{
  "url": "https://openlegislation.uk/eu-regulation-2015-174/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2015-174/annex.json",
  "legislation": "eur/2015/174",
  "legislation_title": "Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2015-174",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annex I to Regulation (EU) No 10/2011 is amended as follows:\n(1) Table 1 is amended as follows:\n(a) the entries concerning FCM substances Nos 161, 241, 344, 364, 410, 713, 784, 799, 880 and 881 are replaced by the following:\nCommission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’\n‘161\n92160\n000087-69-4\nL-(+)-tartaric acid\nyes\nno\nno\n241\n22960\n0000108-95-2\nphenol\nno\nyes\nno\n3\n344\n13810\n0000505-65-7\n1,4-butanediol formal\nno\nyes\nno\n0,05\n15\n30\n(21)\n21821\n364\n15404\n0000652-67-5\n1,4:3,6-dianhydrosorbitol\nno\nyes\nno\n5\nOnly to be used as:\n(a) a co-monomer in poly(ethylene-co-isosorbide terephthalate);\n(b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters.\nPolyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.\n410\n62720\n0001332-58-7\nkaolin\nyes\nno\nno\nParticles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.\n713\n43480\n0064365-11-3\ncharcoal, activated\nyes\nno\nno\nOnly for use in PET at maximum 10 mg/kg of polymer.\nSame purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 with exception of ash content which can be up to 10 % (w/w).\n0007440-44-0\n784\n95420\n0745070-61-5\n1,3,5-tris (2,2-di-methylpropanamido) benzene\nyes\nno\nno\n5\n799\n77708\npolyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols\nyes\nno\nno\n1,8\nIn compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.\n880\n31348\nacids, fatty (C8-C22), esters with pentaerythritol'\nyes\nno\nno\n881\n25187\n0003010-96-6\n2,2,4,4-tetramethylcyclobutane-1,3-diol\nno\nyes\nno\n5\nOnly for:\n(a) repeated use articles for long term storage at room temperature or below and hotfill;\n(b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.\n(b) the following entries are inserted in numerical order of the FCM substance numbers:\n‘\n859\n(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform\nyes\nno\nno\nOnly to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.\nWhen used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.\nThe diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.\n903\n37486-69-4\n2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]\nyes\nno\nno\nOnly to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:\n(a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times;\n(b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.\n969\n24937-78-8\nethylene-vinyl acetate copolymer wax\nyes\nno\nno\nOnly to be used as a polymeric additive up to 2 % w/w in polyolefins.\nThe migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.\n998\n(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform\nyes\nno\nno\nOnly to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.\nWhen used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.\nThe diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.\n1017\n25618-55-7\npolyglycerol\nyes\nno\nno\nTo be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.\n1043\n(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform\nyes\nno\nno\nOnly to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.\nWhen used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.\nThe diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.\n’\n(c) The entry concerning FCM substance No 725 is deleted.\n(2) In Table 2, the entries concerning group restrictions Nos 15 and 30 are replaced by the following:\n‘\n15\n98\n196\n344\n15\nexpressed as formaldehyde\n30\n254\n344\n672\n5\nexpressed as 1,4-butanediol\n’\n(3) In Table 3, the following entry is added:\n‘\n(21)\nIn case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2015/174/annex",
    "retrieved_at": "2026-11-01T14:46:54.325116+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."
}