{
  "url": "https://openlegislation.uk/eu-regulation-2013-816/annex-II",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-816/annex-II.json",
  "legislation": "eur/2013/816",
  "legislation_title": "Commission Regulation (EU) No 816/2013 of 28 August 2013 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Neutral methacrylate copolymer and Anionic methacrylate copolymer in solid food supplements and the Annex to Commission Regulation (EU) No 231/2012 as regards the specifications for Basic methacrylate copolymer (E 1205), Neutral methacrylate copolymer and Anionic methacrylate copolymer (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-816",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": null,
  "text": "The Annex to Regulation (EU) No 231/2012 is amended as follows:\n(1) The purity section of the entry for E 1205 (Basic methacrylate copolymer) is replaced by the following:\n‘\nPurity\nLoss of drying\nNot more than 2,0 % (105 °C, 3 h)\nAlkali value\n162-198 mg KOH/g of dried substance\nSulphated ash\nNot more than 0,1 %\nResidual monomers\nButylmethacrylate < 1 000 mg/kg\nMethyl methacrylate < 1 000 mg/kg\nDimethylaminoethyl methacrylate < 1 000 mg/kg\nSolvent residues\npropan-2-ol < 0,5 %\nButanol < 0,5 %\nMethanol < 0,1 %\nArsenic\nNot more than 1 mg/kg\nLead\nNot more than 3 mg/kg\nMercury\nNot more than 0,1 mg/kg\nCadmium\nNot more than 1 mg/kg\n’\n(2) The following entries for E 1206 and E 1207 are inserted after the entry for E 1205 (Basic methacrylate copolymer):\n‘ E 1206 NEUTRAL METHACRYLATE COPOLYMER\nSynonyms\nEthyl acrylate methyl methacrylate polymer; Ethyl acrylate, methyl methacrylate polymer; Ethyl acrylate, polymer with methyl methacrylate; Methyl methacrylate, ethyl acrylate polymer; Methyl methacrylate, polymer with ethyl acrylate\nDefinition\nNeutral methacrylate copolymer is a fully polymerised copolymer of methyl methacrylate and ethyl acrylate. It is produced using a process of emulsion polymerisation. It is manufactured by redox initiated polymerisation of the monomers ethyl acrylate, methyl methacrylate by using a free radical donor redox initiator system stabilised with polyethylene glycol monostearyl ether and vinylic acid/sodium hydroxide. Residual monomers are removed by means of water vapour distillation.\nCAS No\n9010-88-2\nChemical name\nPoly(ethylacrylate-co-methyl methacrylate) 2:1\nChemical formula\nPoly[(CH2:CHCO2CH2CH3)-co-(CH2:C(CH3)CO2CH3)]\nWeight average molecular weight\nApproximately 600 000 g/mol\nAssay/Residue on evaporation\n28,5–31,5 %\n1 g dispersion is dried in an oven for 3 hours at 110 °C.\nDescription\nMilky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour.\nIdentification\nInfrared absorption spectroscopy\nCharacteristic of the compound\nViscosity\nMax. 50 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)\npH-value\n5,5–8,6\nRelative density (at 20 °C)\n1,037–1,047\nSolubility\nThe dispersion is miscible with water in any proportion. The polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Not soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2.\nPurity\nSulphated ash\nNot more than 0,4 % in the dispersion\nResidual monomers\nTotal of monomers (sum of methyl methacrylate and ethyl acrylate): not more than 100 mg/kg in the dispersion\nResidual emulsifier\nPolyethylene glycol monostearyl ether (macrogol stearyl ether 20) not more than 0,7 % in the dispersion\nSolvent residues\nEthanol not more than 0,5 % in the dispersion\nMethanol not more than 0,1 % in the dispersion\nArsenic\nNot more than 0,3 mg/kg in the dispersion\nLead\nNot more than 0,9 mg/kg in the dispersion\nMercury\nNot more than 0,03 mg/kg in the dispersion\nCadmium\nNot more than 0,3 mg/kg in the dispersion\nE 1207 ANIONIC METHACRYLATE COPOLYMER\nSynonyms\nMethyl acrylate, methyl methacrylate, methacrylic acid polymer; Methacrylic acid, polymer with methyl acrylate and methyl methacrylate\nDefinition\nAnionic methacrylate copolymer is a fully polymerised copolymer of methacrylic acid, methyl methacrylate and methyl acrylate. It is manufactured in aqueous medium by emulsion polymerisation of methyl methacrylate, methyl acrylate and methacrylic acid using a free radical initiator stabilised with sodium lauryl sulphate and polyoxyethylene sorbitan monooleate (polysorbate 80). Residual monomers are removed by means of water vapour distillation.\nCAS No\n26936-24-3\nChemical name\nPoly (methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 7:3:1\nChemical formula\nPoly[(CH2:CHCO2CH3)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)COOH)]\nWeight average molecular weight\nApproximately 280 000 g/mol\nAssay/Residue on evaporation\n28,5–31,5 %\n1 g of the dispersion is dried in an oven for 5 hours at 110 °C.\n9,2–12,3 % methacrylic acid units on dry substance.\nDescription\nMilky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour.\nIdentification\nInfrared absorption spectroscopy\nCharacteristic of the compound\nViscosity\nMax. 20 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)\npH-value\n2,0–3,5\nRelative density (at 20 °C)\n1,058–1,068\nSolubility\nThe dispersion is miscible with water in any proportion. The polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2. Soluble above pH 7,0.\nPurity\nAcid value\n60–80 mg KOH/g of dried substance\nSulphated ash\nNot more than 0,2 % in the dispersion\nResidual monomers\nTotal of monomers (sum of methacrylic acid, methyl methacrylate and methyl acrylate): not more than 100 mg/kg in the dispersion\nResidual emulsifiers\nSodium lauryl sulphate not more than 0,3 % on the dry substance\nPolysorbate 80 not more than 1,2 % on the dry substance\nSolvent residues\nMethanol not more than 0,1 % in the dispersion\nArsenic\nNot more than 0,3 mg/kg in the dispersion\nLead\nNot more than 0,9 mg/kg in the dispersion\nMercury\nNot more than 0,03 mg/kg in the dispersion\nCadmium\nNot more than 0,3 mg/kg in the dispersion\n’",
  "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/2013/816/annex/II",
    "retrieved_at": "2026-11-01T14:48:26.811248+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."
}