Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down the health rules concerning animal by-products not intended for human consumption (presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)

EXPLANATORY MEMORANDUM

A. Procedure

In October 2000 the Commission submitted a proposal for a Regulation of the European Parliament and the Council laying down the health rules concerning animal by-products not intended for human consumption (COM(2000)574-C5-0539/2000-2000/0259(COD)) for adoption by the co-decision procedure laid down in Article 251 of the Treaty establishing the European Community.

On 12 June 2001 the European Parliament took position in first reading. The Parliament adopted 92 amendments, of which 86 were accepted by the Commission in their entirety or in part or on conditions or after reformulation.

In the light of these developments, the Commission has drafted this amended proposal. The amendments are in 'bold' and 'underlined' where adding or modifying, and in 'strikeout', where deleting text. Reformulation follows in most cases from developments in Council or in order to ensure internal consistency of the proposal. Only extensive linguistic changes will be mentioned below.

B. Explanation of the amendments

(1) Prohibition of intraspecies recycling

The European Parliament's amendments 1, 9, 18, 60, 79, 80 and 94 and the part of amendments 45, 62 and 71 aiming to extend the prohibition of intraspecies recycling to animal species other than ruminants, for which the cannibalism is prohibited since 1994, have been welcomed by the Commission and by the Council and have been introduced in the proposal by amending the concerned Articles and Annexes. This prohibition was recently recommended by the Scientific Steering Committee as a precautionary measure and by other national scientific bodies, such as the UK's SEAC. As we learned from the development of the BSE epidemic, the practice of intraspecies recycling may increase the risk of recycling potential infectivity due to the absence of a species barrier.

(2) Traceability

The European Parliament's amendments 27, 46, 48-50, 76, 83, 84 and 86 and of the parts of amendments 26, 35 and 71 which introduce additional requirements to improve traceability of products or to strengthen the requirements on traceability established by the Commission proposal, have been taken into account by amending the concerned Articles and Annexes. However, the requirement of the marking of unprocessed Category 1 material proposed by amendment 24 to Article 4 and part of amendment 45 to Article 7 have been introduced only in the case of Specified Risk Material, as applying markers to cadavers does not bring any additional benefits and would be not in line with the recently adopted TSE Regulation, which derogates from this requirement. The marking of unprocessed category 2 material, including manure as proposed by amendment 31 and part of amendments 35 to Article 5 and part of amendment 45 to Article 7 has not been taken into account for the same reasons. Furthermore, the olfactory and denaturing marking is accepted only in principle as at this stage we have not yet identified an appropriate and safe marker which has these qualities.

(3) Cross-contamination

The European Parliament's amendments 28, 37, 44, 51, 54, 55, 57, 58, 61, 70, 73, 75, 77, 78, 93 and 97, and of the part of amendment 45 which introduce additional and stricter requirements to avoid cross-contamination, have been taken into account by amending the concerned Articles and Annexes. The Commission proposal already establishes a complete separation during collection and transport of animal waste not intended for human food or animal feed, and a complete separation of plants dedicated to feed production from plants processing animal waste destined for destruction.

(4) Derogation for burial and burning

The European Parliament's amendments 29, 38,63 and 69, which introduce a derogation for burial and burning of cadavers and Specified Risk Material in remote areas and in case of outbreaks of serious transmissible diseases because of the danger of propagating health risks or because of a lack of disposal capacity, have been reflected in Articles 2, 4 and 5 and in the new Article 21a.

(5) Incinerators/Review of methods of disposal

The European Parliament's amendments 52 and 99 and the parts of amendments 25, 26, 35 and 43 setting public health requirements for incinerators which are not covered by the scope of Directive 2000/76 on the incineration of waste and introducing the legal possibility of reviewing the authorised method of disposal following new scientific advice, have been taken into account in the proposal by amending the concerned Articles and in the new Article 9a and Annex XII.

(6) Catering waste

The European Parliament's amendments 15 and the part of amendment 16 and 103 which introduce catering waste in the scope of the Regulation, have been taken into account by amending the concerned Articles. However, the following conditions have been introduced, in line with the Council discussion:

- catering waste is covered by the Regulation only when destined to specific purposes in order to avoid duplication with environmental legislation or to avoid hindering the development of new environmental rules on biodegradable waste, and

- catering waste from international means of transport belongs to the highest risk category 1 and shall be destroyed as already required by existing Community legislation, and

- the definition of catering waste includes catering waste from household kitchen as well. This is to ensure consistency with forthcoming legislation on Classical Swine Fever and on animal nutrition, and

- the continuation of swill feeding using catering waste is prohibited. First of all, this practice is not compatible with the prohibition of intraspecies recycling and with the demand for full traceability of feed ingredients, both of which have been strongly requested by the Parliament. Secondly, the recent dioxin crisis and the current outbreaks of foot-and-mouth disease, both adequately illustrate why the continuation of this feeding practice is not appropriate. This is to ensure consistency with forthcoming legislation on Classical Swine Fever and on animal nutrition.

Therefore, the European Parliament's amendments 102 and the part of the amendment 103 to Article 6, which propose to allow the continuation of swill feeding using catering waste, have not been taken into account.

(7) Manure and prohibition of spreading organic fertilisers on pasture land

The European Parliament's part of amendments 90 and 91 clarifying that a harmonised health certificate for the trade of manure shall be laid down by Comitology have been taken into account by amending Annex VI. The request to annex this certificate to the Regulation is considered to be superfluous as it is already the case, and, therefore, has not been taken into account. The part of amendment 92 which spells out the possibility of authorising equivalent processing treatments for manure following scientific advice, which, in any case, is not prevented by the Commission proposal, has been taken into account by amending the same Annex VI. It is considered premature to make reference to a concordance table before evaluation of the scientific committee. Therefore, the part of amendment 92 referring to that table, has not been taken into account. The European Parliament's part of amendment 62 to Article 20 which excludes solid dung and composting from the prohibition of spreading on pasture land has not been taken into account, as manure in any form is already excluded by this prohibition and as there is no justification for excluding compost from a general policy relating to the spreading of proteinaceus material on pasture land. However, a new definition of pasture land has been introduced, limiting de facto the prohibition of spreading organic fertilisers on land grazed by farmed animals. Detailed rules for the implementation of this prohibition can be fixed by Standing Committee procedure following scientific advice, giving the possibility to allow the spreading of certain organic fertilisers even on pasture land if animals are not allowed to graze for a certain period after the fertilisation.

(8) Processing standards before incineration

The European Parliament's amendment 53 which requires the use of pressure cooking standards for animal by-products even if the resulting material is burned has been taken into account by amending Articles 4 and 5. However, for reason of consistency with the TSE Regulation and in line with the outcome of Council's discussions, it is proposed that this process be used before incineration if required by the national competent authority. This would allow Member States to require this process when, for example, a long period of storage is needed before incineration. It must be noted that many other amendments of the Parliament would maintain this flexibility.

(9) Rendered fats

The European Parliament's part of amendments 35 and 61, which prohibit the use of rendered fats from category 2 material for the production of fat derivatives for the cosmetic and pharmaceutical industry, have been taken into account by amending Articles 2, 5 and 18. Amendment 88 to Annex V has not been taken into account as restrictions on the importation of ruminant products due to a TSE risk, including rendered fats, are laid down by the TSE Regulation.

(10) Date of entry into force

The European Parliament proposes an earlier date of entry into force of the Regulation and that Member States forward a report to the Commission attesting to the actual implementation of the Regulation. The two related amendments 68 and 64 have been taken into account by amending Articles 38 and 35, as this latter specifically deals with communications of national provisions, following reformulation in line with the Council position. A new recital 23 referring to those amendments, has been introduced.

(11) Specified Risk Material

The European Parliament's amendment 21 which makes a cross reference to the TSE Regulation, has been taken into account by amending Article 4.

(12) Exportation

The European Parliament's amendments 30 and 39 prohibiting the exportation of Category 1 and Category 2 material have been taken into account by amending Articles 4 and 5. However, certain animal products as game trophies, which are derived from category 1 material, manure and processed manure, organic fertilisers and fats derivatives, which belong to category 2 material or are derived therefrom, are currently exported to third countries (and imported from them), subject to conditions established by Community legislation, which are recast in Annex VI. Therefore, it is clarified in the text that these amendments are without prejudice to those products. Furthermore, the European Parliament's amendment 59 and the part of amendment 61, which clarify that the requirements for placing on the market of products shall also apply for their exportation, have been accordingly reflected in Articles 17 and 18.

(13) Refrigeration

The European Parliament's parts of amendments 72 and 96, on refrigeration of raw category 3 material during storage and transportation, have been taken into account by amending Annexes II and VIII. However, in line with outcome of Council's discussions, it is proposed to limit the requirement of refrigeration only to raw material which is not processed within 24 hours from slaughter. It must be noted that this tolerance is already established by Community legislation for raw material destined to certain food products.

(14) Additional category 2 material

The European Parliament's amendment 34 adding products which failed import checks to category 2 material, for reason of consistency with the Annex and existing Community legislation, has been taken into account by amending Article 5. However, it is clarified that this shall apply unless the products are re-dispatched or their importation is accepted under restrictions laid down under Community legislation.

(15) Various topics

The European Parliament's amendments 2, 3, 6, 8, 13 and 14 to a number of recitals have been taken into account in the proposal. The part of amendment 11 to recital 14 removing the reference to increasing productivity has been also taken into account, but not the rest, as the original reference to the Treaty is correct.

Amendments 4, 10 and 12 to a number of recitals, have not been taken into account as it is contrary to correct legal practice to introduce recitals which are not matched by provisions in the text, or to delete recitals or part of recitals which are matched by provisions in the text.

The European Parliament's amendment 16 introducing genetic material in the scope, has been taken into account clarifying that this material is covered only for its disposal when is not longer needed for reproductive purposes.

Finally, the European Parliament's amendments 40, 41, 47, 56, 65, 66, 67 74, 81, 82, 87, 89 and 98 on various topics have been taken into account by amending various Articles and Annexes, as they are fully in line with the basic objectives of the Regulation.

2000/0259 (COD)

Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down the 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],

[1] OJ C

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

[4] OJ C

Whereas:

(1) Council Directive 90/667/EC 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 [5] established the principle that all animal waste, regardless of its source, may be used for the production of feed material following appropriate treatment.

[5] OJ L 363, 27.12.1990, p. 51. Directive as last amended by the Act of Accession of Austria, Finland and Sweden.

(2) The Scientific Steering Committee has adopted a number of opinions. The main conclusion of those scientific opinions 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 on the basis of the nature of animal by-products used. The possibility of using certain animal materials should be limited, so as to apply only to products deemed suitable for human consumption. Moreover, the existing possibility of recycling within a species for the purpose of feeding animals must cease. Alternative methods to the production of feed material should be laid down for the use or disposal of animal by-products.

(4) In the light of the experience gained in recent years, it is appropriate to clarify the relationship between Directive 90/667/EEC and Council Directive 75/442/EEC of 15 July 1975 on waste [6], in order to avoid confusion and conflict of interest among the competent authorities of the Member States. In particular, when an animal by-product is consigned to a disposal or recovery operation, it should be treated as waste in order to ensure that it is disposed of or recovered in such a way that the objectives of Article 4 of Directive 75/442/EEC are achieved and the human health and environment are protected. Furthermore, 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.

[6] OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).

(5) The International Scientific Conference on Meat-and-Bone Meal organised by the Commission and the European Parliament, held in Brussels on 1-2 July 1997, has 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, in order 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 in order to bring it in line with the new scientific information.

(5a) The European Parliament, in its resolution of 16 November 2000 [7], called for a ban on the production of animal feed and on feeding practices involving the recycling of animal waste in the case of cattle, sheep and goats and all other species of animal, including poultry and fish, until Member States could guarantee application of existing European legislation on the prevention of BSE (heat treatment at 133ºC for 20 minutes at a pressure of 3 bar; guaranteed separation of SRM) and until the exclusion of fallen stock proposed by this Regulation enters into force.

[7] OJ C 223, 8.8.2001, p.281

(5b) The European Parliament, in its resolution of 16 November 2000, stressed 'that the open declaration of all ingredients which form part of any animal feed produced and marketed in the European Union needs to be delivered by the animal feed industry'.

(5c) The source and the spread of the BSE epidemic are due to the contamination of animal meal, which could have been avoided if Member States had applied the decisions taken at Community level.

(6) From October 1996, the Food and Veterinary Office of the Commission (FVO) carried out a number of rounds of inspections to 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.

(7) In order to avoid any risk of dispersal of pathogens and/or residues, animal by-products should be separated, processed and stored in an approved and supervised plant designated by the Member State concerned or else be disposed of in another 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.

(7a) The animal by-products whose use in animal feed is authorised must be separated by animal category at every stage of processing, storage and transport.

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

(9) In order to take into account certain practices, it should be possible to derogate from the processing laid down for controlled uses.

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

(11) 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 [8] and 97/579/EC [9] should be consulted wherever necessary.

[8] OJ L 169, 27.6.1997, p. 85. Decision as amended by Decision 2000/443/EC (OJ L 179, 18.7.2000, p. 13).

[9] OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision 2000/443/EC.

(12) A wide variety of approaches exist in Member States as regards the financial support for processing and disposal of animal by-products. In order 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.

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

(14) Animal by-products not destined to 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. In order to ensure rational development in this sector , 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.

(15) In order to ensure that products imported from third 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 third 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/EEC [10]. In order to ensure that such petfood and raw material are only used for their intended purpose, it is necessary to lay down appropriate control measures on importation of material covered by such derogations.

[10] OJ L 125, 23.5.1996, p. 3 [amendment proposed by COM(2000) 320].

(16) 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.

(17) The abovementioned objectives are pursued by 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 [11].

[11] OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Decision 1999/724/EC (OJ L 290, 12.11.1999, p. 32).

(18) Several Decisions implementing Directives 90/667/EEC and 92/118/EEC have been adopted by the Council and by the Commission. Furthermore, Directive 92/118/EEC has been substantially amended and further amendments are to be made. Consequently, at present the sector of products of animal origin not destined to human consumption is regulated by a great number of different Community legislative acts. Therefore, there is a need for a simplification of the Community legislation dealing with these products.

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

(20) The products concerned should be subject to precise monitoring, including by Community's inspection, and to the rules for veterinary checks 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 [12].

[12] OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive 92/118/EEC.

(21) 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 third countries [13].

[13] OJ L 24, 30.1.1998, p. 9.

(22) 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 [14] 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 [15] should therefore be repealed.

[14] OJ L 202, 26.8.1995, p. 8.

[15] OJ L 204, 4.8.1999, p. 37.

(23) The implementation of the new health requirements established by this Regulation will require adjustments by the industry. Therefore, a period of time should be provided for the implementation of those requirements. Furthermore, Member States should inform the Commission of the measures taken to ensure compliance with this Regulation following its entry into force, in order to enable the Commission on the basis of the information received, to prepare and submit a report to the European Parliament and to the Council accompanied, if appropriate, by legislative proposals.

(24) In order to take account of technical and scientific progress, close and effective co-operation should be ensured between the Commission and the Member States within the Standing Veterinary Committee set up by Council Decision 68/361/EEC [16].

[16] OJ L 255, 18.10.1968, p. 23.

(25) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [17], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision,

[17] OJ L 184, 17.7.1999, p. 23.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1 Scope

1. This Regulation lays down:

(a) the animal health and public health rules for the collection, transport, storing, handling, processing and use or disposal of animal by-products in order to prevent these products from presenting a risk to animal or public health;

(b) the animal and public health rules for the placing on the market, trade and importation of animal by-products and products derived therefrom, intended for purposes other than human consumption.

2. Without prejudice to the relevant animal and public health rules, this Regulation shall not apply to:

(a) 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;

(b) liquid milk and colostrum disposed of or used on the farm of origin;

(c) carcases or parts of wild animals not suspected of being infected with diseases communicable to man or animals;

(d) 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(e) catering waste, unless:

(i) from means of transport operating internationally,

(ii) destined for animal consumption,

(iii) destined for use in a biogas plant or for composting; and

(f) ova, embryos and semen intended for breeding purposes.

3. This Regulation shall not affect national veterinary legislation applicable to the eradication and control of certain diseases .

