{
  "url": "https://openlegislation.uk/eu-regulation-2012-201/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-201/introduction.json",
  "legislation": "eur/2012/201",
  "legislation_title": "Commission Implementing Regulation (EU) No 201/2012 of 8 March 2012 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 nitroxinil (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-201",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Regulation (EU) No 201/2012\nof 8 March 2012\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 nitroxinil\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 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 should be established in accordance with Regulation (EC) No 470/2009.\n(2)\nPharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.\n(3)\nNitroxinil is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and ovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.\n(4)\nIreland has submitted to the European Medicines Agency a request for an opinion for the extrapolation of the existing entry for nitroxinil applicable to bovine and ovine milk.\n(5)\nThe Committee for Medicinal Products for Veterinary Use has recommended the establishment of an MRL for nitroxinil for bovine and ovine milk and the removal of the provision ‘Not for use in animals from which milk is produced for human consumption’.\n(6)\nThe entry for nitroxinil in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the recommended MRL for bovine and ovine milk and to remove the existing provision ‘Not for use in animals from which milk is produced for human consumption’.\n(7)\nIt is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.\n(8)\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/2012/201/introduction",
    "retrieved_at": "2026-11-01T14:49:32.578410+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."
}