{
  "url": "https://openlegislation.uk/eu-regulation-2019-138/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-138/introduction.json",
  "legislation": "eur/2019/138",
  "legislation_title": "Commission Implementing Regulation (EU) 2019/138 of 29 January 2019 amending Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013 as regards the name of the holder of the authorisation for feed additives (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-138",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Regulation (EU) 2019/138\nof 29 January 2019\namending Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013 as regards the name of the holder of the authorisation for feed additives\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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition and in particular Article 13(3) thereof,\nWhereas:\n(1)\nIn accordance with Council Directive 70/524/EEC monensin sodium and narasin, were authorised as feed additives by, respectively, Commission Regulations (EC) No 1356/2004 and (EC) No 1464/2004.\n(2)\nIn accordance with Regulation (EC) No 1831/2003, endo-1,4-beta-mannanase and diclazuril were authorised as feed additives by, respectively, Commission Regulations (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Commission Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013.\n(3)\nThe holder of authorisation, Eli Lilly and Company Ltd, has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation for the feed additives concerned.\n(4)\nThe holder of authorisation claims that, with effect from 30 March 2018, Elanco GmbH, a division of Eli Lilly and Company Ltd owns the marketing rights for the additives concerned. The holder of authorisation has submitted relevant data supporting its request.\n(5)\nThe proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additives concerned. The European Food Safety Authority was informed of the application.\n(6)\nTo allow Elanco GmbH to exploit its marketing rights it is necessary to change the terms of the authorisations concerned.\n(7)\nRegulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013, should, therefore, be amended accordingly.\n(8)\nSince safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to allow a transitional period during which existing stocks may be used up.\n(9)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 268, 18.10.2003, p. 29."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Council Directive of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 251, 27.7.2004, p. 6)."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "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 (OJ L 270, 18.8.2004, p. 8)."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "Commission Regulation (EC) No 786/2007 of 4 July 2007 concerning the authorisation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell) as a feed additive (OJ L 175, 5.7.2007, p. 8)."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "Commission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs (OJ L 265, 4.10.2008, p. 3)."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "Commission Regulation (EU) No 1118/2010 of 2 December 2010 concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999 (OJ L 317, 3.12.2010, p. 5)."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "Commission Regulation (EU) No 169/2011 of 23 February 2011 concerning the authorisation of diclazuril as a feed additive for guinea fowls (holder of authorisation Janssen Pharmaceutica N.V.) (OJ L 49, 24.2.2011, p. 6)."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "Commission Implementing Regulation (EU) No 888/2011 of 5 September 2011 concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V..) and amending Regulation (EC) No 2430/1999 (OJ L 229, 6.9.2011, p. 9)."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003 (OJ L 192, 13.7.2013, p. 35)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/138/introduction",
    "retrieved_at": "2026-11-01T14:43:37.183396+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."
}