Commission Delegated Regulation (EU) 2023/647 of 13 January 2023 amending Delegated Regulation (EU) 2020/686 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)
Commission Delegated Regulation (EU) 2023/647of 13 January 2023amending Delegated Regulation (EU) 2020/686 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)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 160(1) and (2), and Articles 162(4) and 164(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 Part IV, Title I, Chapter 5, of Regulation (EU) 2016/429 as regards the traceability and animal health requirements and animal health certification 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)During the implementation of Delegated Regulation (EU) 2020/686 several Member States and stakeholders indicated that following recent developments and specialisations in the germinal product sector, the definition of embryo collection team should also include a team which only collects and handles unfertilised oocytes. That definition and the related requirements should therefore be amended to cover such a team.(6)Germinal product establishments of processing may engage in other processes than sex-sorting of semen. In the interest of the traceability of the processed products, the supplementary traceability requirements previously applicable only to sex-sorted semen should be equally extended to all processed products.(7)Article 19 of Delegated Regulation (EU) 2020/686 lays down a derogation from the animal health requirements for donor bovine, porcine, ovine, caprine and equine animals moved between semen collection centres. Experience from Member States and stakeholders with the implementation of that Article have indicated legal uncertainty as regards the degree of involvement of official veterinarians. That Article should therefore be clarified.(8)Article 36 of Delegated Regulation (EU) 2020/686 lays down animal health requirements for movements within the Union of germinal products of dogs and cats, mainly to mitigate rabies and promote compliance with preventive animal health measures against Echinococcus multilocularis. Member States and stakeholders have questioned the relevance and proportionality of these requirements. As the relevant international standards of the World Organisation for Animal Health (WOAH) do not contain comparable requirements, Article 36 of Delegated Regulation (EU) 2020/686 and related wording in requirements concerning official certification and notification of movement of germinal products of dogs and cats between Member States should be deleted.(9)Part 2 of Annex II to Delegated Regulation (EU) 2020/686 lays down additional animal health requirements for porcine donor animals. In accordance with Part 2, Chapter I, point 1(c)(iv), of that Annex, animals positive for infection with porcine reproductive and respiratory syndrome virus are to be removed immediately from the quarantine accomodation. Member States and stakeholders have questioned the proportionality of this requirement in the light of practical and scientifically proven difficulties with current diagnostic methods. Therefore, Delegated Regulation (EU) 2020/686 should be amended in order to provide for different possibilities of follow-up when using different types of diagnostic methods to confirm or rule out suspected cases in accordance with Commission Delegated Regulation (EU) 2020/689Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211)..(10)Part 2 of Annex II to Delegated Regulation (EU) 2020/686 lays down additional animal health requirements, including testing for classical swine fever of porcine animals kept at semen collection centres. However, the relevant international standards of the WOAH do not require testing of such animals in countries where outbreaks of classical swine fever have not been reported and vaccination against this disease has not been practised in the preceding 12 months. Therefore, testing for that disease of porcine animals kept at semen collection centres should be discontinued in those countries which neither have reported classical swine fever, nor have vaccinated against it in the preceding 12 months.(11)References to the epizootic haemorrhagic disease virus should be amended to align them with references to that virus in other Union acts and to clarify that all serotypes of that virus are covered by the rules. In addition, requirements related to infection with epizootic haemorrhagic disease virus should more closely follow international standards of the WOAH to provide for the possibility of a vector-free period as an optional and additional risk mitigating measure related to that infection, to ensure safe trade in germinal products of bovine, ovine and caprine animals.(12)Annex III to Delegated Regulation (EU) 2020/686 lays down additional animal health requirements with respect to the addition of antibiotics to semen, including their compulsory addition to semen of bovine and porcine animals. While those requirements are in line with international standards of the WOAH, those international standards are in the process of being amended, towards the voluntary, more flexible and prudent use of antibiotics. In addition, information from scientific literature, Member States and stakeholders indicates similar needs. Therefore, the relevant requirements should be streamlined and made optional.(13)After the publication of Delegated Regulation (EU) 2020/686 in the Official Journal of the European Union, some substantial errors were spotted. In particular, the wording in relation to the prevention of the entry of unauthorised persons to semen collection centres and germinal product processing establishments created legal uncertainty. Furthermore, an incorrect reference in the text applicable to certain equine animals entering semen collection centres for equine animals unintentionally changed the requirements whose fulfilment centre veterinarians are to ensure. In the interest of legal certainty and clarity, those errors should be corrected.(14)Delegated Regulation (EU) 2020/686 should therefore be amended and corrected accordingly,HAS ADOPTED THIS REGULATION: