Prováděcí nařízení Komise (EU) 2026/1189 ze dne 4. června 2026, kterým se mění prováděcí nařízení (EU) 2021/405, pokud jde o uplatňování omezení používání určitých antimikrobních léčivých přípravků, a zrušuje prováděcí nařízení (EU) 2024/2598

THE EUROPEAN COMMISSION,

Article 2 Article 2 Repeal

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)OJ L 95, 7.4.2017, p. 1 , ELI: http://data.europa.eu/eli/reg/2017/625/oj. , 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 UnionOJ L 116, 4.5.2023, p. 1 , ELI: http://data.europa.eu/eli/reg_del/2023/905/oj. , and in particular Article 5(1) thereof,

OJ L 95, 7.4.2017, p. 1 , ELI: http://data.europa.eu/eli/reg/2017/625/oj.

(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 the Union legislation in certain areas. In particular, Regulation (EU) 2017/625 provides that the Commission may require that only consignments of certain animals and goods from a third country or region thereof which appears on a list drawn up by the Commission for that purpose are to enter the Union.

(2) Article 118(1) of Regulation (EU) 2019/6 of the European Parliament and of the CouncilRegulation (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). 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) 2022/1255Commission 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). .

(3) Delegated Regulation (EU) 2023/905 supplements Article 118(1) of Regulation (EU) 2019/6 by establishing 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. Among those conditions, Article 4(1), point (a) of Delegated Regulation (EU) 2023/905 establishes that the consignments of animals and products of animal origin concerned are to enter the Union, only if they originate from a third country or a region thereof listed by the Commission for that purpose.

(4) Commission Implementing Regulation (EU) 2024/2598Commission 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 (OJ L, 2024/2598, 7.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2598/oj). lays down the list of the third countries or regions thereof 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.

(5) Commission Implementing Regulation (EU) 2021/405Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118 , ELI: http://data.europa.eu/eli/reg_impl/2021/405/oj). lays down the lists of third countries or regions thereof from which the entry into the Union of consignments of certain animals and goods intended for human consumption is permitted.

(6) To ensure transparency and facilitate the enforcement by Member States of the import conditions applying to consignments of certain animals and goods intended for human consumption entering the Union, it is appropriate to consolidate in one single implementing act the list laid down in the Annex to Implementing Regulation (EU) 2024/2598 with other lists of third countries or regions thereof guaranteeing that consignments of certain animals and goods exported to the Union comply with the relevant requirements in Regulation (EU) 2017/625. Therefore, Implementing Regulation (EU) 2024/2598 should be repealed and the list set out in the Annex to that Implementing Regulation should be inserted as a new Annex in Implementing Regulation (EU) 2021/405.

(7) Since the adoption of Implementing Regulation (EU) 2024/2598, the following countries and regions thereof have submitted the evidence and guarantees referred to in Article 5(2) of Delegated Regulation (EU) 2023/905 concerning compliance with the requirements laid down in Article 3 of the same Regulation: Armenia, Burkina Faso, Benin, Brunei, Belize, Guernsey, India, Indonesia, Iran, Kenya, Kyrgyz Republic, Sri Lanka, Mauritius, Nigeria, Serbia, Eswatini, Tunisia, Tanzania, Uganda, Uzbekistan and Wallis and Futuna. Consequently, they should be included in the list of third countries or regions thereof from which certain animals and products of animal origin may enter into the Union, as indicated in the Annex.

(8) Albania intends to use for the production of products intended for export to the Union only raw crustaceans either from Member States or from other third countries approved for imports of raw crustaceans into the Union. Albania has provided the required evidence and guarantees and should therefore be listed with a Δ for crustaceans in the Annex to this Regulation.

(9) North Macedonia has provided the required evidence and guarantees for the inclusion of casings. Therefore, North Macedonia should be listed with an X for casings in the Annex to this Regulation.

(10) Thailand is currently listed with a Δ for eggs, indicating the intention to use for the production of products intended for export to the Union only eggs either from Member States or from other third countries approved for imports of eggs into the Union. Thailand has provided the required evidence and guarantees for the inclusion of domestic eggs and should therefore be listed with an X for eggs, instead of a Δ, in the Annex to this Regulation.

(11) Uruguay has provided the required evidence and guarantees for the inclusion of aquaculture (finfish and finfish products and molluscs). Therefore, Uruguay should be listed with an X (only finfish and finfish products) and with an M for molluscs in the Annex to this Regulation.

(12) Colombia intends to use for the production of products intended for export to the Union only eggs either from Member States or from other third countries approved for imports of eggs into the Union. Colombia has provided the required evidence and guarantees and should therefore be listed with a Δ for eggs in the Annex to this Regulation.

(13) Singapore is currently listed with a X and a footnote 11 for aquaculture (only finfish and finfish products). Singapore has provided the required evidence and guarantees for the inclusion of crustaceans. Therefore, the footnote 11 restricting the entry to finfish and finfish products only should be deleted in the Annex to this Regulation.

(14) Australia is currently listed with an X for eggs. However, Australia has informed the Commission that it is not interested in further exporting eggs to the Union. The marking X for eggs should therefore be deleted in the Annex to this Regulation.

(15) Falkland Islands is currently listed with an X for aquaculture (only finfish and finfish products). However, Falkland Islands has informed the Commission that it is not interested in further exporting aquaculture products to the Union. The marking X for aquaculture should therefore be deleted from the Annex to this Regulation.

(16) Ukraine is currently listed with an X for rabbit. However, Ukraine has informed the Commission that it is not interested in further exporting of rabbit to the Union. The marking of X for rabbit should therefore be deleted from the Annex to this Regulation.

(17) Brazil is currently listed with an X for bovine, equine, poultry, aquaculture, honey and casings. However, the Commission has not received information guaranteeing that Brazil implemented the necessary measures to ensure that the requirements laid down in Article 3 of Delegated Regulation (EU) 2023/905 will be complied with by 3 September 2026 for these categories. Therefore, the marking X for bovine, equine, poultry, aquaculture, honey and casings should be deleted from the Annex to this Regulation.

(18) Implementing Regulation (EU) 2021/405 should therefore be amended accordingly.

(19) As Implementing Regulation (EU) 2024/2598 applies from 3 September 2026 , Article 1 of this Regulation should also start to apply from that date.

(20) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

The third countries or regions thereof which provided the Commission with evidence and guarantees of compliance with the requirements laid down in Article 3 of Delegated Regulation (EU) 2023/905 as regards certain animals and products of animal origin intended for export to the Union are marked with an X, for the relevant species or commodities, in Annex XVIa to this Regulation.

The third countries or regions thereof which intend to use for the production of products intended for export to the Union only animals or products of animal origin originating either from Member States or from other third countries approved for imports of such animals or products of animal origin into the Union in accordance with paragraph 1 of this Article, are marked with a Δ, for the relevant species or commodities, in Annex XVIa to this Regulation.

Implementing Regulation (EU) 2024/2598 is repealed.

OJ L 116, 4.5.2023, p. 1 , ELI: http://data.europa.eu/eli/reg_del/2023/905/oj.

Article 2b Article 2b 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 as regards the restrictions on the use of certain antimicrobial medicinal products laid down in Article 118(1) of Regulation (EU) 2019/6 1.The third countries or regions thereof which provided the Commission with evidence and guarantees of compliance with the requirements laid down in Article 3 of Delegated Regulation (EU) 2023/905 as regards certain animals and products of animal origin intended for export to the Union are marked with an X, for the relevant species or commodities, in Annex XVIa to this Regulation. 2.The third countries or regions thereof which intend to use for the production of products intended for export to the Union only animals or products of animal origin originating either from Member States or from other third countries approved for imports of such animals or products of animal origin into the Union in accordance with paragraph 1 of this Article, are marked with a Δ, for the relevant species or commodities, in Annex XVIa to this Regulation.

Article 3 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 .

Article 1 shall apply from 3 September 2026 .

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).

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).

Commission 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 (OJ L, 2024/2598, 7.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2598/oj).

Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118 , ELI: http://data.europa.eu/eli/reg_impl/2021/405/oj).

HAS ADOPTED THIS REGULATION: