Commission Implementing Regulation (EU) 2023/594 of 16 March 2023 laying down special disease control measures for African swine fever and repealing Implementing Regulation (EU) 2021/605 (Text with EEA relevance)

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Regulation lays down rules on:

(a) special disease control measures regarding African swine fever to be applied for a limited period of time by the Member States (¹) which are listed or which have areas listed in Annex I and II (the Member States concerned). Those special disease control measures apply to kept and wild porcine animals and to products obtained from porcine animals in addition to the measures applicable in the protection, surveillance, further restricted and infected zones established by the competent authorities of those Member States in accordance with Article 21(1) and Article 63 of Delegated Regulation (EU) 2020/687.

(b) listing at Union level in Annex I of restricted zones I, II and III following outbreaks of African swine fever;

(c) listing at Union level in Annex II, following an outbreak of African swine fever in a previously disease-free Member State or zone: (i) of the restricted zones, which comprise protection and surveillance zones, in the case of an outbreak of African swine fever in kept porcine animals; (ii) of the infected zones, in the case of an outbreak of that disease in wild porcine animals.

This Regulation applies to:

(a) the movements of consignments of: (i) porcine animals kept in establishments located in restricted zones I, II and III and in infected zones referred to in paragraph 1, point (c)(ii); (ii) germinal products, products of animal origin and animal by-products obtained from kept porcine animals referred to in point (a)(i); (iii) fresh meat and meat products, including casings, from restricted zones I, II and III or infected zones referred to in paragraph 1, point (c)(ii), where such meat or meat products are obtained from porcine animals kept in areas outside those restricted and infected zones and slaughtered either — in slaughterhouses located in restricted zones I, II or III or in infected zones referred to in paragraph 1, point (c)(ii); or — in slaughterhouses located outside those restricted and infected zones;

(b) the movements of: (i) consignments of wild porcine animals in all Member States; (ii) consignments, including those for private use by hunters, of products of animal origin and animal by-products obtained from wild porcine in the restricted zones I, II and III or processed in establishments located in those restricted zones;

(c) food business operators handling the consignments referred to in points (a) and (b);

(d) all Member States concerning awareness raising on African swine fever;

(e) all Member States concerning the establishment of national action plans for wild porcine animals in order to avoid the spread of African swine fever in the Union.

Article 2

Definitions

For the purposes of this Regulation, the definitions laid down in Delegated Regulation (EU) 2020/687 shall apply.

In addition, the following definitions shall apply:

(a) ‘porcine animal’ means an animal of the species of ungulates of the family Suidae listed in Annex III to Regulation (EU) 2016/429;

(b) ‘germinal products’ means porcine semen, oocytes and embryos obtained from kept porcine animals for artificial reproduction;

(c) ‘restricted zone I’ means an area of a Member State listed in Part I of Annex I with a precise geographical delimitation subject to special disease control measures and bordering restricted zones II or III;

(d) ‘restricted zone II’ means an area of a Member State listed in Part II of Annex I due to an outbreak of African swine fever in a wild porcine animal with a precise geographical delimitation subject to special disease control measures;

(e) ‘restricted zone III’ means an area of a Member State listed in Part III of Annex I due to an outbreak of African swine fever in a kept porcine animal with a precise geographical delimitation subject to special disease control measures;

(f) ‘previously disease-free Member State or zone’ means a Member State or zone of a Member State, where African swine fever has not been confirmed either in kept or in wild porcine animals during the preceding period of twelve months;

(g) ‘area listed in Annex II’ means an area of a Member State listed in Annex II: (i) in Part A thereof, as an infected zone, following confirmation of an outbreak of African swine fever in a wild porcine animal in a previously disease-free Member State or zone; or (ii) in Part B thereof, as a restricted zone, comprising protection and surveillance zones, following an outbreak of African swine fever in a kept porcine animal in a previously disease-free Member State or zone;

(h) ‘Category 2 materials’ means animal by-products referred to in Article 9 of Regulation (EC) No 1069/2009 obtained from kept porcine animals;

(i) ‘Category 3 materials’ means animal by-products referred to in Article 10 of Regulation (EC) No 1069/2009 obtained from kept porcine animals;

(j) ‘animal by-products approved plant’ means a plant approved by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009;

(k) ‘approved germinal product establishment’ means an establishment defined in Article 2, point (2), of Commission Delegated Regulation (EU) 2020/686 (²);

(l) ‘registered germinal product establishment’ means an establishment defined in Article 2, point (1), of Delegated Regulation (EU) 2020/686.

