COMMISSION IMPLEMENTING REGULATION (EU) 2022/160

of 4 February 2022

laying down uniform minimum frequencies of certain official controls to verify compliance with Union animal health requirements in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and repealing Regulations (EC) No 1082/2003 and (EC) No 1505/2006

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (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) (1), and in particular Article 20, paragraph 3, first subparagraph, point (a), thereof,

Whereas:

(1) Regulation (EU) 2017/625 lays down general rules for official controls performed by the competent authority for the verification of compliance with rules in a number of areas, including animal health, on a risk basis and with appropriate frequencies. That Regulation also lays down methods and techniques for official controls, which include, among others, inspections of premises, animals and goods under the control of operators.

(2) Regulation (EU) 2017/625 provides for uniform practical arrangements for the performance of official controls regarding uniform minimum frequencies of official controls to be laid down, where necessary to respond to specific hazards and risks to animal health and to verify compliance with disease prevention and control measures.

(3) Before the entry into application of Regulation (EU) 2016/429 of the European Parliament and of the Council (2), a number of legal acts on animal health laid down rules for minimum frequencies for official controls, in particular inspections. Regulation (EU) 2016/429 repealed those legal acts with effect from 21 April 2021.

(4) Commission Delegated Regulation (EU) 2019/2035 (3) lays down requirements for approval, among others, of hatcheries and establishments keeping poultry, establishments for assembly operations for ungulates and poultry, assembly centres of dogs, cats and ferrets, animal shelters for dogs, cats and ferrets, control posts, environmentally isolated production establishments for bumble bees, quarantine establishments and confined establishments of terrestrial animals.

(5) Commission Delegated Regulation (EU) 2020/686 (4) lays down requirements for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals may be moved to another Member State.

(6) Commission Delegated Regulation (EU) 2020/691 (5) lays down requirements for approval of certain aquaculture establishments and groups of aquaculture establishments keeping aquatic animals posing a significant animal health risk.

(7) It is important that the competent authority verifies by way of regular official controls, in particular by way of inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625, that the animals and germinal products are continued to be kept and produced under the uniform approval conditions for establishments, that are intended to mitigate risks and hazards associated with diseases listed in Regulation (EU) 2016/429 and with emerging diseases. To respond to those uniform hazards and risks to human and animal health posed by those diseases, uniform minimum frequencies for inspections in certain approved establishments should be laid down in this Regulation.

(8) For approved germinal product establishments any uniform minimum frequency for inspections should take into account the non-seasonal nature of collecting semen of bovine and porcine animals.

(9) Any uniform minimum frequency for inspections in certain approved aquaculture establishments and approved groups of aquaculture establishments should take into account the risk ranking of that establishment or group of establishments in accordance with Commission Delegated Regulation (EU) 2020/689 (6).

(10) As regards identification and registration of certain animals, Commission Regulations (EC) No 1082/2003 (7) and Commission Regulation (EC) No 1505/2006 (8) lay down the minimum level of controls or checks to be carried out in establishments keeping bovine, ovine and caprine animals each year as well as the number of animals to be inspected in each of those establishment.

(11) Delegated Regulation (EU) 2019/2035 also lays down detailed requirements for the identification and registration of bovine, ovine and caprine animals to ensure their traceability.

(12) Bovine, ovine or caprine animals that are not identified or registered in accordance with the requirements laid down in Delegated Regulation (EU) 2019/2035 may play a role in spreading diseases listed in Regulation (EU) 2016/429 and in emerging diseases. To mitigate that uniform hazard and risk to human and animal health, to regularly verify compliance of operators with the requirements laid down in Delegated Regulation (EU) 2019/2035 and to ensure the uniform implementation of Regulation (EU) 2017/625, uniform minimum frequencies for inspections during the performance of official controls on identification and registration of bovine, ovine, and caprine animals should be laid down.

(13) Delegated Regulation (EU) 2019/2035 did not explicitly repeal Regulations (EC) No 1082/2003 and (EC) No 1505/2006. To ensure legal certainty, this Regulation should repeal those Regulations.

(14) The rules laid down in this Regulation should apply to the United Kingdom in respect of Northern Ireland, in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community in conjunction with Annex 2 to that Protocol.

(15) 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:

Article 1 Subject matter and scope This Regulation lays down uniform minimum frequencies for official controls, in particular, inspections of animals and germinal products, and the conditions under which they are kept or produced in the following establishments: (a) approved establishments for kept terrestrial animals and hatching eggs referred to in Article 1(1), point (a), of Delegated Regulation (EU) 2019/2035; (b) approved germinal product establishments referred to in Article 3 of Delegated Regulation (EU) 2020/686; (c) certain aquaculture establishments approved pursuant to Article 176(1), of Regulation (EU) 2016/429 and groups of aquaculture establishments approved pursuant to Article 177, of that Regulation; (d) registered establishments for kept terrestrial animals referred to in Article 1(1) point (a), of Delegated Regulation (EU) 2019/2035 that keep bovine, ovine or caprine animals.

Article 2 Definitions For the purposes of this Regulation, the following definitions laid down in Regulation (EU) 2016/429, in Delegated Regulation (EU) 2019/2035, Delegated Regulation (EU) 2020/686, Delegated Regulation (EU) 2020/688 (9) and Delegated Regulation (EU) 2020/990 (10) shall apply: (a) ‘establishment’ as defined in Article 4, point (27), of Regulation (EU) 2016/429; (b) ‘hatchery’ as defined in Article 4, point (47), of Regulation (EU) 2016/429; (c) ‘assembly operation’ as defined in Article 4, point (49), of Regulation (EU) 2016/429; (d) ‘assembly centre of dogs, cats and ferrets’ as defined in Article 2, point (7), of Delegated Regulation (EU) 2019/2035; (e) ‘animal shelter’ as defined in Article 2, point (8), of Delegated Regulation (EU) 2019/2035; (f) ‘control post’ as defined in Article 2, point (9), of Delegated Regulation (EU) 2019/2035; (g) ‘environmentally isolated production establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2019/2035; (h) ‘approved quarantine establishment’ as defined in Article 3, point (9), of Delegated Regulation (EU) 2020/688; (i) ‘confined establishment’ as defined in Article 4, point (48), of Regulation (EU) 2016/429; (j) ‘approved germinal product establishment’ as defined in Article 2, point (2), of Delegated Regulation (EU) 2020/686; (k) ‘approved aquaculture establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2020/990; (l) ‘approved group of aquaculture establishments’ as defined in Article 2, point (11), of Delegated Regulation (EU) 2020/990.

Article 3 Uniform minimum frequency of inspections in certain approved establishments The competent authorities of Member States (11) shall perform at least once every calendar year, official controls on, in particular inspections of, animals and hatching eggs and the conditions under which those animals and hatching eggs are kept or produced in the following types of establishments on its territory that have obtained approval from the competent authority: (a) hatcheries and establishments keeping poultry; (b) establishments for assembly operations for ungulates and poultry; (c) assembly centres of dogs, cats and ferrets; (d) animal shelters for dogs, cats and ferrets; (e) control posts; (f) environmentally isolated production establishments for bumble bees; (g) approved quarantine establishments; (h) confined establishments.

Article 4 Uniform minimum frequency of inspections in approved germinal product establishments The competent authorities of the Member States shall perform official controls on, and in particular, inspections of, germinal products, except hatching eggs, and the conditions under which those germinal products are produced every calendar year in the following types of establishments on its territory that have obtained approval from the competent authority: (a) at least twice every calendar year, semen collection centres for bovine and porcine animals; (b) at least once every calendar year: (i) semen collection centres for ovine, caprine and equine animals; (ii) embryo collection or production teams; (iii) germinal product processing establishments; (iv) germinal product storage centres.

Article 5 Uniform minimum frequency of inspections in certain approved aquaculture establishments and in certain approved groups of aquaculture establishments The competent authority of a Member State shall perform official controls on, and in particular, inspections of, aquaculture animals and the conditions under which those animals are kept in certain approved aquaculture establishments and approved groups of aquaculture establishments on its territory. Those official controls shall take into account the risk ranking of the approved aquaculture establishment or the approved group of aquaculture establishments determined by the competent authority pursuant to Part 1, Chapter 1, point 1.2, of Annex VI to Delegated Regulation (EU) 2020/689 or the risk ranking of the establishments in dependent compartments referred to in Article 73(3), point (b), of that Regulation, as follows: (a) high-risk establishments shall be inspected at least once every calendar year; (b) medium-risk establishments shall be inspected at least once every two calendar years; (c) low-risk establishments shall be inspected at least once every three calendar years.

Article 6 Uniform minimum frequency of inspections in establishments keeping bovine, ovine and caprine animals The competent authority of a Member State shall perform official controls on, and in particular, inspections of, the identification and registration of bovine, ovine and caprine animals every calendar year in at least 3 % of establishments on its territory keeping those animals.

Article 7 Repeals 1. Regulations (EC) No 1082/2003 and (EC) No 1505/2006 are repealed. 2. References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in the Annex.

Article 8 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 February 2022. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 95, 7.4.2017, p. 1.

(2) 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 084 31.3.2016, p. 1).

(3) Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314, 5.12.2019, p. 115).

(4) 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 (OJ L 174, 3.6.2020, p. 1).

(5) Commission Delegated Regulation (EU) 2020/691 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for aquaculture establishments and transporters of aquatic animals (OJ L 174, 3.6.2020, p. 345).

(6) Commission 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).

(7) Commission Regulation (EC) No 1082/2003 of 23 June 2003 laying down detailed rules for the implementation of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the minimum level of controls to be carried out in the framework of the system for the identification and registration of bovine animals (OJ L 156, 25.6.2003, p. 9).

(8) Commission Regulation (EC) No 1505/2006 of 11 October 2006 implementing Council Regulation (EC) No 21/2004 as regards the minimum level of checks to be carried out in relation to the identification and registration of ovine and caprine animals (OJ L 280, 12.10.2006, p. 3).

(9) Commission 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).

(10) Commission 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).

(11) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to ‘Member States’ include the United Kingdom in respect of Northern Ireland.