S.I. No. 332 of 2000

European Communities (Specified Risk Material) Regulations, 2000

I, Joe Walsh, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 ( No. 27 of 1972 ), and for the purpose of giving effect to Commission Decision No. 2000/418/EC ¹ of 29 June 2000, hereby make the following Regulations:-

1.        (1)      These Regulations may be cited as the European Communities (Specified Risk Material) Regulations, 2000.

(2)     These Regulations shall come into operation on the 17th day of October, 2000.

2.        (1)      In these Regulations -

“authorised officer” means a person who, for the time being, stands appointed under Regulation 14 or an inspector;

“carcase” means the carcase of a bovine, caprine or ovine animal (cattle, goats or sheep);

“the Commission Decision” means Commission Decision No. 2000/418/EC of 29 June 2000;

“inspector” means an inspector within the meaning of the Diseases of Animals Act, 1966 (No. 6 of 1966) ;

“the Minister” means the Minister for Agriculture, Food and Rural Development;

“protein” means the proteinaceous material derived from rendering animal tissues;

“rendering” includes any process involving crushing, cooking or grinding;

“specified risk material” means -

(a)     the skull including the brain and eyes, the tonsils, the spinal cord and the ileum of a bovine animal aged over 12 months,

(b)     the skull including the brain and eyes, the tonsils and the spinal cord of a caprine or ovine animal aged over 12 months or which has a permanent incisor tooth erupted through the gum, and

(c)     the spleen of a caprine or ovine animal,

and includes anything left attached to such material after dissection of the carcase and any animal matter which comes into contact with the material after it has been removed from the carcase;

“tallow” means the fatty material derived from rendering animal tissues.

(2)     In these Regulations -

(a)     a reference to a Regulation is to a Regulation of these Regulations, unless it appears that reference to some other provision is intended;

(b)     a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it appears that reference to some other provision is intended.

(3)     A word or expression that is used in these Regulations and is also used in the Commission Decision has, unless the contrary intention appears, the meaning in these Regulations that it has in the Commission Decision.

3.        (1)      A person shall not remove specified risk material from a carcase other than at -

(a)     premises -

(i)      licensed for the time being as an abattoir under the Abattoirs Act, 1988 (No. 8 of 1988) , or

(ii)     approved for the time being as a slaughterhouse or cutting plant under the European Communities (Fresh Meat) Regulations, 1997 ( S.I. No. 434 of 1997 ), or

(iii)    approved for the time being as a high-risk rendering plant under the European Communities (Disposal, Processing and Placing on the Market of Animal By-Products) Regulations, 1994 ( S.I. No. 257 of 1994 ) and under Regulation 8, or

(b)     a knackery licensed for the time being by the Minister under the European Communities (Knackery) Regulations, 1996 ( S.I. No. 396 of 1996 ).

However, the vertebral column may be removed at the point of sale to the consumer.

(2)     When specified risk material is removed from a carcase in accordance with paragraph (1), the owner or person in charge of the premises or knackery concerned shall ensure that the specified risk material -

(a)     does not come into contact with any other animal material while in the premises or the knackery,

(b)     is, immediately following its removal, placed in leakproof containers marked with the words “specified risk material”, and

(c)     is dealt with in accordance with the provisions of these Regulations.

(3)     Where specified risk material is not removed from a dead animal not slaughtered for human consumption, the parts of the body containing the specified risk material or the entire body shall be treated as specified risk material.

(4)     The Minister may, on application, decide to allow the dispatch of heads or carcases containing specified risk material to another Member State after agreement with that other Member State both to receive the material and to the specific conditions to be applied to such movements.

4.       Where specified risk material is removed from a carcase in accordance with Regulation 3, the owner or person in charge of the premises or knackery concerned shall ensure that it is stained immediately with a dye or marker approved by the Minister for this purpose, and in any event before it is frozen.

5.       (1)      The Minister may, on application, approve a dye or marker for the staining of specified risk material where he is satisfied that -

(a)     it is suitable for this purpose, and

(b)     it does not present hazards to human food or animal feed.

(2)     An application for an approval under this Regulation shall be made in such form as the Minister may specify.

(3)     The Minister may, if he is not satisfied that the provisions of these Regulations are being or have been complied with by a person granted an approval under this Regulation or will be complied with by an applicant for such an approval, revoke the approval or refuse to grant such an approval.

(4)     Where the Minister proposes to revoke an approval granted under this Regulation or refuse to grant such an approval, he shall -

(a)     notify the person concerned in writing of the proposal and the reasons therefor,

(b)     notify the person in writing that he, or a person acting on his behalf, may make representations to the Minister in relation to the proposal within 14 days of the receipt by him of the notification, and

(c)     consider any such representations duly made before deciding whether to proceed with the proposal or not.

6.        (1)      A person shall not use the bones of the head and vertebral column of bovine, caprine or ovine animals for the production of mechanically recovered meat.

(2)     With effect from 31 December 2000, a person shall not use the slaughter technique (known as “pithing”) where, after stunning, an elongated rod-shaped instrument is introduced into the cranial cavity to lacerate the central nervous tissue of bovine, caprine or ovine animals whose meat is intended for human or animal consumption.

7.        (1)      A person shall not move or cause to be moved specified risk material from premises in which it has been removed from a carcase in accordance with Regulation 3 other than to -

(a)     premises which stand approved for the time being by the Minister under this Regulation for the storage of specified risk material, or

(b)     a rendering plant which stands approved for the time being by the Minister under Regulation 8 for the rendering of specified risk material.

(2)     The Minister may, on application by an owner or person in charge of premises, grant licenses in respect of premises which have been approved by him for the storage of -

(a)     specified risk material, or

(b)     protein or tallow which has been obtained from specified risk material after it has been rendered,

where he is satisfied that they are properly equipped and have sufficient facilities for storing and handling such products in a manner to keep them separate from any other products on the premises.

(3)     An application for a license under this Regulation shall be made in such form as the Minister may specify.

(4)     The Minister may, if he is not satisfied that the provisions of these Regulations are being or have been complied with by a person granted a license under this Regulation or will be complied with by an applicant for such a license, revoke the license or refuse to grant the license.

(5)     Where the Minister proposes to revoke the license granted under this Regulation, or to refuse to grant such a license, he shall -

(a)     notify the person concerned in writing of the proposal and of the reasons therefor,

(b)     notify the person in writing that he, or the person acting on his behalf, may make representations to the Minister in relation to the proposal within 14 days of the receipt by him of the notification, and

(c)     consider any such representations duly made before deciding whether to proceed with the proposal or not.

(6)     The owner or person in charge of premises which have been approved under this Regulation shall keep, for a period of six years following the date on which specified risk material, or protein or tallow obtained from the rendering of specified risk material, arrives at the premises, a record in writing of -

(a)     the weight of the specified risk material, or protein or tallow obtained from the rendering of specified risk material, delivered;

(b)     the date of delivery; and

(c)     the place from which it was consigned.

(7)     The owner or person in charge of the premises approved under this Regulation shall ensure that specified risk material, or protein or tallow obtained from the rendering of specified risk material, is kept separate from all other products on the premises.

(8)     A person shall not remove specified risk material, or protein or tallow obtained from the rendering of specified risk material, from premises approved under this Regulation other than to -

(a)     another premises approved for the time being to store specified risk material, or protein or tallow obtained from the rendering of specified risk material, under this Regulation,

(b)     in the case of specified risk material, a rendering plant approved for the time being to process specified risk material under Regulation 8, or

(c)     in the case of protein or tallow obtained from the rendering of specified risk material, premises approved by the Minister for the destruction or disposal of such protein or tallow under Regulation 11.

(9)     Where specified risk material, or protein or tallow obtained from the rendering of specified risk material, is removed from premises in accordance with paragraph (8), the owner or person in charge of the premises from which it is removed shall keep, for a period of six years from the date on which it is removed, a record in writing of -

(a)     the weight of the specified risk material, or protein or tallow obtained from the rendering of specified risk material, removed,

(b)     the date of its removal, and

(c)     the place of destination.

(10)   Notwithstanding the other provisions of this Regulation, the Minister may, where he is satisfied that there is a serious and immediate risk to animal or human health, suspend without notice a licence granted under this Regulation.

8.        (1)      The Minister may, on application by the owner or person in charge thereof, grant a licence to a rendering plant which has been approved by him for the purposes of rendering specified risk material where he is satisfied that -

(a)     it has suitable facilities to ensure that specified risk material and the protein or tallow derived from the rendering of such material are kept separate from all other products at the plant, and

(b)     no other products, other than specified risk material, will be rendered at the plant.

(2)     An application for a licence under this Regulation shall be made in such form as the Minister may specify.

(3)     The Minister may, if he is not satisfied that the provisions of these Regulations are being or have been complied with by a person granted a licence under this Regulation or will be complied with by an applicant for such a licence, revoke the licence or refuse to grant such a licence.

(4)     Where the Minister proposes to revoke a licence granted under this Regulation, or refuse to grant such a licence, he shall -

(a)     notify the person concerned in writing of the proposal and of the reasons therefor,

(b)     notify the person in writing that he, or a person acting on his behalf, may make representations to the Minister in relation to the proposal within 14 days of the receipt by him of the notification, and

(c)     consider any such representations duly made before deciding whether to proceed with the proposal or not.

(5)     The owner or person in charge of a plant which has been approved under this Regulation shall keep, for a period of six years following the date on which specified risk material arrives at the plant, a record in writing of -

(a)     the weight of the specified risk material delivered,

(b)     the date of delivery, and

(c)     the place from which it was consigned.

(6)     The owner or person in charge of a plant approved under this Regulation shall ensure that -

(a)     specified risk material is kept separate from all other products on the premises;

(b)     the protein or tallow obtained from the rendering of specified risk material is not removed from the plant other than to -

(i)     premises which stand approved for the time being under Regulation 7, or

(ii)     premises which stand approved for the time being by the Minister for the destruction or disposal of such protein or tallow under Regulation 11.

(7)     Notwithstanding the other provisions of this Regulation, the Minister may, where he is satisfied that there is a serious and immediate risk to animal or human health, suspend without notice a licence granted under this Regulation.

9.       A person rendering a whole carcase shall do so only at a rendering plant approved for the time being under Regulation 8 as if the carcase were specified risk material.

10.      (1)     Specified risk material, or protein or tallow obtained from the rendering of specified risk material, shall not be transported to premises which have been approved under Regulations 7 or 11 or a rendering plant which has been approved under Regulation 8 other than by a vehicle or other means of transport approved by the Minister for that purpose under this Regulation.

(2)     The Minister may, on application by the owner or person in charge thereof, grant approval in respect of a vehicle or other means of transport for the purposes of the transport of specified risk material, or protein or tallow obtained from the rendering of specified risk material, where he is satisfied that -

(a)     it is suitable for the purpose of such transport, and

(b)     the owner or person in charge thereof has adequate facilities for the cleansing and disinfection of the vehicle or other means of transport, and

(c)     the owner or person in charge thereof will maintain a written record in such form and contain such particulars as the Minister may require, for a period of six years, of the weight and origin of the specified risk material.

(3)     The Minister may, if he is not satisfied that the provisions of these Regulations are being or have been complied with by a person granted a licence under this Regulation or will be complied with by an applicant for such a licence, revoke the licence or refuse to grant the licence.

11.      (1)     The Minister may, on application by an owner or person in charge thereof, grant a licence to premises approved by him for the disposal or destruction of protein or tallow obtained from the rendering of specified risk material, where he is satisfied that -

(a)     the destruction or disposal concerned may lawfully be carried out at the premises concerned, and

(b)     the method of destruction or disposal carried out at the premises does not pose any risk to animal or human health and is carried out in accordance with the provisions laid down in paragraph 3 of Annex I to the Commission Decision.

(2)     An application for a licence under this Regulation shall be made in such form as the Minister may specify.

(3)     The Minister may, if he is not satisfied that the provisions of these Regulations are being or have been complied with by a person granted a licence under this Regulation or will be complied with by an applicant for such a licence, revoke the licence or refuse to grant the licence.

(4)     Where the Minister proposes to revoke a licence granted under this Regulation, or to refuse to grant such a licence, he shall -

(a)     notify the person concerned in writing of the proposal and the reasons therefor,

(b)     notify the person in writing that he, or a person acting on his behalf, may make representations to the Minister in relation to the proposal within 14 days of the receipt by him of the notification, and

(c)     consider any such representations duly made before deciding whether to proceed with the proposal or not.

(5)     The owner or person in charge of premises which have been approved under this Regulation shall keep, for a period of six years following the date on which the protein or tallow arrives at the premises, a record in writing of -

(a)     the weight of the protein or tallow delivered,

(b)     the date of delivery, and

(c)     the place from which the protein and tallow was consigned.

(6)     A person shall not dispose of or destroy, or attempt to dispose of or destroy, protein or tallow obtained from the rendering of specified risk material other than at premises approved by the Minister under this Regulation.

(7)     Notwithstanding the other provisions of this Regulation, the Minister may, where he is satisfied that there is a serious and immediate risk to animal or human health, suspend without notice a licence granted under this Regulation.

12.      (1)     The Minister may attach such conditions to a licence granted under Regulations 7, 8 or 11, or vary or revoke any such conditions, as he may deem necessary for the purposes of these Regulations.

(2)     A person shall not contravene any condition attached to a licence under paragraph (1), including any condition as may be varied thereunder.

13.      (1)     With effect from 31 March 2001, a person shall not import products of animal origin, as defined in Annex II to the Commission Decision, containing material derived from bovine, caprine or ovine animals from third countries or regions thereof, unless an accompanying health certificate has been supplemented by a declaration signed by a veterinary surgeon of the competent authority of the country of production in the format laid down in Article 6(2)(a) of the Commission Decision.

(2)     The provisions of paragraph (1) shall apply where the Minister is satisfied that:-

(a)     the third country of production has not submitted a dossier referred to in Article 6(3)(a) of the Commission Decision to the Commission in support of its request to be exempted from the provisions of the Commission Decision, or

(b)     the third country has submitted a dossier referred to in Article 6(3)(b) of the Commission Decision and the outcome of a risk assessment identifying all potential risk factors is not considered satisfactory.

14.      (1)     The Minister may appoint such and so many persons as he thinks fit to be authorised officers for the purposes of these Regulations.

(2)     An inspector or an authorised officer, when exercising any power conferred on him for the purposes of these Regulations, shall, if so requested by any person affected, produce evidence in writing of his appointment as an authorised officer or inspector.

15.      (1)      An authorised officer may for the purposes of these Regulations or the Commission Decision -

(a)     at all reasonable times, enter any premises or place, and any vehicle, wagon, vessel or other means of transport (other than any premises, place or means of transport consisting of a dwelling or other than so much thereof as consists of a dwelling) where he reasonably suspects that any animal, product or document which he considers should be examined or inspected for the purposes of his functions under these Regulations is to be found,

(b)     there or at any other place, examine and inspect any animal, product or document and in the case of an animal, an inspector may carry out a clinical inspection thereof,

(c)     take, without payment of compensation, such samples of any product at the premises or place or on or in the means of transport as he may reasonably require for the purposes of his functions under these Regulations and carry out or have carried out on the samples such analyses, examinations, checks and inspections as he considers necessary or expedient for the purposes of such functions,

(d)     there or at any other place, carry out or have carried out such examinations, checks and inspections of the premises, place or means of transport and any equipment, machinery or plant and any product found there as he reasonably considers necessary or expedient for the purposes of such functions,

(e)     require any person at the premises or place or on or in the means of transport and the owner or person in charge thereof and any person employed in connection therewith to give to him such information and to produce to him such books, certificates, documents and other records, including any records required to be kept by these Regulations, within the power or procurement of the person as he may reasonably require for the purposes of his functions under these Regulations,

(f)     examine and take copies of, or of extracts from, any such records as aforesaid,

(g)     seize and detain anything found there which he reasonably believes to be evidence of an offence under these Regulations.

(2)     A person shall not, in purported compliance with a requirement under paragraph (1)(e) above, give information to an authorised officer that he knows to be false or misleading in a material respect.

16.      (1)      A person who contravenes a provision of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,500 or to imprisonment for a term not exceeding six months or to both.

(2)     A person shall not obstruct or impede an authorised officer in the due exercise of any of the functions of the officer under these Regulations.

(3)     Where an offence under these Regulations is committed by a body corporate and is proven to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentioned offence.

17.      An offence under these Regulations may be prosecuted by the Minister.

18.      The provisions of these Regulations shall not apply to:-

(a)     cosmetic or medicinal products or medical devices, together with their starting materials or intermediate products;

(b)     products not destined for use in human food, animal feed or fertilisers, together with their starting materials or intermediate products;

(c)     products of animal origin destined for exhibition, teaching, research, special studies or analysis, provided those products are not eventually consumed by humans or by animals other than those kept for the research projects concerned.

19.      These Regulations are in addition to and not in substitution for -

(a)     the European Communities (Disposal, Processing and Placing on the Market of Animal By-Products) Regulations, 1994 ( S.I. No. 257 of 1994 ),

(b)     the European Communities (Importation of Bovine Animals and Products obtained from Bovine Animals from the United Kingdom) Regulations, 1999 ( S.I. No. 464 of 1999 ),

(c)     the European Communities (Mammalian Animal Waste) Regulations, 1998 ( S.I. No. 2 of 1998 ),

(d)     the European Communities (Processing of Mammalian Animal Waste) Regulations, 2000 ( S.I. No. 182 of 2000 ).

20.      The Diseases of Animals (Bovine Spongiform Encephalopathy) (Specified Risk Material) Order, 1997 ( S.I. No. 80 of 1997 ) and the Diseases of Animals (Bovine Spongiform Encephalopathy) (Specified Risk Material) (Amendment) Order, 1998 ( S.I. No. 144 of 1998 ) are hereby revoked.

21.      A local authority shall execute and enforce this Order within its functional areas in respect of any abattoir licensed by the Minister in accordance with the provisions of the Abattoirs Act, 1988 ( S.I. No. 8 of 1988 ).

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Regulations implement Commission Decision 2000/418/EC of 29 June 2000 and govern the rules for the removal, isolation and disposal of specified risk material for the purposes of the control of Bovine Spongiform Encephalopathy.

Published by the Stationary Office, Dublin.

¹ O.J. No. L 158 of 30.6.2000, p. 76.