(a) for the public and animal health rules for animal by-products and derived products laid down in Regulation (EC) No 1069/2009;

(b) concerning certain samples and items exempt from veterinary checks at border inspection posts as provided for in Article 16(1)(e) and (f) of Directive 97/78/EC.

(a) biodiesel which fulfils the requirements for the disposal and use of derived products set out in point 2(b) of Section 3 of Chapter IV of Annex IV;

(b) processed petfood which fulfil the specific requirements for processed petfood set out in point 7(a) of Chapter II of Annex XIII;

(c) dogchews which fulfil the specific requirements for dogchews set out in point 7(b) of Chapter II of Annex XIII;

(d) hides and skins of ungulates which fulfil the specific requirements for the end point for those products set out in point C of Chapter V of Annex XIII;

(e) wool and hair, which fulfil the specific requirements for the end point for those products set out in point B of Chapter VII of Annex XIII;

(f) feathers and down, which fulfil the specific requirements for the end point for those products set out in point C of Chapter VII of Annex XIII;

(g) fur which fulfils the special requirements for the end point for that product set out in Chapter VIII of Annex XIII;

(h) fish oil for the production of medicinal products which fulfils the special requirements for the end point for that product set out in Chapter XIII of Annex XIII;

(i) gasoline and fuels which fulfil the specific requirements for products from the multi-step catalytic process for the production of renewable fuels set out in point 2(c) of Section 3 of Chapter IV of Annex IV;

(j) oleochemical products derived from rendered fats and which fulfil the requirements set out in Chapter XI of Annex XIII.

(a) in incineration plants and co-incineration plants which have been granted a permit in accordance with Directive 2000/76/EC; or

(b) for plants not required to have a permit under Directive 2000/76/EC, in incineration and co-incineration plants which have been approved by the competent authority to carry out disposal by incineration, or disposal or recovery of animal by-products or derived products, if they are waste, by co-incineration, in accordance with Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009.

(a) the combustion plants fall within the scope of Chapter V of Annex III hereto;

(b) the combustion plants comply with all the relevant general conditions and specific requirements set out in Chapters IV and V of Annex III hereto;

(c) administrative procedures are in place to ensure that the requirements for the approval of the combustion plants are checked annually.

(a) the application for approval that is submitted by the operator to the competent authority in accordance with Article 24(1)(d) of Regulation (EC) No 1069/2009 must contain evidence certified by the competent authority or by a professional organisation authorised by the competent authorities of the Member State, that the combustion plant in which the poultry manure is used as a fuel fully meets the emission limit values and monitoring requirements set out in point 4 of Section B of Chapter V of Annex III hereto;

(b) the procedure for approval provided for in Article 44 of Regulation (EC) No 1069/2009 shall not be completed until at least two consecutive checks, one of them unannounced, have been carried out by the competent authority or by a professional organisation authorised by that authority, during the first six months of the operating of the combustion plant, including the necessary temperature and emission measurements. After the results of those checks showed compliance with the parameters set out in point 4 of Section B of Chapter V of Annex III hereto, full approval can be granted.

(a) imported petfood or petfood produced from imported materials, from Category 1 material referred to in Article 8(c) of Regulation (EC) No 1069/2009;

(b) Category 3 material referred to in Article 10(f) and (g) of Regulation (EC) No 1069/2009, provided that:

(a) the general conditions for processing set out in Section 1;

(b) the requirements for wastewater treatment set out in Section 2;

(c) the specific requirements for the processing of Category 1 and 2 materials set out in Section 3;

(d) the specific requirements for the processing of Category 3 materials set out in Section 4.

(a) the hygiene and processing requirements set out in Chapter II;

(b) the standard processing methods set out in Chapter III, provided such methods are used in the establishment or plant;

(c) the alternative processing methods set out in Chapter IV, provided such methods are used in the establishment or plant.

(a) the requirements applicable to biogas and composting plants set out in Chapter I;

(b) the hygiene requirements applicable to biogas and composting plants set out in Chapter II;

(c) the standard transformation parameters set out in Section 1 of Chapter III;

(d) the standards for digestion residues and compost set out in Section 3 of Chapter III.

(a) Category 1 and 2 materials and meat-and-bone meal or animal fat derived from Category 1 and 2 materials;

(b) processed animal protein.

(a) Category 1 and 2 materials and meat-and-bone meal or animal fat derived from Category 1 and 2 materials;

(b) processed animal protein.

(a) zoo animals;

(b) fur animals;

(c) dogs from recognised kennels or packs of hounds;

(d) dogs and cats in shelters;

(e) maggots and worms for fishing bait;

(f) circus animals.

(a) zoo animals;

(b) fur animals;

(c) dogs from recognised kennels or packs of hounds;

(d) dogs and cats in shelters;

(e) maggots and worms for fishing bait;

(f) circus animals.

(a) in feeding stations, to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity, subject to compliance with the conditions set out in Section 2 of Chapter II of Annex VI;

(b) outside feeding stations, if appropriate without prior collection of the dead animals, to wild animals referred to point 1(a) of Section 2 of Chapter II of Annex VI, subject to compliance with the conditions set out in Section 3 of that Chapter.

(a) the special disposal rules for animal by-products set out in Section 1;

(b) the rules for the burning and burial of animal by-products in remote areas set out in Section 2;

(c) the rules for the burning and burial of bees and apiculture by-products set out in Section 3.

(a) comply with the requirements for collection, transport and identification set out in Chapters I and II of Annex VIII;

(b) are accompanied during transport by commercial documents or health certificates in accordance with the requirements set out in Chapter III of Annex VIII.

(a) Chapter I, where they manufacture petfood as referred to in Article 24(1)(e) of that Regulation;

(b) Chapter II, where they store animal by-products as referred to in Article 24(1)(i) of that Regulation and where they handle animal by-products after their collection, by way of the following operations referred to in Article 24(1)(h) of that Regulation:

(c) Chapter III, where they store derived products for certain intended purposes as referred to in Article 24(1)(j) of that Regulation.

(a) approved operators who are transporting animal by-products or derived products as an ancillary activity;

(b) operators who have been registered for transport activities in accordance with Regulation (EC) No 183/2005.

(a) operators handling or generating game trophies or other preparations referred to in Chapter VI of Annex XIII hereto for private or non-commercial purposes;

(b) operators handling or disposing research and diagnostic samples for educational purposes;

(c) operators transporting dry untreated wool and hair, provided they are securely enclosed in packaging, and directly dispatched to a plant producing derived products for uses outside the feed chain or to a plant carrying out intermediate operations, under conditions which prevent the spreading of pathogenic agents;

(d) operators using small quantities of Categories 2 and 3 materials referred to in Articles 9 and 10 of Regulation (EC) No 1069/2009 or of products derived therefrom, for the purpose of direct supply of the products within the region to the final user, on the local market or to local retail establishments, if the competent authority does not consider such activity to present a risk of spreading any serious transmissible disease to humans or animals; this point shall not apply where those materials are used as feed for farmed animals other than fur animals.

(a) the general requirements for the processing and the placing on the market set out in Chapter I;

(b) the specific requirements for processed animal proteins and other derived products set out in Chapter II;

(c) the requirements for certain fish feed and fishing baits set out in Chapter III.

(a) the establishment or plant has adequate facilities for the receipt of the intermediate products, which prevent the transmission of diseases communicable to humans or animals;

(b) the intermediate products do not pose any risk of transmission of diseases communicable to humans or animals, due to their purification or to other treatments to which the animal by-products in the intermediate product have been submitted, due to the concentration of animal by-products in the intermediate product or due to adequate bio-security measures for the handling of the intermediate products;

(c) the establishment or plant keeps records on the amount of materials received, their category, if applicable, and the establishment, plant or operator to whom they have supplied their products; and

(d) unused intermediate products or other surplus materials from the establishment or plant, such as expired products, are disposed of in accordance with Regulation (EC) No 1069/2009.

(a) unprocessed manure;

(b) untreated feathers and parts of feathers and down;

(c) beeswax in the form of honeycomb.

(a) wool and hair which has been factory-washed or which has been treated by another method which ensures that no unacceptable risks remain;

(b) furs which have been dried at an ambient temperature of 18 °C for a period of at least two days at a humidity of 55 %;

(c) wool and hair produced from animals other than those of the porcine species, which has been treated by factory-washing which consisting of the immersion of the wool and hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide;

(d) wool and hair produced from animals other than those of the porcine species, which is dispatched directly to a plant producing derived products from wool and hair for the textile industry and has been treated by at least one of the following methods:

(e) wool and hair that is dry and securely enclosed in packaging, produced from animals other than those of the porcine species, which is intended for dispatch to a plant producing derived products from wool and hair for the textile industry and meets all of the following requirements:

(a) the specific requirements for the import and transit of Category 3 material and derived products for uses in the feed chain, other than for petfood or feed to fur animals, set out in Chapter I of that Annex;

(b) the specific requirements for the import and transit of animal by-products and derived products for uses outside the feed chain for farmed animals, set out in Chapter II of that Annex.

(a) those materials must not be Category 1 materials derived from any of the following animals:

(b) those materials must not be intended for any of the following uses:

(c) the materials must be imported with a label and must comply with the specific requirements for certain movements of animal by-products set out in Section 1 of Chapter IV of Annex XIV hereto;

(d) the materials must be imported in accordance with sanitary certification requirements laid down in national legislation.

(a) the introduction of the consignment must have been authorised in advance by the competent authority of the Member State of destination; and

(b) the consignment must be sent directly from the point of entry into the Union to the authorised user.

