{
  "url": "https://openlegislation.uk/eu-regulation-2011-363/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-363/introduction.json",
  "legislation": "eur/2011/363",
  "legislation_title": "Commission Regulation (EU) No 363/2011 of 13 April 2011 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 isoeugenol (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-363",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) No 363/2011\nof 13 April 2011\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 isoeugenol\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 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)\nAn application for the establishment of maximum residue limits (hereinafter ‘MRL’) for isoeugenol in Atlantic salmon and rainbow trout has been submitted to the European Medicines Agency.\n(4)\nThe Committee for Medicinal Products for Veterinary Use recommended establishing MRL for isoeugenol for fin fish species, applicable to muscle and skin in natural proportions.\n(5)\nTable 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include MRL for the substance isoeugenol for fin fish species.\n(6)\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(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 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/2011/363/introduction",
    "retrieved_at": "2026-11-01T14:50:12.834102+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."
}