{
  "url": "https://openlegislation.uk/eu-regulation-2004-1464/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2004-1464/introduction.json",
  "legislation": "eur/2004/1464",
  "legislation_title": "Commission Regulation (EC) No 1464/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive ‘Monteban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2004-1464",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EC) No 1464/2004\nof 17 August 2004\nconcerning the authorisation for 10 years of the additive ‘Monteban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances\n(Text with EEA relevance)\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Community,\nHaving regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, and in particular Article 9g(5)(b) thereof,\nWhereas:\n(1)\nIn accordance with Directive 70/524/EEC, coccidiostats included in Annex I to that Directive before 1 January 1988 were provisionally authorised as from 1 April 1998 and transferred to Chapter I of Annex B with a view to their re-evaluation as additives linked to a person responsible for putting them into circulation. The narasin product, Monteban, is an additive belonging to the group ‘Coccidiostats and other medicinal substances’ listed in Chapter I of Annex B to Directive 70/524/EEC.\n(2)\nThe person responsible for putting into circulation Monteban submitted an application for authorisation and a dossier, according to Article 9g(2) and (4) of that Directive.\n(3)\nArticle 9g(6) of Directive 70/524/EEC allows the automatic extension of the period of authorisation of the additives concerned until the Commission takes a decision in cases where, for reasons beyond the control of the authorisation holder, no decision may be taken on the application before the expiry date of the authorisation. This provision is applicable to the authorisation of Monteban. The Commission requested a full risk evaluation from the Scientific Committee for Animal Nutrition on 26 April 2001 and this request was consequently transferred to the European Food Safety Authority. Several requests for additional information were made during the re-evaluation process, making it impossible to complete the re-evaluation within the time limits required by Article 9g.\n(4)\nThe Scientific Panel on Additives and Products or Substances used in Animal Feed attached to the European Food Safety Authority has delivered a favourable opinion with regard to the safety and to the efficacy of Monteban for chickens for fattening.\n(5)\nThe re-evaluation of Monteban carried out by the Commission showed that the relevant conditions laid down in Directive 70/524/EEC are satisfied. Monteban should therefore be authorised for 10 years as an additive linked to the person responsible for putting it into circulation and included in Chapter I of the list referred to Article 9t(b) of that Directive.\n(6)\nAs the authorisation for the additive is now linked to a person responsible for putting it into circulation, and replaces the previous authorisation which was not linked to any specific person, it is appropriate to delete the latter authorisation.\n(7)\nSince there are no safety reasons for withdrawing the product narasin from the market immediately, it is appropriate to allow a transitional period of six months for the disposal of existing stocks of the additive.\n(8)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1289/2004 (OJ L 243, 15.7.2004, p. 15)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2004/1464/introduction",
    "retrieved_at": "2026-11-01T14:55:20.423281+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."
}