Prováděcí nařízení Komise (EU) 2026/1305 ze dne 11. června 2026, kterým se mění prováděcí nařízení (EU) 2020/1641 o dovozu živých, chlazených, zmrazených nebo zpracovaných mlžů, ostnokožců, pláštěnců a mořských plžů určených k lidské spotřebě ze Spojených států amerických

THE EUROPEAN COMMISSION,

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 126(3) and Article 129(1) thereof,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law)OJ L 84, 31.3.2016, p. 1 , ELI: http://data.europa.eu/eli/reg/2016/429/oj. , and in particular Article 238(3) thereof,

The Annex to Implementing Regulation (EU) 2020/1641 is replaced by the text set out in the Annex to this Regulation.

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

(1) Commission Implementing Regulation (EU) 2020/1641Commission Implementing Regulation (EU) 2020/1641 of 5 November 2020 regarding imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the United States of America (OJ L 370, 6.11.2020, p. 4 , ELI: http://data.europa.eu/eli/reg_impl/2020/1641/oj). establishes rules and a model certificate for imports into the Union of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption from the United States.

(2) Article 118(1) read in combination with Article 107(2) 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). establishes that operators in third countries are not to use antimicrobial medicinal products in animals to promote growth or increase yield. From Article 118(1) of Regulation (EU) 2019/6 it follows that also medicinal products containing antimicrobials that are 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). are not to be used in respect of animals or products of animal origin, exported from third countries to the Union.

(3) Commission Delegated Regulation (EU) 2023/905Commission 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 (OJ L 116, 4.5.2023, p. 1 , ELI: http://data.europa.eu/eli/reg_del/2023/905/oj). supplements Regulation (EU) 2019/6 by establishing conditions for the entry into the Union of consignments of live food-producing animals and products of animal origin intended for human consumption that are exported from third countries to the Union.

(4) Article 4 of Delegated Regulation (EU) 2023/905 requires among others that consignments of live food-producing animals and products of animal origin intended for human consumption are to only enter the Union where they are accompanied by an official certificate attesting compliance with the Union rules on the use of antimicrobial medicinal products laid down in Article 3 of the same delegated Regulation.

(5) An attestation concerning compliance with these Union rules should therefore be inserted in the model certificate set out in the Annex to Implementing Regulation (EU) 2020/1641.

(6) In the interests of clarity and consistency of Union rules, the model certificate set out in the Annex to Implementing Regulation (EU) 2020/1641 should be updated, including updating references, notes and structural elements, and be replaced by the model certificate set out in the Annex to this Regulation.

(7) Implementing Regulation (EU) 2020/1641 should therefore be amended accordingly.

(8) In order to avoid any disruption to trade as regards the entry into the Union of consignments of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption from the United States due to the amendments made to the Annex to Implementing Regulation (EU) 2020/1641 by this Regulation, the use of official certificates issued in accordance with Implementing Regulation (EU) 2020/1641 as applicable prior to the amendments made by this Regulation, should continue to be authorised during a transitional period, subject to certain conditions.

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

For a transitional period until 3 December 2026 , the use of official certificates issued in accordance with the model set out in the Annex to Implementing Regulation (EU) 2020/1641, as applicable before the amendments made to that Regulation by the this Regulation, shall continue to be authorised for the entry into the Union of consignments of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the USA provided that those certificates were issued no later than 3 September 2026 .

OJ L 84, 31.3.2016, p. 1 , ELI: http://data.europa.eu/eli/reg/2016/429/oj.

Article 1 Article 1

Article 2 Article 2

Article 3 Article 3

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

Commission Implementing Regulation (EU) 2020/1641 of 5 November 2020 regarding imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the United States of America (OJ L 370, 6.11.2020, p. 4 , ELI: http://data.europa.eu/eli/reg_impl/2020/1641/oj).

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

HAS ADOPTED THIS REGULATION: