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Document 02021R0605-20220517
Commission Implementing Regulation (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (Text with EEA relevance)Text with EEA relevance
Consolidated text: Commission Implementing Regulation (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (Text with EEA relevance)Text with EEA relevance
Commission Implementing Regulation (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (Text with EEA relevance)Text with EEA relevance
02021R0605 — EN — 17.05.2022 — 017.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/605 of 7 April 2021 laying down special control measures for African swine fever (OJ L 129 15.4.2021, p. 1) |
Amended by:
COMMISSION IMPLEMENTING REGULATION (EU) 2021/605
of 7 April 2021
laying down special control measures for African swine fever
(Text with EEA relevance)
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
This Regulation lays down rules on:
special disease control measures regarding African swine fever to be applied for a limited period of time by the Member States ( 1 ) which have restricted zones I, II or III listed in Annex I (the Member States concerned).
These 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 the infected zones established by the competent authority of the Member State concerned in accordance with Articles 21(1) and 63 of Delegated Regulation (EU) 2020/687.
special disease control measures regarding African swine fever to be applied for a limited period of time by all Member States.
This Regulation applies to:
the movements of consignments of:
porcine animals kept in establishments located in restricted zones I, II and III outside those zones;
germinal products, products of animal origin and animal by-products obtained from kept porcine animals referred to in point (a)(i);
the movements of:
consignments of wild porcine animals in all Member States;
consignments and movements 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 restricted zones I, II and III;
food business operators handling consignments referred to in points (a) and (b);
all Member States concerning awareness raising on African swine fever.
The rules referred to in paragraph 1 cover the following:
Chapter II lays down special rules for the establishment of restricted zones I, II and III in the event of an outbreak of African swine fever and the application of special disease control measures in all Member States;
Chapter III lays down 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;
Chapter IV lays down special risk-mitigating measures concerning African swine fever for food businesses in the Member States concerned;
Chapter V lays down special disease control measures applicable to wild porcine animals in the Member States;
Chapter VI lays down special information and training obligations in the Member States;
Chapter VII lays down final provisions.
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:
‘porcine animal’ means an animal of the species of ungulates of the family Suidae listed in Annex III to Regulation (EU) 2016/429;
‘germinal products’ means porcine semen, oocytes and embryos obtained from kept porcine animals for artificial reproduction;
‘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;
‘restricted zone II’ means an area of a Member State listed in Part II of Annex I with a precise geographical delimitation subject to special disease control measures;
‘restricted zone III’ means an area of a Member State listed in Part III of Annex I with a precise geographical delimitation subject to special disease control measures;
‘previously disease-free Member State’ means a Member State, where African swine fever has not been confirmed in kept porcine animals during the previous period of 12 months;
‘Category 2 materials’ means animal by-products referred to in Article 9 of Regulation (EC) No 1069/2009 obtained from kept porcine animals;
‘Category 3 materials’ means animal by-products referred to in Article 10 of Regulation (EC) No 1069/2009 obtained from kept porcine animals.
CHAPTER II
SPECIAL RULES FOR THE ESTABLISHMENT OF RESTRICTED ZONES I, II AND III IN THE EVENT OF AN OUTBREAK OF AFRICAN SWINE FEVER AND THE APPLICATION OF SPECIAL DISEASE CONTROL MEASURES IN ALL MEMBER STATES
Article 3
Special rules for the establishment of restricted and infected zones in the event of an outbreak of African swine fever
In the event of an outbreak of African swine fever in kept or wild porcine animals, the competent authority of the Member State shall establish either:
in case of an outbreak in kept porcine animals, a restricted zone in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687 and under the conditions set out in that Article; or
in 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 in the event of an outbreak of African swine fever in wild porcine animals in a Member State
Article 7
Special rules for the listing of restricted zones III in the event of an outbreak of African swine fever in kept porcine animals in the Member State
However, where only a first and single outbreak of African swine fever in kept porcine animals has been confirmed in an area of a previously disease-free Member State, that area shall not be listed as a restricted zone III in Part III of Annex I to this Regulation.
Article 8
General application of special disease control measures in restricted zones I, II and III
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 to be applied in accordance with Delegated Regulation (EU) 2020/687 in:
restricted zones established in accordance with Article 21(1) of Delegated Regulation (EU) 2020/687;
infected zones established in accordance with Articles 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 consignments of kept porcine animals and products thereof in the Member States concerned
Article 9
Specific prohibitions in relation to movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones
Article 10
Specific prohibitions in relation to movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those zones
The competent authority of the Member State concerned shall prohibit movements of consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those zones.
Article 11
Specific prohibitions in relation to movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those zones
Article 12
Specific prohibitions in relation to movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those zones
Article 13
General prohibitions in relation to movements of consignments of kept porcine animals and products thereof considered a risk of 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 zones
Article 14
General conditions for derogations from specific prohibitions in relation to movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones
By way of derogation from the specific prohibitions provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones in the cases covered by Articles 22, 23, 24, 25, 28 and 29 and under the specific conditions provided for in those Articles, and:
the general conditions laid down Article 28(2) to (7) of Delegated Regulation (EU) 2020/687; and
the additional general conditions concerning:
movements of consignments of kept porcine animals from restricted zones I, II and III laid down in Article 15;
establishments for kept porcine animals located in restricted zones I, II and III laid down in Article 16;
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 additional general conditions referred to 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:
the kept porcine animals need to be moved to another slaughterhouse due to exceptional circumstances, such as a major breakdown in the slaughterhouse;
the slaughterhouse of destination is located either:
in restricted zones I, II or III of the same Member State; or
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;
the movement is authorised by the competent authority of the Member State concerned.
Article 15
Additional general conditions related to movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones
The competent authority of the Member State concerned shall authorise movements of porcine animals kept in restricted zones I, II and III outside those zones in the cases covered by Articles 22 to 25 and 28 to 30 under the specific conditions provided for in those Articles provided that:
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 restricted zones II and III into either:
that establishment; or
the epidemiological unit where the porcine animals to be moved were kept completely separated. The competent authority 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;
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:
by an official veterinarian;
within the period of last 24 hours prior to the time of movement of the consignment of porcine animals or prior to the time of the collection of germinal products; and
in accordance with Article 3(1) and (2) of Delegated Regulation (EU) 2020/687 and point A.1 of Annex I thereto.
if necessary, following the instructions of the competent authority, pathogen identification tests have been carried prior to the date of the movement of the consignment from the establishment of dispatch or prior to the date of the collection of germinal products:
following the clinical examination referred to in point (b) for porcine animals kept in the establishment, including those animals to be moved or to be used for the collection of germinal products; and
in accordance with point A.2 of Annex I to Delegated Regulation (EU) 2020/687.
The competent authority of a 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 outside those zones to establishments located within the same Member State concerned, the clinical examination referred to in paragraph (1)(b):
shall be carried out only for animals to be moved; or
does not have to be carried out, provided that:
the establishment of dispatch have been visited by an official veterinarian with a frequency referred to in Article 16(a)(i) and with a favourable outcome of all the visits by an official veterinarian during a period of at least 12 months before the date of movement, indicating that:
the continuous surveillance referred to in Article 16(c) has been in place in the establishment of dispatch during a period of at least 12 months before the date of movement.
