Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (Text with EEA relevance) (Text with EEA relevance)

• (d) there is documented evidence that the animals have been vaccinated against African horse sickness with a complete primary course, and revaccinated according to the manufacturer’s recommendations, with a licensed vaccine against all serotypes of the African horse sickness virus present in the source population at least 40 days prior to entry into the vector-protected establishments, and the animals were kept in isolation in vector-protected establishments for a period of at least 40 days prior to the date of dispatch to the Union;

• (e) the animals were kept in isolation in vector-protected establishments for a period of at least 30 days prior to the date of dispatch to the Union and underwent a serological test for the detection of antibodies against the African horse sickness virus, carried out by the same laboratory, on the same day, on blood samples taken during the isolation period in vector-protected establishments on two occasions with an interval of between 21 and 30 days. The second of these must have been taken within a period of 10 days prior to the date of dispatch to the Union, with negative results in each case or with a negative result in an agent identification test for African horse sickness virus on the second sample.

2.2.   Specific requirements for Venezuelan equine encephalomyelitis

Equine animals must comply with at least one of the following requirements:

• (a) the animals have been vaccinated against Venezuelan equine encephalomyelitis with a complete primary course and revaccinated in accordance with the manufacturer’s recommendations during a period of not less than 60 days and not more than 12 months prior to the date of dispatch to the Union and were kept in isolation in vector-protected establishments for a period of at least 21 days prior to the date of dispatch to the Union, and during that period they remained clinically healthy, and their body temperature, taken daily, remained within the normal physiological range. Any other equine animal on the same establishment which showed a rise in body temperature, taken daily, was subjected to a blood test for virus isolation for Venezuelan equine encephalomyelitis with negative results;

• (b) the animals have not been vaccinated against Venezuelan equine encephalomyelitis and were kept in isolation in vector-protected establishments for a period of at least 21 days prior to the date of dispatch to the Union, and during that period they remained clinically healthy, and their body temperature, taken daily, remained within the normal physiological range. During isolation period, the animals were subjected to a diagnostic test for Venezuelan equine encephalomyelitis, with negative results, conducted on a sample taken not less than 14 days after the date of commencement of isolation of the animals in the vector-protected establishments; and the animals remained protected from vector insects until dispatch to the Union. Any other equine animal on the same establishment that showed a rise in body temperature, taken daily, was subjected to a blood test for virus isolation for Venezuelan equine encephalomyelitis with negative results;

• (c) the animals were subjected to a haemagglutination inhibition test for Venezuelan equine encephalomyelitis carried out by the same laboratory on the same day on samples taken on two occasions with an interval of 21 days, the second of which was taken during a period of 10 days prior to the date of dispatch to the Union, without an increase in antibody titre, and an reverse transcription polymerase chain reaction (RT-PCR) test for the detection of Venezuelan equine encephalomyelitis virus genome, carried out with negative result on a sample taken within 48 hours prior to the date of dispatch to the Union, and have been protected from vector attacks from the moment of the RT-PCR sampling until loading for dispatch, by a combined use of approved insect repellents and insecticides on the animals and disinsection of the stable and the means in which they are transported.

2.3.   Specific requirements for infection with Burkholderia mallei (Glanders)

Equine animals must have undergone a complement fixation test for glanders, as described in point 3.1 of Chapter 2.5.11 of the OIE Terrestrial Manual (Version adopted 2015). The test must have been carried out, with negative results, at a serum dilution of 1 in 5 on a blood sample taken within a period of 30 days prior to the date of dispatch to the Union.

2.4.   Specific requirements for dourine

Equine animals must have undergone a complement fixation test for dourine, as described in point 3.1 of Chapter 2.5.3 of the OIE Terrestrial Manual (Version adopted 2013). The test must have been carried out, with negative results, at a serum dilution of 1 in 5 on a blood sample taken within a period of 30 days prior to the date of dispatch to the Union. In addition, the tested animals must not have been used for breeding during the period of at least 30 days prior to and after the date the sample was taken.

2.5.   Specific conditions for surra (Trypanosoma evansi)

Equine animals must have undergone a card agglutination test for trypanosomiasis (CATT), as described in point 2.3 of Chapter 2.1.21 of the OIE Terrestrial Manual (Version adopted 2012). The test must have been carried out, with negative results, at a serum dilution of 1 in 4 on a blood sample taken within a period of 30 days prior to the date of dispatch to the Union.

2.6.   Specific conditions for equine infectious anaemia

Equine animals must have undergone an agar gel immunodiffusion test (AGID test) or to an enzyme-linked immunoassay (ELISA) for equine infectious anaemia, as described in points 2.1 and 2.2 of Chapter 2.5.6 of the OIE Terrestrial Manual (Version adopted 2013). The test must have been carried out, with negative results, on a blood sample taken within a period not exceeding 90 days prior to the date of dispatch to the Union.

3. VECTOR-PROTECTED ESTABLISHMENT

Minimum criteria for the granting of a status of vector-protected establishment:

• (a) it has appropriate physical barriers at entry and exit points, for example double-door entry-exit system;

• (b) the openings of the vector-protected establishment must be vector-screened with mesh of appropriate gauge, impregnated regularly with an approved insecticide according to the instructions of the manufacturer;

• (c) vector surveillance and control must be carried out within and around the vector-protected establishment;

• (d) measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector-protected establishment;

• (e) standard operating procedures must be in place, including descriptions of back-up and alarm systems, for the operation of the vector-protected establishment and for the transport of the animals from that establishment to the place of loading for dispatch to the Union.

ANNEX XII

UNGULATES INTENDED FOR CONFINED ESTABLISHMENTS

PART A

Minimum periods without reported disease in the confined establishment of origin of the ungulates intended for confined establishments in the Union:

	1. Bovine animals	2. Ovine animals	3. Caprine animals	4. Porcine animals	5. Camelid animals	6. Cervid animals	7. Ungulates others than those referred to in columns 1, 2, 3, 4, 5, 6 [^E0027]
Foot and mouth disease	6 months	6 months	6 months	6 months	6 months	6 months	6 months
Infection with Rift Valley fever virus	6 months	6 months	6 months	NA	6 months	6 months	6 months
Infection with Mycoplamsma mycoides subsp. Mycoides SC (Contagious bovine pleuropneumonia)	6 months	NA	NA	NA	NA	NA	6 months
Infection with peste des petits ruminants virus	NA	6 months	6 months	NA	6 months	6 months	NA
Sheep pox and goat pox	NA	6 months	6 months	NA	NA	NA	NA
Contagious caprine pleuropneumonia	NA	6 months	6 months	NA	NA	NA	6 months
African swine fever	NA	NA	NA	6 m	NA	NA	NA
Classical swine fever	NA	NA	NA	6 m	NA	NA	NA
Infection with lumpy skin disease virus	6 m	NA	NA	NA	NA	NA	NA
Infection with Burkholderia mallei (Glanders)	NA	NA	6 months	NA	6 months	NA	NA
Infection with Brucella abortus, B. melitensis and B. suis	6 months	6 months	6 months	6 months	6 months	6 months	6 months
Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis)	6 months	6 months	6 months	6 months	6 months	6 months	6 months
Rabies	6 months	6 months	6 months	6 months	6 months	6 months	6 months
Surra (Trypanosoma evansi)	30 days	30 days	30 days	NA	180 days	30 days	30 days
Anthrax	30 days	30 days	30 days	30 days	30 days	30 days	30 days
Infection with bluetongue virus (Serotypes 1-24)	6 months	6 months	6 months	NA	6 months	6 months	6 months
Infection with Aujeszky’s disease virus	NA	NA	NA	12 months	NA	NA	NA
NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable

only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882

PART B

Minimum areas (radius) and periods without reported disease in the area around the confined establishment of origin of the ungulates intended for confined establishments in the Union:

	1. Bovine animals	2. Ovine animals	3. Caprine animals	4. Porcine animals	5. Camelid animals	6. Cervid animals	7. Ungulates others than those referred to in column 1, 2, 3, 4, 5, 6 [^E0028]
Foot and mouth disease	10 km/30 days	10 km/30 days	10 km/30 days	10 km/30 days	10 km/30 days	10 km/30 days	10 km/30 days
Infection with Rift Valley fever virus	150 km/30 days	150 km/30 days	150 km/30 days	NA	150 km/30 days	150 km/30 days	150 km/30 days
Infection with Mycoplamsma mycoides subsp. Mycoides SC (Contagious bovine pleuropneumonia)	10 km/30 days	NA	NA	NA	NA	NA	10 km/30 days
Infection with Peste des petits ruminants virus	NA	10 km/30 days	10 km/30 days	NA	10 km/30 days	10 km/30 days	NA
Sheep pox and goat pox	NA	10 km/30 days	10 km/30 days	NA	NA	NA	NA
Contagious caprine pleuropneumonia	NA	10 km/30 days	10 km/30 days	NA	NA	NA	10 km/30 days
African swine fever	NA	NA	NA	10 km/12 months	NA	NA	NA
Classical swine fever	NA	NA	NA	10 km/12 months	NA	NA	NA
Infection with lumpy skin disease virus	150 km/30 days	NA	NA	NA	NA	NA	NA
Infection with bluetongue virus (Serotypes 1-24)	150 km/30 days	150 km/30 days	150 km/30 days	NA	150 km/30 days	150 km/30 days	150 km/30 days
Infection with epizootic haemorrhagic disease virus	150 km/30 days	150 km/30 days	150 km/30 days	NA	150 km/30 days	150 km/30 days	150 km/30 days
Infection with Aujeszky’s disease virus	NA	NA	NA	5 km/12 months [^E0029]	NA	NA	NA
NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable

only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882

in addition, a virology and serology test must be carried out to rule out the presence of the disease 30 days prior to dispatch to the Union

PART C

Minimum periods of disease freedom of the third country or territory or zone thereof where the confined establishment of origin is located for ungulates intended for confined establishments in the Union:

	1. Bovine animals	2. Ovine animals	3. Caprine animals	4. Porcine animals	5. Camelid animals	6. Cervid animals	7. Ungulates others than those referred to in columns 1, 2, 3, 4, 5, 6 [^E0030]
Foot and mouth disease	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]	12 m [^E0031]	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]
Infection with rinderpest virus	12 months	12 months	12 months	12 months	12 months	12 months	12 months
Infection with Rift Valley fever virus	48 months [^E0031]	48 months [^E0031]	48 months [^E0031]	NA	48 months [^E0031]	48 months [^E0031]	48 months [^E0031]
African swine fever	NA	NA	NA	12 months [^E0031]	NA	NA	NA
Classical swine fever	NA	NA	NA	12 months [^E0031]	NA	NA	NA
Infection with Brucella abortus, B. melitensis and B. suis	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]	12 months [^E0031]
Infection with bluetongue virus (Serotypes 1-24)	24 months [^E0031]	24 months [^E0031]	24 months [^E0031]	NA	24 months [^E0031]	24 months [^E0031]	24 months [^E0031]
Infection with epizootic haemorrhagic disease virus	24 months [^E0031]	24 months [^E0031]	24 months [^E0031]	NA	24 months [^E0031]	24months [^E0031]	24 months [^E0031]
NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable

only applicable for listed species in accordance with the Annex to Commission Implementing Regulation (EU) 2018/1882

or alternative guarantees are provided by the competent authority of the third country or territory according to Part D

PART D

Alternative guarantees to be provided by the competent authority of the third country or territory as regards certain listed diseases

Foot and mouth disease	(a) the animals must have undergone a serological test for evidence of foot and mouth disease virus infection carried out in accordance with one of the prescribed tests for international trade laid down in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (OIE Terrestrial Manual), with negative results, on samples taken within a period of 10 days prior to the date of dispatch to the Union; and (b) for Bovidae, Cervidae and Elephas spp.: a probang test for evidence of foot and mouth disease virus infection carried out in accordance with the procedures laid down in the OIE Terrestrial Manual, with negative results. The test must have been carried out: (i) 10 days prior to the date of dispatch to the Union, for species other than African buffalo (Syncerus caffer); (ii) on two occasions 15 days at least apart, the second of which must have been taken during the period of 10 days prior to the date of dispatch to the Union, for African buffalo (Syncerus caffer).
Infection with Rift Valley fever virus	(a) the animals must: (i) have been kept in quarantine in a vector-protected facility in the approved confined establishment for a period of at least 30 days prior to the date of dispatch to the Union; (ii) have showed no disease symptoms of infection with Rift valley fever virus for a period of at least 30 days prior to the date of dispatch to the Union; (iii) have been protected from vectors when transported between the vector-protected facility referred to in point (i) and loading for dispatch to the Union; and (b) the animals have undergone a virus neutralisation test with negative results for evidence of infection with Rift valley fever virus in accordance with the OIE Terrestrial Manual, carried out firstly on samples taken at the date of commencement of the quarantine period and secondly on samples taken at least 42 days from that that date and and during a period of 10 days prior to the dispatch to the Union.
African swine fever	The animals have undergone a virology and serology test for the detection of African swine fever and classical swine fever in accordance with the test prescribed for international trade in the OIE Terrestrial Manual, carried out on samples taken during the period of 30 days prior to the date of dispatch to the Union.
Classical swine fever	The animals have undergone a virology and serology test for the detection of African swine fever and classical swine fever in accordance with the test prescribed for international trade in the OIE Terrestrial Manual, carried out on samples taken during the period of 30 days prior to the date of dispatch to the Union.
Infection with Brucella abortus, B. melitensis and B. suis	The animals: (a) have undergone a test as laid down and prescribed for international trade by the OIE Terrestrial Manual, on samples taken during the period of the 30 days prior to the date of dispatch to the Union; or (b) they are castrated males of any age.
Infection with bluetongue virus (Serotypes 1-24)	The animals must comply with the requirements set out in one of the following points: (a) they have been kept in quarantine in a vector-protected facility in the confined establishment for a period of at least 30 days prior to the date of dispatch to the Union and have undergone a serology test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus carried out in accordance with the OIE Terrestrial Manual with negative results, carried out at least 28 days after the introduction of the animals into the confined establishment; (b) they have been kept in quarantine in a vector-protected facility in the approved confined establishment for a period of at least 30 days prior to the date of dispatch to the Union and have undergone a PCR test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus in accordance with the OIE Terrestrial Manual, with negative results, carried out at least 14 days after the introduction into the confined establishment; (c) they come from a seasonally disease-free area and have undergone during that disease-free period a serology test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus according to the OIE Terrestrial Manual, with negative results, carried out on samples taken at least 28 days after introduction of the animals into the confined establishment; (d) they come from a seasonally free area and have undergone during that period a PCR test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus in accordance with the OIE Terrestrial Manual, with negative results, carried out on samples taken at least 14 days after the introduction of the animals into the approved confined establishment.
Infections with epizootic haemorrhagic disease virus	The animals must comply with the requirements set out in one of the following points: (a) they have been kept in quarantine in a vector-protected facility in the confined establishment for a period of at least 30 days prior to the date of dispatch to the Union and have undergone a serology test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus carried out in accordance with the OIE Terrestrial Manual with negative results, carried out at least 28 days after the introduction of the animals into the confined establishment; (b) they have been kept in quarantine in a vector-protected facility in the approved confined establishment for a period of at least 30 days prior to the date of dispatch to the Union and have undergone a PCR test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus in accordance with the OIE Terrestrial Manual, with negative results, carried out at least 14 days after the introduction into the confined establishment; (c) they come from a seasonally disease-free area and have undergone during that disease-free period a serology test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus according to the OIE Terrestrial Manual, with negative results, carried out on samples taken at least 28 days after introduction of the animals into the confined establishment; (d) they come from a seasonally free area and have undergone during that period a PCR test for infection with bluetongue virus (1-24) and infection with epizootic haemorrhagic disease virus in accordance with the OIE Terrestrial Manual, with negative results, carried out on samples taken at least 14 days after the introduction of the animals into the approved confined establishment.

PART E

Requirements as regards the absence of vaccination against certain diseases for the third country or territory of origin or zone thereof and for the ungulates intended for confined establishments:

	1. Bovine animals	2. Ovine animals	3. Caprine animals	4. Porcine animals	5. Camelid animals	6. Cervid animals	7. Ungulates others than those referred to in columns 1, 2, 3, 4, 5, 6 [^E0032]
Foot and mouth disease	NVA	NVA	NVA	NVA	NVA	NVA	NVA
Infection with Rift Valley fever virus	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]	NA	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]
Classical swine fever	NA	NA	NA	NVA	NA	NA	NA
Infection with Brucella abortus, B. melitensis and B. suis	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]	NVA [^E0033]
Infection with Aujeszky’s disease virus	NA	NA	NA	NVA	NA	NA	NA
NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable	NVA =  the ungulates intended to the Union have not been vaccinated NA =  not applicable

only applicable for listed species in accordance with Commission Implementing Regulation (EU) 2018/1882

or alternative guarantees are provided by the competent authority of the third country or territory according to Part D of this Annex

PART F

Requirements for the vector-protected facility in confined establishments in third countries

Where required in Part D of this Annex, the vector-protected facility in the confined establishments in third countries or territories must comply with the following requirements:

• (a) has appropriate physical barriers at entry and exit points;

• (b) the openings of the vector-protected facility must be vector-screened with mesh of appropriate gauge, impregnated regularly with an approved insecticide according to the instructions of the manufacturer;

• (c) vector surveillance and control must be carried out within and around the vector-protected facility;

• (d) measures must be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector-protected facility;

• (e) standard operating procedures must be in place, including descriptions of back-up and alarm systems, for the operation of the vector-protected facility and for the transport of the animals from that structure to the place of loading for dispatch to the Union.

ANNEX XIII

MINIMUM REQUIREMENTS FOR VACCINATION PROGRAMMES AND ADDITIONAL SURVEILLANCE CARRIED OUT IN A THIRD COUNTRY OR TERRITORY OR ZONE THEREOF VACCINATING AGAINST HIGHLY PATHOGENIC AVIAN INFLUENZA

1. MINIMUM REQUIREMENTS FOR VACCINATION PROGRAMMES CARRIED OUT IN A THIRD COUNTRY OR TERRITORY OR ZONE THEREOF

Vaccination programmes against highly pathogenic avian influenza submitted by a third country or territory must include at least the following information:

• (1) a description of the reasons for the decision to introduce the vaccination;

• (2) data on the epidemiological evolution of the disease, including previous outbreaks in poultry or wild birds;

• (3) the main objectives of the vaccination strategy, selected bird population(s) and area;

• (4) a risk assessment based on:
• — highly pathogenic avian influenza outbreaks within that third country or territory, or zone thereof,
• — highly pathogenic avian influenza outbreaks in a neighbouring country or territory, or zone thereof,
• — other risk factors such as certain areas, type of poultry husbandry or categories of poultry or captive birds;

• (5) a description of the geographical area, including maps, in which vaccination is carried out;

• (6) the number of establishments keeping poultry or captive birds in vaccination area;

• (7) the number of establishments keeping poultry or captive birds where vaccination is carried out, if different from the number referred to in point 6;

• (8) the species and categories of poultry or captive birds exempted from vaccination and reasoning for that exemption;

• (9) the species and categories of poultry or captive birds in the geographical area where vaccination is carried out;

• (10) the approximate number of poultry or captive birds in the establishments referred to in point 7;

• (11) a summary of the vaccine characteristics, including the name of the product(s) and the name of the manufacturer(s), and routes of administration, authorisation and quality control and guarantees that the vaccine used do not contain live avian influenza virus, whether attenuated or not;

• (12) the handling, storage, supply, distribution and sale of avian influenza vaccines on the national territory;

• (13) the implementation of a Differentiating Infected from Vaccinated Animals (DIVA) strategy;

• (14) the envisaged duration of the vaccination campaign;

• (15) the intended final use of vaccinated poultry or captive birds, and products thereof. Also taking into account vaccinated hatching eggs, if applicable;

• (16) the provisions and restrictions on movements of vaccinated poultry or captive birds and products thereof. Also taking into account vaccinated hatching eggs, if applicable;

• (17) clinical and laboratory tests, such as efficacy and pre-movement testing, carried out in the establishments vaccinated or located in the vaccination area;

• (18) the record keeping system on the vaccination.

2. ADDITIONAL SURVEILLANCE IN THIRD COUNTRIES OR TERRITORIES OR ZONES THEREOF THAT CARRY OUT VACCINATION AGAINST HIGHLY PATHOGENIC AVIAN INFLUENZA

Where vaccination is carried out in a third country or territory or zone thereof, all establishments where vaccination against highly pathogenic avian influenza is carried out must be required to undergo laboratory testing and the following information must be submitted to the Commission, in addition to the information referred to in Annex II:

• (1) number of vaccinated establishments in the area per category;

• (2) number of vaccinated establishments to be sampled per poultry category;

• (3) use of sentinel birds (namely, the species and number of sentinel birds used per epidemiological unit);

• (4) number of samples taken per establishment and/or epidemiological unit;

• (5) data on vaccine efficacy.

ANNEX XIV

ANIMAL HEALTH REQUIREMENTS FOR RATITES, HATCHING EGGS THEREOF AND FRESH MEAT OF RATITES ORIGINATING IN A THIRD COUNTRY OR TERRITORY OR ZONE THEREOF NOT FREE FROM INFECTION WITH NEWCASTLE DISEASE VIRUS

• 1.Breeding ratites, productive ratites and ratites intended for slaughter originating in a third country or territory or zone thereof not free from infection with Newcastle disease virus must:

• (a) have been placed under official surveillance for a period of at least 21 days prior to the date of dispatch of the consignment for entry into the Union;

• (b) have been kept in complete isolation during the period referred to in point (a), away from direct or indirect contact with other birds, in facilities approved by the competent authority of the third country or territory of origin for this purpose;

• (c) have undergone a virus detection test for infection with Newcastle disease virus;

• (d) come from flocks in which surveillance for infection with Newcastle disease virus was carried out under a statistically-based sampling plan which produced negative results for a period of at least 6 months immediately prior to the date of dispatch of the consignment for entry into the Union.

• 2.Day-old chicks of ratites and hatching eggs of ratites originating in a third country or territory or zone thereof not free from infection with Newcastle disease virus, must come from flocks:

• (a) which were placed in isolation under official surveillance for a period of at least 30 days prior to the date of laying of the hatching eggs intended for entry into the Union or of the hatching eggs from which the day-old chicks destined for entry into the Union are derived;

• (b) which underwent a virus detection test for infection with Newcastle disease virus;

• (c) where surveillance for infection with Newcastle disease virus was carried out under a statistically-based sampling plan which produced negative results for a period of at least 6 months immediately prior to the date of dispatch of the consignment for entry to the Union;

• (d) which were not in contact with poultry which do not fulfil the guarantees under points (a), (b) and (c) during the period of 30 days prior to the date of laying and during the laying of the hatching eggs intended for entry into the Union or of the hatching eggs from which the day-old chicks destined for entry into the Union are derived.

• 3.Fresh meat of ratites originating in a third country or territory or zone thereof not free from infection with Newcastle disease virus must:

• (a) be de-boned and skinned;

• (b) come from ratites which for a period of at least 3 months prior to the date of slaughter were kept on establishments:
• (i) on which there was no outbreak of infection with Newcastle disease virus or highly pathogenic avian influenza during the 6 months prior to the date of slaughter;
• (ii) around which there were no outbreaks of highly pathogenic avian influenza or infection with Newcastle disease virus for a period of at least 3 months prior to the date of slaughter within 10 km of the perimeter of the part of the establishment containing the ratites, including, where appropriate, the territory of a neighbouring Member State or third country;
• (iii) on which surveillance for infection with Newcastle disease virus was carried out under a statistically-based sampling plan, which produced negative results for a period of at least 6 months prior to the date of slaughter;

• (c) have undergone surveillance as referred to in point (b)(iii):
• (i) by serology, in the case of ratites not vaccinated against infection with Newcastle disease virus;
• (ii) by tracheal swabs of ratites, in the case of ratites vaccinated against infection with Newcastle disease virus;

• (d) come from ratites which, if vaccinated against infection with Newcastle disease virus, were not vaccinated with vaccines that did not meet the specific criteria set out in Part 1 of Annex XV during the period of 30 days prior to the date of slaughter.

• 4.The virus detection testing provided for in paragraphs 1(c) and 2(b) must have been carried out:

• (a) within 7 to 10 days of the date the ratites entered isolation;

• (b) on cloacal swabs or faeces samples from each bird.

• 5.The virus detection testing provided for in paragraphs 1(c) and 2(b) must have shown that no avian paramyxovirus type 1 isolates with an Intracerebral Pathogenicity Index (ICPI) of more than 0,4 were found. In addition, favourable results must have been available from all birds in the consignment before:

• (a) breeding ratites, productive ratites or ratites intended for slaughter left the facilities referred in 1(b) for dispatch to the Union;

• (b) day-old chicks left the hatchery for dispatch to the Union;

• (c) hatching eggs were loaded for dispatch to the Union.

ANNEX XV

CRITERIA FOR VACCINES AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS AND REQUIREMENTS FOR CONSIGNMENTS OF POULTRY, HATCHING EGGS AND FRESH MEAT OF POULTRY ORIGINATING FROM A THIRD COUNTRY OR TERRITORY OR ZONE THEREOF VACCINATING AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS

1. CRITERIA FOR VACCINES AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS

1.1.   General criteria

• (a) Vaccines must comply with the standards set out in the chapter on Newcastle disease in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE).

• (b) Vaccines must be registered by the competent authorities of the third country or territory of origin concerned before being allowed to be distributed and used. For such registration, the competent authorities of the third country or territory of origin concerned must rely on a complete file submitted by the applicant containing data on the efficacy and innocuity of the vaccine. In the case of imported vaccines, the competent authorities of the third country or territory of origin may rely on data checked by the competent authorities of the country where the vaccine is produced, insofar as these checks have been carried out in conformity with OIE standards.

• (c) In addition to the requirements set out in points (a) and (b), imports or the production and distribution of the vaccines must be controlled by the competent authorities of the third country or territory of origin concerned.

• (d) Before distribution of the vaccines is allowed, each batch of vaccines must be tested on innocuity, in particular regarding attenuation or inactivation and freedom from extraneous agents, and on efficacy. The testing is performed under the control of the competent authorities of the third country or territory of origin.

1.2.   Specific criteria

Live attenuated vaccines against infection with Newcastle disease virus must be prepared from a Newcastle disease virus strain for which the master seed has been tested and shown to have an ICPI of either:

• (a) less than 0,4 , if not less than 10⁷ EID50 are administered to each bird in the ICPI test; or

• (b) less than 0,5 , if not less than 10⁸ EID50 are administered to each bird in the ICPI test.

2. ANIMAL HEALTH REQUIREMENTS FOR POULTRY AND HATCHING EGGS ORIGINATING FROM A THIRD COUNTRY OR TERRITORY OR ZONE THEREOF WHERE VACCINES USED AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS DO NOT MEET THE SPECIFIC CRITERIA SET OUT IN POINT 1

Poultry and hatching eggs originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1.2 must meet the requirements set out below:

• (a) poultry, the flock of origin of the day-old chicks and the flock of origin of hatching eggs must not have been vaccinated with such vaccines for a period of at least 12 months prior to the date the consignment is loaded for dispatch to the Union;

• (b) the flock of origin of poultry and of hatching eggs must have undergone a virus isolation test for infection with Newcastle disease virus not earlier than 2 weeks prior to the date of loading of the consignment for dispatch to the Union or, in the case of hatching eggs, not earlier than 2 weeks prior to the date the eggs were collected. The test must have been carried out in an official laboratory on a random sample of cloacal swabs taken from at least 60 birds in each flock, and no avian paramyxoviruses with an ICPI of more than 0,4 have been found;

• (c) poultry, except day-old chicks, the flock of origin of the day-old chicks and the flocks of origin of hatching eggs must have been kept in isolation under official surveillance on the establishment of origin during the two-week period referred to in point (b);

• (d) poultry, except day-old chicks, the flock of origin of the day-old chicks and the flock of origin of hatching eggs must not have been in contact with poultry not meeting the requirements set out in points (a) and (b):
• (i) in the case of poultry, during the period of 60 days prior to the date the consignment was loaded for dispatch to the Union;
• (ii) in the case of hatching eggs, during the period of 60 days prior to the date the eggs were collected;

• (e) the hatching eggs from which the day-old chicks are derived must not have been in contact in the hatchery or during transport to the hatchery with poultry or hatching eggs not meeting the requirements set out in points (a) to (d).

3. ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF POULTRY ORIGINATING FROM A THIRD COUNTRY OR TERRITORY OR ZONE THEREOF WHERE VACCINES USED AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS DO NOT MEET THE SPECIFIC CRITERIA SET OUT IN POINT 1

Fresh meat of poultry originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1.2 must originate from poultry that meet the following health requirements:

• (a) the poultry have not been vaccinated with live attenuated vaccines prepared from an infection with Newcastle disease virus master seed showing a higher pathogenicity than lentogenic strains of the virus within the period of 30 days prior to the date of slaughter;

• (b) the poultry underwent a virus isolation test for infection with Newcastle disease virus, carried out in an official laboratory at the time of slaughter on a random sample of cloacal swabs from at least 60 birds in each flock concerned, and in which no avian paramyxoviruses with an ICPI of more than 0,4 were found;

• (c) the poultry have not been in contact during the period of 30 days prior to the date of slaughter with poultry that does not fulfil the conditions set out in points (a) and (b).

4. INFORMATION TO BE PROVIDED WHEN FLOCKS OF ORIGIN OF POULTRY, FLOCKS OF ORIGIN OF HATCHING EGGS AND HATCHING EGGS ARE VACCINATED AGAINST INFECTION WITH NEWCASTLE DISEASE VIRUS

Where the flocks of origin of poultry, the flocks of origin of hatching eggs or hatching eggs are vaccinated against infection with Newcastle disease virus, the following information must be provided for the consignment:

• (a) identification of the flock;

• (b) age of the birds;

• (c) date of vaccination;

• (d) name and type of virus strain used;

• (e) batch number of the vaccine;

• (f) name of the vaccine;

• (g) manufacturer of the vaccine.

ANNEX XVI

REQUIREMENTS AS REGARDS THE INFORMATION TO BE MENTIONED ON THE CONTAINERS OF POULTRY, CAPTIVE BIRDS AND HATCHING EGGS

• 1.Breeding poultry and productive poultry must be transported in containers which bear the following indications:

• (a) the name and ISO code of the third country or territory of origin;

• (b) the species of poultry concerned;

• (c) the number of animals;

• (d) the category and type of production for which they are intended;

• (e) the name, address and approval number of the establishment of origin;

• (f) the name of the Member State of destination.

• 2.Poultry intended for slaughter must be transported in containers which bear the following indications:

• (a) the name and ISO code of the third country or territory of origin;

• (b) the species of poultry concerned;

• (c) the number of animals;

• (d) the category and type of production for which they are intended;

• (e) the name, address and registration number of the establishment of origin;

• (f) the name of the Member State of destination.

• 3.Day-old chicks must be transported in containers which bear the following indications:

• (a) the name and ISO code of the third country or territory of origin;

• (b) the species of poultry concerned;

• (c) the number of animals;

• (d) the category and type of production for which they are intended;

• (e) the name, address and approval number of the establishment of origin of the day-old chicks;

• (f) the approval number of the establishment of origin of the flock of origin;

• (g) the name of the Member State of destination.

• 4.Captive birds must be transported in containers which bear the following indications:

• (a) the name and ISO code of the third country or territory of origin;

• (b) the number of animals;

• (c) the name, address and approval number of the establishment of origin;

• (d) the specific identification number of the container;

• (e) the name of the Member State of destination.

• 5.Hatching eggs of poultry must be transported in containers which bear the following indications:

• (a) the word ‘hatching’;

• (b) the name and ISO code of the third country or territory of origin;

• (c) the species of poultry concerned;

• (d) the number of eggs;

• (e) the category and type of production for which they are intended;

• (f) the name, address and approval number of the establishment of origin of the eggs;

• (g) the approval number of the establishment of origin of the flock of origin, if different from point (f);

• (h) the name of the Member State of destination.

• 6.Specified pathogen-free eggs must be transported in containers which bear the following indications:

• (a) the wording ‘SPF eggs for diagnostic, research or pharmaceutical use only’;

• (b) the name and ISO code of the third country or territory of origin;

• (c) the number of eggs;

• (d) the name, address and approval number of the establishment of origin;

• (e) the name of the Member State of destination.

• 7.Hatching eggs of captive birds must be transported in containers which bear the following indications:

• (a) the name and ISO code of the third country or territory of origin;

• (b) the number of eggs;

• (c) the name, address and approval number of the establishment of origin;

• (d) the specific identification number of the container;

• (e) the name of the Member State of destination.

