Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (Text with EEA relevance) (Text with EEA relevance)

PART I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

Chapter 1 of Part II lays down the requirements for the approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals are moved to another Member State in relation to:

(a) quarantine, isolation and other biosecurity measures;

(b) surveillance requirements;

(c) facilities and equipment;

(d) responsibilities, competence and specialised training of personnel and veterinarians for the activity of germinal product establishments;

(e) responsibilities of the competent authority approving germinal product establishments;

(f) special rules for the cessation of activities of those germinal product establishments.

Chapter 2 of Part II lays down the requirements on:

(a) the information to be included by the competent authority in the register of registered germinal product establishments;

(b) the information to be included by the competent authority in the register of the of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals; and the rules for the availability to the public of that register when germinal products of those animals are to be moved between Member States.

Chapter 3 of Part II lays down:

(a) the rules for the record-keeping obligations on operators of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals, and the requirements for record-keeping in respect of the germinal products collected, produced or processed in such an establishment after it has ceased its activities;

(b) the traceability requirements for germinal products of: (i) bovine, porcine, ovine, caprine and equine animals; (ii) dogs (Canis lupus familiaris) and cats (Felis silvestris catus); (iii) terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments; (iv) animals of the families Camelidae and Cervidae.

Chapter 1 of Part III lays down the animal health requirements, including derogations, for movements between Member States of germinal products of bovine, porcine, ovine, caprine and equine animals, specifying:

(a) the rules for the collection, production, processing and storage of germinal products in the approved germinal product establishments;

(b) the animal health requirements for donor animals from which germinal products were collected, and concerning isolation or quarantine for those animals;

(c) the laboratory and other tests to be carried out on donor animals and germinal products;

(d) the animal health requirements for the collection, production, processing, storage and other procedures, and for the transport of germinal products.

Chapter 2 of Part III, for movements between Member States of germinal products of bovine, porcine, ovine, caprine and equine animals, lays down:

(a) the rules on animal health certification;

(b) the information to be contained in the animal health certificate;

(c) the requirements concerning self-declaration document;

(d) the notification requirements.

Chapter 3 of Part III lays down the animal health, certification and notification requirements for movements between Member States of germinal products of:

(b) terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments;

(c) animals of the families Camelidae and Cervidae.

Part IV lays down certain transitional measures regarding Directives 88/407/EEC, 89/556/EEC, 90/429/EEC and 92/65/EEC in relation to:

(a) the approval of semen collection centres, semen storage centres, embryo collection teams and embryo production teams;

(b) the marking of straws and other packages in which semen, oocytes or embryos are placed, stored and transported;

(c) the use of animal health certificates issued before 21 April 2021;

(d) the movements between Member States of semen, oocytes and embryos collected, produced, processed and stored before 21 April 2021.

Article 2

Definitions

For the purposes of this Regulation, in addition to the definitions laid down in Article 1 of Implementing Regulation (EU) 2018/1882, the following definitions shall apply:

(1) ‘registered germinal product establishment’ means a germinal product establishment, other than an approved germinal product establishment, registered with the competent authority in accordance with point (a) of the first subparagraph of Article 93 of Regulation (EU) 2016/429;

(2) ‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre, approved in accordance with Article 97 of Regulation (EU) 2016/429;

(3) ‘bovine animal’ or ‘animal of the bovine species’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;

(4) ‘porcine animal’ or ‘animal of the porcine species’ means an animal of the ungulate species of Sus scrofa;

(5) ‘ovine animal’ or ‘animal of the ovine species’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;

(6) ‘caprine animal’ or ‘animal of the caprine species’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;

(7) ‘equine animal’ or ‘animal of the equine species’ means an animal of the species of solipeds belonging to genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species;

(8) ‘animal health certificate’ means a document issued by the competent authority of the Member State of origin to accompany a consignment of germinal products to their place of destination as referred to in Article 161(4) of Regulation (EU) 2016/429;

(9) ‘self-declaration document’ means a document issued by the operator to accompany a consignment of germinal products to their place of destination as referred to in Articles 32 and 46;

(10) ‘gene bank’ means a repository of animal genetic material for ex situ conservation and sustainable use of genetic resources of kept terrestrial animals, held by a host institution authorised or recognised by the competent authority to fulfil these tasks;

(11) ‘semen collection centre’ means a germinal product establishment approved by the competent authority for the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals intended for movement to another Member State, as referred to in Article 4;

(12) ‘embryo collection team’ means a germinal product establishment comprised of a group of professionals or a structure approved by the competent authority for the collection, processing, storage and transport of oocytes or in vivo derived embryos of bovine, porcine, ovine, caprine or equine animals intended for movement to another Member State, as referred to in Article 4;

(13) ‘embryo production team’ means a germinal product establishment comprised of a group of professionals or a structure approved by the competent authority for the collection, processing, storage and transport of oocytes, and the in vitro production, where applicable with stored semen, processing, storage and transport of embryos, of bovine, porcine, ovine, caprine or equine animals both intended for movement to another Member State, as referred to in Article 4;

(14) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;

(15) ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova;

(16) ‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;

(17) ‘consignment of germinal products’ means a quantity of semen, oocytes, in vivo derived embryos or in vitro produced embryos dispatched from a single approved germinal product establishment covered by a single animal health certificate;

(18) ‘germinal product processing establishment’ means a germinal product establishment approved by the competent authority for the processing, including semen sex-sorting where appropriate, and the storage of semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals of one or more species, or any combination of types of germinal products or species, intended for movement to another Member State, as referred to in Article 4;

(19) ‘germinal product storage centre’ means a germinal product establishment approved by the competent authority for the storage of semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals of one or more species, or any combination of types of germinal products or species, intended for movement to another Member State, as referred to in Article 4;

(20) ‘centre veterinarian’ means the veterinarian responsible for the activities carried out at the semen collection centre, at the germinal product processing establishment or at the germinal product storage centre as laid down in this Regulation;

(21) ‘team veterinarian’ means the veterinarian responsible for the activities carried out by an embryo collection team or by an embryo production team as laid down in this Regulation;

(22) ‘unique approval number’ means a number assigned by the competent authority;

(23) ‘withdrawal date of the approval’ means the date on which the competent authority has suspended or withdrawn the approval of an approved germinal product establishment in accordance with Article 100 of Regulation (EU) 2016/429;

(24) ‘unique registration number’ means a number assigned to a registered germinal product establishment;

(25) ‘quarantine accommodation’ means a facility authorised by the competent authority for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a period of at least 28 days before they are admitted to a semen collection centre;

(26) ‘establishment free from (disease)’ means an establishment granted the status in accordance with the requirements set out in Article 20 of Delegated Regulation (EU) 2020/689;

(27) ‘official laboratory’ means a laboratory, situated in a Member State or third country or territory, designated in accordance with Article 37 of Regulation (EU) 2017/625 by the competent authority to carry out the tests provided for in Articles 24 and 25 of this Regulation;

(28) ‘IMSOC’ means an information management system for official controls for the integrated operation of the mechanisms and tools through which data, information and documents concerning official controls and other official activities are managed, handled, and automatically exchanged as referred to in Article 131 of Regulation (EU) 2017/625;

(29) ‘endangered breed’ means a local breed, recognised by a Member State to be endangered, genetically adapted to one or more traditional production systems or environments in that Member State and where the endangered status is scientifically established by a body possessing the necessary skills and knowledge in the area of endangered breeds as referred to in Article 2(24) of Regulation (EU) 2016/1012;

(30) ‘approved eradication programme’ means a disease eradication programme implemented in a Member State or zone thereof as approved by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429;

(31) ‘batch of donor animals’ means a group of animals of the same health status from which germinal products are collected and processed at the same time, and transported together.

PART II

APPROVAL OF GERMINAL PRODUCT ESTABLISHMENTS, REGISTERS, RECORD-KEEPING AND TRACEABILITY

CHAPTER 1

Approval of germinal product establishments

Article 3

Requirements for the approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals

Operators of the following germinal product establishments for bovine, porcine, ovine, caprine and equine animals shall apply in accordance with Article 94(1)(b) of Regulation (EU) 2016/429 to the competent authority for approval for the purpose of moving consignments of germinal products of those animals to other Member States:

(a) the establishment where semen of bovine, porcine, ovine, caprine or equine animals is collected, processed and stored for approval as a semen collection centre;

(b) the group of professionals or the structure supervised by a team veterinarian competent to perform the collection, processing and storage of oocytes or embryos of bovine, porcine, ovine, caprine or equine animals for approval as an embryo collection team;

(c) the group of professionals or the structure supervised by a team veterinarian competent to perform the collection, processing and storage of oocytes and production, processing and storage of embryos of bovine, porcine, ovine, caprine or equine animals for approval as an embryo production team;

(d) the establishment where fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals are processed and stored for approval as a germinal product processing establishment;

(e) the establishment where fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals are stored for approval as a germinal product storage centre.

Article 4

Approval by the competent authority of germinal product establishments for bovine, porcine, ovine, caprine and equine animals

The competent authority shall only grant approval of a germinal product establishment for bovine, porcine, ovine, caprine or equine animals as referred to in Article 97 of Regulation (EU) 2016/429 after it has ensured that it complies with the following requirements:

(a) the operator has appointed: (i) a centre veterinarian responsible for the activities set out in: — point 1 of Part 1 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (a) of Article 3 as a semen collection centre, — point 1 of Part 4 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (d) of Article 3 as a germinal product processing establishment, — point 1 of Part 5 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (e) of Article 3 as a germinal product storage centre; or (ii) a team veterinarian responsible for the activities set out in: — point 1 of Part 2 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (b) of Article 3 as a embryo collection team, — point 1 of Part 3 of Annex I, in the case of an application for approval of a germinal product establishment referred to in point (c) of Article 3 as a embryo production team;

(b) the facilities, equipment and operational procedures for the activity in question comply with the requirements set out in: (i) point 2 of Part 1 of Annex I, in respect of the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals; (ii) part 2, point 2, of Annex I, in respect of the collection, processing, storage and transport of oocytes or embryos of bovine, porcine, ovine, caprine or equine animals; (iii) point 2 of Part 3 of Annex I, in respect of the collection of oocytes and of the production, processing, storage and transport of embryos of bovine, porcine, ovine, caprine or equine animals, including the processing and storage of semen and oocytes used for the embryo production; (iv) point 2 of Part 4 of Annex I, in respect of the processing, storage and transport of fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals; (v) point 2 of Part 5 of Annex I, in respect of the storage and transport of fresh, chilled or frozen semen, oocytes or embryos of bovine, porcine, ovine, caprine or equine animals.

Article 5

Special rules for the cessation of activities of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals

Where the operator of an approved germinal product establishment for bovine, porcine, ovine, caprine and equine animals ceases its activity, that operator shall ensure that prior to the withdrawal date of the approval all consignments of semen, oocytes or embryos collected or produced and stored in that germinal product establishment have been moved:

(a) to a germinal product storage centre for further storage; or

(b) for reproduction purposes to an establishment where bovine, porcine, ovine, caprine or equine animals are kept; or

(c) for safe disposal or use as animal by-products in accordance with Article 13 of Regulation (EC) No 1069/2009.

CHAPTER 2

Registers to be kept by the competent authority of registered and approved germinal product establishments

Article 6

Register to be kept by the competent authority of registered germinal product establishments

The competent authority shall include at least the following information in the register referred to in paragraph 1, for each registered germinal product establishment:

(a) the name, contact details and, where available, the Uniform Resource Locator (URL) of the website of the registered germinal product establishment;

(b) the address of the registered germinal product establishment;

(c) the type of germinal products and animal species for which it was registered;

(d) the unique registration number assigned by the competent authority and the date of the registration;

(e) if activities of the registered germinal product establishment have ceased, the date of cessation of those activities.

Article 7

Register to be kept by the competent authority of approved germinal product establishments for bovine, porcine, ovine, caprine and equine animals

The competent authority shall include at least the following information in the register referred to in paragraph 1 for each approved germinal product establishment:

(a) the name, contact details and, where available, the URL of the website of the germinal product establishment;

(b) the address of the germinal product establishment;

(c) the name of the centre veterinarian or the team veterinarian;

(d) the type of germinal products, the type of the germinal product establishment and animal species for which the approval has been granted;

(e) the unique approval number assigned by the competent authority and the date of the approval.

Where the competent authority has suspended or withdrawn the approval of an approved germinal product establishment in accordance with Article 100(2) of Regulation (EU) 2016/429, it shall, without undue delay: