Commission Delegated Regulation (EU) 2021/880 of 5 March 2021 amending Delegated Regulation (EU) 2020/686 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards the traceability, animal health and certification requirements for movements within the Union of germinal products of certain kept terrestrial animals (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/880of 5 March 2021amending Delegated Regulation (EU) 2020/686 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards the traceability, animal health and certification requirements for movements within the Union of germinal products of certain kept terrestrial animals(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')OJ L 84, 31.3.2016, p. 1., and in particular Article 122(1) and (2), Article 160(1) and (2), Article 162(3) and (4), Article 163(5), Article 164(2), Article 165(3) and Article 279(2) thereof,Whereas:(1)Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases which are transmissible to animals or humans, including rules for the registration and approval of germinal product establishments, and for the traceability and animal health requirements for movements of consignments of germinal products within the Union. Regulation (EU) 2016/429 also empowers the Commission to adopt rules to supplement certain non-essential elements of that Regulation by means of delegated acts.(2)Commission Delegated Regulation (EU) 2020/686Commission 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 (OJ L 174, 3.6.2020, p. 1). lays down supplementing rules for the approval of germinal product establishments, record keeping and traceability of germinal products, as well as animal health and certification requirements for movements within the Union of germinal products of certain kept terrestrial animals.(3)The rules laid down in this Regulation are required to supplement those laid down in Chapters 1, 2 and 5 of Title I of Part IV of Regulation (EU) 2016/429, as regards the approval of germinal product establishments, the registers of germinal product establishments to be kept by the competent authorities, the record-keeping obligations of operators, the traceability and animal health requirements, and animal health certification and notification requirements for movements within the Union of consignments of germinal products of certain kept terrestrial animals in order to prevent the spread of transmissible animal diseases within the Union by those products.(4)These rules are substantively linked and many are intended to be applied in tandem. In the interests of simplicity and transparency, as well as to facilitate their application and to avoid a multiplication of rules, they therefore should be laid down in a single act rather than in a number of separate acts with many cross-references and the risk of duplication.(5)Article 11 of Delegated Regulation (EU) 2020/686 lays down the traceability requirements for germinal products of dogs and cats, terrestrial animals other than bovine, porcine, ovine, caprine and equine animals kept at confined establishments, and animals of the families Camelidae and Cervidae. Establishment where germinal products are collected, produced, processed or stored should be registered or approved by the competent authority and a registration or approval number should be assigned to that establishment. The registration or approval number is a part of the mark on the straws or other packages in which germinal products are placed. Paragraph 1(c) of Article 11 of Delegated Regulation (EU) 2020/686 should be amended to provide a clarity of such requirement.(6)Article 13 of Delegated Regulation (EU) 2020/686 lays down a derogation for the movements to other Member States of semen of ovine and caprine animals from the establishments where those animals are kept. Donor animals, regardless of whether the place of collection of semen is a semen collection centre or an establishment, should not be used for natural breeding during the period of at least 30 days prior to the date of first collection and during the period of collection of the semen intended for movement to another Member State. Such a requirement should be included in Article 13 of Delegated Regulation (EU) 2020/686.(7)Articles 30 and 39 of Delegated Regulation (EU) 2020/686 provide for a 10-day validity period of an animal health certificate issued for a consignment of germinal products intended to be moved between Member States. As germinal products are not perishable goods, there should not be any limit to the validity period of these animal health certificates.(8)Articles 35, 43 and 48 of Delegated Regulation (EU) 2020/686 lay down rules for emergency procedures for the notification of movements of consignments of germinal products between Member States in the event of disturbances caused to the information management system for official controls (IMSOC). Articles 99 and 107 of Commission Delegated Regulation (EU) 2020/688Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140). lay down rules on the same matter for movements between Member States of consignments of certain terrestrial animals. However, the wording of the provisions concerned in both Delegated Regulations differ. For the sake of consistency and clarity of procedures, Articles 35, 43 and 48 of Delegated Regulation (EU) 2020/686 should be amended by aligning their wording with that of Articles 99 and 107 of Delegated Regulation (EU) 2020/688.(9)Part IV of Delegated Regulation (EU) 2020/686 lays down certain transitional measures regarding Council Directives 88/407/EECCouncil Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10)., 89/556/EECCouncil Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1)., 90/429/EECCouncil Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species (OJ L 224, 18.8.1990, p. 62). and 92/65/EECCouncil Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54). in relation to the approval of semen collection centres, semen storage centres, embryo collection teams and embryo production teams and the marking of straws and other packages in which semen, oocytes or embryos are placed, stored and transported. However, in order to enable continuity of the movements between Member States of germinal products fulfilling the requirements laid down in those Directives, which were collected or produced, processed and stored before 21 April 2021, certain additional transitional provisions concerning those movements and the use of animal health certificates issued before 21 April 2021 should be laid down in this Regulation.(10)Part 1 of Annex II to Delegated Regulation (EU) 2020/686 lays down additional animal health requirements for bovine donor animals. In accordance with point 1(b)(i) and point 2(a) of Chapter I of Part 1 of that Annex bovine semen donors are to be subjected to an intradermal tuberculin test for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis). However, there is also a gamma-interferon assay listed in point 2 of Part 2 of Annex I to Delegated Regulation (EU) 2020/688 as another diagnostic method for infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis). Therefore, Delegated Regulation (EU) 2020/686 should be amended in order to provide for the possibility of using of both diagnostic methods.(11)Points 1 and 2 of Annex IV to Delegated Regulation (EU) 2020/686 lay down information that is to be contained in the animal health certificate for germinal products. The date of dispatch of the consignment has been unintentionally omitted from that information and therefore it should be inserted in those provisions. In addition, point 1(f)(i) of Annex IV to that Delegated Regulation requires the breed of donor animal to be specified in the animal health certificate for germinal products of bovine, porcine, ovine, caprine and equine animals. Such information is unnecessary from an animal health point of view and therefore should be removed from the required information to be contained in the animal health certificate for germinal products of bovine, porcine, ovine, caprine and equine animals.(12)After the publication of Delegated Regulation (EU) 2020/686 in the Official Journal of the European Union, some clerical errors and unintentional omissions were spotted. In the interest of legal certainty and clarity, those errors and omissions should be corrected.(13)Delegated Regulation (EU) 2020/686 should therefore be amended accordingly.(14)As Delegated Regulation (EU) 2020/686 applies from 21 April 2021, this Regulation should also apply from that date,HAS ADOPTED THIS REGULATION:
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