Common Position (EC) No 12/2002

adopted by the Council on 20 November 2001

with a view to adopting Regulation (EC) No .../2002 of the European Parliament and of the Council of ... laying down health rules concerning animal by-products not intended for human consumption

(2002/C 45 E/06)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

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

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

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

(1) Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedingstuffs of animal or fish origin and amending Directive 90/425/EEC(4) established the principle that all animal waste, regardless of its source, may be used for the production of feed material following appropriate treatment.

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

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

(4) In the light of the experience gained in recent years, it is appropriate to clarify the relationship between Directive 90/667/EEC and Community environmental legislation. This Regulation should not affect the application of existing environmental legislation or hinder the development of new rules on environmental protection, particularly as regards biodegradable waste.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(26) The products concerned should be subject to the rules for veterinary checks, including checks by experts from the Commission, and any protective measures laid down by Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(11).

(27) Effective checks should be carried out on products imported into the Community. This can be achieved by implementing the controls laid down in Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from non-member countries(12).

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

(29) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Veterinary Committee set up by Council Decision 68/361/EEC(15).

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

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down animal and public health rules for:

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

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

2. This Regulation shall not apply to:

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

(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, or

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

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

(g) transit by sea or by air.

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

Article 2

Definitions

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

(a) animal by-products: entire bodies or parts of animals or products of animal origin referred to in Articles 4, 5 and 6 not intended for human consumption, including ova, embryos and semen;

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

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

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

(e) animal: any vertebrate or invertebrate animal (including fish, reptiles and amphibians);

(f) farmed animal: any animal that is kept, fattened or bred by humans and used for the production of food (including meat, milk and eggs), wool, fur, feathers, skins or any other product of animal origin;

(g) wild animal: any animal not kept by humans;

(h) pet animal: any animal belonging to species normally nourished and kept, but not consumed, by humans for purposes other than farming;

(i) competent authority: the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which that central authority has delegated that competence, in particular for the control of feedingstuffs; it shall also include, where appropriate, the corresponding authority of a non-member country;

(j) placing on the market: any operation the purpose of which is to sell animal by-products, or products derived therefrom covered by this Regulation, to a third party in the Community or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party;

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

(l) transit: a movement through the Community from one non-member country to another;

(m) producer: any person whose activity produces animal by-products;

(n) TSEs: all transmissible spongiform encephalopathies, except those occurring in humans;

(o) specified risk material: material referred to in Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(17).

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

Article 3

General obligations

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

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

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

CHAPTER II

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

Article 4

Category 1 material

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

(a) all body parts, 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,

(ii) animals killed in the context of TSE eradication measures,

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

(iv) experimental animals as defined by Article 2 of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(18), and

(v) wild animals, when suspected of being infected with diseases communicable to humans or animals;

(b) (i) specified risk material, and

(ii) where, at the time 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 substances prohibited under Directive 96/22/EC have been administered 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 of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC(19), if such residues exceed the permitted level laid down by Community legislation or, in the absence thereof, by national legislation;

(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 mixtures, sludge and materials removed from drains from those premises;

(e) catering waste from means of transport operating internationally; and

(f) mixtures of Category 1 material with either Category 2 material or Category 3 material or both, including any material destined for processing in a Category 1 processing plant.

2. Category 1 material shall be collected, transported and identified without undue delay in accordance with Article 7 and, except as otherwise provided in Articles 23 and 24, shall be:

(a) directly disposed of as waste by incineration in an incineration plant approved in accordance with Article 12;

(b) processed in a processing plant approved under Article 13 using any of processing methods 1 to 5 or, where the competent authority so requires, processing method 1, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex VI, Chapter I, and finally disposed of as waste by incineration or by coincineration in an incineration or coincineration plant approved in accordance with Article 12;

(c) with the exclusion of material referred to in paragraph 1(a)(i) and (ii), processed in a processing plant approved in accordance with Article 13 using processing method 1, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex VI, Chapter I, and finally disposed of as waste by burial in a landfill approved under Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(20);

(d) in the case of catering waste referred to in paragraph 1(e), disposed of as waste by burial in a landfill approved under Directive 1999/31/EC; or

(e) in the light of developments in scientific knowledge, 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. These means may either supplement or replace those provided for in subparagraphs (a) to (d).

3. Intermediate handling or storage of Category 1 material shall take place only in Category 1 intermediate plants approved in accordance with Article 10.

4. Category 1 material shall not be imported or exported except in accordance with this Regulation or with rules laid down under the procedure referred to in Article 33(2). However, the import or export of specified risk material shall take place only in accordance with Article 8(1) of Regulation (EC) No 999/2001.

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 and digestive tract content;

(b) all animal materials collected when treating waste water from slaughterhouses other than slaughterhouses covered by Article 4(1)(d) or from Category 2 processing plants, including screenings, materials from desanding, grease and oil mixtures, sludge and materials removed from drains from those 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 non-member countries and, in the course of the inspections provided for in Community legislation, fail to comply with the veterinary requirements for their importation into the Community, unless they are returned or their importation is accepted under restrictions laid down under Community legislation;

(e) animals and parts of animals, other than those referred to in Article 4, that die other than by being slaughtered for human consumption, including animals killed to eradicate an epizootic disease;

(f) mixtures of Category 2 material with Category 3 material, including any material destined for processing in a Category 2 processing plant; and

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

2. Category 2 material shall be collected, transported and identified without undue delay in accordance with Article 7 and, except as otherwise provided in Articles 23 and 24, shall be:

(a) directly disposed of as waste by incineration in an incineration plant approved in accordance with Article 12;

(b) processed in a processing plant approved in accordance with Article 13 using any of processing methods 1 to 5 or, where the competent authority so requires, processing method 1, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex VI, Chapter I, and:

(i) disposed of as waste either by incineration or by coincineration in an incineration or coincineration plant approved in accordance with Article 12, 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, pharmaceuticals and medical devices, in a Category 2 oleochemical plant approved in accordance with Article 14;

(c) processed in a processing plant approved in accordance with Article 13 using processing method 1, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex VI, Chapter I, and:

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

(ii) transformed in a biogas plant or in a composting plant approved in accordance with Article 15, or

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

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

(e) in the case of manure, digestive tract content separated from the digestive tract, milk and colostrum, if the competent authority does not consider them to present a risk of spreading any serious transmissible disease:

(i) used without processing as raw material in a biogas plant or in a composting plant approved in accordance with Article 15 or treated in a technical plant approved for this purpose in accordance with Article 18,

(ii) applied to land in accordance with this Regulation, or

(iii) transformed in a biogas plant or composted in accordance with rules laid down under the procedure referred to in Article 33(2);

(f) in the case of entire bodies or parts of wild animals not suspected of being infected with diseases communicable to humans or animals, used to produce game trophies in a technical plant approved for this purpose in accordance with Article 18; or

(g) disposed of by other means, or used in other ways, in accordance with rules laid down under the procedure referred to in Article 33(2), after consultation of the appropriate scientific committee. These means or ways may either supplement or replace those provided for in subparagraphs (a) to (f).

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 10.

4. Category 2 material shall not be placed on the market or exported except in accordance with this Regulation or with rules laid down under the procedure referred to in Article 33(2).

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) parts of slaughtered animals, which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons;

(b) parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcases that are fit for human consumption in accordance with Community legislation;

(c) hides and skins, hooves and horns, pig bristles and feathers originating from animals that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation;

(d) blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such 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) former foodstuffs of animal origin, or former foodstuffs containing products of animal origin, other than catering waste, which are no longer intended for human 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 that do not show clinical signs of any disease communicable through that product to humans or animals;

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

(i) fresh by-products from fish 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 humans or animals;

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

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

2. Category 3 material shall be collected, transported and identified without undue delay in accordance with Article 7 and, except as otherwise provided in Articles 23 and 24, shall be:

(a) directly disposed of as waste by incineration in an incineration plant approved in accordance with Article 12;

(b) processed in a processing plant approved in accordance with Article 13 using any of processing methods 1 to 5, in which case the resulting material shall be permanently marked, where technically possible with smell, in accordance with Annex VI, Chapter I, and disposed of as waste either by incineration or by coincineration in an incineration or coincineration plant approved in accordance with Article 12 or in a landfill approved under Directive 1999/31/EC;

(c) processed in a processing plant approved in accordance with Article 17;

(d) transformed in a technical plant approved in accordance with Article 18;

(e) used as raw material in a petfood plant approved in accordance with Article 18;

(f) transformed in a biogas plant or in a composting plant approved in accordance with Article 15;

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

(h) in the case of material of fish origin, ensiled or composted in accordance with rules laid down under the procedure referred to in Article 33(2); or

(i) disposed of by other means, or used in other ways, in accordance with rules laid down under the procedure referred to in Article 33(2), after consultation of the appropriate scientific committee. These means or ways may either supplement or replace those provided for in subparagraphs (a) to (h).

3. Intermediate handling or storage of Category 3 material shall take place only in Category 3 intermediate plants approved in accordance with Article 10.

Article 7

Collection, transportation and storage

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

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

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

4. The storage of processed products shall take place only in storage plants approved in accordance with Article 11.

5. However, Member States may decide not to apply the provisions of this Article to manure transported between two points located on the same farm or between farms and users located in the same Member State.

Article 8

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

1. Animal by-products and processed products shall be sent to other Member States only subject to the conditions laid down in paragraphs 2 to 6.

2. The Member State of destination must have authorised the receipt of Category 1 material, Category 2 material, processed products derived from Category 1 or Category 2 material and processed animal protein. Member States may make the application of processing method 1 prior to dispatch a condition of authorisation.

3. Animal by-products, and processed products referred to in paragraph 2, shall be:

(a) accompanied by a commercial document or, when required by this Regulation, a health certificate, and

(b) conveyed directly to the plant of destination, which must have been approved in accordance with this Regulation.

4. When Member States send Category 1 material, Category 2 material, processed products derived from Category 1 or Category 2 material and processed animal protein to other Member States, the competent authority of the place of origin shall inform the competent authority of the place of destination of each consignment by means of the ANIMO system, or by another method by mutual agreement. The message shall contain the information specified in Annex II, Chapter I, paragraph 2.

5. When informed of its dispatch in accordance with paragraph 4, the competent authority of the place of destination shall inform the competent authority of the place of origin of the arrival of each consignment by means of the ANIMO system, or by another method by mutual agreement.

6. Member States of destination shall ensure, through regular checks, that the designated plants on their territory use consignments only for authorised purposes and keep full records demonstrating compliance with this Regulation.

Article 9

Records

1. Any person consigning, transporting or receiving animal by-products shall keep a record of consignments. Records shall contain the information, and be kept for the period, specified in Annex II.

2. However, this Article shall not apply to manure transported between two points located on the same farm or locally between farms and users located in the same Member State.

CHAPTER III

APPROVAL OF INTERMEDIATE, STORAGE, INCINERATION AND COINCINCERATION, CATEGORY 1 AND 2 PROCESSING, CATEGORY 2 AND CATEGORY 3 OLEOCHEMICAL, BIOGAS AND COMPOSTING PLANTS

Article 10

Approval of intermediate plants

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

2. To be approved, Category 1 or Category 2 intermediate plants must:

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

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

(c) undergo the plant's own checks provided for in Article 25; and

(d) be checked by the competent authority in accordance with Article 26.

3. To be approved, Category 3 intermediate plants must:

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

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

(c) undergo the plant's own checks provided for in Article 25; and

(d) be checked by the competent authority in accordance with Article 26.

Article 11

Approval of storage plants

1. Storage plants shall be subject to approval by the competent authority.

2. To be approved, storage plants must:

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

(b) be checked by the competent authority in accordance with Article 26.

Article 12

Approval of incineration and coincineration plants

1. The incineration and coincineration of processed products shall take place in accordance with the provisions of Directive 2000/76/EC. The incineration and coincineration 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 coincineration plants shall be approved under that Directive or in accordance with paragraph 2 or 3.

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

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

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

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

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

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

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

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

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

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

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

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

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

(f) fulfil the applicable temperature measurement requirements laid down in Annex IV, Chapter V; and

(g) fulfil the conditions concerning abnormal operating laid down in Annex IV, 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.

Article 13

Approval of Category 1 and Category 2 processing plants

1. Category 1 and Category 2 processing plants shall be subject to approval by the competent authority.

2. To be approved, Category 1 and Category 2 processing plants must:

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

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

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

(d) undergo the plant's own checks provided for in Article 25;

(e) be checked by the competent authority in accordance with Article 26; and

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

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

Article 14

Approval of Category 2 and Category 3 oleochemical plants

1. Oleochemical plants shall be subject to approval by the competent authority.

2. To be approved, Category 2 oleochemical plants must:

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

(d) be checked by the competent authority in accordance with Article 26.

3. To be approved, Category 3 oleochemical plants must process rendered fats derived only from Category 3 material and meet the relevant requirements referred to in paragraph 2.

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

Article 15

Approval of biogas plants and composting plants

1. Biogas plants and composting plants shall be subject to approval by the competent authority.

2. To be approved, biogas plants and composting plants must:

(a) meet the requirements of Annex VI, Chapter II, Part A;

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

(c) be checked by the competent authority in accordance with Article 26;

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

(e) ensure that digestion residues and compost, as appropriate, comply with the microbiological standards laid down in Annex VI, Chapter II, Part D.

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

CHAPTER IV

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

Article 16

General animal health provisions

1. Member States shall take all necessary measures to guarantee that animal by-products, and products derived therefrom referred to in Annexes VII and VIII, are not dispatched from any holding situated in a 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 plant 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 that:

(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/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease(21);

(b) were not slaughtered in a plant 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 placing on the market of animal by-products, and products derived therefrom referred to in Annexes VII and VIII, that come from a territory or part of a territory subject to animal health restrictions 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 a plant approved for that purpose by the Member State where the animal health problem occurred;

(c) are properly identified;

(d) comply with the requirements laid down in Annexes VII and VIII, or with detailed rules to be laid down 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 17

Approval of Category 3 processing plants

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

2. To be approved, Category 3 processing plants must:

(a) meet the requirements of Annex V, Chapter I, and Annex VII, Chapter I;

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

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

(d) undergo the plant's own checks provided for in Article 25;

(e) be checked by the competent authority in accordance with Article 26; and

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

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

Article 18

Approval of petfood plants and technical plants

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

2. To be approved, the petfood plant or the technical plant must:

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

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

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

(iii) depending on the products, to 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) to keep a record of the information obtained pursuant to points (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) to inform the competent authority, should the result of the laboratory examination referred to in point (iii) or any other information available to them reveal the existence of a serious animal health or public health hazard; and

(b) to be checked by the competent authority in accordance with Article 26.

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

Article 19

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

Member States shall ensure that processed animal protein and other processed products that could be used as 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 17;

(b) have been prepared exclusively with Category 3 material, as specified in Annex VII;

(c) have been handled, processed, stored and transported in accordance with Annex VII and in such a manner as to ensure compliance with Article 22; and

(d) meet the specific requirements laid down in Annex VII.

Article 20

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

1. Member States shall ensure that petfood, dogchews, technical products, other than those referred to in paragraphs 2 and 3, and those animal by-products referred to in Annex VIII are placed on the market or exported only if they:

(a) meet either:

(i) the specific requirements laid down in Annex VIII, or

(ii) when a product could be used both as a technical product and as feed material, and Annex VIII contains no specific requirements, the specific requirements laid down by the relevant Chapter of Annex VII; and

(b) come from plants approved and supervised in accordance with Article 18 or, in the case of animal by-products referred to in Annex VIII, from other plants approved in accordance with Community veterinary legislation.

2. Member States shall ensure that organic fertilisers and soil improvers produced from processed products, other than those produced from manure and digestive tract content, 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 appropriate 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 oleochemical plant approved in accordance with Article 14 from rendered fats resulting from the processing of Category 2 material in a Category 2 processing plant approved in accordance with Article 13 following the application of any of processing methods 1 to 5;

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

(c) meet any specific requirements laid down in Annex VIII.

Article 21

Safeguard measures

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

Article 22

Restrictions on use

1. The following uses of animal by-products and processed products 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 containing or derived from catering waste; and

(c) the application to pasture land of organic fertilisers and soil improvers, other than manure.

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 23

Derogations regarding the use of animal by-products

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; and

(b) the use of animal by-products for taxidermy purposes in technical plants approved for this purpose in accordance with Article 18.

2. (a) Member States may also authorise the use of the animal by-products specified in subparagraph (b) for the feeding of the animals specified in subparagraph (c), under the supervision of the competent authorities and in accordance with the rules laid down in Annex IX.

(b) The animal by-products referred to in subparagraph (a) are:

(i) 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 humans or animals, and

(ii) Category 3 material referred to in Article 6(1)(a) to (j) and, subject to Article 22, in Article 6(1)(l);

(c) The animals referred to in subparagraph (a) are:

(i) zoo animals,

(ii) circus animals,

(iii) reptiles and birds of prey other than zoo or circus animals,

(iv) fur animals,

(v) wild animals the meat of which is not destined for human consumption,

(vi) dogs from recognised kennels or packs of hounds, and

(vii) maggots for fishing bait.

(d) In addition, Member States may authorise the use of Category 1 material referred to in Article 4(1)(b)(ii) for the feeding of endangered species of necrophagous birds in accordance with rules laid down under the procedure referred to in Article 33(2).

3. Member States shall inform the Commission of:

(a) the use made of the derogations referred to in paragraph 2; and

(b) the verification arrangements introduced to ensure that the animal by-products concerned are used only for authorised purposes.

4. Each Member State shall draw up a list of users and collection centres authorised and registered pursuant to paragraph 2(c)(iv), (vi) and (vii) within its territory. Each user and collection centre shall be assigned an official number for inspection purposes and to be able to trace the origin of the products concerned.

The competent authority shall supervise the premises of users and collection centres referred to in the previous subparagraph and have free access at all time to all parts of such premises, to ensure compliance with the requirements referred to in paragraph 2.

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

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

Article 24

Derogations regarding the disposal of animal by-products

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

(a) dead pet animals 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; and

(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 (OIE), if the competent authority rejects transport to the nearest incineration or processing plant because of the danger of propagation of health risks or because a widespread outbreak of an epizootic disease 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 or 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 1 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 measures necessary:

(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 laid down under the procedure referred to in Article 33(2).

CHAPTER VI

CONTROLS AND INSPECTIONS

Article 25

Plants' own-checks

1. Operators and owners of intermediate 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 control points in the plants;

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

(c) in the case of processing plants, take representative samples to check compliance:

(i) of each processed batch with the standards for the products established by this Regulation, and

(ii) with the maximum permitted levels of physicochemical residues laid down in Community legislation;

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

(e) introduce a system ensuring the traceablility of each batch dispatched.

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 of the full details of the nature of the sample and the batch from which it was derived;

(b) establish the causes of failures of compliance;

(c) reprocess or dispose of the contaminated batch under the supervision of the competent authority;

(d) ensure that no material suspected or known to be contaminated is moved from the plant before being reprocessed under the supervision of the competent authority and re-sampled officially in order to comply with the standards laid down in this Regulation, unless destined for disposal;

(e) increase the frequency of sampling and testing of production;

(f) investigate animal by-products records appropriate to the finished sample; and

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

3. Detailed arrangements for implementing this Article, including rules concerning the frequency of checks and reference methods for microbiological analyses, may be laid down under the procedure referred to in Article 33(2).

Article 26

Official controls and lists of approved plants

1. The competent authority shall at regular intervals carry out inspections and supervision at plants approved in accordance with this Regulation. Inspections and supervision of processing plants shall take place in accordance with Annex V, 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 the principles of the system of hazard analysis and critical control points (HACCP).

3. If the inspection carried out by the competent authority reveals that one or more of the requirements of this Regulation are not being met, the competent authority shall take appropriate action.

4. Each Member State shall draw up a list of plants approved in accordance with this Regulation within its territory. It shall assign an official number to each plant, which identifies the plant with respect to the nature of its activities. Member States shall send copies of the list and updated versions to the Commission and other Member States.

5. Detailed arrangements for implementing this Article, including rules concerning the frequency of checks and reference methods for microbiological analyses, may be laid down under the procedure referred to in Article 33(2).

CHAPTER VII

COMMUNITY CONTROLS

Article 27

Community controls in Member States

1. Experts from the Commission may make on-the-spot checks, in cooperation with the competent authorities of Member States, in so far as is necessary for the 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 authority of the results of the checks made.

2. Rules for the implementation of this Article, in particular those governing the procedure for cooperation with national competent authorities, shall be laid down under the procedure referred to in Article 33(2).

CHAPTER VIII

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

Article 28

General provisions

The provisions applicable to the importation of products referred to in Annexes VII and VIII from non-member 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 non-member 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 laid down under the procedure referred to in Article 33(2).

Article 29

Prohibitions and compliance with Community rules

1. The importation and transit of animal by-products and processed products shall be prohibited, except in accordance with this Regulation.

2. The importation into, and the transit through, the Community of the products referred to in Annexes VII and VIII may take place only if such products satisfy the requirements set out in paragraphs 3 to 6.

3. Products referred to in Annexes VII and VIII shall, save as otherwise specified in those Annexes, come from a non-member country or parts of non-member 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 non-member country;

(b) the organisation of the competent authority and its inspection services in the non-member country, the powers of those 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 non-member country can give regarding compliance with the relevant health conditions;

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

(f) the result of any Community inspections in the non-member country;

(g) the health status of the livestock, other domestic animals and wildlife in the non-member 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 non-member 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 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 non-member country and their implementation, including rules on imports from other countries.

4. Products referred to in Annexes VII and VIII, except for technical products, must come from plants on a Community list drawn up under the procedure referred to in Article 33(2) on the basis of a communication from the competent authorities of the non-member 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 non-member country.

Approved lists shall be amended as follows:

(a) the Commission shall inform the Member States of the modifications proposed by the non-member country concerned to the lists of plants 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 plants referred to in point (a) to send any written comments to the Commission;

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

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

5. Technical products referred to in Annex VIII must come from plants that the competent authorities of the non-member countries have approved and registered.

6. Save as otherwise specified in Annexes VII and VIII, a health certificate corresponding to the model laid down in Annex X, certifying that the products meet the conditions referred to in those Annexes and come from plants offering such conditions, must accompany consignments of products referred to in those Annexes.

7. Pending the compilation of the list provided for in paragraph 4 and the adoption of model certificates as referred to in paragraph 6, Member States may maintain the controls provided for in Directive 97/78/EC and certificates provided for under existing national rules.

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 non-member country, a group of non-member countries or a region of a non-member country to the production, manufacture, handling, storage and transport of one or more categories of products referred to in Annexes VII and VIII offer guarantees equivalent to those applied in the Community, if the non-member country supplies objective proof in this respect.

The decision shall set out the conditions governing the importation and/or transit 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 that must accompany the product;

(b) specific health requirements applicable to importation into, and/or transit through, the Community; and

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

3. Detailed rules for the application of this Article shall be laid down under 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 non-member countries or parts thereof and determining conditions for importation and/or transit;

(b) verifying compliance with:

(i) the conditions for inclusion in a Community list of non-member countries,

(ii) import and/or transit conditions,

(iii) the conditions for recognising equivalence of measures,

(iv) any emergency measures applied under Community legislation.

The Commission shall appoint experts from the Member States responsible for these checks.

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 ask the non-member 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 question 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, hereinafter referred to as "the Committee".

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

3. The Committee shall adopt its rules of procedure.

Article 34

Consultation of scientific committees

The appropriate scientific committees shall be consulted on any matter within the scope of this Regulation that could have an effect on animal or public health.

Article 35

National provisions

1. Member States shall communicate to the Commission the text of the provisions of any national law that 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 the Council accompanied, if appropriate, by legislative proposals.

3. Member States may adopt or maintain national rules restricting the use of organic fertilisers and soil improvers further than envisaged in this Regulation pending the adoption of Community rules for their use in accordance with Article 20(2). Member States may adopt or maintain national rules restricting the use of fat derivatives produced from Category 2 material further than envisaged in this Regulation pending the addition to Annex VIII of Community rules for their use in accordance with Article 32.

Article 36

Financial arrangements

The Commission shall prepare a report on the financial arrangements in Member States for the processing, collection, storage and disposal of animal by-products accompanied by appropriate proposals.

Article 37

Repeal

Directive 90/667/EEC and Decisions 95/348/EC and 1999/534/EC shall be repealed with effect from six months after the entry into force of this Regulation.

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

Article 38

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

It shall apply six months after the date of its entry into force. However, Article 12(2) shall apply as specified in Article 20 of Directive 2000/76/EC.

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

Done at ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 96 E, 27.3.2001, p. 40.

(2) OJ C 193, 10.7.2001, p. 32.

(3) Opinion of the European Parliament of 12 June 2001 (not yet published in the Official Journal), Council Common Position of 20 November 2001 and Decision of the European Parliament of ... (not yet published in the Official Journal).

(4) OJ L 363, 27.12.1990, p. 51. Directive as last amended by the 1994 Act of Accession.

(5) OJ C 223, 8.8.2001, p. 281.

(6) OJ L 332, 28.12.2000, p. 91.

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

(8) OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision 2000/443/EC.

(9) OJ L 125, 23.5.1996, p. 3.

(10) OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Decision 2001/7/EC (OJ L 2, 5.1.2001, p. 27).

(11) OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive 92/118/EEC.

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

(13) OJ L 202, 26.8.1995, p. 8.

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

(15) OJ L 255, 18.10.1968, p. 23.

(16) OJ L 184, 17.7.1999, p. 23.

(17) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1326/2001 (OJ L 177, 30.6.2001, p. 60).

(18) OJ L 358, 18.12.1986, p. 1.

(19) OJ L 125, 23.5.1996, p. 10.

(20) OJ L 182, 16.7.1999, p. 1.

(21) OJ L 62, 15.3.1993, p. 69. Directive as last amended by the 1994 Act of Accession.

ANNEX I

SPECIFIC DEFINITIONS

For the purpose of this Regulation:

1. "apiculture products" means honey, beeswax, royal jelly, propolis or pollen used in bee-keeping;

2. "batch" means a unit of production produced in a single plant using uniform production parameters - or a number of such units, when stored together - and that can be identified for the purposes of recall and re-treatment or disposal should tests show that to be necessary;

3. "biogas plant" means a plant in which biological degradation of products of animal origin is undertaken under anaerobic conditions for the production and collection of biogas;

4. "blood products" means 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 fractions thereof and mixtures;

5. "blood" means fresh whole blood;

6. "bloodmeal" means products derived from the heat-treatment of blood in accordance with Annex VII, Chapter II, and intended for animal consumption or organic fertilisers;

7. "canned petfood" means heat-processed petfood contained within a hermetically sealed container;

8. "Category 1 or Category 2 intermediate plant" means 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 and where certain preliminary activities, such as removal of hides and skins and performing post-mortem examinations, may take place;

9. "Category 1 processing plant" means a plant in which Category 1 material is processed before its final disposal;

10. "Category 2 oleochemical plant" means a plant processing rendered fats derived from Category 2 material under conditions set out in Annex VI, Chapter III;

11. "Category 2 processing plant" means a plant in which Category 2 material is processed before its final disposal, further transformation or use;

12. "Category 3 intermediate plant" means 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;

13. "Category 3 oleochemical plant" means a plant processing rendered fats derived from Category 3 material;

14. "Category 3 processing plant" means a plant in which Category 3 material is processed into processed animal protein and other processed products that could be used as feed material;

15. "catering waste" means all waste food originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

16. "coincineration plant" means a disposal site as defined in Article 3(5) of Directive 2000/76/EC;

17. "coincineration" means the disposal of animal by-products or products derived therefrom in a coincineration plant;

18. "collection centres" means premises collecting and treating certain animal by-products intended to be used for the feeding of the animals specified in Article 23(2)(c);

19. "composting plant" means a plant in which biological degradation of products of animal origin is undertaken under aerobic conditions;

20. "digestion residues" means residues resulting from the transformation of animal by-products in a biogas plant;

21. "digestive tract content" means the content of the digestive tract of mammals and ratites, whether or not separated from the digestive tract;

22. "dogchews" means untanned products for pet animals to chew, produced from hides and skins of ungulates or other animal material;

23. "feed material" means those feed materials, as defined in Directive 96/25/EC(1), that are of animal origin including processed animal proteins, blood products, rendered fats, fish oil, fat derivatives, gelatin and hydrolysed proteins, dicalcium phosphate, milk, milk-based products and colostrum;

24. "fishmeal" means processed animal protein derived from sea animals, except sea mammals;

25. "fur animals" means animals kept or reared for the production of fur and not used for human consumption;

26. "gelatin" means 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);

27. "greaves" means the protein-containing residue of rendering, after partial separation of fat and water;

28. "hermetically sealed container" means a container that is designed and intended to be secure against the entry of micro-organisms;

29. "hides and skins" means all cutaneous and subcutaneous tissues;

30. "high-capacity incineration plant" means an incineration plant other than a low-capacity incineration plant;

31. "hydrolysed proteins" means polypeptides, peptides and aminoacids, and mixtures thereof, obtained by the hydrolysis of animal by-products;

32. "incineration plant" means a disposal site as defined in Article 3(4) of Directive 2000/76/EC;

33. "incineration" means the disposal of animal by-products or products derived therefrom in an incineration plant;

34. "laboratory reagent" means 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;

35. "landfill" means a disposal site as defined by Directive 1999/31/EC;

36. "low-capacity incineration plant" means an incineration plant with a throughput of less than 50 kg of animal by-products per hour;

37. "manure" means any excrement and/or urine of farmed animals, with or without litter, and guano;

38. "organic fertilisers" and "soil improvers" mean materials of animal origin 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 manure, digestive tract content, compost and digestion residues;

39. "pasture land" means land covered with grass or other herbage and grazed by farmed animals;

40. "petfood plant" means a plant producing petfood or dogchews and in which certain animal by-products are used in the preparation of such petfood or dogchews;

41. "petfood" means food for pet animals containing Category 3 material;

42. "processed animal protein" means animal proteins derived entirely from Category 3 material, which have been treated in accordance with this Regulation so as to render them suitable for direct use as feed material or other use in feedingstuffs, including petfood, or use in organic fertilisers or soil improvers; it does not include blood products, milk, milk-based products, colostrum, gelatin, hydrolysed proteins and dicalcium phosphate;

43. "processed petfood" means petfood, other than raw petfood, that has undergone treatment in accordance with the requirements of Annex VIII;

44. "processed products" means animal by-products that have undergone one of the processing methods or another treatment required by Annex VII or VIII;

45. "processing methods" means the methods listed in Annex V, Chapter III;

46. "processing plant" means an animal by-products processing plant;

47. "product used for in vitro diagnosis" means a packaged product, ready for use by the end user, containing a blood product, and used as a 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 or genetic abnormality or to determine safety and compatibility with reagents;

48. "raw petfood" means petfood which has not undergone any preserving process other than chilling, freezing or quick freezing to ensure preservation;

49. "remote areas" means areas where the animal population is so small, and where facilities are so far away, that the arrangements necessary for collection and transport would be unacceptably onerous compared to local disposal;

50. "rendered fats" means fats derived from processing of Category 2 material or Category 3 material;

51. "storage plant" means a plant, other than establishments and intermediaries covered by Directive 95/69/EC(2), in which processed products are temporarily stored before their final use or disposal;

52. "tanning" means 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;

53. "technical plant" means a plant in which animal by-products are used to produce technical products;

54. "technical products" means products directly 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, serum of equidae, blood products, pharmaceuticals, medical devices, cosmetics, bone products for china, gelatin and glue, organic fertilisers, soil improvers, rendered fats, fat derivatives, processed manure and milk and milk-based products;

55. "unprocessed feathers and parts of feathers" means feathers and parts of feathers that have not been treated with a steam current or by some other method ensuring that no pathogens are transmitted;

56. "unprocessed wool" means sheep's wool that has neither undergone factory washing nor been obtained from tanning;

57. "unprocessed hair" means ruminant hair that has neither undergone factory washing nor been obtained from tanning;

58. "unprocessed pig bristles" means pig bristles that have neither undergone factory washing nor been obtained from tanning.

(1) Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC (OJ L 125, 23.5.1996, p. 35). Directive as last amended by Directive 2001/46/EC (OJ L 234, 1.9.2001, p. 55).

(2) Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).