ANNEX XVII

REQUIREMENTS FOR TESTING OF CONSIGNMENTS OF LESS THAN 20 HEADS OF POULTRY OTHER THAN RATITES AND LESS THAN 20 HATCHING EGGS THEREOF BEFORE THEIR ENTRY INTO THE UNION

Consignments of less than 20 heads of poultry other than ratites or less than 20 hatching eggs of poultry other than ratites must have been tested negative for the diseases referred to in point (e) of Article 49 and point (e)(ii) of Article 110 as follows:

• (a) in the case of breeding poultry, productive poultry and poultry intended for slaughter other than ratites, the animals must have been tested negative in serological and/or bacteriological tests within the period of 30 days prior to the date of loading of the consignment for dispatch to the Union;

• (b) in the case of hatching eggs of poultry other than ratites and day-old chicks other than ratites, the flock of origin must have tested negative in serological tests and/or bacteriological tests within the period of 90 days prior to the date of loading of the consignment for dispatch to the Union at a level which gives 95 % confidence of detecting infection at 5 % prevalence;

• (c) where the animals have been vaccinated against infection with any serotype of Salmonella or Mycoplasma, only bacteriological testing must be used, but the confirmation method must be capable of differentiating live vaccinal strains from field strains.

ANNEX XVIII

SAMPLING AND TESTING OF POULTRY OTHER THAN RATITES AFTER THE ENTRY INTO THE UNION

• 1.The official veterinarian shall take samples for virological examination from breeding poultry other than ratites, productive poultry other than ratites and day-old chicks other than ratites which have entered into the Union from a third country or territory or zone thereof. The samples must be collected as follows:

• (a) between the seventh and the fifteenth day following the date when the animals were placed in the establishments of destination in the Union, cloacal swabs must be taken at a level which gives a 95 % confidence of detecting infection at 5 % prevalence;

• (b) testing of samples must be carried out for:
• (i) highly pathogenic avian influenza;
• (ii) infection with Newcastle disease virus.

• 2.Samples may be pooled to a maximum of five samples from individual birds in each pool.

ANNEX XIX

ANIMAL HEALTH REQUIREMENTS FOR GRANTING APPROVAL OF THE ESTABLISHMENT OF ORIGIN OF CAPTIVE BIRDS

• 1.The animal health requirements in relation to biosecurity measures, as referred to in Article 56, are as follows:

• (a) only animals coming from other approved establishments may be introduced into the establishment;

• (b) birds may be introduced into the establishment from sources other than approved establishments after approval for such introduction is given by the competent authority of the third country or territory, provided that such animals are isolated for at least 30 days from the date they were introduced into the establishment, in accordance with the instructions given by the competent authority of the third country or territory, before being added to the collection of birds in the establishment.

• 2.The animal health requirements in relation to the facilities and equipment on the establishment, as referred to in Article 56, are as follows:

• (a) the establishment must be clearly demarcated and separated from its surroundings;

• (b) the establishment must have adequate means for catching, confining and isolating animals and have available adequate approved quarantine facilities and approved procedures for animals coming from establishments that have not been approved;

• (c) the establishment must either have suitable arrangements or on-site facilities and equipment for the appropriate disposal of the bodies of animals which die of a disease or are euthanised.

• 3.The animal health requirements in relation to record keeping, as referred to in Article 56, are as follows:

• (a) the operator responsible for the establishment must keep up-to-date records indicating:
• (i) the number and identity (namely the age, sex, species and individual identification number where practical) of the animals of each species present in the establishment;
• (ii) the number and identity (namely the age, sex, species and individual identification number where practical) of animals arriving in the establishment or leaving it, together with information on their origin or destination, the transport from or to the establishment and the animal health status;
• (iii) the results of blood tests or any other diagnostic procedures;
• (iv) cases of disease and, where appropriate, the treatment administered;
• (v) the results of the post-mortem examinations on animals that have died in the establishment, including still-born animals;
• (vi) observations made during any isolation or quarantine period;

• (b) the operator responsible for the establishment must keep the records referred to in point (a) following the date of approval, for a period of at least 10 years.

• 4.The animal health requirements in relation to personnel, as referred to in Article 56, are as follows:

• (a) the person responsible for the establishment must have adequate ability and knowledge;

• (b) the operator responsible for the establishment must secure, by contract or other legal instrument, the services of a veterinarian approved by and under the control of the competent authority of the third country or territory, who:
• (i) ensures that appropriate disease surveillance and control measures in relation to the disease situation of the third country or territory concerned are approved by the competent authority and applied in the establishment; such measures must include the following:
• — an annual disease surveillance programme including appropriate zoonoses control of the animals,
• — clinical, laboratory and post-mortem testing of animals suspected to be affected by diseases,
• — vaccination of susceptible animals against diseases as appropriate, in conformity with the Terrestrial Animal Health Code and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE;
• (ii) ensures that any suspect deaths or the presence of any other symptoms indicative of highly pathogenic avian influenza, infection with Newcastle disease virus or avian chlamydiosis is notified without delay to the competent authority of the third country or territory;
• (iii) ensures that animals entering the establishment have been isolated as necessary and in accordance with the requirements of paragraph 1(b) and with the instructions, if any, given by the competent authority of the third country or territory.

• 5.The animal health requirements in relation to health status, as referred to in Article 56, are as follows:

• (a) the establishment must be free from highly pathogenic avian influenza, infection with Newcastle disease virus and avian chlamydiosis; in order for the establishment to be declared free from those diseases, the competent authority of the third country or territory shall assess the records on the animal health status kept for a period of at least three years prior to the date of the application for approval and the results of the clinical and laboratory tests carried out on the animals therein. However, new establishments must only be approved based on the results of the clinical and laboratory tests carried out on the animals in such establishments;

• (b) the operator responsible for the establishment must either have an arrangement with a laboratory to perform post-mortem examinations, or have one or more appropriate premises where such examinations may be performed by a competent person under the authority of a veterinarian approved for that purpose by the competent authority of the third country or territory.

ANNEX XX

EXAMINATION, SAMPLING AND TESTING PROCEDURES OF CAPTIVE BIRDS FOR HIGHLY PATHOGENIC AVIAN INFLUENZA AND NEWCASTLE DISEASE

• 1.During quarantine either the sentinel birds, or if sentinel birds are not used, the captive birds, shall must undergo the following procedures:

• (a) cases involving the use of sentinel birds:
• (i) blood samples for serological examination must be taken from all sentinel birds within a period of not less than 21 days following the date of their entry into the quarantine and within a period of at least 3 days prior to the date of the end of the quarantine;
• (ii) if sentinel birds show positive or inconclusive serological results for the samples referred to in point (i):
• — the imported birds must undergo a virological examination,
• — cloacal swabs (or faeces) and tracheal or oropharyngeal swabs must be taken from at least 60 birds, or from all birds if the consignment is less than 60 birds;

• (b) cases not involving the use of sentinel birds:
• — imported birds must be examined virologically (i.e. serological testing is not appropriate),
• — tracheal or oropharyngeal or cloacal swabs (or faeces) must be taken from at least 60 birds, or from all birds if the consignment is less than 60 birds, during the period of the first 7 to 15 days of the quarantine.

• 2.In addition to the testing set out in point 1, the following samples must be taken for virological examination:

• (a) cloacal swabs (or faeces) and tracheal or oropharyngeal swabs, if possible, from clinically ill birds or ill sentinel birds;

• (b) from the intestinal contents, brain, trachea, lungs, liver, spleen, kidneys and other obviously affected organs as soon as possible following death, from:
• (i) dead sentinel birds and all birds dead on arrival in quarantine and those which die during quarantine; or
• (ii) in the case of high mortality in large consignments made of small birds, from at least 10 % of the dead birds.

• 3.For virological examination, pooling of samples up to a maximum of five samples of individual birds in one pool is allowed.

• Faecal material must be pooled separately from other organ and tissue samples.

ANNEX XXI

SPECIFIC REQUIREMENTS AS REGARDS DOGS, CATS AND FERRETS INTENDED FOR ENTRY INTO THE UNION

1. RABIES ANTIBODY TITRATION TEST REQUIREMENTS

The rabies antibody titration test shall:

• (a) be carried out without undue delay after sample collection on a sample collected by an official veterinarian or an authorised veterinarian as defined in Article 2(1) of Delegated Regulation (EU) 2026/131 at least 30 days after the date of the primary vaccination, or within a current valid vaccination series, and not less than 90 days before the date of issue of the animal health certificate accompanying the consignment of animals to the Union;

• (b) measure a titre of neutralising antibody to rabies virus equal to or greater than 0,5 IU/ml and using a method prescribed in the relevant part of the chapter concerning rabies in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (WOAH);

• (c) be performed in one of the following:
• (i) an official laboratory designated in accordance with Article 37 of Regulation (EU) 2017/625 for the performance of the rabies antibody titration test and for which the competent authority has provided to the Commission its name and contact details; or
• (ii) a laboratory in a third country or territory listed in Annex VIII to Implementing Regulation (EU) 2021/404 designated by the competent authority of the third country as meeting the requirements laid down in Article 37(4) and (5) of Regulation (EU) 2017/625 for the performance of the rabies antibody titration test and for which the competent authority has provided to the Commission its name and contact details;

• (d) be certified by an official report from the designated laboratory referred to in point (c) as regards the results of the rabies antibody titration test. A report issued from 1 January 2028 shall bear a security feature in the format of a code to permit verification of its authenticity on the dedicated internet-based pages of the designated laboratory and be attached to the animal health certificate referred to in point (a);

• (e) not have to be renewed on an animal which, following the antibody rabies titration test with satisfactory results, has been revaccinated against rabies within the period of validity of the primary vaccination referred to in point (a) and all subsequent valid vaccinations in the series.

2. TREATMENT AGAINST INFESTATION WITH ECHINOCCOCUS MULTILOCULARIS

Prior to entering a Member State or zone thereof with disease-free status for Echinococcus multilocularis, dogs shall be treated against infestation with Echinococcus multilocularis, as follows:

• (a) the treatment shall consist of an approved veterinary medicinal product which contains the appropriate dose of praziquantel or other pharmacologically active substances, which alone or in combination, have proven to reduce the burden of mature and immature intestinal forms of Echinococcus multilocularis in dogs at least as effectively as praziquantel;

• (b) the product shall be administered by a veterinarian within a period commencing not more than 120 hours and ending not less than 24 hours prior to the time of entering that Member State or zone.

ANNEX XXII

REQUIREMENTS AS REGARDS THE RESIDENCY PERIODS OF HATCHING EGGS BEFORE THE ENTRY INTO THE UNION

Category of hatching eggs	Minimum residency period applies to	Minimum residency period in the third country or territory of origin or zone thereof, as referred in Article 98(a)	Minimum residency period in the establishment of origin, as referred to in Article 98(b)	Minimum period without contact with poultry or hatching eggs of lower health status, captive birds or wild birds *as referred to in Article 98(c)*
Hatching eggs of poultry	Flock of origin	3 months	6 weeks	6 weeks
Consignments of less than 20 hatching eggs of poultry other than ratites	Flock of origin	3 months	3 weeks	3 week

ANNEX XXIII

REQUIREMENTS AS REGARDS THE RESIDENCY PERIOD BEFORE SLAUGHTER OR KILLING OF THE KEPT UNGULATES OF ORIGIN OF THE FRESH MEAT

• 1.The period during which the ungulates must have remained in the third country or territory of origin or zone thereof before the date of slaughter or killing, as referred to in Article 131(2)(a), must be either:

• (a) at least 3 months prior that date; or

• (b) less than 3 months prior to that date, if the ungulates are less than 3 months of age.

• 2.Kept ungulates must have remained in their establishment of origin without having come into contact with ungulates of a lower health status, as referred to in Article 131(2)(b) and (c), for at least the 40 days prior to the date of slaughter or killing, where such animals:

• (a) originate from a third country, territory or zone thereof which applies one or more of the specific conditions set out in Part B of Annex XXIV;

• (b) are covered by the derogation provided for in Article 132.

ANNEX XXIV

DISEASE FREEDOM IN THE THIRD COUNTRY OR TERRITORY OF ORIGIN OF THE PRODUCTS OF ANIMAL ORIGIN

PART A

Minimum periods (in months) of disease freedom of the third country or territory of origin or zone thereof in accordance with Article 133(1).

	1. Bovine animals	2. Ovine animals	3. Caprine animals	4. Porcine animals	5. Camelid animals	6. Cervid animals	7. Ungulates other than those referred to in columns 1, 2, 3, 4, 5, 6 [^E0034]
Foot and mouth disease	12 m [^E0035]	12 m [^E0035]	12 m [^E0035]	12 m [^E0035]	12 m [^E0035]	12 m [^E0035]	12 m [^E0035]
Infection with rinderpest virus	12 m	12 m	12 m	12 m	12 m	12 m	12 m
African swine fever	NA	NA	NA	12 m	NA	NA	NA
Classical swine fever	NA	NA	NA	12 m [^E0035]	NA	NA	NA
NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable	NA =  not applicable

only applicable to listed species in accordance with Annex to Commission Implementing Regulation (EU) 2018/1882

this period may be reduced where specific conditions, in accordance with Part B, are provided by the competent authority of the third country or territory

PART B

Specific conditions to be provided by the competent authority where the third country or territory or zone thereof has been free of the disease for a period of less than 12 months as provided for in the derogation laid down in Article 133(1):

Foot and mouth disease	Supplementary information to guarantee the determination of a date from which the third country or territory or zone thereof is considered free from the disease
Classical swine fever	Supplementary information to guarantee the determination of a date from which the third country or territory or zone thereof is considered free from the disease

ANNEX XXV

VACCINATION IN THE THIRD COUNTRY OR TERRITORY OF ORIGIN OR ZONE THEREOF AND IN THE ESTABLISHMENT OF ORIGIN OF THE ANIMALS FROM WHICH THE FRESH MEAT IS OBTAINED

PART A

Animal health requirements regarding the absence of vaccination in the third country or territory of origin or zone thereof and in the establishment of origin of the ungulates from which the fresh meat is obtained:

	1. Bovine animals	2. Ovine animals	3. Caprine animals	4. Porcine animals	5. Camelid animals	6. Cervid animals	7. Ungulates other than those referred to in columns 1, 2, 3, 4, 5, 6 [^E0036]
Foot and mouth disease	NV/NVE [^E0037]	NV/NVE [^E0037]	NV/NVE [^E0037]	NV/NVE	NV/NVE [^E0037]	NV/NVE [^E0037]	NV/NVE [^E0037]
Infection with rinderpest virus	NV/NVE [^E0037]	NV/NVE [^E0037]	NV/NVE [^E0037]	NV/NVE	NV/NVE [^E0037]	NV/NVE [^E0037]	NV/NVE [^E0037]
African swine fever	NA	NA	NA	NV/NVE	NA	NA	NA
Classical swine fever	NA	NA	NA	NV/NVE	NA	NA	NA
NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable	NV =  for a period of at least 12 months prior to the date of dispatch to the Union: no vaccination has been carried out in the third country or territory or zone thereof and there have been no entries of vaccinated animals in the third country territory or zone NVE =  no vaccinated animals in the establishment of origin of the ungulates from which the fresh meat is obtained NA =  not applicable

only applicable for listed species in accordance with Annex to Commission Implementing Regulation (EU) 2018/1882

or specific conditions, in accordance with Part B, are provided by the competent authority of the third country or territory

PART B

Specific conditions to be provided by the competent authorities where vaccination against foot and mouth disease has been carried out in the third country or territory or zone thereof for a period of less than 12 months as referred to in Article 133(3)

1. FROM A THIRD COUNTRY, TERRITORY OR ZONE THEREOF WHICH IS FREE FROM FOOT AND MOUTH DISEASE AND WHERE VACCINATION AGAINST FOOT AND MOUTH DISEASE STRAINS A, O OR C IS PRACTISED

The competent authority of the third country or territory of origin must provide supplementary information to guarantee the absence of foot and mouth disease virus in fresh meat and compliance with the following requirements:

• (a) a vaccination programme against foot and mouth disease is carried out in kept bovine animals and controlled by the competent authority of the third country or territory of origin;

• (b) the fresh meat is obtained from either:
• (i) bovine, ovine and caprine animals that originate from establishments in and around which, in an area with a 25 kilometres radius, foot and mouth disease or rinderpest have not been reported during the 60 days prior to the date of dispatch to the slaughterhouse; or
• (ii) kept ungulates of listed species other than bovine, ovine, caprine and porcine that originate from establishments in and around which in an area of 50 kilometres radius, foot and mouth disease or rinderpest have not been reported during the 90 days prior to the date of dispatch to the slaughterhouse; or
• (iii) wild ungulates that comply with the requirements laid down in Article 138;

• (c) the meat is de-boned fresh meat other than offal that was obtained from carcasses:
• (i) in which the main accessible lymph nodes have been removed;
• (ii) which have been submitted to maturation at a temperature above +2 °C for at least 24 hours before the bones were removed;
• (iii) in which the pH value of the meat was below 6,0 when tested electronically in the middle of the longissimus-dorsi muscle after maturation and before de-boning.

2. FROM A THIRD COUNTRY, TERRITORY OR ZONE THEREOF WHICH IS FREE FROM FOOT AND MOUTH DISEASE AND WHERE VACCINATION AGAINST FOOT AND MOUTH DISEASE STRAINS A, O OR C IS PRACTISED AND IS SUBJECT TO ADDITIONAL SPECIFIC CONDITIONS

In addition to the requirements set out in point 1, the competent authority of the third country or territory must comply with additional specific conditions in relation to the vaccination programme which support the absence of foot and mouth disease virus in fresh meat from the zone.

3. FOOT AND MOUTH DISEASE-FREE ZONES WHERE VACCINATION IS NOT PRACTISED

3.1.   Foot and mouth disease strains SAT or ASIA 1

Where fresh meat originates from a foot and mouth disease-free zone where vaccination is not practised, but that zone is in a third country or territory in which vaccination against foot and mouth disease (FMD) strains SAT or ASIA 1 is practised in other zones or where those strains are endemic in part(s) of the third country or territory or in the neighbouring Member State or third countries, the competent authorities of a third country or territory of origin of such meat must provide the necessary supplementary information to guarantee the absence of the foot and mouth disease virus in the fresh meat and to guarantee compliance with the following animal health requirements:

• (a) the fresh meat is obtained from either:
• (i) kept animals of listed species that originate from establishments in and around which, in an area of 10 kilometres radius, foot and mouth disease or rinderpest have not been reported during the period of 12 months prior to the date of slaughter; or
• (ii) wild ungulates that comply with the requirements laid down in Article 138;

• (b) the meat is not authorised for export to the Union until 21 days have elapsed following the date of slaughter;

• (c) the meat is de-boned fresh meat other than offal, obtained from carcasses:
• (i) in which the main accessible lymphnodes have been removed;
• (ii) which have been submitted to maturation at a temperature above +2 °C for a period of at least 24 hours before the bones were removed.

3.2.   Foot and mouth disease strains A, O or C

Where fresh meat originates in a foot and mouth free zone where vaccination against foot and mouth disease is not practised, but that zone is in a third country or territory in which vaccination against foot and mouth disease strains A, O or C is practised, and where the competent authorities of the third country or territory have provided additional guarantees on conditions specific for the third country or territory or zone and which support the absence of foot and mouth disease virus in the fresh meat from the zone, the competent authorities of the third country or territory of origin must provide the following supplementary information:

• (a) guarantees that the surveillance programme for foot and mouth disease applicable for the free zone, demonstrating the absence of foot and mouth disease, is carried out and controlled by the competent authorities of the third country or territory of origin;

• (b) guarantees on the application of the animal health requirements set out in points (b) and (c) of Point 1.

ANNEX XXVI

RISK MITIGATING TREATMENTS FOR MEAT PRODUCTS

1. RISK MITIGATING TREATMENTS FOR MEAT PRODUCTS LISTED IN DESCENDING ORDER OF SEVERITY