Article 2 Definitions

For the purpose of this Regulation, the following definitions and the definitions laid down in Annex I shall apply:

(1) Animal by-products: whole carcases or parts of animal or products of animal origin referred to in Articles 4, 5 and 6 not intended for human consumption, including ova, embryos, semen and catering waste;

(2) Category 1 material: animal by-products referred to in Article 4;

(3) Category 2 material: animal by-products referred to in Article 5;

(4) Category 3 material: animal by-products referred to in Article 6;

(5) Animals: any vertebrate or invertebrate animal (including fish, reptiles or amphibians);

(6) Farmed animals: any animal which is kept, fattened or bred for the production of food (meat, milk, eggs), wool, fur, feathers, skins, or any other product of animal origin;

(7) Wild animals: animals not kept by man, excluding fish;

(8) Pet animals: animals belonging to species normally nourished and kept, but not consumed, by man for purposes other than farming;

(9) Competent authority: the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which it has delegated that competence;

(10) Placing on the market: any operation the purpose of which is to supply animal by-products, or products derived therefrom covered by this Regulation, to a third party for sale, or any other form of transfer against payment or free of charge to a third party and storage with a view to supply to a third party, regardless of whether the operation takes place within a Member State, between Member States or between a Member State and a third country or vice versa;

(11) Trade: trade between Member States in goods within the meaning of Article 23(2) of the Treaty;

(12) Producer: any person whose activity produces animal by-products;

(13) Processing plant: an animal by-products processing plant;

(14) Category 1 processing plant: a plant in which Category 1 material is processed before its final disposal or further transformation;

(15) Category 2 processing plant: a plant in which Category 2 material is processed before its final disposal or further transformation;

(16) Category 3 processing plant: a plant in which Category 3 materials are processed into feed material;

(17) Processing methods: methods listed in Annex III, Chapter III;

(18) Category 2 oleochemical plant: a plant processing rendered fats derived from Category 2 material under conditions set out in Annex IV, Chapter III;

(18a) Category 3 oleochemical plant: a plant processing rendered fats derived from Category 3 material;

(19) Incineration: the disposal of animal by-products or products derived therefrom in an incineration plant;

(20) Co-incineration: the disposal of animal by-products or products derived therefrom in a co-incineration plant;

(21) Incineration plant: disposal site as defined in Article 3(4) of Directive 2000/76/EC [18];

[18] OJ L 332, 28.12.2000, p.91.[COM(1998) 558 final].

(21a) high-capacity incineration plant: an incineration plant with a throughput of 50 kilograms or more of animal by-products per hour;

(21b) low-capacity incineration plant: an incineration plant with a throughput of less that 50 kilograms of animal by-products per hour;

(22) Co-incineration plant: disposal site as defined in Article 3(5) of Directive 2000/76/EC;

(23) Landfill: disposal site as defined by Council Directive 1999/31/EC [19];

[19] OJ L 182, 16.7.1999, p. 1.

(24) Biogas plant: a plant in which biological degradation of organic material is undertaken under anaerobic conditions for the production and collections of biogas;

(25) Composting plant: a plant in which biological degradation of organic material is undertaken under aerobic conditions;

(26) Technical products: products derived from certain animal by-products, intended for purposes other than human or animal consumption, including tanned and treated hides and skins, game trophies, processed wool, hair, bristles, feathers and part of feathers, apiculture products, serum of equidae, blood products, pharmaceutical, bone products for china, gelatine and glue, processed manure;

(27) Technical plant: a plant producing technical products;

(28) Category 1 or Category 2 intermediate plant: a plant in which unprocessed Category 1 or Category 2 material is handled and/or temporarily stored for the purpose of further transportation to its final destination; it may be used for certain preliminary processing activities, such as removal of ruminant hides and skins, performing of post-mortem examination;

(29) Category 3 intermediate plant: a plant in which unprocessed Category 3 material is sorted and/or cut and/or chilled or deep frozen into blocks and/or temporarily stored for the purpose of further transporting to its final destination;

(30) Collection centres: premises collecting and treating certain animal by-products intended to be used as feed for categories of animals referred to in Article 21(1)(c);

(31) Storage plant: a plant, other than establishments and intermediaries covered by Council Directive 95/69/EC [20], in which processed animal by-products are temporarily stored before their final use or disposal;

[20] OJ L 332, 30.12.1995, p. 15.

(32) Unprocessed animal by-products: animal by-products which have only undergone refrigeration or other treatment not resulting in sufficiently safe destruction of pathogenic agents;

(33) Processed animal protein: animal proteins derived entirely from Category 3 material, which have been treated so as to render them suitable for direct use as feed material or organic fertilisers or soil improvers or in a feedingstuff for animals or in petfood ; it includes fishmeal, meatmeal, bonemeal, meat-and-bone meal, bloodmeal, dry greaves, feathermeal, hoofmeal, hornmeal and other similar products, including mixture or products containing these products;

(34) Feed material: feed of animal origin for farmed animals, including processed animal proteins, rendered fats, fish oil, gelatine and hydrolysed proteins, dicalcium phosphate, milk and milk products;

(35) Organic fertilisers and soil improvers: materials of animal origin that are used to maintain or improve plant nutrition and the physical and chemical properties and biological activity of soils, either separately or together; they may include compost or digestion residues from biogas production;

(36) Batch: a quantity of a product produced, manufactured or packaged under practically the same conditions;

(37) Rendered fats: fats derived from processing of Category 2 material or Category 3 material;

(38) Greaves: the protein-containing residue of rendering, after partial separation of fat and water;

(39) Petfood: food for pet animals which may contain Category 3 material;

(40) Dogchews: untanned edible products for pet animals produced from hides and skins of ungulates or other animal material;

(41) Petfood plant: a plant producing petfood or petfood ingredients or dogchews and in which certain animal by-products are used in the preparation of such petfood or petfood ingredients or dogchews;

(42) Manure: any excrement and/or urine of cloven-hoofed animals, equidae and/or poultry, with or without litter, and guano;

(43) TSEs: all transmissible spongiform encephalopathies with the exception of those occurring in humans;

(44) Specified Risk material: Material referred to in Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention and control of certain transmissible spongiform encephalopathies [21].;

[21] OJ L147, 31.5.2001, p.1

(45) Catering waste: all waste food originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

(46) Remote areas: areas where the concentration of livestock is so low, and where facilities are so far away, that the arrangements necessary for the collection and transport would be unacceptably onerous compared to local disposal;

(47) Pasture land: land covered with grass or other herbage which may be grazed by farmed animals.

Article 3 General obligations

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

CHAPTER II

CATEGORISATION, COLLECTION, TRANSPORTATION AND INTERMEDIATE STORAGE OF ANIMAL BY-PRODUCTS

Article 4 Category 1 material

1. Category 1 material shall comprise animal by-products of the following description, or any material containing such by-products:

(a) all parts of the body, including hides and skins, of the following animals:

(i) animals suspected of being infected by a TSE in accordance with Regulation (EC) No 999/2001 or in which the presence of a TSE has been officially confirmed, including animals which were killed in the context of TSE eradication measures,

(ii) animals other than farmed animals and wild animals, including in particular pet animals, zoo animals and circus animals,

(iii) experimental animals as defined by Article 2 of Council Directive 86/609/EEC [22],

[22] OJ L 358, 18.12.1986, p. 1.

(iv) wild animals not kept by man when suspected of being infected with diseases communicable to man or animals;

(b) (i) specified risk material;and

(ii) where, at the point of disposal, specified risk material has not been removed, entire bodies of dead animals containing specified risk material;

(c) products derived from animals to which have been administrated substances prohibited under Directive 96/22/EC and products of animal origin containing residues of environmental contaminants and other substances listed in Group B (3) of Annex I to Council Directive 96/23/EC [23], if such residues exceed the permitted level laid down by Community legislation or, in the absence thereof, by national legislation;

[23] OJ L 125, 23.5.1996, p.10.

(d) all animal material collected when treating waste water from Category 1 processing plants and other premises in which specified risk material is removed, including screenings, materials from desanding, grease and oil mixture, and sludge, and materials removed from drains from those premises;

(e) catering waste from means of transport operating internationally,

(f) mixtures of Category 1 material with either Category 2 material or Category 3 material or both.

2. Category 1 material shall be collected and transported without undue delay in accordance with Article 7 and, except as otherwise provided in Articles 21 and 21a, shall be, after being permanently marked in case of specified risk material in accordance with Regulation 999/2001,:

(a) directly disposed of as waste by incineration in an incineration plant approved in accordance with Article 9a;

(b) processed in a processing plant approved under Article 10 following the application of any processing methods 1 to 5 referred to in Annex III, Chapter III or, where the competent authority so requires, of processing method 1, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex IV, Chapter I, and finally disposed of as waste by incineration or by co-incineration in an incineration or co-incineration plant in accordance with Article 9a;

(c) with the exclusion of material as referred to in paragraph 1(a)(i), processed in a processing plant approved in accordance with Article 10 following processing method 1 referred to in Annex III, Chapter III, and the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex IV, Chapter I, and finally disposed of as waste by means of burial in a landfill approved under Directive 1999/31/EC;

(d) disposed of by other means that are approved in accordance with the procedure referred to in Article 33(2), after consultation of the appropriate Scientific Committee.

3. Intermediate handling or storage of Category 1 material shall take place only in Category 1 intermediate plants approved in accordance with Article 9.

