Introductory text

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’)^f1, and in particular Article 96(3) and Article 123 thereof,

Whereas:

Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases, which are transmissible to animals or to humans. Those rules cover, inter alia, germinal products of kept terrestrial animals of the bovine, porcine, ovine, caprine and equine species and of other species. It also lays down rules for the registration and approval of establishments for germinal products of bovine, porcine, ovine, caprine and equine animals. Regulation (EU) 2016/429 also lays down rules concerning the traceability and animal health requirements for movements of consignments of germinal products within the Union. It also empowers the Commission to adopt delegated and implementing acts in order to ensure the smooth functioning of the new legal framework established by that Regulation.

Commission Delegated Regulation (EU) 2020/686^f2 lays down rules supplementing Regulation (EU) 2016/429 as regards the approval of germinal product establishments and the traceability and animal health requirements for movements of consignments of germinal products of certain kept terrestrial animals within the Union.

Accordingly, it is necessary to establish rules for the uniform implementation of the requirements laid down in Regulation (EU) 2016/429, and the supplementing rules laid down in Delegated Regulation (EU) 2020/686, concerning the information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals, and the time-limits for providing that information. It is also necessary to lay down rules concerning the technical requirements and specifications for the marking of germinal products of bovine, porcine, ovine, caprine and equine animals, and the operational requirements for the traceability of consignments of those germinal products.

Article 96(3) of Regulation (EU) 2016/429 provides that the Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals are to be moved to another Member State, and the time-limits for providing such information. The timeframe for the competent authority to consider such applications should be sufficiently long in order to allow it to carry out an in-depth analysis, but it should not exceed a period of 90 days before the intended date of commencement of activity by operators, so that they are able to start their activity within a reasonable time period.

As Delegated Regulation (EU) 2020/686 provides for five different types of approved germinal product establishments, operators should indicate in their applications for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals the nature of the activities that they intend to carry out therein. The biosecurity plan for the operation of the germinal product establishment should also be included in such application. In addition, given the important role of the centre and team veterinarians responsible for the activities of approved germinal product establishments, their details should be indicated in applications for approval of germinal product establishments.

Rules on the marking of straws and other packages where germinal products of bovine, porcine, ovine, caprine and equine animals are placed should be laid down at Union level in order to ensure their traceability. When setting the standards for that marking, account should be taken of practices in this regard already implemented by Member States, and also of the recommendations of the International Committee for Animal Recording (ICAR)^f3. Where a bar code is printed on a straw or other package, the ICAR recommends that it is either of type 128C, or if of a different type, that three more digits corresponding to the international code of each germinal product establishment recorded in the United States National Association of Animal Breeders (NAAB)^f4 are added at the beginning of the national bar code.

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

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: