Sanitary requirements for export of fat derivatives not intended for human consumption to be used outside the feed chain, intended for dispatch to or for transit through the European Union Chapter 14 (A)
HA 2315 (Amended October 21, 2013)

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II. Health Information

II.1. consist of fat derivatives that satisfy the health requirements below;

II.2. consist of fat derivatives intended for purposes outside the feed chain, other than in cosmetics, pharmaceuticals and medical devices;

II.3. have 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. have been prepared from rendered fats exclusively produced from the following materials:

II.4.1. in case the fat derivatives are intended for uses outside the feed chain, other than in organic fertilisers, soil improvers, cosmetics, pharmaceuticals and medical devices, the following Category 1 materials:

  • either [- the following material:
    • (i) specified risk material;
    • (ii) entire bodies or parts of dead animals containing specified risk material at the time of disposal;]
  • and/or [- animal by-products which have been 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;]
  • and/or [- 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 levels laid down by Union legislation or, in the absence thereof, by legislation of the Member State of importation;]

II.4.2. in case the fat derivatives are intended for use in organic fertilisers or soil improvers or other uses outside the feed chain, other than in cosmetics, pharmaceuticals and medical devices, the following Category 2 materials:

  • either [- animal by-products containing residues of authorised substances or contaminants exceeding the permitted levels referred to in Article 15(3) of Directive 96/23/EC;]
  • and/or [- products of animal origin which have been declared unfit for human consumption due to the presence of foreign bodies in those products;]
  • and/or [- animals and parts of animals, other than those referred to in Articles 8 and 10 of Regulation (EC) No 1069/2009, that died other than being slaughtered or killed for human consumption, including animals killed for disease control purposes;]

II.4.3. the following Category 3 materials:

  • 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;
    • (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 [- blood of animals which did not show any signs of disease communicable through blood to humans or animals, obtained from 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 Union legislation;]
  • 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 [- blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not show signs of any disease communicable through that product to humans or animals;]
  • 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;]
  • and/or [- the following material originating from animals which did not show any signs of disease communicable through that material to humans or animals:
    • (i) shells from shellfish with soft tissue or flesh;
    • (ii) the following originating from terrestrial animals:
      • hatchery by-products,
      • eggs,
      • egg by-products, including egg shells;
    • (iii) day-old chicks killed for commercial reasons;]

II.5. in case of fat derivatives produced from animal by-products referred to in point II.4.1 and point II.4.2:

  • (a) have been produced using the following methods:
    • either [transesterification or hydrolysis at least 200 °C, under corresponding appropriate pressure, for 20 minutes (glycerol, fatty acids and esters)]
    • or [saponification with NaOH 12M (glycerol and soap):
      • either [in a batch process at 95 °C for three hours;]
      • or [in a continuous process at 140 °C, 2 bars (2000 hPa) for eight minutes;]]
    • or [hydrogenation at 160 °C at 12 bars (12000 hPa) pressure for 20 minutes;]
  • (b) are packaged in new containers or in containers that have been cleaned, and all precautions are taken to prevent its contamination which bear labels indicating "NOT FOR HUMAN OR ANIMAL CONSUMPTION";

II.6. in case of fat derivatives produced from animal by-products referred to in point II.4.3, the fat derivatives have been produced in accordance with one of the processing methods [1]-[2]-[3]-[4]-[5]-[6]-[7](2) referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011.

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