4. The methods of disposal referred to under points (a) to (d) of paragraph 2 above shall be revised in the light of developments in scientific knowledge in accordance with the procedure referred to in Article 33 (2), after consultation of the appropriate Scientific Committee.

5. Category 1 material, other than products derived therefrom referred to in Annex VI, shall not be exported to third countries.

Article 5 Category 2 material

1. Category 2 material shall comprise animal by-products of the following description, or any material containing such by-products:

(a) manure from all animal species and the digestive tract content from mammalian species;

(b) all animal materials collected when treating waste water from slaughterhouses other than slaughterhouses referred to in Article 4(1)(d) or from Category 2 processing plants, including screenings, materials from desanding, grease and oil mixture, and sludge, and materials removed from drains from these premises;

(c) products of animal origin containing residues of veterinary drugs and contaminants listed in Group B (1) and (2) of Annex I to Directive 96/23/EC, if such residues exceed the permitted level laid down by Community legislation;

(d) products of animal origin, other than Category 1 material, that are imported from third countries and which, in the course of inspections provided for in Community legislation, fail to comply with the veterinary requirements for their importation into the Community, unless they are re-dispatched or their importation is accepted under restrictions laid down under Community legislation;

( e) mixtures of Category 2 material with Category 3 material;

( f) animal by-products other than Category 1 material or Category 3 material.

2. Category 2 material shall be collected and transported without undue delay in accordance with Article 7 and, except as otherwise provided in Articles 21 and 21a, shall be:

(a) directly disposed of as waste by incineration or by co-incineration in an incineration or co-incineration plant approved in accordance with Article 9a;

(b) processed in a processing plant approved in accordance with Article 10 following the application of any processing methods 1 to 5 referred to in Annex III, Chapter III or, where the competent authority so requires, of processing method 1, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex IV, Chapter I, and :

(i) disposed of as waste either by incineration or by co-incineration in an incineration or co-incineration plant approved in accordance with Article 9a , or

(ii) in the case of rendered fats, further processed into fat derivatives for use in organic fertilisers or soil improvers or for other technical uses, other than in cosmetics, pharmaceutical and medical devices, in an Category 2 oleo-chemical plant approved in accordance with Article 11,

(c) processed in a processing plant approved in accordance with Article 10 following the application of processing method 1 referred to in Annex III, Chapter III, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex IV, Chapter I, and:

(i) in the case of resulting proteinaceous material, used as organic fertiliser or soil improver in compliance with requirements, if any, adopted in accordance with the procedure referred to in Article 33(2), after consultation of the appropriate Scientific Committee, or

(ii) transformed in a biogas plant or in a composting plant approved in accordance with Article 12, or

(iii) disposed of as waste by burial in a landfill pursuant to Directive 1999/31/EC;

(d) in case of material of fish origin, ensiled or composted in compliance with rules to be adopted in accordance with the procedure referred to in Article 33(2);

(e) in the case of manure and digestive tract content and material collected from slaughterhouses referred to in paragraph 1(b):

(i) used without processing as raw material in a biogas plant or in a composting plant or treated in a technical plant approved for this purpose,

(ii) if not suspected of being capable of spreading a serious transmissible diseases, spread on land in accordance with this Regulation;

(f) disposed of by other means that are approved in accordance with the procedure referred to in Article 33(2), after consultation of the appropriate Scientific Committee.

3. Intermediate handling or storage of Category 2 material, other than manure, shall take place only in Category 2 intermediate plants approved in accordance with Article 9.

4. The methods of disposal referred to under points (a) to (f) of paragraph 2 above shall be revised in the light of developments in scientific knowledge in accordance with the procedure referred to in Article 33 (2), after consultation of the appropriate Scientific Committee.

5. Category 2 material, other than products derived therefrom referred to in Annex VI, shall not be exported to third countries.

Article 6 Category 3 material

1. Category 3 material shall comprise animal by-products of the following description, or any material containing such by-products:

(a) all parts of slaughtered animals, which are declared fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reason;

(b) all parts of slaughtered animal , which have been rejected as unfit for human consumption but are not affected by any signs of diseases communicable to man or animals and have been derived from carcases passed fit for human consumption in accordance with Community legislation;

(c) hides and skins, hooves and horns, pig bristles and feathers originating from animals which have been slaughtered in a slaughterhouse, have undergone an ante-mortem inspection and been passed fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation;

(d) blood obtained from animals which have been slaughtered in a slaughterhouse, have undergone an ante-mortem inspection and been passed fit, as a result of that inspection, for slaughter for human consumption in accordance with Community legislation;

(e) animal by-products derived from the production of products intended for human consumption, including degreased bones and greaves;

(f) foodstuffs of animal origin, or foodstuffs containing products of animal origin, other than catering waste, which were originally intended for human consumption but are destined for animal consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects which do not present any risk to humans or animals;

(g) raw milk originating from animals which do not show clinical signs of any disease communicable through that product to man or animals;

(h) fish or other sea animals, except sea mammals, caught in the open sea for the purposes of fishmeal production;

(i) fresh fish offal from plants manufacturing fish products for human consumption;

(j) shells, hatchery by-products and cracked egg by-products originating from animals which did not show clinical signs of any disease communicable through that product to man or animals;

(k) blood, hides and skins, hooves, feathers, wool, horns, hair and fur originating from animals which did not show clinical signs of any disease communicable through that product to man or animals;

(l) catering waste other than as referred to in Article 4(1)(e).

2. Category 3 material shall be collected and transported refrigerated in accordance with Annex II, without undue delay in accordance with Article 7 and, except as otherwise provided in Articles 21 and 21a, shall be:

(a) directly disposed of as waste by incineration or by co-incineration in an incineration or co-incineration plant in accordance with Article 9a;

(b) processed in a processing plant approved in accordance with Article 15;

(c) processed in a technical plant approved in accordance with Article 16;

(d) used as raw material in a petfood plant approved in accordance with Article 16;

(e) processed in a processing plant approved in accordance with Article 10 or in a processing plant approved in accordance with Article 15 and the resulting material is finally disposed of as waste either by incineration or by co-incineration in an incineration or co-incineration plant approved in accordance with Article 9a or in landfill approved under Directive 1999/31/EC;

(f) transformed in a biogas plant or in a composting plant approved in accordance with Article 12, or

(g) in case of catering waste referred to in paragraph 1(l), transformed in a biogas plant or composted in compliance with rules to be adopted in accordance with the procedure referred to in Article 33(2), or, pending the adoption of such rules, in accordance with national law.

3. Intermediate handling and/or storage of Category 3 material shall take place only in Category 3 intermediate plants approved in accordance with Article 9.

Article 7 Collection and transportation

1. Animal by-products and processed products derived therefrom shall be collected, transported and identified in accordance with Annex II.

The three categories of animal by-products shall be kept strictly and completely separate throughout their handling, collection and transport, and they shall

(a) in case of Category 1 and Category 2 material and products derived therefrom referred to in Articles 4 and 5, be permanently marked, where technically possible with smell, in accordance with Annex IV, Chapter I;

(b) in case of Category 3 material always be stored and transported refrigerated or frozen in accordance with Annexes II and VIII, and be kept separate by animal species.

2. During transport, a commercial document or, when required by this Regulation, a health certificate shall accompany animal by-products and processed products. The commercial document and health certificate shall meet the requirements, and be kept for the period, specified in Annex II.

3. Member States shall ensure that appropriate arrangements exist to guarantee the collection and transportation of Category 1 and Category 2 material in accordance with Annex II.

Article 8 Records

1. Producers consigning animal by-products from any premises shall keep a record of each consignment showing:

(a) the date on which the material was taken from the premises;

(b) the quantity and description of the material and of the marker, if appropriate;

(c) the destination to which it was consigned; and

(d) the name of the haulier transporting it.

2. Any person transporting animal by-products shall, at the time of collection, record:

(a) the address of the premises from which the material was collected;

(b) the date on which the material was collected;

(c) the quantity and description of the material and of the marker, if appropriate;

(d) the destination to which it is to be taken.

3. Any person receiving animal by-products shall keep a record of incoming consignments showing:

(a) the date on which the material arrived;

(b) the address of the premises from which the material was consigned;

(c) the quantity and description of the material and of the marker, if appropriate;

(d) the name and address of the haulier who transported it.

4. The records referred to in paragraphs 1, 2 and 3 shall be kept for a period of at least two years for presentation to the competent authorities.

Article 9 Intermediate plants and storage plants

1. Category 1, 2 and 3 intermediate plants and storage plants shall be subject to approval by the competent authority.

2. In order to be approved , the Category 1 or Category 2 intermediate plant must:

(a) meet the requirements of Annex VIII, Chapter I;

(b) handle and store Category 1 or Category 2 material in accordance with Annex VIII, Chapter II, Part B;

(c) have undergone the establishment's own checks provided for in Article 22;

(d) be checked by the competent authority in accordance with Article 23.

3. In order to be approved , the Category 3 intermediate plant must:

(a) be physically separated from plants for Category 1 and 2 material and meet the requirements of Annex VIII, Chapter I;

(b) handle and store Category 3 material in accordance with Annex VIII, Chapter II, Part A;

(c) have undergone the establishment's own checks provided for in Article 22;

(d) be checked by the competent authority in accordance with Article 23.

4. In order to be approved, storage plants must:

(a) meet the requirements of Annex VIII, Chapter III;

(b) store processed animal by-products in accordance with Annex VIII, Chapter III, point 3;

(c) be supervised by the competent authority.

Article 9a Approval of incineration and co-incineration plants

1. The incineration and co-incineration of processed products shall take place in accordance with the provisions of Directive 2000/76/EC. The incineration and co-incineration of animal by-products shall take place either in accordance with the provisions of Directive 2000/76/EC or, when that Directive does not apply, in accordance with the provisions of this Regulation. Incineration and co-incineration plants shall be approved under that Directive or in accordance with paragraph 2 and 3.

2. To be approved by the competent authority for the purpose of disposing of animal by-products, a high capacity incineration or co-incineration plant to which Directive 2000/76/EC does not apply must:

(a) fulfil the general conditions laid down in Annex XII , Chapter I;

(b) fulfil the operating conditions laid down in Annex XII , Chapter II;

(c) fulfil the requirements laid down in Annex XII, Chapter III, concerning water discharges;

(d) fulfil the requirements laid down in Annex XII, Chapter IV, concerning residues;

(e) fulfil the temperature measurement requirements laid down in Annex XII, Chapter V; and

(f) fulfil the conditions concerning abnormal operating laid down in Annex XII, Chapter VI.

3. To be approved by the competent authority for the purpose of disposing of animal by-products, a low-capacity incineration and co-incineration plant to which Directive 2000/76/EC does not apply must:

(a) be used only for the disposal of dead pet an imals and/or Category 2 and 3 material;

(b) when located on a holding, be used only for the disposal of materila from that particular holding;

(c) fulfil the general conditions laid down in Annex XII, Chapter I;

(d) fulfil the applicable operating conditions laid down in Annex XII, Chapter II;

(e) fulfil the requirements laid down in annex XII, Chapter IV, concerning residues;

(f) fuilfil the temperature measurement requirements laid down in Annex XII, Chapter V; and

(g) fulfil the conditions concerning abnormal operating laid down in Annex XII, Chapter VI.

4. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

5. The requirements of paragraphs 2 and 3 may be modified in the light of developments in scientific knowledge in accordance with the procedure referred to in Article 33(2), after consultation of the appropriate Scientific Committee.

CHAPTER III

APPROVAL OF CATEGORY 1 AND 2 PROCESSING PLANTS, BIOGAS PLANTS, COMPOSTING PLANTS AND OLEO-CHEMICAL PLANTS

Article 10 Approval of Category 1 and Category 2 processing plants

1. Member States shall approve for all or part of their territory one or more Category 1 and Category 2 processing plants for the collection and processing of Category 1 or Category 2 material. A Member State may decide to designate a Category 1 or Category 2 processing plant in another Member State after agreement with that State.

2. In order to be approved by the competent authority, Category 1 and Category 2 processing plants must:

(a) meet the requirements of Annex III, Chapter I;

(b) handle, process and store the Category 1 or Category 2 material in accordance with Annex III, Chapter II and Annex IV, Chapter I;

(c) be validated by the competent authority in accordance with Annex III, Chapter V;

(d) have undergone the establishment's own checks provided for in Article 22;

(e) be checked by the competent authority in accordance with Article 23;

(f) establish and implement methods of monitoring and checking the critical control points on the basis of the process used;

(g) ensure that the products after processing satisfy the requirements of Annex IV, Chapter I.

3. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Article 11 Approval of oleo-chemical plants

1. Oleo-chemical plants shall be subject to approval by the competent authority.

2. In order to be approved, a Category 2 oleo-chemical plant must:

(a) process the rendered fats derived from Category 2 material in accordance with the standards laid down in Annex IV, Chapter III;

(b) establish and implement methods of monitoring and checking the critical control points on the basis of the process used;

(c) keep a record of the information obtained pursuant to point (b) for presentation to the competent authority;

(d) be under the supervision of the competent authority to ensure that the operator or manager of the establishment complies with the requirements of this Regulation.

3. In order to be approved, an oleo-chemical plant for Category 3 shall process rendered fat derived only from Category 3 material and shall meet the requirements for oleo-chemical plants for Category 2 material in accordance with paragraph 2.

4. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Article 12 Approval of biogas plants and composting plants

1. Biogas plants and composting plants which transform animal by-products shall be subject to approval by the competent authority.

2. In order to be approved, a biogas plant and composting plant must:

(a) meet the requirements of Annex IV, Chapter II, section A;

(b) handle and transform the animal by-products in accordance with Annex IV, Chapter II, sections B and C;

(c) be checked by the competent authority;

(d) establish and implement methods of monitoring and checking the critical control points;

(e) ensure that digestion residues comply with the microbiological standards laid down in Annex IV, Chapter II, section D.

3. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Article 13 Dispatch of processed animal by-products to incineration or co-incineration plants or to landfill

1. Processed animal by-products may be sent for disposal by incineration or co-incineration or landfill only subject to the following conditions:

(a) processed animal by-products must be:

(i) transported in sealed covered containers or vehicles which bear the clear indication 'not for animal consumption - for incineration/co-incineration/landfill only', as appropriate,

(ii) consigned only to incineration or co-incineration plants approved under Directive .../.../EC [on the incineration of waste] or to landfill approved under Directive 1999/31/EC;

(b) the competent authority of the place of origin must inform the competent authority of the place of destination of the dispatch of each consignment;

(c) the competent authority of the place of destination must inform the competent authority of the place of origin of the arrival of each consignment;

(d) the competent authority of the place of destination must ensure that the designated plant or landfill uses the consignment only for the authorised purposes and keeps full records demonstrating compliance with this Regulation.

2. Processed animal by-products may be sent for disposal by incineration or co-incineration to other Member States only subject to the following conditions:

(a) the Member State of destination must have authorised the receipt of the material;

(b) the processed animal by-products must:

(i) be accompanied by an official certificate as laid down in Annex VII,

(ii) be transported in sealed covered containers or vehicles which bear the clear indication 'not for animal consumption - for incineration or co-incineration only,' if appropriate in the language of the Member States of origin, destination and transit,

(iii) be conveyed directly to the incineration or co-incineration plant;

(c) Member States which send processed animal by-products to other Member States must inform the competent authority of the place of destination of each consignment by means of the ANIMO system and the words 'Not for animal consumption - For incineration or co-incineration only' must be contained in the ANIMO message;

(d) Member States of destination must inform the competent authority of the place of origin of the arrival of each consignment by means of the ANIMO system;

(e) Member States of destination must ensure that the designated plants on their territory use the consignment only for the authorised purposes and keep full records demonstrating compliance with this Regulation.

CHAPTER IV

PLACING ON THE MARKET OF PROCESSED ANIMAL PROTEINS AND OTHER FEED MATERIAL, PETFOOD, DOGCHEW AND TECHNICAL PRODUCTS

Article 14 General animal health provisions

1. Member States shall take all necessary measures to guarantee that animal by-products and products derived therefrom, referred to in Annex V and Annex VI, are not dispatched from any holding, situated in zone subject to restrictions because of the occurrence of a disease to which the species from which the product is derived is susceptible or from any plants or zone from which movements or trade would constitute a risk to the animal health status of the Member States or areas of Member States except where products are treated in accordance with this Regulation.

2. The measures referred to in paragraph 1 shall guarantee that the products are obtained from animals which:

(a) come from a holding, territory or part of a territory or, in the case of aquaculture products, from a farm, zone or part of a zone, not subject to animal health restrictions applicable to the animals and products concerned, and in particular restrictions under disease control measures imposed by Community legislation or by virtue of a serious transmissible disease listed in Council Directive 92/119/EC [24];

[24] OJ L 62 of 15.3.1993, p. 69.

(b) were not slaughtered in an establishment in which animals infected, or suspected of being infected, with one of the diseases covered by the rules referred to in (a) were present at the time of slaughter.

3. Subject to compliance with the disease-control measures referred to in paragraph 2(a), the marketing of animal by-products, and products derived therefrom referred to in Annex V and VI, which come from a territory or part of a territory subject to animal health restriction but are not infected or suspected of being infected shall be permitted provided that, as appropriate, the products:

(a) are obtained, handled, transported and stored separately from or at different times from products fulfilling all animal health conditions;

(b) have undergone a treatment sufficient to eliminate the animal health problem concerned in accordance with this Regulation at an establishment approved for that purpose by the Member State where the animal health problem occurred;

(c) are properly identified;

(d) comply with the special conditions laid down in Annexes V and VI, or with detailed rules to be adopted in accordance with the procedure referred to in Article 33(2).

Conditions alternative to those set out in the first subparagraph may be laid down in specific situations by decisions adopted in accordance with the procedure referred to in Article 33(2). Such decisions shall take account of any measures concerning the animals or tests to be carried out on them and the specific characteristics of the disease in the species concerned and shall specify any measures needed to ensure the protection of animal health in the Community.

Article 15 Approval of Category 3 processing plants

1. Category 3 processing plants shall be subject to approval by the competent authority.

2. In order to be approved, Category 3 processing plants must:

(a) be physically separated from plants for Category 1 and 2 material and meet the requirements of Annex III, Chapter I and II and Annex V;

(b) handle, process and store only Category 3 material in accordance with Annex V;

(c) have been validated by the competent authority in accordance with Annex III, Chapter V;

(d) have undergone the establishment's own checks provided for in Article 22 and be supervised by the competent authority in accordance with Article 23;

(e) ensure that after processing the products satisfy the requirements of Annex V, Chapter I.

3. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Article 16 Approval of petfood plants and technical plants

1. Petfood plants and technical plants shall be subject to approval by the competent authority.

2. In order to be approved, the petfood plant or the technical plant must:

(a) undertake, in the light of the specific requirements laid down in Annex VI for the products the plant produces, to:

(i) comply with the specific production requirements set out in this Regulation;

(ii) establish and implement methods of monitoring and checking the critical control points on the basis of the process used;

(iii) depending on the products, take samples for analyses in a laboratory recognised by the competent authority for the purposes of checking compliance with the standards established by this Regulation;

(iv) keep a record of the information obtained pursuant to (ii) and (iii) for presentation to the competent authority. The results of the checks and tests shall be kept for at least two years;

(v) should the result of the laboratory examination referred to in (iii) or any other information available to them reveal the existence of a serious animal health or public health hazard, inform the competent authority;

(vi) consign only products accompanied by a commercial document indicating the nature of the product, the name and the veterinary approval number of the establishment of production;

(b) be under the supervision of the competent authority to ensure that the operator or manager of the establishment complies with the requirements of this Regulation.

3. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Article 17 Placing on the market and export of processed animal protein and other feed material

Member States shall ensure that processed animal proteins and other feed material are placed on the market or exported only if they :

(a) have been prepared in a Category 3 processing plant approved and supervised in accordance with Article 15 and in such a way that recycling within the species can be avoided;

(b) have been prepared exclusively with Category 3 material listed in points (a) to (j) of Article 6(1);

(c) have been handled, processed, stored and transported in accordance with Annex V;

(d) comply with the standards laid down in Annex V.

Article 18 Placing on the market and export of petfood, dogchews and technical products

1. Member States shall ensure that petfood, dogchew and technical products, except as referred to in paragraphs 2 and 3, are placed on the market or exported only if they:

(a) meet the specific requirements laid down in Annex VI;

(b) come from establishments approved and supervised in accordance with Article 16.

2. Member States shall ensure that organic fertilisers or soil improvers produced from processed products, other than those produced from manure and digestive tract contents, are placed on the market or exported only if they meet requirements, if any, laid down in accordance with the procedure referred to in Article 33(2), after consultation of the appopriate Scientific Committee.

3. Member States shall ensure that fat derivatives produced from Category 2 material are placed on the market or exported only if they:

(a) have been prepared in a Category 2 oleo-chemical plant approved in accordance with Article 11, from rendered fats derived from processing of Category 2 material in a Category 2 processing plant approved in accordance with Article 10 following the application of any processing methods 1 to 5,

(b) have been handled, processed, stored and transported in accordance with Annex IV, and

(c) meet the specific requirements in Annex IV

Article 19 Safeguard measures

Article 10 of Directive 90/425/EEC shall apply to the products covered by Annexes V and VI to this Regulation.

Article 20 Limits on use

1. The following uses of animal by-products and products derived therefrom are prohibited:

(a) the feeding of a species with processed animal protein derived from the bodies or parts of bodies of animals of the same species;

(b) the feeding of farmed animals other than fur animals with catering waste or feed material derived from catering waste;

(c) the spreading on pasture land of organic fertilisers and soil improvers, other than manure, is prohibited.

2. Rules for the implementation of this Article, including rules concerning control measures, shall be adopted in accordance with the procedure referred to in Article 33(2). Derogations from paragraph 1(a) may be granted in relation to fish and fur animals by the same procedure, after consultation of the appropriate Scientific Committee.

CHAPTER V

DEROGATIONS

Article 21 Derogations

1. Member States may authorise under the supervision of the competent authorities:

(a) the use of animal by-products for diagnostic, educational and research purposes;

(b) the use of animal by-products for taxidermy purposes in technical plants approved for this purpose in accordance with Article 16;

(c) in accordance with the rules laid down in Annex IX, the use of Category 2 material, provided that it comes from animals which were not killed or did not die as a result of the presence or suspected presence of a disease communicable to man or animals, and Category 3 material referred to in Article 6(1)(a) to (j), for the feeding of:

(i) zoo animals,

(ii) circus animals,

(iii) reptiles other than zoo or circus animals,

(iv) fur animals,

(v) wild animals of endangered species,

(vi) wild animals of any species where this is necessary because of severe nutritional conditions or for preparing documentary reports,

(vii) recognised kennels or packs of hounds,

(viii) maggots for fishing bait.

2. Member States shall inform the Commission where they make use of the derogations referred to in paragraph 1 and shall notify it of the verification arrangements they introduce to prevent the animal by-products concerned from being used for unauthorised purposes.

3. Each Member State shall draw up a list of users and collection centres authorised and registered pursuant to paragraph 1(c) within its own territory. Each user and collection centre shall be assigned an official number for inspection purposes and in order to be able to trace the origin of the products concerned.

The premises of users and collection centres shall be supervised by the competent authority, which shall at all time have free access to all parts of the premises, in order to ensure compliance with the requirements referred to in paragraph 1(c).

If such inspection reveal that those requirements are not being complied with, the competent authority shall take appropriate action.

4. Detailed rules concerning verification measures may be adopted in accordance with the procedure referred to in Article 33(2).

Article 21a

Derogations regarding the disposal of animal by-products

1. The competent authority may, where necessary, decide that:

(a) dead pet animals, other than animals referred to in Article 4(1)(a)(i), may be directly disposed of as waste by burial;

(b) the following animal by-products originating in remote areas may be disposed of as waste by burning or burial on site:

(i) Category 1 material referred to in article 4(1)(b)(ii),

(ii) Category 2 material, and

(iii) Category 3 material,

(c) animal by-products may be disposed of as waste by burning or burial on site in the event of an outbreak of a disease mentioned in List A of the International Office of Epizootic Diseases, if the competent authority rejects transport to the nearest incineration or processing plant because of the dangers of propagation of health risks or because a widespread disease outbreak leads to a lack of capacity at such plants.

2. No derogation may be granted in respect of Category 1 material referred to in Article 4(1)(a)(i).

3. In the case of Category 1 material referred to in Article 4(1)(b)(ii), burning and burial may take place in accordance with paragraph 1(b) or (c) only if the competent authority authorises and supervises the method used and is satisfied that it precludes all risk of transmission of TSEs.

4. Member States shall inform the Commission of:

(a) the use they make of the possibilities provided for in paragraph 1(b) in respect of Category I and Category 2 material; and

(b) the areas that they categorise as remote areas for the purpose of applying paragraph 1(b) and the reasons for that categorisation.

5. The competent authority shall take the necessary measures:

(a) to ensure that the burning or burial of animal by-products does not endanger animal or human health; and

(b) to prevent the abandonment, dumping or uncontrolled disposal of animal by-products.

6. Detailed arrangements for implementing this Article may be adopted in accordance with the procedure referred to in Article 33(2).

