ANNEX IISupplementary provisions
ANNEX II In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for E 1207 (Anionic methacrylate copolymer): ‘ E 1208 POLYVINYLPYRROLIDONE-VINYL ACETATE COPOLYMER Synonyms Copolyvidon; copovidone; 1-vinyl-2-pyrrolidone-vinyl acetate copolymer; 2-pyrrolidinone, 1-ethenyl-, polymer with ethenyl acetate Definition It is produced by free radical copolymerisation of N-vinyl-2-pyrrolidone and vinyl acetate in solution in propan-2-ol, in the presence of initiators. Einecs Chemical name Acetic acid, ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone Chemical formula (C 6 H 9 NO) n .(C 4 H 6 O 2 ) m Average Viscosity Molecular Weight Between 26 000 and 46 000 g/mol. Assay Nitrogen content 7,0-8,0 % Description The physical state is described as a white to yellowish-white powder or flakes with an average particle size of 50-130 μm. Identification Solubility Freely soluble in water, ethanol, ethylene chloride and ether. Infrared absorption spectroscopy To be identified European Colour Test (BY Colour) Minimum BY5 K-value ( *1 ) (1 % solids in aqueous solution) 25,2-30,8 pH value 3,0-7,0 (10 % aqueous solution) Purity Vinylacetate component in copolymer Not more than 42,0 % Free vinyl acetate Not more than 5 mg/kg Total ash Not more than 0,1 % Aldehyde Not more than 2 000 mg/kg (as acetaldehyde) Free-N-vinylpyrrolidone Not more than 5 mg/kg Hydrazine Not more than 0,8 mg/kg Peroxide content Not more than 400 mg/kg Propan-2-ol Not more than 150 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg ( *1 ) K-value: dimensionless index, calculated from kinematic viscosity measurements of dilute solutions, used to indicate the likely degree of polymerisation or molecular size of a polymer.’