CHAPTER II

SPECIAL RULES FOR THE ESTABLISHMENT OF RESTRICTED AND INFECTED ZONES IN THE EVENT OF AN OUTBREAK OF AFRICAN SWINE FEVER

Article 3

Special rules for the immediate establishment of restricted and infected zones in the event of an outbreak of African swine fever in kept or wild porcine animals

In the event of an outbreak of African swine fever in kept or wild porcine animals, the competent authority of the Member State shall immediately establish either:

(a) in the case of an outbreak in kept porcine animals, a restricted zone in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 and subject to the conditions laid down in that Article; or

(b) in the case of an outbreak in wild porcine animals, an infected zone in accordance with Article 63 of Delegated Regulation (EU) 2020/687.

Article 4

Special rules for the establishment of an additional restricted zone in the event of an outbreak of African swine fever in kept or wild porcine animals

Article 5

Special rules for the listing of restricted zones I in the event of an outbreak of African swine fever in kept or wild porcine animals in an area of a Member State bordering an area where no outbreak of African swine fever has been officially confirmed

Article 6

Special rules for the listing of restricted zones II or infected zones in the event of an outbreak of African swine fever in wild porcine animals in a Member State

The competent authority of the Member State concerned shall ensure that the infected zone established in accordance with Article 63 of Delegated Regulation (EU) 2020/687 is adjusted without delay to comprise, at least for that Member State, the relevant:

(a) restricted zone II listed in Annex I to this Regulation for that Member State; or

(b) infected zone listed in Part A of Annex II to this Regulation.

Article 7

Special rules for the listing of restricted zones in the event of an outbreak of African swine fever in kept porcine animals in a Member State

The competent authority of the Member State concerned shall ensure that the restricted zone established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 is adjusted without delay to comprise, at least for that Member State, the relevant:

(a) restricted zone III listed in Annex I to this Regulation for that Member State; or

(b) a restricted zone, which comprises protection and surveillance zones, listed in Part B of Annex II to this Regulation.

Article 8

General and specific application of special disease control measures in restricted zones I, II and III and in infected zones listed in Annex II

The Member States concerned shall apply the special disease control measures laid down in this Regulation in restricted zones I, II and III in addition to the disease control measures required to be applied in accordance with Delegated Regulation (EU) 2020/687 in:

(a) restricted zones established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687;

(b) infected zones established in accordance with Article 63 of Delegated Regulation (EU) 2020/687.

CHAPTER III

SPECIAL DISEASE CONTROL MEASURES APPLICABLE TO CONSIGNMENTS OF PORCINE ANIMALS KEPT IN RESTRICTED ZONES I, II AND III AND PRODUCTS OBTAINED THEREOF IN THE MEMBER STATES CONCERNED

SECTION 1

Application of specific prohibitions on movements of consignments of kept porcine animals and products thereof in the member states concerned

Article 9

Specific prohibitions on movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones

The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 1 shall not apply to:

(a) movements of consignments of porcine animals kept in a restricted zone I to establishments located in the same or other restricted zones I, to restricted zones II and III or outside those restricted zones provided that the establishment of destination is located in the territory of the same Member State concerned;

(b) movements of consignments of porcine animals kept in confined establishments located in restricted zones I, II and III provided that: (i) the competent authority of the Member State concerned assessed the risks arising from such movements and that assessment indicated that the risk of the spread of African swine fever is negligible; (ii) the porcine animals are only moved to another confined establishment located in the same Member State concerned.

Article 10

Specific prohibitions on movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those restricted zones

The competent authority of the Member State concerned may decide that the prohibition provided for in paragraph 1 shall not apply to movements of consignments of germinal products of porcine animals kept in confined establishments located in restricted zones II and III provided that:

(a) the competent authority of the Member State concerned assessed the risks arising from such movements and that assessment indicated that the risk of the spread of African swine fever is negligible;

(b) the germinal products are only moved to another confined establishment located in the same Member State concerned.

Article 11

Specific prohibitions on movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those restricted zones

Article 12

Specific prohibitions on movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those restricted zones

Article 13

General prohibitions on movements of consignments of kept porcine animals and products thereof considered a risk for the spread of African swine fever

The competent authority of the Member State concerned may prohibit, within the territory of the same Member State, the movements of consignments of kept porcine animals and products obtained from kept porcine animals if the competent authority considers that there is a risk for the spread of African swine fever to, from or through those kept porcine animals or products thereof.

SECTION 2

General and specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zones i, ii and iii outside those restricted zones

Article 14

General conditions for derogations from specific prohibitions on movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones

By way of derogation from the specific prohibitions on movements of consignments of porcine animals kept in restricted zones I, II and III within and outside those restricted zones laid down in Article 9(1), the competent authority of the Member State concerned may authorise such movements in the cases covered by Articles 22 to 25 and Articles 28, 29 and 30 subject to compliance with the specific conditions laid down in those Articles, and the following conditions:

(a) the general conditions laid down Article 43(2) to (7) of Delegated Regulation (EU) 2020/687; and

(b) the additional general conditions concerning: (i) movements of consignments of kept porcine animals within and outside restricted zones I, II and III laid down in Article 15 where applicable; (ii) establishments for kept porcine animals located in restricted zones I, II and III laid down in Article 16; (iii) the means of transport used for the transportation of kept porcine animals from restricted zones I, II and III laid down in Article 17.

The competent authority of the Member State concerned may decide that the additional general conditions laid down in Articles 15 and 16 shall not apply to movements of consignments of porcine animals kept in slaughterhouses located in the restricted zones I, II and III provided that:

(a) the kept porcine animals need to be moved to another slaughterhouse due to exceptional circumstances, such as a major breakdown in the slaughterhouse;

(b) the slaughterhouse of destination is located either: (i) in restricted zones I, II or III of the same Member State; or (ii) in exceptional circumstances, such as the absence of the slaughterhouses referred to in point (b)(i), outside restricted zones I, II or III in the territory of the same Member State;

(c) the movement is authorised by the competent authority of the Member State concerned.

Article 15

Additional general conditions on movements of consignments of porcine animals kept and germinal products collected in restricted zones I, II and III within and outside those restricted zones

The competent authority of the Member State concerned shall authorise movements of consignments of porcine animals kept in restricted zones I, II and III or germinal products of those animals collected in restricted zones II and III within and outside those restricted zones in the cases covered by Articles 22 to 25 and Articles 28 to 34 subject to compliance with the specific conditions laid down in those Articles and the following additional general conditions:

(a) the porcine animals have been kept in and have not been moved from the establishment of dispatch for a period of at least 30 days prior to the date of movement, or since birth, if they are younger than 30 days of age, and during that period no other kept porcine animals have been introduced from establishments located in restricted zones II that do not comply with the additional general conditions laid down in this Article and in Article 16 and from establishments located in restricted zones III into either: (i) that establishment of dispatch; or (ii) the epidemiological unit where the porcine animals to be moved were kept completely separated. The competent authority of the Member State concerned shall determine, after carrying out a risk assessment, the boundaries of such epidemiological unit confirming that the structure, size and distance between different epidemiological units and the operations being carried out ensure separate facilities for housing, keeping and feeding of kept porcine animals so that the African swine fever virus cannot spread from one epidemiological unit to another;

(b) a clinical examination has been carried out on the porcine animals kept in the establishment of dispatch, including those animals to be moved or used for the collection of germinal products, with favourable results concerning African swine fever: (i) by an official veterinarian; (ii) within the period of 24 hours prior to the time of: — the movement of the consignment of porcine animals, or — the collection of the germinal products; and (iii) in accordance with Article 3(1) and (2) of Delegated Regulation (EU) 2020/687 and point A.1 of Annex I thereto.

(c) if necessary, following the instructions of the competent authority, pathogen identification tests have been carried out prior to the date of the movement of those consignments from the establishment of dispatch or prior to the date of the collection of germinal products: (i) following the clinical examination referred to in point (b) for porcine animals kept in the establishment of dispatch, including those porcine animals to be moved or to be used for the collection of germinal products; and (ii) in accordance with point A.2 of Annex I to Delegated Regulation (EU) 2020/687.

The competent authority of the Member State concerned may decide that, in the case of movements of consignments of kept porcine animals from establishments of dispatch located in restricted zones I and II within and outside those restricted zones to establishments located within the same Member State concerned, the clinical examination referred to in paragraph 1, point (b):

(a) shall be carried out only for porcine animals to be moved; or

(b) shall not be required to be carried out, provided that: (i) the establishment of dispatch has been visited by an official veterinarian with a frequency rate referred to in Article 16(1), point (a)(i), and with a favourable outcome of all the visits by an official veterinarian during a period of at least twelve months prior to the date of movement of the consignment of porcine animals, indicating that: — the biosecurity requirements referred to in Article 16(1), point (b), have been implemented in the establishment of dispatch; — a clinical examination with favourable results concerning African swine fever has been carried out by an official veterinarian during those visits on the porcine animals kept in the establishment of dispatch in accordance with Article 3(1) and (2) of Delegated Regulation (EU) 2020/687 and point A.1 of Annex I thereto; (ii) the continuous surveillance referred to in Article 16(1), point (c), has been in place in the establishment of dispatch during a period of at least twelve months prior to the date of movement of the consignment of porcine animals.

The competent authority of the Member State concerned may decide that, in the case of movements of consignments of kept porcine animals from an establishment of dispatch located in a restricted zone III to establishments located within that restricted zone III or within restricted zones I or II in the same Member State concerned, the clinical examination referred to in paragraph 1, point (b):

(a) shall be carried out only for the porcine animals to be moved; or