ANNEX IISupplementary provisions
ANNEX II In the Annex to Regulation (EU) No 231/2012 the following entry is inserted after the entry for E 1209: ‘ E 1210 CARBOMER Synonyms carbomer, carboxypolymethylene; carbomer homopolymer Definition High-molecular mass polymers obtained by polymerisation of acrylic acid and crosslinking with allyl pentaerythritol. The polymers are synthesised in ethyl acetate using a peroxide to initiate free-radical polymerisation. CAS No 9007-20-9 (primary CAS), 9003-01-4 (secondary CAS) Chemical name Carbomer homopolymer, allyl pentaerythritol cross-linked Chemical formula -(CH 2 -CH) m -( XM ) p COOH m: number of monomer units; XM: crosslinker, p: number of crosslinker units, with m >> p Weight average molecular weight Assay Carboxylic acid content not less than 56 % and not more than 68 % (on dried substance) Description White or almost white, fluffy, hygroscopic powder or granules Identification Attenuated total reflective infra-red spectroscopy Proton nuclear magnetic resonance spectroscopy Characteristic of the compound Viscosity (Brookfield viscosimetry, 20 rpm) 25 °C Type B Type A Type A 29 400 -39 400 mPa.s 4 000 -11 000 mPa.s Physical form powder powder granules Pass through 40 mesh, % 425 μm - - 95 min Pass through 100 mesh, % 150 μm - - 10 max Solubility Insoluble in water. Water-swellable and forms hydrogels in aqueous dispersions. Purity Residual monomers Acrylic acid not more than 100 mg/kg Residual crosslinker tri and tetra-allyl pentaerythritol not more than 1 000 mg/kg Residual solvant Ethyl acetate not more than 0,5 % w/w 2-ethylhexanol not more than 100 mg/kg 2-ethylhexylacetate not more than 100 mg/kg Lower molecular weight fraction < 1 000 Da Not more than 0,75 % w/w Loss on drying Not more than 2 % Sulphated ashes Not more than 2,5 %’