# 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), Annex II Extent: E+W+S+N.I. The Annex to Regulation (EU) No 231/2012 is amended as follows: (1) The purity section of the entry for E 1205 (Basic methacrylate copolymer) is replaced by the following: ‘ Purity Loss of drying Not more than 2,0 % (105 °C, 3 h) Alkali value 162-198 mg KOH/g of dried substance Sulphated ash Not more than 0,1 % Residual monomers Butylmethacrylate < 1 000 mg/kg Methyl methacrylate < 1 000 mg/kg Dimethylaminoethyl methacrylate < 1 000 mg/kg Solvent residues propan-2-ol < 0,5 % Butanol < 0,5 % Methanol < 0,1 % Arsenic Not more than 1 mg/kg Lead Not more than 3 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 1 mg/kg ’ (2) The following entries for E 1206 and E 1207 are inserted after the entry for E 1205 (Basic methacrylate copolymer): ‘ E 1206 NEUTRAL METHACRYLATE COPOLYMER Synonyms Ethyl 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 Definition Neutral 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. CAS No 9010-88-2 Chemical name Poly(ethylacrylate-co-methyl methacrylate) 2:1 Chemical formula Poly[(CH2:CHCO2CH2CH3)-co-(CH2:C(CH3)CO2CH3)] Weight average molecular weight Approximately 600 000 g/mol Assay/Residue on evaporation 28,5–31,5 % 1 g dispersion is dried in an oven for 3 hours at 110 °C. Description Milky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour. Identification Infrared absorption spectroscopy Characteristic of the compound Viscosity Max. 50 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry) pH-value 5,5–8,6 Relative density (at 20 °C) 1,037–1,047 Solubility The 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. Purity Sulphated ash Not more than 0,4 % in the dispersion Residual monomers Total of monomers (sum of methyl methacrylate and ethyl acrylate): not more than 100 mg/kg in the dispersion Residual emulsifier Polyethylene glycol monostearyl ether (macrogol stearyl ether 20) not more than 0,7 % in the dispersion Solvent residues Ethanol not more than 0,5 % in the dispersion Methanol not more than 0,1 % in the dispersion Arsenic Not more than 0,3 mg/kg in the dispersion Lead Not more than 0,9 mg/kg in the dispersion Mercury Not more than 0,03 mg/kg in the dispersion Cadmium Not more than 0,3 mg/kg in the dispersion E 1207 ANIONIC METHACRYLATE COPOLYMER Synonyms Methyl acrylate, methyl methacrylate, methacrylic acid polymer; Methacrylic acid, polymer with methyl acrylate and methyl methacrylate Definition Anionic 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. CAS No 26936-24-3 Chemical name Poly (methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 7:3:1 Chemical formula Poly[(CH2:CHCO2CH3)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)COOH)] Weight average molecular weight Approximately 280 000 g/mol Assay/Residue on evaporation 28,5–31,5 % 1 g of the dispersion is dried in an oven for 5 hours at 110 °C. 9,2–12,3 % methacrylic acid units on dry substance. Description Milky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour. Identification Infrared absorption spectroscopy Characteristic of the compound Viscosity Max. 20 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry) pH-value 2,0–3,5 Relative density (at 20 °C) 1,058–1,068 Solubility The 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. Purity Acid value 60–80 mg KOH/g of dried substance Sulphated ash Not more than 0,2 % in the dispersion Residual monomers Total of monomers (sum of methacrylic acid, methyl methacrylate and methyl acrylate): not more than 100 mg/kg in the dispersion Residual emulsifiers Sodium lauryl sulphate not more than 0,3 % on the dry substance Polysorbate 80 not more than 1,2 % on the dry substance Solvent residues Methanol not more than 0,1 % in the dispersion Arsenic Not more than 0,3 mg/kg in the dispersion Lead Not more than 0,9 mg/kg in the dispersion Mercury Not more than 0,03 mg/kg in the dispersion Cadmium Not more than 0,3 mg/kg in the dispersion ’ --- Source: https://www.legislation.gov.uk/eur/2013/816/annex/II (the official version) Page: https://openlegislation.uk/eu-regulation-2013-816/annex-II Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.