Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

The milk and the milk products derived from the ovine and caprine animals of a holding placed under official control, which are present on that holding from the date when the presence of the TSE is suspected until the results of the confirmatory examinations are available, shall only be used within that holding.

CHAPTER B

Measures following confirmation of the presence of a TSE in bovine, ovine and caprine animals

• 1.The inquiry referred to in Article 13(1)(b) must identify:

• (a) in the case of bovine animals:
• — all other ruminants on the holding of the animal in which the disease was confirmed,
• — where the disease was confirmed in a female animal, its progeny born within a period of two years prior to, or after, the clinical onset of the disease,
• — all animals of the cohort of the animal in which the disease was confirmed,
• — the possible origin of the disease,
• — other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source,
• — the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;

• (b) in the case of ovine and caprine animals:
• — all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed,
• — insofar as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed,
• — all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent,
• — the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source,
• — the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question.

• 2.The measures laid down in Article 13(1)(c) shall comprise at least the following:

• 2.1. In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide:
• — not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal,
• — to defer the killing and destruction of animals of the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death.

• 2.2. In the case of confirmation of TSE in an ovine or caprine animal:
• 2.2.1. In cases where BSE cannot be excluded If BSE cannot be excluded after the results of the secondary molecular testing carried out in accordance with the methods and protocols set out in Annex X, Chapter C, point 3.2(c) (ii), the killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b). The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined. The milk and the milk products derived from the animals to be destroyed, which were present on the holding between the date of confirmation that BSE cannot be excluded and the date of complete destruction of the animals, shall be disposed of in accordance with Article 12 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (³⁵). Following the killing and complete destruction of all animals, the conditions set out in point 3 shall apply to the holding.
• 2.2.2. In cases where BSE and atypical scrapie can be excluded If BSE and atypical scrapie are excluded in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, the holding shall be subject to the conditions set out in point (a). In addition, pursuant to the decision of the Member State responsible for the holding, the holding shall be subject to the conditions of either option 1 set out in point (b), or option 2 set out in point (c), or option 3 set out in point (d). In case of a holding with a mixed ovine and caprine flock, the Member State responsible for the holding may decide to apply the conditions of one of the options to the ovine animals of the holding and a different option to the caprine animals of the holding:
• (a) The milk and milk products derived from the animals to be destroyed or slaughtered and which were present on the holding between the date of confirmation of the case of TSE and the date of the completion of the measures to be applied in the holding as laid down in point (b) and (c), or derived from the infected flock/herd until all the restrictions laid down in point (d) and point 4 are lifted, shall not be used for the feeding of ruminants, except for the feeding of ruminants within that holding. The placing on the market of such milk and milk products as feed for non-ruminants shall be limited to the territory of the Member State responsible for the holding. The commercial document accompanying consignments of such milk and milk products and any packaging containing such consignments shall be clearly marked with the words: ‘shall not be fed to ruminants’. The use and the storage of feedingstuffs containing such milk and milk products shall be prohibited on holdings where ruminants are kept. Bulk feedingstuffs containing such milk and milk products shall be transported by means of vehicles which do not transport feedingstuffs for ruminants at the same time. If those vehicles are subsequently used for the transport of feedingstuffs intended for ruminants, they shall be thoroughly cleaned in order to avoid cross- contamination, in accordance with a procedure approved by the Member State responsible for the holding.
• (b) Option 1 — killing and complete destruction of all animals The killing and complete destruction, without delay, of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The animals over 18 months of age killed for destruction shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. The prion protein genotype of all ovine animals, up to a maximum of 50, shall be determined. By way of derogation from the conditions set out in the first paragraph of option 1, Member States may decide instead to carry out the measures listed in (i) or (ii):
• (i) to replace the killing and complete destruction of all animals, without delay, by their slaughtering for human consumption, without delay, provided that:
• — the animals are slaughtered for human consumption within the territory of the Member State responsible for the holding;
• — all animals which are over 18 months of age slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.
• (ii) to exempt the lambs and kids less than three months old from killing and complete destruction without delay, provided that they are slaughtered for human consumption not later than when they are three months of age. Movement of animals mentioned in points (i) and (ii) from the holding to the slaughterhouse shall be allowed. Following the killing and complete destruction or slaughtering for human consumption of all animals the conditions set out in point 3 shall apply to the holding where it has been decided to apply option 1.
• (c) Option 2 – killing and complete destruction of the susceptible animals only The prion protein genotyping of all ovine and caprine animals present in the holding, except lambs and kids less than three months old provided that they are slaughtered for human consumption not later than when they are three months of age. Killing and complete destruction, without delay, of all ovine and/or caprine animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:
• — breeding rams of the ARR/ARR genotype,
• — breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,
• — ovine animals carrying at least one ARR allele which are intended solely for human consumption,
• — caprine animals carrying at least one of the following alleles: K222, D146 and S146,
• — if the Member State responsible for the holding so decides, lambs and kids less than three months old provided that they are slaughtered for human consumption not later than when they are three months of age. The animals over 18 months of age killed for destruction, shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. By way of derogation from the conditions set out in the first and second paragraph of option 2, Member States may decide instead to carry out the measures listed in (i), (ii) or (iii):
• (i) to replace the killing and complete destruction of the animals referred to in the second paragraph of option 2 by their slaughtering for human consumption, provided that:
• — the animals are slaughtered for human consumption within the territory of the Member State responsible for the holding,
• — all animals over 18 months of age slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2;
• (ii) to delay the genotyping and subsequent killing and complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2, for a period not exceeding three months. This derogation can be applied in situations where the index case is confirmed close to the commencement of the lambing and/or kidding season, provided that the ewes and/or goats and their new-born are kept isolated from ovine and/or caprine animals of other holdings during the whole period;
• (iii) to delay the killing and complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2 for a maximum period of three years from the date of confirmation of the index case, in ovine or caprine flocks and holdings where ovine and caprine animals are kept together. The application of the derogation set out in the present paragraph shall be limited to cases where the Member State responsible for the holding considers that the epidemiological situation cannot be handled without killing the relevant animals, but that this cannot be carried out immediately due to the low level of resistance in the ovine and caprine population of the holding, coupled with other considerations, including economic factors. Breeding rams other than those of the ARR/ARR genotype shall be killed or castrated without delay. All possible measures to quickly build up genetic resistance in the ovine and/or caprine population of the holding shall be implemented, including reasoned breeding and culling of ewes to increase the frequency of the ARR allele and eliminate the VRQ allele, and the breeding of bucks carrying the K222, D146 or S146 alleles. The Member State responsible for the holding shall ensure that the number of animals to be killed at the end of the period of delay is not greater than immediately after the index case was confirmed. In the case of the application of the derogation set out in the present paragraph, the measures set out in point 4 shall apply to the holding until the complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2, after which the restrictions laid down in point 3 shall be applicable. Following the killing and complete destruction or slaughtering for human consumption of the animals referred to in the second paragraph of option 2, the conditions set out in point 3 shall apply to the holding.
• (d) Option 3 – no mandatory killing and complete destruction of animals A Member State may decide not to kill and completely destroy the animals identified by the inquiry referred to in the second and third indents of point 1(b) where the criteria laid down in at least one of the following four indents are met:
• — it is difficult to obtain replacement male ovine animals of the ARR/ARR genotype and female ovine animals carrying at least one ARR allele and no VRQ allele, or caprine animals carrying at least one of the following alleles: K222, D146 and S146,
• — the frequency of the ARR allele within the ovine breed or holding or the K222, D146 or S146 alleles within the caprine breed or holding is low,
• — it is deemed necessary in order to avoid inbreeding,
• — it is deemed necessary by the Member State based on a reasoned consideration of all the epidemiological factors. The prion protein genotype of all ovine and caprine animals, up to a maximum of 50 of each species, shall be determined within a period of three months from the date of confirmation of the index case of classical scrapie. When additional classical scrapie cases are detected in a holding where option 3 is being applied, the relevance of the reasons and criteria founding the decision to apply option 3 to this holding shall be reassessed by the Member State. If it is concluded that applying option 3 does not ensure a proper control of the outbreak, the Member State shall switch the management of this holding from option 3 to either option 1 or option 2 as laid down in points (b) and (c). The conditions set out in point 4 shall immediately apply to a holding where it has been decided to apply option 3. The Member States allowing recourse to option 3 in the management of classical scrapie outbreaks shall keep records of the reasons and criteria founding each individual application decision. —————

• 2.3. If an animal infected with TSE has been introduced from another holding:
• (a) a Member State may decide, based on the history of the infected animal, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed;
• (b) in the case of land used for common grazing by more than one flock or herd, Member States may decide to limit the application of eradication measures to a single flock or herd, based on a reasoned consideration of all the epidemiological factors;
• (c) where more than one flock or herd is kept on a single holding, Member States may decide to limit the application of the eradication measures to the flock or herd in which the TSE has been confirmed, provided it has been verified that the flocks or herds have been kept isolated from each other and that the spread of infection between the flocks or herds through either direct or indirect contact is unlikely.

• 3.Following the killing and complete destruction or slaughtering for human consumption of all animals identified in a holding in accordance with point 2.2.1, point 2.2.2(b) or point 2.2.2(c), the following restrictions shall apply:

• 3.1. The holding shall be subject to an intensified TSE monitoring protocol. This shall include the testing for the presence of TSE in animals over the age of 18 months, which have died or have been killed in the holding but not in the framework of a disease eradication campaign. Ovine animals of the ARR/ARR genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles are exempt. Testing shall be carried out in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.

• 3.2. Only the following animals may be introduced to the holding:
• — male ovine animals of the ARR/ARR genotype,
• — female ovine animals carrying at least one ARR allele and no VRQ allele,
• — caprine animals provided that a cleaning and disinfection of all animal housing on the premises has been carried out following destocking.

• 3.3. Only the following breeding rams, breeding bucks and ovine and caprine germinal products may be used in the holding:
• — male ovine animals of the ARR/ARR genotype,
• — semen from rams of the ARR/ARR genotype,
• — embryos carrying at least one ARR allele and no VRQ allele,
• — breeding bucks and caprine germinal products as defined in the measures decided by the Member State to build up genetic resistance in the caprine population of the holding.

• 3.4. Movements of animals from the holding shall either be allowed for the purposes of destruction or shall be subject to the following conditions:
• (a) the following animals may be moved from the holding for all purposes, including breeding:
• — ARR/ARR ovine animals,
• — ewes carrying one ARR allele and no VRQ allele, provided that they are moved to other holdings which are restricted following the application of measures in accordance with points 2.2.2(b) (option 1), 2.2.2(c) (option 2), or 2.2.2(d) (option 3),
• — caprine animals carrying at least one of the following alleles: K222, D146 and S146,
• — caprine animals provided that they are moved to other holdings which are restricted following the application of measures in accordance with points 2.2.2(b) (option 1), 2.2.2(c) (option 2) or 2.2.2(d) (option 3);
• (b) the following animals may be moved from the holding to go directly for slaughter for human consumption:
• — ovine animals carrying at least one ARR allele,
• — caprine animals,
• — if the Member State so decides, lambs and kids less than three months old on the date of slaughter,
• — all animals when the Member State has decided to apply the derogations laid down in points 2.2.2(b)(i) and 2.2.2(c)(i);
• (c) if the Member State so decides, lambs and kids may be moved to one other holding located within its territory solely for the purposes of fattening prior to slaughter subject to compliance with the following conditions:
• — the holding of destination does not contain any ovine or caprine animals other than those being fattened prior to slaughter,
• — at the end of the fattening period, the lambs and kids originating from the holdings subject to the eradication measures shall be transported directly to a slaughterhouse located within the territory of the same Member State to be slaughtered not later than when they are 12 months of age.

• 3.5. The restrictions set out in points 3.1 to 3.4 shall continue to apply to the holding:
• (a) until the date of attainment of ARR/ARR status by all ovine animals in the holding, provided that no caprine animals are kept on the holding; or
• (b) until the date all caprine animals on the holding carry at least one of the K222, D146 or S146 alleles, provided that no ovine animals are kept on the holding; or
• (c) until the date of attainment of ARR/ARR status by all ovine animals on the holding and all caprine animals on the holding carry at least one of the K222, D146 or S146 alleles; or
• (d) for a period of two years from the date when all the measures referred to in point 2.2.1, point 2.2.2(b), or point 2.2.2(c) have been completed, provided that no TSE case other than atypical scrapie is detected during this two-year period.

• 4.Following the decision to implement option 3 laid down in point 2.2.2(d) or the derogation provided for in point 2.2.2(c)(iii) the following measures shall immediately apply to the holding:

• 4.1. The holding shall be subject to an intensified TSE monitoring protocol. This shall include the testing for the presence of TSE in animals over the age of 18 months which:
• — have been slaughtered for human consumption,
• — have died or been killed on the holding but not in the framework of a disease eradication campaign. Ovine animals of the ARR/ARR genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles are exempt. Testing shall be carried out in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.

• 4.2. The conditions set out in points 3.2 and 3.3 shall apply. However, by way of derogation from points 3.2 and 3.3, a Member State may allow the introduction and use in the holding of
• — male ovine animals and their semen carrying at least one ARR allele and no VRQ allele including for breeding,
• — female ovine animals carrying no VRQ allele,
• — embryos carrying no VRQ allele, subject to compliance with the following conditions:
• — the breed of the animal kept on the holding is an endangered breed,
• — the breed of the animal kept on the holding is subject to a breeding programme aiming at the preservation of the breed carried out by a breed society as defined in Article 2(5) of Regulation (EU) 2016/1012 or a competent authority in accordance with Article 38 of that Regulation, and
• — the frequency of the ARR allele within that breed is low.

• 4.3. Movement of animals from the holding shall be allowed for the purposes of destruction or to go directly for slaughter for human consumption or shall be subject to the following conditions:
• (a) rams and ewes of the ARR/ARR genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles, may be moved from the holding for all purposes, including breeding, provided that they are moved to other holdings which are subject to the application of measures in accordance with points 2.2.2(c) (option 2) or 2.2.2(d) (option 3);
• (b) if the Member State so decides, lambs and kids may be moved to one other holding located within its territory solely for the purposes of fattening prior to slaughter subject to compliance with the following conditions:
• — the holding of destination does not contain any ovine or caprine animals other than those being fattened prior to slaughter,
• — at the end of the fattening period, the lambs and kids shall be transported directly to a slaughterhouse located within the territory of the same Member State to be slaughtered not later than when they are 12 months of age.

• 4.4. The Member State shall ensure that no semen, embryo and ova are dispatched from the holding.

• 4.5. Common grazing of all ovine and caprine animals in the holding with ovine and caprine animals of other holdings shall be prohibited during the lambing and/or kidding period. Outside of the lambing and/or kidding period, common grazing shall be subject to restrictions to be determined by the Member State, based on a reasoned consideration of all the epidemiological factors.

• 4.6. The restrictions set out in points 4.1 to 4.5 shall apply for a period of two years following the detection of the last TSE case, other than atypical scrapie, on the holdings where option 3 laid down in point 2.2.2(d) has been implemented.

CHAPTER C

Minimum requirements for a breeding programme for resistance to TSEs in ovine animals in accordance with article 6A

PART 1

General requirements

• 1.The breeding programme shall concentrate on flocks of high genetic merit, as defined in point 3 of Annex I of Commission Decision 2002/1003/EC.

• However, Member States where a breeding programme is in place may decide to allow sampling and genotyping of breeding rams only, in flocks not participating in the breeding programme.

• 2.A database shall be established containing at least the following information:

• (a) the identity, breed and number of animals in all flocks participating in the breeding programme;

• (b) the identification of the individual animals sampled under the breeding programme, including breeding rams sampled in flocks not participating in the breeding programme;

• (c) the results of any genotyping tests.

• 3.A system of uniform certification shall be established in which the genotype of each animal sampled under the breeding programme, including breeding rams sampled in flocks not participating in the breeding programme, is certified by reference to its individual identification number.

• 4.A system for the identification of animals and samples, the processing of samples and the delivery of results shall be established which minimises the possibility of human error. The effectiveness of that system shall be subject to regular random checking.

• 5.Genotyping of blood or other tissues collected for the purposes of the breeding programme, including from breeding rams sampled in flocks not participating in the breeding programme, shall be carried out in laboratories that have been approved under the breeding programme.

• 6.The competent authority of the Member State may assist breed societies, to establish genetic banks consisting of semen, ova and embryos representative of prion protein genotypes which are likely to become rare as a result of the breeding programme.

• 7.Breeding programmes shall be drawn up for each breed, taking account of:

• (a) frequencies of the different alleles within the breed;

• (b) rarity of the breed;

• (c) avoidance of inbreeding or genetic drift.

• 8.Where the Member State allows, in accordance with the second paragraph of point 1, the sampling and genotyping of breeding rams in flocks not participating in the breeding programme, the prion protein genotype for the codons 136, 141, 154 and 171 shall be determined for a minimum sample representative of the entire ovine population of the Member State, either:

• (a) once every 3 years with a minimum sample of at least 1 560 ovine animals; or

• (b) at a frequency and with a sample size determined by the Member State based on compliance with the following criteria:
• (i) the sampling design takes into account relevant epidemiological data collected during previous surveys, including data concerning the prion protein genotype of sheep for the codons 136, 141, 154 and 171 by breed, region, age, sex and flock type;
• (ii) the sampling design allows at a minimum to detect a change of 5 % in genotype prevalence over a 3-year period, with a 80 % power and 95 % confidence level.

PART 2

Specific rules for participating flocks

• 1.The breeding programme shall be aimed at increasing the frequency of the ARR allele within the flock, while reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs.

• 2.The minimum requirements for participating flocks shall be the following:

• (a) all animals in the flock that are to be genotyped shall be individually identified using secure means;

• (b) all rams intended for breeding within the flock shall be genotyped before being used for breeding;

• (c) any male animal carrying the VRQ allele shall be slaughtered or castrated, within six months following the determination of its genotype; any such animal shall not leave the holding except for slaughter;

• (d) female animals that are known to carry the VRQ allele shall not leave the holding except for slaughter;

• (e) male animals, including semen donors used for artificial insemination, other than those certified under the breeding programme, shall not be used for breeding within the flock.

• 3.Member States may decide to grant derogations from the requirements set out in point 2(c) and (d) for the purposes of the protection of breeds and production traits.

• 4.Member States shall inform the Commission of any derogation granted under point 3 and of the criteria used.

PART 3

Specific rules for breeding rams sampled in flocks not participating in the breeding programme

• 1.Rams to be sampled shall be individually identified using secure means.

• 2.Any ram found to carry the VRQ allele shall not leave the holding except for slaughter.

PART 4

The framework for the recognition of the TSE-resistant status of flocks of ovine animals

• 1.The framework for the recognition of the TSE-resistant status of flocks of ovine animals shall recognise the TSE-resistant status of flocks of ovine animals that as a result of participation in the breeding programme as provided for in Article 6a, satisfy the criteria required in that programme.

• That recognition shall be granted on at least the following two levels:

• (a) level I flocks shall be flocks composed entirely of ovine animals of the ARR/ARR genotype;

• (b) level II flocks shall be flocks whose progeny have been sired exclusively by rams of the ARR/ARR genotype.

• Member States may decide to grant recognition on further levels to suit national requirements.

• 2.Regular random sampling of ovine animals from TSE-resistant flocks shall be carried out:

• (a) on the holding or at the slaughterhouse to verify their genotype;

• (b) in the case of level I flocks, in animals over 18 months of age at the slaughterhouse, for TSE testing in accordance with Annex III.

PART 5

Reports to be provided to the Commission by the Member States

Member States introducing national breeding programmes to select for resistance to TSE in their ovine populations shall:

• 1. notify to the Commission the requirements for such programmes;

• 1. submit to the Commission a report when changes are made to such programmes.

ANNEX VIII

PLACING ON THE MARKET AND EXPORT

CHAPTER A

Conditions for intra-Union trade in live animals, semen and embryos

SECTION A

Conditions which apply to ovine and caprine animals and semen and embryos thereof

• 1. Holdings with a negligible risk of classical scrapie and a controlled risk of classical scrapie:

• 1.1. For the purpose of intra-Union trade, Member States shall, where applicable, establish and supervise an official scheme for the recognition of holdings with a negligible risk of classical scrapie and holdings with a controlled risk of classical scrapie. Based on that official scheme, they shall, where applicable, establish and maintain lists of holdings of ovine and caprine animals with a negligible risk and holdings with a controlled risk of classical scrapie.

• 1.2. A holding of ovine animals having the TSE-resistance level I status, as laid down in Annex VII, Chapter C, Part 4, point 1(a), and where no case of classical scrapie has been confirmed for a period of at least the preceding seven years, may be recognised as having a negligible risk of classical scrapie. A holding of ovine animals, caprine animals, or ovine and caprine animals may also be recognised as having a negligible risk of classical scrapie provided that it has complied with the following conditions for a period of at least the preceding seven years:
• (a) ovine and caprine animals are permanently identified and records are maintained, to enable them to be traced back to their holding of birth;
• (b) records of movements of ovine and caprine animals in and out of the holding are maintained;
• (c) only the following ovine and caprine animals are introduced into the holding:
• (i) ovine and caprine animals from holdings with a negligible risk of classical scrapie;
• (ii) ovine and caprine animals from holdings which have met the conditions set out in points (a) to (i) for a minimum period of the preceding seven years or for at least the same period of time as the period of time during which the holding, where they are to be introduced, has met the conditions set out in those points;
• (iii) ovine animals of the ARR/ARR prion protein genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles;
• (iv) ovine or caprine animals that comply with the conditions set out in point (i) or (ii) except during the period when they were kept at a semen collection centre, provided that the semen collection centre complies with the following conditions:
• — the semen collection centre is approved in accordance with Part II, Chapter 1, of Commission Delegated Regulation (EU) 2020/686 (³⁶),
• — for a period of the preceding seven years, only those ovine or caprine animals from holdings which have fulfilled during that period the conditions set out in points (a), (b) and (e), and which were subject to regular checks by an official veterinarian or a veterinarian authorised by the competent authority, were introduced into the semen collection centre,
• — no case of classical scrapie has been confirmed at the semen collection centre for a period of the preceding seven years,
• — biosecurity measures are in place at the semen collection centre to ensure that ovine and caprine animals kept at that centre and coming from holdings with a negligible or a controlled risk status for classical scrapie have no direct or indirect contact with ovine and caprine animals coming from holdings of a lower classical scrapie status;
• (d) the holding is subject to regular checks to verify compliance with the conditions set out in points (a) to (i) by an official veterinarian or a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an annual basis;
• (e) no case of classical scrapie has been confirmed;
• (f) all ovine and caprine animals over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2. By way of derogation from that specific condition, Member States may decide that all ovine and caprine animals over 18 months of age with no commercial value, culled at the end of their productive life instead of being slaughtered for human consumption, are inspected by an official veterinarian, and all those exhibiting wasting signs or neurological signs are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2;
• (g) only the following ova and embryos of animals of the ovine and caprine species are introduced into the holding:
• (i) ova and embryos from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which comply with the following requirements:
• — they are permanently identified to enable them to be traced back to their holding of birth,
• — they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency,
• — they showed no clinical sign of classical scrapie at the time of collection of the ova or embryos;
• (ii) ova and embryos of animals of the ovine species carrying at least one ARR allele and of animals of the caprine species carrying at least one of the K222, D146 or S146 alleles;
• (h) only the following semen of animals of the ovine and caprine species are introduced into the holding:
• (i) semen from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible risk or a controlled risk of classical scrapie, or which comply with the following requirements:
• — they are permanently identified to enable them to be traced back to their holding of birth,
• — they showed no clinical sign of classical scrapie at the time of semen collection;
• (ii) semen from rams of the ARR/ARR prion protein genotype and from bucks carrying at least one of the K222, D146 or S146 alleles;
• (i) ovine and caprine animals on the holding have no direct or indirect contact, including shared grazing, with ovine and caprine animals from holdings of a lower classical scrapie status.