(a) the consignment shall be sealed with a serially numbered seal at the border inspection post of entry to the Union by the veterinary services of the competent authority;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC shall be stamped ‘ONLY FOR TRANSIT TO RUSSIA VIA THE EU’ on each page by the official veterinarian of the competent authority responsible for the border inspection post;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC shall be complied with;

(d) the consignment is certified as acceptable for transit on the Common Veterinary Entry Document provided for in Annex III to Regulation (EC) No 136/2004 by the official veterinarian of the border inspection post of introduction.

(a) the consignment is sealed with a serially numbered seal by the official veterinarian at the border inspection post of entry;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC are stamped ‘ONLY FOR TRANSIT TO THIRD COUNTRIES VIA THE EU’ on each page by the official veterinarian at the border inspection post of entry;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with;

(d) the consignment is certified as acceptable for transit on the Common Veterinary Entry Document referred to in Article 2(1) of Regulation (EC) No 136/2004 by the official veterinarian at the border inspection post of entry.

(a) official controls in processing plants as set out in Chapter I;

(b) official controls of other activities which involve the handling of animal by-products, and derived products as set out in Sections 1 to 9 of Chapter III.

(a) processed animal protein and other derived products referred to in Chapter II of Annex X hereto;

(b) petfood and certain other derived products referred to in Annex XIII hereto;

(c) animal by-products and the derived products imported into or in transit through the Union as referred to in Annex XIV hereto.

(a) Regulation (EC) No 811/2003;

(b) Decision 2003/322/EC;

(c) Decision 2003/324/EC;

(d) Regulation (EC) No 878/2004;

(e) Decision 2004/407/EC;

(f) Regulation (EC) No 79/2005;

(g) Regulation (EC) No 92/2005;

(h) Regulation (EC) No 181/2006;

(i) Regulation (EC) No 197/2006;

(j) Regulation (EC) No 1192/2006;

(k) Regulation (EC) No 2007/2006.

(a) provided that they have been produced from one of the following:

(b) even though they have not been mixed with a component to exclude the subsequent use of the mixture for feeding purposes.

1. ‘fur animals’ means animals kept or reared for the production of fur and not used for human consumption;

2. ‘blood’ means fresh whole blood;

3. ‘feed material’ means those feed materials, as defined in Article 3(2)(g) of Regulation (EC) No 767/2009, that are of animal origin, including processed animal proteins, blood products, rendered fats, egg products, fish oil, fat derivatives, collagen, gelatine and hydrolysed proteins, dicalcium phosphate, tricalcium phosphate, milk, milk-based products, milk-derived products, colostrum, colostrum products and centrifuge or separator sludge;

4. ‘blood products’ means derived products 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. ‘processed animal protein’ means animal protein derived entirely from Category 3 material, which have been treated in accordance with Section 1 of Chapter II of Annex X (including blood meal and fishmeal) 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, milk-derived products, colostrum, colostrum products, centrifuge or separator sludge, gelatine, hydrolysed proteins and dicalcium phosphate, eggs and egg-products, including eggshells, tricalcium phosphate and collagen;

6. ‘blood meal’ means processed animal protein derived from the heat treatment of blood or fractions of blood in accordance with Section 1 of Chapter II of Annex X;

7. ‘fishmeal’ means processed animal protein derived from aquatic animals, except sea mammals;

8. ‘rendered fats’ means either fats derived from the processing of:

9. ‘fish oil’ means oil derived from the processing of aquatic animals or oil from the processing of fish for human consumption, which an operator has destined for purposes other than human consumption;

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

11. ‘collagen’ means protein-based products derived from hides, skins, bones and tendons of animals;

12. ‘gelatine’ 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;

13. ‘greaves’ means the protein-containing residue of rendering, after partial separation of fat and water;

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

15. ‘white water’ means a mixture of milk, milk-based products or products derived thereof with water which is collected during the rinsing of dairy equipment including containers used for dairy products, prior to their cleaning and disinfection;

16. ‘canned petfood’ means heat-processed petfood contained within a hermetically sealed container;

17. ‘dogchews’ means products for pet animals to chew, produced from untanned hides and skins of ungulates or from other material of animal origin;

18. ‘flavouring innards’ means a liquid or dehydrated derived product of animal origin used to enhance the palatability values of petfood;

19. ‘petfood’ means feed, other than material referred to in Article 24(2), for use as feed for pet animals, and dogchews consisting of animal by-products or derived products which:

20. ‘processed petfood’ means petfood, other than raw petfood, which has been processed in accordance with point 3 of Chapter II of Annex XIII;

21. ‘raw petfood’ means petfood containing certain Category 3 material which has not undergone any preserving process other than chilling or freezing;

22. ‘catering waste’ means all waste food, including used cooking oil originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

23. ‘digestion residues’ means residues, including the liquid fraction, resulting from the transformation of animal by-products in a biogas plant;

24. ‘digestive tract content’ means the content of the digestive tract of mammals and ratites;

25. ‘fat derivatives’ means derived products from rendered fats, which, as regards rendered fats of Category 1 or Category 2 material, have been processed in accordance with Chapter XI of Annex XIII;

26. ‘guano’ means a natural product which has been collected from the excrements of bats or wild sea birds and which is not mineralised;

27. ‘meat-and-bone meal’ means animal protein derived from the processing of Category 1 or Category 2 materials in accordance with one of the processing methods set out in Chapter III of Annex IV;

28. ‘treated hides and skins’ means derived products from untreated hides and skins, other than dogchews, that have been:

29. ‘untreated hides and skins’ means all cutaneous and subcutaneous tissues that have not undergone any treatment, other than cutting, chilling or freezing;

30. ‘untreated feathers and parts of feathers’ means feathers and parts of feathers, other than feathers or parts of feathers, which have been treated:

31. ‘untreated wool’ means wool, other than wool which has:

32. ‘untreated hair’ means hair, other than hair which has:

33. ‘untreated pig bristles’ means pig bristles, other than pig bristles which have:

34. ‘display item’ means animal by-products or derived products intended for exhibitions or artistic activities;

35. ‘intermediate product’ means a derived product:

36. ‘laboratory reagent’ means a packaged product, ready for use, containing animal by-products or derived products and intended as such or in combination with substances of non-animal origin for specific laboratory use as a reagent or reagent product, calibrator or control material to detect, measure, examine or produce other substances;

37. ‘product used for in vitro diagnosis’ means a packaged product, ready for use, containing a blood product or another animal by-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, 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; it does not include donated organs or blood;

38. ‘research and diagnostic samples’ means animal by-products and derived products intended for the following purposes: examination in the context of diagnostic activities or analysis for the promotion of progress in science and technology, in the context of educational or research activities;

39. ‘trade samples’ means animal by-products or derived products intended for particular studies or analyses with a view to carrying out a production process or developing feedingstuffs or other derived products, including testing of machinery, for use in an establishment or plant which is:

40. ‘co-incineration’ means the recovery or disposal of animal by-products or derived products, if they are waste, in a co-incineration plant;

41. ‘combustion’ means a process involving the oxidisation of fuel in order to use the energy value of the animal by-products or derived products, if they are not waste;

42. ‘incineration’ means the disposal of animal by-products or derived products as waste, in an incineration plant, as defined in point 4 of Article 3 of Directive 2000/76/EC;

43. ‘incineration and co-incineration residues’ means any residues as defined in point 13 of Article 3 of Directive 2000/76/EC, which are generated by incineration or co-incineration plants treating animal by-products or derived products;

44. ‘colour-coding’ means the systematic use of colours as set out in point 1(c) of Chapter II of Annex VIII for displaying information as provided for in this Regulation on the surface or on part of the surface of a packaging, container or vehicle, or on a label or symbol applied to them;

45. ‘intermediate operations’ means the operations, other than storage, referred to in Article 19(b);

46. ‘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;

47. ‘taxidermy’ means the art of preparing, stuffing and mounting the skins of animals with lifelike effect, so that no unacceptable risks to public and animal health may be transmitted through the mounted skin;

48. ‘trade’ means trade in goods between Member States as referred to in Article 28 of the Treaty on the Functioning of the European Union;

49. ‘processing methods’ means the methods listed in Chapters III and IV of Annex IV;

50. ‘batch’ means a unit of production produced in a single plant using uniform production parameters, such as the origin of the materials, or a number of such units, when produced in continuous order in a single plant and stored together as a shipping unit;

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

52. ‘biogas plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under anaerobic conditions;

53. ‘collection centres’ means premises other than processing plants in which the animal by-products referred to in Article 18(1) of Regulation (EC) No 1069/2009 are collected with the intention to be used for feeding to the animals referred to in the same Article;

54. ‘composting plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under aerobic conditions;

55. ‘co-incineration plant’ means any stationary or mobile plant whose main purpose is the generation of energy or the production of material products as defined in point 5 of Article 3 of Directive 2000/76/EC;

56. ‘incineration plant’ means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of waste as defined in point 4 of Article 3 of Directive 2000/76/EC;

57. ‘petfood plant’ means premises or facilities for the production of petfood or flavouring innards, as referred to in Article 24(1)(e) of Regulation (EC) No 1069/2009;

58. ‘processing plant’ means premises or facilities for the processing of animal by-products as referred to in Article 24(1)(a) of Regulation (EC) No 1069/2009, in which animal by-products are processed in accordance with Annex IV and/or Annex X.

1. In Estonia, Latvia and Finland, the following fur animals may be fed with meat-and-bone meal or other products which have been processed in accordance with Chapter III of Annex IV and which are derived from bodies or parts of bodies of animals of the same species:

▼M1

▼B

2. In Estonia and Latvia, fur animals of the species American mink (Mustela vison) may be fed with meat-and-bone meal or other products which have been processed in accordance with the processing methods set out in Chapter III of Annex IV and which are derived from bodies or parts of bodies of animals of the same species.

3. The feeding referred to in points 1 and 2 shall take place under the following conditions:

(a) The waiting period of at least 21 days referred to in Article 11(1)(c) of Regulation (EC) No 1069/2009 must have been observed,

(b) Only organic fertilisers and soil improvers have been used which comply with Article 32(1) and (2) of Regulation (EC) No 1069/2009 and with Chapter II of Annex XI hereto.

(a) manure and guano;

(b) digestive tract content, milk, milk-based products, milk-derived products, colostrum and colostrum products, which the competent authority does not consider to present a risk for the spread of any serious animal disease.

1. Operators of incineration and co-incineration plants referred to in Article 6(1)(b) of this Regulation shall ensure that the following hygiene conditions are met in the plants under their control:

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

3. Animals must not have access to the plants, animal by-products and derived products that are awaiting incineration or co-incineration or to ash resulting from the incineration or co-incineration of animal by-products.

4. If the incineration or co-incineration plant is located on a livestock holding:

5. The storage of animal by-products and derived products that are awaiting incineration or co-incineration and of ashes must be in covered, correctly identified and, if appropriate, leak proof containers.

6. Incompletely incinerated animal by-products must be reincinerated or disposed of by other means, other than by disposal in an authorised landfill, in accordance with Articles 12, 13 and 14, as applicable, of Regulation (EC) No 1069/2009.

1. Incineration and co-incineration residues shall be minimised in their amount and harmfulness. Such residues must be recovered, where appropriate, directly in the plant or outside it in accordance with relevant Union legislation or disposed of in an authorised landfill.

2. Transport and intermediate storage of dry residues, including dust, shall take place in such a way as to prevent dispersal in the environment, such as in closed containers.

1. Techniques shall be used to monitor the parameters and conditions relevant to the incineration or co-incineration process.

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

3. The functioning of any automated monitoring equipment shall be subject to control and to an annual surveillance test.

4. Temperature measurement results shall 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.

(a) The plants must be equipped for each line with at least one auxiliary burner. This burner shall be switched on automatically when the temperature of the combustion gases after the last injection of combustion air falls below 850 °C or 1 100 °C, as applicable. It must also be used during plant start-up and shut-down operations to ensure that the temperature of 850 °C or of 1 100 °C, as applicable, is maintained at all times during these operations and as long as unburned material is in the chamber where the incineration or co-incineration is carried out.

(b) When animal by-products or derived products are introduced into the chamber where the incineration or co-incineration is carried out by a continuous process, the plant must operate an automatic system to prevent the introduction of animal by-products or derived products at start-up, until the temperature of 850 °C or of 1 100 °C, as applicable, has been reached, and whenever the temperature is not maintained.

(c) The operator must operate the incineration plant in such manner that a level of incineration is achieved such that the slag and bottom ashes total organic carbon content is less than 3 % or their loss on ignition is less than 5 % of the dry weight of the material. If necessary, appropriate techniques of pre-treatment shall be used.

1. Sites of high capacity plants, including associated storage areas for animal by-products, shall be designed in such a way as to prevent unauthorised and accidental release of any polluting substances into soil, surface water and groundwater.

2. Storage capacity shall be provided for contaminated rainwater run-off from the plant site or for contaminated water arising from spillage or firefighting operations.

The operator shall, if necessary, ensure that such rainwater and such water can be tested and treated before discharge, when necessary.

(a) only be used for the disposal of:

(b) when Category 1 materials referred to in Article 8(b) of Regulation (EC) No 1069/2009 are introduced into the low-capacity plant, be equipped with an auxiliary burner;

(c) operate in such way that the animal by-products are completely reduced to ash.

1. Operators of combustion plants referred to in Article 6(6) shall ensure that the following conditions are met in the combustion plants under their control:

2. Operators of the combustion plants shall take all necessary precautions concerning the reception of animal by-products or derived products to prevent or limit as far as practicable, risks to human or animal health and the environment.

3. Animals must not have access to the combustion plant or to the animal by-products and derived products awaiting combustion or the ash resulting from the combustion.

4. Where the combustion plant is located on a holding keeping animals of food producing species:

5. The animal by-products and derived products that are awaiting combustion as a fuel and the combustion residues must be stored in a closed and covered dedicated area, or in covered and leak-proof containers.

6. The combustion of animal by-products or derived products shall be carried out under conditions which prevent cross-contamination of feed for animals.

1. Combustion plants must be designed, built, equipped and operated in such a way that even under the most unfavourable conditions the animal by-products and derived products are treated for at least for 2 seconds at a temperature of 850 °C or for at least 0,2 seconds at a temperature of 1 100 °C.

2. The gas resulting from the process is raised in a controlled and homogeneous fashion for 2 seconds to a temperature of 850 °C or for 0,2 seconds to a temperature of 1 100 °C.

The temperature must be measured near the inner wall or at another representative point of the combustion chamber, as authorised by the competent authority.

3. Automated techniques shall be used to monitor the parameters and conditions relevant to the combustion process.

4. Temperature measurement results shall be recorded automatically and presented in an appropriate fashion to enable the competent authority to verify compliance with the permitted operating conditions referred to in points 1 and 2 in accordance with procedures to be decided upon by the relevant authority.

5. The operator of a combustion plant shall ensure that the fuel is combusted in such a way that the total organic carbon content of the slags and bottom ashes is less than 3 % or their loss on ignition is less than 5 % of the dry weight of the material.

1. Combustion residues shall be minimised in their amount and harmfulness. Such residues must be recovered, or where it is not appropriate, disposed of or used in accordance with relevant Union legislation.

2. The transport and intermediate storage of dry residues, including dust, shall take place in closed containers or in another way which prevents dispersal into the environment.

1. The combustion plant shall be equipped with facilities which automatically shut down operations in the case of a breakdown or abnormal operating conditions until normal operations can be resumed.

2. Incompletely combusted animal by-products and derived products must be combusted again or disposed of by means referred to in Articles 12, 13 and 14 of Regulation (EC) No 1069/2009 other than disposal in an authorised landfill.

1. Starting material:

For this process, a fat fraction derived from animal by-products of all categories may be used provided it meets the following conditions:

2. Methodology:

Combustion of animal fat as a fuel in a stationary internal combustion engine shall be carried out as follows:

3. Operating conditions:

By way of derogation from the requirements set out in the first paragraph of point 2 of Section 2 of Chapter IV, requirements based on other process parameters, which ensure an equivalent environmental outcome may be authorised by the competent authority responsible for environmental issues.

1. Type of plant:

On-farm combustion plant with a total rated thermal input not exceeding 5 MW.

2. Starting material and scope:

Exclusively unprocessed poultry manure, as referred to in Article 9(a) of Regulation (EC) No 1069/2009, to be used as a fuel for combustion in accordance with the requirements set out in point 3 to 5.

The combustion of other animal by-products or derived products and of manure of other species or generated outside the holding shall not be allowed for use as a fuel in on-farm combustion plants referred to in point 1.

3. Specific requirements for poultry manure used as a fuel for combustion:

4. Emission limit values and monitoring requirements:

5. Changes of operation and breakdowns:

1. Processing plants shall meet the following requirements, for processing by pressure sterilisation or in accordance with the processing methods referred to in Article 15(1)(b) of Regulation (EC) No 1069/2009:

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 means of transport, other than ships, in which they are transported.

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

4. All processing plants must have a waste-water disposal system meeting the requirements set out by the competent authority in accordance with Union legislation.

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 on the basis of an assessment of the capacity of the laboratory to carry out those analyses, be accredited according to internationally recognised standards or be subject to regular controls by the competent authority, to assess the capacity of the laboratory to carry out those analyses.

6. If on the basis of a risk assessment, the volume of products treated requires the regular or permanent presence of the competent authority, the processing plants must have an adequately equipped lockable room for the exclusive use of the inspection service.

1. Processing plants processing Category 1 material and other premises where specified risk material is removed, slaughterhouses and processing plants processing Category 2 material shall have a pre-treatment process for the retention and collection of animal material as an initial step in the treatment of wastewater.

The equipment used in the pre-treatment process shall consist of drain traps or screens with apertures with a filter pore or a mesh size of no more than 6 mm in the downstream end of the process or equivalent systems that ensure that the solid particles in the wastewater passing through them are no more than 6 mm.

2. Wastewater from the premises as referred to in point 1 must enter a pre-treatment process which shall ensure that all wastewater has been filtered through the process before being drained off the premises. No grinding, maceration or any other processing or application of pressure shall be carried out which could facilitate the passage of solid animal material through the pre-treatment process.

3. All animal material retained in the pre-treatment process in premises as referred to in point 1 shall be collected and transported as Category 1 or Category 2 material, as appropriate, and disposed of in accordance with Regulation (EC) No 1069/2009.

4. Wastewater having passed the pre-treatment process in premises referred to in point 1 and wastewater from other premises handling or processing animal by-products shall be treated in accordance with Union legislation, without restrictions in accordance with this Regulation.

5. In addition to the requirements laid down in point 4, the competent authority may oblige operators to treat wastewater originating in the unclean sector of processing plants and in plants or establishments carrying out intermediate operations with Category 1 material or Category 2 material or storing Category 1 material or Category 2 material, in accordance with conditions which ensure that risks from pathogens are mitigated.

