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Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption

Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the Economic and Social Committee(2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 12 September 2002.

Whereas:

  1. 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 feedingstuffs of animal or fish origin and amending Directive 90/425/EEC(4) established the principle that all animal waste, regardless of its source, may be used for the production of feed material following appropriate treatment.

  2. The Scientific Steering Committee has adopted a number of opinions since the adoption of that Directive. Their main conclusion is that animal by-products derived from animals not fit for human consumption following health inspection should not enter the feed chain.

  3. In the light of those scientific opinions, a distinction should be drawn between the measures to be implemented, depending on the nature of animal by-products used. The possible uses of certain animal materials should be limited. Rules should be laid down for the use of animal by-products other than in feed and for their disposal.

  4. In the light of the experience gained in recent years, it is appropriate to clarify the relationship between Directive 90/667/EEC and Community environmental legislation. This Regulation should not affect the application of existing environmental legislation or hinder the development of new rules on environmental protection, particularly as regards biodegradable waste. In this regard, the Commission has given a commitment that by the end of the year 2004 a Directive on biowaste, including catering waste, will be prepared with the aim of establishing rules on safe use, recovery, recycling and disposal of this waste and of controlling potential contamination.

  5. The International Scientific Conference on Meat-and-Bone Meal organised by the Commission and the European Parliament, held in Brussels on 1 and 2 July 1997, initiated a debate concerning the production and feeding of meat-and-bone meal. The Conference called for further reflection on the future policy in this area. In November 1997, to launch the widest possible public debate about the future of the Community's feed legislation, the Commission finalised a consultation paper on meat-and-bone meal. Following that consultation, it appears that there is a general recognition of the need to amend Directive 90/667/EEC to bring it in line with the new scientific information.

  6. The European Parliament, in its resolution of 16 November 2000 on BSE and safety of animal feed(5), called for a ban on the use of animal protein in feed until the present Regulation enters into force.

  7. Scientific advice suggests that the practice of feeding an animal species with proteins derived from the bodies, or parts of bodies, of the same species presents a risk of spreading disease. As a precautionary measure, this practice should therefore be prohibited. Implementing rules should be adopted to ensure the necessary separation of animal by-products destined for use in feed at every stage of processing, storage and transport. However, there should be scope to establish derogations from this general prohibition in relation to fish and fur animals if justified by scientific advice.

  8. Catering waste containing products of animal origin can also be a vector for the spread of disease. All catering waste generated from means of transport operating internationally should be disposed of safely. Catering waste produced within the Community should not be used for the feeding of farmed animals other than fur animals.

  9. From October 1996, the Food and Veterinary Office of the Commission (FVO) carried out a number of rounds of inspections in Member States, to assess the presence and management of main risk factors and surveillance procedures with regard to BSE. Part of the assessment covered the systems of commercial rendering and other methods of animal waste disposal. General conclusions and a number of recommendations were drawn up following those inspections, with particular reference to the traceability of animal by-products.

  10. To avoid any risk of dispersal of pathogens and/or residues, animal by-products should be processed, stored and kept separated in an approved and supervised plant designated by the Member State concerned or be disposed of in a suitable manner. In certain circumstances, especially when it is justified by distance, time of transport, or capacity problems, the designated processing, incineration or co-incineration plant could be located in another Member State.

  11. Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste(6) does not apply to incineration plants if the waste treated consists solely of animal carcases. It is necessary to lay down minimum requirements for such incineration plants to protect animal and public health. Pending the adoption of Community requirements, Member States may adopt environmental legislation for such plants. Less strict requirements should apply to low-capacity incineration plants, such as those located on farms and at pet crematoria, to reflect the lower risk posed by the material treated and to avoid unnecessary transport of animal by-products.

  12. Specific rules should be laid down on controls for processing plants, with particular reference to detailed procedures for the validation of processing methods and for self-supervision of production.

  13. Derogations from the rules on the use of animal by-products may be appropriate to facilitate the feeding of animals not destined for human consumption. The competent authorities should control such uses.

  14. Derogations may also be appropriate to permit the disposal of animal by-products on site in controlled circumstances. The Commission should receive the information necessary to enable it to monitor the situation and to lay down implementing rules if appropriate.

  15. Community inspections should be carried out in the Member States to ensure uniform implementation of the health requirements. Such inspections should also include audit procedures.

  16. The basis for Community legislation on health issues is sound science. To this end, the relevant scientific committees set up by Commission Decisions 97/404/EC(7) and 97/579/EC(8) should be consulted wherever necessary. In particular, further scientific advice is required on the use of products of animal origin in organic fertilisers and soil improvers. Pending the adoption of Community rules in the light of this advice, Member States may maintain or adopt national rules that are stricter than those envisaged in this Regulation, provided that such rules comply with other applicable Community legislation.

  17. A wide variety of approaches exists in Member States as regards the financial support for processing, collection, storage and disposal of animal by-products. To ensure that the conditions of competition between agricultural products are not affected, it is necessary to carry out an analysis and, if necessary, to take appropriate measures at Community level.

  18. In the light of the above, a fundamental revision of the Community rules applicable to animal by-products appears to be necessary.

  19. Animal by-products not destined for human consumption (in particular processed animal protein, rendered fats, petfood, hides and skins and wool) are included in the list of products in Annex I to the Treaty. The placing on the market of such products constitutes an important source of income for part of the farming population. To ensure rational development in this sector and increase productivity, animal health and public health rules for the products in question should be laid down at Community level. Given the significant risks of the spread of diseases to which animals are exposed, particular requirements should apply to the placing on the market of certain animal by-products, particularly in regions with a high health status.

  20. To ensure that products imported from non-member countries are of a hygiene standard which is at least equal or equivalent to the hygiene standard applied by the Community, a system of approval should be introduced for non-member countries and their establishments, together with a Community inspection procedure to ensure that the conditions for such approval are observed. The importation from third countries of petfood and raw material for petfood can take place subject to conditions different from those applicable to such material produced in the Community, in particular as regards the guarantees required concerning the residues of substances prohibited in accordance with Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock farming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC(9). To ensure that such petfood and raw material are used only for their intended purpose, it is necessary to lay down appropriate control measures on importation of material covered by such derogations.

  21. Animal by-products that pass through the Community in transit, and those originating in the Community and destined for export, can create a risk for animal and public health within the Community. Certain requirements laid down by this Regulation should therefore apply to such movements.

  22. The accompanying document for products of animal origin is the best way of satisfying the competent authority of the place of destination that a consignment complies with the provisions of this Regulation. The health certificate should be maintained for the purposes of verifying the destination of certain imported products.

  23. Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC(10) pursues the abovementioned objectives.

  24. The Council and the Commission have adopted several Decisions implementing Directives 90/667/EEC and 92/118/EEC. Furthermore, Directive 92/118/EEC has been substantially amended and further amendments are to be made. Consequently, a great number of Community acts currently regulate the animal by-products sector and there is a need for simplification.

  25. Such simplification will lead to more transparency with regard to specific health rules for products of animal origin not destined for human consumption. Simplification of the specific health legislation must not lead to deregulation. It is therefore necessary to maintain and, to ensure public and animal health protection, to tighten the detailed health rules for products of animal origin not destined for human consumption.

  26. The products concerned should be subject to the rules for veterinary checks, including checks by experts from the Commission, and any protective measures laid down by 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(11).

  27. Effective checks should be carried out on products imported into the Community. This can be achieved by implementing the controls laid down in 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 non-member countries(12).

  28. Directive 90/667/EEC, Council Decision 95/348/EC of 22 June 1995 laying down the veterinary and animal health rules applicable in the United Kingdom and Ireland to the treatment of certain types of waste intended to be marketed locally as feedstuffs for certain animal categories(13) and Council Decision 1999/534/EC of 19 July 1999 on measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies and amending Commission Decision 97/735/EC(14) should therefore be repealed.

  29. To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(15).

  30. The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(16),

HAVE ADOPTED THIS REGULATION:

CHAPTER I GENERAL PROVISIONS

Article 1 Scope

1.

