Legal provisions of COM(2000)574 - Health rules concerning animal by-products not intended for human consumption

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dossier COM(2000)574 - Health rules concerning animal by-products not intended for human consumption.
document COM(2000)574 EN
date October  3, 2002


Contents

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, unless such material contains no specified risk material or parts of such material;

(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 co-incineration in an incineration or co-incineration 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 co-incineration plant approved in accordance with Article 12, or

(ii) in the case of rendered fats, further processed into fat derivatives for use in organic fertilizers 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 fertilizer 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 co-incineration in an incineration or co-incineration 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, with the exception of Category 3 catering waste 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. They shall, in particular, include information concerning the quantity and a description of the material and its marking.

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. In accordance with Article 4 of Council Directive 75/442/EEC of 15 July 1975 on waste(21), Member States shall take the necessary measures to ensure that Category 3 catering waste is collected, transported and disposed of without endangering human health and without harming the environment.

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

6. 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 CO-INCINCERATION, 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 co-incineration plants

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

2. To be approved by the competent authority for the purpose of disposing of animal by-products, a high-capacity incineration or co-incineration plant to which Directive 2000/76/EC does not apply must 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 co-incineration 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(22);

(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 fertilizers 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 fertilizers 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, under the supervision of the competent authorities, of Category 1 material referred to in Article 4(1)(b)(ii) for the feeding of endangered or protected species of necrophagous birds in accordance with rules laid down under the procedure referred to in Article 33(2) after consultation of the European Food Safety Authority.

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 times to all parts of such premises, to ensure compliance with the requirements referred to in paragraph 2.

If such inspections 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 third countries of petfood and raw material for petfood production, derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC, shall be permitted provided that such raw material is permanently 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 third country or parts of third countries on a list to be drawn up and updated in accordance with the procedure referred to in Article 33(2).

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

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

(a) the legislation of the third country;

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

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

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

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

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

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

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 third country to the Commission declaring that the plant complies with the Community requirements and is subject to supervision by an official inspection service in the third country.

Approved lists shall be amended as follows:

(a) the Commission shall inform the Member States of the modifications proposed by the third country concerned to the lists of 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 (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 Committee on the Food Chain and Animal Health 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 third 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 third country, a group of third countries or a region of a third country to the production, manufacture, handling, storage and transport of one or more categories of products referred to in Annexes VII and VIII offer guarantees equivalent to those applied in the Community, if the third country supplies objective proof in this respect.

The decision shall set out the conditions governing the importation 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 third 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 third 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 third country to take appropriate measures or shall suspend consignments of products and immediately inform the Member States.

CHAPTER IX - FINAL PROVISIONS

Article 32 - Amendments to Annexes and transitional measures

1. 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).

2. With regard to the ban on the feeding of catering waste referred to in Article 22, where appropriate control systems are in place in Member States prior to the application of this Regulation, transitional measures shall be adopted, in accordance with paragraph 1, to permit the continued use in feed of certain types of catering waste under strictly controlled circumstances for a period of not more than four years as from 1 November 2002. These measures shall ensure that there is no undue risk to animal or public health during the transitional period.

Article 33 - Regulatory procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, 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 fertilizers 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.

This Regulation 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 and Articles 22(1)(b) and 32 shall apply from 1 November 2002.


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