{
  "url": "https://openlegislation.uk/eu-regulation-2011-1282/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-1282/annex.json",
  "legislation": "eur/2011/1282",
  "legislation_title": "Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission 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-2011-1282",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annex I to Regulation (EU) No 10/2011 is amended as follows:\n(1) in Table 1 the following lines are inserted in numerical order of the FCM substance numbers:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n855\n40560\n(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate\nyes\nno\nno\nOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.\n856\n40563\n(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate\nyes\nno\nno\nOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.\n857\n66765\n0037953-21-2\n(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer\nyes\nno\nno\nOnly to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.\n863\n15260\n0000646-25-3\n1,10-decanediamine\nno\nyes\nno\n0,05\nOnly to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.\n873\n93460\ntitanium dioxide reacted with octyltriethoxysilane\nyes\nno\nno\nReaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.\n894\n93360\n0016545-54-3\nthiodipropionic acid, ditetradecyl ester\nyes\nno\nno\n(14)\n895\n47060\n0171090-93-0\n3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols\nyes\nno\nno\n0,05\nOnly to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products.\n896\n71958\n0958445-44-8\n3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt\nyes\nno\nno\nOnly to be used in the polymerisation of fluoropolymers when:\nprocessed at temperatures higher than 280 °C for at least 10 minutes,\nprocessed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.\n923\n39150\n0000120-40-1\nN,N-bis(2-hydroxyethyl)dodecanamide\nyes\nno\nno\n5\nThe residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, should not result in a migration of diethanolamine higher than 0,3 mg/kg food.\n(18)\n924\n94987\ntrimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids\nyes\nno\nno\n0,05\nOnly for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products.\n926\n71955\n0908020-52-0\nperfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt\nyes\nno\nno\nOnly to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.\n971\n25885\n0002459-10-1\ntrimethyl trimellitate\nno\nyes\nno\nOnly to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.\n(17)\n972\n45197\n0012158-74-6\ncopper hydroxide phosphate\nyes\nno\nno\n973\n22931\n0019430-93-4\n(perfluorobutyl)ethylene\nno\nyes\nno\nOnly to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.\n974\n74050\n939402-02-5\nphosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters\nyes\nno\nyes\n5\nSML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis product 4-t-amylphenol.\nThe migration of the hydrolysis product 2,4-di-t-amylphenol should not exceed 0,05 mg/kg.\n(2) in Table 1 for the following substance, the content of the columns (2), (5), (6) and (10) is replaced by the following:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n438\n13303\n0002162-74-5\nbis(2,6-diisopropylphenyl) carbodiimide\nno\nyes\nno\n0,05\nExpressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline\n(3) in Table 1 for the following substance, the content of the column (3) is replaced by the following:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n797\n76807\n0073018-26-5\npolyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol\nyes\nno\nyes\n(31)\n(32)\n(4) in Table 1 for the following substances, the content of the column (8) is replaced by the following:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n239\n19975\n0000108-78-1\n2,4,6-triamino-1,3,5-triazine\nyes\nyes\nno\n2,5\n25420\n93720\n376\n66905\n0000872-50-4\nN-methylpyrrolidone\nyes\nno\nno\n60\n(5) in Table 1 for the following substance, the content of the columns (8) and (10) is replaced by the following:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n452\n38885\n0002725-22-6\n2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine\nyes\nno\nno\n5\n(6) in Table 1 for the following substances, the content of the column (10) is replaced by the following:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n794\n18117\n0000079-14-1\nglycolic acid\nno\nyes\nno\nOnly to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.\n812\n80350\n0124578-12-7\npoly(12-hydroxystearic acid)-polyethyleneimine copolymer\nyes\nno\nno\nOnly to be used in plastics up to 0,1 % w/w.\nPrepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.\n(7) in Table 1 for the following substance, the content of the columns (10) and (11) is replaced by the following:\nFCM substance No\nRef. No\nCAS No\nSubstance name\nUse as additive or polymer production aid(yes/no)\nUse as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)\nFRF applicable(yes/no)\nSML[mg/kg]\nSML(T)[mg/kg](Group restriction No)\nRestrictions and specifications\nNotes on verification of compliance\n(1)\n(2)\n(3)\n(4)\n(5)\n(6)\n(7)\n(8)\n(9)\n(10)\n(11)\n862\n15180\n0018085-02-4\n3,4-diacetoxy-1-butene\nno\nyes\nno\n0,05\nSML including the hydrolysis product 3,4-dihydroxy-1-butene\nOnly to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.\n(17)\n(19)\n(8) in Table 2 for the following group restriction, the content of the columns (2) and (4) is replaced by the following:\nGroup restriction No\nFCM substance No\nSML (T)[mg/kg]\nGroup restriction specification\n(1)\n(2)\n(3)\n(4)\n14\n294\n5\nExpressed as the sum of the substances and their oxidation products\n368\n894\n(9) in Table 3 the following notes on verification of compliance are inserted in numerical order:\nNote No\nNotes on verification of compliance\n(1)\n(2)\n(18)\nThere is a risk that the SML could be exceeded from low-density polyethylene (LDPE)\n(19)\nThere is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/1282/annex",
    "retrieved_at": "2026-11-01T14:49:42.404517+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."
}