Article 16
Additional general conditions related to establishments of kept porcine animals located in restricted zones I, II and III
The competent authority of the Member State concerned shall only authorise movements of porcine animals kept in establishments located in restricted zones I, II and III outside those zones in the cases covered by Articles 22 to 25 and 28 to 30 and under the specific conditions provided for in those Articles provided that:
the establishment of dispatch has been visited by an official veterinarian at least once after the listing of the restricted zones I, II and III in Annex I to this Regulation or during a period of the last three months prior to the movement, and is subject to regular visits by official veterinarians as provided for in Article 26(2) of Delegated Regulation (EU) 2020/687 as follows:
in the restricted zones I and II: at least twice a year, with an interval of at least four months between such visits;
in the restricted zone III: at least once every three months.
The competent authority may decide to carry out visits to the establishment in restricted zone III with a frequency referred to in paragraph (a)(i) based on the favourable outcome of the last visit after the listing of the restricted zones I, II and III in Annex I to this Regulation or during a period of the last three months prior to the movement indicating that the biosecurity requirements referred to in paragraph (b) are implemented and the continuous surveillance referred to in paragraph (c) is in place in that establishment.
the establishment of dispatch implements biosecurity requirements for African swine fever:
in accordance with the reinforced biosecurity measures set out in Annex II; and
as established by the Member State concerned;
continuous surveillance by means of testing with pathogen identification tests for African swine fever is carried out in the establishment of dispatch:
in accordance with Article 3(2) of Delegated Regulation (EU) 2020/687 and Annex I thereto;
with negative results each week on at least the first two dead kept porcine animals over the age of 60 days or, in the absence of such dead animals over the age of 60 days, on any dead kept porcine animals after weaning, in each epidemiological unit;
at least during the monitoring period for African swine fever set out in Annex II to Delegated Regulation (EU) 2020/687 before the movement of the consignment from the establishment of dispatch.
The competent authority of the Member State concerned may decide that the stock-proof fencing provided for in point (2)(h) of Annex II referred to in paragraph (1)(b)(i) of this Article shall not be required for establishments of kept porcine animals for a period of three months after a confirmation of a first outbreak of African swine fever in that Member State provided that:
the competent authority of the Member State has assessed the risks deriving from such decision and that assessment indicates that the risk of the spread of African swine fever is negligible;
an alternative system is in place ensuring that porcine animals kept in establishments are separated from wild porcine animals in Member States where the population of wild porcine animals is present;
kept porcine animals from those establishments are not moved to another Member States.
Article 17
Additional general conditions related to the means of transport used for the transportation of porcine animals kept in restricted zones I, II and III outside those zones
The competent authority of the Member State concerned shall only authorise movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones if the means of transport used for transportation of those consignments:
comply with requirements laid down in Article 24(1) of Delegated Regulation (EU) 2020/687; and
are cleaned and disinfected in accordance with Article 24(2) of Delegated Regulation (EU) 2020/687 under the control or supervision of the competent authority of the Member State concerned.
SECTION 3
Obligations on operators with regard to animal health certificates
Article 18
Operators’ obligations with regard to animal health certificates for movements of consignments of porcine animals kept in restricted zones I, II and III outside those zones
Operators shall only move consignments of porcine animals kept in restricted zones I, II and III outside those zones within the Member State concerned or to another Member State in cases covered by Articles 22 to 25 and 28 to 30 if those consignments are accompanied by an animal health certificate as provided for in Article 143(1) of Regulation (EU) 2016/429 that contains at least one of the following attestations of compliance with the requirements provided for in this Regulation:
‘Porcine animals kept in restricted zone I in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’;
‘Porcine animals kept in restricted zone II in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’;
‘Porcine animals kept in restricted zone III in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’;
However, in the case of movements within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in second subparagraph of Article 143(2) of Regulation (EU) 2016/429.
Article 19
Operators’ obligations with regard to animal health certificates for movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals from restricted zones I, II and III
Operators shall only move consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones I and II outside those zones within the same Member State concerned or to another Member State in cases covered by Articles 38 and 39, if those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains:
the information required in accordance with Article 3 of Delegated Regulation (EU) 2020/2154; and
at least one of the following attestations of compliance with the requirements provided for in this Regulation:
‘Fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone I in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’;
‘Fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’
Operators shall only move consignments of processed meat products, including casings, obtained from porcine animals kept in restricted zones I, II and III outside those zones within the same Member State concerned or to another Member State provided that:
products of animal origin have undergone the relevant risk-mitigating treatment set out in Annex VII to Delegated Regulation (EU) 2020/687;
those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains:
the information required in accordance with Article 3 of Delegated Regulation (EU) 2020/2154; and
the following attestation of compliance with the requirements provided for in this Regulation:
‘Processed meat products, including casings, obtained from porcine animals kept in restricted zones I, II and III in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’
Operators shall only move consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and slaughtered in slaughterhouses located in restricted zones I, II and III outside those zones within the same Member State concerned or to another Member State, if those consignments are accompanied by:
an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains the information required in accordance with Article 3 of Delegated Regulation (EU) 2020/2154; and
the following attestation of compliance with the requirements provided for in this Regulation:
‘Fresh meat and meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and slaughtered in restricted zones I, II and III in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’
Operators shall only move consignments of meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and processed in restricted zones I, II and III outside those zones within the same Member State concerned or to another Member State if those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains:
the information required in accordance with Article 3 of Delegated Regulation (EU) 2020/2154; and
the following attestation of compliance with the requirements provided for in this Regulation:
‘Meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and processed in restricted zones I, II and III in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’
The competent authority of the Member State concerned may decide that a health mark or, where relevant, an identification mark provided for in point (b) of Article 5(1) of Regulation (EC) No 853/2004 applied on the fresh or processed meat, meat products, including casings, in establishments designated in accordance with Article 41(1) of this Regulation or establishments which handle fresh or processed meat, meat products, including casings, obtained from porcine animals kept in restricted zone I or areas outside restricted zones I, II and III, can substitute the animal health certificate for movements of the following consignments of:
the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones I and II outside those zones within the same Member State concerned or to another Member State, as laid down in paragraph 1;
the processed meat products, including casings, obtained from porcine animals kept in restricted zones I and II outside those zones within the same Member State concerned or to another Member State, as laid down in paragraph 2;
the fresh meat and meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and slaughtered in slaughterhouses located in restricted zones I, II and III outside those zones within the same Member State concerned or to another Member State, as laid down in paragraph 3;
the processed meat products, including casings, obtained from porcine animals kept in areas outside restricted zones I, II and III and processed in restricted zones I, II and III outside those zones within the same Member State concerned or to another Member State, as laid down in paragraph 4.
