Commission Implementing Regulation (EU) 2021/934 of 9 June 2021 laying down special control measures for classical swine fever (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’)⁽¹⁾, and in particular Article 71(3) thereof,

Whereas:

1. Classical swine fever is an infectious viral disease affecting kept and wild porcine animals and can have a severe impact on the concerned animal population and the profitability of farming causing disturbance to movements of consignments of those animals and products thereof within the Union and exports to third countries. The spread of the disease can significantly affect the productivity of the farming sector due to both direct and indirect losses.

2. Commission Implementing Decision 2013/764/EU⁽²⁾ lays down animal health control measures in relation to classical swine fever in the Member States and it has been amended several times to take account mainly of developments in the epidemiological situation in the Union as regards that disease. It applies until 21 April 2021.

3. Regulation (EU) 2016/429 establishes a new legislative framework for the prevention and control of diseases, which are transmissible to animals or humans. Classical swine fever is listed under Article 5(1)(a)(ii) of that Regulation, and is subject to the disease prevention and control rules laid down therein. In addition, Annex II to Commission Implementing Regulation (EU) 2018/1882⁽³⁾ lists classical swine fever as a Category A, D and E disease affecting Suidae and Tayassuidae, while Commission Delegated Regulation (EU) 2020/687⁽⁴⁾ supplements the rules for the control of Category A, B and C diseases laid down in Regulation (EU) 2016/429, including disease control measures for classical swine fever. Those three acts apply from 21 April 2021.

4. It is necessary to align the current Union control measures for classical swine fever laid down in Implementing Decision 2013/764/EU with the new legislative framework for animal health established by Regulation (EU) 2016/429. It is also necessary to align Union rules as much as possible with international standards, such as those set out in Chapter 15.2 ‘Infection with classical swine fever virus’ of the Terrestrial Animal Health Code of the World Organization for Animal Health⁽⁵⁾ (OIE Code).

5. The overall situation of classical swine fever in the Member States concerned by that disease, both on an epidemiological and risk management level, poses a persistent risk for its possible further spread in the Union. The general disease control measures laid down in Regulation (EU) 2016/429 and in Delegated Regulation (EU) 2020/687 do not cover all specific details and aspects in relation to the spread and the epidemiological situation of classical swine fever. It is therefore appropriate to lay down special disease control measures for a limited period of time, under conditions appropriate to the situation of classical swine fever in the Union, in order to ensure that the necessary measures are implemented in an uniform manner in the Union whenever there is a risk for the spread of that disease.

6. Regulation (EU) 2016/429 defines an outbreak as the officially confirmed occurrence of a listed disease or an emerging disease in one or more animals in an establishment or other place where animals or kept or located. The rules laid down in this Regulation should take account of whether or not the outbreak of classical swine fever occurred in wild or kept porcine animals.

7. This Regulation should provide for a regionalisation approach, which should apply in addition to the disease control measures laid down in Delegated Regulation (EU) 2020/687. This Regulation should list the restricted zones of the Member States concerned by classical swine fever in order to maintain the regionalisation approach established by Implementing Decision 2013/764/EU.

8. As regards risks for the spread of classical swine fever, movements of consignments of porcine animals and different porcine commodities pose different levels of risk. As a general rule, movements of consignments of kept porcine animals, germinal products and animal by-products of porcine origin from restricted zones pose a higher level of risk in terms of exposure and consequences, than movements of consignments of products of animal origin, including in particular fresh meat and meat products. Therefore, movements of consignments of kept porcine animals and various high-risk products of porcine origin from the restricted zones listed in Annex I to this Regulation should be prohibited in a manner proportionate to the risk involved, and taking into account the rules laid down in Delegated Regulation (EU) 2020/687 and in Commission Delegated Regulation (EU) 2020/2154⁽⁶⁾.

9. The rules laid down in Commission Delegated Regulation (EU) 2020/686⁽⁷⁾ supplement Regulation (EU) 2016/429 as regards the approval of germinal product establishments, the registers of germinal product establishments to be kept by the competent authorities, the record-keeping obligations of operators, the traceability and animal health requirements, and animal health certification and notification 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. Therefore, the rules laid down in this Regulation should refer to Commission Delegated Regulation (EU) 2020/689⁽⁸⁾, as regards the information required to be kept by the competent authorities of approved germinal product establishments for porcine animals.

10. Regulation (EC) No 1069/2009 of the European Parliament and of the Council⁽⁹⁾ lays down animal health rules for animal by-products in order to prevent and minimise risks to animal health arising from those by-products. In addition, Commission Regulation (EU) No 142/2011⁽¹⁰⁾ lays down certain animal health rules for animal by-products falling within the scope of Regulation (EC) No 1069/2009, including rules regarding the certification requirements for movements of consignments of animal by-products in the Union. Those legal acts do not cover all specific details and aspects in relation to the risk of the spread of classical swine fever through animal by-products obtained from kept and wild porcine animals in the restricted zones listed in Annex I to this Regulation. It is therefore appropriate to lay down in this Regulation special disease control measures for animal by-products and movements of consignments of such by-products from restricted zones listed in Annex I to this Regulation, in order to ensure that the necessary measures are implemented in an uniform manner in the Union whenever there is a risk for the spread of that disease.