This Regulation lays down animal and public health rules for:

  1. the collection, transport, storage, handling, processing and use or disposal of animal by-products, to prevent these products from presenting a risk to animal or public health;

  2. the placing on the market and, in certain specific cases, the export and transit of animal by-products and those products derived therefrom referred to in Annexes VII and VIII.

2.

This Regulation shall not apply to:

  1. raw petfood originating from retail shops or in premises adjacent to sale points, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot;

  2. liquid milk and colostrum disposed of or used on the farm of origin;

  3. entire bodies or parts of wild animals not suspected of being infected with diseases communicable to humans or animals, except for fish landed for commercial purposes and bodies or parts of wild animals used to produce game trophies;

  4. raw petfood for use on site derived from animals slaughtered on the farm of origin for use as foodstuffs by the farmer and his family only, in accordance with national legislation;

  5. catering waste, unless:

    1. from means of transport operating internationally,

    2. destined for animal consumption, or

    3. destined for use in a biogas plant or for composting;

  6. ova, embryos and semen intended for breeding purposes; and

  7. transit by sea or by air.

3.

This Regulation shall not affect veterinary legislation having as its objective the eradication and control of certain diseases.

Article 2 Definitions

1.

For the purpose of this Regulation, the following definitions shall apply:

(a)animal by-products:
entire bodies or parts of animals or products of animal origin referred to in Articles 4, 5 and 6 not intended for human consumption, including ova, embryos and semen;
(b)Category 1 material:
animal by-products referred to in Article 4;
(c)Category 2 material:
animal by-products referred to in Article 5;
(d)Category 3 material:
animal by-products referred to in Article 6;
(e)animal:
any vertebrate or invertebrate animal (including fish, reptiles and amphibians);
(f)farmed animal:
any animal that is kept, fattened or bred by humans and used for the production of food (including meat, milk and eggs), wool, fur, feathers, skins or any other product of animal origin;
(g)wild animal:
any animal not kept by humans;
(h)pet animal:
any animal belonging to species normally nourished and kept, but not consumed, by humans for purposes other than farming;
(i)competent authority:
the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which that central authority has delegated that competence, in particular for the control of feedingstuffs; it shall also include, where appropriate, the corresponding authority of a non-member country;
(j)placing on the market:
any operation the purpose of which is to sell animal by-products, or products derived therefrom covered by this Regulation, to a third party in the Community or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party;
(k)trade:
trade between Member States in goods within the meaning of Article 23(2) of the Treaty;
(l)transit:
a movement through the Community from one non-member country to another;
(m)producer:
any person whose activity produces animal by-products;
(n)TSEs:
all transmissible spongiform encephalopathies, except those occurring in humans;
(o)specified risk material:
material referred to in Annex V to 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(17).
2.

The specific definitions set out in Annex I shall also apply.

Article 3 General obligations

1.

Animal by-products, and products derived therefrom, shall be collected, transported, stored, handled, processed, disposed of, placed on the market, exported, carried in transit and used in accordance with this Regulation.

2.

However, Member States may regulate under national law the importation and placing on the market of products not referred to in Annexes VII and VIII, pending the adoption of a decision in accordance with the procedure referred to in Article 33(2). They shall immediately inform the Commission of the use that they make of this possibility.

3.

Member States shall, either individually or cooperatively, ensure that adequate arrangements are in place, and that a sufficient infrastructure exists, to ensure compliance with the requirement of paragraph 1.

