I is amended in accordance with Annex I to this Regulation;
(2)
the text set out in Annex II to this Regulation is added as Annex XVIII.

Entry into force
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles(1), and in particular Article 18(3) thereof,
(1) The scope of UN Regulation No 155(2)on cyber security and cyber security management system has been extended to include rules on cybersecurity for L-category vehicles (two- and three-wheel vehicles and quadricycles). To make UN Regulation No 155 applicable to L-category vehicles within the Union, it is necessary to include a reference to it in Commission Delegated Regulation (EU) No 44/2014(3).
(2) L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 and pedal cycles with pedal assistance exempted from the application of Regulation (EU) No 168/2013 under its Article 2(2), point (h), are not technically different from a cybersecurity perspective. The latter cycles, representing the vast majority (97 % on average) of the product offer of the majority of bicycle manufacturers, would be subject to the cybersecurity requirements laid down in Regulation (EU) 2024/2847 of the European Parliament and of the Council(4), whereas the former cycles, representing only a minority (3 % on average) of the product offer of most bicycle manufacturers, would be subject to the cybersecurity requirements of the UN Regulation No 155. Bicycle manufacturers producing electrically assisted bicycles with digital elements are often involved in the production of both pedal cycles with pedal assistance as defined under the exception clause of Article 2(2), point (h), of Regulation (EU) No 168/2013 and L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013. Developing the compliance with a different set of cybersecurity requirements for only a minority segment of the total production would create a disproportionate administrative burden for bicycle manufacturers. For those reasons, it is appropriate to exclude L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 from the scope of Delegated Regulation (EU) No 44/2014 as regards cyber security requirements set out therein.
(3) As L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013 are subject to the requirements of Regulation (EU) 2024/2847 under Commission Delegated Regulation (EU) 2025/1535(5), it is appropriate to align the applicability of the requirements of UN Regulation No 155 with the date of application of Regulation (EU) 2024/2847.
(4) Besides ensuring the compliance of new vehicle types, national authorities and manufacturers need additional time sufficient to ensure that also all existing vehicle types become compliant with the cybersecurity rules under UN Regulation No 155.
(5) Delegated Regulation (EU) No 44/2014 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:

Amendments to Delegated Regulation (EU) No 44/2014

Delegated Regulation (EU) No 44/2014 is amended as follows:
(1)
Annex I is amended in accordance with Annex I to this Regulation;
(2)
the text set out in Annex II to this Regulation is added as Annex XVIII.

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
ANNEX IIn Annex I to Delegated Regulation (EU) No 44/2014, in the table, the following row is added:

‘155
Cyber security and cyber security management system
Supplement 3 to the 00 series of amendments
OJ L, 2025/5, 10.1.2025, ELI: http://data.europa.eu/eli/reg/2025/5/oj
L1e, L2e, L3e, L4e, L5e, L6e and L7e, except L1e category vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013’

ANNEX II
‘ANNEX XVIII
Requirements applying to the protection of vehicles against cyberattacks 1. Requirements
1.1. “Type of vehicle with regard to cybersecurity” means a category of vehicles which do not differ in the following respects:
(a) the manufacturer’s designation of the vehicle type;
(b) essential aspects of the electric/electronic architecture and external interfaces with respect to cyber security.
1.2. Vehicles of categories L1e, L2e, L3e, L4e, L5e, L6e and L7e, except L1e vehicles designed to pedal referred to in Article 3, point (94)(b), of Regulation (EU) No 168/2013, shall meet all the relevant requirements of UN regulation No 155. 1.3. Points 1.1 and 1.2 shall apply as follows:
(a) to new vehicle types from 11 December 2027;
(b) to existing vehicle types from 11 June 2029. ’

Commission Delegated Regulation (EU) 2025/1449 of 18 July 2025 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council concerning specific hygiene rules for emergency slaughter of domestic ungulates, for tuna frozen in brine and for highly refined products

Official Journalof the European Union ENL series
2025/1449 29.10.2025
(1) Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. Food business operators are required to comply, inter alia, with the specific requirements laid down in Annex III to that Regulation.
(2) Annex III, Section I, Chapter VI, to Regulation (EC) No 853/2004 provides that food business operators are to ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if the meat complies with the requirements laid down in that Chapter. Point 5 of that Chapter VI requires a declaration by the food business operator to accompany the slaughtered animal to the slaughterhouse. The content of that declaration is included in the food chain information required in accordance with Point 3 of Section III of Annex II of Regulation (EC) No 853/2004. For clarity and the avoidance of possible duplication, point 5 of Chapter VI of Annex III to Regulation (EC) No 853/2004 should be replaced by a reference to the food chain information required in accordance with Section III of Annex II to that Regulation.
(3) Annex III, Section VIII, Chapter I, Part I.C, point 1, to Regulation (EC) No 853/2004 requires freezer vessels to have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C. Point 2 of that Part requires freezing vessels to have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004, where the whole fish intended for canning is frozen in brine, its temperature is to be not more than – 9 °C. This point also lays down that even if the whole fish initially frozen in brine at a temperature of not more than – 9 °C is subsequently frozen at a temperature of – 18 °C, it is to be destined for canning.
(4) Official controls carried out by Member States and audits and official controls carried out by the Commission both in Member States and in third countries, have shown that, in practice, freezer vessels could not reach the temperature of – 18 °C for freezing tuna in brine. The audit reports have also shown that certain food business operators have illegally placed on the market as unprocessed tuna for direct human consumption, tuna frozen in brine at – 9 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004 such tuna can only be destined for canning. This practice can expose consumers to health risks, as an excessive production of histamine results in scombroid syndrome.
(5) An increasing number of notifications have been issued on the Rapid Alert System for Food and Feed (RASFF) regarding the presence of histamine above the limit set in row 1.26 of Chapter I of Annex I to Commission Regulation (EC) No 2073/2005(2)in vacuum-packed thawed tuna loins, treated with additives, and of scombroid food poisoning associated with the consumption of such products. Member States have taken measures following official controls but recent RASFF notifications demonstrated that these measures have not solved the issue.
(6) Commission consultations with the competent authorities of the Member States and stakeholders’ organisations showed that freezing technologies on board certain vessels have substantially improved and it is now possible to freeze tuna in brine at – 18 °C while maintaining their organoleptic characteristics and ensuring the safety of the tuna where subject to certain conditions. It is therefore appropriate to lay down requirements regarding the freezing of tuna in brine at – 18 °C intended for the production of prepared fishery products. These requirements should also ensure that the operators carry out appropriate own-checks and facilitate the official controls to be carried out by the competent authorities, necessary to differentiate those freezing vessels from those freezing tuna in brine at – 9 °C and only destined for canning.
(7) Those requirements should ensure that the freezer vessels are equipped so as to be able to freeze tuna in brine at – 18 °C for a pre-determined period of time. In addition, the food business operators concerned should be able to monitor the temperature of the brine in real-time, using remote means of communication. Such data should be kept available to Member State competent authorities. The appropriate freezing capacity of freezer vessels freezing tuna in brine should be identified during the approval procedure of such freezer vessels to enable the competent authorities to identify tuna coming from such freezer vessels during official controls and to take action against operators illegally placing on the market tuna not frozen at – 18 °C. Those measures should ensure the proper functioning of the internal market while protecting consumers, in accordance with the objectives of Regulation (EC) No 853/2004.
(8) In addition, it is necessary to set strict time/temperature parameters for freezing tuna in brine at – 18 °C at core in freezer vessels approved for that activity. The decrease of temperature should be carried out in a continuous process, and subject to compliance with established requirements. In particular, the total duration of the freezing process should be established.
(9) Section VIII, Chapter I, Parts I and II of Annex III to Regulation (EC) No 853/2004 should be amended accordingly.
(10) Annex III, Section XVI, to Regulation (EC) No 853/2004 lays down specific requirements for certain highly refined products where food business operators must ensure that the treatment of the raw materials eliminates any animal or public health risk. Products of animal origin authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council(3)are also such highly refined products since the production of such additives eliminates these risks and should therefore be included in Section XVI of that Annex. Some of these additives are derived from insects and therefore insects should be allowed as raw materials for highly refined products. Annex III, Section XVI to Regulation (EC) No 853/2004 should therefore be amended accordingly.
(11) In order to allow the interested parties the necessary time to put in place procedures to comply with new requirements resulting from the amendments to Section VIII to Annex III to Regulation (EC) No 853/2004, by this Regulation, it should apply from 27 January 2026,
(1) in Section I, in Chapter VI, point 5 is replaced by the following:‘5.The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’; ‘5. The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’;
‘5. The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’;
‘5. The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’;
(2) in Section VIII:(a)Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;(b)in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’; (a) Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (i) Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; ‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; (ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’; (iii) Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’; (iv) in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; ‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (b) in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’;
(a) Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (i) Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; ‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; (ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’; (iii) Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’; (iv) in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; ‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(i) Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; ‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.
4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
(ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;
(iii) Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;
(iv) in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; ‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;
(b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;
(c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;
(d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(b) in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’;
(a) Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (i) Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; ‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; (ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’; (iii) Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’; (iv) in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; ‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(i) Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; ‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.
4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
(ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;
(iii) Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;
(iv) in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; ‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;
(b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;
(c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;
(d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(i) Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; ‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.
4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
‘C. Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; 1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. 2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator. 3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. 4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. 5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.
4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
1. Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. (a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; (b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; (c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
2. In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. (a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; (b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) allows real-time onshore monitoring of the temperature of the brine by the food business operator.
3. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.
4. The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. (a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; (b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
5. The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
(ii) Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;
(iii) Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;
(iv) in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; ‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;
(b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;
(c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;
(d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
‘8. Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; (a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; (b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; (c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; (d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;
(b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;
(c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;
(d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(a) where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;
(b) where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;
(c) food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;
(d) for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(b) in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’;
(3) Section XVI is amended as follows:(a)in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;"(b)point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. (a) in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;" ‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1); (b) point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. (i) the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ ‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ (ii) the following subpoint (d) is added:‘(d)insects.’. ‘(d) insects.’.
(a) in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;" ‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
(b) point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. (i) the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ ‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ (ii) the following subpoint (d) is added:‘(d)insects.’. ‘(d) insects.’.
(i) the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ ‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
(ii) the following subpoint (d) is added:‘(d)insects.’. ‘(d) insects.’.
‘(d) insects.’.
(a) in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;" ‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
‘(h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
(b) point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. (i) the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ ‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ (ii) the following subpoint (d) is added:‘(d)insects.’. ‘(d) insects.’.
(i) the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ ‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
(ii) the following subpoint (d) is added:‘(d)insects.’. ‘(d) insects.’.
‘(d) insects.’.
(i) the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ ‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
‘(4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
(ii) the following subpoint (d) is added:‘(d)insects.’. ‘(d) insects.’.
‘(d) insects.’.
‘(d) insects.’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(1), and in particular Article 10(1), second subparagraph, points (a), (b), (c), (d) and (e) thereof,
(1) Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. Food business operators are required to comply, inter alia, with the specific requirements laid down in Annex III to that Regulation.
(2) Annex III, Section I, Chapter VI, to Regulation (EC) No 853/2004 provides that food business operators are to ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if the meat complies with the requirements laid down in that Chapter. Point 5 of that Chapter VI requires a declaration by the food business operator to accompany the slaughtered animal to the slaughterhouse. The content of that declaration is included in the food chain information required in accordance with Point 3 of Section III of Annex II of Regulation (EC) No 853/2004. For clarity and the avoidance of possible duplication, point 5 of Chapter VI of Annex III to Regulation (EC) No 853/2004 should be replaced by a reference to the food chain information required in accordance with Section III of Annex II to that Regulation.
(3) Annex III, Section VIII, Chapter I, Part I.C, point 1, to Regulation (EC) No 853/2004 requires freezer vessels to have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C. Point 2 of that Part requires freezing vessels to have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004, where the whole fish intended for canning is frozen in brine, its temperature is to be not more than – 9 °C. This point also lays down that even if the whole fish initially frozen in brine at a temperature of not more than – 9 °C is subsequently frozen at a temperature of – 18 °C, it is to be destined for canning.
(4) Official controls carried out by Member States and audits and official controls carried out by the Commission both in Member States and in third countries, have shown that, in practice, freezer vessels could not reach the temperature of – 18 °C for freezing tuna in brine. The audit reports have also shown that certain food business operators have illegally placed on the market as unprocessed tuna for direct human consumption, tuna frozen in brine at – 9 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004 such tuna can only be destined for canning. This practice can expose consumers to health risks, as an excessive production of histamine results in scombroid syndrome.
(5) An increasing number of notifications have been issued on the Rapid Alert System for Food and Feed (RASFF) regarding the presence of histamine above the limit set in row 1.26 of Chapter I of Annex I to Commission Regulation (EC) No 2073/2005(2)in vacuum-packed thawed tuna loins, treated with additives, and of scombroid food poisoning associated with the consumption of such products. Member States have taken measures following official controls but recent RASFF notifications demonstrated that these measures have not solved the issue.
(6) Commission consultations with the competent authorities of the Member States and stakeholders’ organisations showed that freezing technologies on board certain vessels have substantially improved and it is now possible to freeze tuna in brine at – 18 °C while maintaining their organoleptic characteristics and ensuring the safety of the tuna where subject to certain conditions. It is therefore appropriate to lay down requirements regarding the freezing of tuna in brine at – 18 °C intended for the production of prepared fishery products. These requirements should also ensure that the operators carry out appropriate own-checks and facilitate the official controls to be carried out by the competent authorities, necessary to differentiate those freezing vessels from those freezing tuna in brine at – 9 °C and only destined for canning.
(7) Those requirements should ensure that the freezer vessels are equipped so as to be able to freeze tuna in brine at – 18 °C for a pre-determined period of time. In addition, the food business operators concerned should be able to monitor the temperature of the brine in real-time, using remote means of communication. Such data should be kept available to Member State competent authorities. The appropriate freezing capacity of freezer vessels freezing tuna in brine should be identified during the approval procedure of such freezer vessels to enable the competent authorities to identify tuna coming from such freezer vessels during official controls and to take action against operators illegally placing on the market tuna not frozen at – 18 °C. Those measures should ensure the proper functioning of the internal market while protecting consumers, in accordance with the objectives of Regulation (EC) No 853/2004.
(8) In addition, it is necessary to set strict time/temperature parameters for freezing tuna in brine at – 18 °C at core in freezer vessels approved for that activity. The decrease of temperature should be carried out in a continuous process, and subject to compliance with established requirements. In particular, the total duration of the freezing process should be established.
(9) Section VIII, Chapter I, Parts I and II of Annex III to Regulation (EC) No 853/2004 should be amended accordingly.
(10) Annex III, Section XVI, to Regulation (EC) No 853/2004 lays down specific requirements for certain highly refined products where food business operators must ensure that the treatment of the raw materials eliminates any animal or public health risk. Products of animal origin authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council(3)are also such highly refined products since the production of such additives eliminates these risks and should therefore be included in Section XVI of that Annex. Some of these additives are derived from insects and therefore insects should be allowed as raw materials for highly refined products. Annex III, Section XVI to Regulation (EC) No 853/2004 should therefore be amended accordingly.
(11) In order to allow the interested parties the necessary time to put in place procedures to comply with new requirements resulting from the amendments to Section VIII to Annex III to Regulation (EC) No 853/2004, by this Regulation, it should apply from 27 January 2026,
HAS ADOPTED THIS REGULATION:

Article 1
Annex III of Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.

Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
However, point (2) of the Annex to this Regulation shall apply from 27 January 2026.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(1), and in particular Article 10(1), second subparagraph, points (a), (b), (c), (d) and (e) thereof,
(1) Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. Food business operators are required to comply, inter alia, with the specific requirements laid down in Annex III to that Regulation.
(2) Annex III, Section I, Chapter VI, to Regulation (EC) No 853/2004 provides that food business operators are to ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if the meat complies with the requirements laid down in that Chapter. Point 5 of that Chapter VI requires a declaration by the food business operator to accompany the slaughtered animal to the slaughterhouse. The content of that declaration is included in the food chain information required in accordance with Point 3 of Section III of Annex II of Regulation (EC) No 853/2004. For clarity and the avoidance of possible duplication, point 5 of Chapter VI of Annex III to Regulation (EC) No 853/2004 should be replaced by a reference to the food chain information required in accordance with Section III of Annex II to that Regulation.
(3) Annex III, Section VIII, Chapter I, Part I.C, point 1, to Regulation (EC) No 853/2004 requires freezer vessels to have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C. Point 2 of that Part requires freezing vessels to have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004, where the whole fish intended for canning is frozen in brine, its temperature is to be not more than – 9 °C. This point also lays down that even if the whole fish initially frozen in brine at a temperature of not more than – 9 °C is subsequently frozen at a temperature of – 18 °C, it is to be destined for canning.
(4) Official controls carried out by Member States and audits and official controls carried out by the Commission both in Member States and in third countries, have shown that, in practice, freezer vessels could not reach the temperature of – 18 °C for freezing tuna in brine. The audit reports have also shown that certain food business operators have illegally placed on the market as unprocessed tuna for direct human consumption, tuna frozen in brine at – 9 °C. In accordance with Annex III, Section VIII, Chapter I, Part II, point 7, of Regulation (EC) No 853/2004 such tuna can only be destined for canning. This practice can expose consumers to health risks, as an excessive production of histamine results in scombroid syndrome.
(5) An increasing number of notifications have been issued on the Rapid Alert System for Food and Feed (RASFF) regarding the presence of histamine above the limit set in row 1.26 of Chapter I of Annex I to Commission Regulation (EC) No 2073/2005(2)in vacuum-packed thawed tuna loins, treated with additives, and of scombroid food poisoning associated with the consumption of such products. Member States have taken measures following official controls but recent RASFF notifications demonstrated that these measures have not solved the issue.
(6) Commission consultations with the competent authorities of the Member States and stakeholders’ organisations showed that freezing technologies on board certain vessels have substantially improved and it is now possible to freeze tuna in brine at – 18 °C while maintaining their organoleptic characteristics and ensuring the safety of the tuna where subject to certain conditions. It is therefore appropriate to lay down requirements regarding the freezing of tuna in brine at – 18 °C intended for the production of prepared fishery products. These requirements should also ensure that the operators carry out appropriate own-checks and facilitate the official controls to be carried out by the competent authorities, necessary to differentiate those freezing vessels from those freezing tuna in brine at – 9 °C and only destined for canning.
(7) Those requirements should ensure that the freezer vessels are equipped so as to be able to freeze tuna in brine at – 18 °C for a pre-determined period of time. In addition, the food business operators concerned should be able to monitor the temperature of the brine in real-time, using remote means of communication. Such data should be kept available to Member State competent authorities. The appropriate freezing capacity of freezer vessels freezing tuna in brine should be identified during the approval procedure of such freezer vessels to enable the competent authorities to identify tuna coming from such freezer vessels during official controls and to take action against operators illegally placing on the market tuna not frozen at – 18 °C. Those measures should ensure the proper functioning of the internal market while protecting consumers, in accordance with the objectives of Regulation (EC) No 853/2004.
(8) In addition, it is necessary to set strict time/temperature parameters for freezing tuna in brine at – 18 °C at core in freezer vessels approved for that activity. The decrease of temperature should be carried out in a continuous process, and subject to compliance with established requirements. In particular, the total duration of the freezing process should be established.
(9) Section VIII, Chapter I, Parts I and II of Annex III to Regulation (EC) No 853/2004 should be amended accordingly.
(10) Annex III, Section XVI, to Regulation (EC) No 853/2004 lays down specific requirements for certain highly refined products where food business operators must ensure that the treatment of the raw materials eliminates any animal or public health risk. Products of animal origin authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council(3)are also such highly refined products since the production of such additives eliminates these risks and should therefore be included in Section XVI of that Annex. Some of these additives are derived from insects and therefore insects should be allowed as raw materials for highly refined products. Annex III, Section XVI to Regulation (EC) No 853/2004 should therefore be amended accordingly.
(11) In order to allow the interested parties the necessary time to put in place procedures to comply with new requirements resulting from the amendments to Section VIII to Annex III to Regulation (EC) No 853/2004, by this Regulation, it should apply from 27 January 2026,
HAS ADOPTED THIS REGULATION:
Annex III of Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
However, point (2) of the Annex to this Regulation shall apply from 27 January 2026.
ANNEXAnnex III to Regulation (EC) No 853/2004 is amended as follows:

(1) | in Section I, in Chapter VI, point 5 is replaced by the following:‘5.The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’; | ‘5. | The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’;
‘5. | The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.’;
(2) | in Section VIII:(a)Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;(b)in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’; | (a) | Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (i) | Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | ‘C. | Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | 1. | Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | (a) | have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; | (b) | have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; | (c) | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | 2. | In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. | (a) | continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; | (b) | allows real-time onshore monitoring of the temperature of the brine by the food business operator. | 3. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. | 4. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | (a) | coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; | (b) | evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | 5. | The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | (ii) | Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’; | (iii) | Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’; | (iv) | in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | ‘8. | Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (a) | where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; | (b) | where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; | (c) | food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; | (d) | for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (b) | in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’;
(a) | Chapter I is amended as follows:(i)Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;(ii)Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;(iii)Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;(iv)in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (i) | Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | ‘C. | Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | 1. | Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | (a) | have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; | (b) | have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; | (c) | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | 2. | In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. | (a) | continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; | (b) | allows real-time onshore monitoring of the temperature of the brine by the food business operator. | 3. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. | 4. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | (a) | coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; | (b) | evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | 5. | The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | (ii) | Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’; | (iii) | Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’; | (iv) | in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | ‘8. | Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (a) | where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; | (b) | where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; | (c) | food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; | (d) | for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(i) | Part I.C is replaced by the following:‘C.Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | ‘C. | Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | 1. | Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | (a) | have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; | (b) | have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; | (c) | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | 2. | In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. | (a) | continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; | (b) | allows real-time onshore monitoring of the temperature of the brine by the food business operator. | 3. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. | 4. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | (a) | coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; | (b) | evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | 5. | The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
‘C. | Requirements for freezer vessels1.Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.2.In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator.3.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.4.The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.5.The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’; | 1. | Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | (a) | have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; | (b) | have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; | (c) | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | 2. | In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. | (a) | continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; | (b) | allows real-time onshore monitoring of the temperature of the brine by the food business operator. | 3. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part. | 4. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | (a) | coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; | (b) | evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | 5. | The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
1. | Freezer vessels must:(a)have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;(b)have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;(c)meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2. | (a) | have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C; | (b) | have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; | (c) | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
(a) | have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;
(b) | have refrigeration equipment with a sufficient capacity to maintain fishery products in the storage holds at not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid down in (a) of this point and must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
(c) | meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part I.B, point 2.
2. | In addition to the requirements laid down in point 1 of this Part, freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must be equipped with a system that:(a)continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;(b)allows real-time onshore monitoring of the temperature of the brine by the food business operator. | (a) | continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement; | (b) | allows real-time onshore monitoring of the temperature of the brine by the food business operator.
(a) | continuously monitors in real-time and records the temperature of the brine on board using electronic means of temperature measurement;
(b) | allows real-time onshore monitoring of the temperature of the brine by the food business operator.
3. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must give access, upon request, to the competent authorities to the data on the temperature of the brine collected through the system referred to in point 2(a) and (b) of this Part.
4. | The food business operators of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, must set up a validation plan regarding the freezing capacity of the freezer vessels freezing tuna in brine, that must include the following:(a)coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;(b)evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards. | (a) | coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish; | (b) | evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
(a) | coherent kinetic studies and a correlation curve between brine and core temperature, on the one hand, and the time and cooling periods as referred to in Part II, points 8(a) and (b), on the other hand; these studies and correlation curve must be based on the tuna temperature recorded by the instruments placed in sampled tunas as well as other criteria that the competent authorities may establish;
(b) | evidence that the temperature probes or sensors are certified in accordance with the relevant international temperature measurements standards.
5. | The competent authority must check the validation plan, and identify the freezing capacity, of freezer vessels that freeze tuna in brine as referred to in Part II, point 8, during the approval process of those freezer vessels in accordance with Article 4(3) of this Regulation or, in the case of freezer vessels flying the flag of a third country, when placing the freezer vessels on the list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.’;
(ii) | Part I.D, point 3 is replaced by the following: ‘Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part I.C, points 1(a) and 1(b).’;
(iii) | Part I.E is replaced by the following: ‘Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 1(b) of Part C concerning their capacity to maintain the temperature.’;
(iv) | in Part II, the following point 8 is added:‘8.Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | ‘8. | Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (a) | where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; | (b) | where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; | (c) | food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; | (d) | for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
‘8. | Whole tuna (genusThunnus and Katsuwonus)may be frozen in brine at – 18 °C at core in freezer vessels referred to in Section VIII, Chapter I, Part I.C, point 2 provided that the decrease in temperature is carried out in a continuous process, and subject to compliance with the following requirements:(a)where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;(b)where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;(c)food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;(d)for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’; | (a) | where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours; | (b) | where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours; | (c) | food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan; | (d) | for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(a) | where a direct freezing process in brine is carried out, its total duration to reach – 18 °C at core must not exceed 96 hours after the first capture of tuna has been placed in brine, and the tuna must reach a core temperature below 0 °C in less than 24 hours;
(b) | where a cooling process in cooled clean seawater is carried out before placing the tuna in brine, the temperature of the mixture of tuna and cooled clean seawater must reach 3 °C in less than 6 hours, and 0 °C in less than 16 hours; the total cooling process in cooled clean seawater must not exceed 72 hours after the first capture of tuna has been placed in the cooled clean seawater tank; once tuna is placed in brine, the total duration of the freezing process, from 0 °C to – 18 °C at core, must not exceed 72 hours;
(c) | food business operators must monitor the salt concentration of the brine and take appropriate action to maintain the salt concentration set out in their validation plan;
(d) | for verification purposes, the food business operators must continuously record the temperature of a sample of tuna through a temperature-measuring instrument inserted in the temperature-sensitive part of the fish that will freeze last.’;
(b) | in Chapter III, Part B, is replaced by the following: ‘Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I, Part I.C, points 1(a) and 1(b).’;
(3) | Section XVI is amended as follows:(a)in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;”(b)point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. | (a) | in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;” | ‘(h) | food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1); | (b) | point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. | (i) | the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ | ‘(4) | when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ | (ii) | the following subpoint (d) is added:‘(d)insects.’. | ‘(d) | insects.’.
(a) | in point (1), subpoint (h) is replaced by the following:‘(h)food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);(*1)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI:http://data.europa.eu/eli/reg/2008/1333/oj).’;” | ‘(h) | food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
‘(h) | food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council(*1);
(b) | point (2) is amended as following:(i)the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’(ii)the following subpoint (d) is added:‘(d)insects.’. | (i) | the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ | ‘(4) | when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ | (ii) | the following subpoint (d) is added:‘(d)insects.’. | ‘(d) | insects.’.
(i) | the following subpoint (4) is added to subpoint (c):‘(4)when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’ | ‘(4) | when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
‘(4) | when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes;’
(ii) | the following subpoint (d) is added:‘(d)insects.’. | ‘(d) | insects.’.
‘(d) | insects.’.
(*1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj).’;’

Commission Delegated Regulation (EU) 2025/1421 of 17 July 2025 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the conformity assessment procedures for EU fertilising products

Official Journalof the European Union ENL series
2025/1421 10.12.2025
(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. An EU fertilising product may only be made available on the market if it has successfully passed the applicable conformity assessment procedure as set out in Annex IV to that Regulation.
(2) The applicable conformity assessment procedure for ammonium nitrate fertilisers of high nitrogen content, as described in Module A1 of Annex IV, Part II, includes a detonation resistance test, and prior thermal cycles, which are to be performed by a laboratory chosen by the manufacturer and to be supervised by a notified body. Due to the explosive potential of ammonium nitrate fertilisers, it is important that the thermal cycles and detonation resistance tests results are reliable. Therefore, only laboratories that are accredited for those activities by a national accreditation body should be eligible.
(3) The conformity assessment procedure described in Module D1 of Annex IV, Part II, of Regulation (EU) 2019/1009 requires notified bodies to carry out periodic audits. For fertilising products containing recovered component materials, the audit frequency is linked to the frequency of the output material sampling as also set out in Annex IV, which results in a high audit density for manufacturers of high tonnages, with up to 48 audits per year. To ensure proportionality of the audit requirement, the frequency of audits should be independent from the sampling frequency, and a general audit frequency of one audit per year should be set out. This will ease the conformity assessment of circular EU fertilising products containing recovered component materials without jeopardising the safety of such materials, as samples would continue to be taken with the same frequency.
(4) In order to allow for a period of transition for manufacturers, the amendment of Module A1 should apply to thermal cycles and detonation resistance tests six months after the entry into force of this Regulation.
(5) Therefore, Regulation (EU) 2019/1009 should be amended accordingly,
(1) in MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING, point 4, the following paragraph is added:‘The thermal cycles and test referred to in points 4.3 and 4.4 shall be carried out in laboratories that are accredited for those activities by a national accreditation body.’;
(2) in MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS, point 6.3.2, the introductory statement is replaced by the following:‘For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, the notified body shall take and analyse output material samples with the following frequency:’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003(1), and in particular Article 42(1) thereof,
(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. An EU fertilising product may only be made available on the market if it has successfully passed the applicable conformity assessment procedure as set out in Annex IV to that Regulation.
(2) The applicable conformity assessment procedure for ammonium nitrate fertilisers of high nitrogen content, as described in Module A1 of Annex IV, Part II, includes a detonation resistance test, and prior thermal cycles, which are to be performed by a laboratory chosen by the manufacturer and to be supervised by a notified body. Due to the explosive potential of ammonium nitrate fertilisers, it is important that the thermal cycles and detonation resistance tests results are reliable. Therefore, only laboratories that are accredited for those activities by a national accreditation body should be eligible.
(3) The conformity assessment procedure described in Module D1 of Annex IV, Part II, of Regulation (EU) 2019/1009 requires notified bodies to carry out periodic audits. For fertilising products containing recovered component materials, the audit frequency is linked to the frequency of the output material sampling as also set out in Annex IV, which results in a high audit density for manufacturers of high tonnages, with up to 48 audits per year. To ensure proportionality of the audit requirement, the frequency of audits should be independent from the sampling frequency, and a general audit frequency of one audit per year should be set out. This will ease the conformity assessment of circular EU fertilising products containing recovered component materials without jeopardising the safety of such materials, as samples would continue to be taken with the same frequency.
(4) In order to allow for a period of transition for manufacturers, the amendment of Module A1 should apply to thermal cycles and detonation resistance tests six months after the entry into force of this Regulation.
(5) Therefore, Regulation (EU) 2019/1009 should be amended accordingly,
HAS ADOPTED THIS REGULATION:

Article 1
Part II of Annex IV to Regulation (EU) 2019/1009 is amended as follows:
(1)
in MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING, point 4, the following paragraph is added:
‘The thermal cycles and test referred to in points 4.3 and 4.4 shall be carried out in laboratories that are accredited for those activities by a national accreditation body.’;
(2)
in MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS, point 6.3.2, the introductory statement is replaced by the following:
‘For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, the notified body shall take and analyse output material samples with the following frequency:’.

Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
Article 1(1) shall apply from 30 December 2025.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003(1), and in particular Article 42(1) thereof,
(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. An EU fertilising product may only be made available on the market if it has successfully passed the applicable conformity assessment procedure as set out in Annex IV to that Regulation.
(2) The applicable conformity assessment procedure for ammonium nitrate fertilisers of high nitrogen content, as described in Module A1 of Annex IV, Part II, includes a detonation resistance test, and prior thermal cycles, which are to be performed by a laboratory chosen by the manufacturer and to be supervised by a notified body. Due to the explosive potential of ammonium nitrate fertilisers, it is important that the thermal cycles and detonation resistance tests results are reliable. Therefore, only laboratories that are accredited for those activities by a national accreditation body should be eligible.
(3) The conformity assessment procedure described in Module D1 of Annex IV, Part II, of Regulation (EU) 2019/1009 requires notified bodies to carry out periodic audits. For fertilising products containing recovered component materials, the audit frequency is linked to the frequency of the output material sampling as also set out in Annex IV, which results in a high audit density for manufacturers of high tonnages, with up to 48 audits per year. To ensure proportionality of the audit requirement, the frequency of audits should be independent from the sampling frequency, and a general audit frequency of one audit per year should be set out. This will ease the conformity assessment of circular EU fertilising products containing recovered component materials without jeopardising the safety of such materials, as samples would continue to be taken with the same frequency.
(4) In order to allow for a period of transition for manufacturers, the amendment of Module A1 should apply to thermal cycles and detonation resistance tests six months after the entry into force of this Regulation.
(5) Therefore, Regulation (EU) 2019/1009 should be amended accordingly,
HAS ADOPTED THIS REGULATION:
Part II of Annex IV to Regulation (EU) 2019/1009 is amended as follows:
(1)
in MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING, point 4, the following paragraph is added:
‘The thermal cycles and test referred to in points 4.3 and 4.4 shall be carried out in laboratories that are accredited for those activities by a national accreditation body.’;
(2)
in MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS, point 6.3.2, the introductory statement is replaced by the following:
‘For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, the notified body shall take and analyse output material samples with the following frequency:’.
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
Article 1(1) shall apply from 30 December 2025.

Commission Delegated Regulation (EU) 2025/1416 of 11 July 2025 amending Delegated Regulation (EU) 2023/2772 as regards the postponement of the date of application of the disclosure requirements for certain undertakings

