
Article 1 
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Article 2 
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 28 August 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX I

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

((1)) In Part B, the following entries for E 1206 and E 1207 are inserted in point 3 ‘Additives other than colours and sweeteners’, after the entry for E 1205 Basic methacrylate copolymer:
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E 1206 Neutral methacrylate copolymer
E 1207 Anionic methacrylate copolymer'
((2)) In Part E, the following entries are inserted in food category 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, after the entry for E 1205 Basic methacrylate copolymer:
'
 E 1206 Neutral methacrylate copolymer 200 000   
 E 1207 Anionic methacrylate copolymer 100 000   '

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:
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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/kgMethyl methacrylate < 1 000 mg/kgDimethylaminoethyl 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):
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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 dispersionMethanol 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


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 substancePolysorbate 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
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