(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.

(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:

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

(g) transit by sea or by air.

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

(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.

(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 by the Commission after consultation of the appropriate scientific committee. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3). Those means may either supplement or replace those provided for in points (a) to (d) of this paragraph.

(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.

(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:

(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:

▼M15

▼B

(d) in the case of material of fish origin, ensiled or composted in compliance with rules adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3);

(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:

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▼B

(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 by the Commission after consultation of the appropriate scientific committee. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3). Those means or ways may either supplement or replace those provided for in points (a) to (f) of this paragraph.

(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).

(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 by the Commission, or, pending the adoption of such rules, in accordance with national law. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3);

(h) in the case of material of fish origin, ensiled or composted in accordance with rules laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3); or

(i) disposed of by other means, or used in other ways, in accordance with rules laid down by the Commission after consultation of the appropriate scientific committee; those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3). Those means or ways may either supplement or replace those provided for in points (a) to (h).

(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.

(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.

(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.

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

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

(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.

(a) be used only for the disposal of dead pet animals, animal by-products as referred to in Articles 4(1) (b), 5(1) and 6(1) to which Directive 2000/76/EC does not apply;

(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;

(g) fulfil the conditions concerning abnormal operating laid down in Annex IV, Chapter VI; and

(h) fulfil the conditions in Annex IV, Chapter VII when used for the disposal of animal by-products referred to in Article 4(1)(b).

(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.

(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.

(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.

(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.

(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 by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 33(4).

(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.

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

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

(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.

(a) meet either:

(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.

(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.

(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.

(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.

(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:

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

(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 by the Commission after consultation of the European Food Safety Authority. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).

(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.

(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:

(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.

(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.

(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.

(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:

(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.

(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.

(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.

(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.

(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.

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

(b) verifying compliance with:

1. ‘apiculture by-products’ means honey, beeswax, royal jelly, propolis or pollen not intended for human consumption;

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. ‘blood meal’ means products derived from the heat treatment of blood or fractions 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 including used cooking oil originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

16. ‘co-incineration plant’ means a disposal site as defined in Article 3(5) of Directive 2000/76/EC;

17. ‘co-incineration’ means the disposal of animal by-products or products derived therefrom in a co-incineration 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 ( 23 ), 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, or guano, that may be either unprocessed or processed in accordance with Chapter III of Annex VIII or otherwise transformed in biogas or composting plants;

38. ‘organic fertilizers’ 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 grazed by or used as feedingstuffs for farmed animals, excluding land to which organic fertilisers and soil improvers have been applied in accordance with Commission Regulation (EC) No 181/2006 ( 24 );

40.  ►M2  ‘petfood plant’ means a plant producing petfood or dogchews or flavouring innards and in which certain animal by-products are used in the preparation of such petfood, dogchews or flavouring innards; ◄

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

42. ‘processed animal protein’ means animal protein derived entirely from Category 3 material, which have been treated in accordance with Chapter II of Annex VII so as to render them suitable for direct use as feed material or for any other use in feedingstuffs, including petfood, or for use in organic fertilisers or soil improvers; however, it does not include blood products, milk, milk-based products, colostrum, gelatine, hydrolysed proteins and dicalcium phosphate, eggs and egg-products, tricalcium phosphate and collagen;

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 ( 25 ), 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 parts of feathers, serum of equidae, blood products, pharmaceuticals, medical devices, cosmetics, bone products for china, gelatin and glue, organic fertilizers, 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 that ensures that no pathogens remain;

56. ‘unprocessed wool’ means sheep's wool that has not undergone factory washing, been obtained from tanning, or been treated by some other method that ensures that no pathogens remain;

57. ‘unprocessed hair’ means ruminant hair that has not undergone factory washing, been obtained from tanning, or been treated by some other method that ensures that no pathogens remain;

58. ‘unprocessed pig bristles’ means pig bristles that have not undergone factory washing, been obtained from tanning, or been treated by some other method that ensures that no pathogens remain;

59. ‘collagen’ means protein-based products derived from hides, skins and tendons of animals, including bones in the case of pigs, poultry and fish;

60. ‘screenings’ means visible solid animal materials retained in the waste water screen where a pre-treatment process as referred to in Annex II, Chapter IX, is required;

61. ‘grease and oil mixture’ means floating animal materials collected at the surface of waste water grease remover systems where a pre-treatment process as referred to in Annex II, Chapter IX, is required;

62. ‘sludge’ means visible solid animal materials or sediments retained in the waste water drains where a pre-treatment process as referred to in Annex II, Chapter IX, is required;

63. ‘material from desanding’ means visible solid animal materials or sediments retained in desanding systems where these constitute a pre-treatment process referred to in Annex II, Chapter IX;

64. ‘flavouring innard’ means a liquid or dehydrated processed product of animal origin used to enhance the palatability values of petfood;

65. ‘colour-coding’ means the systematic use of colours as defined in Chapter I of Annex II for displaying information as provided for in this Regulation on the surface or part of the surface of a packaging, container or vehicle, or on a label or symbol applied to them.

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

2. During transport, a label attached to the packaging, container or vehicle must:

3. Member States may establish systems or lay down rules for the colour-coding of packaging, containers or vehicles used for the transport of animal by-products and processed products originating in and remaining on their territory, provided that those systems or rules do not confuse the colour-coding system provided for in point 1(d).

4. Without prejudice to point 3 of Annex V to Regulation (EC) No 999/2001, Member States may establish systems or lay down rules for the marking of animal by-products originating in and remaining on their territory provided that those systems or rules do not conflict with the marking requirements laid down for processed products in Chapter I of Annex VI to this Regulation.

5. By way of derogation from points 3 and 4, Member States may use the systems or rules referred to in those points for animal by-products originating in but not intended to remain on their territory if the Member State or third country of destination has communicated its agreement.

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:

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

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

1. During transportation, a commercial document or, when required by this Regulation, a health certificate must accompany animal by-products and processed products except in the case of processed products originating from Category 3 material which are supplied within the same Member State by retailers to final users other than business operators.

2. Commercial documents must specify:

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.

(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).

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.

1. A commercial document in accordance with the model set out in this Chapter shall accompany animal by-products and processed products during transportation. However, for the transport of animal by-products and processed products on their own territory Member States may require:

2. Where more than one transporter is involved, each transporter shall fill in a declaration as referred to in point 7 of the commercial document, which shall be part of the document.

(a) Commercial documents shall be produced, according to the layout of the model appearing in this Annex. It shall contain, in the numbered order that appears in the model, the attestations that are required for the transportation of animal by-products and processed products derived there from.

(b) It shall be drawn up in one of the official languages of the MemberState of origin or the MemberState of destination, as appropriate. However, it may also be drawn up in other official Community languages, if accompanied by an official translation or if previously agreed by the competent authority of the MemberState of destination.

(c) The commercial document must be produced at least in triplicate (one original document and two copies). The original document 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.

(d) The original of each commercial document shall consist of a single page, both sides, or, where more text is required it shall be in such a form that all pages needed are part of an integrated whole and indivisible.

(e) If for reasons of identification of the items of the consignment, additional pages are attached to the commercial document, these pages shall also be considered as forming part of the original document by the application of the signature of the person responsible for the consignment, on each of the pages.

(f) When the commercial document, including additional pages referred to in (e), comprises more than one page, each page shall be numbered — (page number) of (total number of pages) — at the bottom and shall bear the code number of the document that has been designated by the responsible person at the top.

(g) The original of the commercial document must be completed and signed by the responsible person. In doing so, the responsible person shall ensure that the principles of documentation as laid down in Chapter III of Annex II to Regulation (EC) No 1774/2002 are followed. The commercial document must specify:

(h) The colour of the signature of the responsible person shall be different to that of the printing.

(i) The commercial document must be kept for a period of at least two years for presentation to the competent authority to verify the records referred to in Article 9 of Regulation (EC) No 1774/2002.

(j) Where Member States decide to use a commercial document in electronic form, the requirements listed in points (a) to (i) shall be complied with as appropriate for such electronic form.

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

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.

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.

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.

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 by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).

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:

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.

1. Incineration or co-incineration plants must be designed, equipped and operated in such a manner as to fulfil the requirements of this Regulation. The following hygiene conditions must be met:

2. The operator of an incineration or co-incineration 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.

3. Incineration or co-incineration 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 oC, 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 oC. It must also be used during plant start-up and shut-down operations to ensure that the temperature of 850 oC is maintained at all times during these operations and as long as unburned material is in the combustion chamber.

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

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

7. Incineration or co-incineration 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.

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

10. Residues resulting from the operation of the incineration or co-incineration 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).

12. Techniques must be used to monitor the parameters and conditions relevant to the incineration or co-incineration process. High-capacity incineration and co-incineration 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.

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.

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

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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.

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

2. Containers, receptacles and vehicles used for transporting unprocessed material must be cleaned in a designated area. That area must be situated or designed to prevent the risk of contamination of processed products.

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

4. Waste water originating in the unclean sector must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific requirements for the treatment of waste water from processing plants may be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).

5. Preventive measures against birds, rodents, insects or other vermin must be taken systematically. A documented pest control programme must be used for that purpose.

6. Cleaning procedures must be established and documented for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning.

7. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented and maintained for at least two years.

8. Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at regular intervals.

9. Processed products must be handled and stored at the processing plant in such a way as to preclude recontamination.

1. If the particle size of the animal by-products to be processed is more than 50 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 50 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 50 millimetres, the process must be stopped and repairs made before the process is resumed.

2. After reduction the animal by-products must be heated to a core temperature of more than 133 oC for at least 20 minutes without interruption at a pressure (absolute) of at least 3 bars produced by saturated steam ( 26 ); the heat treatment may be applied as the sole process or as a pre- or post-process sterilisation phase.

3. The processing may be carried out in batch or continuous systems.

1. If the particle size of the animal by-products to be processed is more than 150 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 150 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 150 millimetres, the process must be stopped and repairs made before the process is resumed.

2. After reduction the animal by-products must be heated to a core temperature greater than 100 oC for at least 125 minutes, a core temperature greater than 110 oC for at least 120 minutes and a core temperature greater that 120 oC for at least 50 minutes.

3. The processing must be carried out in a batch system.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.

1. If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before the process is resumed.

2. After reduction the animal by-products must be heated to a core temperature greater than 100 oC for at least 95 minutes, a core temperature greater than 110 oC for at least 55 minutes and a core temperature greater that 120 oC for at least 13 minutes.

3. The processing may be carried out in batch or continuous systems.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.

1. If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before the process is resumed.

2. After reduction the animal by-products must be placed in a vessel with added fat and heated to a core temperature greater than 100 oC for at least 16 minutes, a core temperature greater than 110 oC for at least 13 minutes, a core temperature greater that 120 oC for at least eight minutes and a core temperature greater that 130 oC for at least three minutes.

3. The processing may be carried out in batch or continuous systems.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.

1. If the particle size of the animal by-products to be processed is more than 20 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 20 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 20 millimetres, the process must be stopped and repairs made before the process is resumed.

2. After reduction the animal by-products must be heated until they coagulate and then pressed so that fat and water are removed from the proteinaceous material. The proteinaceous material must then be heated to a core temperature greater than 80 oC for at least 120 minutes and a core temperature greater than 100 oC for at least 60 minutes.

3. The processing may be carried out in batch or continuous systems.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.

1. The animal by-products must be reduced to at least:

They must then be mixed with formic acid to reduce and maintain the pH to 4,0 or lower. The mixture must be stored for at least 24 hours pending further treatment.

2. Following reduction, the mixture must be heated to:

When using a continuous flow system, the progression of the product through the heat converter must be controlled by means of mechanical commands limiting its displacement in such a way that at the end of the heat treatment operation the product has undergone a cycle which is sufficient in both time and temperature.

1. Any processing method approved by the competent authority where it has been demonstrated to that authority that the final product has been sampled on a daily basis over a period of one month in compliance with the following microbiological standards:

2. Details of the critical control points under which each processing plant satisfactorily complies with the microbiological standards must be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the processing plant. The information to be recorded and monitored must include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed-rate and fat recycling rate.

3. This information must be made available to the Commission on request.

1. The competent authority must supervise processing plants to ensure compliance with the requirements of this Regulation. It must in particular:

2. To allow it to carry out its responsibilities under paragraph 1, the competent authority must have free access at all times to all parts of the processing plant and to records, commercial documents and health certificates.