Official Journalof the European Union ENL series
2025/1416 10.11.2025
(1) Directive (EU) 2022/2464 of the European Parliament and of the Council(2)amended Directive 2013/34/EU to introduce into that Directive certain additional sustainability reporting requirements.
(2) Appendix C of ESRS 1 in Annex I to Commission Delegated Regulation (EU) 2023/2772(3)allows certain undertakings to omit from their reporting certain sustainability information for the first year, or years, of preparation of their sustainability statement.
(3) On 26 February 2025, the Commission adopted the proposal for a Directive of the European Parliament and of the Council amending Directives 2006/43/EC, 2013/34/EU, (EU) 2022/2464 and (EU) 2024/1760 as regards certain corporate sustainability reporting and due diligence requirements(4)(‘the Omnibus Simplification Package’), which proposes, inter alia, a number of amendments to the sustainability reporting requirements introduced by Directive (EU) 2022/2464. In particular, the Commission proposes to reduce the number of undertakings subject to those sustainability reporting requirements. According to the Commission’s proposal, only large undertakings with more than 1 000 employees would remain subject to the requirement to report sustainability information. As part of that Omnibus Simplification Package, the Commission also proposed to amend Article 5 of Directive (EU) 2022/2464 to defer the dates from which Member States are to apply the reporting requirements for those undertakings that would have to report for the first time for financial years 2025 and 2026 (‘stop-the-clock’ proposal). The European Parliament and the Council adopted that stop-the-clock proposal without substantial modifications as Directive (EU) 2025/794 of the European Parliament and of the Council(5), which entered into force on 17 April 2025. However, in order not to prejudge the outcome of the legislative procedure on the Commission’s proposal to amend the sustainability reporting requirements, and in particular the provisions setting out which undertakings will be subject to the reporting requirements in the future, Directive (EU) 2025/794 has not deferred the dates from which Member States are to apply the reporting requirements for undertakings that are to report for the first time with respect to financial year 2024.
(4) Pursuant to the existing timetable of Appendix C of ESRS 1 of Annex I to Delegated Regulation (EU) 2023/2772, undertakings that need to report sustainability information already with respect to financial year 2024 will be subject to a further phasing in of various reporting requirements with respect to financial years 2025 and 2026. Moreover, undertakings with more than 750 employees will not benefit from the same phase-in provisions as other undertakings that are subject to the sustainability reporting requirements. It would not be reasonable to require undertakings to comply with additional reporting requirements when the Commission has made a proposal to ensure that those undertakings will subsequently not have to report any information. Moreover, it would be contrary to the burden reduction objective of the Omnibus Simplification Package to prevent undertakings with more than 750 employees from benefitting from the same phase-in provisions as other undertakings that are subject to the sustainability reporting requirements, especially for those sustainability reporting requirements that are most challenging for undertakings, that is to say the topical standards ESRS E4 (biodiversity and ecosystems), ESRS S2 (workers in the value chain), ESRS S3 (affected communities) and ESRS S4 (consumers and end-users) that are laid down in Annex I to Delegated Regulation (EU) 2023/2772.
(5) Pursuant to ESRS 2, paragraph 17, of Annex I to Delegated Regulation (EU) 2023/2772, an undertaking or a group with up to 750 employees that uses the temporary exemptions in accordance with Appendix C of ESRS 1 for a complete topical standard must nevertheless report certain summarised information on the topic concerned if that undertaking or group has concluded that the topic in question is material. If the temporary exemptions set out in Appendix C of ESRS 1 for a complete topical standard should be applicable also by undertakings with more than 750 employees, it would be necessary – for reasons of consistency – to require the application of ESRS 2, paragraph 17, by any undertaking that uses the temporary exemptions in accordance with Appendix C of ESRS, including the undertakings or groups with more than 750 employees that are to report from financial year 2024.
(6) It is therefore necessary to adapt the phasing-in timetable of Appendix C of ESRS 1 of Annex I to Delegated Regulation (EU) 2023/2772, and to amend paragraph 17 of ESRS 2 of that Delegated Regulation, accordingly.
(7) To enable the undertakings concerned to benefit from that adaptation as soon as possible, this Regulation should enter into force on the third day following that of its publication in theOfficial Journal of the European Union.
(8) On 30 April 2025 the Commission consulted Member States on this draft delegated act during a joint meeting of the Member States’ Expert Group on Sustainable Finance and the Accounting Regulatory Committee, in accordance with the requirements of Article 49(3b), third subparagraph, of Directive 2013/34/EU,
(1) in ESRS 1, Appendix C, ‘List of phased-in Disclosure Requirements’, is replaced by the following:‘Appendix CList of phased-in Disclosure RequirementsThis appendix is an integral part of ESRS 1 and has the same authority as the other parts of the Standard.ESRSDisclosure RequirementFull name of the Disclosure RequirementPhase-in or effective date (including the first year)ESRS 2SBM-1Strategy, business model and value chainThe undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU.ESRS 2SBM-3Material impacts, risks and opportunities and their interaction with strategy and business modelThe undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.ESRS E1E1-6Gross Scopes 1, 2, 3 and Total GHG emissionsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement.ESRS E1E1-9Anticipated financial effects from material physical and transition risks and potential climate-related opportunitiesThe undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.ESRS E2E2-6Anticipated financial effects from pollution-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS E3E3-5Anticipated financial effects from water and marine resources-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS E4All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement.ESRS E4E4-6Anticipated financial effects from biodiversity and ecosystem-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS E5E5-6Anticipated financial effects from resource use and circular economy-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS S1All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-7Characteristics of non-employee workers in the undertaking’s own workforceThe undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement.ESRS S1S1-8Collective bargaining coverage and social dialogueThe undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement.ESRS S1S1-11Social protectionThe undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-12Persons with disabilitiesThe undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-13Training and skills developmentThe undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-14Health and safetyThe undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement.ESRS S1S1-14Health and safetyThe undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement.ESRS S1S1-15Work-life balanceThe undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement.ESRS S2All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement.ESRS S3All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement.ESRS S4All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.’ ESRS Disclosure Requirement Full name of the Disclosure Requirement Phase-in or effective date (including the first year) ESRS 2 SBM-1 Strategy, business model and value chain The undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU. ESRS 2 SBM-3 Material impacts, risks and opportunities and their interaction with strategy and business model The undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures. ESRS E1 E1-6 Gross Scopes 1, 2, 3 and Total GHG emissions Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement. ESRS E1 E1-9 Anticipated financial effects from material physical and transition risks and potential climate-related opportunities The undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures. ESRS E2 E2-6 Anticipated financial effects from pollution-related risks and opportunities The undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. ESRS E3 E3-5 Anticipated financial effects from water and marine resources-related risks and opportunities The undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. ESRS E4 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement. ESRS E4 E4-6 Anticipated financial effects from biodiversity and ecosystem-related risks and opportunities The undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. ESRS E5 E5-6 Anticipated financial effects from resource use and circular economy-related risks and opportunities The undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. ESRS S1 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-7 Characteristics of non-employee workers in the undertaking’s own workforce The undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-8 Collective bargaining coverage and social dialogue The undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-11 Social protection The undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-12 Persons with disabilities The undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-13 Training and skills development The undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-14 Health and safety The undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-14 Health and safety The undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement. ESRS S1 S1-15 Work-life balance The undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement. ESRS S2 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement. ESRS S3 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement. ESRS S4 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.
ESRS Disclosure Requirement Full name of the Disclosure Requirement Phase-in or effective date (including the first year)
ESRS 2 SBM-1 Strategy, business model and value chain The undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU.
ESRS 2 SBM-3 Material impacts, risks and opportunities and their interaction with strategy and business model The undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.
ESRS E1 E1-6 Gross Scopes 1, 2, 3 and Total GHG emissions Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement.
ESRS E1 E1-9 Anticipated financial effects from material physical and transition risks and potential climate-related opportunities The undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.
ESRS E2 E2-6 Anticipated financial effects from pollution-related risks and opportunities The undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E3 E3-5 Anticipated financial effects from water and marine resources-related risks and opportunities The undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E4 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement.
ESRS E4 E4-6 Anticipated financial effects from biodiversity and ecosystem-related risks and opportunities The undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E5 E5-6 Anticipated financial effects from resource use and circular economy-related risks and opportunities The undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS S1 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-7 Characteristics of non-employee workers in the undertaking’s own workforce The undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-8 Collective bargaining coverage and social dialogue The undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-11 Social protection The undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-12 Persons with disabilities The undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-13 Training and skills development The undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-14 Health and safety The undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-14 Health and safety The undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-15 Work-life balance The undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement.
ESRS S2 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement.
ESRS S3 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement.
ESRS S4 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.
ESRS Disclosure Requirement Full name of the Disclosure Requirement Phase-in or effective date (including the first year)
ESRS 2 SBM-1 Strategy, business model and value chain The undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU.
ESRS 2 SBM-3 Material impacts, risks and opportunities and their interaction with strategy and business model The undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.
ESRS E1 E1-6 Gross Scopes 1, 2, 3 and Total GHG emissions Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement.
ESRS E1 E1-9 Anticipated financial effects from material physical and transition risks and potential climate-related opportunities The undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.
ESRS E2 E2-6 Anticipated financial effects from pollution-related risks and opportunities The undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E3 E3-5 Anticipated financial effects from water and marine resources-related risks and opportunities The undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E4 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement.
ESRS E4 E4-6 Anticipated financial effects from biodiversity and ecosystem-related risks and opportunities The undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E5 E5-6 Anticipated financial effects from resource use and circular economy-related risks and opportunities The undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS S1 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-7 Characteristics of non-employee workers in the undertaking’s own workforce The undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-8 Collective bargaining coverage and social dialogue The undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-11 Social protection The undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-12 Persons with disabilities The undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-13 Training and skills development The undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-14 Health and safety The undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-14 Health and safety The undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement.
ESRS S1 S1-15 Work-life balance The undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement.
ESRS S2 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement.
ESRS S3 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement.
ESRS S4 All disclosure requirements All disclosure requirements Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.
(2) in ESRS 2, Section 17, the introductory wording is replaced by the following:‘If an undertaking or group omits the information required by ESRS E4, ESRS S1, ESRS S2, ESRS S3 or ESRS S4 in accordance with the rows of Appendix C of ESRS 1 showing “All disclosure requirements” in the column “Full name of the Disclosure Requirement”, it shall nevertheless disclose whether the sustainability topics covered respectively by ESRS E4, ESRS S1, ESRS S2, ESRS S3 and ESRS S4 have been assessed to be material as a result of the undertaking’s materiality assessment. In addition, if one or more of these topics has been assessed to be material, the undertaking shall, for each material topic:’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC(1), and in particular Article 29b(1), first subparagraph, thereof,
(1) Directive (EU) 2022/2464 of the European Parliament and of the Council(2)amended Directive 2013/34/EU to introduce into that Directive certain additional sustainability reporting requirements.
(2) Appendix C of ESRS 1 in Annex I to Commission Delegated Regulation (EU) 2023/2772(3)allows certain undertakings to omit from their reporting certain sustainability information for the first year, or years, of preparation of their sustainability statement.
(3) On 26 February 2025, the Commission adopted the proposal for a Directive of the European Parliament and of the Council amending Directives 2006/43/EC, 2013/34/EU, (EU) 2022/2464 and (EU) 2024/1760 as regards certain corporate sustainability reporting and due diligence requirements(4)(‘the Omnibus Simplification Package’), which proposes, inter alia, a number of amendments to the sustainability reporting requirements introduced by Directive (EU) 2022/2464. In particular, the Commission proposes to reduce the number of undertakings subject to those sustainability reporting requirements. According to the Commission’s proposal, only large undertakings with more than 1 000 employees would remain subject to the requirement to report sustainability information. As part of that Omnibus Simplification Package, the Commission also proposed to amend Article 5 of Directive (EU) 2022/2464 to defer the dates from which Member States are to apply the reporting requirements for those undertakings that would have to report for the first time for financial years 2025 and 2026 (‘stop-the-clock’ proposal). The European Parliament and the Council adopted that stop-the-clock proposal without substantial modifications as Directive (EU) 2025/794 of the European Parliament and of the Council(5), which entered into force on 17 April 2025. However, in order not to prejudge the outcome of the legislative procedure on the Commission’s proposal to amend the sustainability reporting requirements, and in particular the provisions setting out which undertakings will be subject to the reporting requirements in the future, Directive (EU) 2025/794 has not deferred the dates from which Member States are to apply the reporting requirements for undertakings that are to report for the first time with respect to financial year 2024.
(4) Pursuant to the existing timetable of Appendix C of ESRS 1 of Annex I to Delegated Regulation (EU) 2023/2772, undertakings that need to report sustainability information already with respect to financial year 2024 will be subject to a further phasing in of various reporting requirements with respect to financial years 2025 and 2026. Moreover, undertakings with more than 750 employees will not benefit from the same phase-in provisions as other undertakings that are subject to the sustainability reporting requirements. It would not be reasonable to require undertakings to comply with additional reporting requirements when the Commission has made a proposal to ensure that those undertakings will subsequently not have to report any information. Moreover, it would be contrary to the burden reduction objective of the Omnibus Simplification Package to prevent undertakings with more than 750 employees from benefitting from the same phase-in provisions as other undertakings that are subject to the sustainability reporting requirements, especially for those sustainability reporting requirements that are most challenging for undertakings, that is to say the topical standards ESRS E4 (biodiversity and ecosystems), ESRS S2 (workers in the value chain), ESRS S3 (affected communities) and ESRS S4 (consumers and end-users) that are laid down in Annex I to Delegated Regulation (EU) 2023/2772.
(5) Pursuant to ESRS 2, paragraph 17, of Annex I to Delegated Regulation (EU) 2023/2772, an undertaking or a group with up to 750 employees that uses the temporary exemptions in accordance with Appendix C of ESRS 1 for a complete topical standard must nevertheless report certain summarised information on the topic concerned if that undertaking or group has concluded that the topic in question is material. If the temporary exemptions set out in Appendix C of ESRS 1 for a complete topical standard should be applicable also by undertakings with more than 750 employees, it would be necessary – for reasons of consistency – to require the application of ESRS 2, paragraph 17, by any undertaking that uses the temporary exemptions in accordance with Appendix C of ESRS, including the undertakings or groups with more than 750 employees that are to report from financial year 2024.
(6) It is therefore necessary to adapt the phasing-in timetable of Appendix C of ESRS 1 of Annex I to Delegated Regulation (EU) 2023/2772, and to amend paragraph 17 of ESRS 2 of that Delegated Regulation, accordingly.
(7) To enable the undertakings concerned to benefit from that adaptation as soon as possible, this Regulation should enter into force on the third day following that of its publication in theOfficial Journal of the European Union.
(8) On 30 April 2025 the Commission consulted Member States on this draft delegated act during a joint meeting of the Member States’ Expert Group on Sustainable Finance and the Accounting Regulatory Committee, in accordance with the requirements of Article 49(3b), third subparagraph, of Directive 2013/34/EU,
HAS ADOPTED THIS REGULATION:

Amendments to Delegated Regulation (EU) 2023/2772
Article 1
Annex I to Delegated Regulation (EU) 2023/2772 is amended in accordance with the Annex to this Regulation.

Entry into force and application
Article 2
This Regulation shall enter into force on the third day following that of its publication in theOfficial Journal of the European Union.
It shall apply with respect to financial years beginning on or after 1 January 2025.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC(1), and in particular Article 29b(1), first subparagraph, thereof,
(1) Directive (EU) 2022/2464 of the European Parliament and of the Council(2)amended Directive 2013/34/EU to introduce into that Directive certain additional sustainability reporting requirements.
(2) Appendix C of ESRS 1 in Annex I to Commission Delegated Regulation (EU) 2023/2772(3)allows certain undertakings to omit from their reporting certain sustainability information for the first year, or years, of preparation of their sustainability statement.
(3) On 26 February 2025, the Commission adopted the proposal for a Directive of the European Parliament and of the Council amending Directives 2006/43/EC, 2013/34/EU, (EU) 2022/2464 and (EU) 2024/1760 as regards certain corporate sustainability reporting and due diligence requirements(4)(‘the Omnibus Simplification Package’), which proposes, inter alia, a number of amendments to the sustainability reporting requirements introduced by Directive (EU) 2022/2464. In particular, the Commission proposes to reduce the number of undertakings subject to those sustainability reporting requirements. According to the Commission’s proposal, only large undertakings with more than 1 000 employees would remain subject to the requirement to report sustainability information. As part of that Omnibus Simplification Package, the Commission also proposed to amend Article 5 of Directive (EU) 2022/2464 to defer the dates from which Member States are to apply the reporting requirements for those undertakings that would have to report for the first time for financial years 2025 and 2026 (‘stop-the-clock’ proposal). The European Parliament and the Council adopted that stop-the-clock proposal without substantial modifications as Directive (EU) 2025/794 of the European Parliament and of the Council(5), which entered into force on 17 April 2025. However, in order not to prejudge the outcome of the legislative procedure on the Commission’s proposal to amend the sustainability reporting requirements, and in particular the provisions setting out which undertakings will be subject to the reporting requirements in the future, Directive (EU) 2025/794 has not deferred the dates from which Member States are to apply the reporting requirements for undertakings that are to report for the first time with respect to financial year 2024.
(4) Pursuant to the existing timetable of Appendix C of ESRS 1 of Annex I to Delegated Regulation (EU) 2023/2772, undertakings that need to report sustainability information already with respect to financial year 2024 will be subject to a further phasing in of various reporting requirements with respect to financial years 2025 and 2026. Moreover, undertakings with more than 750 employees will not benefit from the same phase-in provisions as other undertakings that are subject to the sustainability reporting requirements. It would not be reasonable to require undertakings to comply with additional reporting requirements when the Commission has made a proposal to ensure that those undertakings will subsequently not have to report any information. Moreover, it would be contrary to the burden reduction objective of the Omnibus Simplification Package to prevent undertakings with more than 750 employees from benefitting from the same phase-in provisions as other undertakings that are subject to the sustainability reporting requirements, especially for those sustainability reporting requirements that are most challenging for undertakings, that is to say the topical standards ESRS E4 (biodiversity and ecosystems), ESRS S2 (workers in the value chain), ESRS S3 (affected communities) and ESRS S4 (consumers and end-users) that are laid down in Annex I to Delegated Regulation (EU) 2023/2772.
(5) Pursuant to ESRS 2, paragraph 17, of Annex I to Delegated Regulation (EU) 2023/2772, an undertaking or a group with up to 750 employees that uses the temporary exemptions in accordance with Appendix C of ESRS 1 for a complete topical standard must nevertheless report certain summarised information on the topic concerned if that undertaking or group has concluded that the topic in question is material. If the temporary exemptions set out in Appendix C of ESRS 1 for a complete topical standard should be applicable also by undertakings with more than 750 employees, it would be necessary – for reasons of consistency – to require the application of ESRS 2, paragraph 17, by any undertaking that uses the temporary exemptions in accordance with Appendix C of ESRS, including the undertakings or groups with more than 750 employees that are to report from financial year 2024.
(6) It is therefore necessary to adapt the phasing-in timetable of Appendix C of ESRS 1 of Annex I to Delegated Regulation (EU) 2023/2772, and to amend paragraph 17 of ESRS 2 of that Delegated Regulation, accordingly.
(7) To enable the undertakings concerned to benefit from that adaptation as soon as possible, this Regulation should enter into force on the third day following that of its publication in theOfficial Journal of the European Union.
(8) On 30 April 2025 the Commission consulted Member States on this draft delegated act during a joint meeting of the Member States’ Expert Group on Sustainable Finance and the Accounting Regulatory Committee, in accordance with the requirements of Article 49(3b), third subparagraph, of Directive 2013/34/EU,
HAS ADOPTED THIS REGULATION:

Amendments to Delegated Regulation (EU) 2023/2772

Annex I to Delegated Regulation (EU) 2023/2772 is amended in accordance with the Annex to this Regulation.

Entry into force and application

This Regulation shall enter into force on the third day following that of its publication in theOfficial Journal of the European Union.
It shall apply with respect to financial years beginning on or after 1 January 2025.
ANNEXAnnex I to Delegated Regulation (EU) 2023/2772 is amended as follows:

(1) | in ESRS 1, Appendix C, ‘List of phased-in Disclosure Requirements’, is replaced by the following:‘Appendix CList of phased-in Disclosure RequirementsThis appendix is an integral part of ESRS 1 and has the same authority as the other parts of the Standard.ESRSDisclosure RequirementFull name of the Disclosure RequirementPhase-in or effective date (including the first year)ESRS 2SBM-1Strategy, business model and value chainThe undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU.ESRS 2SBM-3Material impacts, risks and opportunities and their interaction with strategy and business modelThe undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.ESRS E1E1-6Gross Scopes 1, 2, 3 and Total GHG emissionsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement.ESRS E1E1-9Anticipated financial effects from material physical and transition risks and potential climate-related opportunitiesThe undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.ESRS E2E2-6Anticipated financial effects from pollution-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS E3E3-5Anticipated financial effects from water and marine resources-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS E4All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement.ESRS E4E4-6Anticipated financial effects from biodiversity and ecosystem-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS E5E5-6Anticipated financial effects from resource use and circular economy-related risks and opportunitiesThe undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.ESRS S1All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-7Characteristics of non-employee workers in the undertaking’s own workforceThe undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement.ESRS S1S1-8Collective bargaining coverage and social dialogueThe undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement.ESRS S1S1-11Social protectionThe undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-12Persons with disabilitiesThe undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-13Training and skills developmentThe undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement.ESRS S1S1-14Health and safetyThe undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement.ESRS S1S1-14Health and safetyThe undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement.ESRS S1S1-15Work-life balanceThe undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement.ESRS S2All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement.ESRS S3All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement.ESRS S4All disclosure requirementsAll disclosure requirementsUndertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.’ | ESRS | Disclosure Requirement | Full name of the Disclosure Requirement | Phase-in or effective date (including the first year) | ESRS 2 | SBM-1 | Strategy, business model and value chain | The undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU. | ESRS 2 | SBM-3 | Material impacts, risks and opportunities and their interaction with strategy and business model | The undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures. | ESRS E1 | E1-6 | Gross Scopes 1, 2, 3 and Total GHG emissions | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement. | ESRS E1 | E1-9 | Anticipated financial effects from material physical and transition risks and potential climate-related opportunities | The undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures. | ESRS E2 | E2-6 | Anticipated financial effects from pollution-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. | ESRS E3 | E3-5 | Anticipated financial effects from water and marine resources-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. | ESRS E4 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement. | ESRS E4 | E4-6 | Anticipated financial effects from biodiversity and ecosystem-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. | ESRS E5 | E5-6 | Anticipated financial effects from resource use and circular economy-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement. | ESRS S1 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-7 | Characteristics of non-employee workers in the undertaking’s own workforce | The undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-8 | Collective bargaining coverage and social dialogue | The undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-11 | Social protection | The undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-12 | Persons with disabilities | The undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-13 | Training and skills development | The undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-14 | Health and safety | The undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-14 | Health and safety | The undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement. | ESRS S1 | S1-15 | Work-life balance | The undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement. | ESRS S2 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement. | ESRS S3 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement. | ESRS S4 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.
ESRS | Disclosure Requirement | Full name of the Disclosure Requirement | Phase-in or effective date (including the first year)
ESRS 2 | SBM-1 | Strategy, business model and value chain | The undertaking shall report the information prescribed by ESRS 2 SBM-1 paragraph 40(b) (breakdown of total revenue by significant ESRS sector) and 40(c) (list of additional significant ESRS sectors) starting from the application date specified in a Commission Delegated Act to be adopted pursuant to article 29b(1) third subparagraph, point (ii), of Directive 2013/34/EU.
ESRS 2 | SBM-3 | Material impacts, risks and opportunities and their interaction with strategy and business model | The undertaking may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS 2 SBM-3 paragraph 48(e) (anticipated financial effects) for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS 2 SBM-3 paragraph 48(e) by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.
ESRS E1 | E1-6 | Gross Scopes 1, 2, 3 and Total GHG emissions | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the datapoints on scope 3 emissions and total GHG emissions for the first 3 years of preparation of their sustainability statement.
ESRS E1 | E1-9 | Anticipated financial effects from material physical and transition risks and potential climate-related opportunities | The undertaking may omit the information prescribed by ESRS E1-9 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E1-9 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E1-9 by reporting only qualitative disclosures for the first 3 years of preparation of its sustainability statement, if it is impracticable to prepare quantitative disclosures.
ESRS E2 | E2-6 | Anticipated financial effects from pollution-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E2-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E2-6 for the first 3 years of preparation of their sustainability statement.Except for the information prescribed by paragraph 40(b) on the operating and capital expenditures occurred in the reporting period in conjunction with major incidents and deposits, the undertaking may comply with ESRS E2-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E3 | E3-5 | Anticipated financial effects from water and marine resources-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E3-5 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a) of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E3-5 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E3-5 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E4 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS E4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS E4 for the first 3 years of preparation of their sustainability statement.
ESRS E4 | E4-6 | Anticipated financial effects from biodiversity and ecosystem-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E4-6 for the first year of preparation of its sustainability statement.The undertaking may comply with ESRS E4-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS E5 | E5-6 | Anticipated financial effects from resource use and circular economy-related risks and opportunities | The undertaking may omit the information prescribed by ESRS E5-6 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS E5-6 for the first 3 years of preparation of their sustainability statement.The undertaking may comply with ESRS E5-6 by reporting only qualitative disclosures, for the first 3 years of preparation of its sustainability statement.
ESRS S1 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first year of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis, where applicable) may omit the information specified in the disclosure requirements of ESRS S1 for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-7 | Characteristics of non-employee workers in the undertaking’s own workforce | The undertaking may omit reporting for all datapoints in this Disclosure Requirement for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting for all datapoints in this Disclosure Requirement for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-8 | Collective bargaining coverage and social dialogue | The undertaking may omit this Disclosure Requirement with regard to its own employees in non-EEA countries for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit this Disclosure Requirement with regard to their own employees in non-EEA countries for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-11 | Social protection | The undertaking may omit the information prescribed by ESRS S1-11 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-11 for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-12 | Persons with disabilities | The undertaking may omit the information prescribed by ESRS S1-12 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-12 for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-13 | Training and skills development | The undertaking may omit the information prescribed by ESRS S1-13 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-13 for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-14 | Health and safety | The undertaking may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the data points on cases of work-related ill health and on number of days lost to injuries, accidents, fatalities and work-related ill health for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-14 | Health and safety | The undertaking may omit reporting on non-employees for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit reporting on non-employees for the first 3 years of preparation of their sustainability statement.
ESRS S1 | S1-15 | Work-life balance | The undertaking may omit the information prescribed by ESRS S1-15 for the first year of preparation of its sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information prescribed by ESRS S1-15 for the first 3 years of preparation of their sustainability statement.
ESRS S2 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S2 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S2 for the first 3 years of preparation of their sustainability statement.
ESRS S3 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S3 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S3 for the first 3 years of preparation of their sustainability statement.
ESRS S4 | All disclosure requirements | All disclosure requirements | Undertakings or groups not exceeding on their balance sheet dates the average number of 750 employees during the financial year (on a consolidated basis where applicable) may omit the information specified in the disclosure requirements of ESRS S4 for the first 2 years of preparation of their sustainability statement. By way of derogation from the first sentence, undertakings as referred to in Article 5(2), first subparagraph, point (a), and third subparagraph, point (a), of Directive (EU) 2022/2464 may omit the information specified in the disclosure requirements of ESRS S4 for the first 3 years of preparation of their sustainability statement.
(2) | in ESRS 2, Section 17, the introductory wording is replaced by the following:‘If an undertaking or group omits the information required by ESRS E4, ESRS S1, ESRS S2, ESRS S3 or ESRS S4 in accordance with the rows of Appendix C of ESRS 1 showing “All disclosure requirements” in the column “Full name of the Disclosure Requirement”, it shall nevertheless disclose whether the sustainability topics covered respectively by ESRS E4, ESRS S1, ESRS S2, ESRS S3 and ESRS S4 have been assessed to be material as a result of the undertaking’s materiality assessment. In addition, if one or more of these topics has been assessed to be material, the undertaking shall, for each material topic:’.