This Regulation lays down public health and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain.

For the purposes of this Regulation, the following definitions shall apply:

1. 1.

   ‘animal by-products’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen;

2. 2.

   ‘derived products’ means products obtained from one or more treatments, transformations or steps of processing of animal by-products;

3. 3.

   ‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004;

4. 4.

   ‘carcase’ means carcase as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004;

5. 5.

   ‘animal’ means any invertebrate or vertebrate animal;

6. 6.

   ‘farmed animal’ means:

   1. (a)

      any animal that is kept, fattened or bred by humans and used for the production of food, wool, fur, feathers, hides and skins or any other product obtained from animals or for other farming purposes;

   2. (b)

      equidae;

7. 7.

   ‘wild animal’ means any animal not kept by humans;

8. 8.

   ‘pet animal’ means any animal belonging to species normally nourished and kept but not consumed, by humans for purposes other than farming;

9. 9.

   ‘aquatic animals’ means aquatic animals as defined in Article 3(1)(e) of Directive 2006/88/EC;

10. 10.

    ‘F1competent authority’ means competent authorities as defined in point (3) of Article 3 of Regulation X1(EU) 2017/625 of the European Parliament and of the Council 40;

11. 11.

    ‘operator’ means the natural or legal persons having an animal by-product or derived product under their actual control, including carriers, traders and users;

12. 12.

    ‘user’ means the natural or legal persons using animal by-products and derived products for special feeding purposes, for research or for other specific purposes;

13. 13.

    ‘establishment’ or ‘plant’ means any place where any operation involving the handling of animal by-products or derived products is carried out, other than a fishing vessel;

14. 14.

    ‘placing on the market’ means any operation the purpose of which is to sell animal by-products or derived products to a third party in F9Great Britain or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party;

15. 15.

    ‘F1transit’ means transit as defined in Article 3(44) of Regulation X1(EU) 2017/625;

16. 16.

    ‘export’ means movement from F10Great Britain to a third country;

17. 17.

    ‘transmissible spongiform encephalopathies (TSEs)’ means all transmissible spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 999/2001;

18. 18.

    ‘specified risk material’ means specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001;

19. 19.

    ‘pressure sterilisation’ means the processing of animal by-products, after reduction in particle size to not more than 50 mm, to a core temperature of more than 133 °C for at least 20 minutes without interruption at an absolute pressure of at least 3 bar;

20. 20.

    ‘manure’ means any excrement and/or urine of farmed animals other than farmed fish, with or without litter;

21. 21.

    ‘authorised landfill’ means a landfill for which a permit has been issued in accordance with F11the Environmental Permitting (England and Wales) Regulations 2016 or the Pollution Prevention and Control (Scotland) Regulations 2012;

22. 22.

    ‘organic fertiliser’ and ‘soil improver’ means materials of animal origin used to maintain or improve plant nutrition and the physical and chemical properties and biological activities of soils, either separately or together; they may include manure, non-mineralised guano, digestive tract content, compost and digestion residues;

23. 23.

    ‘remote area’ means an area where the animal population is so small, and where disposal establishments or plants are so far away that the arrangements necessary for the collection and transport of animal by-products would be unacceptably onerous compared to local disposal;

24. 24.

    ‘food’ or ‘foodstuff’ means food or foodstuff as defined in Article 2 of Regulation (EC) No 178/2002;

25. 25.

    ‘feed’ or ‘feedingstuff’ means feed or feedingstuff as defined in Article 3(4) of Regulation (EC) No 178/2002;

26. 26.

    ‘centrifuge or separator sludge’ means material collected as a by-product after purification of raw milk and separation of skimmed milk and cream from raw milk;

27. 27.

    ‘waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC;

28. 28.

    F12‘constituent nation’ means England, Wales or Scotland;

29. 29.

    F12‘third country’ means a country or territory other than the British Islands;

30. 30.

    F12‘the Implementing Regulation’ means Commission Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive;

31. 31.

    F12‘the Official Controls Regulation’ means Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;

32. 32.

    F12‘the England Trade Regulations’ means the Trade in Animals and Related Products Regulations 2011;

33. 33.

    F12‘the Wales Trade Regulations’ means the Trade in Animals and Related Products (Wales) Regulations;

34. 34.

    F12‘the Scotland Trade Regulations’ means the Trade in Animals and Related Products (Scotland) Regulations.

Category 1 material shall comprise the following animal by-products:

1. (a)

   entire bodies and all body parts, including hides and skins, of the following animals:

   1. (i)

      animals suspected of being infected by a TSE in accordance with Regulation (EC) No 999/2001 or in which the presence of a TSE has been officially confirmed;

   2. (ii)

      animals killed in the context of TSE eradication measures;

   3. (iii)

      animals other than farmed and wild animals, including in particular pet animals, zoo animals and circus animals;

   4. (iv)

      F3animals used in a procedure or procedures defined in Article 3 of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes 41, in cases where the competent authority decides that such animals or any of their body parts have the potential to pose serious health risks to humans or to other animals, as a result of that procedure or those procedures without prejudice to Article 3(2) of Regulation (EC) No 1831/2003;

   5. (v)

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

2. (b)

   the following material:

   1. (i)

      specified risk material;

   2. (ii)

      entire bodies or parts of dead animals containing specified risk material at the time of disposal;

3. (c)

   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 F35... F36reading that Article as if for references to “Community legislation” there were substituted references to “retained EU law”;

4. (d)

   animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted level laid down by F4retained EU law or, in the absence thereof, by F37other national legislation;

5. (e)

   animal by-products collected during the treatment of waste water required by implementing rules adopted under point (c) of the first paragraph of Article 27:

   1. (i)

      from establishments or plants processing Category 1 material; or

   2. (ii)

      from other establishments or plants where specified risk material is being removed;

6. (f)

   catering waste from means of transport operating F38outside the British Islands;

7. (g)

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

Category 2 material shall comprise the following animal by-products:

1. (a)

   manure, non-mineralised guano and digestive tract content;

2. (b)

   animal by-products collected during the treatment of waste water required by implementing rules adopted under point (c) of the first paragraph of Article 27:

   1. (i)

      from establishments or plants processing Category 2 material; or

   2. (ii)

      from slaughterhouses other than those covered by Article 8(e);

3. (c)

   animal by-products containing residues of authorised substances or contaminants exceeding the permitted levels F39set by retained EU law or, in the absence thereof, by other national legislation;

4. (d)

   products of animal origin which have been declared unfit for human consumption due to the presence of foreign bodies in those products;

5. (e)

   products of animal origin, other than Category 1 material, that are:

   1. (i)

      imported or introduced from a third country and fail to comply with F40veterinary legislation forming part of retained EU law for their import or introduction into F41Great Britain except where F4retained EU law allows their import or introduction subject to specific restrictions or their return to the third country; F42...

   2. (ii)

      F43...

6. (f)

   animals and parts of animals, other than those referred to in Article 8 or Article 10,

   1. (i)

      that died other than by being slaughtered or killed for human consumption, including animals killed for disease control purposes;

   2. (ii)

      foetuses;

   3. (iii)

      oocytes, embryos and semen which are not destined for breeding purposes; and

   4. (iv)

      dead-in-shell poultry;

7. (g)

   mixtures of Category 2 material with Category 3 material;

8. (h)

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

Category 3 material shall comprise the following animal by-products:

1. (a)

   carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with F4retained EU law, but are not intended for human consumption for commercial reasons;

2. (b)

   carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human consumption in accordance with F4retained EU law:

   1. (i)

      carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with F4retained EU law, but which did not show any signs of disease communicable to humans or animals;

   2. (ii)

      heads of poultry;

   3. (iii)

      hides and skins, including trimmings and splitting thereof, horns and feet, including the phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of:

      • animals, other than ruminants requiring TSE testing, and

      • ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001;

   4. (iv)

      pig bristles;

   5. (v)

      feathers;

3. (c)

   animal by-products from poultry and lagomorphs slaughtered on the farm as referred to in Article 1(3)(d) of Regulation (EC) No 853/2004, which did not show any signs of disease communicable to humans or animals;

4. (d)

   blood of animals which did not show any signs of disease communicable through blood to humans or animals obtained from the following animals that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with F4retained EU law:

   1. (i)

      animals other than ruminants requiring TSE testing; and

   2. (ii)

      ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001;

5. (e)

   animal by-products arising from the production of products intended for human consumption, including degreased bones, greaves and centrifuge or separator sludge from milk processing;

6. (f)

   products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;

7. (g)

   petfood and feedingstuffs of animal origin, or feedingstuffs containing animal by-products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;

8. (h)

   blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show any signs of disease communicable through that product to humans or animals;

9. (i)

   aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of disease communicable to humans or animals;

10. (j)

    animal by-products from aquatic animals originating from establishments or plants manufacturing products for human consumption;

11. (k)

    the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:

    1. (i)

       shells from shellfish with soft tissue or flesh;

    2. (ii)

       the following originating from terrestrial animals:

       • hatchery by-products,

       • eggs,

       • egg by-products, including egg shells,

    3. (iii)

       day-old chicks killed for commercial reasons;

12. (l)

    aquatic and terrestrial invertebrates other than species pathogenic to humans or animals;

13. (m)

    animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g);

14. (n)

    hides and skins, hooves, feathers, wool, horns, hair and fur originating from dead animals that did not show any signs of disease communicable through that product to humans or animals, other than those referred to in point (b) of this Article;

15. (o)

    adipose tissue from animals which did not show any signs of disease communicable through that material to humans or animals, which were slaughtered in a slaughterhouse and which were considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with F4retained EU law;

16. (p)

    catering waste other than as referred to in Article 8(f).