Commission Delegated Regulation (EU) 2023/361 of 28 November 2022 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases (Text with EEA relevance)

Clinical and laboratory reinforced surveillance shall be implemented in the peri-vaccination and vaccination zones to identify establishments keeping animals of listed species that had contact with the CSF virus without showing clinical signs of the disease.

When at least 30 days have passed since the completion of emergency protective vaccination, the following surveillance shall be initiated:

In the peri-vaccination zone: each establishment keeping animals of listed species shall be visited at least once by an official veterinarian who shall perform sampling for laboratory surveillance with pathogen identification tests targeted at dead kept porcine animals over the age of 60 days. In the absence of such dead animals over the age of 60 days, sampling may be performed on any kept porcine animals that died or were culled after weaning.

In the vaccination zone: each establishment where vaccination was carried out shall be visited by an official veterinarian who shall perform sampling:

• (i) from vaccinated animals of listed species for serology to assess vaccination effectiveness;

• (ii) from at least the first two dead kept porcine animals every week over the age of 60 days for pathogen identification. In the absence of such dead animals over the age of 60 days, sampling may be performed on any kept porcine animals that died or were culled after weaning.

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF CSF IS CARRIED OUT

1. Animals and products thereof subject to prohibition of movements

The following animals, germinal products and products of animal origin from establishments located in the vaccination zone, are subject to prohibition of movements outside of the vaccination zone:

• (a) vaccinated porcine animals;

• (b) semen, oocytes and embryos from donor vaccinated porcine animals;

• (c) fresh meat and meat products, including casings, obtained from vaccinated porcine animals;

2. Germinal products subject to prohibition of collection

Semen, oocytes and embryos for artificial insemination from vaccinated donor porcine animals kept in approved germinal product establishments located in the vaccination zone.

3. Conditions for granting a derogation in accordance with Article 13(2), point (b), Article 13(3), and Article 13(4)

Movements of animals and products thereof that may be authorised:

• 3.1. movements of vaccinated porcine animals, directly from the establishment of origin to:
• (a) a slaughterhouse located as close as possible to the vaccination zone, under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 29(1) and (2) of Delegated Regulation (EU) 2020/687; or
• (b) where as a result of prohibition in point 1 animal welfare problems arise in an establishment where porcine animals are kept, to an establishment as close as possible to the vaccination zone, provided that:
• (i) the general conditions laid down in Article 24, Article 28(2), (3), (4), (5) and (7) of Delegated Regulation (EU) 2020/687 are met;
• (ii) the establishment of destination belongs to the same supply chain and
• (iii) the vaccinated porcine animals are to be moved to complete the production cycle;
• (c) an animal by-product approved plant, under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 37 of Delegated Regulation (EU) 2020/687;

• 3.2. movement of fresh meat from vaccinated porcine animals in accordance with Article 33(1), point (a), of Delegated Regulation (EU) 2020/687 and meat products, including casing, if they have undergone one of the risk-mitigating treatments set out in Annex VII to Delegated Regulation (EU) 2020/687;

PART 4

WAITING PERIODS FOR CSF FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in part 3 of this Annex until:

Waiting period	Type of surveillance to be implemented to demonstrate the absence of occurrence of CSF during the waiting period
3 months after all vaccinated porcine animals have been slaughtered or killed, excluding kept porcine animals referred to in Article 13(2) of Delegated Regulation (EU) 2020/687 when there are means, validated in accordance with the Terrestrial Manual of the WOAH, of distinguishing between vaccinated and infected kept porcine animals	Clinical and laboratory surveillance (pathogen identification and antibody detection), in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex

ANNEX XIII

Highly Pathogenic Avian Influenza (HPAI)

PART 1

SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF HPAI

• 1. Size of the vaccination zone: at least 3 km radius around the affected establishments.

• 1. Size of the peri-vaccination zone: at least 7 km width from the perimeters of the vaccination zone.

• 1. Type of vaccine to be used: Vaccines that do not contain live avian influenza virus (vaccines containing live avian influenza virus, whether attenuated or not, shall not be used).

• 1. Minimum coverage: No specific conditions.

• 1. Targeted animals/species: poultry and/or captive birds kept in the establishments included in the official vaccination plan.

PART 2

SPECIFIC CONDITIONS FOR THE REINFORCED LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERIVACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF HPAI

For the purpose of the reinforced surveillance as laid down in this Part, ‘flock’ means all poultry or captive birds of the same health status kept in the same enclosure and sharing the same airspace.

Laboratory surveillance to early detect occurrence of infection with HPAI field virus shall be implemented by means of pathogen identification methods, in the vaccination and peri-vaccination zones, as follows:

• 1. In the establishments where vaccination has been carried out:
• (a) at least every three weeks, by at least sampling of all dead birds up to 15 collected from each flock within the 48 hours before the sampling. The number of sampled birds per flock, the type of birds sampled and the frequency of the sampling have to enable detection of the infection with the HPAI virus in the vaccinated flock with a probability of at least 99 % and a confidence level of at least 95 %.
• (b) by sampling all dead birds up to 15 per flock when the expected daily mortality rate for that flock is overpassed.

• 1. In the poultry establishments where vaccination has not been carried out:
• (a) by passive surveillance of Galliformes species, and
• (b) by weekly sampling of all dead birds up to 15 per flock of Anseriformes species, collected within a week.

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 in A vaccination zone where emergency protective vaccination for prevention and control of HPAI is carried out

• 1. Animals and products thereof subject to prohibition of movements: vaccinated poultry or captive birds and their products within and outside the vaccination zone.

• 1. Germinal products subject to prohibition of collection: not applicable.

• 1. Conditions for granting a derogation in accordance with Article 13(2), point (b), Article 13(3), and Article 13(4)

• Movements of vaccinated poultry or captive birds and their products within and outside the vaccination zone may be authorised only in the cases covered by and under the same general and specific conditions as those provided for in Articles 28, 29 and 30, Article 31(1) and Articles 33, 34 and 37 of Delegated Regulation (EU) 2020/687.

• After the end of the waiting period, the measures provided for in points 2 to 4 of Part 5 shall remain in place in the establishments keeping vaccinated animals, as long as they keep vaccinated animals.

PART 4

WAITING periods for HPAI FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in part 3 of this Annex until:

Waiting period	Type of surveillance to be implemented to demonstrate the absence of occurrence of HPAI during the waiting period
28 days after completion of the emergency protective vaccination or at the time of the lifting in accordance with Article 55 of Delegated Regulation 2020/687 of the restricted zones established in accordance with Article 21 of that Delegated Regulation, whichever occurred last.	Clinical and laboratory surveillance (pathogen identification), in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex.

PART 5

SPECIFIC CONDITIONS FOR PREVENTIVE VACCINATION OF HPAI

• 1. Type of vaccine to be used: Vaccines that do not contain live avian influenza virus (vaccines containing live avian influenza virus, whether attenuated or not, shall not be used).

• 1. Reinforced surveillance to be implemented in case of preventive vaccination:

• 2.1.For the purpose of the surveillance as laid down in point 2.2 and 2.3, ‘flock’ means all poultry or captive birds of the same health status kept in the same enclosure and sharing the same airspace.

• 2.2.Passive surveillance must be implemented in all the establishments where poultry or captive birds are kept in the area where preventive vaccination against HPAI has been implemented when any clinical signs or post-mortem lesions suggesting HPAI are observed or when there is a change in normal production and health parameters such as mortality rate and feed and water intake.

• 2.3.After the start of vaccination, the following active surveillance must be carried out at least every 30 days by an official veterinarian or under their responsibility in all establishments where vaccinated poultry or captive birds are kept, to detect occurrence of infection with HPAI field virus:

• (a) a clinical examination that includes a check of the production records and health records of the establishment for each flock, including an evaluation of its clinical history and clinical examinations of the poultry or captive birds;

• (b) sampling for testing by pathogen identification methods of all dead birds up to 15 per flock collected within the 48 hours before the sampling;

• (c) out of the high risk period for infection with HPAI virus, the testing required in point (b) may be carried out only in a sufficiently representative sample of establishments where vaccinated poultry or captive birds are kept;

• (d) the number of establishments sampled for the purpose of surveillance as required in point (b) and (c) and the frequency of sampling must comply with:
• (i) the following minimum requirements: Species % of vaccinated establishments to be sampled Frequency of sampling (days) Chicken layers 100 30 25 7 Ducks 100 30 50 7 Turkeys 100 30 25 7 or
• (ii) any scientifically valid sampling design that ensures with at least 95 % confidence that the population of vaccinated poultry and captive birds is free from HPAI, with at least 90 % sensitivity for early detection of infection with HPAI virus.

