{
  "url": "https://openlegislation.uk/eu-regulation-2009-478/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2009-478/introduction.json",
  "legislation": "eur/2009/478",
  "legislation_title": "Commission Regulation (EC) No 478/2009 of 8 June 2009 amending Annexes I and III 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 monepantel (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2009-478",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EC) No 478/2009\nof 8 June 2009\namending Annexes I and III 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 monepantel\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 2 and the third paragraph of Article 4 thereof,\nHaving regard to the opinion 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)\nAn application for establishing maximum residue limits for monepantel, an agent acting against endoparasites, has been submitted to the European Medicines Agency. On the basis of the recommendation of the Committee for Medicinal Products for Veterinary Use, this substance should be added to Annex I to Regulation (EEC) No 2377/90 for ovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.\n(3)\nThe same substance should be added in Annex III to Regulation (EEC) No 2377/90 for caprine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption. The provisional maximum residue limits set out in this Annex for this substance should expire on 1 January 2011.\n(4)\nFor reasons of clarity, it is appropriate to add a new subdivision entitled ‘Others’ to Annexes I and III, as monepantel is a new class of compound which does not fit into the existing subdivisions. Within the subcategory of ‘Agents acting against endoparasites’ the existing subdivisions are based on the chemistry of the compounds and a number of these chemical subdivisions include only single substances. It is preferable to create an ‘Others’ subdivision rather than to go on creating new chemical subdivisions for each new substance class as that would lead to an expanding number of subdivisions containing single substances. For monepantel it is not clear which part of the molecule is key for the pharmacological effect and consequently it is not clear what the appropriate name for a new chemical subdivision for monepantel would be.\n(5)\nRegulation (EEC) No 2377/90 should therefore be amended accordingly.\n(6)\nAn adequate period should be allowed before the amendments contained in this Regulation become applicable, in order to enable Member States to make any adjustment which may be necessary in the light of this Regulation with respect 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 to take account of the provisions of this Regulation.\n(7)\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 311, 28.11.2001, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2009/478/introduction",
    "retrieved_at": "2026-11-01T14:51:28.005771+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."
}