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 1208 (Polyvinylpyrrolidone-vinyl acetate copolymer): ‘E 1209 POLYVINYL ALCOHOL-POLYETHYLENE GLYCOL- GRAFT -COPOLYMER Synonyms Macrogol poly(vinyl alcohol) grafted co-polymer; poly(ethan-1,2-diol-graft-ethanol); ethenol, polymer with oxirane, graft; oxirane, polymer with ethanol, graft; ethylene oxide-vinyl alcohol graft co-polymer Definition Polyvinyl alcohol-polyethylene glycol-graft-co-polymer is a synthetic co-polymer that consists of approximately 75 % PVA units and 25 % PEG units. CAS number 96734-39-3 Chemical name Polyvinyl alcohol-polyethylene glycol- graft -co-polymer Chemical formula Weight Average Molecular Weight 40 000 to 50 000 g/mol Description White to faintly yellow powder Identification Solubility Freely soluble in water and dilute acids and dilute solutions of alkali hydroxides; practically insoluble in ethanol, acetic acid, acetone, and chloroform IR Spectrum Must comply pH value 5,0-8,0 Purity Ester Value 10 to 75 mg/g KOH Dynamic viscosity 50 to 250 mPa·s Loss on drying Not more than 5 % Sulphated Ash Not more than 2 % Vinyl Acetate Not more than 20 mg/kg Acetic acid/Total Acetate Not more than 1,5 % Ethylene glycol Not more than 50 mg/kg Diethylene glycol Not more than 50 mg/kg 1,4-Dioxane Not more than 10 mg/kg Ethylene oxide Not more than 0,2 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg’