Commission Regulation (EU) No 142/2011Dangos y teitl llawn

ANNEX I U.K. DEFINITIONS AS REFERRED TO IN ARTICLE 2

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

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.

‘[F1 fishmeal’ means processed animal protein derived from aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Council Directive 2006/88/EC (1) , and starfish of the species Asterias rubens which are harvested in a mollusc production area;]

8.

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

(a)

animal by-products; or

(b)

products for human consumption, which an operator has destined for purposes other than human consumption;

9.

‘[F1 fish oil’ means oil derived from the processing of aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Directive 2006/88/EC, and starfish of the species Asterias rubens which are harvested in a mollusc production area, 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.

‘[F2 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:

(a)

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

(b)

may contain imported 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 [F3 , reading that Article as if for references to “Community legislation” there were substituted references to “retained EU law];]

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.

‘[F2 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:

(a)

dried;

(b)

dry-salted or wet-salted for a period of at least 14 days prior to dispatch;

(c)

salted for a period of at least seven days in sea salt with the addition of 2 % of sodium carbonate;

(d)

dried for a period of at least 42 days at a temperature of at least 20 °C; or

(e)

subject to a preservation process other than tanning;

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:

(a)

with a steam current; or

(b)

by another method that ensures that no unacceptable risks remain;

31.

‘[F4 untreated wool’ means wool, other than wool which has:

(a)

undergone factory washing;

(b)

been obtained from tanning;

(c)

been treated by another method that ensures that no unacceptable risks remain;

(d)

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

(e)

been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from wool for the textile industry and has undergone at least one of the following treatments:

(i)

chemical depilation by means of slaked lime or sodium sulphide;

(ii)

fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;

(iii)

industrial scouring which consists of the immersion of wool in a water-soluble detergent held at 60–70 °C;

(iv)

storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

32.

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

(a)

undergone factory washing;

(b)

been obtained from tanning;

(c)

been treated by another method that ensures that no unacceptable risks remain;

(d)

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

(e)

been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from hair for the textile industry and has undergone at least one of the following treatments:

(i)

chemical depilation by means of slaked lime or sodium sulphide;

(ii)

fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;

(iii)

industrial scouring which consists of the immersion of hair in a water-soluble detergent held at 60–70 °C;

(iv)

storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;]

33.

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

(a)

undergone factory washing;

(b)

been obtained from tanning; or

(c)

been treated by another method that ensures that no unacceptable risks remain;

34.

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

35.

‘[F5 intermediate product’ means a derived product:

(a)

which is intended for uses within the manufacturing of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products as follows:

(i)

as material in a manufacturing process or in the final production of a finished product;

(ii)

in validation or verification during a manufacturing process; or

(iii)

in quality control of a finished product;

(b)

whose design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as a derived product and to qualify the material directly or as a component of a product for the purposes referred to in point (a);

(c)

which however requires some further manufacturing or transformation, such as mixing, coating, assembling or packaging to make it suitable for placing on the market or putting into service, as applicable, a medicinal product, veterinary medicinal product, medical device for medical and veterinary purposes, active implantable medical device, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagent or cosmetic products;]

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.

‘[F5 trade samples’ means animal by-products or derived products intended for particular studies or analyses authorised by the competent authority in accordance with Article 17(1) of Regulation (EC) No 1069/2009 with a view to carrying out a production process, including the processing of animal by-products or derived products, the development of feedingstuff, pet food or derived products, or the testing of machinery or equipment;]

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 [F6 a waste incineration plant, as defined in Articles 3(40) and 42(1) of Directive 2010/75/EC];

43.

‘incineration and co-incineration residues’ means any residues as defined in [F7 Article 43 of Directive 2010/75/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 F8 ... 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.

F9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 [F10 as defined in Article 3(41) and Article 42(1) of Directive 2010/75/EC];

56.

‘incineration plant’ means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of waste [F11 as defined in Article 3(40) and Article 42(1) of Directive 2010/75/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.

‘[F5 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;]

59.

‘[F12 growing media’ means materials, including potting soil, other than soil in situ , in which plants or mushrooms are grown and which is used independently from soil in situ ;]

60.

‘[F13 process hygiene criterion’ means a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with general requirements for the safety of feed];

61.

[F14 ‘the appropriate authority’ means:

(a)

in relation to England, the Secretary of State;

(b)

in relation to Wales, the Welsh Ministers;

(c)

in relation to Scotland, the Scottish Ministers.

But the appropriate authority is the Secretary of State if consent is given by:

(a)

in relation to Wales, the Welsh Ministers;

(b)

in relation to Scotland, the Scottish Ministers;

62.

‘constituent nation’ means England, Wales or Scotland;

63.

‘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.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2017/786 of 8 May 2017 amending Regulation (EU) No 142/2011 as regards the definitions of fishmeal and fish oil (Text with EEA relevance).

F2 Substituted by Commission Regulation (EU) No 294/2013 of 14 March 2013 amending and correcting 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 (Text with EEA relevance).

F3 Words in Annex 1 point 19(b) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(a)

F4 Substituted by Commission Regulation (EU) No 1063/2012 of 13 November 2012 amending 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 (Text with EEA relevance).

F5 Substituted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending 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 (Text with EEA relevance).

F6 Words in Annex 1 point 42 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(b)

F7 Words in Annex 1 point 43 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(c)

F8 Words in Annex 1 point 44 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(d)

F9 Annex 1 point 48 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(e)

F10 Words in Annex 1 point 55 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(f)

F11 Words in Annex 1 point 56 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(g)

F12 Substituted by Commission Regulation (EU) 2020/762 of 9 June 2020 amending Regulation (EU) No 142/2011 as regards microbiological standards for raw petfood, requirements concerning approved establishments, technical parameters applicable to the alternative method Brookes’ gasification process and hydrolysis of rendered fats, and exports of processed manure, certain blood, blood products and intermediate products (Text with EEA relevance).

F13 Inserted by Commission Regulation (EU) 2020/762 of 9 June 2020 amending Regulation (EU) No 142/2011 as regards microbiological standards for raw petfood, requirements concerning approved establishments, technical parameters applicable to the alternative method Brookes’ gasification process and hydrolysis of rendered fats, and exports of processed manure, certain blood, blood products and intermediate products (Text with EEA relevance).

F14 Annex 1 points 61-63 inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(35)(h)

(1)

[F1 Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals ( OJ L 328, 24.11.2006, p. 14 ).]

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2017/786 of 8 May 2017 amending Regulation (EU) No 142/2011 as regards the definitions of fishmeal and fish oil (Text with EEA relevance).