Commission Implementing Regulation (EU) 2024/351 of 17 January 2024 amending Implementing Regulation (EU) 2021/403 as regards model animal health certificates, model animal health/official certificates, model declarations and model official declarations 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, points (a) and (c), and Article 126(3) thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2021/403 (3) establishes model certificates, in the form of animal health certificates, animal health/official certificates and declarations for, inter alia, the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof falling within the scope of Commission Delegated Regulations (EU) 2020/686 (4) and (EU) 2020/692 (5).

(2) Articles 14 to 25 of Implementing Regulation (EU) 2021/403 provide that the animal health certificates, animal health/official certificates and official declarations to be used for the entry into the Union of certain categories of terrestrial animals and germinal products thereof are to correspond to the models set out in Chapters 1 to 68 of Annex II and in Chapters 1 and 2 of Annex III to that Implementing Regulation. For reasons of clarity and legal consistency, it is necessary to align the wording across all those models.

(3) Article 14 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and animal health/official certificates to be used for the entry into the Union of certain categories of ungulates are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the movements concerned. It is necessary to align grouping of those models depending on the species concerned.

(4) Article 15 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and animal health/official certificates and declarations accompanying those certificates, to be used for the entry into the Union or transit through the Union of certain categories of equine animals are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the movements concerned. Chapters 14 and 15 of that Annex set out respectively the model animal health certificate and the model declaration for transit through the Union of equine animals not intended for slaughter (model ‘EQUI-TRANSIT-X’), and the model animal health certificate and the model declaration for transit through the Union of equine animals intended for slaughter (model ‘EQUI-TRANSIT-Y’). Chapters 14 and 15 of Annex II to Implementing Regulation (EU) 2021/403 should be deleted as no specific requirements for transit through the Union of equine animals have been laid down in Delegated Regulation (EU) 2020/692. Such transits should comply with the requirements for entry into the Union of equine animals. At the entry into the Union, consignments of equine animals for which the Union is not the final destination should be accompanied by a certificate corresponding to the model ‘EQUI-X’ set out in Chapter 12 of Annex II to Implementing Regulation (EU) 2021/403. It is therefore necessary to amend Article 15 of Implementing Regulation (EU) 2021/403 accordingly. Consequently, also the numbering of the models set out in Annex II and referred to in Article 15 of that Implementing Regulation should be aligned.

(5) Articles 14 and 16 of Implementing Regulation (EU) 2021/403 provide that the animal health certificates and animal health/official certificates to be used for the entry into the Union of certain categories of ungulates are to correspond to one of the models set out in Chapters 1 to 12 and 19 to 22 of Annex II to that Implementing Regulation. Commission Delegated Regulation (EU) 2023/119 (6) amended Article 21 of Delegated Regulation (EU) 2020/692. In accordance with that amendment, ungulates, other than equine animals, identified by a physical means of identification displaying the code of the exporting country different from the code conforming to ISO Standard 3166 may enter the Union. That amendment should be reflected in the Notes to Part I of those models.

(6) Articles 20 and 24 of Implementing Regulation (EU) 2021/403 provide that the animal health certificates and animal health/official certificates to be used for the entry into the Union of germinal products of certain categories of ungulates are to correspond to one of the models set out in Chapters 39 to 68 of Annex II to that Implementing Regulation. It is necessary to align those Articles and the titles of those models accordingly.

(7) Council Directive 96/23/EC (7) has been repealed and provisions regarding the entry into the Union as stated in Article 29 of that Directive have been incorporated into Commission Delegated Regulation (EU) 2022/2292 (8). Commission Decision 2011/163/EU (9) has been repealed and its Annex has been incorporated into Commission Implementing Regulation (EU) 2021/405 (10). It is therefore necessary to amend the references to that Directive and Decision in all the models set out in Chapters 1 to 68 of Annex II to Implementing Regulation (EU) 2021/403.

(8) Chapters 4, 4a and 5 of Annex II to Implementing Regulation (EU) 2021/403 set out the model animal health/official certificates for entry into the Union of ovine and caprine animals (model ‘OV/CAP-X’) and ovine and caprine animals intended for slaughter (model ‘OV/CAP-Y’), and for entry into Northern Ireland of ovine and caprine animals from Great Britain applicable until 31 December 2024 (model ‘OV/CAP-X-NI’). The amendment to point 1 of Annex X to Delegated Regulation (EU) 2020/692 by Delegated Regulation (EU) 2023/119 concerning the residency period in the establishment of origin for uncastrated males of ovine animals as regards ovine epididymitis (Brucella ovis) should be reflected in points II.2.12 and II.2.13 of those models.

(9) The amendment to points 2.1 and 2.2 of Annex XI to Delegated Regulation (EU) 2020/692 by Delegated Regulation (EU) 2023/119 concerning alignment of a terminology used in these provisions with the term ‘vector-protected establishment’ should be reflected in points II.3, II.4 and II.5 of Chapter 12 (model ‘EQUI-X’) and point II.3 of Chapter 13 (model ‘EQUI-Y’) of Annex II to Implementing Regulation (EU) 2021/403. Additionally, point II.3.2 of model ‘EQUI-X’ concerning animal health requirements related to African horse sickness and isolation of equine animals in vector-protected establishments situated in third countries assigned to Sanitary Group F should be aligned with provisions of point 2.1 of Annex XI to Delegated Regulation (EU) 2020/692.

(10) Chapter 17 of Annex II to Implementing Regulation (EU) 2021/403 sets out the model animal health certificate and model declaration for the re-entry into the Union of registered horses for competition after temporary export for a period of not more than 90 days to participate in equestrian events organised under the auspices of the Fédération Equestre Internationale (FEI) (model ‘EQUI-RE-ENTRY-90-COMP’). The FEI has informed the Commission about changes to the names of particular equestrian events listed in model ‘EQUI-RE-ENTRY-90-COMP’. It is therefore necessary to amend the model ‘EQUI-RE-ENTRY-90-COMP’ to reflect the necessary changes notified by the FEI. The above-mentioned amendments should also be reflected in the corresponding model declaration.

(11) Chapter 18 of Annex II to Implementing Regulation (EU) 2021/403 sets out the model animal health certificate and model declaration for the re-entry into the Union of registered horses for racing after temporary export for a period of not more than 90 days to participate in specific race events in the United Arab Emirates, Australia, Canada, Hong Kong, Japan, Qatar, Singapore and the United States (model ‘EQUI-RE-ENTRY-90-RACE’). Bahrain and Saudi Arabia have requested the inclusion in the model ‘EQUI-RE-ENTRY-90-RACE’ of the Bahrain Turf Series and the Saudi Cup respectively. In addition, Bahrain has requested to be a part of the International Group/Grade meetings so that the registered horses of Union origin could participate in the Bahrain Turf Series and then in the races in the United Arab Emirates, within the period of maximum 90 days since leaving and until returning to the Union. Bahrain and Saudi Arabia have provided the necessary guarantees, in particular that registered horses of Union origin would have no contact with other animals of a lower health status during the entire period of temporary export and that the possibility of direct contact of registered horses of Union origin with other animals is limited to the period of the races concerned. Furthermore, Bahrain has provided information on the arrangement with the United Arab Emirates related to the animal health requirements for the entry of the registered horses of Union origin to the United Arab Emirates from Bahrain demonstrating that those requirements are at least as strict as those laid down in model ‘EQUI-RE-ENTRY-90-RACE’. It is therefore appropriate to accommodate the requests submitted by Bahrain and Saudi Arabia. The model ‘EQUI-RE-ENTRY-90-RACE’ should be amended accordingly. The above-mentioned amendments should also be reflected in the corresponding model declaration.

(12) Point II.2.2 of the model animal health certificates and animal health/official certificates laid down in Chapters 12, 13, 16, 17 and 18 of Annex II to Implementing Regulation (EU) 2021/403 concerning diseases which are compulsorily notifiable in the country or territory of dispatch, should be deleted as that notification is one of the prerequisites to be ascertained by the competent authorities of third countries or territories, or zones thereof in order to be authorised for the entry into the Union of equine animals. Therefore, it is not necessary for that notification to be certified by individual official veterinarians of the third countries or territories, or zones thereof.

(13) Chapter 38 of Annex II to Implementing Regulation (EU) 2021/403 sets out the model animal health certificate for the entry into the Union of dogs, cats and ferrets (model ‘CANIS-FELIS-FERRETS’). The amendments to Article 73 of and Annex XXI, point 2(b), to Delegated Regulation (EU) 2020/692 by Delegated Regulation (EU) 2023/119 concerning the approval obligation for shelters where consignments of dogs, cats and ferrets are dispatched to the Union and the timeframe during which the treatment against infestation with Echinoccocus multilocularis is to be administered should be reflected respectively in point II.2 and in footnote (10) of Notes to Part II of that model.

(14) Chapters 39 (model ‘BOV-SEM-A-ENTRY’), 42 (model ‘BOV-OOCYTES-EMB-A-ENTRY’), 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 consignments of certain germinal products of bovine, ovine and caprine animal origin. The amendments to Article 2, point (12), Part 5 of Annex II and Part 1 of Annex III to Delegated Regulation (EU) 2020/686 by Commission Delegated Regulation (EU) 2023/647 (11) concerning the definition of embryo collection teams, seasonal freedom from infection with epizootic haemorrhagic disease virus (EHDV) and the addition of antibiotics to semen should be reflected in those models.

(15) Chapters 39 (model ‘BOV-SEM-A-ENTRY’), 42 (model ‘BOV-OOCYTES-EMB-A-ENTRY’), 46 (model ‘BOV-GP-PROCESSING-ENTRY’), 47 (model ‘BOV-GP-STORAGE-ENTRY’), 48 (model ‘OV/CAP-SEM-A-ENTRY’), 50 (model ‘OV/CAP-OOCYTES-EMB-A-ENTRY’), 52 (model ‘OV/CAP-GP-PROCESSING-ENTRY’), 53 (model ‘OV/CAP-GP-STORAGE-ENTRY’), 54 (model ‘POR-SEM-A-ENTRY’), 56 (model ‘POR-OOCYTES-EMB-ENTRY’), 57 (model ‘POR-GP-PROCESSING-ENTRY’) and 58 (model ‘POR-GP-STORAGE-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 should be amended to reflect the amendments to Article 79 of Delegated Regulation (EU) 2020/692 by Delegated Regulation (EU) 2023/119 concerning vaccination against foot and mouth disease.

(16) Point II.6 of Chapters 42 (model ‘BOV-OOCYTES-EMB-A-ENTRY’) and 50 (model ‘OV/CAP-OOCYTES-EMB-A-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 should be adapted to better reflect and implement the requirements laid down in Parts 1 and 5 of Annex II and Part 1 of Annex III to Delegated Regulation (EU) 2020/686 as regards semen used for the production of embryos.

(17) Points II.2.5 and II.2.6 of Chapter 48 (model ‘OV/CAP-SEM-A-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 should be amended to reflect the amendments to point 1 of Annex X to Delegated Regulation (EU) 2020/692 by Delegated Regulation (EU) 2023/119 concerning the residency period in the establishment of origin for uncastrated males of ovine animals as regards ovine epididymitis (Brucella ovis).

(18) Chapter 54 of Annex II to Implementing Regulation (EU) 2021/403 sets out the model animal health certificate for the entry into the Union of consignments of semen of porcine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021, dispatched from the semen collection centre where the semen was collected (model ‘POR-SEM-A-ENTRY’). The amendments to Part 2 of Annex II and Part 1 of Annex III to Delegated Regulation (EU) 2020/686 by Delegated Regulation (EU) 2023/647 concerning testing for classical swine fever virus of porcine animals kept in semen collection centres and the addition of antibiotics to semen should be reflected in that model animal health certificate.

(19) Chapters 56 (model ‘POR-OOCYTES-EMB-ENTRY’) and 63 (model ‘EQUI-OOCYTES-EMB-A-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 should be amended to reflect the amendments to Article 2, point (12), of Delegated Regulation (EU) 2020/686 by Delegated Regulation (EU) 2023/647 concerning the definition of embryo collection teams, and to better reflect and implement the requirements laid down in Parts 1 and 5 of Annex II and Part 1 of Annex III to Delegated Regulation (EU) 2020/686 as regards semen used for the production of embryos.

(20) Chapters 59 (model ‘EQUI-SEM-A-ENTRY’), 63 (model ‘EQUI-OOCYTES-EMB-A-ENTRY’), 66 (model ‘EQUI-GP-PROCESSING-ENTRY’) and 67 (model ‘EQUI-GP-STORAGE-ENTRY’) set out model animal health certificates for the entry into the Union of certain types of consignments of germinal products of equine animals. Point II.1.2 of those models concerning diseases which are compulsorily notifiable in the country or territory of dispatch, should be deleted as that notification is one of the prerequisites to be ascertained by the competent authorities of third countries or territories, or zones thereof in order to be authorised for the entry into the Union of germinal products of equine animals. Therefore, it is not necessary for that notification to be certified by individual official veterinarians of the third countries or territories, or zones thereof.

(21) Chapter 59 (model ‘EQUI-SEM-A-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 should be amended to reflect the amendments to Part 1 of Annex III to Delegated Regulation (EU) 2020/686 by Delegated Regulation (EU) 2023/647 concerning the addition of antibiotics to semen.

(22) Chapters 63 (model ‘EQUI-OOCYTES-EMB-A-ENTRY’), 64 (model ‘EQUI-OOCYTES-EMB-B-ENTRY’) and 65 (model ‘EQUI-OOCYTES-EMB-C-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 should be amended to clarify that testing for equine infectious anaemia involves only one sampling of blood in accordance with Part 4, Chapter II, point 2(b), of Annex II to Delegated Regulation (EU) 2020/686.

(23) Chapter 68 (model ‘GP-CONFINED-ENTRY’) of Annex II to Implementing Regulation (EU) 2021/403 sets out the model animal health certificate for entry into the Union of consignments of semen, oocytes and embryos of terrestrial animals kept at confined establishments which were collected or produced, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692. Points II.1.1 and II.1.2 of that model should be amended to reflect the amendments to Article 117 of Delegated Regulation (EU) 2020/692 by Delegated Regulation (EU) 2023/119 concerning lists of authorised third countries, territories, or zones thereof, and the list of authorised confined establishments of origin.

(24) Implementing Regulation (EU) 2021/403 should therefore be amended accordingly.

(25) The German language version of Annex II to Implementing Regulation (EU) 2021/403 contains non-substantive errors, including erroneous references, minor omissions, as well as terminological, grammatical, and spelling errors, which for reasons of expediency and simplification should be corrected together with the amendments made by this Regulation to that Implementing Regulation since this Regulation replaces Annex II to that Implementing Regulation in its entirety. The other language versions are not affected.

(26) In order to avoid any disruption to trade as regards the entry into the Union of consignments concerned by the amendments made to Annexes II and III to Implementing Regulation (EU) 2021/403 by this Regulation, the use of animal health certificates, animal health/official certificates and official declarations 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.