11. In order to avoid any unnecessary disturbances to trade, it is appropriate to lay down certain conditions and derogations from the prohibitions provided for by this Regulation. The derogations should also take into account the general rules for the prevention and control of animal diseases laid down in Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/687, and the principles of the OIE Code as regards risk mitigation measures for classical swine fever.

12. Article 143 of Regulation (EU) 2016/429 provides that animal health certificates should accompany the movements of consignments of animals, including kept porcine animals. Where derogations from the prohibition on movements of consignments of kept porcine animals from the restricted zones listed in Annex I to this Regulation are applied to such consignments intended for intra-Union movements, those animal health certificates should include a reference to this Regulation, to ensure that adequate and accurate animal health information is provided in those animal health certificates. It is necessary to mitigate the risks arising from movements of consignments, and movements for private use, of fresh meat, meat products and any other products of animal origin obtained from wild porcine animals, bodies of wild porcine animals, which are intended for human consumption, and wild porcine animals from restricted zones listed in Annex I to this Regulation within the same Member State concerned and to other Member States. Risks for the spread of disease should be reduced by prohibiting movements of those products and movements of wild porcine animals by operators as laid down in Article 101 of Commission Delegated Regulation 2020/688⁽¹¹⁾ within and from Member States concerned and to other Member States.

13. Article 167(1)(b) of Regulation (EU) 2016/429 provides that animal health certificates issued by the competent authority of the Member State of origin are to accompany consignments of products of animal origin, including those of porcine origin, that are allowed to be moved from a restricted zone established in accordance with Article 71(3) of that Regulation subject to certain disease control measures. Where this Regulation provides for derogations from prohibitions on movements of consignments of products of animal origin from the restricted zones listed in Annex I hereto, the accompanying animal health certificates should include a reference to this Regulation, so as to ensure that adequate and accurate health information is provided in accordance with Delegated Regulation (EU) 2020/2154.

14. Movements of consignments of fresh or processed meat and meat products, including casings, obtained from porcine animals kept in the restricted zones listed in Annex I to this Regulation, or kept outside those restricted zones but slaughtered in them, should be subject to less stringent certification requirements in order to avoid any unnecessary and overly burdensome trade restrictions. It should be possible to authorise movements of those consignments within the territory of the same Member State and to other Member States based on the health or identification marks applied in establishments, provided that those establishments are designated in accordance with rules laid down in this Regulation. The competent authorities should only designate establishments if the kept porcine animals and products thereof that are eligible for movements outside such restricted zones are clearly separated from those animals and products that are not eligible for such authorised movements.

15. In addition, in specific situations, fresh meat from kept porcine animals should be marked in accordance with the requirements for the marking of fresh meat from protection and surveillance zones set out in Annex IX to Delegated Regulation (EU) 2020/687 or the fresh meat and meat products, including casings, from kept porcine animals should be marked with special marks. These special marks should not be confused with the health mark referred to in Article 48 of Commission Implementing Regulation (EU) 2019/627⁽¹²⁾ or the identification mark provided for in Article 5(1), point (b), of Regulation (EC) No 853/2004 of the European Parliament and of the Council⁽¹³⁾.

16. Certain risk mitigation measures and reinforced biosecurity measures are necessary in order to prevent and control classical swine fever in establishments of kept porcine animals. Those measures should be laid down in the Annex II to this Regulation and should cover establishments subject to derogations for movements of consignments of porcine animals kept in the restricted zones listed in Annex I hereto. These measures should addresses procedures and infrastructures in place in establishments of kept porcine animals; they should also address the risk of animals (other than the kept pigs) roaming in the premises and buildings. This risk is higher when related to wild porcine animals entering the premises and buildings. When other species are involved (pets or pests), acting as fomites, the risk is still present and should be addressed as well.

17. 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 (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Regulation (EU) 2016/429, as well as the Commission acts based on it, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement. Therefore, references to Member States in this Regulation should include the United Kingdom in respect of Northern Ireland.

18. As Regulation (EU) 2016/429 applies with effect from 21 April 2021, this Regulation should apply from the third day following that of its publication in the Official Journal of the European Union in order to apply the measures in a timely manner.

19. This Regulation should apply for a period of at least five years taking into account the Union’s experience in the fight against classical swine fever and the current epidemiological situation and disease management measures in place for this disease in the Member States concerned by that disease. The duration of these measures and the restricted zones listed in Annex I to this Regulation should be monitored and reviewed when new elements appear.

20. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

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