A.  Premises

B.  Processing standards

C.  Processed products

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A.  Premises

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B.  Hygiene requirements

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C.  Processing standards

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D.  Digestion residues and compost

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1. transesterification or hydrolysis at least 200 oC, under corresponding appropriate pressure, for 20 minutes (glycerol, fatty acids and esters); or

2. saponification with NaOH 12M (glycerol and soap):

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A.  Premises

B.  Raw material

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▼B

C.  Processing standards

D.  Processed products

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▼B

A.  Processing standards

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▼B

B.  Storage

C.  Importation

A.  Raw material

B.  Processing standards

C.  Importation

A.  Processing standards

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▼B

B.  Importation of rendered fats

C.  Importation of fish oil

D.  Hygiene requirements

1. Milk must be subjected to one of the following treatments:

2. Milk products must either be subjected to at least one of the treatments provided for in paragraph 1 or be produced from milk treated in accordance with paragraph 1.

3. Whey to be fed to animals of species susceptible to foot-and-mouth disease and produced from milk treated in accordance with paragraph 1 must be collected at least 16 hours after milk clotting and its pH must be recorded as below 6,0 before transport to animal holdings.

4. In addition to the requirements laid down in paragraphs 1, 2 and 3, milk and milk products must meet the following requirements:

5. Raw milk and colostrum must be produced under conditions offering adequate guarantees as regards animal health. Such conditions may be established by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).

1. Member States shall authorise imports of milk and milk products subject to compliance with the following conditions:

2. By way of derogation from paragraph 1.4, Member States shall authorise imports of milk and milk products from third countries so authorised in Column ‘A’ of Annex I to Commission Decision 2004/438/EC ( 33 ) provided that the milk or milk products have undergone a single HTST treatment and have been produced:

3. Where a risk of introduction of an exotic disease or any other risk to animal health is identified, additional conditions for the protection of animal health may be established by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).

A.  Processing standards for gelatin

B.  Processing standards for hydrolysed protein

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C.  Importation

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1. Collagen must be produced by a process ensuring that unprocessed category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion. After that treatment collagen may undergo a drying process.

2. The use of preservatives, other than those permitted under Community legislation shall be prohibited.

3. Collagen must be wrapped, packaged, stored and transported under satisfactory hygiene conditions. In particular:

4. Member States must authorise the importation of collagen if it:

1. Egg products must have been:

2. Member States must authorise the importation of egg products if they:

1. they must have adequate facilities for storing and treating incoming material in complete safety; and

2. they must have adequate facilities for disposing of unused animal by-products remaining after the production of the products in accordance with this Regulation, or this material must be sent to a processing plant or to an incineration or co-incineration plant in accordance with this Regulation.

1. The only animal by-products that may be used to produce petfood and dogchews are those referred to in Article 6(1)(a) to (j). However, raw petfood may only be manufactured from animal by-products referred to in Article 6(1)(a) or Article 6(1)(b).

2. Canned petfood must be subjected to heat treatment to a minimum Fc value of 3.

3. Processed petfood other than canned petfood must:

After the heat treatment, every precaution must be taken to ensure that such processed petfood is not exposed to contamination.

The processed petfood must be packaged in new packaging.

4. Dogchews must be subjected to a treatment during processing sufficient to destroy pathogenic organisms, including salmonella. After that treatment, every precaution must be taken to ensure that such dogchews are not exposed to contamination. The dogchews must be packed in new packaging.

5. Raw petfood must be packed in new packaging preventing any leakage. Effective steps must be taken to ensure that the product is not exposed to contamination throughout the production chain and up to the point of sale. The wording ‘petfood only’ must be visibly and legibly displayed on the packaging.

6. Random samples must be taken during production and/or during storage (before dispatch) to verify compliance with the following standards:

Where:

7. Member States must authorise importation of petfood and dogchews if they:

2. Trade in unprocessed poultry manure is subject to the following conditions:

3. Unprocessed manure of equidae which is traded must not originate from a holding subject to animal health restrictions pertaining to glanders, vesicular stomatitis, anthrax or rabies in accordance with Article 4 (5) of Directive 90/426/EEC.

4. The importation of unprocessed manure is prohibited.

5. The placing on the market of processed manure and processed manure products shall be subject to the following conditions set out in points (a) to (e):

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6. Member States must authorise importation of processed manure and processed manure products if they:

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7. The placing on the market of ‘guano’ is not subject to any animal health conditions.

1. Imports of blood are subject to the requirements laid down in Chapter XI.

2. Member States must authorise imports of blood products for the manufacture of technical products, including material originating from animals to which substances prohibited pursuant to Directive 96/22/EC have been administered, if they:

3. The blood from which blood products for the manufacture of technical products are produced must have been collected:

4. In the case of blood products for the manufacture of technical products which have been derived from animals belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreeds, they must comply with the conditions of either points (a) or (b):

5. In the case of blood products for the manufacture of technical products which have been derived from poultry and other avian species, they must comply with the conditions of either points (a) or (b):

1. Blood may be placed on the market provided that:

2. Blood products may be placed on the market provided that:

3. Blood and blood products from equidae must be packed in sealed impermeable containers which:

1. The blood must comply with the conditions set out in paragraph 1(a) of Section A and must be collected under veterinary supervision either in:

2. The blood products must comply with the conditions set out in paragraph 2 of Section A.

In addition, the blood products referred to in paragraph 2(b)(i) of Section A must have been produced from blood collected from equidae which have been kept for a period of at least three months, or since birth if less than three months old, prior to the date of collection on holdings under veterinary supervision in the third country of collection which during that period and the period of blood collection has been free of:

3. Blood products must come from a technical plant approved by the competent authority of the third country meeting the specific conditions laid down in Article 18 of Regulation (EC) No 1774/2002.

4. Blood and blood products must come from a third country that appears on the list referred to in the following Parts of Annex XI:

5. Blood and blood products shall be packed and labelled in accordance with paragraph 3(a) of Section A and shall be accompanied by a health certificate that conforms to the model set out in Chapter 4(A) of Annex X, duly completed and signed by the official veterinarian.

1. The provisions of this Chapter do not apply:

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2. Within the scope defined in paragraph 1, the provisions of this Chapter apply to fresh, chilled and treated hides and skins. For the purpose of this Chapter, ‘treated hides and skins’ means hides and skins that have been:

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3. Trade in fresh or chilled hides and skins is subject to the same health conditions as those applicable to fresh meat pursuant to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 37 ).

4. Trade in treated hides and skins is authorised on condition that the commercial document provided for in Annex II accompanies each consignment and attests that:

5. Member States must authorise the import of fresh or chilled hides and skins if:

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6. Member States must authorise the import of treated hides and skins if:

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7. Fresh, chilled or treated hides and skins of ungulates must be imported in containers, road vehicles, railway wagons or bales sealed by the competent authority of the third country of dispatch.

1. Without prejudice to the measures adopted pursuant to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein ( 38 ), game trophies:

are not subject to any ban or restriction for reasons of animal health.

2. Without prejudice to the measures adopted pursuant to Regulation (EC) No 338/97, game trophies of ungulates and birds not having undergone the treatment mentioned in paragraph 1(a) are subject to the following conditions. They must:

3. In respect of game trophies consisting solely of bone, horns, hooves, claws, antlers or teeth, the trophies must:

4. In respect of game trophies consisting solely of hides or skin, the trophies must:

5. Member States must authorise the importation of treated game trophies from birds and ungulates, being solely bones, horns, hooves, claws, antlers, teeth, hides or skins, from third countries if:

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6. Member States must, in accordance with the requirements of paragraph 7, authorise the importation of game trophies from birds and ungulates consisting of entire anatomical parts, not having been treated in any way, from third countries:

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▼B

7. Member States must authorise importation of the game trophies referred to in paragraph 6 if:

2. The provisions of paragraph 1 do not apply to decorative feathers or feathers:

3. Member States must authorise the importation of pig bristles from third countries or, in case of regionalisation according to Community legislation, regions thereof, if:

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4. Member States must authorise the importation of unprocessed wool and hair, if they are:

5. The importation of unprocessed feathers and parts of feathers is prohibited.

Member States must authorise the importation of processed feathers and parts of feathers if:

1. Apiculture by-products intended exclusively for use in apiculture must:

2. As the small hive beetle and Tropilaelaps spp. are not present in the Community, the following additional safeguards concerning importation of apiculture products have to be laid down.

3. Member States must authorise the importation of apiculture by-products, other than beeswax in the form of honeycomb, intended for use in apiculture if they:

4. Member States must authorise the importation of beeswax for technical purposes, other than beeswax in the form of honeycomb, if it:

5. The importation of beeswax in the form of honeycomb shall be prohibited.

1. Member States must authorise the importation of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) to produce technical products if:

▼M2

▼B

2. Each consignment must be accompanied by:

▼M2

▼B

3. On dispatch to the Community territory, the material must be enclosed in sealed containers or vehicles or carried in bulk in a ship. If transported in containers, the containers, and in all cases all the accompanying documents, must bear the name and the address of the technical plant.

4. Following the border check provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the material must be transported direct to the technical plant.

5. Records must be kept of the quantity and nature of the material, during manufacture, in such a way as to ensure that the material has actually been used for the intended purposes.

1. come from third countries appearing on the lists set out in part VI and VII(A) and (B) of Annex XI as appropriate;

2. consist only of animal by-products referred to in Article 6(1)(a) to (j) and/or, when intended to be used for petfood, material derived from animals treated as referred to in the second paragraph of Article 28;

however, animal by-products for use in feed for farmed fur animals or for use in raw petfood must consist of animal by-products referred to in Article 6(1)(a) and (b) only;

3. have been deep-frozen at the plant of origin or have been preserved in accordance with Community legislation in such a way to prevent spoiling between dispatch and delivery to the plant of destination;

4. have undergone all precautions to avoid contamination with pathogenic agents;

5. were packed in new packaging preventing any leakage;

6. are accompanied by a certificate that conforms to one of the models set out in Chapter 3(D), 3(F) or 8 of Annex X;

7. following the border checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, they are transported directly either:

8.1. in the case of raw material for petfood production derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC, as referred to in the second paragraph of Article 28 of this Regulation, it shall:

8.2. where a consignment is made up of raw material, which has been treated as referred to in 8.1 above and other non-treated raw material, all the raw materials in the consignment must be marked as laid down in point 8.1(a) and (b) above.

8.3. the marking provided for in point 8.1(a) and (b) and 8.2 shall remain visible from the dispatch and until the delivery to the petfood plant of destination.

1. Rendered fats derived from category 2 material for oleochemical purposes must be produced using methods 1 to 5 as referred to in Annex V, Chapter III.

2. Rendered fats derived from ruminant animals must be purified in such a way that the maximum level of remaining total insoluble impurities does not exceed 0,15 % in weight;

3. Member States must authorise the importation of rendered fats derived from category 2 materials, intended to be processed using a method that at least meets the standards of one of the processes described in Annex VI, Chapter III, if it:

4. The rendered fats must be conveyed by land and/or sea from the country of origin direct to a border inspection post in the Community.

5. Following the checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the rendered fats must be conveyed to a category 2 oleochemical plant where they are to be processed into fat derivatives.

6. The health certificate referred to in paragraph 3 must state that:

7. The health certificate provided for in paragraph 3 must be presented to the competent authority at the border inspection post at the first point of entry of the goods into the Community, and thereafter a copy must accompany the consignment until their arrival at the plant of destination.

8. Following the checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the rendered fats shall be transported directly to the plant of destination.

1. If rendered fat produced from category 2 material is used for the production of fat derivatives a method that at least meets the standards of one of the processes referred to in Chapter III of Annex VI shall be used.

2. Member States shall authorise the importation of fat derivatives only if a health certificate that conforms to the model set out in Chapters 14(A) or 14(B) of Annex X accompanies each consignment.

3. The health certificate referred to in paragraph 2 must state:

4. The health certificate provided for in paragraph 2 must be presented to the competent authority at the border inspection post at the first point of entry of the goods into the Community, and thereafter a copy must accompany the consignment until its arrival at the plant of destination.

5. Following the checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the fat derivatives shall be transported directly to the plants of destination.

1. Only animal by-products referred to in Article 6(1)(a) to (j) may be used for the production of liquid/dehydrated processed products of animal origin used to enhance the palatability values of pet food.

2. Flavouring innards must have been submitted to a treatment method and parameters, which ensure that the product complies with the microbiological standards laid down in Annex VIII, paragraph 6 of Chapter II. After treatment, every precaution must be taken to ensure that the product is not exposed to contamination.

3. The end product must:

4. Member States must authorise the importation of flavouring innards if they:

1. they must originate from animals that:

2. they must have undergone a heat treatment for one hour at a core temperature of at least 80° C;

3. the horns must have been removed without opening the cranial cavity;

4. at any stage of processing, storage or transport, every precaution shall have been taken to avoid cross-contamination;

5. they shall be packed either in new packaging or containers; or transported in vehicles or bulk containers which have been disinfected prior to loading using a product approved by the competent authority;

6. the packaging or containers must:

1. come from a third country appearing on the list referred to in Part XVIII of Annex XI;

2. have been produced in accordance with point A of this Chapter;

3. are accompanied by a health certificate that conforms to the model set out in Chapter 18 of Annex X, duly completed and signed by the official veterinarian;

4. are conveyed following the veterinary checks in the border inspection post at the point of entry into the Union provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, directly to an approved technical plant or an approved storage plant.

(a) Veterinary certificates shall be produced by the exporting country, based on the models appearing in this Annex X, according to the layout of the model that corresponds to the animal by-products concerned. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country or part thereof.

(b) The original of each certificate shall consist of a single page, both sides, or, where more text is required, it shall be in such a form that all pages needed are part of an integrated whole and indivisible.

(c) It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU Member State of destination. However, these Member States may allow other languages, accompanied, if necessary, by an official translation.

(d) If for reasons of identification of the items of the consignment, additional pages are attached to the certificate, these pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying official veterinarian, in each of the pages.

(e) When the certificate, including additional schedules referred to in d), comprises more than one page, each page shall be numbered — (page number) of (total number of pages) — on its bottom and shall bear the code number of the certificate that has been designated by the competent authority on its top.

(f) The original of the certificate must be completed and signed by an official veterinarian. In doing so, the competent authorities of the exporting country shall ensure that the principles of certification equivalent to those laid down in Council Directive 96/93/EC are followed.

(g) The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark.

(h) The original of the certificate must accompany the consignment at the EU border inspection post.

(i) If health certificates are used for consignments in transit, box No I.5 (Consignee) of the relevant health certificate shall be completed with the name and address of the border inspection post through which the consignment is intended to leave the European Community.

A. Blood products:

B. Animal by-products for pharmaceutical use:

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Regulation (EC) No 119/2009 and the following third countries:

C. Animal by-products for technical purposes other than pharmaceutical uses: third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which imports of that category of fresh meat of the respective species is authorised, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Regulation (EC) No 119/2009.

A. Animal by-products from equidae and animals of the bovine, ovine, caprine, and porcine species, including farmed and wild animals:

Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which imports of fresh meat for human consumption of those species of animals is authorised.

B. Raw material from poultry including ratites and wild game-birds:

Third countries or parts of third countries from which Member States authorise imports of fresh poultrymeat, which are listed in Part 1 of Annex I to Regulation (EC) No 798/2008.

C. Raw material from fish:

Third countries listed in Annex II to Decision 2006/766/EC.

D. Raw material from other wild land mammals and Leporidae.

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Part 1 of Annex I to Regulation (EC) No 119/2009, from which Member States authorise imports of fresh meat from the same species.

A. For untreated pig bristles, third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, which are free of African swine fever for the 12 months prior to the date of importation.

B. For treated pig bristles, third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, which may not be free of African swine fever for the 12 months prior to the date of importation.

(a) Part 1 of Annex II to Regulation (EU) No 206/2010;

(b) Annex I to Commission Decision 2004/211/EC ( 45 ); or

(c) Part 1 of Annex I to Regulation (EC) No 798/2008.

— (JP) Japan

— (EC) Ecuador ( 46 )

— (LK) Sri Lanka ( 47 )

— (TW) Taiwan ( 48 )

— (KR) South Korea ( 49 )

— (MY) Malaysia (49) 

— (PK) Pakistan (49) 

— (TW) Taiwan (49) .

A. Untreated blood and blood products: Third countries or parts of third countries listed in Annex I to Decision 2004/211/EC, from which the importation of equidae for breeding and production is allowed.

B. Treated blood products: third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat of domestic equidae.

A. For fresh or chilled hides and skins of ungulates, third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat from the same species.

B. For treated hides and skins of ungulates, third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010.

C. For treated hides and skins of ruminants that are intended for dispatch to the Union and which have been kept separate for a period of 21 days or which are to undergo transport for a period of 21 uninterrupted days before importation, any third country.

A. For treated game trophies of birds and ungulates, being solely bones, horns, hooves, claws, antlers, teeth, hides or skins, any third country.

B. For game trophies of birds consisting of entire parts not having been treated, third countries listed in Part 1 of Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh poultry meat, and the following countries:

C. For game trophies of ungulates consisting of entire parts not having been treated, third countries listed in the appropriate columns for fresh meat of ungulates in Part 1 of Annex II to Regulation (EU) No 206/2010, including any restrictions laid down in the column for special remarks for fresh meat.