- Registration Date 2022-04-28
- Hit 519
upplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards specific rules on official controls performed by the competent authorities on animals, products of animal origin and germinal products, follow-up action to be taken by the competent authority in case of non-compliance with identification and registration rules for bovine, ovine and caprine animals or of non-compliance during transit through the Union of certain bovine animals, and repealing Commission Regulation (EC) No 494/98
(2) Regulation (EU) 2016/429 of the European Parliament and of the Council (2) repealed and replaced 39 acts in the area of animal health as from 21 April 2021. Some of the requirements in the acts repealed by or pursuant to the Regulation (EU) 2016/429 relate, however, to certain animal health-related specificities of official controls and follow-up action to be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.
Article 1
Subject matter and scope
1. This Regulation supplements Regulation (EU) 2017/625 as regards certain specific rules on official controls by the competent authorities of Member States (11) in relation to animals, products of animal origin and germinal products to verify compliance with animal health requirements referred to in Article 1, paragraph (2), point (d), of that Regulation and, where necessary, as regards certain actions taken by the competent authorities following official controls:
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(a) |
in certain establishments keeping animals; |
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(b) |
in certain establishments collecting, producing, processing or storing germinal products. |
2. This Regulation supplements Regulation (EU) 2017/625 as regards a specific action taken by the competent authorities of Member States following official controls in relation to certain bovine animals in transit.
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, Delegated Regulation (EU) 2020/692 and Delegated Regulation (EU) 2020/990 shall apply:
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(a) |
‘establishment’ as defined in Article 4, point (27), of Regulation (EU) 2016/429; |
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(b) |
‘hatchery’ as defined in Article 4, point (47), of Regulation (EU) 2016/429; |
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(c) |
‘assembly operation’ as defined in Article 4, point (49), of Regulation (EU) 2016/429; |
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(d) |
‘assembly centre of dogs, cats and ferrets’ as defined in Article 2, point (7), of Delegated Regulation (EU) 2019/2035; |
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(e) |
‘animal shelter’ as defined in Article 2, point (8), of Delegated Regulation (EU) 2019/2035; |
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(f) |
‘control post’ as defined in Article 2, point (9), of Delegated Regulation (EU) 2019/2035; |
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(g) |
‘environmentally isolated production establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2019/2035; |
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(h) |
‘approved quarantine establishment’ as defined in Article 3, point (9), of Delegated Regulation (EU) 2020/688; |
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(i) |
‘confined establishment’ as defined in Article 4, point (48), of Regulation (EU) 2016/429; |
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(j) |
‘approved germinal product establishment’ as defined in Article 2, point (2), of Regulation (EU) 2020/686; |
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(k) |
‘approved aquaculture establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2020/990; |
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(l) |
‘approved group of aquaculture establishments’ as defined in Article 2, point (11), of Delegated Regulation (EU) 2020/990. |
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(m) |
‘establishment veterinarian’ as defined in Article 2(14) of Delegated Regulation (EU) 2019/2035; |
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(n) |
‘bovine animal’ as defined in Article 2, point (5), of Delegated Regulation (EU) 2020/692. |
Article 3
Official controls in certain approved establishments
1. Official veterinarians, or in the case of approved aquaculture establishments and approved groups of aquaculture establishments, official veterinarians or official aquatic animal health professionals, shall perform official controls to verify compliance with animal health requirements referred to in Article 1, paragraph (2), point (d), of Regulation (EU) 2017/625 and laid down in and pursuant to Regulation (EU) 2016/429, in the following types of establishments that have obtained approval from the competent authority:
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(a) |
hatcheries and establishments keeping poultry; |
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(b) |
establishments for assembly operations for ungulates and poultry; |
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(c) |
assembly centres of dogs, cats and ferrets; |
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(d) |
animal shelters for dogs, cats and ferrets; |
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(e) |
control posts; |
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(f) |
environmentally isolated production establishments for bumble bees; |
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(g) |
approved quarantine establishments; |
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(h) |
confined establishments; |
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(i) |
approved germinal product establishments; |
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(j) |
approved aquaculture establishments |
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(k) |
approved groups of aquaculture establishments. |
The official controls referred to in the first subparagraph shall in particular verify that the operators responsible for the approved establishments continue to comply with the approval requirements for those establishments.