• 2.4.Vaccinated captive birds from confined establishments and from establishments keeping up to 50 captive birds are exempted from the surveillance requested in point 2.3, subpoints (b), (c) and (d).

• 2.5.The surveillance provided for in points 2.2 and 2.3 must remain in place in the establishments keeping vaccinated animals as long as they keep vaccinated animals. By way of derogation, in case of long living vaccinated captive birds or those from confined establishments, the surveillance provided for in points 2.2 and 2.3 must be maintained for a period of 12 months from the date when the last vaccination was applied.

• 1. Animals and products thereof subject to prohibition of movements in accordance with Article 14(1): vaccinated poultry or captive birds and hatching eggs and products of animal origin thereof.

• 1. Conditions for granting a derogation in accordance with Article 14(2), point (b)

• 4.1.Conditions for granting a derogation for movements of vaccinated poultry or captive birds including day-old chicks and hatching eggs derived from such poultry or captive birds:

• (a) They are vaccinated poultry or captive birds for which the results of the passive and active surveillance, implemented in accordance with point (2) of this Part, are negative for detection of infection with HPAI field virus, or they are day-old chicks and hatching eggs derived from such poultry or captive birds, and:
• (i) in case of poultry, these are moved to a slaughterhouse for immediate slaughter; or
• (ii) they are moved from their establishments to other establishments:
• — where vaccination is carried out; or
• — where only vaccinated poultry or captive birds are kept; or
• — where complete separation between vaccinated and non-vaccinated poultry or captive birds can be ensured; and
• (iii) the poultry or captive birds, including day-old chicks and hatching eggs derived from such poultry or captive birds, referred to in subpoints (i) and (ii) are not moved to another Member State; or

• (b) they are vaccinated captive birds from confined establishments moved to a confined establishment in another Member State provided that:
• (i) authorisation of such type of movements has been granted by the competent authority of the Member State of destination;
• (ii) within 72 hours before movement they have been subjected to a sampling for testing by pathogen identification methods with favourable results; or

• (c) they are vaccinated poultry sent for immediate slaughter to another Member State, provided that:
• (i) the surveillance applied in the establishment of origin in accordance with point (2) of this Part has favourable results;
• (ii) poultry of the consignment to be dispatched were clinically inspected with favourable results by an official veterinarian within 72 hours before the time of loading, and favourable results were obtained from testing by pathogen identification methods on samples collected from the flock of origin within 72 hours prior to the time of departure of that consignment from all up to 15 dead birds; or

• (d) they are hatching eggs derived from vaccinated poultry or captive birds:
• (i) which originate from a vaccinated breeding flock for which the passive and active surveillance in accordance with point (2) of this Part has favourable results;
• (ii) which have been disinfected before dispatch in accordance with a method approved by the competent authority;
• (iii) which are transported directly to the hatchery of destination;
• (iv) which are traceable within the hatchery;
• (v) and the movement of which, in case they are moved to another Member State, has been notified by the competent authority of the Member State of origin to the competent authority of the Member State of destination; or

• (e) they are day-old chicks derived from vaccinated poultry:
• (i) which originate from a vaccinated breeding flock for which the reinforced passive and active surveillance in accordance with point (2) of this Part has favourable results;
• (ii) which are placed in a poultry house or shed where there is no resident poultry;
• (iii) and the movement of which, in case they are moved to another Member State, has been notified by the competent authority of the Member State of origin to the competent authority of the Member State of destination.

• (f) by way of derogation from third indent of point 4.1(a)(ii), the vaccinated captive birds from confined establishments moved to another confined establishment for breeding purposes may be kept together with non-vaccinated captive birds that are part of the same breeding programme;

• 4.2.Conditions for granting a derogation for the movement of eggs for human consumption and meat derived from vaccinated poultry:

• (a) The eggs originate from a vaccinated flock for which the surveillance in point (2) of this Part has favourable results and are directly transported to:
• (i) a packing centre designated by the competent authority provided that they are packed in disposable packaging or in a packaging which can be cleaned and disinfected in such way as to inactivate the HPAI virus; or
• (ii) an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004.

• (b) The movement of meat obtained from poultry in accordance with the conditions laid down in points 4.1(a)(i), 4.1(a)(iii) and 4.1(c) may be authorized without further condition.

ANNEX XIV

Infection with Newcastle disease virus (NCD)

PART 1

SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF NCD

• 1. Size of the vaccination zone : No specific conditions.

• 1. Size of the peri-vaccination zone : No specific conditions.

• 1. Type of vaccine to be used : No specific conditions.

• 1. Minimum coverage : all poultry of the species included in the official vaccination plan or captive birds hatched in or transferred to an establishment inside the vaccination zone must be or have been vaccinated.

• 1. Targeted animals/species : Poultry and captive birds.

PART 2

SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF NCD

No specific conditions in addition to the reinforced surveillance in accordance with Article 9(1), point (c).

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF NCD IS CARRIED OUT

• 1.Animals and products subject to prohibition of movements: vaccinated poultry or captive birds and their products within and outside the vaccination zone.

• 2.Germinal products subject to prohibition of collection: not applicable.

• 3.Conditions for granting a derogation in accordance with Article 13(2), point (b), Article 13(3) and Article 13(4). Movements of animals and products thereof that may be authorised:

• Movements of vaccinated poultry or captive birds and their products within and outside the vaccination zone, only in the cases covered by, and under the same general and specific conditions as those provided for in, Articles 28, 29, 30, 31, 33, 34 and 37 of the Delegated Regulation (EU) 2020/687.

PART 4

WAITING PERIODS FOR NCD FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in Part 3 until:

Waiting period	Type of surveillance to be implemented to demonstrate the absence of occurrence of NCD during the waiting period
3 months after completion of the emergency protective vaccination or at the time of the lifting in accordance with Article 55 of Delegated Regulation 2020/687, of the restricted zones established in accordance with Article 21 of that Delegated Regulation, whichever occurred last.	Clinical and laboratory surveillance (pathogen identification and antibody detection), in accordance with Article 9(1), point (c)(ii) to (iv)

ANNEX XV

Classical swine fever (CSF) in wild porcine animals

PART 1

SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF CSF

• 1. Size of the vaccination zone:

• The competent authority shall determine the vaccination zone on the basis of:

• (a) the estimated population of wild porcine animals, its spatial distribution and the landscape structure;

• (b) the risk factors contributing to the spread of CSF, in particular, the risk of its introduction into establishments of kept porcine animals;

• (c) the sampling results.

• 1. Size of the peri-vaccination zone: No specific conditions.

• 1. Type of vaccine to be used or prioritised: Live attenuated vaccines shall be prioritised. Other vaccines may be used only for duly justified reasons.

• 1. Minimum coverage: must be adapted according to the vaccine used, to the local conditions and to the characteristics of the estimated population of wild porcine animals, its spatial distribution and the landscape structure.

• 1. Targeted animals/species: Wild porcine animals of listed species, in accordance with Implementing Regulation (EU) 2018/1882, in the vaccination zone.

• 1. Hunting and other activities likely to cause displacement of wild porcine animal populations: Must be regulated in the vaccination zone at least until the end of the waiting period provided for in part 4. Hunted wild porcine animals must be tested with pathogen identification and antibody detection tests.

PART 2

SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION ZONE DURING EMERGENCY VACCINATION FOR PREVENTION AND CONTROL OF CSF IN WILD PORCINE ANIMALS

In the vaccination zone, after completing oral immunisation, the age class of wild porcine animals that must be examined serologically to detect a new or re-emerging infection depends on the season in which vaccination was completed and the length of time since completion.

Specific surveillance shall be implemented in wild porcine animals in the vaccination zone to verify the success of the vaccination operation. This surveillance shall include reinforced laboratory surveillance to assess immunity levels and detect any virus persistence in the wild porcine animal population; this includes pathogen identification and antibody detection in all hunted, culled and found dead or sick wild porcine animals.

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF CSF IN WILD PORCINE ANIMALS IS CARRIED OUT

1. Animals subject to prohibition of movements

Wild porcine animals.

2. Products subject to prohibition of movements

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.

