{
  "url": "https://openlegislation.uk/eu-regulation-2009-485/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2009-485/introduction.json",
  "legislation": "eur/2009/485",
  "legislation_title": "Commission Regulation (EC) No 485/2009 of 9 June 2009 amending Annex II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards tiludronic acid and iron fumarate (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2009-485",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EC) No 485/2009\nof 9 June 2009\namending Annex II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards tiludronic acid and iron fumarate\n(Text with EEA relevance)\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Community,\nHaving regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, and in particular Article 3 thereof,\nHaving regard to the opinions of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,\nWhereas:\n(1)\nAll pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.\n(2)\nThe substance tiludronic acid in the form of disodium salt is currently included in Annex II to Regulation (EEC) No 2377/90 only for Equidae species for intravenous use.\n(3)\nThe Committee for Medicinal Products for Veterinary Use (hereinafter ‘CVMP’) has received an application for the extension of the existing entry for tiludronic acid in the form of disodium salt to include poultry. Having examined the available data on the residue studies for poultry, the CVMP concluded that there is no need to establish maximum residue limits (hereinafter ‘MRLs’) for tiludronic acid in the form of disodium salt for poultry.\n(4)\nHowever, given the fact that residue studies were conducted only after subcutaneous administration and taking into account that with 12 to 24 hours after administration residues intake from tissues, including injection site would represent 88 % of the estimated acceptable daily intake, the CVMP concluded that the extension was possible only for parenteral use and for use in laying and breeder birds. Therefore, the current entry in Annex II to Regulation (EEC) No 2377/90 for tiludronic acid in the form of disodium salt should be amended so that this substance could be used for parenteral use in poultry species (laying and breeder birds).\n(5)\nThe substance iron fumarate is currently not included in the Annexes to Regulation (EEC) No 2377/90.\n(6)\nThe CVMP has received an application to consider whether the substance iron fumarate should be covered by assessments performed for other iron salts with existing entries in Annex II to Regulation (EEC) No 2377/90, for use in all food producing species.\n(7)\nHaving examined the assessments performed and considering that fumaric acid is a permitted food additive under European Parliament and Council Directive 95/2/EC, the CVMP concluded that the assessments performed for the substances with existing entries in Annex II to Regulation (EEC) No 2377/90, should also apply to iron fumarate. The CVMP considered that no further assessment for iron fumarate is necessary and that there is no need to establish MRLs for iron fumarate. It recommended the inclusion of that substance in Annex II for all food producing species. Therefore this substance should be inserted in Annex II to Regulation (EEC) No 2377/90 for all food producing species.\n(8)\nRegulation (EEC) No 2377/90 should therefore be amended accordingly.\n(9)\nAn adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any adjustment which may be necessary in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products.\n(10)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 224, 18.8.1990, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 61, 18.3.1995, p. 1."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 311, 28.11.2001, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2009/485/introduction",
    "retrieved_at": "2026-11-01T14:51:27.818513+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."
}