ANNEX IISupplementary provisions
ANNEX II 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[(CH 2 :CHCO 2 CH 2 CH 3 )-co-(CH 2 :C(CH 3 )CO 2 CH 3 )] 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[(CH 2 :CHCO 2 CH 3 )-co-(CH 2 :C(CH 3 )CO 2 CH 3 )-co-(CH 2 :C(CH 3 )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’