CHAPTER VI

CONTROLS AND INSPECTIONS TO BE CARRIED OUT ON INTERMEDIATE AND PROCESSING PLANTS

Article 22 Plants' own-checks

1. Operators and owners of intermediate plants and processing plants or their representatives shall adopt all measures necessary to comply with the requirements of this Regulation. They shall put in place, implement and maintain a permanent procedure developed in accordance with the principles of the system of hazard analysis and critical control points (HACCP). They shall in particular:

(a) identify and control the critical points in the plants;

(b) establish and implement methods for monitoring and checking such critical points;

(c) in the case of processing plants, take representatives samples from each processed batch in order to check compliance with the standards for the products established by this Regulation and the maximum permitted levels of physico-chemical residues laid down in Community legislation;

(d) record the results of the checks and tests referred to in (b) and (c) and keep them for a period of at least two years for presentation to the competent authorities;

(e) introduce a system that makes it possible to link each batch dispatched and the time when it was produced.

2. Where the results of a test on samples taken pursuant to paragraph 1(c) do not comply with the provisions of this Regulation, the operator of the processing plant must:

(a) notify the competent authority immediately;

(b) establish the causes of failures of compliance;

(c) ensure that no material suspected or known to be contaminated is moved from the plant before being reprocessed under the direct supervision of the competent authority and re-sampled officially in order to comply with the standards laid down in this Regulation.

3. Detailed arrangements for implementing this Article may be adopted in accordance with the procedure referred to in Article 33(2).

Article 23 Official controls

1. The competent authorities shall at regular intervals carry out inspections and supervision at the intermediate plants and processing plants in accordance with Annex III, Chapter IV.

2. The frequency of inspections and supervision shall depend on the size of the plant, the type of products manufactured, risk assessment and guarantees offered in accordance with Hazard Analysis Critical Control Points implementation.

3. If the inspection carried out by the competent authority reveals that not all of the requirements of this Regulation are being met, the competent authority must take appropriate action. In the case of non-compliance with the provisions of this Article in relation to microbiological standards, and the types of microbiological controls, the manufacturer shall:

(a) notify the competent authority immediately of the full details of the nature of the sample and the batch from which it was derived;

(b) process and reprocess the contaminated batch under the supervision of the competent authority;

(c) increase the intensity of sampling and testing of production;

(d) investigate unprocessed animal by-products records appropriate to the finished sample;

(e) instigate appropriate decontamination and cleaning procedures within the plant.

4. Detailed arrangements for implementing this Article may be adopted in accordance with the procedure referred to in Article 33(2).

Article 24 Frequency of checks and microbiological analyses

1. The detailed arrangements for and frequency of the checks provided for in Articles 22 and 23 shall be established in accordance with the procedure referred to in Article 33(2).

2. The reference methods for the microbiological analyses shall be established in accordance with the procedure referred to in Article 33(2).

Article 25 List of approved plants

Each Member State shall draw up a list of plants approved pursuant to Articles 9 to 12 and Articles 15 and 16 within its own territory. Each plant shall be assigned an official number which identifies the plant with respect to the nature of its activities.

The Member States shall forward the list and its up-dates to the other Member States and to the Commission.

CHAPTER VII

COMMUNITY CONTROLS IN MEMBER STATES

Article 26 Community controls

1. Experts from the Commission may make on-the-spot checks, in cooperation with the competent authorities in the Member States, insofar as is necessary for uniform application of this Regulation. The Member State on whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authorities of the results of the checks made. 2. Rules for the implementation of this Article , in particular those governing the procedure for co-operation with the national competent authorities, shall be adopted in accordance with the procedure referred to in Article 33(2).

CHAPTER VIII

PROVISIONS APPLICABLE TO THE IMPORTATION OF CERTAIN ANIMAL BY-PRODUCTS AND PRODUCTS DERIVED THEREFROM INTO THE COMMUNITY

Article 27 General provisions

The provisions applicable to the importation of products referred to in Annex V and petfood, dogchews and technical products referred to in Annex VI from third countries shall be no more favourable or less favourable that those applicable to the production and marketing of those products in the Community.

However, the importation from third countries of petfood and raw material for petfood production, derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC,shall be permitted provided that such raw material is marked and under specific conditions to be laid down in accordance with the procedure referred to in Article 33(2).

Article 28 Prohibitions

Import of animal by-products and derived products into the Community shall be prohibited, except in accordance with this Regulation.

Article 29 Compliance with Community rules

1. Products referred to in Annexes V and VI may be imported into the Community only if they satisfy the requirements set out in paragraphs 2 to 5.

2. Products referred to in Annexes V and VI must, save as otherwise specified in those Annexes, come from a third country or parts of third countries on a list to be drawn up and updated in accordance with the procedure referred to in Article 33(2).

The list may be combined with other lists drawn up for public and animal health purposes.

When the list is drawn up, particular account shall be taken of:

(a) the legislation of the third country;

(b) the organisation of the competent authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and their authority to monitor effectively the application of their legislation;

(c) the actual health conditions applied to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community;

(d) the assurances the third country can give regarding compliance with the relevant health conditions;

(e) experience of marketing the product from the third country and the results of import checks carried out;

(f) the result of any Community inspections on the third country;

(g) the health status of the livestock, other domestic animals and wildlife in the third country, having particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;

(h) the regularity and speed with which the third country supplies information about the existence of infectious or contagious animal diseases in its territory, in particular the diseases mentioned in Lists A and B of the International Office of Epizootic Diseases (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases as listed in the Aquatic Animal Health Code of the OIE;

(i) the regulations on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries.

3. Products referred in Annex V must come from establishments on a Community list to be drawn up in accordance with the procedure referred to in Article 33(2) on the basis of a communication from the competent authorities of the third country to the Commission declaring that the plant complies with the Community requirements and is subject to supervision by an official inspection service in the third country.

Approved lists shall be amended as follows:

(a) the Commission shall inform the Member States of the modifications proposed by the third country concerned to the lists of establishments within five working days of the receipt of the proposed modifications;

(b) the Member States shall have seven working days, from receipt of the modifications to the lists of establishments referred to in (a) to send any written comments to the Commission;

(c) where written comments are made by at least one Member State, the Commission shall inform the Member States within five working days and include the point on the next meeting of the Standing Veterinary Committee for decision in accordance with the procedure referred to in Article 33(2);

(d) where no comments are received from the Member States within the time limit referred to in (b), the modifications to the list shall be considered to have been accepted by the Member States. The Commission shall inform the Member States within five working days, and imports shall be authorised from such establishments five working days after receipt of this information by the Member States.

4. Products referred to in Annex VI must come from establishments that have been approved and registered by the competent authority of the third countries.

5. Consignments of products referred to in Annexes V and VI, must, save as otherwise specified in those Annexes, be accompanied by a health certificate corresponding to the specimen laid down in Annex X, certifying that the products meet the conditions referred to in those annexes and come from establishments offering such conditions.

Article 30 Equivalence

1. In accordance with the procedure referred to in Article 33(2), a decision may be taken recognising that the health measures applied by a third country, a group of third countries or a region of a third country to the production, manufacture, handling, storage and transport of one or more categories of products referred to in Annexes V and VI offer guarantees equivalent to those applied in the Community, if the third country supplies objective proof in this respect.

The decision shall set out the conditions governing the importation of animal by-products from that region, country or group of countries.

2. The conditions referred to in paragraph 1 shall include:

(a) the nature and content of the health certificate which must accompany the product;

(b) specific health requirements applicable to importation into the Community;

(c) where necessary, procedures for drawing up and amending lists of regions or establishments from which imports are permitted.

3. The detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 33(2).

Article 31 Community inspections and audits

1. Experts from the Commission, where appropriate accompanied by experts from the Member States, may carry out on-the-spot checks with a view to

(a) drawing up the list of third countries or parts thereof and determining conditions for importation;

(b) verifying compliance with:

(i) the conditions for inclusion in a Community list of third countries,

(ii) import conditions,

(iii) the conditions for recognising equivalence of measures ,

(iv) any emergency measures applied under Community legislation.

The experts from the Member States responsible for these checks shall be appointed by the Commission.

2. The checks referred to in paragraph 1 shall be carried out on behalf of the Community, which shall meet the costs incurred.

3. The frequency of and the procedure for the checks referred to in paragraph 1 may be specified in accordance with the procedure referred to in Article 33(2).

4. If a check referred to in paragraph 1 reveals a serious infringement of the health rules, the Commission shall immediately request the third country to take appropriate measures or shall suspend consignments of products and immediately inform the Member States.

CHAPTER IX

FINAL PROVISIONS

Article 32 Amendments to Annexes and transitional measures

After consultation of the appropriate Scientific Committee on any questions that could have an impact on animal or public health, the Annexes may be amended or supplemented and any appropriate transitional measures may be adopted in accordance with the procedure referred to in Article 33(2).

