# Commission Regulation (EU) No 264/2014 of 14 March 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polyvinylpyrrolidone-vinyl acetate copolymer in solid food supplements and the Annex to Commission Regulation (EU) No 231/2012 as regards its specifications (Text with EEA relevance), Annex II

Extent: E+W+S+N.I.

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
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
’

---
Source: https://www.legislation.gov.uk/eur/2014/264/annex/II (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-264/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.