# Commission Regulation (EU) No 685/2014Show full title

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)         

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U.K.

# 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 additives(1), 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 flavourings(2), 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 231/2012(3) 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 uses(4).

(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 1U.K.

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

# Article 2U.K.

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

# Article 3U.K.

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 IU.K.

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                              food additive 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 food additive E 1208:                           

## ANNEX IIU.K.

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**

1

OJ L 354, 31.12.2008, p. 16.                           

2

OJ L 354, 31.12.2008, p. 1.                           

3

Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II                              and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).                           

4

*EFSA Journal* 2013; 11(8):3303.