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1. Definition of specified risk material The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk:

(a) as regards bovine animals:

(i) the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months;

(ii) the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia, of animals aged over 30 months; and (iii) the tonsils, the last four meters of the small intestine, the caecum and the mesentery of animals of all ages.

(b) as regards ovine and caprine animals: the skull, including the brain and eyes, and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum.

2. Specific requirements for Member States with negligible BSE risk status

Tissues listed in point 1.(a)(i) and 1.(b), which are derived from animals whose origin is in Member States with a negligible BSE risk, shall be considered as specified risk material.

3. Marking and disposal Specified risk material shall be stained with a dye or, as appropriate, otherwise marked, immediately on removal, and disposed of in accordance with the rules laid down in Regulation (EC) No 1069/2009, and in particular in Article 12 thereof.

4. Removal of specified risk material 4.1. Specified risk material shall be removed at:

(a) slaughterhouses, or, as appropriate, other places of slaughter;

(b) cutting plants, in the case of vertebral column of bovine animals;

(c) where appropriate, in approved establishments or plants referred to in Article 24(1)(h) of Regulation (EC) No 1069/2009.

4.2. By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material, referred to in Article 8(2), may be authorised in accordance with the procedure referred to in Article 24(3) of this Regulation, provided that that alternative test is listed in Annex X, in accordance with the following conditions:

(a) the alternative tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;

(b) no bovine, ovine or caprine product intended for human consumption or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the alternative tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them;

(c) when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse must be destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.

4.3. By way of derogation from point 4.1, Member States may decide to allow:

(a) the removal of the spinal cord of ovine and caprine animals in cutting plants specifically authorised for that purpose;

(b) the removal of the vertebral column of bovine animals from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for that purpose;

(c) the harvesting of head meat from bovine animals in cutting plants specifically authorised for that purpose in accordance with point 9.

4.4. The rules on the removal of specified risk material set out in this Chapter shall not apply to Category 1 material used in accordance with Article 18(2)(a) of Regulation (EC) No 1069/2009 for feeding to zoo animals, as well as to Category 1 material used in accordance with Article 18(2)(b) of that Regulation for feeding to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity.

5. Measures concerning mechanically separated meat Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3), it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals for the production of mechanically separated meat.

6. Measures concerning laceration of tissues

In addition to the prohibition laid down in Article 8(3) against the use, in Member States, or regions thereof, with a controlled or undetermined BSE risk, of laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity, in bovine, ovine or caprine animals whose meat is intended for human or animal consumption, that prohibition shall also be applicable in Member States with a negligible BSE risk.

7. Harvesting of tongues from bovine animals The tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone, except for tongues of bovine animals whose origin is in Member States with a negligible BSE risk.

8. Harvesting of bovine head meat

8.1. Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions:

(a) harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;

(b) where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;

(c) head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue;

(d) head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent;

(e) without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity:

(f) a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.

8.2. By way of derogation from the requirements of point 8.1, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling.

8.3. If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply.

9. Harvesting of bovine head meat in authorised cutting plants By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are complied with:

(a) the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the cutting plant;

(b) the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;

(c) the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants;

(d) a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination;

(e) the harvesting of head meat shall be carried out in accordance with a control system, recognized by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least:

(i) all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins;

(ii) head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected;

(iii) without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity;

(f) a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.