6. Without prejudice to points 1 to 5, the disposal of animal by-products, including blood and milk, or derived products through the wastewater stream shall be prohibited.

However, Category 3 material comprising of centrifuge or separator sludge may be disposed of through the wastewater stream, provided that it has been subject to one of the treatments for centrifuge or separator sludge set out in Part III of Section 4 of Chapter II of Annex X hereto.

1. Processing plants processing Category 3 materials shall not be located at the same site as processing plants processing Category 1 or Category 2 materials, unless located in a completely separate building.

2. However, the competent authority may authorise the processing of Category 3 material on a site where handling or processing of Category 1 or Category 2 material takes place, if cross-contamination is prevented due to:

3. Processing plants processing Category 3 material shall have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies shall be removed before or during processing.

1. Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records must be kept to show the date of calibration of gauges/recorders.

2. Material that may not have received the specified heat treatment, such as material discharged at start up or leakage from cookers, must be recirculated through the heat treatment or collected and reprocessed or disposed of in accordance with Regulation (EC) No 1069/2009.

1. The critical control points that determine the extent of the heat treatments applied in processing shall include for each processing method as specified in Chapter III:

2. In the case of chemical treatments which have been authorised by the competent authority as processing method 7 in accordance with point G of Chapter III, the critical control points that determine the extent of the chemical treatments applied shall include the pH adjustment achieved.

3. Records shall be maintained for at least two years to show that the minimum process values for each critical control point are applied.

4. Category 3 material shall be processed in accordance with any of the processing methods 1 to 5 or processing method 7, or, in the case of material originating from aquatic animals, with any of the processing methods 1 to 7, as referred to in Chapter III.

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. The animal by-products with the particle size of no greater than 50 millimetres must be heated to a core temperature of more than 133 °C for at least 20 minutes without interruption at a pressure (absolute) of at least 3 bars. The pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (‘saturated steam’); 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 in a manner which ensures that a core temperature greater than 100 °C is achieved for at least 125 minutes, a core temperature greater than 110 °C is achieved for at least 120 minutes and a core temperature greater that 120 °C is achieved for at least 50 minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

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

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 in a manner which ensures that a core temperature greater than 100 °C is achieved for at least 95 minutes, a core temperature greater than 110 °C is achieved for at least 55 minutes and a core temperature greater that 120 °C is achieved for at least 13 minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

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 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 in a manner which ensures that a core temperature greater than 100 °C is achieved for at least 16 minutes, a core temperature greater than 110 °C is achieved for at least 13 minutes, a core temperature greater than 120 °C is achieved for at least eight minutes and a core temperature greater that 130 °C is achieved for at least three minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

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 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 in a manner which ensures that a core temperature greater than 80 °C is achieved for at least 120 minutes and a core temperature greater that 100 °C is achieved for at least 60 minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

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

1. The animal by-products must be reduced to a particle size which is no greater than:

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. After 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 way that at the end of the heat treatment operation the product has undergone a cycle which is sufficient in both time and temperature.

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

1. Any processing method authorised by the competent authority where the following have been demonstrated by the operator to that authority:

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 operator and the competent authority can monitor the operation of the processing plant. The information to be recorded and monitored must include the particle size, and, as appropriate, the critical temperature, the absolute time, pressure profile, raw material feed rate and fat recycling rate.

3. By way of derogation from point 1, the competent authority may authorise the use of processing methods which have been approved prior to the date of entry into application of this Regulation, in accordance with Chapter III of Annex V to Regulation (EC) No 1774/2002.

4. The competent authority shall permanently or temporarily suspend the application of processing methods referred to in points 1 and 3, if it obtains evidence that any of the circumstances specified in point 1(a) or (b) have substantially changed.

5. The competent authority shall inform the competent authority of another Member State upon request about the information at its disposal under points 1 and 2 in relation to an authorised processing method.

1. Materials resulting from the processing of Category 1 and 2 materials shall be permanently marked in accordance with the requirements for the marking of certain derived products set out in Chapter V of Annex VIII.

However, such marking shall not be required for the following materials referred to in Section 2:

2. The competent authority of a Member State shall make the results of official controls available to the competent authority of another Member State upon request, when an alternative method is used for the first time in that Member State, in order to facilitate the introduction of the new alternative method.

(a) Either a sodium hydroxide (NaOH) or potassium hydroxide (KOH) solution (or a combination thereof) must be used in an amount that assures approximate molar equivalency to the weight, type and composition of the animal by-products to be digested.

In the case of high fat in the animal by-products that neutralises the base, the added base must be adjusted so that the molar equivalency referred to is achieved.

(b) Animal by-products must be placed in a steel alloy container. The measured amount of alkali must be added either in solid form or as a solution as referred to in point (a).

(c) The container must be closed and the animal by-products and alkali mixture must be heated to a core temperature of at least 150 °C and at a pressure (absolute) of at least 4 bars for at least:

(d) The process must be carried out in a batch system and the material in the vessel must be constantly mixed in order to facilitate the digestion process until the tissues are dissolved and bones and teeth are softened; and

(e) The animal by-products must be treated in such way that the requirements regarding time, temperature and pressure are achieved at the same time.

(a) The animal by-products must be heated to a core temperature of at least 180 °C for at least 40 minutes without interruption at a pressure (absolute) of at least 12 bar, heated by indirect steam application to the biolytic reactor;

(b) The process must be carried out in a batch and the material in the vessel must be constantly mixed; and

(c) The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure are achieved at the same time.

(a) The animal by-products must be first processed using processing method 1 (pressure sterilisation) as set out in Chapter III in an approved processing plant;

(b) Following the process referred to in point (a), the defatted materials must be treated at a temperature of at least 220 °C for at least 20 minutes at a pressure (absolute) of at least 25 bar, heated in a two-step procedure, first by direct steam injection, secondly indirect in a coaxial heat exchanger;

(c) The process must be carried out in a batch or continuous system and the material is constantly mixed;

(d) The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure are achieved at the same time;

(e) The resulting material must then be mixed with water and anaerobically fermented (biogas transformation) in a biogas reactor;

(f) In the case of starting material of Category 1, the entire process must take place on the same site and in a closed system and the biogas produced during the process must be combusted rapidly in the same plant at a minimum of 900 °C followed by rapid chilling (‘quenching’).

(a) Unless fish oil or rendered fat are used which have been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, the fat fraction derived from animal by-products must be first processed using:

(b) The processed fat must then be processed further using one of the following methods:

(a) The afterburner chamber must be warmed up using natural gas;

(b) The animal by-products must be loaded into the primary chamber of the gasificator and the door must be closed. The primary chamber must have no burners and must be heated instead by the transfer of heat by conduction from the afterburner, which must be underneath the primary chamber. The only air admitted to the primary chamber must be via three inlet valves mounted on the main door to enhance the efficiency of the process;

(c) The animal by-products must be volatilised into complex hydrocarbons and the resultant gases must pass from the primary chamber via a narrow opening at the top of the back wall to the mixing and cracking zones, where they must be broken down into their constituent elements. Finally the gases must pass into the afterburner chamber where they must be burned in the flame of a natural gas fired burner in the presence of excess air;

(d) Each process unit must have two burners and two secondary air fans for back-up in case of burner or fan failure. The secondary chamber must be designed to give a minimum residence time of two seconds at a temperature of at least 950 °C under all conditions of combustion;

(e) On leaving the secondary chamber the exhaust gases must pass through a barometric damper at the base of the stack, which cools and dilutes them with ambient air, maintaining a constant pressure in the primary and secondary chambers;

(f) The process must be carried out over a 24-hour cycle, which includes loading, processing, cool down and ash removal. At the end of the cycle the residual ash must be removed from the primary chamber by a vacuum extraction system into enclosed bags and sealed before transporting;

(g) The gasification of material other than animal by-products must not be permitted.

(a) Unless fish oil or rendered fat are used which has been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, the fat fraction derived from animal by-products must first be processed using:

(b) The fat fraction must be separated from the protein and in the case of fat from ruminant origin which is intended to be combusted in another plant, insoluble impurities in excess of 0,15 % by weight must be removed;

(c) Following the process referred to in points (a) and (b), the fat must be:

(d) The combustion of material of animal origin other than animal fat must not be permitted;

(e) The combustion of the fat derived from Category 1 and Category 2 materials shall take place in the same plant where the fat is rendered with the aim of utilising the energy generated for the rendering processes. However, the competent authority may authorise the movement of that fat to other plants for combustion provided that:

(f) The combustion must be carried out in accordance with Union legislation for the protection of the environment, in particular, with reference to the standards of that legislation regarding best available techniques for the control and monitoring of emissions.

(a) The animal by-products must be loaded into a converter and subsequently treated at a temperature of 80 °C for a period of eight hours. During this period, the material must be constantly reduced in size using appropriate mechanical abrasion equipment.

(b) The material must be subsequently treated at a temperature of 100 °C for at least two hours.

(c) The particle size of the resulting material must not be larger than 20 millimetres;

(d) The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure set out in points (a) and (b) are achieved at the same time;

(e) During the heat treatment of the material, evaporated water must be continually extracted from the air-space above the biofuel and must be passed through a stainless steel condenser. The condensate must be kept at a temperature of at least 70 °C for at least one hour before being discharged as wastewater;

(f) After the heat treatment of the material, the resulting biofuel from the converter must then be discharged and automatically conveyed by a fully covered and interlocked conveyor to incineration or co-incineration on the same site;

(g) The process must be carried out in a batch mode.

(a) Category 2 materials referred to in Article 9(f)(i), (ii) and (iii) of Regulation (EC) No 1069/2009 which are of porcine origin;

(b) Category 3 materials referred to in Article 10(h) of that Regulation which are of porcine origin.