2. The official controls referred to in paragraph 1 of this Article shall include inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625 that shall be performed in accordance with at least the minimum frequencies, where such frequencies are set out in Commission Implementing Regulation (EU) 2022/160 (12).
3. The inspections referred to in paragraph 2 may be combined with:
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(a) |
official controls referred to in Article 9, paragraph (3) of Regulation (EU) 2017/625; |
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(b) |
other official controls to verify compliance with requirements referred to in Article 1, paragraph (2), of Regulation (EU) 2017/625; or |
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(c) |
other official controls, inspections or visits provided for in Union rules. |
Article 4
Specific rules on official controls in confined establishments of terrestrial animals
When performing official controls in confined establishments of terrestrial animals, the official veterinarian shall in particular:
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(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; |
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(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; |
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(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 |
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(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. |
Article 5
Specific rules on official controls to verify compliances with requirements on identification and registration of bovine, ovine or caprine animals and on follow-up action in case of non-compliance therewith
1. Official controls to verify compliance with requirements on identification and registration of bovine, ovine or caprine animals shall include inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625 of bovine, ovine or caprine animals in establishments keeping those animals, performed in accordance with at least the minimum frequency set out in Article 6 of Implementing Regulation (EU) 2022/160.
2. The inspections referred to in paragraph 1 may be combined with:
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(a) |
official controls referred to in Article 9, paragraph (3), of Regulation (EU) 2017/625; |
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(b) |
other official controls to verify compliance with requirements referred to in Article 1, paragraph (2), of Regulation (EU) 2017/625; or |
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(c) |
other official controls, inspections or visits provided for in Union rules. |
3. When selecting the establishments to be inspected, the competent authority shall take into account the following criteria in its risk analysis in addition to those set out in Article 9, paragraph (1), of Regulation (EU) 2017/625:
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(a) |
the number of animals in an establishment; |
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(b) |
the species of animals present and identified in an establishment; |
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(c) |
significant changes in comparison with the number or species of animals in the establishment during the last 5 years; and |
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(d) |
any other relevant criteria defined by its Member State. |
4. Where an inspection referred to in paragraph 1 is performed, the competent authority shall inspect all bovine, ovine and caprine animals in that establishment.
5. By way of derogation from paragraph 4, where the number of animals to be inspected in the establishment exceeds 20, the competent authority may decide to inspect a representative sample of those animals if the number of inspected animals is sufficient to detect 5 % of cases of non-compliance at a 95 % confidence level.
6. Where an inspection referred to in paragraph 1 is performed on a representative sample of animals in an establishment in accordance with paragraph 5 and that inspection confirms non-compliance with the requirements concerning identification and registration, the competent authority shall inspect all other bovine, ovine and caprine animals in the establishment.
7. By way of derogation from paragraph 6, the competent authority may decide to inspect a representative sample of animals in that establishment ensuring that the number of inspected animals is sufficient for the estimation of non-compliance over 5 % with precision of plus or minus 2 % for a 95 % confidence level.
Article 6
Follow-up action in case of non-compliance during transit through the Union of certain bovine animals
When consignments of bovine animals, which comply with specific animal health conditions for entry into the Union are in transit through the Union pursuant to Article 176, paragraph (1), point (b), of Delegated Regulation (EU) 2020/692 in conjunction with Article 34, paragraph (1), point (a) of Delegated Regulation (EU) 2019/2124, the competent authority shall order the slaughter or killing of the animals and their disposal as a Category 2 material referred to in Article 9, point (f)(i) of Regulation (EC) No 1069/2009, in case of any non-compliance during the movement between the border control post of entry into the Union and the border control post where the consignments leave the Union territory.
Article 7
Repeal
Regulation (EC) No 494/98 is repealed.
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.
Division Risk Information Division
Written by Risk Information Division