{
  "url": "https://openlegislation.uk/eu-regulation-2007-1243/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2007-1243/annex.json",
  "legislation": "eur/2007/1243",
  "legislation_title": "Commission Regulation (EC) No 1243/2007 of 24 October 2007 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and the Council laying down specific hygiene rules for food of animal origin (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2007-1243",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annex III to Regulation (EC) No 853/2004 is amended as follows:\n1.. in point 3 of Section VIII, the following paragraph is added:\n‘By way of derogation from point (a), point 7 of Part A of Annex I to Regulation (EC) No 852/2004 may not apply to operators engaged in small-scale coastal fishing within the meaning of Article 26(1) of Council Regulation (EC) No 1198/2006, and carrying out their activities only for short periods of less than 24 hours.’;\n2.. in Section XIV, Chapters III, IV and V are replaced by the following:\n‘CHAPTER III:\nREQUIREMENTS FOR THE MANUFACTURE OF GELATINE\n1.\nThe production process for gelatine must ensure that:\n(a) all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined BSE risk in accordance with Community legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days. This treatment is followed either by:\nan alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a heat treatment step of 138 °C minimum during at least four seconds, or\nan acid treatment (pH < 3,5) during 10 hours minimum with a heat treatment step of 138 °C minimum during at least four seconds, or\na heat-and-pressure process for at least 20 minutes with saturated steam of 133 °C at more than 3 bars, or\nany approved equivalent process;\n(b) other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or more times in succession, followed by purification by means of filtration and heat treatment.\n2.\nA food business operator may produce and store both gelatine intended for human consumption and gelatine not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to gelatine intended for human consumption.\nCHAPTER IV:\nREQUIREMENTS FOR FINISHED PRODUCTS\nFood business operators must ensure that gelatine complies with the residue limits set out in the following table:\nResidue\nLimit\nAs\n1 ppm\nPb\n5 ppm\nCd\n0,5 ppm\nHg\n0,15 ppm\nCr\n10 ppm\nCu\n30 ppm\nZn\n50 ppm\nSO2 (European Pharmacopoeia 2005)\n50 ppm\nH2O2 (European Pharmacopoeia 2005)\n10 ppm\nCHAPTER V:\nLABELLING\nWrapping and packaging containing gelatine must bear the words “gelatine fit for human consumption” and must indicate the date of minimum durability.’;\n3.. in Section XV, Chapter III, point 3 is replaced by the following:\n‘3.\nA food business operator may produce and store both collagen intended for human consumption and collagen not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to collagen intended for human consumption.’;\n4.. the Appendix is replaced by the following:\n‘Appendix to ANNEX III\nMODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION OF GELATINE OR COLLAGEN INTENDED FOR HUMAN CONSUMPTION\nNumber of the commercial document: …\nI.\nIdentification of raw material\nNature of the raw material: …\nAnimal species: …\nType of packaging: …\nNumber of packages: …\nNet weight (kg): …\nII.\nOrigin of raw material\nType, name, address and approval/registration/special authorisation number of the establishment of origin:\n…\nName and address of the consignor: …\nIII.\nDestination of raw material\nType, name, address and approval/registration/special authorisation number of the production establishment of destination:\n…\nName and address of the consignee: …\nIV.\nMeans of transport: …\nDone at …, on …\n…\n(Signature of the operator of the establishment of origin or its representatives)",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 223, 15.8.2006, p. 1.’;"
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Only if different from the establishment of origin."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Only if different from the establishment of destination.’"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2007/1243/annex",
    "retrieved_at": "2026-11-01T14:52:38.311501+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}