Commission Decision

of 29 December 2000

concerning control measures required for the implementation of Council Decision 2000/766/EC concerning certain protection measures with regard to transmissible spongiform encephalopathies and the feeding of animal protein

(notified under document number C(2000) 4412)

(Text with EEA relevance)

(2001/9/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(1), as last amended by Directive 92/118/EEC(2), and in particular Article 9(4) thereof,

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(3), as last amended by Directive 92/118/EEC, and in particular Article 10(4) thereof,

Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(4), and in particular Article 22 thereof,

Whereas:

(1) Council Decision 2000/766/EC of 4 December 2000 concerning certain protection measures with regard to transmissible spongiform encephalopathies and the feeding of animal protein(5), prohibits the feeding of processed animal proteins to certain farmed animals. This prohibition does not apply to certain processed animal proteins subject to conditions to be established.

(2) On 26 June 1998, the Scientific Steering Committee (SSC) adopted an opinion on the safety of dicalcium phosphate precipitated from ruminant bones. That opinion was updated by the SSC on 26 and 27 October 2000. In order to take account of that scientific opinion, it is necessary to lay down requirements for the production of dicalcium phosphate.

(3) On 22 and 23 October 1998, the Scientific Steering Committee (SSC) adopted an opinion on the safety of hydrolysed proteins produced from bovine hides. This opinion was updated by the SSC on 25 and 26 May 2000. In order to take account of that scientific opinion, it is necessary to lay down requirements for the production of hydrolysed proteins. The SSC stated that a maximum molecular weight of 10000 Daltons, for the final product produced, may be used as an indicator of the effectiveness of the production process.

(4) Decision 2000/766/EC establishes that placing on the market, trade, importation and exportation of processed animal proteins for animals not kept, fattened or bred for the production of food may be allowed by Member States. It is necessary to set conditions to ensure that such proteins cannot be used for non authorised purposes.

(5) 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. Member States shall authorise the feeding of fishmeal to animals other than ruminants, only in accordance with the conditions laid down in Annex I.

2. Member States shall authorise the feeding of dicalcium phosphate to animals other than ruminants only in accordance with the conditions laid down in Annex II.

3. Member States shall authorise the feeding of hydrolysed proteins to animals other than ruminants, only in accordance with the conditions laid down in Annex III.

4. Member States shall ensure that, for the purpose of trade, dicalcium phosphate and hydrolysed proteins are accompanied by an official certificate as laid down in Annex IV.

5. Member States shall forward to the other Member States and to the Commission the list of approved processing plants producing fishmeal, dicalcium phosphate and hydrolysed proteins, which operate in accordance with the conditions laid down by this Decision, within 15 days after the entry into force of this Decision. Any modification to the list shall be notified immediately to the other Member States and to the Commission.

Article 2

Member States shall ensure that feedingstuffs, including pet food, containing processed animal proteins as defined by Decision 2000/766/EC, other than fishmeal, dicalcium phosphate and hydrolysed proteins, which is destined to animals which are not kept, fattened or bred for the production of food, is manufactured in plants which prepare exclusively feed for those animals.

Article 3

1. Member States may send to other Member States processed animal proteins, as defined in Decision 2000/766/EC, provided they are destined for uses not prohibited by Article 3(1)(a) of that Decision, and only if the following additional conditions are fulfilled:

(a) the Member State of destination must have authorised the receipt of the processed animal proteins;

(b) the processed animal proteins shall be accompanied by an official certificate as laid down in Annex V;

(c) the processed animal proteins must be transported in sealed, covered containers or vehicles, in such a way as to prevent loss and conveyed directly to the petfood or feed plants;

(d) Member States which send processed animal proteins to other Member States must inform by means of the ANIMO system(6) the competent authority of the place of destination of each consignment sent. The words "not for feed destined to animals which are kept, fattened or bred for the production of food" must be contained in the ANIMO message;

(e) Member States of destination must inform the competent authority of the place of origin, by means of the ANIMO system, of the arrival of each consignment; if such information is not provided, Member States of origin shall immediately take appropriate action;

(f) Member States of destination must ensure that the designated plants on their territory use the consignment only for the authorised purposes.

2. Member States may export to third countries processed animal proteins, as defined in Decision 2000/766/EC, provided they are destined for uses not prohibited by Article 3(1)(a) of that Decision, only if the following conditions are fulfilled:

(a) a bilateral agreement with the third country shall be made prior to exportation, which includes an undertaking from the third country to respect the final use and not to export the processed animal protein unless incorporated in a product destined for uses not prohibited by Article 3(1)(a) of Decision 2000/766/EC;

(b) the processed animal proteins shall be accompanied by an official certificate as laid down in Annex V.

Member States which allow such exportation shall inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, for the effective implementation, of this Decision, in the context of the Standing Veterinary Committee.

3. Member States shall ensure that imported processed animal proteins, as defined in Decision 2000/766/EC, destined for uses not prohibited by Article 3(1)(a) of that Decision, shall be dealt with in accordance with the conditions laid down in Article 8 of Council Directive 97/78/EC(7).

4. Member States shall carry out documentary checks and tests on feed materials and compound feedingstuffs throughout the production and distribution chain to ensure compliance with the provisions of this Decision and Decision 2000/766/EC. These checks and tests shall be carried out, inter alia, in farms in which ruminants are kept with other animal species.

Member States shall inform the Commission of the results of these checks by 31 May 2001.

5. The additional control measures set out in paragraphs 1, 2 and 3 shall not apply:

- to pet food referred to by Chapter 4 of Annex I to Directive 92/118/EEC, and

- to products exempted by Article 2(2) of Decision 2000/766/EC, from the prohibition established by Article 2(1) of that Decision, provided they fulfil, where applicable, the conditions set out in the Annexes I to III to the present Decision.

6. The additional control measures set out in paragraph 1 shall not apply to processed animal proteins referred to in Article 4 of Commission Decision 97/735/EC(8), as last amended by Decision 1999/534/EC(9).

Article 4

Article 2 of Decision 97/735/EC shall not apply to consignments of processed animal proteins which are accompanied by the health certificate referred to in Article 3(1)(b) of the present Decision.

Article 5

This Decision shall apply from 1 January 2001.

Article 6

This Decision is addressed to the Member States.

Done at Brussels, 29 December 2000.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 395, 30.12.1989, p. 13.

(2) OJ L 62, 15.3.1993, p. 49.

(3) OJ L 224, 18.8.1990, p. 29.

(4) OJ L 24, 30.1.1998, p. 9.

(5) OJ L 306, 7.12.2000, p. 32.

(6) Commission Decision 91/398/EEC (OJ L 221, 9.8.1991, p. 30).

(7) OJ L 24, 30.1.1998, p. 9.

(8) OJ L 294, 28.10.1997, p. 7.

(9) OJ L 204, 4.8.1999, p. 37.

ANNEX I

CONDITIONS REFERRED TO IN ARTICLE 1(1)

1. Fishmeal shall be produced in processing plants dedicated only to fishmeal production, which are approved for this purpose by the competent authority in accordance with Article 5(2) of Directive 90/667/EEC.

2. Before release for free circulation in Community territory, each consignment of imported fishmeal shall be analysed in accordance with Commission Directive 98/88/EC(1).

3. Fishmeal shall be transported directly from the processing plants to the establishments manufacturing animal feed, by means of vehicles which at the same time do not transport other feed materials. If the vehicle is subsequently used for the transport of other products, it shall be thoroughly cleaned and inspected before and after the transport of fishmeal.

4. Fishmeal shall be transported directly from the border inspection post to the establishments manufacturing animal feed, in accordance with the conditions laid down in Article 8 of Directive 97/78/EC, by means of vehicles which at the same time do not transport other feed materials. If the vehicle is subsequently used for the transport of other products, it shall be thoroughly cleaned and inspected before and after the transport of fishmeal.

5. By way of derogation from points 3 and 4, intermediate storage of fishmeal may be allowed only if it is carried out in dedicated storage plants which are authorised for this purpose by the competent authority.

6. Feedingstuffs containing fishmeal can be produced only in establishments manufacturing animal feed which do not prepare feedingstuffs for ruminant animals and which are authorised for this purpose by the competent authority.

By way of derogation from this provision, the production of feedingstuffs for ruminant animals in establishments which also produce feedingstuffs containing fishmeal for other animal species may be permitted by the competent authority on condition that:

- the transport and storage of feed materials destined to ruminant animals is completely separate from feed material prohibited for feeding to ruminant animals, and

- the storage, transport, manufacturing and packaging facilities for the compound feedingstuffs destined to ruminant animals are completely separate, and

- records detailing the purchases and uses of fishmeal and the sales of feedingstuff containing fishmeal are made available to the competent authority, and

- routine tests are carried out on feedingstuffs destined to ruminant animals to ensure that prohibited processed animal proteins as defined by Article 1 of Decision 2000/766/EC are not present.

7. The labelling of feedingstuffs containing fishmeal shall clearly indicate the words "it contains fishmeal - cannot be fed to ruminant animals".

8. Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which at the same time do not transport feed for ruminant animals. If the vehicle is subsequently used for the transport of other products, it shall be thoroughly cleaned and inspected before and after the transport of bulk feedingstuffs containing fishmeal.

9. The use and storage of feedingstuffs, other than pet food referred to by Chapter 4 of Annex I to Directive 92/118/EEC, containing fishmeal shall be prohibited in farms where ruminant animals are kept, fattened or bred for the production of food.

By way of derogation from this provision, the competent authority may permit the use and storage of feedingstuffs containing fishmeal in farms where ruminant animals are kept, if they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal is fed to ruminant animals.

(1) OJ L 318, 27.11.1998, p. 45.

ANNEX II

CONDITIONS REFERRED TO IN ARTICLE 1(2)

1. Dicalcium phosphate shall be produced in processing plants approved by the competent authority in accordance with Article 5(2) of Directive 90/667/EEC.

2. Dicalcium phosphate from defatted bones shall:

- be derived from bones fit for human consumption following ante- and post-mortem inspection,

- be produced by a process which ensures that all bone-material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and pH < 1,5) over a period of at least two days followed by a treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7, which is finally air dried with inlet temperature of 65 °C to 325 °C and end temperature between 30 °C to 65 °C or by an equivalent process approved in accordance with the procedure of Article 17 of Directive 89/662/EEC.

3. Feedingstuffs containing dicalcium phosphate from defatted bones can be produced only in establishments manufacturing animal feed which do not prepare feedingstuffs for ruminant animals and which are authorised for this purpose by the competent authority.

By way of derogation from this provision, the production of feedingstuffs for ruminant animals in establishments which also produce feedingstuffs containing dicalcium phosphate from deffatted bones for other animal species may be permitted by the competent authority on condition that:

- the transport and storage of feed materials destined for ruminant animals is completely separate from feed material prohibited for feeding to ruminant animals, and

- the storage, transport, manufacturing and packaging facilities for the compound feedingstuffs destined for ruminant animals are completely separate, and

- records detailing the purchases and uses of dicalcium phosphate from defatted bones and the sales of feedingstuff containing dicalcium phosphate from defatted bones are made available to the competent authority, and

- routine tests are carried out on feedingstuffs destined for ruminant animals to ensure that prohibited processed animal proteins as defined by Article 1 of Decision 2000/766/EC are not present.

4. The labelling of the feedingstuffs containing dicalcium phosphate from defatted bones shall clearly indicate the words "it contains dicalcium phosphate from defatted bones - cannot be fed to ruminant animals".

5. Bulk feedingstuffs containing dicalcium phosphate from defatted bones shall be transported by mean of vehicles which at the same time do not transport feed for ruminant animals. If the vehicle is subsequently used for the transport of other products, it shall be thoroughly cleaned and inspected before and after the transport of bulk feedingstuffs containing dicalcium phosphate from defatted bones,

6. The use and storage of feedingstuffs, other than pet food referred to by Chapter 4 of Annex I to Directive 92/118/EEC, containing dicalcium phosphate from defatted bones shall be prohibited in farms where ruminant animals are kept, fattened or bred for the production of food.

By way of derogation from this provision, the competent authority may permit the use and storage of feedingstuffs containing dicalcium phosphate from defatted bones in farms where ruminant animals are kept, if they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate from defatted bones is fed to ruminant animals.

ANNEX III

CONDITIONS REFERRED TO IN ARTICLE 1(3)

1. Hydrolysed proteins from hides and skins shall:

- be derived from hides and skins obtained from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante- and post-mortem inspection,

- be produced by a production process which involves appropriate measures to minimise contamination of hides and skins, preparation of the raw material by brining, liming and intensive washing followed by exposure of the material to a pH of > 11 for > 3 hours at temperature > 80 °C and followed by heat treatment at > 140 °C for 30 minutes at > 3,6 bar, or by an equivalent production process approved in accordance with the procedure of Article 17 of Directive 89/662/EEC,

- be produced in a processing plant dedicated only to hydrolysed proteins production, which are approved for this purpose by the competent authority in accordance with Article 5(2) of Directive 90/667/EEC,

- be sampled after processing and found to have a molecular weight below 10000 Dalton.

2. Feedingstuffs containing hydrolysed proteins can be produced only in plants manufacturing animal feedingstuffs which do not prepare feedingstuffs for ruminant animals and which are authorised for this purpose by the competent authority,

By way of derogation from this provision, the production of feedingstuffs for ruminant animals in establishments which also produce feedingstuffs containing hydrolysed proteins for other animal species may be permitted by the competent authority on condition that:

- the transport and storage of feed materials destined to ruminant animals is completely separate from feed material prohibited for feeding to ruminant animals, and

- the storage, transport, manufacturing and packaging facilities for the compound feedingstuffs destined to ruminant animals are completely separate, and

- records detailing the purchases and uses of hydrolysed proteins and the sales of feedingstuff containing hydrolysed proteins are made available to the competent authority, and

- routine tests are carried out on feedingstuffs destined to ruminant animals to ensure that prohibited processed animal proteins as defined by Article 1 of Decision 2000/766/EC are not present.

3. The labelling of feedingstuffs containing hydrolysed proteins shall clearly indicate the words "it contains hydrolysed proteins - cannot be fed to ruminant animals".

4. Bulk feedingstuffs containing hydrolysed proteins shall be transported by means of vehicles which at the same time do not transport feed for ruminant animals. If the vehicle is subsequently used for the transport of other products, it shall be thoroughly cleaned and inspected before and after the transport of bulk feedingstuffs containing hydrolysed proteins.

5. The use and storage of feedingstuffs, other than pet food referred to by Chapter 4 of Annex I to Directive 92/118/EEC, containing hydrolysed proteins shall be prohibited in farms where ruminants are kept, fattened or bred for the production of food.

By way of derogation for this provision, the competent authority may permit the use and storage of feedingstuffs containing hydrolysed proteins in farms where ruminant animals are kept, if they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing hydrolysed proteins is fed to ruminant animals.

ANNEX IV

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ANNEX V

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