{
  "url": "https://openlegislation.uk/eu-regulation-2010-759/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2010-759/introduction.json",
  "legislation": "eur/2010/759",
  "legislation_title": "Commission Regulation (EU) No 759/2010 of 24 August 2010 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 tildipirosin (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2010-759",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) No 759/2010\nof 24 August 2010\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 tildipirosin\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 for pharmacologically active substances intended for use in the European 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)\nAn application for the establishment of maximum residue limits (hereinafter ‘MRL’) for tildipirosin in bovine and porcine species has been submitted to the European Medicines Agency.\n(4)\nThe Committee for Medicinal Products for Veterinary Use (hereinafter ‘CVMP’) recommended establishing a provisional MRL for tildipirosin for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption. The provisional MRL set out for muscle should not apply to the injection site, where residue levels should not exceed 11 500 μg/kg.\n(5)\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. The CVMP recommended to extrapolate the provisional MRLs for tildipirosin from bovine to caprine species.\n(6)\nThe CVMP recommended establishing provisional MRLs for tildipirosin for porcine species, applicable to muscle, skin, fat, liver and kidney. The provisional MRL set out for muscle should not apply to the injection site, where residue levels should not exceed 7 500 μg/kg.\n(7)\nTable 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the substance tildipirosin for bovine, caprine and porcine species. The provisional MRLs set out in that table for tildipirosin for bovine, caprine and porcine species should expire on 1 January 2012.\n(8)\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(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/2010/759/introduction",
    "retrieved_at": "2026-11-01T14:50:40.171564+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."
}