CHAPTER II CATEGORISATION, COLLECTION, TRANSPORTATION, DISPOSAL, PROCESSING, USE AND INTERMEDIATE STORAGE OF ANIMAL BY-PRODUCTS

Article 4 Category 1 material

Article 5 Category 2 material

Article 6 Category 3 material

Article 7 Collection, transportation and storage

Article 8 Dispatch of animal by-products and processed products to other Member States

Article 9 Records

CHAPTER III APPROVAL OF INTERMEDIATE, STORAGE, INCINERATION AND CO-INCINCERATION, CATEGORY 1 AND 2 PROCESSING, CATEGORY 2 AND CATEGORY 3 OLEOCHEMICAL, BIOGAS AND COMPOSTING PLANTS

Article 10 Approval of intermediate plants

Article 11 Approval of storage plants

Article 12 Approval of incineration and co-incineration plants

Article 13 Approval of Category 1 and Category 2 processing plants

Article 14 Approval of Category 2 and Category 3 oleochemical plants

Article 15 Approval of biogas plants and composting plants

CHAPTER IV PLACING ON THE MARKET AND USE OF PROCESSED ANIMAL PROTEINS AND OTHER PROCESSED PRODUCTS THAT COULD BE USED AS FEED MATERIAL, PETFOOD, DOGCHEWS AND TECHNICAL PRODUCTS AND APPROVAL OF RELATED PLANTS

Article 16 General animal health provisions

Article 17 Approval of Category 3 processing plants

Article 18 Approval of petfood plants and technical plants

Article 19 Placing on the market and export of processed animal protein and other processed products that could be used as feed material

Article 20 Placing on the market and export of petfood, dogchews and technical products

Article 21 Safeguard measures

Article 22 Restrictions on use

CHAPTER V DEROGATIONS

Article 23 Derogations regarding the use of animal by-products

Article 24 Derogations regarding the disposal of animal by-products

CHAPTER VI CONTROLS AND INSPECTIONS

Article 25 Plants' own-checks

Article 26 Official controls and lists of approved plants

CHAPTER VII COMMUNITY CONTROLS

Article 27 Community controls in Member States

CHAPTER VIII PROVISIONS APPLICABLE TO THE IMPORTATION AND TRANSIT OF CERTAIN ANIMAL BY-PRODUCTS AND PRODUCTS DERIVED THEREFROM

Article 28 General provisions

Article 29 Prohibitions and compliance with Community rules

Article 30 Equivalence

Article 31 Community inspections and audits

CHAPTER IX FINAL PROVISIONS

Article 32 Amendments to Annexes and transitional measures

Article 33 Regulatory procedure

Article 34 Consultation of scientific committees

Article 35 National provisions

Article 36 Financial arrangements

Article 37 Repeal

Article 38 Entry into force

ANNEX ISPECIFIC DEFINITIONS

ANNEX IIHYGIENE REQUIREMENTS FOR THE COLLECTION AND TRANSPORT OF ANIMAL BY-PRODUCTS AND PROCESSED PRODUCTS

ANNEX IIIHYGIENE REQUIREMENTS FOR INTERMEDIATE AND STORAGE PLANTS

ANNEX IVREQUIREMENTS FOR INCINERATION AND CO-INCINERATION PLANTS TO WHICH DIRECTIVE 2000/76/EC DOES NOT APPLY

ANNEX VGENERAL HYGIENE REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1, 2 AND 3 MATERIAL

ANNEX VISPECIFIC REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1 AND 2 MATERIAL AND FOR BIOGAS AND COMPOSTING PLANTS

ANNEX VIISPECIFIC HYGIENE REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE MARKET OF PROCESSED ANIMAL PROTEIN AND OTHER PROCESSED PRODUCTS THAT COULD BE USED AS FEED MATERIAL

ANNEX VIIIREQUIREMENTS FOR THE PLACING ON THE MARKET OF PETFOOD, DOGCHEWS AND TECHNICAL PRODUCTS

ANNEX IXRULES APPLICABLE TO THE USE OF CERTAIN CATEGORY 2 AND CATEGORY 3 MATERIAL FOR THE FEEDING OF CERTAIN ANIMALS IN ACCORDANCE WITH ARTICLE 23(2)

ANNEX XMODEL HEALTH CERTIFICATES FOR THE IMPORTATION FROM THIRD COUNTRIES OF CERTAIN ANIMAL BY-PRODUCTS AND PRODUCTS DERIVED THEREFROM

ANNEX XILists of third countries from which Member States may authorise imports of animal by-products not intended for human consumption