Article 20
Operators’ obligations with regard to animal health certificates for movements of consignments of germinal products obtained from porcine animals kept in establishments located in restricted zones II and III outside those zones
Operators shall only move consignments of germinal products obtained from porcine animals kept in restricted zones II and III outside those zones within the same Member State concerned or to another Member State in cases covered by Articles 31 and 32, if those consignments are accompanied by an animal health certificate as provided for in Article 161(1) of Regulation (EU) 2016/429 that contains at least one of the following attestations of compliance with the requirements provided for in this Regulation:
‘Germinal products obtained from porcine animals kept in restricted zones II in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’;
‘Germinal products obtained from porcine animals kept in restricted zone III in compliance with the special control measures relating to African swine fever laid down in Commission Implementing Regulation (EU) 2021/605.’.
However, in the case of movements within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in second subparagraph of Article 161(2) of Regulation (EU) 2016/429.
Article 21
Operators’ obligations with regard to animal health certificates for movements of consignments of Category 2 and 3 materials obtained from porcine animals kept in restricted zones II and III outside those zones
Operators shall only move consignments of Category 2 and 3 materials obtained from porcine animals kept in restricted zones II and III outside those zones within the same Member State concerned or to another Member State in cases covered by Articles 33 to 37, if those consignments are accompanied by:
the commercial document referred to in Chapter III of Annex VIII to Commission Regulation (EU) No 142/2011; and
an animal health certificate referred to in Article 22(5) of Regulation (EU) 2020/687;
However, in the case of movements within the same Member State concerned, the competent authority may decide that an animal health certificate shall not be issued as referred to in Article 22(6) of Regulation (EU) 2020/687.
SECTION 4
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone I outside that zone
Article 22
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone I outside that zone
By way of derogation from the prohibition provided for in Article 9(1), the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zone I outside that zone to:
an establishment located in the territory of the same Member State concerned:
in another restricted zone I;
in restricted zones II and III;
outside the restricted zones I, II and III;
an establishment located in the territory of another Member State;
third countries.
The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687;
the additional general conditions laid down in Article 14(2) and Articles Article 15(1)(b)(c), (2) and (3), and Articles 16 and 17.
SECTION 5
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone II outside that zone
Article 23
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone II outside that zone in the territory of the same Member State concerned
By way of derogation from the prohibition provided for in Article 9, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zone II outside that zone to an establishment located in the territory of the same Member State concerned:
in another restricted zone II;
in restricted zones I and III;
outside the restricted zones I, II and III.
The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687;
the additional general conditions laid down in Article 14(2) and Articles 15, 16 and 17.
Article 24
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone II outside that zone to a slaughterhouse located in the territory of the same Member State concerned for the purpose of immediate slaughter
By way of derogation from the prohibition provided for in Article 9, the competent authority of the Member State concerned may authorise movements of consignments of porcine animals kept in restricted zone II outside that zone to a slaughterhouse located in the territory of the same Member State concerned, provided that:
the kept porcine animals are moved for the purpose of immediate slaughter;
the slaughterhouse of destination is designated in accordance with Article 41(1).
The competent authority shall only grant the authorisations provided for in paragraph 1 subject to compliance with:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687;
the additional general conditions laid down in Article 14(2), Article 15(1)(b)(c), (2) and (3), and Articles 16 and 17.
Article 25
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone II outside that zone to restricted zones II or III in another Member State
The competent authority shall only grant the authorisations provided for in paragraph 1 provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Article 14(2) and Articles 15, 16 and 17 are met;
a channelling procedure has been set up in accordance with Article 26;
the kept porcine animals comply with any other additional appropriate guarantees related to African swine fever based on a positive outcome of a risk assessment of the measures against the spread of that disease:
required by the competent authority of the establishment of dispatch;
approved by the competent authorities of the Member States of passage and of the establishment of destination, prior to the movement of the kept porcine animals;
no outbreak of African swine fever has been officially confirmed in kept porcine animals in accordance with Article 11 of Delegated Regulation (EU) 2020/687 during a period of at least past 12 months in the establishment of dispatch;
the operator has notified the competent authority in advance of the intention to move the consignment of kept porcine animals in accordance with point (b) of Article 152 of Regulation (EU) 2016/429 and Article 96 of Delegated Regulation (EU) 2020/688.
The competent authority of the establishment of dispatch shall:
draw up a list of establishments that comply with the guarantees referred to in paragraph 2(d);
immediately inform the Commission and the other Member States of the guarantees provided for in paragraph (2)(d) and of the approval by the competent authorities provided for in the paragraph 2(d)(ii).
Article 26
Specific channelling procedure for granting derogations for movements of consignments of porcine animals kept in restricted zone II outside that zone to restricted zones II or III in another Member State
The competent authority of the Member State concerned shall set up a channelling procedure as provided for in Article 25(2)(c) for movements of consignments of porcine animals kept in restricted zone II outside that zone to an establishment located in restricted zones II or III in another Member State under the control of the competent authorities of:
the establishment of dispatch;
passage;
the establishment of destination.
The competent authority of the establishment of dispatch shall:
ensure that each means of transport used for movements referred to in paragraph 1 are:
individually accompanied by a satellite navigation system to determine, transmit and record its real time location;
sealed by an official veterinarian immediately after the loading of the consignment of kept porcine animals; only an official veterinarian or enforcement authority of the Member State concerned, as agreed with the competent authority, may break the seal and replace it with a new one, where relevant.
inform in advance the competent authority of the place of the establishment of destination and, where relevant, the competent authority of the place of passage, of the intention to send the consignment of kept porcine animals;
set up a system whereby operators are required to immediately notify the competent authority of the place of the establishment of dispatch of any accident or breakdown of any means of transport used in the transportation of the consignment of kept porcine animals;
ensure the establishment of an emergency plan, the chain of command and the necessary arrangements for cooperation between the competent authorities referred to in paragraph 1(a), (b) and (c) in the event of possible accidents during the transport, any major breakdown or any fraudulent action by operators.
Article 27
Obligations on the competent authority of the Member State concerned of the place of the establishment of destinations for consignments of porcine animals kept in restricted zone II of another Member State
The competent authority of the Member State concerned of the place of the establishment of destinations for consignments of porcine animals kept in restricted zone II of another Member State shall:
notify without undue delay the competent authority of the establishment of dispatch of the arrival of the consignment;
ensure that kept porcine animals either:
remain in the establishment of destination for at least the monitoring period for African swine fever set out in Annex II to Delegated Regulation (EU) 2020/687; or
are moved directly to a slaughterhouse designated in accordance with Article 41(1) of this Regulation.
SECTION 6
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone III outside that zone
Article 28
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone III outside that zone to a restricted zone II in the same Member State concerned
By way of derogation from the prohibition provided for in Article 9, in exceptional circumstances, where as a result of that prohibition animal welfare problems arise in an establishment where porcine animals are kept, the competent authority of the Member State concerned may authorise movements of porcine animals kept in restricted zone III outside that zone to an establishment located in restricted zone II in the territory of the same Member State provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Article 14(2), Articles 15, 16 and 17 are met;
the establishment of destination belongs to the same supply chain and kept porcine animals are to be moved to complete the production cycle.
Article 29
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zone III outside that zone for immediate slaughter in the same Member State concerned
By way of derogation from the prohibition provided for in Article 9, in exceptional circumstances, where as a result of prohibition referred to in Article 5(1) animal welfare problems arise in an establishment where porcine animals are kept, and in the case of logistic limitations in the slaughter capacity of the slaughterhouses located in the restricted zone III and designated in accordance with Article 41(1) or in the absence of the designated slaughterhouse in the restricted zone III, the competent authority of the Member State concerned may authorise for the purpose of immediate slaughter movements of porcine animals kept in restricted zone III outside that zone to a slaughterhouse designated in accordance with Article 41(1) in the same Member State as near as possible to the establishment of dispatch located:
in a restricted zone II;
in a restricted zone I, where it is not possible to slaughter the animals in the restricted zone II;
outside of restricted zones I, II and III, where it is not possible to slaughter the animals in the restricted zones III, II and I.
The competent authority of the Member State concerned shall only grant an authorisation provided for in paragraph 1 provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Article 14(2) and Articles 15(1)(b)(c) and (2), 16 and 17 are met;
The competent authority of the Member State concerned shall ensure that:
the kept porcine animals are destined for immediate slaughter directly to a slaughterhouse designated in accordance with Article 41(1);
on arrival at the designated slaughterhouse, the porcine animals from restricted zone III are kept separately from other porcine animals and are slaughtered either;
on a specific day when only porcine animals from restricted zone III are slaughtered; or
at the end of a slaughter day thereby ensuring that other kept porcine animals are not slaughtered thereafter;
after the slaughtering of the porcine animals from restricted zone III, and before the slaughtering of other kept porcine animals starts, the slaughterhouse must be cleaned and disinfected in accordance with the instructions of the competent authority of the Member State concerned.
The competent authority of the Member State concerned shall ensure that:
animal by-products obtained from porcine animals kept in restricted zone III and moved outside that zone are processed or disposed in accordance with Articles 33 and 36;
fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone III and moved outside restricted zone III are processed and stored in accordance with Article 40.
SECTION 7
Specific conditions for derogations authorising movements of porcine animals kept in restricted zones I, II and III outside those zones to an animal by-products approved plant
Article 30
Specific conditions for derogations authorising movements of consignments of porcine animals kept in restricted zones I, II and III to an animal by-products approved plant located outside restricted zones I, II and III situated within the same Member State concerned
By way of derogation from the prohibitions provided for in Article 9, the competent authority of the Member State concerned may authorise movements of porcine animals kept in restricted zones I, II and III to an animal by-products approved plant located outside restricted zones I, II and III situated within the same Member State concerned in which:
the kept porcine animals are immediately killed; and
the resulting animal by-products are disposed in accordance with Regulation (EC) No 1069/2009.
The competent authority of the Member State concerned shall only grant an authorisation provided for in paragraph 1 provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Articles 14(2) and 17 are met.
SECTION 8
Specific conditions for authorising movements of consignments of germinal products obtained from porcine animals kept in restricted zone II outside that zone
Article 31
Specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in restricted zone II from that zone in the territory of the same Member State concerned
By way of derogation from the prohibition provided for in Article 10, the competent authority of the Member State concerned may authorise movements of consignments of germinal products from germinal product establishment located in restricted zone II to another restricted zone II and restricted zones I and III or to areas outside restricted zones I, II and III in the territory of the same Member State provided that:
the germinal products were collected or produced, processed and stored in establishments and were obtained from kept porcine animals that comply with conditions laid down in Article 15(1)(b)(c) and (2) and Article 16;
the donor males and donor females of the porcine animals were kept at germinal product establishments where no other kept porcine animals were introduced from restricted zones II and III during a period of at least 30 days prior to the date of the collection or production of germinal products.
Article 32
Specific conditions for derogations authorising movements of consignments of germinal products obtained from porcine animals kept in restricted zone II from that zone to restricted zones II and III in another Member State
By way of derogation from the prohibition provided for in Article 10, the competent authority of the Member State concerned may authorise movements of consignments of germinal products obtained from porcine animals kept in restricted zone II from an approved germinal product establishment located in restricted zone II to restricted zones II and III in the territory of another Member State concerned provided that:
the germinal products were collected or produced, processed and stored at germinal product establishments under the conditions laid down in Article 15(1)(b)(c) and (2) and Article 16;
the donor males and donor females of the porcine animals were kept in approved germinal product establishments where no other kept porcine animals were introduced from restricted zones II and III during a period of at least 30 days prior to the date of the collection or production of germinal products;
the consignments of germinal products comply with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of African swine fever:
required by the competent authorities of the establishment of dispatch;
approved by the competent authority of the Member State of the establishment of destination, prior to the movement of the germinal products.
The competent authority of the Member State concerned shall:
draw up a list of approved germinal product establishments that comply with the conditions laid down in paragraph 1 and which are authorised for movements of germinal products from restricted zone II in that Member State concerned to restricted zones II and III in another Member State concerned; that list shall contain the information required to be kept by the competent authority of the Member State concerned on approved germinal product establishments for porcine animals as laid down in Article 7 of Delegated Regulation (EU) 2020/686;
make the list provided for in point (a) available to the public on its website and keep it up-to-date;
provide the Commission and the Member States with the link to the website referred to in paragraph (b).
SECTION 9
Specific conditions for derogations authorising movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those zones
Article 33
Specific conditions for derogations authorising movements of consignments of animal by-products obtained from porcine animals kept in restricted zones II and III outside those zones within the same Member State for the purpose of processing or disposal
The transport operator responsible for the movements of animal by-products referred to in paragraph 1 shall:
enable the competent authority to control by means of a satellite navigation system the real time movement of the means of transport;
keep the electronic records of that movement for a period of at least two months from the date of movement.
The competent authority may decide that the satellite navigation system referred to in paragraph 1 shall be replaced by an individual sealing of means of transport provided that:
consignments of animal by-products obtained from porcine animals kept in restricted zones II and III are only moved within the same Member State for the uses referred to in paragraph 1;
each means of transport is sealed by an official veterinarian immediately after the loading of the consignment of animal by-products; only an official veterinarian or enforcement authority of the Member State, as agreed with the competent authority, may break the seal and replace it with a new one, where relevant.
Article 34
Specific conditions for derogations authorising movements of consignments of manure obtained from porcine animals kept in restricted zones II and III outside those zones within the same Member State
The transport operator responsible for the movements of consignments of manure, including litter and used bedding, referred to in paragraphs 1 and 2 shall:
enable the competent authority to control by means of a satellite navigation system the real time movement of the means of transport;
keep the electronic records of that movement for a period of at least two months from the date of movement.
Only an official veterinarian or enforcement authority of the Member State, as agreed with the competent authority, may break the seal and replace it with a new one, where relevant.
Article 35
Specific conditions for authorising movements of consignments of Category 3 materials obtained from porcine animals kept in restricted zones II outside those zones within the same Member State for the purpose of the processing of animal by-products referred to in Article 24(1)(a), (e) and (g) of Regulation (EC) No 1069/2009
By way of derogation from Article 11(1), the competent authority of the Member State concerned may authorise movements of consignments of Category 3 materials obtained from porcine animals kept in restricted zone II outside that zone to a plant or establishment approved by the competent authority for the purposes of further processing into processed feed, for the manufacturing of processed pet food, derived products intended for uses outside the feed chain, or transformation of animal by-products into biogas or compost as referred to in Article 24(1)(a), (e) and (g) of Regulation (EC) No 1069/2009 located outside the restricted zone II situated within the same Member States provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Articles 14(2) are met;
the Category 3 materials originate from kept porcine animals and establishments that comply with the general conditions laid down in Articles 15(1)(b)(c), (2) and (3) and Article 16;
the Category 3 materials are obtained from porcine animals kept in restricted zone II and slaughtered either:
in restricted zone II of:
or
outside restricted zone II situated in the same Member State concerned in accordance with Article 24;
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location;
the consignments of Category 3 materials are moved from the slaughterhouse designated in accordance with Article 41(1) directly to:
a processing plant for the processing of derived products referred to in Annex X to Regulation (EU) No 142/2011;
a pet food plant approved for the production of processed pet food referred to in point 3(a) and (b)(i) to (iii) of Chapter II of Annex XIII to Regulation (EU) No 142/2011;
a biogas or a compost plant approved for the transformation of animal by-products into compost or biogas in accordance with the standard transformation parameters referred to in Section 1 of Chapter III of Annex V to Regulation (EU) No 142/2011; or
a processing plant for the processing of derived products referred to in Annex XIII to Regulation (EU) No 142/2011.
The transport operator responsible for the movements of consignments of Category 3 materials shall:
enable the competent authority to control by means of a satellite navigation system the real time movement of the means of transport;
keep the electronic records of that movement for a period of at least two months from the date of movement.
The competent authority may decide that the satellite navigation system referred to in paragraph 1(e) shall be replaced by an individual sealing of means of transport provided that:
the Category 3 materials are:
obtained from porcine animals kept in restricted zones II;
only moved within the same Member State for the uses referred to in paragraph 1;
each means of transport is sealed by an official veterinarian immediately after the loading of the consignment of Category 3 materials; only an official veterinarian or enforcement authority of the Member State, as agreed with the competent authority, may break the seal and replace it with a new one, where relevant.
Article 36
Specific conditions for derogations authorising movements of consignments of Category 2 materials obtained from porcine animals kept in restricted zones II and III outside those zones for the purpose of processing and disposal in another Member States
By way of derogation from Article 11(1), the competent authority of the Member State concerned may authorise movements of consignments of animal by-products of Category 2 materials obtained from porcine animals kept in restricted zones II and III to a processing plant to be processed by methods 1 to 5, as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011, or to an incineration or co-incineration plant, as referred to in Article 24(1)(a),(b) and (c) of Regulation (EC) No 1069/2009, located in another Member States, provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Articles 14(2) are met;
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location;
The transport operator responsible for movements of consignments of Category 2 materials shall:
enable the competent authority to control by means of a satellite navigation system the real time movement of the means of transport; and
keep the electronic records of that movement for a period of at least two months from the date of movement.
Article 37
Specific conditions for derogations authorising movements of consignments of Category 3 materials obtained from porcine animals kept in restricted zone II outside that zone for further processing or transformation in another Member States
By way of derogation from Article 11(1), the competent authority of the Member State concerned may authorise movements of consignments of Category 3 materials obtained from porcine animals kept in restricted zone II outside that zone to a plant or establishment approved by the competent authority for the processing of Category 3 materials into processed feed, processed pet food, derived products intended for uses outside the feed chain, or the transformation of Category 3 materials into biogas or compost as referred to in Article 24(1)(a), (e) and (g) of Regulation (EC) No 1069/2009, located in another Member States, provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Article 14(2) are met;
the Category 3 materials originate from kept porcine animals and establishments that comply with the general conditions laid down in Articles 15(1)(b)(c), (2) and (3), and Article 16;
the Category 3 materials are obtained from porcine animals kept in restricted zone II and slaughtered either:
in restricted zone II of:
or
outside restricted zone II situated in the same Member State concerned in accordance with Article 24;
the means of transport is individually equipped with a satellite navigation system to determine, transmit and record its real time location;
the animal by-products are moved directly from the slaughterhouse designated in accordance with Article 41(1) to:
a processing plant for the processing of derived products referred to in Annexes X and XIII to Regulation (EU) No 142/2011;
a pet food plant approved for the production of processed pet food referred to in point 3(b)(i)(ii) and (iii) of Chapter II of Annex XIII to Regulation (EU) No 142/2011;
a biogas or a compost plant approved for transformation of animal by-products into compost or biogas in accordance with the standard transformation parameters referred to in Section 1 of Chapter III of Annex V to Regulation (EU) No 142/2011.
The transport operator responsible for movements of consignments of Category 3 materials shall:
enable the competent authority to control by means of a satellite navigation system the real time movement of the means of transport; and
keep the electronic records of the movement for a period of at least two months from the date of movement.
SECTION 10
Specific conditions for derogations authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those zones
Article 38
Specific conditions for authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II outside that zone in the territory of the same Member State concerned
By way of derogation from prohibitions provided for in Article 12, the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II outside that zone in the territory of the same Member State concerned, provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the fresh meat and meat products, including casings, are obtained from porcine animals kept in establishments that comply with the additional general conditions laid down in Article 14(2), Article 15(1)(b)(c), (2) and (3), and Article 16;
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 41(1).
By way of derogation from prohibitions provided for in Article 12, if conditions laid down in paragraph 1 are not met, the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II outside that zone in the territory of the same Member State concerned, provided that:
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 41(1);
the fresh meat and meat products, including casings, either
in the case of fresh meat only, are marked and moved in accordance with the specific conditions for authorising movements of fresh meat obtained from kept animals of listed species from certain establishments laid down in Article 33(2) of Delegated Regulation (EU) 2020/687 to a processing establishment to undergo one of the relevant risk-mitigating treatments set out in Annex VII thereto;
or
have been marked in accordance with Article 44 with a special health mark or, where relevant, an identification mark that is not oval and cannot be confused with the health or identification mark as referred to in points (a) and (b) of Article 5(1) of Regulation (EC) No 853/2004; and
are only intended for movement within the same Member State concerned.
Article 39
Specific conditions for derogations authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II outside that zone to other Member States and to third countries
By way of derogation from prohibitions provided for in Article 12, the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II outside that zone to other Member States and to third countries, provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Article 14(2) are met;
the fresh meat and meat products, including casings, are obtained from porcine animals kept in establishments that comply with the general conditions laid down in Articles 15 and 16;
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 41(1).
Article 40
Specific conditions for derogations authorising movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone III to other restricted zones I, II and III or areas outside restricted zones I, II and III in the territory of the same Member State
By way of derogation from prohibitions provided for in Article 12, the competent authority of the Member State concerned may authorise movements of consignments of fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone III to other restricted zones I, II and III or areas outside restricted zones I, II and III in the territory of the same Member State, provided that:
the general conditions laid down in Article 28(2) to (7) of Delegated Regulation (EU) 2020/687 are met;
the additional general conditions laid down in Article 14(2) are met;
the fresh meat and meat products, including casings, are obtained from porcine animals:
kept in establishments that comply with the general conditions laid down in Articles 15 and 16; and
slaughtered:
the fresh meat and meat products, including casings, have been produced in establishments designated in accordance with Article 41(1); and either
in the case of fresh meat only, are marked and moved in accordance with the specific conditions for authorising movements of fresh meat obtained from kept animals of listed species from certain establishments laid down in Article 33(2) of Delegated Regulation (EU) 2020/687 to a processing establishment to undergo one of the relevant risk-mitigating treatments set out in Annex VII thereto;
or
have been marked in accordance with Article 44 with a special health mark or, where relevant, an identification mark that is not oval and cannot be confused with the health or identification mark as referred to in points (a) and (b) of Article 5(1) of Regulation (EC) No 853/2004; and
are only intended for movement within the same Member State concerned.
CHAPTER IV
SPECIAL RISK-MITIGATING MEASURES CONCERNING AFRICAN SWINE FEVER FOR FOOD BUSINESSES IN THE MEMBER STATES CONCERNED
Article 41
Special designation of slaughterhouses, cutting plants, cold stores, meat processing and game handling establishments
The competent authority of the Member State concerned shall, following an application by a food business operator, designate establishments for:
the immediate slaughter of kept porcine animals from restricted zones II and III:
within those restricted zones II and III;
outside those restricted zones II and III, as referred to in Articles 24 and 29;
the cutting, processing and storage of the fresh meat and meat products, including casings, from porcine animals kept in restricted zones II and III as referred to in Articles 38, 39 and 40;
the preparation of game meat as referred to in point 1(1.18) of Annex I to Regulation (EC) No 853/2004 and the processing and storage of the fresh meat and meat products from wild porcine animals obtained in restricted zones I, II and III as provided for in Articles 48 and 49 of this Regulation;
the preparation of game meat as referred to in point 1(1.18) of Annex I to Regulation (EC) No 853/2004 and the processing and storage of the fresh meat and meat products from wild porcine animals, if those establishments are located in restricted zones I, II and III as provided for in Articles 48 and 49 of this Regulation.
The competent authority may decide that the designation referred to in paragraph 1 shall not be required for establishments processing, cutting and storing fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III and from wild porcine animals obtained in the restricted zones I, II and III, and establishment referred to in paragraph 1(d), provided that:
the fresh meat and meat products, including casings, of porcine origin are marked with a special health mark or, where relevant, an identification mark referred to in Article 44 in those establishment;
the fresh meat and meat products, including casings, of porcine origin from those establishment are only intended for the same Member State concerned;
animal by-products of porcine origin from those establishments are only processed or disposed of in accordance with Article 33 within the same Member State.
The competent authority of the Member State concerned shall:
provide the Commission and other Member States with a link to the website of the competent authority with a list of designated establishments and their activities referred to in paragraph 1;
keep the list provided for in paragraph (a) updated.
Article 42
Special conditions for the designation of establishments for the immediate slaughter of porcine animals kept in restricted zone II and III
The competent authority of the Member State concerned shall only designate establishments for the immediate slaughter of porcine animals kept in restricted zone II and III, provided that:
the slaughtering of porcine animals kept outside restricted zones II and III and of porcine animals kept in the restricted zones II and III that are subject to authorised movements provided for in Articles 24 and 29 and the production and storage of products thereof are carried out separately from the slaughtering of porcine animals kept in restricted zones I, II and III and from the production and storage of products thereof that do not comply with relevant:
additional general conditions laid down in Articles 15, 16 and 17; and
specific conditions provided for in Articles 24 and 29;
the operator of the establishment has in place documented instructions or procedures approved by the competent authority of the Member State concerned to ensure that the conditions laid down in paragraph (a) are met.
Article 43
Special conditions for the designation of establishments for cutting, processing and storing of the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III
The competent authority of the Member State concerned shall only designate establishments for the cutting, processing and storing of the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III subject to authorised movement provided for in Articles 38, 39 and 40, provided that:
the cutting, processing and storing of the fresh meat and meat products, including casings, obtained from porcine animals kept outside restricted zones II and III and from porcine animals kept in restricted zones II and III are carried out separately from fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zones II and III that do not comply with:
additional general conditions laid down in Articles 15, 16 and 17; and
specific conditions provided for in Articles 38, 39 and 40;
the operator of the establishment has in place documented instructions or procedures approved by the competent authority of the Member State concerned to ensure that the conditions laid down in paragraph (a) are met.
Article 44
Special health or identification marks
The competent authority of the Member States concerned shall ensure that the following products of animal origin are marked with a special health mark or, where relevant, an identification mark that is not oval and cannot be confused with the health mark or identification mark provided for in Article 5(1) of Regulation (EC) No 853/2004:
the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone III, as laid down in Article 40(d)(ii);
the fresh meat and meat products, including casings, obtained from porcine animals kept in restricted zone II, if the specific conditions for authorising movements of those consignments outside restricted zone II provided for in Article 38(1) are not met, as laid down in accordance with Article 38(2)(b)(ii):
the fresh meat and meat products from wild porcine animals moved within restricted zone I or outside that zone from the establishment designated in accordance with Article 41(1), as laid down in the first indent of Article 49(1)(c)(iii).
CHAPTER V
SPECIAL DISEASE CONTROL MEASURES APPLICABLE TO WILD PORCINE ANIMALS IN THE MEMBER STATES
Article 45
Specific prohibitions in relation to the movements of wild porcine animals
The competent authorities of all Member States shall prohibit movements of wild porcine animals by operators as provided for in Article 101 of Delegated Regulation (EU) 2020/688:
within the whole territory of the Member State;
from the whole territory of the Member State to:
other Member States; and
third countries.
Article 46
Specific prohibitions in relation to movements within restricted zones I, II and III and from those zones of fresh meat, meat products and any other products of animal origin, animal by-products and derived products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption
The competent authorities of the Member States concerned shall prohibit movements within restricted zones I, II and III and from those zones of fresh meat, meat products and any other products of animal origin, animal by-products and derived products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption:
for private domestic use;
linked to the activities of hunters who supply small quantities of wild porcine game or wild game meat of porcine origin directly to the final consumer or to local retail establishments directly supplying the final consumer, as provided for in Article 1(3)(e) of Regulation (EC) No 853/2004.
Article 47
General prohibitions in relation to movements of consignments of products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, considering 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 fresh meat, meat products and any other products obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, if the competent authority considers that there is a risk for the spread of African swine fever to, from or through those wild porcine animals or products thereof.
Article 48
Specific conditions for derogations authorising movements within restricted zones I, II and III and from those zones of consignments of processed meat products obtained from wild porcine animals
By way of derogation from the prohibition provided for in Article 46(1), the competent authority of the Member State concerned may authorise movements within restricted zones I, II and III and from those zones of consignments of processed meat products obtained from wild porcine animals from establishment located in restricted zones I, II and III to:
other restricted zones I, II and III situated in the same Member State concerned;
areas outside restricted zones I, II and III of the same Member State concerned; and
to other Member States and to third countries.
The competent authority of the Member State concerned shall only authorise movements of consignments of processed meat products obtained from wild porcine animals from establishments located in restricted zone I, II and III referred to in paragraph 1 provided that:
pathogen identification tests for African swine fever have been carried out for each wild porcine animal used for the production and processing of meat products in restricted zone I, II and III;
the competent authority obtained negative results of the pathogen identification tests for African swine fever referred to in point (a) before the treatment referred to in point (c)(ii);
meat products from wild porcine animals:
were produced, processed and stored in establishments designated in accordance with Article 41(1); and
have undergone the relevant risk-mitigating treatment for products of animal origin from restricted zones in accordance with Annex VII to Delegated Regulation (EU) 2020/687, as regards African swine fever.
Article 49
Specific conditions for derogations authorising movements within restricted zones I, II and III and from restricted zone I of fresh meat, meat products and any other products of animal origin obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption
By way of derogation from the prohibitions provided for in Article 46(1) and (2), the competent authority of the Member State concerned may authorise movements within restricted zone I and from that zone of the fresh meat, meat products and any other products of animal origin obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, to other restricted zones I, II and III or to areas outside restricted zones I, II and III of the same Member State, provided that:
pathogen identification tests for African swine fever have been carried out for every relevant wild porcine animal before the movement of the fresh meat, meat products and any other products of animal origin from that wild porcine animals;
the competent authority of the Member State concerned obtained negative results for the pathogen identification tests for African swine fever referred to in point (a) before the movement;
the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, are moved within or outside restricted zone I within the same Member State:
for private domestic use; or
linked to the activities of hunters who supply small quantities of wild porcine game or wild game meat of porcine origin directly to the final consumer or to local retail establishments directly supplying the final consumer, as provided for in Article 1(3)(e) of Regulation (EC) No 853/2004; or
from the establishment designated in accordance with Article 41(1) where the fresh meat and meat products have been marked either:
By way of derogation from the prohibitions provided for in Article 46(2), the competent authority of the Member State concerned may authorise movements of the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, within restricted zones II and III of the same Member State, provided that:
pathogen identification tests for African swine fever have been carried out for every relevant wild porcine animal before the movement of the fresh meat, meat products and any other products of animal origin from that wild porcine or body of that wild porcine animal, which is intended for human consumption;
the competent authority of the Member State concerned obtained negative results for the pathogen identification tests for African swine fever referred to in point (a) before the movement;
the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, are moved within restricted zones II and III within the same Member State for:
private domestic use;
or
in accordance with Article 33(2) of Delegated Regulation (EU) 2020/687 are moved to a processing establishment to undergo one of the relevant risk-mitigating treatments set out in Annex VII thereto.
Article 50
Operators’ obligations with regard to animal health certificates for consignments of fresh meat, meat products and any other products of animal origin, obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption, for movements outside restricted zones I, II and III
Operators shall only move outside restricted zones I, II and III the consignments of fresh meat, meat products, and any other products of animal origin obtained from wild porcine animals and bodies of wild porcine animals, which are intended for human consumption:
in cases covered by Articles 48 and 49; and
if those consignments are accompanied by an animal health certificate as provided for in Article 167(1) of Regulation (EU) 2016/429 that contains:
the information required in accordance with Article 3 of Delegated Regulation (EU) 2020/2154; and
at least one of the following attestations of compliance with the requirements provided for in this Regulation:
However, in the case of movement within the same Member State concerned, the competent authority may decide that an animal health certificate does not have to be issued as referred to in first subparagraph of Article 167(1) of Regulation (EU) 2016/429.
Article 51
Specific conditions for authorising movements within restricted zones I, II and III and outside those zones of consignments of animal by products and derived products from wild porcine animals
By way of derogation from prohibitions laid down in Article 46(1), the competent authority of the Member State concerned may authorise movements within restricted zones I, II and III and outside those zones of consignments of animal by-products from wild porcine animals to other restricted zones I, II and III and to areas outside restricted zones I, II and III of the same Member State provided that:
the animal by-products are collected, transported and disposed of in accordance with Regulation (EC) No 1069/2009;
for the movements outside restricted zones I, II and III, the means of transport are individually equipped with a satellite navigation system to determine, transmit and record its real time location. The transport operator shall enable the competent authority to control the real time movement of the means of transport and keep the electronic records of the movement for a period of at least two months from the time of the movement of the consignment.
Article 52
Operators’ obligations with regard to animal health certificates for movements of consignments of animal by-products from wild porcine animals outside restricted zones I, II and III in the territory of the same Member State concerned
Operators shall only move consignments of animal by-products from wild porcine animals outside restricted zones I, II and III within the same Member State concerned in case referred to in Article 51(2), if those consignments are accompanied by:
a commercial document referred to in Chapter III of Annex VIII to Commission Regulation (EU) No 142/2011; and
an animal health certificate referred to in Article 22(5) of Regulation (EU) 2020/687;
However, the competent authority of the Member State concerned may decide that an animal health certificate shall not be issued as referred to in Article 22(6) of Regulation (EU) 2020/687.
CHAPTER VI
SPECIAL INFORMATION AND TRAINING OBLIGATIONS IN THE MEMBER STATES
Article 53
Special information obligations of the Member States concerned
For that purpose, the Member States concerned shall organise and carry out regular public awareness campaigns to promote and spread information on the special disease control measures laid down in this Regulation.
The Member States concerned shall inform the Commission and the other Member States in the framework of the Standing Committee on Plants, Animals, Food and Feed, of the following:
changes in the epidemiological situation as regards African swine fever in their territory;
results of surveillance for African swine fever carried out in restricted zones I, II and III and areas outside restricted zones I, II and III in kept and wild porcine animals;
other measures and initiatives taken to prevent, control and eradicate African swine fever.
Article 54
Special trainings obligations of the Member States concerned
The Member States concerned shall organise and carry out regularly or at appropriate intervals specific trainings about the risks of African swine fever and possible prevention, control and eradication measures for at least the following targeted groups:
veterinarians;
farmers keeping porcine animals;
hunters.
Article 55
Special information obligations of all Member States
All Member States shall ensure that:
on major land infrastructure routes, such as international communication roads and railway, and related land transport networks, appropriate information on the risks of the transmission of African swine fever and on the special disease control measures laid down in this Regulation are brought to the attention of travellers:
in a visible and prominent manner;
presented in a way that is easily understood by travellers coming from, and going to:
the necessary measures are in place to raise awareness among stakeholders active in the kept porcine animals sector including small-size establishments of the risks for the introduction of the African swine fever virus and to provide them with the most appropriate information on reinforced biosecurity measures for establishments of kept porcine animals located in the restricted zones I, II and III as provided for in Annex II, in particular the measures to be enforced in restricted zones I, II and III, by the means best suited to bringing such information to their attention.
All Member States shall raise awareness on African swine fever among:
the public as provided for in Article 15 of Regulation (EU) 2016/429;
veterinarians, farmers and hunters and provide them with the most appropriate information on risk mitigation and reinforced biosecurity measures as provided for in:
Annex II to this Regulation;
Union’s guidelines on African swine fever as agreed with the Member States at the Standing Committee on Plants, Animals, Food and Feed;
available scientific evidence provided by the European food safety authority;
the Terrestrial Animal Health Code of the World Organisation for Animal Health.
CHAPTER VII
FINAL PROVISIONS
Article 56
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 April 2021 to 20 April 2028.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
RESTRICTED ZONES
PART I
1. Germany
The following restricted zones I in Germany:
Bundesland Brandenburg:
Bundesland Sachsen:
Bundesland Mecklenburg-Vorpommern:
2. Estonia
The following restricted zones I in Estonia:
3. Greece
The following restricted zones I in Greece:
4. Latvia
The following restricted zones I in Latvia:
5. Lithuania
The following restricted zones I in Lithuania:
6. Hungary
The following restricted zones I in Hungary:
7. Poland
The following restricted zones I in Poland:
w województwie kujawsko - pomorskim:
w województwie warmińsko-mazurskim:
w województwie podlaskim:
w województwie mazowieckim:
w województwie podkarpackim:
w województwie świętokrzyskim:
w województwie łódzkim:
w województwie śląskim:
w województwie pomorskim:
w województwie lubuskim:
w województwie dolnośląskim:
w województwie wielkopolskim:
w województwie opolskim:
w województwie zachodniopomorskim:
w województwie małopolskim:
8. Slovakia
The following restricted zones I in Slovakia:
9. Italy
The following restricted zones I in Italy:
Piedmont Region:
Liguria Region:
Emilia-Romagna Region:
Lombardia Region:
PART II
1. Bulgaria
The following restricted zones II in Bulgaria:
2. Germany
The following restricted zones II in Germany:
Bundesland Brandenburg:
Bundesland Sachsen:
Bundesland Mecklenburg-Vorpommern:
3. Estonia
The following restricted zones II in Estonia:
4. Latvia
The following restricted zones II in Latvia:
5. Lithuania
The following restricted zones II in Lithuania:
6. Hungary
The following restricted zones II in Hungary:
7. Poland
The following restricted zones II in Poland:
w województwie warmińsko-mazurskim:
w województwie podlaskim:
w województwie mazowieckim:
w województwie lubelskim:
w województwie podkarpackim:
w województwie małopolskim:
w województwie pomorskim:
w województwie świętokrzyskim:
w województwie lubuskim:
w województwie dolnośląskim:
w województwie wielkopolskim:
w województwie łódzkim:
w województwie zachodniopomorskim:
w województwie opolskim:
8. Slovakia
The following restricted zones II in Slovakia:
9. Italy
The following restricted zones II in Italy:
Piedmont Region:
Piedmont Region:
Liguria Region:
PART III
1. Bulgaria
The following restricted zones III in Bulgaria:
2. Italy
The following restricted zones III in Italy:
3. Poland
The following restricted zones III in Poland:
w województwie warmińsko-mazurskim:
w województwie lubelskim:
w województwie podkarpackim:
w województwie lubuskim:
w województwie wielkopolskim:
w województwie dolnośląskim:
w województwie świętokrzyskim:
w województwie małopolskim:
4. Romania
The following restricted zones III in Romania:
5. Slovakia
The following restricted zones III in Slovakia:
ANNEX II
REINFORCED BIOSECURITY MEASURES FOR ESTABLISHMENTS OF KEPT PORCINE ANIMALS LOCATED IN RESTRICTED ZONES I, II AND III
(as referred to in Article 16(1)(b)(i))
1. The following reinforced biosecurity measures, as referred to in Article 16(1)(b)(i) shall apply to establishments of kept porcine animals located in restricted zones I, II and III situated in the Member States concerned in the case of authorised movements of consignments of:
porcine animals kept in restricted zones I, II and III outside those zones as provided for in Articles 22, 23, 24, 25, 28 and 29;
germinal products obtained from porcine animals kept in restricted zone II outside that zone as provided for in Articles 31 and 32;
animal by-products obtained from porcine animals kept in restricted zone II outside that zone as provided for in Articles 35 and 37;
fresh meat, meat products, including casings, obtained from porcine animals kept in restricted zones II and III outside those zones as provided for in Articles 38, 39 and 40.
2. The operators of establishments of kept porcine animals located in restricted zones I, II and III situated in the Member States concerned in the case of authorised movements outside those zones shall ensure that the following reinforced biosecurity measures are applied in establishments of kept porcine animals:
there must be no direct or indirect contact between kept porcine animals and at least:
other kept porcine animals from other establishments;
wild porcine animals;
appropriate hygienic measures such as a change of clothes and footwear on entering and leaving the premises where porcine animals are kept;
washing and disinfection of hands and disinfection of footwear at the entrance to the premises where porcine animals are kept;
the absence of any contact with kept porcine animals for a period of at least 48 hours after any hunting activity related to wild porcine animals or any other contact with wild porcine animals;
a prohibition on unauthorized persons or means of transport entering the establishment, including the premises, where porcine animals are kept;
adequate record-keeping of persons and means of transport accessing the establishment where the porcine animals are kept;
the premises and buildings of the establishment where porcine animals are kept must:
be built in such a way that no other animals can enter the premises and buildings or have contact with the kept porcine animals or their feed and bedding material;
allow for the washing and disinfection of hands;
allow for the cleaning and disinfection of the premises;
have appropriate changing facilities for footwear and clothes at the entrance to the premises where porcine animals are kept;
stock-proof fencing of at least the premises where the porcine animals are kept and buildings where feed and bedding are kept;
a biosecurity plan approved by the competent authority of the Member State concerned taking account of the profile of the establishment and national legislation must be in place; that biosecurity plan shall at least include:
the establishment of the ‘clean’ and ‘dirty’ areas for personnel appropriate to the farm typology, such as changing rooms, shower, dining room;
the setting up and the review, when applicable, of the logistical arrangements for the entry of new kept porcine animals into the establishment;
the procedures for the cleaning and disinfection of the facilities, transport, equipment and personnel hygiene;
rules on food for personnel on site and a prohibition on the keeping of porcine animals by the personnel, where relevant and if applicable;
dedicated recurrent awareness programme for personnel on the establishment;
the setting up and the review, when applicable, of logistical arrangements in order to ensure a proper separation between different epidemiological units and to avoid porcine animals being in contact, directly or indirectly, with animal by-products and other units;
the procedures and instructions for enforcement of biosecurity requirements during the construction or repair of the premises or buildings;
internal audit or self-evaluation for enforcing the biosecurity measures.
( 1 ) 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.