LegalizeCommission Implementing Regulation (EU) 2024/2598 of 4 October 2024 laying down the list of third countries or regions thereof authorised for the entry into the Union of certain animals and products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the application of the prohibition on the use of certain antimicrobial medicinal products
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 127(2) thereof,
Having regard to Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union (2), and in particular Article 5(1) thereof,
Whereas:
(1) Regulation (EU) 2017/625 lays down rules for official controls and other control activities performed by the competent authorities of the Member States in order to verify compliance with Union legislation in specific areas. In particular, Article 1(4) of Regulation (EU) 2017/625 provides that that Regulation is to apply to official controls for the verification of compliance with Article 118(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council (3). Regulation (EU) 2017/625 also provides that the Commission may require that consignments of certain animals and goods are only to enter the Union from third countries or regions thereof which appear on a list drawn up by the Commission for that purpose.
(2) Article 118(1) of Regulation (EU) 2019/6 requires that, as regards animals or products of animal origin exported from third countries to the Union, the following products are not to be used: (i) antimicrobial medicinal products for the purpose of promoting growth or to increase yield; and (ii) antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 (4).
(3) Delegated Regulation (EU) 2023/905 supplements Regulation (EU) 2019/6 as regards, among other things, the conditions for the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption from third countries or regions thereof, in order to ensure that they comply with the prohibition on the use of antimicrobial medicinal products for growth promotion and yield increase and of antimicrobials reserved for the treatment of certain infections in humans. Those conditions include that the consignments of animals and products of animal origin concerned may only enter the Union if they originate from a third country or a region thereof that is included in a list drawn up by the Commission for that purpose.
(4) In accordance with Article 5(2) of Delegated Regulation (EU) 2023/905, that list should only include third countries or regions thereof, which have submitted appropriate evidence and guarantees that the animals and products of animal origin concerned comply with the prohibition on the use of antimicrobial medicinal products for growth promotion and yield increase and of antimicrobials reserved for treatment of certain infections in humans, including information received on the procedures in place to guarantee traceability and origin.
(5) The third countries or regions thereof which have submitted the evidence and guarantees referred to in Article 5(2) of Delegated Regulation (EU) 2023/905 should therefore be included in the list of authorised third countries or regions thereof from which animals and products of animal origin may enter into the Union.
(6) The conditions for entry into the Union of consignments of animals or products of animal origin laid down in Delegated Regulation (EU) 2023/905 apply as from 24 months after the date of application of Commission Implementing Regulation (EU) 2024/399 (5). Therefore, this Regulation should also apply from 3 September 2026.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
This Regulation establishes the list of third countries or regions thereof referred to in Article 4(1), point (a), of Delegated Regulation (EU) 2023/905 from which the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption is permitted as regards the application of the prohibition on the use of certain antimicrobial medicinal products laid down in Article 118(1) of Regulation (EU) 2019/6.
Article 2
List of third countries or regions thereof authorised for the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption
The third countries or regions thereof in which, as regards animals and products of animal origin intended for export to the Union, the requirements laid down in Article 3 of Delegated Regulation (EU) 2023/905 are complied with, are marked with ‘X’, for the relevant species or commodities, in the Annex to this Regulation.
The third countries or regions thereof, which, for the production of products intended for export to the Union, intend to process only animals or products of animal origin originating either from Member States or from other third countries listed in the Annex in accordance with paragraph 1 of this Article, are marked with ‘Δ’, for the relevant species or commodities, in the Annex.
Article 3
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 3 September 2026.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 October 2024.
For the Commission The President Ursula VON DER LEYEN
(1) OJ L 95, 7.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/625/oj.
(2) OJ L 116, 4.5.2023, p. 1, ELI: http://data.europa.eu/eli/reg_del/2023/905/oj.
(3) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43, ELI: http://data.europa.eu/eli/reg/2019/6/oj).
(4) Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 191, 20.7.2022, p. 58, ELI: http://data.europa.eu/eli/reg_impl/2022/1255/oj).
(5) Commission Implementing Regulation (EU) 2024/399 of 29 January 2024 amending Annex III to Implementing Regulation (EU) 2020/2235 and Annex II to Implementing Regulation (EU) 2021/403 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals (OJ L, 2024/399, 12.2.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/399/oj).
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.