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

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 (²⁹). 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

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.

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.

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.

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.

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

ANNEX VIII

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

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:

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

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 (³²) 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

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 (³³) 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).

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).

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

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.

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;

(h) 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 products were produced and handled in a manner which ensures that they did not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process.

1.Imports of products of bovine, ovine and caprine animal origin referred to in Section A 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 from which the products of bovine, ovine and caprine animal origin were derived passed ante mortem and post mortem inspections;

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

(d) 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, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

(e) 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;

(f) 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 products were produced and handled in a manner which ensures that they did not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process.

2.For products of bovine animal origin, by way of derogation from point 1(d) 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.

3.When the removal of the vertebral column is required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, 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.

4.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 in the case of imports.

5.In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines 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 from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante mortem and post mortem inspections;

(c) if the intestines are sourced from a country or region where there have been BSE indigenous cases: (i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been enforced; or (ii) 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.

1.Imports of products of bovine, ovine and caprine animal origin referred to in Section A 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 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, as defined in the OIE Terrestrial Animal Health Code, 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 killed, after stunning, by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity;

(c) the products of bovine, ovine and caprine animal origin do not contain and are not derived from: (i) specified risk material as defined in point 1 of Annex V to this Regulation; (ii) nervous and lymphatic tissues exposed during the deboning process; (iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

2.For products of bovine animal origin, by way of derogation from point 1(c), 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.

3.When removal of the vertebral column is required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, 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.

4.Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which 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 in the case of imports.

5.In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines 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 an undetermined BSE risk;

(b) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante mortem and post mortem inspections;

(c) if the intestines are sourced from a country or region where there have been BSE indigenous cases: (i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or (ii) 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.

CHAPTER D

Imports of animal by-products and derived products from bovine, ovine and caprine origin

This Chapter shall apply to the following animal by-products, as defined in points (1) of Article 3 of Regulation (EC) No 1069/2009 and the following derived products as defined in point (2) of that Article, provided that those animal by-products and derived products are of bovine, ovine and caprine animal origin:

(a) rendered fats derived from Category 2 material, which are intended to be used as organic fertilisers or soil improvers, as defined in point 22 of Article 3 of Regulation (EC) No 1069/2009;

(b) bones and bone products derived from Category 2 material;

(c) rendered fats derived from Category 3 material which are intended to be used as organic fertilisers or soil improvers or as feed, as defined in points 22 and 25 respectively of Article 3 of Regulation (EC) No 1069/2009, or their starting materials;

(d) pet food including dog chews;

(e) blood products;

(f) processed animal protein;

(g) bones and bone products derived from Category 3 material;

(h) gelatine and collagen derived from materials other than hides and skins;

(i) Category 3 material and derived products other than those referred to in points (c) to (h) excluding: (i) fresh hides and skins, treated hides and skins; (ii) gelatine and collagen derived from hides and skins; (iii) fat derivatives.

(a) the animal by-product or derived product: (i) does not contain and is not derived from specified risk material as defined in point 1 of Annex V to this Regulation; and (ii) does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except if the animals, from which the animal by-product or derived product 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; and (iii) is derived from animals which have not been killed, after stunning, by laceration of the central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC; or (b) the animal by-product or derived product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.

(a) the animal by-product or derived product originates from a country or region, which is classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC, and in which there has been no BSE indigenous case; or (b) the animal by-product or derived product originates from a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC in which there has been a BSE indigenous case, and the animal by-product or derived product was derived from animals born 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 in that country or region. By way of derogation from the preceding paragraph, the attestation referred to in points (a) and (b) shall not be required for the importation of processed petfood, which is packaged and labelled in accordance with Union legislation.

(a) the ovine and caprine animals from which those animal by-products or derived products have been derived have been kept continuously since birth in a country where the following conditions are fulfilled: (i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or a confirmation of classical scrapie; (iv) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years; (b) the milk and milk products of ovine or caprine animals originate from holdings where no official restrictions are imposed due to a suspicion of TSE; (c) the milk and milk products of ovine or caprine animals originate from holdings where no case of classical scrapie has been diagnosed during a period of at least the preceding seven years or, following the confirmation of a case of classical scrapie: (i) all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele, other ovine animals carrying at least one ARR allele and caprine animals carrying at least one of the K222, D146 or S146 alleles; or (ii) all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for a period of at least two years since the date of confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype and caprine animals carrying at least one of the K222, D146 or S146 alleles: — animals which have been slaughtered for human consumption; and — animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.

CHAPTER E

Imports of ovine and caprine animals

Ovine and caprine animals imported into the Union shall be subject to the presentation of an animal health certificate attesting that they have been kept continuously since birth in a country where the following conditions are fulfilled:

(1) classical scrapie is compulsorily notifiable;

(2) an awareness, surveillance and monitoring system is in place;

(3) ovine and caprine animals affected with classical scrapie are killed and completely destroyed;

(4) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years.

In addition to the conditions set out in points 1 to 4, the animal health certificate shall attest that:

(5) for ovine and caprine animals for breeding imported into the Union and intended for Member States other than those with a negligible risk of classical scrapie or those with an approved national scrapie control programme listed in Annex VIII, Chapter A, Section A, point 3.2, the following conditions have been complied with: (a) the imported ovine and caprine animals come from a holding or holdings that have complied with the conditions laid down in Annex VIII, Chapter A, Section A, point 1.3; or (b) they are ovine animals of the ARR/ARR prion protein genotype or caprine animals carrying at least one of the K222, D146 or S146 alleles, and they come from a holding or holdings where no official movement restriction has been imposed due to BSE or classical scrapie during the last 2 years; or (c) for ovine and caprine animals from Great Britain imported into Northern Ireland until 31 December 2024, the imported ovine and caprine animals come from a holding or holdings: (i) where no official movement restriction has been imposed due to BSE or classical scrapie during the last 3 years; and (ii) which have applied, before 1 January 2022, to the official scheme for the recognition of holdings having a controlled risk of classical scrapie in accordance with the conditions laid down in Annex VIII, Chapter A, Section A, point 1.3, and which comply with the conditions laid down in points (a) to (i) thereof at the time of import into Northern Ireland.

(6) For ovine and caprine animals for all uses except immediate slaughter imported into the Union and intended for a Member State with a negligible risk of classical scrapie or with an approved national scrapie control programme listed in point 3.2 of Section A of Chapter A of Annex VIII, the following conditions have been complied with: (a) they come from a holding or holdings that have complied with the conditions of point 1.2 of Section A of Chapter A of Annex VIII; or (b) they are ovine animals of the ARR/ARR prion protein genotype or caprine animals carrying at least one of the K222, D146 or S146 alleles, and they come from a holding where no official movement restriction has been imposed due to BSE or classical scrapie during the last two years.

CHAPTER F

Imports of products of animal origin from farmed and wild cervid animals

1.When fresh meat, minced meat, meat preparations and meat products as defined in points 1.10, 1.13, 1.15 and 7.1 respectively of Annex I to Regulation (EC) No 853/2004, derived from farmed cervid animals, are imported into the Union from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:

‘This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.’

2.When fresh meat, minced meat, meat preparations and meat products as defined in points 1.10, 1.13, 1.15 and 7.1 respectively of Annex I to Regulation (EC) No 853/2004, derived from wild cervid animals, are imported into the Union from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:

‘This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.’

3.The importation into the Union of urine hunting lures derived from cervids shall be prohibited.

CHAPTER H

Import of ovine and caprine semen and embryos

Ovine and caprine semen and embryos imported into the Union shall be subject to the presentation of an animal health certificate attesting that:

(1) the donor animals have been kept continuously since birth in a country where the following conditions are fulfilled: (a) classical scrapie is compulsorily notifiable; (b) an awareness, surveillance and monitoring system is in place; (c) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (d) the feeding to ovine and caprine animals of meat-and-bone meal, or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years; and

(2) the donor animals have been kept continuously for a period of three years preceding the date of the collection of the exported semen or embryos in a holding or holdings which have satisfied during that period all the requirements set out in point 1.3.(a) to (f) of Section A of Chapter A of Annex VIII 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) of that Section; or (a) in the case of semen of animals of the ovine species, the semen has been collected from male animals of the ARR/ARR prion protein genotype and in the case of semen of animals of the caprine species, the semen has been collected from male animals carrying at least one of the K222, D146 or S146 alleles; or (b) in the case of embryos of animals of the ovine species, the embryos carry at least one ARR allele and in the case of embryos of animals of the caprine species, the embryos carry at least one of the K222, D146 or S146 alleles.

ANNEX X

CHAPTER C

Sampling and laboratory testing

1. Sampling

Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (the Manual). In addition to, or in the absence of, OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the EU reference laboratory.

In particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the EU reference laboratory, in order to ensure the detection of all known strains of TSE in small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid test is negative. Where the result is positive or inconclusive the residual tissues must be subject to confirmatory testing, and be processed subsequently in accordance with the EU reference laboratory guidelines on discriminatory testing and classification — ‘TSE strain characterisation in small ruminants: A technical handbook for National Reference Laboratories in the EU’.

The samples shall be correctly marked as to the identity of the sampled animal.

2. Laboratories

Any laboratory examination for TSE shall be carried out in official diagnostic laboratories designated for that purpose by the competent authority.

3. Methods and protocols

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:

(i) the immunohistochemical (IHC) method;

(ii) Western blot;

(iii) the demonstration of characteristic fibrils by electron microscopy;

(iv) histopathological examination;

(v) the combination of rapid tests as laid down in the third subparagraph.

If the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.

Rapid tests may be used for both primary screening of suspect cases and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the EU reference laboratory —‘OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test’, and provided that:

(i) the confirmation is carried out in a national reference laboratory for TSEs; and

(ii) one of the two rapid tests is a Western blot; and

(iii) the second rapid test used: — includes a negative tissue control and a bovine BSE sample as positive tissue control, — is of a different type than the test used for the primary screening; and

(iv) if a rapid Western blot is used as the first test, the result of that test must be documented and the blot image submitted to the national reference laboratory for TSEs; and

(v) where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols.

If the result of one of the confirmatory examinations referred to in points (i) to (v) of the first subparagraph is positive, the animal shall be regarded as a positive BSE case.

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I shall be examined by a rapid test.

When the result of the rapid test is inconclusive or positive, the sample shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:

(i) the immunohistochemical (IHC) method;

(ii) Western blot;

(iii) the demonstration of characteristic fibrils by electron microscopy;

(iv) histopathological examination;

(v) the combination of rapid tests as laid down in the fourth subparagraph.

Where the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.

Rapid tests may be used for both primary screening and, if inconclusive or positive, for subsequent confirmation, according to the guidelines from the EU reference laboratory — ‘OIE rules for the official confirmation of BSE in bovines (based on an initial reactive result in an approved rapid test) by using a second rapid test, and provided that’:

(i) the confirmation is carried out in a national reference laboratory for TSEs; and

(ii) one of the two rapid tests is a Western blot; and

(iii) the second rapid test used: — includes a negative tissue control and a bovine BSE sample as positive tissue control, — is of a different type than the test used for the primary screening; and

(iv) if a rapid Western blot is used as the first test, the result of that test must be documented and the blot image submitted to the national reference laboratory for TSEs; and

(v) where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols.

An animal shall be regarded a positive BSE case if the result of the rapid test is inconclusive or positive, and at least one of the confirmatory examinations referred to in points (i) to (v) of the second subparagraph is positive.

Samples from all positive BSE cases shall be forwarded to a laboratory, appointed by the competent authority, which has participated successfully in the latest proficiency testing organised by the EU reference laboratory for discriminatory testing of confirmed BSE cases, where they shall be further tested in accordance with the methods and protocols laid down in the EU reference laboratory's method for the classification of bovine TSE isolates (a two-blot method for the provisional classification of bovine TSE isolates).

Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:

(i) the immunohistochemical (IHC) method;

(ii) Western blot;

(iii) the demonstration of characteristic fibrils by electron microscopy;

(iv) histopathological examination.

In case the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.

Rapid tests may be used for primary screening of suspect cases. Such tests may not be used for subsequent confirmation.

Where the result of the rapid test used for primary screening of suspect cases is positive or inconclusive, the sample shall be subjected to an examination by one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph. Where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.

If the result of one of the confirmatory examinations referred to in points (i) to (iv) of the first subparagraph is positive, the animal shall be regarded as a positive TSE case.

Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test, in order to ensure the detection of all known strains of TSE.

When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by histopathology, immunohistochemistry, Western blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in point (a). If the result of the confirmatory examination is negative or inconclusive, the tissues shall be submitted to a further examination by immunohistochemistry or Western blotting.

If the result of one of the confirmatory examinations is positive, the animal shall be regarded as a positive TSE case.

Samples that, following the examinations referred to in points (a) or (b), are regarded as positive TSE cases, but which are not considered atypical cases, shall be examined to exclude the presence of BSE only when they come from an index case. Other cases, which display characteristics that, according to the testing laboratory, merit investigation, shall also be examined to exclude the presence of BSE.

For the exclusion of the presence of BSE, samples shall be examined by a discriminatory Western blotting method, listed in the guidelines of the EU reference laboratory. The discriminatory examination shall be performed by an official laboratory, designated by the competent authority, which has participated successfully in the latest proficiency testing organised by the EU reference laboratory for the use of such a method.

TSE cases in which the presence of BSE cannot be excluded according to the guidelines issued by the EU reference laboratory by the primary molecular testing referred to in point (i), shall be referred immediately to the EU reference laboratory, with all the relevant information available. The samples shall be submitted to further investigation and confirmation by at least one alternative method, differing immunochemically from the original primary molecular method. The design of the secondary molecular testing, in accordance with the latest scientific knowledge and laboratory expertise, shall be approved on a case-by-case basis by the EU reference laboratory, as described in its guidelines. The EU reference laboratory shall be assisted by a panel of experts referred to as the Strain Typing Expert Group (STEG), as well as by a representative of the relevant national reference laboratory.

The results shall be interpreted by the EU reference laboratory assisted by the STEG, as well as a representative of the relevant national reference laboratory. The Commission shall be informed immediately about the outcome of that interpretation.

Samples indicative of BSE or inconclusive for BSE, following secondary molecular testing, shall be further analysed by mouse bioassay for final confirmation. The nature or quantity of available material may influence the bioassay design, which will be approved by the EU reference laboratory assisted by the STEG on a case by case basis. Bioassays will be performed by the EU reference laboratory, or by laboratories designated by the EU reference laboratory.

The results shall be interpreted by the EU reference laboratory assisted by the STEG. The Commission shall be informed immediately about the outcome of that interpretation.

Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunohistochemistry, Western blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations with positive results shall be carried out in the event of the first appearance of the disease.

In particular, where BSE is suspected in a species other than bovine animals, the cases shall be referred to the EU reference laboratory assisted by the STEG for further characterisation.

4. Rapid tests

For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:

— the immunoblotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),

— the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test),

— the microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),

— the immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA & HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),

— the lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),

— the two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit).

For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), only the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:

— the sandwich immunoassay for PrPRes detection (short assay protocol) carried out following denaturation and concentration steps (Bio-Rad TeSeE SAP rapid test),

— the sandwich immunoassay for PrPRes detection with the TeSeE Sheep/Goat Detection kit carried out following denaturation and concentration steps with the TeSeE Sheep/Goat Purification kit (Bio-Rad TeSeE Sheep/Goat rapid test),

— the immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (HerdChek BSE-Scrapie Antigen (IDEXX Laboratories)),

In all rapid tests, sample tissue on which the test must be applied must comply with the manufacturer's instructions for use.

Producers of rapid tests must have a quality assurance system in place that has been approved by the EU reference laboratory and ensures that the test performance does not change. Producers must provide the EU reference laboratory with the test protocols.

Changes to rapid tests and to test protocols may only be made after prior notification to the EU reference laboratory and provided that the EU reference laboratory finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.

5. Alternative tests

(To be defined)