Commission Implementing Regulation (EU) 2025/636 of 25 March 2025 amending Annexes III and V to Implementing Regulation (EU) 2020/2235 as regards model animal health certificates, model official certificates, model animal health/official certificates and private attestation, for the entry into the Union or transit through the Union to a third country of consignments of certain categories of animals and goods intended for human consumption

THE EUROPEAN COMMISSION,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 on laying specific hygiene rules for food of animal origin (1), and in particular Article 7(2), point (a), 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’) (2), and in particular Articles 238(3) and 239(3) thereof,

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) (3), and in particular Article 90, first paragraph, point (a) and Article 126(3) 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 (4), and in particular Article 6 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2020/2235 (5) lays down rules regarding animal health certificates provided for in Regulation (EU) 2016/429, official certificates and attestations provided for in Regulation (EU) 2017/625, and animal health/official certificates based on both those Regulations, required, among other things, for the entry into or transit though the Union of consignments of certain categories of animals and goods intended for human consumption.

(2) Chapters 1 (model ‘BOV’), 2 (model ‘OVI’), 3 (model ‘POR’), 4 (model ‘EQU’), 5 (model ‘RUF’), 7 (model ‘SUF’), 10 (model ‘RUM-MSM’), 11 (model ‘SUI-MSM’), 13 (model ‘POU’), 15 (model ‘RAT’), 19 (model ‘E’), 20 (model ‘EP’), 23 (model ‘RM’), 24 (model ‘MP-PREP’), 25 (model ‘MPNT’), 26 (model ‘MPST’), 27 (model ‘CAS’), 28 (model ‘FISH-CRUST-HC’), 29 (model ‘EU-FISH’), 30 (model ‘FISH/MOL-CAP’), 31 (model ‘MOL-HC’), 33 (model ‘MILK-RM’), 34 (model ‘MILK-RMP/NT’), 35 (model ‘DAIRY-PRODUCTS-PT’), 36 (model ‘DAIRY-PRODUCTS-ST’), 37 (model ‘COLOSTRUM’), 38 (model ‘COLOSTRUM-BP’), 45 (model ‘HON’) and 49 (model ‘PAO’) of Annex III to Implementing Regulation (EU) 2020/2235 set out model certificates for the entry into the Union of consignments of certain products of animal origin for human consumption. Commission Implementing Regulation (EU) 2024/2598 (6) lays 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 attestation as regards Delegated Regulation (EU) 2023/905 in those model certificates should therefore be amended to include a reference to that list in Implementing Regulation (EU) 2024/2598.

(3) An alternative certification option should be added to the animal health attestations in all model certificates for the entry into the Union of products of animal origin intended for human consumption set out in Annex III to Implementing Regulation (EU) 2020/2235 for consignments of such products that are intended for a destination outside the Union and are authorised in Part 1 of Annex XXII to Commission Implementing Regulation (EU) 2021/404 (7) for transit through the Union with the use of an animal health certificate corresponding to the relevant model certificate set out in Annex III to Implementing Regulation (EU) 2020/2235.

(4) Chapters 13 (model ‘POU’) and 15 (model ‘RAT’) of Annex III to Implementing Regulation (EU) 2020/2235 set out model certificates for entry into the Union of fresh meat intended for human consumption, excluding minced meat and mechanically separated meat, of poultry other than ratites, and of ratites. In point II.2.1(d) of model ‘POU’ and in point II.2.2 of model ‘RAT’, an alternative certification option regarding infection with Newcastle disease virus should be added for consignments from zones with the entry ‘N’ in column 4 of the table in Part 1, Section B, of Annex XIV to Implementing Regulation (EU) 2021/404.

(5) Chapters 24 (model ‘MP-PREP’), 25 (model ‘MPNT’) and 26 (model ‘MPST’) set out model certificates for the entry into the Union of meat preparations and certain meat products intended for human consumption. The amendment to Article 15 of Commission Delegated Regulation (EU) 2022/2292 (8) by Commission Delegated Regulation (EU) 2025/637 (9), clarifying the types of establishments in which fresh meat used for manufacturing of meat preparations and certain meat products may be obtained (i.e. slaughterhouses, game handling establishments, cutting plants, and establishments producing minced meat, meat preparations and mechanically separated meat), should be reflected in those model certificates.

(6) Chapter 29 (model ‘EU-FISH’) of Annex III to Implementing Regulation (EU) 2020/2235 sets out the model official certificate for the entry into the Union of fishery products intended for human consumption caught by vessels flying the flag of a Member State and transferred in third countries with or without storage. As fishery products from wild catch are excluded from the application of the provisions of Article 6 of Delegated Regulation (EU) 2022/2292 requiring the third country or region thereof of such fishery products’ origin to have a control plan for pharmacologically active substances, pesticides and contaminants and taking into account that such fishery products are caught by vessels flying the flag of a Member State, the third country where the transfer of fishery products takes place has no responsibility to monitor compliance with Union legislation on contaminants in accordance with Commission Regulation (EU) 2023/915 (10), and on pesticide residues in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council (11), consequently, the two alternatives of point II.1(c) of that model certificate should be deleted.

