Commission Regulation (EU) No 685/2014 of 20 June 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards polyvinyl alcohol-polyethylene glycol-graft-co-polymer in solid food supplements Text with EEA relevance

• CELEX: Regulation (EU) No 685/2014
• Articles: 5

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

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

(1)

in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 1208 Polyvinylpyrrolidone-vinyl acetate copolymer:

‘E 1209

Polyvinyl alcohol-polyethylene glycol- graft -co-polymer’

(2)

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 food additive E 1208:

‘E 1209

Polyvinyl alcohol-polyethylene glycol- graft -co-polymer

100 000 ’

ANNEX II

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’