Sanitary Requirements for Export of Gelatin Intended for Human Consumption from Canada to European Union
HA2816 (Amended 2017-07-01)

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  • it comes from (an) establishment(s) implementing a programme based on the Hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004;
  • it has been produced from raw materials that met the requirements of Chapters I and II of Section XIV of Annex III to Regulation (EC) No 853/2004;
  • it has been manufactured in compliance with the conditions set out in Chapter III of Section XIV of Annex III to Regulation (EC) No 853/2004;
  • it satisfies the criteria of Chapter IV of Section XIV of Annex III to Regulation (EC) No 853/2004 and of Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1);

and, if of bovine, ovine and caprine animal origin,
it has been derived from animals which have passed ante mortem and post mortem inspections,
and, except for gelatine derived from hides and skins,

either

  • [it comes from a country or a region classified in accordance with Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a country or region posing a negligible BSE risk;
  • the gelatine does not contain and is not derived from specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1);
  • the gelatine does not contain and is not derived from mechanically separated meat obtained from bones of bovine, ovine or caprine animals, except for gelatine derived from animals that were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk in which there has been no BSE indigenous cases;
  • the animals, from which the gelatine is derived were not slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, except if the animals were born, continuously reared and slaughtered in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a negligible BSE risk;
  • [the animals, from which the gelatine is derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk, and the animals were not fed with meat-and-bone meal or greaves, as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health];
  • [the animals, from which the gelatine is derived, originate from a country or region classified in accordance with Decision 2007/453/EC as a country or region posing an undetermined BSE risk, and the gelatine was produced and handled in a manner which ensures that it did not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process.]]

or

  • [it comes from a country or a region classified in accordance with Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a country or region posing a controlled BSE risk;
  • the animals, from which the gelatine is derived, were not killed after stunning by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity;
  • the gelatine does not contain and is not derived from specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

or

  • [it comes from a country or a region classified in accordance with Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a country or region posing a negligible BSE risk;
  • the gelatine is derived both from animals born, continuously reared and slaughtered in a country or region with negligible BSE risk in accordance with Decision 2007/453/EC, and from animals born in a country or region classified in accordance with Decision 2007/453/EC as a country or region posing a controlled BSE risk, and which were not killed after stunning by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity;
  • the gelatine does not contain and is not derived from specified risk material as defined in point 1 of Annex V to Regulation (EC) No  999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

or

  • [it comes from a country or a region classified in accordance with Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a country or region with an undetermined BSE risk;
  • the animals, from which the gelatine is derived, were not fed meat-and-bone meal or greaves derived from ruminants, as defined in the Terrestrial Animal health Code of the World Organisation for Animal Health;
  • the animals, from which the gelatine is derived, were not killed after stunning by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity;
  • the gelatine is not derived from:
    1. specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001;
    2. nervous and lymphatic tissues exposed during the deboning process;
    3. mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]
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