(1)

Regulation (EU) 2017/625 lays down general rules for official controls performed by the competent authorities for the verification of compliance with rules in a number of areas, including animal health requirements. That Regulation also lays down methods and techniques for official controls, which include inspections of premises, animals and goods under the control of operators. In addition, Regulation (EU) 2017/625 lays down possible actions to be taken by the competent authorities in case of established non-compliance with, among others, animal health requirements referred to in Article 1, paragraph (2), point (d), of that Regulation.

(2)

Regulation (EU) 2016/429 of the European Parliament and of the Council (2) repealed and replaced 39 acts in the area of animal health as from 21 April 2021. Some of the requirements in the acts repealed by or pursuant to the Regulation (EU) 2016/429 relate, however, to certain animal health-related specificities of official controls and follow-up action to be taken in case of established non-compliances under Regulation (EU) 2017/625 as set out in Article 138 thereof. Such specific rules on official controls and follow-up actions to be taken by the competent authority in case of established non-compliance should therefore be laid down in this Regulation.

(3)

Specificities of official controls and follow-up actions in case of established non-compliances related to animal health are interrelated. They apply to subsequent stages of a given situation and very often, apply to the same types of operators and establishments. Where specific follow-up actions are needed, they should be laid down together with the requirements for specificities of official controls related to animal health. This provides for a comprehensive set of measures enabling an easier implementation and contributing to the overall simplification of the legal framework in this area.

(4)

Performance of official controls and follow-up actions in establishments approved in accordance with Commission Delegated Regulations (EU) 2019/2035 (3), (EU) 2020/686 (4), (EU) 2020/688 (5) or (EU) 2020/990 (6) requires specific qualifications and competencies in the veterinary field. Official controls in those approved establishments involve assessment and verification of a wide variety of specific data and information related to animals kept therein. Some of these data and information are the results of observations made in animals, while others are collected and recorded by operators, animal health professionals, veterinarians, or aquatic animal health professionals. Such data and information can concern among other things the physiological or pathological state of animals, epidemiological factors, the results of physical, clinical or post-mortem examinations and laboratory tests, and data and information collected in relation to biosecurity measures in establishments and the appropriate use and maintence of equipment and facilities.

(5)

In addition, in germinal product establishments, the complexity and technicality of this particular sector requires specialised knowledge from the competent authority responsible for official controls in order to ensure an efficient and effective execution of its duties.

(6)

It is therefore appropriate that official veterinarians should perform the official controls in approved establishments that keep animals or handle germinal products in accordance with Regulation (EU) 2016/429. Rules on the performance of official controls in those establishments should be set out in this Regulation.

(7)

In addition, in some Member States for historical reasons, or due to the lack of veterinarians dealing with aquatic diseases, there exists a specialised profession called ‘aquatic animal health professionals’. These professionals are traditionally not veterinarians but they practice aquatic animal medicine. This Regulation should therefore respect the decision of those Member States, which recognise that profession. In those cases, official aquatic animal health professionals should be able to undertake activities assigned to official veterinarians when performing official controls in approved aquaculture establishments. In accordance with Article 12(2) of Regulation (EU) 2016/429 these aquatic animal health professionals may undertake activities assigned to veterinarians in animal health area, provided, that they are authorised to do so by the Member State concerned under national law. This principle should apply also in this Regulation.

(8)

Among the establishments approved pursuant to Regulation (EU) 2016/429, confined establishments are particular as they often keep a wide variety of animal species permanently and exchange them with other confined establishments. Requirements for approval and the safe operation of confined establishments in relation to quarantine, isolation and other biosecurity measures, disease surveillance and control measures under the responsibility of the establishment’s veterinarians, play an important role to ensure that exchanges of animals do not pose a risk in spreading listed or emerging animal diseases between or within Member States. It is therefore appropriate to specify the official controls that should take place in confined establishments.

(9)

As regards official controls to verify compliance with rules on identification and registration of bovine, ovine and caprine animals, specific criteria should be laid down to assist the competent authorities with the risk analysis for the selection of the animals and establishments to be inspected. When those official controls are performed on a representative sample of animals and those official controls identify non-compliance with identification and registration requirements, the competent authorities should inspect all animals in that establishment as a follow-up action.

(10)

Union rules authorise the transit through the Union of bovine animals for breeding and production which otherwise do not comply with the animal health requirements for entry into the Union, under specific derogations and conditions laid down in Commission Delegated Regulations (EU) 2019/2124 (7) and (EU) 2020/692 (8). Such transit should not jeopardise animal and public health in the Union. In case of non-compliance, irregularity or emergency during transit, the competent authority should therefore order the slaughter or killing of those animals, as that is the most appropriate measure to safeguard animal and public health and animal welfare. In those cases, the competent authority should also order the safe disposal of the resulting animal by-products in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council (9).

(11)

Commission Regulation (EC) No 494/98 (10) lays down administrative sanctions to be applied when non-compliances with the conditions or requirements for the identification and registration of bovine animals is established. Delegated Regulation (EU) 2019/2035 did not expressly repeal that Regulation. In addition, the administrative sanctions laid down in Regulation (EC) No 494/98 have become redundant in view of the measures set out in Article 138(2) of Regulation (EU) 2017/625. To ensure legal certainty and consistency, this Regulation should repeal Regulation (EC) No 494/98.

(12)

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,

(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 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.

(m)

‘establishment veterinarian’ as defined in Article 2(14) of Delegated Regulation (EU) 2019/2035;

(n)

‘bovine animal’ as defined in Article 2, point (5), of Delegated Regulation (EU) 2020/692.

(a)

verify through the examination of the movement records that the animals entering the given confined establishment come only from another confined establishment or are quarantined in accordance with Part 9, point 1, of Annex I to Delegated Regulation (EU) 2019/2035;

(b)

verify that the results of the clinical, laboratory and post-mortem examinations carried out by the confined establishment’s veterinarian rule out any suspicion of listed or emerging diseases;

(c)

verify that if the presence of listed or emerging diseases is suspected, the operator responsible for the confined establishment notifies that suspicion to the competent authority and mitigates the potential risks to spread such diseases within and outside the confined establishment; and

(d)

audit the activity of the confined establishment’s veterinarian and the implementation and results of the disease surveillance plan referred to in Part 9, point 2(a), of Annex I to Delegated Regulation (EU) 2019/2035 and in particular verify that the disease surveillance plan has been reviewed and updated at least annually in accordance with those requirements.