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

in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for E 1207 Anionic methacrylate copolymer:

E 1208

Polyvinylpyrrolidone-vinyl acetate copolymer

in Part E, in food category 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, the following new entry is inserted after the entry for E 1207 Anionic methacrylate copolymer:

E 1208

Polyvinylpyrrolidone-vinyl acetate copolymer.

100 000

In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for E 1207 (Anionic methacrylate copolymer):

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.
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	(C6H9NO)n.(C4H6O2)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 % 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