Sanitary requirements for export of gelatine and collagen not intended for human consumption to be used as feed material or for purposes outside the feed chain, intended for dispatch to or for transit through the European Union Chapter 11
HA 2380 (Amended October 21, 2013)

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II. Health Information

II.1. consists of gelatine/collagen that satisfy the health requirements below;

II.2. consist exclusively of gelatine/collagen not intended for human consumption;

II.3. has been prepared and stored in a plant approved, validated and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009, in order to kill pathogenic agents;

II.4. has been prepared exclusively with the following animal by-products:

  • either [- 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 Union legislation, but are not intended for human consumption for commercial reasons;]
  • and/or [- 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 Union legislation:
    • (i) carcases or bodies and parts of animals which are rejected as unfit for human consumption in accordance with Union legislation, but which did not show any signs of disease communicable to humans or animals;
    • (ii) heads of poultry;
    • (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;
    • (iv) pig bristles;
    • (v) feathers;]
  • and/or [- animal by-products arising from the production of products intended for human consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing;]
  • and/or [- 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 arises;]
  • and/or [- 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;]
  • and/or [- aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases communicable to humans or animals;]
  • and/or [- animal by-products from aquatic animals originating from plants or establishments manufacturing products for human consumption;]

II.5. the gelatine/collagen:

  • (a) was wrapped, packaged, stored and transported under satisfactory hygiene conditions, and in particular wrapping and packaging took place in a dedicated room, and only preservatives permitted under Union legislation were used. Wrappings and packages containing gelatine/collagen carry the words "GELATINE/COLLAGEN SUITABLE FOR ANIMAL CONSUMPTION"; and
  • either [(b) in the case of gelatine, has been produced by a process that is ensuring that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses, involving pH adjustment, extraction by heating one or several times in succession, followed by purification by means of filtration and sterilisation, in order to kill pathogenic agents;]
  • or [(b) in the case of collagen, has been produced by a process that 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, in order to kill pathogenic agents;]

II.6. in the case of gelatine/collagen from materials other than hides and skins:

  • either [the product does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council or mechanically separated meat obtained from bones of bovine, ovine or caprine animals; and the animals from which this product is derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;]
  • or [the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001;]

II.7. in the case of gelatine/collagen from materials other than hides and skins:
in addition as regards TSE:

  • either [in case of animal by-products intended for feeding ruminants and containing milk or milk products of ovine or caprine origin, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last three years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last three years:
    • (i) it has been subject to regular official veterinary checks;
    • (ii) no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No 999/2001, has been diagnosed or, following the confirmation of a classical scrapie case:
      • all animals in which classical scrapie was confirmed have been killed and destroyed, and
      • all goats and sheep on the holding have been killed and destroyed, except for breeding rams of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele,
    • (iii) ovine and caprine animals, with the exception of sheep of the ARR/ARR prion genotype, are introduced into the holding only if they come from a holding which complies with the requirements set out in points (i) and (ii).]
  • or [in case of animal by-products intended for feeding ruminants and containing milk or milk products of ovine or caprine origin, and destined to a Member State listed in the Annex to Commission Regulation (EC) No 546/2006, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last seven years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last seven years:
    • (i) it has been subject to regular official veterinary checks;
    • (ii) no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No 999/2001, has been diagnosed or, following the confirmation of a classical scrapie case:
      • all animals in which classical scrapie was confirmed have been killed and destroyed, and
      • all goats and sheep on the holding have been killed and destroyed, except for breeding rams of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele;
    • (iii) ovine and caprine animals, with the exception of sheep of the ARR/ARR prion genotype, are introduced into the holding only if they come from a holding which complies with the requirements set out in points (i) and (ii).]
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