3. Conditions for granting a derogation in accordance with Article 13(3)

• 3.1.By way of derogation from the movement restrictions established under point 2, the competent authority may authorize the movement of fresh meat, meat products and any other products of animal origin, animal by-products and derived products within and outside the vaccination zone, provided that the following conditions are met:

• (a) a risk assessment conducted by the competent authority demonstrates that such movement does not pose a risk of spreading CSF;

• (b) bodies of wild porcine animals are tested for the presence of the CSF virus, with negative results obtained prior to any further movement for processing or treatment;

• (c) the movement of bodies of wild porcine animals to the processing and storage establishment take place under strict biosecurity measures;

• (d) the processing and storage of bodies of wild porcine animals and their derived products take place in establishments designated by the competent authority, ensuring compliance with biosecurity and CSF control measures;

• (e) either:
• (i) the products undergo the risk-mitigating treatments as set out in Annex VII to Delegated Regulation (EU) 2020/687; or
• (ii) the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals are moved within the restricted zone:
• — for private domestic use; or
• — by hunters for the supply of 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), point (e), of Regulation (EC) No 853/2004;

• 3.2.The competent authority shall document and monitor all authorized movements under this derogation and ensure compliance with the conditions set out in paragraph 3.1.

PART 4

WAITING PERIODS FOR CSF FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in part 3 of this Annex until:

Waiting period	Type of surveillance to be implemented demonstrating the absence of occurrence of CSF during the waiting period
12 months after the end date of the last vaccination campaign in wild porcine animals, and supported by the favourable conclusions of the implementation of an exit strategy that demonstrated absence of CSF virus circulation.	Clinical and laboratory surveillance (pathogen identification in wild porcine animals found dead or killed) in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex

ANNEX XVI

African swine fever (ASF) in kept porcine animals

PART 1

SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF ASF IN KEPT PORCINE ANIMALS

• 1. Size of the vaccination zone: No specific conditions.

• 1. Size of the peri-vaccination zone: No specific conditions.

• 1. Type of vaccine to be used: ASF vaccines holding a centralised marketing authorization granted by the Commission in accordance with Article 44(9)of Regulation 2019/6

• 1. Minimum coverage: Vaccine coverage must be at least 95 % of establishments in the vaccination zone representing 80 % of targeted animals in each of those establishments.

• 1. Targeted animals/species: Animals of listed species, in accordance with Implementing Regulation (EU) 2018/1882, kept in the vaccination zone.

PART 2

SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF ASF

Clinical and laboratory reinforced surveillance shall be implemented in the peri-vaccination and vaccination zones to identify establishments keeping animals of listed species that had contact with the ASF virus (ASFV) without showing clinical signs of the disease.

When at least 30 days have passed since the completion of emergency protective vaccination, the following surveillance shall be initiated:

In the peri-vaccination zone, each establishment shall be visited at least once by an official veterinarian who shall perform sampling for laboratory surveillance with pathogen identification tests targeted at dead kept porcine animals over the age of 60 days. In the absence of such dead animals over the age of 60 days, sampling may be performed on any kept porcine animals that died or were culled after weaning.

In the vaccination zone, each establishment where vaccination was carried out shall be visited by an official veterinarian who shall perform sampling:

• (i) for serology from vaccinated animals of listed species to assess vaccination effectiveness.

• (ii) for pathogen identification from at least the first two dead kept porcine animals every week over the age of 60 days. In the absence of such dead animals over the age of 60 days, sampling may be performed on any kept porcine animals that died or were culled after weaning.

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF ASF IS CARRIED OUT

1. Animals and products thereof subject to prohibition of movements

The following animals, germinal products and products of animal origin from establishments located in the vaccination zone, within and outside of the vaccination zone:

• (a) kept porcine animals;

• (b) semen, oocytes and embryos from donor kept porcine animals;

• (c) fresh meat and meat products, including casings, obtained from kept porcine animals.

2. Germinal products subject to prohibition of collection

Semen, oocytes and embryos for artificial insemination from vaccinated donor porcine animals kept in approved germinal product establishments located in the vaccination zone.

3. Conditions for granting a derogation in accordance with Article 13(2), point (b), Article 13(3), and Article 13(4)

Movements of animals and products thereof that may be authorised:

• 3.1.movements of kept porcine animals, directly from the establishment of origin in the vaccination zone:

• (a) to a slaughterhouse for immediate slaughter located in the vaccination zone; or

• (b) to a slaughterhouse for immediate slaughter located as close as possible to the vaccination zone, in the same Member State, under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 29(1) and (2) of Delegated Regulation (EU) 2020/687;

• (c) to an animal by-products approved plant for killing and disposal, under the same conditions as those provided for in Article 24, Article 28(2), (3), (4), (5) and (7) and Article 37 of Delegated Regulation (EU) 2020/687;

• 3.2.movement of fresh meat from kept porcine animals in accordance with the provisions of Article 33(1), point (a), of Delegated Regulation (EU) 2020/687 and of meat products from kept porcine animals, including casings, if they have undergone one of the risk-mitigating treatment set out in Annex VII to Delegated Regulation (EU) 2020/687.

PART 4

WAITING PERIODS FOR ASF FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in part 3 of this Annex until:

Waiting period	Type of surveillance to be implemented demonstrating the absence of occurrence of ASF during the waiting period
3 months after all vaccinated porcine animals have been slaughtered or killed, excluding kept porcine animals referred to in Article 13(2) of Regulation (EU) 2020/687 when there are means, validated in accordance with the Terrestrial Manual of the WOAH, of distinguishing between vaccinated and infected kept porcine animals	Clinical and laboratory surveillance (pathogen identification and antibody detection) in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex

ANNEX XVII

African swine fever (ASF) in wild porcine animals

PART 1

SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY VACCINATION FOR PREVENTION AND CONTROL OF ASF IN WILD PORCINE ANIMALS

• 1. Size of the vaccination zone: The competent authority shall determine the vaccination zone on the basis of:

• a) the estimated population of wild porcine animals, its spatial distribution and the landscape structure;

• b) the risk factors contributing to the spread of ASF, in particular, the risk of its introduction into establishments of kept porcine animals;

• c) the sampling results.

• 1. Size of the peri-vaccination zone: No specific conditions.

• 1. Type of vaccine to be used or prioritised: ASF vaccines holding a centralised marketing authorization granted by the Commission in accordance with Article 44(9) of Regulation 2019/6.

• 1. Minimum coverage: must be adapted according to the vaccine used, to the local conditions and to the characteristics of the estimated population of wild porcine animals, its spatial distribution and the landscape structure.

• 1. Targeted animals/species: Wild porcine animals of listed species, in accordance with Implementing Regulation (EU) 2018/1882, in the vaccination zone.

• 1. Hunting and other activities likely to cause displacement of wild porcine animal populations: Must be regulated in the vaccination zone at least until the end of the waiting period provided for in part 4. Hunted wild porcine animals must be tested with antibody detection and pathogen identification tests.

PART 2

SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION ZONE DURING EMERGENCY VACCINATION FOR PREVENTION AND CONTROL OF ASF IN WILD PORCINE ANIMALS

In the vaccination zone, after completing oral immunisation, the age class of wild porcine animals that must be examined serologically to detect a new or re-emerging infection depends on the season in which vaccination was completed and the length of time since completion.

Specific surveillance shall be implemented in wild porcine animals in the vaccination zone to verify the success of the vaccination operation.

This surveillance shall include reinforced laboratory surveillance to assess immunity levels and detect any virus persistence in the population of wild porcine animals; this includes pathogen identification and antibody detection in all hunted, culled and found dead or sick wild porcine animals.

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF ASF IN WILD PORCINE ANIMALS IS CARRIED OUT

1. Animals subject to prohibition of movements

Wild porcine animals.

2. Products subject to prohibition of movements

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.

3. Conditions for granting a derogation in accordance with Article 13(3)

• 3.1.By way of derogation from the movement restrictions established under point 2, the competent authority may authorize the movement of fresh meat, meat products and any other products of animal origin, animal by-products and derived products within and outside the vaccination zone, provided that the following conditions are met:

• (a) a risk assessment conducted by the competent authority demonstrates that such movement does not pose a risk of spreading ASF;

• (b) bodies of wild porcine animals are tested for the presence of the ASF virus, with negative results obtained prior to any further movement for processing or treatment;

• (c) the movement of bodies of wild porcine animals to the processing and storage establishment take place under strict biosecurity measures;

• (d) the processing and storage of bodies of wild porcine animals and their derived products take place in establishments designated by the competent authority, ensuring compliance with biosecurity and ASF control measures;

• (e) either:
• (i) the products undergo the risk-mitigating treatments as set out in Annex VII to Delegated Regulation (EU) 2020/687; or
• (ii) the fresh meat, meat products and any other products of animal origin from wild porcine animals and bodies of wild porcine animals are moved within the restricted zone:
• — for private domestic use; or
• — by hunters for the supply of 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), point (e), of Regulation (EC) No 853/2004.

• 3.2.The competent authority shall document and monitor all authorized movements under this derogation and ensure compliance with the conditions set out in point 3.1.

PART 4

WAITING PERIODS FOR ASF FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in part 3 of this Annex until:

Waiting period	Type of surveillance to be implemented to demonstrate the absence of occurrence of ASF during the waiting period
12 months after the end date of the last vaccination campaign in wild porcine animals, and supported by the favourable conclusions of the implementation of an exit strategy that demonstrated absence of ASF virus circulation.	Clinical and laboratory surveillance (pathogen identification in wild porcine animals found dead or killed) in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex

ANNEX XVIII

Sheep pox and goat pox (SPGP)

PART 1

SPECIFIC CONDITIONS FOR THE IMPLEMENTATION OF EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF SHEEP POX AND GOAT POX

• 1. Size of the vaccination zone: No specific rules.

• 1. Size of the peri-vaccination zone: No specific conditions.

• 1. Type of vaccine to be used: No specific rules.

• 1. Minimum coverage: Vaccine coverage must be at least 95 % of the establishments in the vaccination zone representing at least 80 % of the targeted animals in the vaccination zone.

• 1. Targeted animals/species: Animals of listed species in accordance with Implementing Regulation (EU) 2018/1882 kept in the vaccination zone, including at least ovine and caprine animals.

PART 2

SPECIFIC CONDITIONS FOR THE REINFORCED CLINICAL AND LABORATORY SURVEILLANCE TO BE IMPLEMENTED IN THE VACCINATION AND PERI-VACCINATION ZONES DURING EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF SHEEP POX AND GOAT POX

Reinforced clinical surveillance: surveillance for sheep pox and goat pox clinical signs as well as for increased mortality in small ruminants.

PART 3

ANIMALS AND PRODUCTS SUBJECT TO PROHIBITION OF MOVEMENTS AND CONDITIONS FOR GRANTING A DEROGATION IN ACCORDANCE WITH ARTICLE 13 IN A VACCINATION ZONE WHERE EMERGENCY PROTECTIVE VACCINATION FOR PREVENTION AND CONTROL OF SHEEP POX AND GOAT POX IS CARRIED OUT

• 1.Animals and products thereof subject to prohibition of movements:

• The same animals and products, located in the vaccination zones, as those subject to restrictions in establishments located in protection and surveillance zones established in the event of an outbreak of sheep pox and goat pox, as provided for in Article 27 of Delegated Regulation (EU) 2020/687.

• 2.Germinal products subject to prohibition of collection: semen, oocytes and embryos from animals of listed species.

• 3.Conditions for granting a derogation in accordance with Article 13(2), point (b), Article 13(3), and Article 13(4).

• Movements that may be authorised are the following:

• 3.1.Movements of vaccinated animals and products thereof, under the same conditions as those provided for in Article 43 of Delegated Regulation (EU) 2020/687.

• 3.2.Movements of unvaccinated animals and products thereof, provided that their establishments of origin do not keep vaccinated animals anymore.

PART 4

WAITING PERIODS FOR SHEEP POX AND GOAT POX FOLLOWING EMERGENCY PROTECTIVE VACCINATION

The competent authority shall maintain in the vaccination zone the conditions provided for in part 3 of this Annex until:

Waiting period	Type of surveillance to be implemented to demonstrate the absence of occurrence of sheep pox and goat pox during the waiting period
30 days after disinfection of the last affected establishment and the slaughter or killing of all vaccinated animals	Clinical and laboratory surveillance (pathogen identification and antibody detection) in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex
8 months after the last vaccination or the disinfection of the last affected establishment, which ever occurred last	Clinical and laboratory surveillance (pathogen identification and antibody detection) in accordance with Article 9(1), point (c)(ii) to (iv) and Part 2 of this Annex