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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives1, and in particular Article 10(3) and Article 14 thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings2, and in particular Article 7(5) thereof,

Whereas:

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)
Commission Regulation (EU) No 231/20123 lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.
(3)

Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

(4)

On 13 September 2011, an application was submitted for authorisation of the use of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (PVA-PEG graft co-polymer) in aqueous instant-release film coatings for food supplements. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5)
The European Food Safety Authority evaluated the safety of PVA-PEG graft co-polymer when used as a food additive and concluded that its use in food supplements as film coating is of no safety concern for the proposed uses4.
(6)

PVA-PEG graft co-polymer is intended for use in aqueous instant-release film coatings for food supplements. It protects against unpleasant tastes or odours, improves appearance, makes tablets easier to swallow, gives a distinctive appearance, and protects sensitive active ingredients. A specific property of the substance is that it is extremely flexible, has low viscosity, and dissolves rapidly in acidic, neutral, and alkaline aqueous media. It is therefore appropriate to authorise the use of PVA-PEG graft co-polymer as a glazing agent in solid food supplements and to assign E 1209 as E-number to that additive.

(7)

The specifications for PVA-PEG graft co-polymer should be included in Regulation (EU) No 231/2012 when it is included in the Union lists of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

(8)

Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 June 2014.

For the Commission

The President

José Manuel Barroso

ANNEX I

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

  1. (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. (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

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’