• 1.3. A holding of ovine animals, caprine animals or ovine and caprine animals may be recognised as having a controlled risk of classical scrapie provided that it has complied with the following conditions for a period of at least the preceding three years:
• (a) ovine and caprine animals are permanently identified and records are maintained, to enable them to be traced back to their holding of birth;
• (b) records of movements of ovine and caprine animals in and out of the holding are maintained;
• (c) only the following ovine and caprine animals are introduced into the holding:
• (i) ovine and caprine animals from holdings with a negligible or a controlled risk of classical scrapie;
• (ii) ovine and caprine animals from holdings which have met the conditions set out in points (a) to (i) for a minimum period of the preceding three years or for at least the same period of time as the period of time during which the holding, where they are to be introduced, has met the conditions set out in those points;
• (iii) ovine animals of the ARR/ARR prion protein genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles;
• (iv) ovine or caprine animals that comply with the conditions set out in point (i) or (ii) except during the period when they were kept at a semen collection centre, provided that the semen collection centre complies with the following conditions:
• — the semen collection centre is approved in accordance with Part II, Chapter 1, of Delegated Regulation (EU) 2020/686,
• — for a period of the preceding three years, only those ovine or caprine animals from holdings which have fulfilled during that period the conditions set out in points (a), (b) and (e), and which were subject to regular checks by an official veterinarian or a veterinarian authorised by the competent authority, were introduced into the semen collection centre,
• — no case of classical scrapie has been confirmed at the semen collection centre during the period of the preceding three years,
• — biosecurity measures are in place at the semen collection centre to ensure that ovine and caprine animals kept at that centre and coming from holdings with a negligible or a controlled risk status for classical scrapie have no direct or indirect contact with ovine and caprine animals coming from holdings of a lower classical scrapie status;
• (d) the holding is subject to regular checks to verify compliance with the conditions set out in points (a) to (i) by an official veterinarian or a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an annual basis;
• (e) no case of classical scrapie has been confirmed;
• (f) all ovine and caprine animals over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2. By way of derogation from that specific condition, Member States may decide that all the ovine and caprine animals over 18 months of age with no commercial value culled at the end of their productive life instead of being slaughtered for human consumption, are inspected by an official veterinarian, and all those exhibiting wasting signs or neurological signs are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2;
• (g) only the following ova and embryos of animals of the ovine and caprine species are introduced into the holding:
• (i) ova and embryos from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which comply with the following requirements:
• — they are permanently identified to enable them to be traced back to their holding of birth,
• — they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency,
• — they showed no clinical sign of classical scrapie at the time of collection of the ova or embryos,
• (ii) ova and embryos of animals of the ovine species carrying at least one ARR allele and of animals of the caprine species carrying at least one of the K222, D146 or S146 alleles;
• (h) only the following semen of animals of the ovine and caprine species are introduced into the holding:
• (i) semen from donor animals which have been kept since birth in a Member State with a negligible risk of classical scrapie, or in a holding with a negligible risk or with a controlled risk of classical scrapie, or which comply with the following requirements:
• — they are permanently identified to enable them to be traced back to their holding of birth,
• — they showed no clinical sign of classical scrapie at the time of semen collection;
• (ii) semen from rams of the ARR/ARR prion protein genotype and from bucks carrying at least one of the K222, D146 or S146 alleles;
• (i) ovine and caprine animals of the holding have no direct or indirect contact, including shared grazing, with ovine and caprine animals from holdings of a lower classical scrapie status.

• 1.4. If a case of classical scrapie is confirmed in a holding with a negligible risk or a controlled risk of classical scrapie, or in a holding found to have an epidemiological link to a holding with a negligible risk or a controlled risk of classical scrapie as a result of an inquiry referred to in Part 1 of Chapter B of Annex VII, the holding with a negligible risk or a controlled risk of classical scrapie shall be immediately deleted from the list referred to in point 1.1 of this Section. The Member State shall immediately inform the other Member States which have introduced ovine and caprine animals originating from, or semen or embryos collected from ovine and caprine animals kept in the infected holding during a period of the preceding seven years in the case of a holding with a negligible risk of classical scrapie or during the period of the preceding three years in the case of a holding with a controlled risk of classical scrapie.

• 1. Member States or zones of a Member State with a negligible risk of classical scrapie

• 2.1.Where a Member State considers that its territory or part of its territory poses a negligible risk of classical scrapie, it shall submit to the Commission appropriate supporting documentation, setting out in particular that:

• (a) a risk assessment has been conducted, and it has demonstrated that appropriate measures are currently in place and have been taken for the relevant period of time to manage any risk identified. This risk assessment shall identify all potential factors for classical scrapie occurrence and their historic perspective, in particular the:
• (i) importation or introduction of ovine and caprine animals or their semen and embryos potentially infected with classical scrapie;
• (ii) extent of knowledge of the population structure and husbandry practices of ovine and caprine animals;
• (iii) feeding practices, including consumption of meat-and-bone meal or greaves derived from ruminants;
• (iv) importation of milk and milk products of ovine and caprine animals origin intended for use in feeding of ovine and caprine animals;

• (b) for a period of at least the preceding seven years, ovine and caprine animals displaying clinical signs compatible with classical scrapie have been tested;

• (c) for a period of at least the preceding seven years, a sufficient number of ovine and caprine animals over 18 months of age, representative of ovine and caprine animals slaughtered, that have died or have been killed for reasons other than slaughter for human consumption, have been tested annually, to provide a 95 per cent level of confidence of detecting classical scrapie if it is present in that population at a prevalence rate exceeding 0,1 per cent and no case of classical scrapie has been reported during that period;

• (d) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin has been banned and effectively enforced in the whole Member State for a period of at least seven years;

• (e) introductions from other Member States of ovine and caprine animals and semen and embryos thereof are carried out in accordance with point 4.1.(b) or point 4.2.;

• (f) introductions from third countries of ovine and caprine animals and semen and embryos thereof are carried out in accordance with Chapter E or Chapter H of Annex IX.

• 2.2.The negligible risk status for classical scrapie of the Member State or of the zone of the Member State may be approved in accordance with the procedure referred to in Article 24(2).

• The Member State is to notify the Commission of any change in the information submitted according to point 2.1. relating to the disease.

• The negligible risk status approved in accordance with point 2.2. may, in the light of such notification, be withdrawn in accordance with the procedure referred to in Article 24(2).

• 2.3.The Member States or zone of the Member State with a negligible risk for classical scrapie are the following:

• — Austria

• — Czechia

• — Slovenia

• — Finland

• — Sweden.

• 1. National control programme for classical scrapie:

• 3.1.a Member State which has a national control programme for classical scrapie covering all of its territory:

• (a) may submit its national control programme to the Commission, outlining in particular:
• — the distribution of classical scrapie in the Member State,
• — the reasons for national control programme, taking into consideration the importance of the disease and the cost/benefit ratio,
• — the status categories defined for holdings and the standards which must be attained in each such category,
• — the test procedures to be used,
• — the national control programme monitoring procedures,
• — the action to be taken if, for any reason, a holding loses its status,
• — the measures to be taken if the results of checks carried out in accordance with the national control programme programme are positive,

• (b) the programme referred to in point (a) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2); amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2).

• 3.2.The national scrapie control programmes of the following Member States are hereby approved:

• — Denmark,

• — Slovenia.

• 1. Intra-Union trade in ovine and caprine animals and semen and embryos thereof

The following conditions shall apply:

• 4.1. Ovine and caprine animals:
• (a) ovine and caprine animals for breeding destined to Member States other than those with a negligible risk of classical scrapie or with an approved national scrapie control programme shall:
• (i) come from a holding or holdings with a negligible risk or a controlled risk of classical scrapie; or
• (ii) come from a Member State or zone of a Member State with a negligible risk of classical scrapie; or
• (iii) in the case of ovine animals, be of the ARR/ARR prion protein genotype and in the case of caprine animals, carry at least one of the K222, D146 or S146 alleles, provided they do not come from a holding subject to the restrictions set out in Annex VII, Chapter B, points 3 and 4.
• (b) ovine and caprine animals for all intended uses except immediate slaughter destined to Member States with a negligible risk of classical scrapie or with an approved national scrapie control programme shall:
• (i) come from a holding or holdings with a negligible risk of classical scrapie; or
• (ii) come from a Member State or zone of a Member State with a negligible risk of classical scrapie; or
• (iii) in the case of ovine animals, be of the ARR/ARR prion protein genotype and in the case of caprine animals, carry at least one of the K222, D146 or S146 alleles, provided they do not come from a holding subject to the restrictions set out in Annex VII, Chapter B, points 3 and 4.
• (c) By way of derogation from points (a) and (b), the requirements set out in those points shall not apply to ovine and caprine animals which are kept in and moved exclusively between confined establishments as defined in Article 4, point (48), of Regulation (EU) 2016/429 (³⁷).
• (d) By way of derogation from points (a) and (b), the competent authority of a Member State may authorise intra-Union trade in animals that do not comply with the requirements set out in those points, provided that it has received prior consent from the competent authority of the Member States of destination of those animals, and provided that the animals comply with the following conditions:
• (i) the breed of the animals is an endangered breed;
• (ii) the animals are entered in a breeding book for that breed in the Member State of dispatch. This breeding book is established and maintained by a breed society, recognised in accordance with Article 4(3) of Regulation (EU) 2016/1012, or by a competent authority of that Member State, in accordance with Article 38 of that Regulation. The animals are also to be entered in a breeding book for that breed in the Member State of destination. This breeding book is also established and maintained by a breed society, recognised in accordance with Article 4(3) of Regulation (EU) 2016/1012, or by a competent authority of that Member State in accordance with Article 38 of that Regulation;
• (iii) in the Member State of dispatch and in the Member State of destination, the breed societies or competent authorities referred to in point (ii) carry out a breeding programme aimed at the preservation of that breed;
• (iv) the animals do not come from a holding subject to the restrictions set out in Annex VII, Chapter B, points 3 and 4;
• (v) following the entry of the animals not fulfilling the requirements set out in points (a) or (b) into the recipient holding in the Member State of destination, the movement of all ovine and caprine animals in that holding shall be restricted in accordance with point 3.4 of Chapter B of Annex VII, for a period of three years. When the Member State of destination has negligible risk of classical scrapie or has an approved national scrapie control programme this restriction shall be maintained for a period of seven years. By way of derogation from the first paragraph of this point, such restriction on intra-Union trade or to movements of animals within the Member State shall not apply to animals belonging to an endangered breed, which are destined for a holding where this endangered breed is bred. The breed shall be subject to a breeding programme aiming at the preservation of the breed and carried out by a breed society as defined in Article 2(5) of Regulation (EU) 2016/1012 or a competent authority in accordance with Article 38 of that Regulation. Following the intra-Union trade or domestic movement referred to in the second paragraph of point (v), the movement of all ovine and caprine animals on the holding or holdings receiving animals moved under that derogation shall be restricted in accordance with the first and second paragraphs of point (v).