(7) Chapter 45 (model ‘HON’) of Annex III to Implementing Regulation (EU) 2020/2235 sets out the model official certificate for the entry into the Union of honey and other apiculture products intended for human consumption. The amendment to Article 13 of Delegated Regulation (EU) 2022/2292 by Commission Delegated Regulation (EU) 2023/2652 (12) allowing consignments of honey and other apiculture products intended for human consumption to enter the Union only if they were dispatched from, obtained and/or prepared in establishments that appear on the lists drawn up and kept up to date in accordance with Article 127(3), point (e)(ii), of Regulation (EU) 2017/625 should be reflected in that model certificate.

(8) Chapter 50 (model ‘COMP’) of Annex III to Implementing Regulation (EU) 2020/2235 sets out the model animal health/official certificate for the entry into the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine not derived from ruminant bones, collagen not derived from ruminant bones and highly refined products, and any quantity of colostrum-based products. As gelatine, collagen and fishery products from wild catch contained in those composite products are excluded from the application of the requirements laid down in Articles 6 to 12 of Delegated Regulation (EU) 2022/2292, certification of those composite products’ components in relation to those requirements should not be covered by point II.2(e) of that model certificate.

(9) Moreover, Chapter 50 (model ‘COMP’) of Annex III to Implementing Regulation (EU) 2020/2235 should be amended to reflect the requirements provided for in Article 21 of Delegated Regulation (EU) 2022/2292 as regards certification of non-shelf-stable composite products containing honey and other apiculture products. Furthermore, that model certificate should reflect the amendment of Article 13 of Delegated Regulation (EU) 2022/2292 by Delegated Regulation (EU) 2023/2652 as regards the establishment(s) of origin of honey and other apiculture products intended for human consumption.

(10) In addition, in point 3 of the model private attestation in Annex V to Implementing Regulation (EU) 2020/2235, the exemption concerning gelatine and collagen should be limited to gelatine or collagen not derived from ruminant bones in accordance with Article 22(1), point (a)(i), of Delegated Regulation (EU) 2022/2292. In point 10 of the model private attestation, the origin of dairy products contained in shelf-stable composite products should be clarified to reflect the animal health requirements laid down in Article 163 of Commission Delegated Regulation (EU) 2020/692 (13).

(11) In the interests of clarity and consistency of Union rules, the model certificates and the model attestation set out in Annexes III and V to Implementing Regulation (EU) 2020/2235 should be updated and clarified, including updating titles, references, notes and structural elements and clarifying the wording of certain requirements, and replaced by the model certificates and the model attestation set out in Annexes I and II to this Regulation. Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly.

(12) In order to avoid any disruption to trade as regards the entry into the Union and transit through the Union to a third country of consignments of certain categories of animals and goods referred to in Articles 8 to 30a and 33 of Implementing Regulation (EU) 2020/2235 due to the amendments made to Annexes III and V to Implementing Regulation (EU) 2020/2235 by this Regulation, the use of certificates or attestations issued in accordance with Implementing Regulation (EU) 2020/2235, as applicable prior to the amendments made by this Regulation, should continue to be authorised during a transitional period subject to certain conditions.

(13) 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

Article 2

For a transitional period until 19 February 2026, the use of animal health certificates, official certificates, animal health/official certificates or private attestations issued in accordance with the models set out in Annexes III and V to Implementing Regulation (EU) 2020/2235, as applicable before the amendments made to that Implementing Regulation by this Regulation, shall continue to be authorised for the entry into or transit through the Union to a third country of consignments of certain categories of animals and goods referred to in Articles 8 to 30a and 33 of Implementing Regulation (EU) 2020/2235, provided that those certificates or attestations were issued no later than 19 November 2025.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 March 2025.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 139, 30.4.2004, p. 55, ELI: http://data.europa.eu/eli/reg/2004/853/oj.

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

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

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

(5) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2020/2235/oj).

(6) 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).

(7) Commission Implementing Regulation (EU) 2021/404 of of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2021/404/oj).

(8) Commission Delegated Regulation (EU) 2022/2292 of 6 September 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption (OJ L 304, 24.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_del/2022/2292/oj).

(9) Commission Delegated Regulation (EU) 2025/637 of 29 January 2025 amending Delegated Regulation (EU) 2022/2292 as regards the requirements for the entry into the Union of certain dairy products, certain food additives derived from animals, collagen casings, minced meat, meat preparations, mechanically separated meat and composite products containing gelatine capsules (OJ L, 2025/637, 29.4.2025, ELI: http://data.europa.eu/eli/reg_del/2025/637/oj).

(10) Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103, ELI: http://data.europa.eu/eli/reg/2023/915/oj).

(11) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj).

(12) Commission Delegated Regulation (EU) 2023/2652 of 15 September 2023 amending and correcting Delegated Regulation (EU) 2022/2292 with regard to requirements for the entry into the Union of honey, meat, highly refined products, gelatine capsules, fishery products and requirements for private attestation and amending Delegated Regulation (EU) 2021/630 as regards private attestation requirements for composite products exempted from official controls at border control posts (OJ L, 2023/2652, 28.11.2023, ELI: http://data.europa.eu/eli/reg_del/2023/2652/oj).