Commission Delegated Regulation (EU) 2021/1705 of 14 July 2021 amending Delegated Regulation (EU) 2020/692 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/1705of 14 July 2021amending Delegated Regulation (EU) 2020/692 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin(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 Articles 234(2), 237(4), 239(2) and 279(2) thereof,Whereas:(1)Commission Delegated Regulation (EU) 2020/692Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379). supplements the animal health rules laid down in Regulation (EU) 2016/429, as regards the entry into the Union, and the movement and handling after entry, of consignments of certain animals, germinal products and products of animal origin.(2)After the publication of Delegated Regulation (EU) 2020/692 on 3 June 2020 in the Official Journal of the European Union, certain minor mistakes or omissions were spotted in the provisions of that Delegated Regulation. Those mistakes and omissions should be corrected and Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.(3)In addition, certain rules laid down in Delegated Regulation (EU) 2020/692 should be amended in order to ensure that they are consistent with rules laid down in other delegated acts adopted pursuant to Regulation (EU) 2016/429, and Regulation (EU) 2017/625 of the European Parliament and of the CouncilRegulation (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) (OJ L 95, 7.4.2017, p. 1)..(4)It is also necessary to amend Delegated Regulation (EU) 2020/692 to cover certain circumstances that were initially omitted from the scope of that act, and to cover certain possibilities that are provided for in Union acts that were adopted prior to Regulation (EU) 2016/429, and that should be maintained in the framework of Regulation (EU) 2016/429. This is important in order to ensure a smooth transition from the requirements laid down in those earlier Union acts concerning the entry into the Union of animals, germinal products and products of animal origin, or to clarify the species and categories of animals and products of animal origin to which certain requirements should apply or should not apply.(5)Delegated Regulation (EU) 2020/692 should also ensure a smooth transition from the requirements laid down in earlier Union acts concerning the entry into the Union of aquatic animals and products of animal origin thereof, as they have proven to be effective. Therefore, the aim and substance of those existing rules should be maintained in that Delegated Regulation, but adapted to suit the new legislative framework established by Regulation (EU) 2016/429.(6)In addition, the animal health requirements laid down in Delegated Regulation (EU) 2020/692 should not apply to products of animal origin from aquatic animals other than live aquatic animals, except those which are intended for further processing in the Union, given that there are no significant animal health reasons to include such products within the scope of that Delegated Regulation. Article 1(6) of Delegated Regulation (EU) 2020/692, setting out the scope of that act, should therefore be amended.(7)The definition of a porcine animal, as currently laid down in Article 2, point (8), of Delegated Regulation (EU) 2020/692 is suitable only for the purpose of the entry into the Union of those animals. 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)., which lays down rules on the movement within the Union of germinal products, provides for a different definition of porcine animals, which is appropriate for donors of germinal products. Therefore, the definition of porcine animals in Delegated Regulation (EU) 2020/692 should be amended to cover the entry into the Union of both porcine animals and germinal products of porcine animals.(8)The definition of "well-boat" currently laid down in Article 2, point (48), of Delegated Regulation (EU) 2020/692 is not in line with the definition of "well-boat" set out in Article 2, point (2), of Commission Delegated Regulation (EU) 2020/990Commission Delegated Regulation (EU) 2020/990 of 28 April 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health and certification requirements for movements within the Union of aquatic animals and products of animal origin from aquatic animals (OJ L 221, 10.7.2020, p. 42).. In the interests of consistency of Union rules, the definition in Article 2, point (48), of Delegated Regulation (EU) 2020/692 should be amended to bring it into line with the definition set out in Delegated Regulation (EU) 2020/990.(9)Delegated Regulation (EU) 2020/692 lays down requirements in relation to the inspection of terrestrial animals prior to their dispatch to the Union, which in the case of poultry cover also their flock of origin. It should, however, be clarified that those requirements do not apply to the flock of origin of day-old chicks, in accordance with the requirements applicable until 21 April 2021, laid down in Commission Regulation (EC) No 798/2008Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).. Article 13(1) of Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.(10)Delegated Regulation (EU) 2020/692, which applies from 21 April 2021, should ensure a smooth transition from the requirements laid down in earlier Union acts concerning the entry into the Union of terrestrial animals, and germinal products and products of animal origin from terrestrial animals, as they have proved to be effective. Therefore, the aim and substance of those rules should be maintained in that Delegated Regulation, but adapted to suit the new legislative framework established by Regulation (EU) 2016/429. Article 11(1) of Commission Regulation (EU) No 206/2010Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1). provided that, following their introduction into the Union, consignments of ungulates, other than ungulates intended for confined establishments, are to remain on the holding of destination for a period of at least 30 days, unless they are dispatched directly to a slaughterhouse. Regulation (EU) No 206/2010 was repealed by Delegated Regulation (EU) 2020/692. However, Delegated Regulation (EU) 2020/692 does not provide for the possibility to move ungulates to a slaughterhouse during the 30-day period after their entry into the Union. Article 26 of Delegated Regulation (EU) 2020/692 should therefore be amended to provide for that possibility, as movements during that period do not give rise to any significant animal health concerns.(11)In addition, the derogation from the requirement regarding the 30-day period of residency in the establishment of destination after entry into the Union provided for in Article 26 of Delegated Regulation (EU) 2020/692 that currently applies only to equine animals intended for competition, races and cultural events should be extended to all equine animals, and that Article should be amended accordingly.(12)Delegated Regulation (EU) 2020/692 provides for a derogation from the requirements laid down in that act for the entry into the Union of consignments of poultry and hatching eggs of poultry in the case consignments of less than 20 heads of poultry other than ratites, and consignments of less than 20 hatching eggs of poultry other than ratites. Certain requirements in relation to the means of transport, the containers in which they are transported to the Union, vaccination against highly pathogenic avian influenza and disinfection that apply for poultry and hatching eggs, should, however, also apply for the entry into the Union of consignments of less than 20 heads of poultry, other than ratites, and less than 20 hatching eggs of poultry, other than ratites. Articles 49 and 101 of Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.(13)Delegated Regulation (EU) 2020/692 provides that all captive birds dispatched to the Union should have been vaccinated against infection with Newcastle disease virus. This, however, is not practically possible and is inconsistent with the requirements for the entry into Member States with status free from infection against Newcastle disease virus without vaccination. Article 57 of Delegated Regulation (EU) 2020/692 should therefore be amended to clarify that the requirements as regards the vaccines used against infection with Newcastle disease virus apply in the case where captive birds have been vaccinated against that disease.(14)Racing pigeons fall within the definition of "captive birds" laid down in Article 4, point (10), of Regulation (EU) 2016/429. Therefore, the specific animal health requirements for captive birds laid down in Part II, Title 3, Chapter 2, of Delegated Regulation (EU) 2020/692 apply also to those animals. However, those requirements limit the possibility for the entry into the Union of racing pigeons from a third country or territory or zone thereof with the intention that they will fly back to that third country or territory or zone. Moreover, racing pigeons introduced into the Union with the intention to fly back to the third country or territory of origin or zone thereof do not pose the same animal health risk as other captive birds. Delegated Regulation (EU) 2020/692 should therefore be amended to provide for a derogation from the specific animal health requirements for captive birds for the entry into the Union of racing pigeons from a third country or territory or zone thereof where they are normally kept, with the intention to be immediately released with the expectation that they will fly back to that third country or territory or zone thereof.(15)Article 74 of Delegated Regulation (EU) 2020/692 lays down the identification requirements for the entry into the Union of dogs, cats and ferrets. As regards the requirements for their means of identification, it refers to implementing acts adopted by the Commission pursuant to Article 120 of Regulation (EU) 2016/429. However, such implementing acts have not yet been adopted, as Article 277 of Regulation (EU) 2016/429 provides that Regulation (EU) No 576/2013 of the European Parliament and of the CouncilRegulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1). is to continue to apply until 21 April 2026 in respect of non–commercial movements of pet animals of those species. Article 74 of Delegated Regulation (EU) 2020/692 should therefore be amended in order to refer to the requirements of Regulation (EU) No 576/2013.(16)Due to an omission, there are no provisions in Delegated Regulation (EU) 2020/692 concerning the inspection of consignments of germinal products prior to their dispatch to the Union. In order to ensure that consignments of germinal products comply with the requirements of Delegated Regulation (EU) 2020/692 before they are permitted to enter the Union, that Delegated Regulation should therefore be amended so that it lays down rules related to necessary examinations and checks of those consignments.(17)Article 86 of Delegated Regulation (EU) 2020/692 provides that consignments of oocytes and embryos of bovine animals should be allowed to enter the Union if a donor animal comes from an establishment free from enzootic bovine leukosis. Article 87(2) of that Delegated Regulation provides for a derogation for an establishment not free from enzootic bovine leukosis subject to the conditions that the donor animals are less than 2 years of age, and that there has been no clinical case of enzootic bovine leukosis during a period of at least the preceding 3 years. That derogation should apply for bovine donor animals regardless of their age. Article 87(2) of Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.(18)Delegated Regulation (EU) 2020/692 provides that hatching eggs of poultry must originate from flocks that have been subjected to a clinical inspection within a period of 24 hours prior to the time of loading of the consignment of hatching eggs for dispatch to the Union. However, third countries and stakeholders have indicated that that requirement unjustifiably increases the administrative burden for competent authorities and operators and constitutes a risk to the biosecurity of the establishments. Considering that those eggs originate in approved establishments that apply strict biosecurity rules, it is appropriate to allow for a wider timeframe for the clinical inspection of the flock of origin of the hatching eggs, similar to what is provided for in 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). for the movement of those products between Member States. Therefore, Article 107 of Delegated Regulation (EU) 2020/692 should be amended accordingly.(19)Chapter 4 of Title 2 of Part III of Delegated Regulation (EU) 2020/692 lays down requirements for the entry into the Union of specified pathogen-free eggs, including requirements in relation to the establishment of origin of those eggs. Delegated Regulation (EU) 2020/692 should be amended to provide that those establishments in third countries are approved in accordance with the rules that apply for those establishments in the Union.(20)Aquatic animals as defined in Article 4, point (3), of Regulation (EU) 2016/429 includes kept animals and wild animals. Aquatic animals may therefore, be permitted to enter the Union from aquaculture establishments and from wild habitats. Hence, they may be dispatched from a "place of origin" or from an "establishment of origin". Delegated Regulation (EU) 2020/692 should permit that possibility and Article 167, points (a) and (d), of Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.(21)Article 172 of Delegated Regulation (EU) 2020/692 provides for derogations for certain categories of aquatic animals and products thereof from the requirement to originate from a disease-free third country, territory, zone or compartment. In all cases, however, aquaculture animals and products thereof, that fall within the scope of Delegated Regulation (EU) 2020/692, must originate from an establishment, that is either registered or approved in accordance with Part IV, Title II, Chapter 1, of Regulation (EU) 2016/429. This Regulation should therefore, amend Article 172 of Delegated Regulation (EU) 2020/692 to make it clear that the derogation it provides, applies not to Article 170, but specifically to Article 170(1) of that Delegated Regulation.(22)Due to an omission, Article 174(3) of Delegated Regulation (EU) 2020/692 should be amended so that it refers to paragraph Article 170(1)(a)(iii), rather than to Article 170(a)(iii).(23)Article 226(3) of Regulation (EU) 2016/429 provides for Member States to have approved national measures for a disease other than a listed disease referred to in Article 9(1), point (d), of that Regulation. Article 175 of Delegated Regulation (EU) 2020/692 and Annex XXIX thereto should be amended to clarify that Member States may take such measures not only for non-listed diseases, but also for diseases listed in Article 9(1), point (e), of Regulation (EU) 2016/429.(24)Due to the lengthy stocking capabilities for semen, oocytes and embryos, Part IV of Delegated Regulation (EU) 2020/692 should lay down certain transitional measures regarding germinal products collected, produced, processed and stored in accordance with 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).. Those measures should concern the approval of semen collection centres, semen storage centres, embryo collection teams and embryo production teams under those Directives, and the marking of straws and other packages in which semen, oocytes or embryos are placed, stored and transported. Those measures should also concern the requirements for the collection, production, processing and storage of germinal products, for the animal health of donor animals and for the laboratory and other tests carried out on donor animals and germinal products under those Directives. It is necessary to ensure that there is no disruption in trade in those germinal products, given their importance for the animal breeding sector. Therefore, to ensure the continuity of the entry into the Union of consignments of germinal products collected or produced before 21 April 2021 that fulfil the requirements laid down in Directives 88/407/EEC, 89/556/EEC, 90/429/EEC and 92/65/EEC, certain transitional provisions should be laid down in Delegated Regulation (EU) 2020/692. That Delegated Regulation should be amended accordingly.(25)Table 1 of Annex III to Delegated Regulation (EU) 2020/692 lays down, amongst other things, the requirements as regards the residency periods of equine animals before their entry into the Union. In particular, specific residency periods are laid down for equine animals other than registered equine animals, registered equine animals and the re-entry after temporary export of registered horses. Those residency periods should be more detailed to target the risks arising from the entry of equine animals not intended for slaughter, registered horses and equine animals intended for slaughter, as well as for the re-entry after temporary export of registered horses. That Annex should be amended accordingly.(26)Table 2 of Annex III to Delegated Regulation (EU) 2020/692 lays down the requirements as regards the residency periods of poultry before their entry into the Union. In particular, specific residency periods are laid down for productive poultry for the production of meat or eggs for consumption and for productive poultry for restocking supplies of game birds, but not for productive poultry for the production of other products. A specific residency period should, therefore, be laid down also for the category of productive poultry for the production of other products. That Annex should be amended accordingly.(27)Point 2 of Annex XV to Delegated Regulation (EU) 2020/692 lays down the animal health requirements for poultry and hatching eggs originating in a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of that Annex. Further clarification should, however, be provided on which of those requirements apply to poultry, hatching eggs and their flocks of origin. That Annex should be amended accordingly.(28)The rules provided in Delegated Regulation (EU) 2020/692 supplement those laid down in Regulation (EU) 2016/429. As those rules are interrelated, they are laid down together in one single act. In the interest of clarity and for their effective application, it is appropriate for the rules amending Delegated Regulation (EU) 2020/692 to be also laid down in a single delegated act providing a comprehensive set of requirements for the entry into the Union of animals, germinal products and products of animal origin.(29)Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.(30)Delegated Regulation (EU) 2020/692 applies from 21 April 2021. In the interest of legal certainty, this Regulation should enter into force as a matter of urgency,HAS ADOPTED THIS REGULATION: