COMMISSION DECISION of 18 July 1996 on the approval of alternative heat treatment systems for processing animal waste with a view to the inactivation of spongiform encephalopathy agents (Text with EEA relevance) (96/449/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Annex II, Chapter II, paragraph 6 (c) thereof,

Whereas Commission Decision 92/562/EEC (2), as amended by the Act of Accession of Austria, Finland and Sweden, was adopted to define alternative systems of heat treatment provided for in paragraph 6 (c) of Annex II, Chapter II to Directive 90/667/EEC;

Whereas in 1994 phase 1 of a scientific study into the physical parameters which must be applied in order to inactivate the agents of BSE and scrapie identified the minimum parameters necessary for inactivation of the BSE agent; it also identified certain processes which were not effective;

Whereas Commission Decision 94/382/EC of 27 June 1994 on the approval of alternative heat treatment systems for processing animal waste of ruminant origin, with a view to the inactivation of spongiform encephalopathy agents (3), as amended by Decision 95/29/EC (4), has been adopted to establish the minimum standards for use in the alternative systems provided for in Decision 92/562/EEC, and to prohibit the use of the systems which are not effective;

Whereas the minimum standards laid down in Decision 94/382/EC were considered to be provisional, pending the results of future studies;

Whereas the results of phase 2 of this study showed that only one system tested was capable of fully inactivating the scrapie agent in meat-and-bone meal;

Whereas, therefore, it is necessary to ensure that systems which have been shown to be ineffective are not used for the processing of mammalian animal waste in order to protect animal health from the hazard of spongiform encephalopathy agents in animal feed, unless an effective sterilization phase is added to the process;

Whereas, at its meeting on 1 to 3 April 1996, the Council concluded that a Commission Decision in accordance with the Standing Veterinary Committee procedure should be adopted to require that all animal waste of mammalian origin in the Community is to be processed by a method that has been demonstrated as being de facto effective for the inactivation of the agents of scrapie and BSE; whereas the only such method at present is the application of heat in a batch-rendering system which achieves minimum 133 °C at 3 bar for a minimum period of 20 minutes; whereas this may be applied as the sole process or as a pre- or post-process sterilization phase;

Whereas it is necessary to define the maximum particle size and the minimum time and temperature to be applied in approved systems, in order to ensure that such systems are running in accordance with procedures which have been shown to be effective;

Whereas specific rules for the control of plants must be put in place;

Whereas on 12 December 1994 the Scientific Veterinary Committee recommended detailed procedures for the validation of rendering processes; whereas these procedures should be used to ensure that the parameters laid down in this Decision are achieved on a plant-by-plant basis;

Whereas it is necessary to provide for a transitional period to allow for the adaptation or replacement of rendering equipment;

Whereas Commission Decision 96/239/EC of 27 March 1996 on emergency measures to protect against bovine spongiform encephalopathy (5), as amended by Decision 96/362/EC (6), has laid down specific conditions for production of gelatin, di-calcium phosphate, amino acids, peptides, tallow and tallow products in the United Kingdom;

Whereas conditions for trade are already laid down for animal products covered by Council Directive 92/118/EEC (7), as last amended by Commission Decision 96/405/EC (8), and in particular Annex 1, Chapters 1, 2, 3, 4, 5, 7, 8, 9 and 10 thereof; whereas, therefore, these may be exempted from the requirements of this Decision;

Whereas, furthermore, products which will be used for industrial purposes, where it can be assured that they will not be used in any food or feed chain, can also be exempted from the requirements of this Decision;

Whereas derogations for special uses of animal waste, in particular for the feeding of fur animals, are laid down in Directive 90/667/EEC, in particular in Article 7 (ii) thereof; whereas these uses may also be exempted from the requirements of this Decision;

Whereas Decision 94/382/EC should therefore be repealed;

Whereas the measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,

HAS ADOPTED THIS DECISION:

Article 1

1. This Decision shall apply to the processing of mammalian animal waste within the scope of Directive 90/667/EEC, without prejudice to the provisions of Decision 96/239/EC.

2. This Decision shall not apply to:

(a) (i) the processing of low risk material within the meaning of Directive 90/667/EEC for the production of pet food;

(ii) feed for animals subject to the derogation provided for in Article 7 (ii) of Directive 90/667/EEC, in particular, for fur animals;

(iii) gelatin;

(iv) hides and skins, hooves, horns, hair;

(v) glands and organs for pharmaceutical use;

(vi) blood and blood products;

(vii) milk and milk products;

(viii) rendered fats;

(ix) bones fit for human consumption;

(b) products derived from mammalian animal waste which it can be assured will not enter any food or feed chain.

Article 2

1. Member States shall not authorize the processing of animal waste unless it is processed in accordance with the parameters laid down in the Annex.

2. Member States shall authorize plants for the processing of animal waste only if they have been shown to be operating in accordance with the conditions set out in the Annex and have been validated according to procedures defined by the Scientific Veterinary Committee.

3. Member States shall carry out official checks of the operation of authorized plants at regular intervals. Records of the residence time, temperature, pressure and particle size for the authorized plants must be maintained.

4. Member States which already require conditions for the processing of animal waste which exceed those provided for in paragraph 1 may maintain their existing requirements.

5. Notwithstanding the provisions of paragraph 1, Member States may authorize the processing of animal waste by a method which does not achieve the parameters set out in the Annex if such processing is preceded or followed by a process which achieves the parameters set out in the Annex, or if the resulting proteinaceous material is destroyed by burial, incineration, burning as fuel or a similar method which ensures safe disposal.

Article 3

The provisions of this Decision shall apply from 1 April 1997.

However, 90 days after the notification of this Decision, Member States shall take all necessary measures to ensure that material which has been obtained by a method which does not achieve the parameters set out in the Annex is used in a way which avoids the risk of transmitting BSE and/or scrapie.

Article 4

Decision 94/382/EC is repealed with effect from 1 April 1997.

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 18 July 1996.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ No L 363, 27. 12. 1990, p. 51.

(2) OJ No L 359, 9. 12. 1992, p. 23.

(3) OJ No L 172, 7. 7. 1994, p. 25.

(4) OJ No L 38, 18. 2. 1995, p. 17.

(5) OJ No L 78, 28. 3. 1996, p. 47.

(6) OJ No L 139, 12. 6. 1996, p. 17.

(7) OJ No L 62, 15. 3. 1993, p. 49.

(8) OJ No L 165, 4. 7. 1996, p. 40.

ANNEX

Minimum parameters for the processing of mammalian animal waste excluding fats:

>TABLE>

Processing may be carried out in batch or continuous system.