• 4.2. Semen and embryos of animals of the ovine and caprine species shall:
• (a) be collected from animals which have been kept continuously since birth on a holding or holdings with a negligible risk or a controlled risk of classical scrapie, except where the holding is a semen collection centre, provided that the semen collection centre complies with the conditions set out in point 1.3.(c)(iv); or
• (b) be collected from animals which have been kept continuously for the last three years before the collection on a holding or holdings which have complied with all the conditions set out in point 1.3. (a) to (f) for three years, except where the holding is a semen collection centre, provided that the semen collection centre complies with the conditions set out in point 1.3.(c)(iv); or
• (c) be collected from animals which have been kept continuously since birth in a country or zone with a negligible risk of classical scrapie; or
• (d) in the case of semen of animals of the ovine species, be collected from male animals of the ARR/ARR prion protein genotype and in the case of semen of animals of the caprine species, be collected from male animals carrying at least one of the K222, D146 or S146 alleles; or
• (e) in the case of embryos of animals of the ovine species, be carrying at least one ARR allele, in the case of embryos of animals of the caprine species, be carrying at least one of the K222, D146 or S146 alleles.

SECTION C

Conditions which apply to cervids

• 1.List of Member States and areas thereof established in relation to chronic wasting disease

• 1.1. Member States where cases of chronic wasting disease have been confirmed:
• (a) Finland
• (b) Sweden

• 1.2. Areas of Finland and Sweden defined in relation to the risk of chronic wasting disease linked to traditional cross-border movements of live semi-domesticated reindeer to and from Norway:
• (a) in Finland: the area located between the Norwegian-Finnish border and the Norwegian-Finnish Reindeer Fence;
• (b) in Sweden:
• — the county of Norrbotten,
• — the county of Västerbotten,
• — the county of Jämtland,
• — the county of Västernorrland,
• — the Älvdalen municipality in the county of Dalarna,
• — the municipalities of Nordanstig, Hudiksvall and Söderhamn in the county of Gävleborg.

• 2.Movements of live cervids from Norway into the Union

• 2.1. The movements of live cervids from Norway into the Union shall be prohibited.

• 2.2. By way of derogation from point 2.1, the following movements of live cervids shall be permitted:
• (a) movements from Norway to the areas in Sweden listed in point 1.2(b) of live semi-domesticated reindeer for seasonal grazing, provided that the competent authority of Sweden gives its prior written consent to such movements;
• (b) the return from Norway to the areas in Sweden listed in point 1.2(b) of live semi-domesticated reindeer after seasonal grazing in Norway, provided that the competent authority of Sweden gives its prior written consent to such movements;
• (c) movements from Norway to the areas in Finland listed in point 1.2(a) of live semi-domesticated reindeer for seasonal grazing;
• (d) the return from Norway to Finland of live semi-domesticated reindeer which have grazed in Norway in the area located between the Norwegian-Finnish border and the Norwegian-Finnish Reindeer Fence;
• (e) movements from Norway to Sweden or Finland of live cervids for direct slaughter, provided that the competent authority of the Member State of destination gives its prior written consent to such movements;
• (f) movements from Norway to the areas in Sweden listed in point 1.2(b) of live semi-domesticated reindeer for sportive or cultural events, provided that the competent authority of Sweden gives its prior written consent to the movement of each consignment;
• (g) the return from Norway to the areas in Sweden listed in point 1.2(b) of live semi-domesticated reindeer after having taken part in sportive or cultural events in Norway, provided that the competent authority of Sweden gives its prior written consent to the movement of each consignment;
• (h) transit of live cervids from Norway through Sweden or Finland and destined to Norway, provided that the competent authority of the Member State of transit gives its prior written consent.

• 3.Movements of live cervids out of the areas of Finland and Sweden with a tradition of cross-border movements with Norway of semi-domesticated reindeer

• 3.1. The movements of live cervids out of the areas listed in point 1.2 shall be prohibited.

• 3.2. By way of derogation from point 3.1, the following movements of live cervids out of the areas listed in point 1.2 shall be permitted:
• (a) movements of live cervids to Norway, provided that the competent authority of Norway gives its prior written consent to such movements;
• (b) movements of live cervids for direct slaughter in Finland or Sweden, provided that the competent authority of destination gives its prior written consent to such movements;
• (c) movements from the areas of Sweden listed in point 1.2(b) to Finland of live forest reindeer, provided that the competent authority of Finland gives its prior written consent to such movements;
• (d) movements of live cervids from a confined establishment as defined in Article 4(48) of Regulation (EU) 2016/429 of the European Parliament and of the Council (³⁸) and located in an area listed in point 1.2(b) of this Annex, to a confined establishment, as defined in Article 4(48) of Regulation (EU) 2016/429, in Sweden, provided that the competent authority of Sweden gives its prior written consent to such movements.

• 4.Movements of live cervids out of a Member State where chronic wasting disease has been confirmed

• 4.1. Without prejudice to the provisions laid down in point 3, the movements of live cervids out of a Member State listed in point 1.1 to other Member States shall be prohibited.

• 4.2. By way of derogation from point 4.1, the following movements of live cervids out of a Member State listed in point 1.1 shall be permitted:
• (a) movements of live cervids for direct slaughter in another Member State listed in point 1.1 or Norway;
• (b) movements of live cervids for purposes other than direct slaughter to another Member State listed in point 1.1 or Norway, provided that the competent authority of destination gives its prior written consent to such movements;
• (c) movements of live cervids from a confined establishment as defined in, Article 4(48) of Regulation (EU) 2016/429 to a confined establishment, as defined in Article 4(48) of Regulation (EU) 2016/429, in another Member State, provided that the competent authority of destination gives its prior written consent to such movements.

CHAPTER B

Conditions relating to progeny of TSE suspect or confirmed animals referred to in Article 15(2)

It shall be prohibited to place on the market the last-born progeny to which female bovine animals infected with a TSE or BSE-confirmed ovine or caprine animals gave birth during the preceding two-year period or during the period that followed the appearance of the first clinical signs of the onset of the disease.

CHAPTER C

Conditions for intra-Community trade in certain products of animal origin

SECTION A

Products

The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided that they are derived from bovine, ovine and caprine animals that satisfy the requirements of Section B:

• — fresh meat,

• — minced meat,

• — meat preparations,

• — meat products.

SECTION B

Requirements

The products referred to in Section A must satisfy the following requirements:

• (a) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

• (b) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

• (c) the products of bovine, ovine and caprine animal origin are not derived from:
• (i) specified risk material as defined in Annex V;
• (ii) nervous and lymphatic tissues exposed during the deboning process; and
• (iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

SECTION C

Urine hunting lures from cervids

• 1.The movement into the Union of consignments of urine hunting lures derived from cervids originating in Norway shall be prohibited.

• 2.The manufacture, placing on the market and use of urine hunting lures derived from cervids originating in the Member States listed in Chapter A, Section C, point 1.1 shall be prohibited.

CHAPTER D

Conditions applicable to exports

Live bovine animals and products of animal origin derived therefrom are to be subject — as regards exports to third countries — to the rules laid down in this Regulation for intra-Community trade.

ANNEX IX

IMPORTATION INTO THE UNION OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGIN

CHAPTER B

Imports of bovine animals

SECTION A

Imports from a country or a region with a negligible BSE risk

Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:

• (a) the animals were born and continuously reared in a country or region or countries or regions classified in accordance with Commission Decision 2007/453/EC (³⁹) as countries or regions posing a negligible BSE risk;

• (b) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the following bovine animals:
• (i) all BSE cases;
• (ii) all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period; or
• (iii) if the results of the investigation referred to in indent (ii) are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases; and

• (c) if there have been BSE indigenous cases in the country concerned, the animals were born:
• (i) after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced; or
• (ii) after the date of birth of the last BSE indigenous case if born after the date of the feed ban referred to in indent (i).

SECTION B

Imports from a country or a region with a controlled BSE risk

Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that:

• (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk;

• (b) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the following bovine animals:
• (i) all BSE cases;
• (ii) all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period; or
• (iii) if the results of the investigation referred to in indent (ii) are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases;

• (c) the animals were born:
• (i) after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced; or
• (ii) after the date of birth of the last BSE indigenous case if born after the date of the feed ban referred to in indent (i).

SECTION C

Imports from a country or a region with undetermined BSE risk

Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that:

• (a) the country or region has been categorised in accordance with Decision 2007/453/EC as a country or region with undetermined BSE risk;

• (b) the feeding of ruminants with meat-and-bone meal and greaves from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been banned and the ban has been effectively enforced in the country or region;

• (c) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the following bovine animals:
• (i) all BSE cases;
• (ii) all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period; or
• (iii) if the results of the investigation referred to in indent (ii) are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases;

• (d) the animals were born:
• (i) at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the OIE Terrestrial Animal Health Code, has been effectively enforced; or
• (ii) after the date of birth of the last BSE indigenous case if born after the date of the feed ban referred to in indent (i).

CHAPTER C

Imports of products of animal origin from bovine, ovine or caprine animals

SECTION A

Products

The following products of bovine, ovine and caprine origin, as defined in the following points of Annex I to Regulation (EC) No 853/2004, shall be subject to the conditions set out in Sections B, C or D of this Chapter depending on the BSE risk category of the country of origin:

• — fresh meat, as defined in point 1.10 thereof,

• — minced meat, as defined in point 1.13 thereof,

• — mechanically separated meat, as defined in point 1.14 thereof,

• — meat preparations, as defined in point 1.15 thereof,

• — meat products, as defined in point 7.1 thereof,

• — rendered animal fat, as defined in point 7.5 thereof,

• — greaves, as defined in point 7.6 thereof,

• — gelatine, as defined in point 7.7 thereof, other than derived from hides and skins,

• — collagen, as defined in point 7.8 thereof, other than derived from hides and skins,

• — treated stomachs, bladders and intestines, as defined in point 7.9 thereof.

SECTION B

Imports from a country or a region with a negligible BSE risk

Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:

• (a) the country or region is classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk;

• (b) the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante mortem and post mortem inspections;

• (c) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in point 1 of Annex V to this Regulation;

• (d) if the animals, from which the products of bovine animal origin were derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled or an undetermined BSE risk, by way of derogation from point (c) of this Section, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported. In the case of such imports, the carcasses or wholesale cuts of carcasses of bovine animals containing a vertebral column which is defined as specified risk material in accordance with point 1 of Annex V to this Regulation shall be identified by a clearly visible red stripe on the label referred to in Article 13 or 15 of Regulation (EC) No 1760/2000. Furthermore, specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which the removal of the vertebral column is required, shall be added to the Common Veterinary Entry Document (CVED) referred to in Article 2(1) of Regulation (EC) No 136/2004;

• (e) the products of bovine, ovine and caprine animal origin do not contain and are not derived from mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except if the animals, from which the products of bovine, ovine and caprine animal origin are derived, were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been no BSE indigenous cases;

• (f) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, except if the animals from which the products of bovine, ovine and caprine animal origin are derived, were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk;

• (g) if the animals, from which the products of bovine, ovine and caprine animal origin were derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk, the animals have not been fed with meat-and-bone meal or greaves, as defined in the OIE Terrestrial Animal Health Code;