Commission Implementing Regulation (EU) 2025/544 of 25 March 2025 amending Implementing Regulation (EU) 2021/403 as regards model animal health certificates and model animal health/official certificates for the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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’) (1), 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) (2), 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 (3), and in particular Article 6 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2021/403 (4) establishes, among other things, model certificates in the form of animal health certificates or animal health/official certificates for the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof.

(2) Article 14, point (e), of Implementing Regulation (EU) 2021/403 provides that the animal health/official certificate to be used for the entry into Northern Ireland of ovine and caprine animals from Great Britain is to correspond to the model ‘OV/CAP-X-NI’ set out in Chapter 4a of Annex II to that Implementing Regulation. That model was applicable until 31 December 2024, and therefore that point and that model should now be deleted.

(3) In addition, Chapters 1 (model ‘BOV-X’), 2 (model ‘BOV-Y’), 4 (model ‘OV/CAP-X’), 5 (model ‘OV/CAP-Y’), 7 (model ‘SUI-X’), 8 (model ‘SUI-Y’), 12 (model ‘CAM-CER’), 13 (model ‘EQUI-X’), 14 (model ‘EQUI-Y’), 22 (model ‘BPP’), 23 (model ‘BPR’), 29 (model ‘SP’), 30 (model ‘SR’) and 31 (model ‘POU-LT20’) of Annex II to Implementing Regulation (EU) 2021/403 set out model animal health certificates or animal health/official certificates for the entry into the Union of consignments of certain categories of terrestrial animals. Commission Implementing Regulation (EU) 2024/2598 (5) 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 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. It is therefore necessary to amend those model certificates accordingly.

(4) Chapter 4 (model ‘OV/CAP-X’) of Annex II to Implementing Regulation (EU) 2021/403 sets out the model animal health/official certificate for the entry into the Union of ovine and caprine animals. The amendment to Chapter E, points (5)(b) and (6)(b), of Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council (6) by Commission Regulation (EU) 2024/887 (7) concerning caprine animals genetically resistant to classical scrapie strains should be reflected in point II.2.12 of that model certificate. It is therefore necessary to amend that model certificate accordingly.

(5) Point II.1.11.4 of model certificate in Chapter 18 (model ‘CONFINED-RUM’) and point II.1.11.5 of model certificate in Chapter 21 (model ‘CONFINED-HIPPO’) of Annex II to Implementing Regulation (EU) 2021/403 should be aligned to reflect the diseases referred to in Article 33, point (b), of Delegated Regulation (EU) 2020/692. The references to infection with Brucella abortus, B. melitensis and B. suis and infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis) should therefore be deleted from those points. Those model certificates should therefore be amended accordingly.

(6) Chapters 22 (model ‘BPP’), 23 (model ‘BPR’), 24 (model ‘DOC’), 25 (model ‘DOR’), 26 (model ‘HEP’), 27 (model ‘HER’), 29, (model ‘SP’), 30 (model ‘SR’), 31 (model ‘POU-LT20’) and 32 (model ‘HE-LT20’) of Annex II to Implementing Regulation (EU) 2021/403 set out the model certificates for the entry into the Union of certain categories of poultry, ratites and germinal products thereof. In the relevant points of those model certificates, 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 V to Implementing Regulation (EU) 2021/404. Those model certificates should therefore be amended accordingly.

(7) Chapters 48 (model ‘OV/CAP-SEM-A-ENTRY’) and 50 (model ‘OV/CAP-OOCYTES-EMB-A-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 set out model animal health certificates for the entry into the Union of certain consignments of semen, oocytes and embryos of ovine and caprine animals. The amendment to Chapter H, points (2)(a) and (b), of Annex IX to Regulation (EC) No 999/2001 by Regulation (EU) 2024/887 concerning donor caprine animals genetically resistant to classical scrapie strains should be reflected in the alternatives in point II.4.13.2 of model ‘OV/CAP-SEM-A-ENTRY’ and the alternatives in point II.4.9.2 of model ‘OV/CAP-OOCYTES-EMB-A-ENTRY’. Those model certificates should therefore be amended accordingly.

(8) In the interests of clarity and consistency of Union rules, the model certificates set out in Annex II to Implementing Regulation (EU) 2021/403 should be updated, including updating references, notes and structural elements, and replaced by the model certificates set out in the Annex to this Regulation. Implementing Regulation (EU) 2021/403 should therefore be amended accordingly.

(9) In order to avoid any disruption to trade as regards the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof due to the amendments made to Annex II to Implementing Regulation (EU) 2021/403 by this Regulation, the use of animal health certificates or animal health/official certificates issued in accordance with Implementing Regulation (EU) 2021/403 as applicable prior to the amendments made by this Regulation, should continue to be authorised during a transitional period, subject to certain conditions.

(10) 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

Implementing Regulation (EU) 2021/403 is amended as follows:

(1) Article 14, point (e), is deleted;

(2) Annex II is replaced by the text set out in the Annex to this Regulation.

Article 2

For a transitional period until 12 February 2026, the use of animal health certificates or animal health/official certificates issued in accordance with the models set out in Annex II to Implementing Regulation (EU) 2021/403, as applicable before the amendments made to that Implementing Regulation by this Regulation, shall continue to be authorised for the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof provided that those certificates were issued no later than 12 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 84, 31.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/429/oj.

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

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

(4) Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 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 and model animal health/official certificates, for the entry into the Union and movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (OJ L 113, 31.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2021/403/oj).

(5) 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 of use of certain antimicrobial medicinal products (OJ L 2024/2598, 7.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2598/oj).

(6) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147 31.5.2001, p. 1, ELI: http://data.europa.eu/eli/reg/2001/999/oj).

(7) Commission Regulation (EU) 2024/887 of 22 March 2024 amending Annexes IV, VIII, and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards animal feeding, placing on the market and importation into the Union (OJ L, 2024/887, 25.3.2024, ELI: http://data.europa.eu/eli/reg/2024/887/oj).