(a) Following their collection on a holding for which the competent authority has authorised the use of the processing method, based on an assessment of the animal density of the holding, the likely mortality rate and the potential risks for public and animal health which may arise, the animal by-products must be placed into a container which has been constructed in accordance with point (b)(‘the container’) and which has been placed at a dedicated site in accordance with points (c) and (d) (‘the dedicated site’).

(b) The container must:

(c) The container must be placed in a dedicated site which is physically separate from the holding.

That site must have dedicated access routes for the movement of materials and for collection vehicles.

(d) The container and the site must be constructed and laid out in accordance with Union legislation for the protection of the environment, in order to prevent odours and risks to soil and groundwater.

(e) The container must be linked to a pipe for gaseous emissions, which must be equipped with appropriate filters to prevent the transmission of diseases communicable to humans and animals.

(f) The container must be closed for the process of hydrolysis for a period of at least three months, in such a way that any unauthorised opening is prevented.

(g) The operator must put in place procedures to prevent the transmission of diseases communicable to humans or animals by movements of personnel.

(h) The operator must:

(i) The operator must keep records of:

(j) The operator must empty the container at regular intervals for a check:

(k) Following hydrolysis, the materials must be collected, used and disposed of in accordance with Article 13(a), (b), (c) or Article 13(e)(i) of Regulation (EC) No 1069/2009.

(l) The process must be carried out in a batch mode.

(m) Any other handling or use of the hydrolysed materials, including their application to land, shall be prohibited.

(a) The dry matter content of the manure must be determined by using the CEN EN 12880:2000 ( 53 ) method ‘Characterization of sludges. Determination of dry residue and water content’.

For this process, the dry matter content must be between 15 % and 70 %.

(b) The amount of lime which has to be added must be determined in such way that one of the combinations of time and temperature set out in point (f) is achieved.

(c) The particle size of the animal by-products to be processed must be no greater than 12 mm.

If necessary, the particles of the manure must be reduced in size in such a way that that maximum particle size is achieved.

(d) The manure must be mixed with quick lime (CaO) which has a medium to high reactivity of less than six minutes to achieve a 40 °C rise in temperature as per the criteria in the reactivity test 5.10 in the CEN EN 459-2:2002 method ( 54 ).

The mixing must be carried out with two mixers which are operating in line, with two screws per mixer.

Both mixers must:

The mean blending duration must be approximately two minutes.

(e) The mixture must be mixed for a period of at least six hours into a stockpile with a minimum size of two tonnes.

(f) At monitoring points which must be introduced into the stockpile, continuous measurements must be carried out to demonstrate that the mixture in the stockpile reaches a pH of at least 12 during one of the following periods of time, during which period one of the corresponding following temperatures must be achieved:

(g) The process must be carried out in a batch mode.

(h) A permanent written procedure based on the HACCP principles must be put in place.

(i) Operators may demonstrate to the competent authority, by way of a validation according to the following requirements, that a process using a mixing device which is different from the mixing device referred to in point (d) or using dolime (CaOMgO) instead of quick lime is at least as efficient as the process set out in points (a) to (h):

That validation must:

(a) For this process, the following materials may be used:

(b) The use of rendered fats derived from Category 1 material for this process shall be prohibited.

(a) The rendered fat must be submitted to a pre-treatment which consists of:

(b) The pre-treated materials must be submitted to a multi-step catalytic process which consists of a hydro-deoxygenisation step, followed by an isomerisation step.

The materials must be submitted to a pressure of at least 20 bars at a temperature of at least 250 °C for at least 20 minutes.

1. Products derived from the processing of:

2. Materials resulting from processing in accordance with:

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3. Any waste other than animal by-products and derived products provided for in point 2, resulting from the processing of animal by-products in accordance with this Section, such as sludge, filter contents, ash and digestion residues, shall be disposed of in accordance with Regulation (EC) No 1069/2009 and with this Regulation.

1. A biogas plant must be equipped with a pasteurisation/hygienisation unit, which cannot be by-passed for the animal by-products or derived products introduced with a maximum particle size of 12 mm before entering the unit, with:

2. By way of derogation from point 1, a pasteurisation /hygienisation unit shall not be mandatory for biogas plants that transform only:

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3. If the biogas plant is located on or next to premises where farmed animals are kept and the biogas plant does not only use manure, milk or colostrum which accrues from those animals, the plant shall be located at a distance from the area where such animals are kept.

That distance shall be determined in a manner which ensures that there is no unacceptable risk for the transmission of a disease communicable to humans or animals from the biogas plant.

In all cases, there must be total physical separation between that biogas plant and the animals and their feed and bedding, with fencing where necessary.

4. Each biogas plant must have its own laboratory or make use of an external laboratory. The laboratory must be equipped to carry out necessary analyses and be approved by the competent authority, be accredited according to internationally recognised standards or be subject to regular controls by the competent authority.

1. A composting plant must be equipped with a closed composting reactor or closed area, which cannot be by-passed for the animal by-products or derived products introduced into the plant, and it must be equipped with the following:

2. By way of derogation from point 1, other types of composting systems may be allowed provided they:

3. If the composting plant is located on or next to premises where farmed animals are kept and the composting plant does not only use manure, milk or colostrum which accrues from those animals, the composting plant shall be located at a distance from the area where animals are kept.

That distance shall be determined in a manner which ensures that there is no unacceptable risk for the transmission of a disease communicable to humans or animals from the composting plant.

In all cases, there must be total physical separation between that composting plant and the animals and their feed and bedding, with fencing where necessary.

4. Each composting plant must have its own laboratory or make use of an external laboratory. The laboratory must be equipped to carry out necessary analyses and be approved by the competent authority, be accredited according to internationally recognised standards or be subject to regular controls by the competent authority.

1. Animal by-products must be transformed as soon as possible after arrival at the biogas or composting plant. They must be stored properly until treated.

2. Containers, receptacles and vehicles used for transporting untreated material must be cleaned and disinfected in a designated area.

That area must be situated or designed so as to prevent risk of contamination of treated products.

3. Preventive measures against birds, rodents, insects or other vermin must be taken systematically.

A documented pest-control programme must be used for that purpose.

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

5. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented.

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

7. Digestion residues and compost must be handled and stored at the biogas or composting plant in such way as to prevent recontamination.

1. Category 3 material which is used as raw material in a biogas plant equipped with a pasteurisation/hygienisation unit must be submitted to the following minimum requirements:

However, Category 3 milk, milk-based products, milk-derived products, colostrum and colostrum products may be used without pasteurisation/hygienisation as raw material in a biogas plant, if the competent authority does not consider them to present a risk of spreading any serious transmissible disease to humans or animals.

The minimum requirements set out in points (b) and (c) of this point shall also apply to Category 2 material which is introduced into a biogas plant without prior processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009.

2. Category 3 material which is used as raw material in a composting plant must be submitted to the following minimum requirements:

The minimum requirements set out in points (b) and (c) of this point shall also apply to Category 2 material which is composted without prior processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009.

1. The competent authority may authorise the use of parameters other than the parameters set out in point 1 of Section 1 of Chapter I and other than the standard transformation parameters, provided that the applicant for such use demonstrates that such parameters ensure adequate reduction of biological risks. That demonstration shall include a validation, which shall be carried out in accordance with the following requirements:

2. By way of derogation from point 1, pending the adoption of rules as referred to in Article 15(2)(a)(ii) of Regulation (EC) No 1069/2009, the competent authority may authorise the use of specific requirements other than those laid down in this Chapter, provided that they guarantee an equivalent effect regarding the reduction of pathogens, for:

3. Where the materials referred to in point 2(b) or derived products referred to in Article 10(g) of Regulation (EC) No 1069/2009 are the only starting material of animal origin being treated in a biogas or composting plant, the competent authority may authorise the use of specific requirements other than those specified in this Chapter provided that it:

4. Operators may place on the market digestion residues and compost, which have been produced according to parameters which have been authorised by the competent authority:

Where in the case of point (a) or (b):

2. Digestion residues or compost, which do not comply with the requirements set out in this Section, shall be resubmitted to transformation or composting, and in the case of Salmonella handled or disposed of in accordance with the instructions of the competent authority.

3. When animal by-products are transformed into biogas or composted together with materials which are not of animal origin, the competent authority may authorise operators to take representative samples after the pasteurisation referred to in point 1(a) of Section 1 of Chapter I or after composting referred to in point 1 of Section 2, as applicable, and before the mixing with materials which are not of animal origin takes place, in order to monitor the efficiency of the transformation or composting of the animal by-products, as applicable.

1. Operators shall ensure that consignments of research and diagnostic samples are accompanied by a commercial document, which must specify:

2. Users that handle research and diagnostic samples shall take all necessary measures to avoid the spreading of diseases communicable to humans or animals during the handling of the materials under their control, in particular by way of the application of good laboratory practice.

3. Any subsequent use of research and diagnostic samples for purposes other than those referred to in point 38 of Annex I shall be prohibited.

4. Unless they are kept for reference purposes, research and diagnostic samples and any products derived from the use of those samples shall be disposed of:

5. Users that handle research and diagnostic samples shall keep a register of consignments of such samples.

The register shall include the information referred to in point 1 and the date and method of disposal of the samples and of any derived products.

6. By way of derogation from points 1, 4 and 5, the competent authority may accept the handling and disposal of research and diagnostic samples for educational purposes under other conditions which ensure that no unacceptable risks for public or animal health arise.

1. Trade samples and display items may only be transported, used and disposed of in accordance with points 1 to 4 and 6 of Section 1.

2. Unless trade samples are kept for reference purposes, they shall be, after the particular studies or analyses have been concluded:

3. After the exhibition or after the artistic activity has been concluded, display items shall be redispatched to the Member State of origin, dispatched or disposed of, in accordance with point 2.

1. The animal by-products shall be transported to the users or to collection centres in accordance with Sections 1 and 3 of Chapter I of Annex VIII.

2. Collection centres shall be registered by the competent authority, provided that:

3. Member States may authorise the use of a processing plant for Category 2 material as a collection centre.

4. Operators of collection centres supplying material, other than animal by-products originating from aquatic animals and from aquatic invertebrates, to final users must ensure that it undergoes one of the following treatments:

1. The competent authority may authorise the use of Category 1 material referred to in Article 18(2)(b) of Regulation (EC) No 1069/2009 for the feeding of the following endangered and protected species in feeding stations under the following conditions:

2. When a Member State applies to the Commission to be included into the list set out under point 1(a), it shall submit:

1. The competent authority must be satisfied, on the basis of an assessment of the specific situation of the species concerned and their habitat, that the conservation status of the species will be improved;

2. The competent authority must identify in the authorisation, holdings or herds within a geographically defined feeding zone under the following conditions:

(a) The competent authority must have granted an authorisation to the operator responsible for the feeding. The competent authority shall grant such authorisations provided that:

(b) The authorisation granted by the competent authority must be immediately suspended in the case of:

(c) The operator responsible for the feeding shall:

1. If the competent authority authorises the disposal of animal by-products on site in accordance with Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009, such disposal may take place:

2. The burning of animal by-products on the sites referred to in Article 19(1)(b), (c) and (e) of Regulation (EC) No 1069/2009 must be carried out in such a way to ensure that they are burnt:

3. The burial of animal by-products on the sites referred to in Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009 must be carried out to ensure that they are buried:

4. In the case of disposal in accordance with Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009, the movement of the animal by-products from the place of origin to the place of disposal must be carried out under the following conditions:

(a) 10 % of the bovine population of the Member State concerned;

(b) 25 % of the ovine and caprine population of the Member State concerned;

(c) 10 % of the porcine population of the Member State concerned; and

(d) a percentage of the population of other species which is determined by the competent authority, on the basis of an assessment of the possible risks for public and animal health which arise from the disposal of animals of those species by burning or burial on site.

(a) the materials do not exceed a volume of 20 kg per week from the establishment or plant where the materials are collected, regardless of the species of origin of the materials;

(b) the materials are collected, transported and disposed of by means which prevent the transmission of unacceptable risks to public and animal health;

(c) the competent authority carries out regular checks, including checks on the records kept by operators, in the establishments or plants where the materials are collected, to ensure compliance with the provisions of this Section.

1. Applications for authorisation of an alternative method of use or disposal of animal by-products or derived products as referred to in Article 20 of Regulation (EC) No 1069/2009 (applications) shall be submitted in one of the official languages of the European Union as referred to in Article 1 of Regulation No 1 of 1958.

2. Interested parties that submit such applications in a language other than English shall validate the official translation of their application, which EFSA shall provide, prior to the assessment.

The period referred to in Article 20(5) of Regulation (EC) No 1069/2009 shall only start once the interested party has validated the official translation of the application.

1. Applications shall contain all the necessary information to allow EFSA to assess the safety of the proposed alternative method, and in particular describe:

2. The application referred to in paragraph 1 shall moreover:

3. Validated direct measurements as referred to in paragraph 2(d) above shall mean:

4. The HACCP plan referred to in paragraph 2(b) must be based on the critical parameters which are used to obtain the risk reduction, in particular:

The critical limits retained in the HACCP plan must be defined, based on the results of the experimental validation and/ or of the model provided.

If the successful functioning of the process can only be demonstrated with reference to technical parameters which are specifically related to the equipment used in the process, the HACCP plan must also include the technical limits which must be met, in particular energy uptake, number of pump strokes or dosage of chemicals.

Information must be given on the critical and technical parameters that are to be monitored and recorded in a continuous manner or after defined intervals and on the methods used for measuring and monitoring.

The variability of parameters under typical production conditions must be taken into account.

The HACCP plan must reflect normal and abnormal/ emergency operating conditions including a breakdown of the process and it must specify possible corrective actions which are to be applied in the case of abnormal/emergency operating conditions.

5. The applications shall also contain sufficient information on:

6. Applications shall be submitted with documentary evidence, in particular:

7. Applications shall include a contact address for the interested party, which shall include the name and full address, telephone and/or fax number and/or the electronic mail address of a particular person that is responsible as or on behalf of the interested party.

1. As from the starting point in the manufacturing chain referred to in Article 4(1) of Regulation (EC) No 1069/2009, animal by-products and derived 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 derived products, other than derived products which are placed on the market in accordance with Regulation (EC) No 767/2009 and which are stored and transported in accordance with Annex II to Regulation (EC) No 183/2005, must be maintained in a clean condition.

In particular, unless they are dedicated to the carriage of particular animal by-products or derived products in a way which avoids cross-contamination, they must be:

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

However, reusable containers may be used, provided the competent authority has authorised such use:

4. Packaging material must be disposed of, by incineration or by other means in accordance with Union legislation.

1. The transport of animal by-products destined for the production of feed material or raw petfood must take place at an appropriate temperature, in the case of animal by-products from meat and meat products which have been destined for purposes other than human consumption, at a maximum of 7 °C, unless they are used for feeding purposes in accordance with Chapter I of Annex II, in order to avoid any risk to animal or public health.

2. Unprocessed Category 3 material destined for the production of feed material or petfood must be stored and transported chilled, frozen or ensiled, unless:

3. The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature throughout transport, and allow that temperature to be monitored.

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

2. During transport and storage, 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 derived 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(c).

4. 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 set out for derived products in Chapter V of this Annex.

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.

6. However:

1. During transportation, a commercial document in accordance with the model set out in this Chapter, or, when required by this Regulation, a health certificate must accompany animal by-products and derived products.

However, such document or certificate shall not be necessary, provided that:

2. 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.

Member States may require that proof of the arrival of the consignments is provided by the TRACES system or by a fourth copy of the commercial document which is sent back by the receiver to the producer.

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

4. A commercial document in accordance with the model set out under point 6 shall accompany animal by-products and derived products as from the starting point in the manufacturing chain referred to in Article 4(1) of Regulation (EC) No 1069/2009, during transportation within the Union.

However, in addition to the authorisation to transmit information by way of an alternative system as referred to in the second subparagraph of Article 21(3) of Regulation (EC) No 1069/2009, the competent authority may authorise that animal by-products and derived products which are transported on its territory are accompanied by:

5. Records and related commercial documents or health certificates shall be kept for a period of at least two years for presentation to the competent authority.

6. Model commercial document

Notes

1. The records as referred to in Article 22(1) of Regulation (EC) No 1069/2009 for animal by-products and derived products, other than compound feeds as defined in Article 3(2)(h) of Regulation (EC) No 767/2009, which have been manufactured from animal by-products or from derived products and which are placed on the market in accordance with Article 4 of Regulation (EC) No 767/2009, shall contain:

2. By way of derogation from point 1 of this Section, operators do not have to keep the information referred to in point 1(a) and points (b)(i), (c)(i) and (iii) and d(ii) and (iii) separately, if they keep a copy of the commercial document laid down in Chapter III for each consignment and make such information available in conjunction with the other information required under point 1 of this Section.

3. Operators of incineration plants and co-incineration plants shall keep records of the quantities and category of the animal by-products and derived products incinerated or co-incinerated, as applicable, and the date at which those operations were carried out.

1. in the case of final users, the quantity used, the animals that it is intended to be fed to and the date of use;

2. in the case of collection centres:

(a) the number of furs and carcases of animals fed with materials originating of their own species; and

(b) each consignment in order to ensure the traceability of the material.

1. the quantities of organic fertilisers and soil improvers applied;

2. the date on which the organic fertilisers and soil improvers were applied to land and the places of such application;

3. the dates, following the application of the organic fertiliser or soil improver, on which livestock has been allowed to graze on the land or on which the land has been cut for herbage to be used for feeding.

(a) the quantities produced each day;

(b) the species of origin, including an indication of whether the aquatic animals were caught in the wild or produced in aquaculture;

(c) in the case of fishmeal from farmed fish which is intended for feeding to farmed fish of another species, the scientific name of the species of origin.

(a) the quantities, categories and species of animal by-products burned or buried;

(b) the date and place of burning and burial.

1. In processing plants for the processing of Category 1 or Category 2 material, derived products shall be permanently marked with glyceroltriheptanoate (GTH) in such a way that:

2. The operators of processing plants referred to in point 1 shall have in place a system of monitoring and recording of parameters suitable to demonstrate to the competent authority that the required homogeneous minimum concentration of GTH is achieved.

That monitoring and recording system shall include the determination of the content of intact GTH as triglyceride in a cleaned petroleum-ether 40-70 extract of GTH from samples taken at regular intervals.

3. The marking with GTH shall not be required for:

(a) storing and treating incoming material in complete safety; and

(b) disposing of unused animal by-products remaining after the production of the products in accordance with this Regulation, or such material must be sent to an incineration plant, a co-incineration plant, a processing plant or, in the case of Category 3 material, to a biogas or composting plant in accordance with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009 and with this Regulation.

(a) sorting;

(b) cutting;

(c) chilling;

(d) freezing;

(e) salting or other preservation processes;

(f) removal of hides and skins;

(g) removal of specified risk material;

(h) operations involving the handling of animal by-products which are carried out in compliance with obligations under Union veterinary legislation, such as post-mortem examination or the taking of samples;

(i) hygienisation/pasteurisation of animal by-products destined for transformation into biogas or composting, prior to such transformation or composting in another establishment or plant in accordance with Annex V hereto;

(j) sieving.

1. Premises and facilities where intermediate operations are carried out shall meet at least the following requirements:

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

1. The sorting of animal by-products shall be carried out in such a way as to avoid any risk of the propagation of animal diseases.

2. At all times during storage, animal by-products shall be handled and stored separately from other goods and in such a way as to prevent any propagation of pathogens.

3. Animal by-products shall be stored properly, including under appropriate temperature conditions, until re-dispatched.

1. Premises and facilities storing derived products from Category 3 material must not be at the same site as premises storing derived products from Category 1 or Category 2 material, unless cross-contamination is prevented due to the layout and management of the premises, such as by means of storage in completely separate buildings.

2. The plant must:

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

4. Derived products must be stored properly until redispatched.

1. The storage of the products referred to in Part II of Section 4 of Chapter II of Annex X shall take place at an appropriate temperature to avoid any risk to public or animal health in a dedicated approved or registered storage establishment or plant or in a dedicated, separate storage area within an approved or registered storage establishment or plant.

2. Samples of the final products taken during storage or at the time of withdrawal from storage, shall at least comply with the microbiological standards set out in Chapter I of Annex X.

1. Operators of registered plants or establishments or other registered operators shall handle animal by-products and derived products under the following conditions:

2. Operators shall keep records in a form which is accessible to the competent authority.

3. Registered operators transporting animal by-products or derived products, other than between premises of the same operator, shall in particular:

Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g

1. Processed animal protein of mammalian origin must have been submitted to processing method 1 (pressure sterilisation) as set out in Chapter III of Annex IV.

However,

2. Non-mammalian processed animal protein, with the exception of fishmeal, must have been submitted to any of processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV.

3. Fishmeal must have been submitted to:

1. Processed animal protein must be packed and stored in new or sterilised bags or stored in properly constructed bulk bins or in storage sheds.

Sufficient measures must be taken to minimise condensation inside bins, conveyors or elevators.

2. Products in conveyors, elevators and bins must be protected from casual contamination.

3. Equipment for handling processed animal protein must be maintained in a clean and dry condition and must have adequate inspection points so that equipment can be examined for cleanliness.

All storage facilities must be emptied and cleaned regularly, to the extent necessary to prevent contamination.

4. Processed animal protein must be kept dry.

Leakages and condensation in the storage area must be prevented.

(a) any of the processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV; or

(b) another method which ensures that the blood product complies with the microbiological standards for derived products set out in Chapter I of this Annex.

(a) using processing methods 1 to 7, as set out in Chapter III of Annex IV; or

(b) in accordance with another method which ensures that the product complies with the microbiological standards for derived products set out in Chapter I of this Annex.

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

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

3. Whey to be fed to animals of species susceptible to foot-and-mouth disease and produced from milk treated in accordance with point 1 must:

4. In addition to the requirements set out in points 1, 2 and 3, milk, milk-based products and milk-derived products must meet the following requirements:

5. Raw milk must be produced under conditions offering adequate guarantees as regards animal health.

6. Colostrum and colostrum products must:

1. The requirements laid down in points 2 and 3 of this Part shall apply to the processing, use and storage of milk, milk-based products and milk-derived products which are Category 3 material, as referred to in Article 10(e) of Regulation (EC) No 1069/2009, other than centrifuge or separator sludge, and milk, milk-based products and milk-derived products referred to in Article 10(f) and (h) of that Regulation, that have not been processed in accordance with Part I of this Section.

2. The competent authority shall authorise milk processing establishments approved or registered in accordance with Article 4 of Regulation (EC) No 853/2004 to supply milk, milk-based products and milk-derived products for the purposes referred to in point 3 of this Part provided the establishment concerned ensures the traceability of the products.

3. Milk, milk-based products and milk-derived products may be supplied and used as feed material:

4. The competent authority may authorise the supply of colostrum which does not comply with the conditions set out in point B.6 of Part I from one farmer to another farmer within the same Member State for feeding purposes, under conditions which prevent the transmission of health risks.

1. Unless the gelatine has been produced in accordance with Section XIV of Annex III to Regulation (EC) No 853/2004, it must be produced by a process that ensures that Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses.

The pH must be adjusted subsequently. Gelatine must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation.

2. After having been subjected to the processes referred to in point 1, gelatine may undergo a drying process and, where appropriate, a process of pulverisation or lamination.

3. The use of preservatives, other than sulphur dioxide and hydrogen peroxide, shall be prohibited.

(a) a room or a dedicated place must be provided for storing materials for wrapping and packaging;

(b) wrapping and packaging must take place in a room or in a place intended for that purpose.

(a) a pH of more than 11 for more than three hours at a temperature of more than 80 °C and subsequently by heat treatment at more than 140 °C for 30 minutes at more than 3,6 bar; or

(b) a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar.

1. Dicalcium phosphate must be produced by a process that comprises the three following stages:

2. Where dicalcium phosphate is derived from defatted bones, it shall be derived from bones referred to in Article 10(a) of Regulation (EC) No 1069/2009.

(a) that all bone that is Category 3 material is finely crushed and degreased in counterflow with hot water (bone chips must be less than 14 mm);

(b) continuous cooking with steam at 145 °C during 30 minutes at 4 bars;

(c) separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation;

(d) granulation of the tricalcium phosphate after drying in a fluidised bed with air at 200 °C.

1. Unless the collagen has been produced in accordance with the requirements for collagen set out in Section XV of Annex III to Regulation (EC) No 853/2004, it 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 Union legislation shall be prohibited.

(a) a room or a dedicated place must be provided for storing materials for wrapping and packaging;

(b) wrapping and packaging must take place in a room or in a place intended for that purpose.

(a) submitted to any of the processing methods 1 to 5 or processing method 7 set out in Chapter III of Annex IV;

(b) submitted to another method and parameters which ensure that the products comply with the microbiological standards for derived products set out in Chapter I; or

(c) treated in accordance with the requirements for eggs and egg products set out in Chapters I, II and III of Section X of Annex III to Regulation (EC) No 853/2004.

(i) has undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004 or in accordance with this Regulation;

(ii) is composed of or contain one or more of the following Category 3 materials referred to in Article 10(f) of Regulation (EC) No 1069/2009:

(iii) has not been in contact with any other Category 3 materials; and

(iv) all necessary precautions have been taken to prevent the contamination of the material.

1. Animal by-products from fish or aquatic invertebrates and derived products therefrom that are intended as feed for farmed fish or for other aquaculture species shall:

2. The competent authority may lay down conditions, aimed at preventing unacceptable risks for the transmission of diseases communicable to humans or animals, for the use of aquatic animals and of aquatic and terrestrial invertebrates:

1. Trade in unprocessed manure of species other than poultry or equidae between Member States shall be subject to the following conditions, in addition to the consent of the Member State of destination referred to in Article 48(1) of Regulation (EC) No 1069/2009:

2. Trade in unprocessed poultry manure between Member States shall be subject to the following conditions, in addition to the consent of the Member State of destination referred to in Article 48(1) of Regulation (EC) No 1069/2009:

3. Model health attestation to be added to the commercial document:

4. Unprocessed manure of equidae may be traded between Member States, provided that the Member State of destination has given its consent to the trade as referred to in Article 48(1) of Regulation (EC) No 1069/2009, and provided it does 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 2009/156/EC.

5. In accordance with Article 48(1)(c)(ii) of Regulation (EC) No 1069/2009, the competent authority of the Member State of destination may require operators dispatching unprocessed manure from another Member State:

6. The competent authority may authorise the dispatch of manure transported between two points located on the same farm subject to conditions for the control of possible health risks, such as obligations for the operators concerned to keep appropriate records.

(a) They must come from a plant for derived products for uses outside the feed chain or from a biogas or a composting plant or from a plant for the manufacturing of organic fertilisers or soil improvers.

(b) They shall have been subjected to a heat treatment process of at least 70 °C for at least 60 minutes and they shall have been subjected to reduction in spore-forming bacteria and toxin formation, where they are identified as a relevant hazard.

(c) However, the competent authority may authorise the use of other standardised process parameters than those referred to in point (b), provided an applicant demonstrates that such parameters ensure minimising of biological risks.

That demonstration shall include a validation, which shall be carried out as follows:

Details on the relevant process parameters used in a plant as well as other critical control points shall be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the plant. Information relating to a process authorised under this point must be made available to the Commission on request;

(d) Representative samples of the manure taken during or immediately after processing at the plant in order to monitor the process must comply with the following standards:

where:

Processed manure or processed manure products not complying with the standards in this point shall be regarded as unprocessed;

(e) They must be stored in such a way that once processed contamination or secondary infection and dampness is minimised. They must therefore be stored in:

1. Organic fertilisers and soil improvers, other than manure, digestive tract content, compost, milk, milk-based products, milk-derived products, colostrum, colostrum products and digestion residues from the transformation of animal by-products or derived products into biogas, shall be produced by:

▼M4

▼B

2. Organic fertilisers and soil improvers which consist of or which have been produced from meat-and-bone meal derived from Category 2 material or from processed animal protein, shall be mixed, in a registered establishment or plant, with a sufficient minimum proportion of a component which is authorised by the competent authority of the Member State where the product is to be applied to land, in order to exclude the subsequent use of the mixture for feeding purposes.