ANNEX II

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

CHAPTER I

Identification

1. All necessary measures must be taken to ensure that:

(a) Category 1, Category 2 and Category 3 materials are identifiable and kept separate and identifiable during collection and transportation; and

(b) processed products are identifiable and kept separate and identifiable during transportation.

2. During transport, a label attached to the vehicle, container, carton or other packaging material must clearly indicate:

(a) the category of the animal by-products or, in the case of processed products, the category of animal by-products from which the processed products were derived; and

(b) (i) in the case of Category 3 material, the words "not for human consumption",

ii) in the case of Category 2 material, other than manure and digestive tract content, and processed products derived therefrom, the words "not for animal consumption", or

iii) in the case of Category 1 material and processed products derived therefrom, the words "for disposal only".

CHAPTER II

Vehicles and containers

1. Animal by-products and processed products must be collected and transported in sealed new packaging or covered leak-proof containers or vehicles.

2. Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with animal by-products or processed products, must be:

(a) cleaned, washed and disinfected after each use;

(b) maintained in a clean condition; and

(c) clean and dry before use.

3. Reusable containers must be dedicated to the carriage of a particular product to the extent necessary to avoid cross-contamination.

CHAPTER III

Commercial documents and health certificates

1. During transportation, a commercial document or, when required by this Regulation, a health certificate must accompany animal by-products and processed products.

2. Commercial documents must specify:

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

(b) the description of the material, including the information referred to in Chapter I, the animal species for Category 3 material and processed products derived therefrom destined for use as feed material and, if applicable, the ear-tag number;

(c) the quantity of the material;

(d) the place of origin of the material;

(e) the name and the address of the carrier;

(f) the name and the address of the receiver and, if applicable, its approval number; and

(g) if appropriate:

(i) the approval number of the plant of origin, and

ii) the nature and the methods of the treatment.

3. The commercial document must be produced at least in triplicate (one original and two copies). The original must accompany the consignment to its final destination. The receiver must retain it. The producer must retain one of the copies and the carrier the other.

4. A model for the commercial document may be laid down under the procedure referred to in Article 33(2).

5. Health certificates must be issued and signed by the competent authority.

CHAPTER IV

Records

The records referred to in Article 9 must contain the information referred to in Chapter III, paragraph 2, as follows. They must contain:

(a) the information referred to in subparagraphs (b) and (c); and

(b) in the case of records kept by any person consigning animal by-products, the information referred to in subparagraphs (a), (e) and, if known, (f); or

(c) in the case of records kept by any person transporting animal by-products, the information referred to in subparagraphs (a), (d) and (f); or

(d) in the case of records kept by any person receiving animal by-products, the date of reception and the information referred to in subparagraphs (d) and (e).

CHAPTER V

Retention of documents

The commercial document and the health certificate referred to in Chapter III, and the records referred to in Chapter IV, must be kept for a period of at least two years for presentation to the competent authority.

CHAPTER VI

Temperature conditions

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

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

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

CHAPTER VII

Specific rules for transit

The carriage of animal by-products and processed products in transit must meet the requirements of Chapters I, II, III and VI.

CHAPTER VIII

Control measures

The competent authority must take the necessary measures to control the collection, transport, use and disposal of animal by-products and processed products, including by checking the keeping of required records and documents and, when this Regulation requires it or the competent authority considers it necessary, by sealing.

When the competent authority applies a seal to a consignment of animal by-products or processed products, it must inform the competent authority of the place of destination.

ANNEX III

HYGIENE REQUIREMENTS FOR INTERMEDIATE AND STORAGE PLANTS

CHAPTER I

Requirements for the approval of intermediate plants

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

(a) The premises must be adequately separated from the public highway and other premises such as slaughterhouses. The layout of plants must ensure the total separation of Category 1 and Category 2 material from Category 3 material from reception until dispatch.

(b) The plant must have a covered space to receive animal by-products.

(c) The plant must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in such a way as to facilitate the draining of liquids.

(d) The plant must have adequate lavatories, changing rooms and washbasins for staff.

(e) The plant must have appropriate arrangements for protection against pests, such as insects, rodents and birds.

(f) The plant must have a waste-water disposal system which meets hygiene requirements.

(g) Where it is necessary for the purpose of achieving the objectives of this Regulation, plants must have suitable temperature-controlled storage facilities of sufficient capacity for maintaining animal by-products at appropriate temperatures and designed to allow the monitoring and recording of those temperatures.

2. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received and the vehicles, other than ships, in which they are transported. Adequate facilities must be provided for the disinfecting of vehicle wheels.

CHAPTER II

General hygiene requirements

A. Category 3 intermediate plants

1. The plant must not engage in activities other than the importation, collection, sorting, cutting, chilling, freezing into blocks, temporary storage and dispatching of Category 3 material.

2. The sorting of Category 3 material must be carried out in such a way as to avoid any risk of the propagation of animal diseases.

3. All the time during sorting or storage, Category 3 material must be handled and stored separately from goods other than other Category 3 material and in such a way as to prevent any propagation of pathogens and to ensure compliance with Article 22.

4. Category 3 material must be stored properly, and, where appropriate, chilled or frozen, until re-dispatched.

5. Packaging material must be incinerated or disposed of by some other means in accordance with instructions from the competent authority.

B. Category 1 or Category 2 intermediate plants

6. The plant must not engage in activities other than the collection, handling, temporary storage and dispatching of Category 1 or Category 2 material.

7. The sorting of the Category 1 or Category 2 material must be carried out in such a way as to avoid any risk of the propagation of animal diseases.

8. All the time during storage, the Category 1 or Category 2 material must be handled and stored separately from other goods and in such a way as to prevent any propagation of pathogens.

9. Category 1 or Category 2 material must be stored properly, including under appropriate temperature conditions, until re-dispatched.

10. Packaging material must be incinerated or disposed of by some other means in accordance with instructions from the competent authority.

11. Waste water must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific requirements for the treatment of waste water from Category 1 and Category 2 intermediate plants may be laid down in accordance with the procedure referred to in Article 33(2).

CHAPTER III

Requirements for the approval of storage plants

Premises and facilities must meet at least the following requirements.

1. Premises storing processed products derived from Category 3 material must not be at the same site as premises storing processed products derived from Category 1 or Category 2 material, unless in a completely separate building.

2. The plant must:

(a) have a covered space to receive the products;

(b) be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in such a way as to facilitate the draining of liquids;

(c) have adequate lavatories, changing rooms and washbasins for staff; and

(d) have appropriate arrangements for protection against pests, such as insects, rodents and birds.

3. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which the products are received and the vehicles, other than ships, in which they are transported. Adequate facilities must be provided for the disinfecting of vehicle wheels.

4. Products must be stored properly until re-dispatched.

ANNEX IV

REQUIREMENTS FOR INCINERATION AND COINCINERATION PLANTS TO WHICH DIRECTIVE 2000/76/EC DOES NOT APPLY

CHAPTER I

General conditions

1. Incineration or coincineration plants must be designed, equipped and operated in such a manner as to fulfil the requirements of this Regulation.

2. The operator of an incineration or coincineration plant must take all necessary precautions concerning the reception of animal by-products to prevent, or limit as far as practicable, direct risks to human or animal health.

CHAPTER II

Operating conditions

3. Incineration or coincineration plants must be designed, equipped, built and operated in such a way that the gas resulting from the process is raised in a controlled and homogeneous fashion, even under the most unfavourable conditions, to a temperature of 850 °C, as measured near the inner wall or at another representative point of the combustion chamber as authorised by the competent authority, for two seconds.

4. Each line of high-capacity incineration plants must be equipped with at least one auxiliary burner. This burner must be switched on automatically when the temperature of the combustion gases after the last injection of combustion air falls below 850 °C. It must also be used during plant start-up and shut-down operations to ensure that the temperature of 850 °C is maintained at all times during these operations and as long as unburned material is in the combustion chamber.

5. High-capacity incineration or coincineration plants must have and operate an automatic system to prevent feed with animal by-products:

(a) at start-up, until the temperature of 850 °C has been reached; and

(b) whenever the temperature of 850 °C is not maintained.

6. Animal by-products should, where practicable, be placed straight in the furnace without direct handling.

CHAPTER III

Water discharges

7. Incineration or coincineration plant sites, including associated storage areas for animal by-products, must be designed in such a way as to prevent unauthorised and accidental release of any polluting substances into soil, surface water and groundwater in accordance with the provisions provided for in relevant Community legislation. Moreover, storage capacity must be provided for contaminated rainwater run-off from the incineration plant site or for contaminated water arising from spillage or fire-fighting operations.

8. The storage capacity must be adequate to ensure that such waters can be tested and treated before discharge where necessary.

CHAPTER IV

Residues

9. For the purposes of this Chapter, "residues" means any liquid or solid material generated by the incineration or coincineration process, the waste-water treatment or other processes within the incineration or coincineration plant. They include bottom ash and slag, fly ash and boiler dust.

10. Residues resulting from the operation of the incineration or coincineration plant must be minimised in their amount and harmfulness. Residues must be recycled, where appropriate, directly in the plant or outside in accordance with relevant Community legislation.

11. Transport and intermediate storage of dry residues in the form of dust must take place in such a way as to prevent dispersal in the environment (e.g., in closed containers).

CHAPTER V

Temperature measurement

12. Techniques must be used to monitor the parameters and conditions relevant to the incineration or coincineration process. High-capacity incineration and coincineration plants must have and use temperature measurement equipment.

13. The approval issued by the competent authority, or conditions attached to it, must lay down temperature measurement requirements.

14. The appropriate installation and the functioning of any automated monitoring equipment must be subject to control and to an annual surveillance test. Calibration must be carried out by means of parallel measurements with the reference methods at least every three years.

15. Temperature measurement results must be recorded and presented in an appropriate fashion to enable the competent authority to verify compliance with the permitted operating conditions laid down in this Regulation in accordance with procedures to be decided upon by that authority.

CHAPTER VI

Abnormal operating

16. In the case of a breakdown, or abnormal operating conditions, the operator must reduce or close down operations as soon as practicable until normal operations can be resumed.

ANNEX V

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

CHAPTER I

General requirements for the approval of Category 1, 2 and 3 processing plants

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

(a) premises for the processing of animal by-products must not be at the same site as slaughterhouses, unless in a completely separate building or part of a building. Unauthorised persons and animals must not have access to the plant;

(b) the processing plant must have a clean and unclean sector, adequately separated. The unclean sector must have a covered place to receive animal by-products and must be constructed in such a way that it 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 production capacity for hot water and steam for the processing of animal by-products;

(d) the unclean sector 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:

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

(ii) recording devices to record continuously the results of these measurements; and

(iii) an adequate safety system to prevent insufficient heating;

(f) to prevent recontamination of the finished product by incoming animal by-products, 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 processing of that product and the storage of the processed product.

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

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

4. All processing plants must have a waste-water disposal system meeting the competent authority's requirements.

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 carry out necessary analyses and be approved by the competent authority.

CHAPTER II

Gene