Article 33 Regulatory procedure

1. The Commission shall be assisted by the Standing Veterinary Committee instituted by Article 1 of Decision 68/361/EEC.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be 15 days.

Article 34 Consultation of scientific committees

The appropriate Scientific Committees shall be consulted on any matter falling within the scope of this Regulation which could have an effect on animal or public health.

Article 35 Communication of national provisions

1. The Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Regulation.

2. In particular, Member States shall inform the Commission of the measures taken to ensure compliance with this Regulation within one year of its entry into force. On the basis of the information received, the Commission shall submit a report to the European Parliament and to the Council accompanied, if appropriate, by legislative proposals.

Article 36 Financing rules

The Commission shall prepare a report on the financial support in Member States for the processing and disposal of the animal by-products, with particular reference to Category 1 and Category 2 material, accompanied by appropriate proposals.

Article 37 Repeal

Directive 90/667/EEC and Decisions 95/348/EC and 1999/534/EC are repealed.

References to Directive 90/667/EEC shall be construed as references to this Regulation.

Article 38 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

It shall apply six months after the date of its entry into force. [25].

[25] This date has been indicated to provide a period of 18 months for the implementation of the new provisions.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

Definitions

Gelatine: natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, (including fish and poultry);

Hydrolysed proteins: mixtures of polypeptides, peptides and aminoacids obtained by the hydrolysis of collagen;

Hides and skins: all cutaneous and subcutaneous tissues;

Tanning: the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents;

Processed petfood: petfood, other than raw petfood, which has undergone a treatment which ensure its stability;

Canned petfood: heat processed petfood contained within a hermetically sealed container;

Hermetically sealed container: container that is designed and intended to be secure against the entry of micro-organism;

Raw petfood: petfood which has not undergone any preserving process other than chilling, freezing or quick freezing or equivalent processes to ensure preservation;

Fishmeal: processed animal protein derived from sea animals, except sea mammals

Blood: fresh whole blood;

Blood products: Products derived from blood or fractions of blood, excluding blood meal. They include: dried/frozen/liquid plasma, dried whole blood, dried/frozen/liquid red cells or fraction thereof and mixtures;

Bloodmeal: Blood products derived from the heat-treatment of blood in accordance with Annex V, Chapter II and intended for animal consumption or fertilisers;

Blood products for technical and pharmaceutical use: Blood products intended for technical of pharmaceutical purposes;

Products used for in vitro diagnosis: a packaged product, ready for use by the end user, containing a blood product, and used as reagent, reagent product, calibrator, kit or any other system, whether used alone or in combination, intended to be used in vitro for the examination of samples of human or animal origin, with the exception of donated organs or blood, solely or principally with a view to the diagnosis of a physiological state, state of health, disease ir genetic abnormality or to determine safety and compatibility with reagents;

Laboratory reagents: a packaged product, ready for use by the end user, containing a blood product, and intended for laboratory use as reagent or reagent product, whether used alone or in combination;

Unprocessed wool, hair and bristles: sheep's wool, ruminant hair and pig bristles which have not undergone factory washing or been obtained from tanning;

Unprocessed feathers and parts of feathers: feathers and part of feathers which have not been treated with a steam current or by some other method ensuring that no pathogens are transmitted;

Apiculture products: honey, beewax, royal jelly, propolis or pollen, not intended for human consumption or industrial use.

ANNEX II

Hygiene requirements for the collection and transport of animal by-products

1. All the necessary measures shall be taken to assure that Category 1, Category 2 and Category 3 materials and products derived therefrom are identifiable and kept strictly separated and identifiable during collection and transportation.

2. Animal by-products must be collected and transported in suitable containers or vehicles in such a way as to prevent leakage. The containers or vehicles must be adequately covered. Vehicles for refrigerated transport must have been designed in such a way that the temperature required can be maintained throughout the period of transport.

3. Vehicles, tarpaulin covers and reusable containers must be cleaned and disinfected after each use and must be maintained in a clean conditions.

4. Where animal by-products are not transported directly in bulk, the information on the origin, name and nature of the animal by-products and the words 'Animal by-products - Not for human consumption' must also be indicated on a label attached to the container, cartons or other packaging material in letters at least 2 cm high.

5. During transportation,

(a) Unprocessed and processed animal by-products, and products derived therefrom must be accompanied either

(i) by a commercial document, specifying:

- the date on which the material was taken from the premises

- the description of the material including its category in accordance with this Regulation, the animal species forCategory 3 material and to processed products derived therefrom destined for use as feed material and, if applicable, the ear tag number

- with the exception of manure, the nature of the material, indicated by means of the words 'Animal by-products - not fit for human consumption'

- the quantity of the material

- the place origin of the material

- the name and the address of the carrier

- the name and the address of the receiver and the registration number.

- if appropriate,

I) the approval or registration number of the plant of origin

II) the nature and the methods of the treatment

The commercial document must be produced in triplicate (1 original and two copies). The original shall accompany the consignment to its final destination and shall be retained by the receiver, one copy shall be retained by the producer, another shall be retained by the carrier.

or

(ii) when specifically requested by this Regulation, by a health certificate issued and signed by the competent authority.

The commercial document and the health certificate referred to in (i) and (ii) shall be kept for a period of at least two years for presentation to the competent authorities

A model for the commercial document referred to in (i) or for the health certificate referred to in (ii) may be laid down in accordance with the procedure referred to in Article 33 (2).

6. The competent authority shall take the necessary measures to control the movements of unprocessed and processed animal by-products and products derived therefrom by checking the keeping of required records and documents, which shall accompany those products during their transport to the place of destination, and, if necessary, by sealing.

7. The transport of animal by-products must take place at an appropriate temperature, to avoid any risk to animal or human health.

8. Unprocessed Category 3 material destined for the production of feed material or petfood must be transported chilled or frozen, unless processed within 24 hours of departure.

9. The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature throughout transport.

ANNEX III

General hygiene requirements for animal by-products processing plants

CHAPTER I

General conditions for the approval of animal by-products processing plants

1. Premises and facilities must meet at least the following requirements:

(a) The premises of the processing plant must be adequately separated from the public highway and other premises such as slaughterhouses. Premises for the processing of animal by-products of Category 1 and 2 must not be at the same site as slaughterhouses, unless in a completely separate part of a building. Unauthorised persons and animals shall have no access to the plant.

(b) The processing plant must have a clean and unclean section, adequately separated. The unclean section must have a covered place to receive the animal by-products and must be constructed in such a way that is easy to clean and disinfect. Floors must be laid in such a way as to facilitate the draining of liquids. The processing plant must have adequate lavatories, changing rooms and washbasins for staff.

(c) The processing plant must have sufficient capacity and hot water and steam production for the processing of animal by-products.

(d) The unclean section must, if appropriate, contain equipment to reduce the size of animal by-products and equipment for loading the crushed animal by-products into the processing unit.

(e) All installations in which animal by-products are processed must operate in accordance with the requirements of Chapter II. Where heat treatment is required, all installations must be equipped with:

- measuring equipment to monitor temperature against time and, if necessary, pressure at critical points;

- recording devices to record continuously the results of these measurements;

- an adequate safety system to prevent insufficient heating.

(f) To prevent recontamination of the finished product by incoming unprocessed animal by-product, there must be a clear separation between the area of the plant where incoming material for processing is unloaded and the areas set aside for the process of that product and the storage of the processed product.

2. The processing plant must have adequate facilities for cleaning and disinfecting the vehicles or containers and recipients in which animal by-products are received - other than ships - or in which it is transported.

3. Adequate facilities must be provided for the disinfecting of vehicle wheels, upon leaving the unclean section of the processing plant.

4. A waste-water disposal system meeting the Competent Authority's requirements is required for all processing plants.

5. The processing plant must have its own laboratory or make use of the services of an external laboratory. The laboratory must be equipped to make the essential analysis and must be approved by the competent authority.

CHAPTER II

General conditions of hygiene

1. Animal by-products must be processed as soon as possible after arrival. They must be stored properly until processed.

2. Containers, recipients and vehicles used for the transport of animal by-products must be cleaned, washed and disinfected after each use. Containers, recipients and vehicles used for transporting unprocessed material shall be cleaned in a designate area. This area shall be situated or designed to prevent the risk of contamination of processed products.

3. Persons working in the unclean section must not enter the clean section without changing their working clothes and footwear or without disinfecting the latter. Equipment and utensils shall not be taken from the unclean section into clean section. Personnel movement procedure shall be established to control the movement of personnel between areas and to prescribe the proper use of foot baths and wheel baths.

4. Waste water originati