3. The competent authority shall authorise the component referred to in point 2 according to the following:

The competent authority shall make the list of the authorised components available to the Commission and to other Member States upon request.

4. However, the requirements referred to in point 2 shall not apply:

5. Producers of organic fertilisers and soil improvers must ensure that decontamination of pathogens is carried out prior to their placing on the market, in accordance with:

(a) in bulk, under appropriate conditions that prevent contamination;

(b) packaged or in big bags, in the case of organic fertilisers or soil improvers destined for sale to final users; or

(c) in the case of storage on farm, in an adequate storage space to which no farmed animals have access.

1. The import and transit of intermediate products shall be authorised, provided that:

2. An establishment or plant may be registered or approved by the competent authority of a third country, as referred to in point 1(e), provided that:

3. The intermediate products imported into the Union shall be checked at the border inspection post in accordance with Article 4 of Directive 97/78/EC and transported directly from the border inspection post either to:

4. Intermediate products in transit through the Union shall be transported in accordance with Article 11 of Directive 97/78/EC.

5. The official veterinarian at the border inspection post concerned shall inform the authority in charge of the establishment or plant at the place of destination of the consignment by means of the TRACES system.

6. The operator or owner of the establishment or plant of destination or his representative shall keep records in accordance with Article 22 of Regulation (EC) No 1069/2009 and shall provide the competent authority on request with the necessary details of purchases, sales, uses, stocks and disposals of surplus of the intermediate products for the purposes of checking compliance with this Regulation.

7. The competent authority shall ensure, in accordance with Directive 97/78/EC, that the consignments of intermediate products are sent from the Member State where the inspection at the border inspection post must be carried out to the plant of destination, as referred to in point 3 or, in the case of transit, to the border inspection post of exit.

8. The competent authority shall carry out documentary checks at regular intervals for the purpose of reconciliation of the quantities of intermediate products imported on the one hand, and stocked, used, dispatched or disposed of on the other, in order to check compliance with this Regulation.

9. For consignments of intermediate products in transit, the competent authorities responsible for the border inspection posts of entry and of exit respectively shall cooperate as necessary to ensure that effective checks are carried out and to ensure the traceability of such consignments.

(a) storing and treating incoming material under conditions which prevent the introduction of risks to public and animal health;

(b) disposing of unused animal by-products and derived products remaining after production, unless the unused material is sent for processing or disposal to another establishment or plant, in accordance with this Regulation.

(a) Category 3 material, other than material referred to in Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009; and

(b) in the case of imported petfood or petfood produced from imported materials, from Category 1 material comprising of animal by-products derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC.

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

(b) Processed petfood other than canned petfood must:

After production, 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.

1. Operators may only use animal by-products which may be used as raw material for processed petfood and dogchews in accordance with point 2 of Chapter II for the production of liquid or dehydrated derived products used to enhance the palatability values of petfood.

2. Flavouring innards must have been submitted to a treatment method and parameters, which ensure that the product complies with the microbiological standards set out in point 5 of Chapter II of this Annex. After treatment, every precaution must be taken to ensure that the product is not exposed to contamination.

3. The end product must be:

1. Blood may be placed on the market for such purposes provided that it has been collected:

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

3. Blood and blood products from equidae must be packed in sealed impermeable containers which, in the case of blood from equidae, bear the approval number of the slaughterhouse or facilities of collection referred to in point 1(b).

(a) the plant has storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities;

(b) the storage rooms are kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials;

(c) if raw material not in conformity with this Chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this Chapter throughout the period of receipt, storage, processing and dispatch;

(d) in the case of trimmings and splittings derived from limed hides, the trimmings and splittings are submitted to a treatment which ensures that no risks to public and animal health remain before being used for the production of:

1. Untreated hides and skins may be placed on the market subject to the health conditions applicable to fresh meat pursuant to Directive 2002/99/EC.

2. Treated hides and skins may be placed on the market, provided that:

1. Hides and skins of ungulates which pursuant to the decision of an operator are destined for purposes other than human consumption, and which comply with the requirements of Regulation (EC) No 853/2004 for raw materials for gelatine or collagen intended for use in food may be placed on the market without restrictions in accordance with this Regulation.

2. The following treated hides and skins may be placed on the market without restrictions in accordance with this Regulation:

3. By way of derogation from point C.2, the competent authority may require that consignments of treated hides and skins referred to in point 2(c) and (d) are accompanied by a commercial document in accordance with the model set out under point 6 of Chapter III of Annex VIII, when they are supplied to establishments or plants producing petfood, organic fertilisers or soil improvers or transforming those materials into biogas.

1. Untreated wool, untreated hair, untreated pig bristles and untreated feathers, parts of feathers and down must be Category 3 materials referred to in Article 10(b) (iii), (iv) and (v) and Article 10(h) and (n) of Regulation (EC) No 1069/2009.

They must be securely enclosed in packaging and dry.

However, in the case of untreated feathers, parts of feathers and down sent directly from the slaughterhouse to the processing plant, the competent authority may allow a derogation from the requirement to dry materials transported on its territory, provided that:

2. Movements of pig bristles and wool and hair of animals of the porcine species from regions in which African swine fever is endemic shall be prohibited except for pig bristles and wool and hair of animals of the porcine species that have:

3. The provisions of point 1 shall not apply to decorative feathers or feathers:

(a) it has undergone factory-washing which consists of the immersion of the wool and hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or

(b) it is dispatched directly to a plant producing derived products from wool or hair for the textile industry and such wool or hair has undergone at least one of the following treatments:

1. not come from an area which is subject of a prohibition order associated with an occurrence of:

2. meet the requirements provided for in Article 8(a) of Directive 92/65/EEC.

1. Rendered fats derived from Category 1 material or from Category 2 material which are destined for oleochemical purposes must be produced using any of the processing methods 1 to 5 as set out in Chapter III of Annex IV.

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.

1. The following processes may be used to produce fat derivatives from rendered fats derived from Category 1 and Category 2 material:

2. Fat derivatives produced in accordance with this Chapter may only be placed on the market:

3. End point for products derived from rendered fats:

Fat derivatives which have been processed as referred to in point 1 may be placed on the market for uses indicated in point 2 without restrictions in accordance with this Regulation.

(a) they must originate from animals that:

(b) they must have undergone a heat treatment for one hour at a core temperature of at least 80 °C;

(c) the horns must be removed without opening the cranial cavity;

(d) at any stage of processing, storage or transport, every precaution shall be taken to avoid cross-contamination;

(e) 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;

(f) the packaging or containers must:

(a) they must consist of or have been produced from, as applicable, Category 3 material referred to in the column ‘raw materials’ of Table 1;

(b) they must comply with the import and transit conditions set out in the column ‘import and transit conditions’ of Table 1;

(c) they must come from a third country or part of a third country listed in the column ‘third countries’ list’ of Table 1;

(d) they must come from an establishment or plant which is registered or approved by the competent authority of the third country, as applicable, and which is on the list of such establishments and plants referred to in Article 30; and

(e) they must be:

1. Before consignments are released for free circulation within the Union, the competent authority must sample processed animal protein from imported consignments at the border inspection post to ensure compliance with the general requirements of Chapter I of Annex X.

The competent authority must:

2. By way of derogation from point 1, when six consecutive tests on bulk consignments originating in a given third country prove negative, the competent authority of the border inspection post may carry out random sampling of subsequent bulk consignments from that third country.

If one of those random samples proves positive, the competent authority carrying out the sampling must inform the competent authority of the third country of origin so that it can take appropriate measures to remedy the situation.

The competent authority of the third country of origin must bring these measures to the attention of the competent authority carrying out the sampling.

In the event of a further positive result from the same source, the competent authority of the border inspection post must sample each consignment from the same source until six consecutive tests again prove negative.

3. Competent authorities must keep a record for at least three years of the results of sampling carried out on all consignments that have undergone sampling.

4. Where a consignment imported into the Union proves to be positive for salmonella or where it does not meet the microbiological standards for enterobacteriaceae set out in Chapter I of Annex X, it must either:

(a) be entirely or partly derived from porcine raw material and come from a third country or a part of the territory of a third country free from foot-and-mouth disease for the previous 24 months and free from classical swine fever and African swine fever for the previous 12 months;

(b) be entirely or partly derived from poultry raw material and come from a third country or a part of the territory of a third country free from Newcastle disease and avian influenza for the previous six months;

(c) be entirely or partly derived from ruminant raw material and come from a third country or a part of the territory of a third country free from foot-and-mouth disease for the previous 24 months and free from rinderpest for the previous 12 months; or

(d) where there has been an outbreak of one of the diseases referred to in points (a), (b) and (c) during the relevant period referred to in those points, have been subjected to one of the following heat treatments:

Details of the critical control points shall be recorded by operators and maintained so that the owner, operator or their representative and, as necessary, the competent authority can monitor the operation of the plant; and the recorded information shall include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed rate and fat recycling rate.

A. The following requirements shall apply to the importation of milk, milk-based products, milk-derived products, colostrum and colostrum products:

B. The following requirements shall apply to the importation of colostrum and colostrum products:

(a) they must consist of or have been produced from animal by-products referred to in the column ‘raw materials’ of Table 2;

(b) they must comply with the import and transit conditions set out in the column ‘import and transit conditions’ of Table 2;

(c) they must come from a third country or part of a third country listed in the column ‘third countries’ list’ of Table 2;

(d) they must come from an establishment or plant which is registered or approved by the competent authority of the third country, as applicable, and which is on the list of such establishments and plants referred to in Article 30; and

(e) they must be: