{
  "url": "https://openlegislation.uk/eu-regulation-2014-20/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-20/introduction.json",
  "legislation": "eur/2014/20",
  "legislation_title": "Commission Implementing Regulation (EU) No 20/2014 of 10 January 2014 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance butafosfan (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2014-20",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Regulation (EU) No 20/2014\nof 10 January 2014\namending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance butafosfan\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council, and in particular Article 14 in conjunction with Article 17 thereof,\nHaving regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,\nWhereas:\n(1)\nThe maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry are established in accordance with Regulation (EC) No 470/2009.\n(2)\nPharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010.\n(3)\nButafosfan is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for bovine species, while establishing the absence of the need to establish an MRL.\n(4)\nAn application for the extension of the existing entry for butafosfan applicable to porcine species has been submitted to the European Medicines Agency.\n(5)\nThe Committee for Medicinal Products for Veterinary Use recommended that there is no need to establish an MRL for butafosfan for porcine species.\n(6)\nAccording to Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for another species.\n(7)\nThe CVMP recommended the extrapolation of the evaluation results of butafosfan from bovine and porcine species to all mammalian food-producing species.\n(8)\nThe entry for butafosfan in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the substance butafosfan for all mammalian food-producing species, while establishing the absence of the need to establish an MRL.\n(9)\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 152, 16.6.2009, p. 11."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 15, 20.1.2010, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2014/20/introduction",
    "retrieved_at": "2026-11-01T14:48:00.161249+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."
}