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 (Text with EEA relevance)

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 Article 146(2), point (a) of the first subparagraph of Article 156(2) and Articles 162(5), 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 points (a) and (c) of the first paragraph of Article 90 and Article 126(3) thereof,

Whereas:

(1) Regulation (EU) 2016/429 lays down rules on animal diseases that are transmissible to animals or to humans, including requirements for official animal health certification for various movements of terrestrial animals and their products. It also empowers the Commission to adopt implementing acts laying down rules for model forms for animal health certificates and declarations as well rules concerning the information to be contained in certain documents and declarations required for the entry into the Union of consignments of animals and of germinal products. In addition, that Regulation empowers the Commission to lay down special rules concerning model forms for the animal health certificates, declarations and other documents for certain categories of animals and germinal products. Regulation (EU) 2016/429 also provides that animal health certificates may include other information required under other Union legislation.

(2) Furthermore, in accordance with Article 146(2) as well as with point (a) of the first subparagraph of Article 156(2) and Article 162(5) of Regulation (EU) 2016/429, that Regulation empowers the Commission to adopt implementing acts laying down rules for model forms of animal health certificates for movements to another Member State of certain terrestrial animals and germinal products of those terrestrial animals.

(3) Therefore, for the uniform implementation of rules laid down in Regulation (EU) 2016/429, model animal health certificates and animal health/official certificates containing the animal health requirements for movements between Member States and for entry into the Union of certain terrestrial animals and of germinal products of those terrestrial animals should be set out in this Regulation.

(4) Commission Delegated Regulation (EU) 2020/686 (3) lays down supplementing rules as regards registered and approved germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain terrestrial animals. Annex IV to that Regulation lays down supplementing rules concerning information to be contained in the animal health certificate for germinal products of bovine, porcine, ovine, caprine and equine animals and of other animals listed therein, moved between Member States. In accordance with that Regulation, such animal health certificates should contain, inter alia, relevant information on animal health situation. Therefore, supplementing rules and requirements laid down in Delegated Regulation (EU) 2020/686 should be taken into account in this Regulation and model certificates set out herein.

(5) Commission Delegated Regulation (EU) 2020/688 (4) lays down supplementing rules for the prevention and control of animal diseases transmissible to animals or to humans laid down in Article 5(1) of Regulation (EU) 2016/429 as regards movements within the Union of terrestrial animals and hatching eggs. That Regulation lays down specific requirements for such movements and supplementing rules for animal health certification, in particular, rules regarding information to be contained in the animal health certificates for certain terrestrial animals and hatching eggs moved to another Member State. Therefore, this Regulation and the model certificates set out herein should take into account the supplementing rules laid down in Delegated Regulation (EU) 2020/688.

(6) Commission Delegated Regulation (EU) 2020/692 (5) lays down supplementing animal health requirements for entry into the Union of, inter alia, certain terrestrial animals and germinal products of the species and categories of kept terrestrial animals listed therein. In particular, in accordance with that Regulation, such consignments shall be accompanied by an animal health certificate, and if provided in that Regulation, by declarations or other documents. Therefore, the relevant guarantees laid down in Delegated Regulation (EU) 2020/692 should take into account by the model certificates set out in this Regulation.

(7) In addition, Delegated Regulation (EU) 2020/686 lays down particular definitions for, inter alia, certain germinal products and germinal products establishments. Furthermore, for the purposes of that Delegated Regulation, Delegated Regulation (EU) 2020/692 lays down specific definitions for, inter alia, certain terrestrial animals, as well as defines “specified pathogen-free eggs” and “unique approval number”. Therefore, this Regulation should also have regard to certain definitions laid down in Delegated Regulations (EU) 2020/686 and (EU) 2020/692.

(8) Model certificates required for animal health, animal welfare and for public health reasons are currently laid down in various legal acts. For reasons of clarity and legal certainty, as well as for easy access by the competent authorities, the relevant operators and the public, it is appropriate to consolidate model certificates for the movements between Member States and for entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof in one single legal act.

(9) Commission Implementing Regulation (EU) 2020/2235 (6) lays down the model animal health certificates, model official certificates and model animal health/official certificates for the movements within the Union or between Member States of consignments of animals and products, providing for the compatibility of such certificates with the Trade Control and Expert System (TRACES) and for facilitation of the system of certification in the Union. Therefore, the model animal health certificates and animal health/official certificates for the movements between Member States of the consignments of certain categories of terrestrial animals and germinal products thereof set out in this Regulation should be drawn up on the basis of the model animal health certificate and the model animal health/official certificate for movements between Member States set out in Chapter 1 of Annex I to Implementing Regulation (EU) 2020/2235.

(10) Furthermore, in order to ensure consistency and to improve efficiency of the certification, the model animal health certificates and the animal health/official certificates for the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof set out in this Regulation should be drawn up on the basis of the model animal health certificate and on the basis of the model animal health/official certificate for the entry into the Union set out in Chapter 3 of Annex I to Implementing Regulation (EU) 2020/2235.

(11) Article 237(1)(a) of Regulation (EU) 2016/429 provides that the Member States shall permit the entry into the Union of consignments of animals, germinal products and products of animal origin if they are accompanied by an animal health certificate, unless a derogation is provided for in Article 237(4)(a) of that Regulation. Article 126(2)(c) of Regulation (EU) 2017/625 establishes the requirement that consignments of certain animals and goods entering the Union are to be accompanied by an official certificate, an official attestation or any other evidence that the consignments comply with the relevant requirements established by the rules referred to in Article 1(2) of that Regulation. Therefore, in order to avoid inconsistencies and to facilitate official controls upon the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof, this Regulation should set out model animal health certificates and a model animal health/official certificates for such consignments entering the Union.

(12) Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities performed by the competent authorities of the Member States to ensure compliance with the rules referred to in Article 1(2) of that Regulation, which comprise, among others, rules on food safety at all stages of production, processing and distribution and animal health and welfare requirements. That Regulation provides for certain rules on official certification when the rules referred to in its Article 1(2) require the issuance of official certificates. In particular, that Regulation empowers the Commission to adopt implementing acts laying down rules concerning model official certificates and for the issuance and replacement of such certificates. In the absence of more specific rules in Regulation (EU) 2016/429, relevant rules on official certification apply to the animal health certificates and to the animal health/official certificates set out in this Regulation.

(13) The rules referred to in Article 1(2) of Regulation (EU) 2017/625 include animal health requirements, but also, inter alia, rules in the area of food safety and animal welfare. In the interests of legal clarity, and in order to minimise the administrative burden during the issuance of certificates, this Regulation should include animal health certificates and animal health/official certificates, to be signed by the official veterinarian. In order to facilitate the performance of official controls upon the entry into the Union, and within the Union, of consignments of certain categories of terrestrial animals and germinal products thereof and reduce administrative burden, model animal health certificates and model animal health/official certificates set out in this Regulation should comply with Regulation (EU) 2016/429 and with Regulation (EU) 2017/625.

(14) To facilitate official controls at the border control posts of entry into the Union, the requirements for certificates for the entry into the Union should include linguistic requirements.

(15) Regulation (EU) 2016/429 aims at reducing the administrative burden in relation to certification and notification by using information technology as far as possible for multiple purposes. In addition, that Regulation lays down certain rules regarding the possibility for electronic animal health certificates to accompany certain consignments instead of animal health certificates issued on paper. Regulation (EU) 2017/625 provides that the Information Management System for Official Controls (IMSOC) is to allow for the production, handling and transmission of official certificates, including in electronic form. Commission Implementing Regulation (EU) 2019/1715 (7) provides that TRACES is the IMSOC component enabling certificates to be produced electronically, thus preventing possible fraudulent or deceptive practices in respect of animal health certificates or animal health/official certificates. Therefore, in order to ensure an adequate level of security of electronic means of certification and taking into account the aim to harmonise the process of certification, model certificates set out in this Regulation should be compatible with TRACES.

(16) Point (c) of the first paragraph of Article 90 of Regulation (EU) 2017/625 empowers the Commission to adopt implementing acts laying down rules concerning the procedures to be followed for the issuance of replacement certificates. Therefore, it is appropriate to establish common requirements as regards the replacement of certificates, which should apply to animal health certificates and to animal health/official certificates, to be signed by the official veterinarian, and these common requirements should be set out in this Regulation.

(17) To avoid misuse and abuse, it is important to lay down rules concerning the cases where a replacement certificate may be issued and the requirements that such certificates need to meet. These cases should be limited to administrative errors and to cases where the initial certificate has been damaged or lost.

(18) Model animal health certificates and model animal health/official certificates for movements of certain categories of terrestrial animals and germinal products thereof should contain details of the consignment and specific animal and public health information, as well as animal welfare information, where necessary, certified by the official veterinarian. In the case of movements between Member States, both model animal health certificates and animal health/official certificates should contain a part designated to draw up a record of official controls performed during such movements and at the place of destination, as well as the results of those official controls.

(19) Commission Decision 2010/470/EU (8) lays down model health certificates for trade within the Union in semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species, having regard to Council Directive 92/65/EEC (9). However, Regulation (EU) 2016/429 repealed and replaced Directive 92/65/EEC as from 21 April 2021. In addition, Regulation (EU) 2016/429 as well as other Union legislation repealed certain other acts mentioned in the model certificates set out in that Decision. Therefore, for reasons of harmonisation and clarity, in order to avoid duplication of rules, the model health certificates laid down in Decision 2010/470/EU should be replaced by the model certificates laid down in this Regulation and Decision 2010/470/EU should be repealed.

(20) It is appropriate to introduce a transitional period to take into account the specific situation of competent authorities in third countries that need to make the necessary arrangements to ensure compliance with this Regulation and the specific situation of shipments of consignments of terrestrial animals and germinal products thereof accompanied by certificates issued in accordance with Commission Regulations (EC) No 798/2008 (10) and (EU) No 206/2010 (11), Commission Implementing Regulations (EU) No 139/2013 (12) and (EU) 2018/659 (13), Commission Decisions 2006/168/EC (14), 2010/470/EU and 2010/472/EU (15) as well as those issued in accordance with Commission Implementing Decisions 2011/630/EU (16), 2012/137/EU (17) and (EU) 2019/294 (18) before the date of application of this Regulation.

(21) As Regulation (EU) 2016/429 applies with effect from 21 April 2021, this Regulation should also apply from that date.

(22) 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

Subject matter and scope

(a) for movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof (Annex I); and

(b) for the entry into the Union of consignments of certain categories of terrestrial animals and germinal products thereof (Annex II).

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘registered germinal product establishment’ means a germinal product establishment as defined in point (1) of Article 2 of Delegated Regulation (EU) 2020/686;

(2) ‘approved germinal product establishment’ means a germinal product establishment as defined in point (2) of Article 2 of Delegated Regulation (EU) 2020/686;

(3) ‘semen’ means semen as defined in point (14) of Article 2 of Delegated Regulation (EU) 2020/686;

(4) ‘oocytes’ means oocytes as defined in point (15) of Article 2 of Delegated Regulation (EU) 2020/686;

(5) ‘embryo’ means embryo as defined in point (16) of Article 2 of Delegated Regulation (EU) 2020/686;

(6) ‘semen collection centre’ means a germinal product establishment as defined in point (11) of Article 2 of Delegated Regulation (EU) 2020/686;

(7) ‘embryo collection team’ means a germinal product establishment as defined in point (12) of Article 2 of Delegated Regulation (EU) 2020/686;

(8) ‘embryo production team’ means a germinal product establishment as defined in point (13) of Article 2 of Delegated Regulation (EU) 2020/686;

(9) ‘germinal product processing establishment’ means a germinal product establishment as defined in point (18) of Article 2 of Delegated Regulation (EU) 2020/686;

(10) ‘germinal product storage centre’ means a germinal product establishment as defined in point (19) of Article 2 of Delegated Regulation (EU) 2020/686;

(11) ‘bovine animal’ means bovine animal as defined in point (5) of Article 2 of Delegated Regulation (EU) 2020/692;

(12) ‘ovine animal’ means an ovine animal as defined in point (6) of Article 2 of Delegated Regulation (EU) 2020/692;

(13) ‘caprine animal’ means a caprine animal as defined in point (7) of Article 2 of Delegated Regulation (EU) 2020/692;