# Commission Regulation (EU) No 816/2013Show full title

Commission Regulation (EU) No 816/2013 of 28 August 2013 amending Annex II to Regulation (EC) No 1333/2008 of the European            Parliament and of the Council as regards the use of Neutral methacrylate copolymer and Anionic methacrylate copolymer in solid            food supplements and the Annex to Commission Regulation (EU) No 231/2012 as regards the specifications for Basic methacrylate            copolymer (E 1205), Neutral methacrylate copolymer and Anionic methacrylate copolymer (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 816/2013                     

# of 28 August 2013

# amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Neutral                        methacrylate copolymer and Anionic methacrylate copolymer in solid food supplements and the Annex to Commission Regulation                        (EU) No 231/2012 as regards the specifications for Basic methacrylate copolymer (E 1205), Neutral methacrylate copolymer and                        Anionic methacrylate copolymer                     

# (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), Article 14 and Article 30(5) 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 including colours and sweeteners 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)Applications for authorisation of the use of Anionic methacrylate copolymer and Neutral methacrylate copolymer as glazing                              agents in solid food supplements were submitted on 25 and 27 April 2009 and were made available to the Member States.

(5)The European Food Safety Authority evaluated the safety of Neutral methacrylate copolymer(4) and Anionic methacrylate copolymer(5) when used as food additives and concluded that their use in solid food supplements at the proposed use levels is not of a                              safety concern.

(6)There is a technological need for the use of Neutral methacrylate copolymer and Anionic methacrylate copolymer in solid food                              supplements. Neutral methacrylate copolymer is intended to be used as a sustained-release glazing agent. Sustained-release                              formulations allow the continuous dissolution of a nutrient over a defined time. Anionic methacrylate copolymer is intended                              to be used as a glazing agent to protect the stomach against irritating ingredients and/or to protect sensitive nutrients                              against disintegration by the gastric acid. It is therefore appropriate to authorise the use of both food additives in solid                              food supplements and to assign E 1206 as E-number to Neutral methacrylate copolymer and E 1207 as E-number to Anionic methacrylate                              copolymer.

(7)Commission Regulation (EU) No 1129/2011(6) authorised the use of Basic methacrylate copolymer (E 1205) in solid food supplements and Regulation (EU) No 231/2012 sets                              out the specifications for that food additive, including the maximum levels for arsenic, lead, mercury and copper. Those specifications                              should be updated to take into account the maximum levels for lead, mercury and cadmium in food supplements as set out in                              Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs(7).

(8)Maximum level of arsenic in food supplements has not been set at the Union level. However, specific levels are laid down in                              the laws of Member States. Therefore, it is appropriate to update specifications of Basic methacrylate copolymer (E 1205)                              in Regulation (EU) No 231/2012 as regards arsenic to take into account the laws of Member States.

(9)Maximum level of copper in food supplements has not been set at the Union level and there is no indication of copper presence                              at toxicologically significant levels in Basic methacrylate copolymer (E 1205). It is therefore appropriate to delete copper                              from the purity section for Basic methacrylate copolymer (E 1205) in Regulation (EU) No 231/2012.

(10)Specifications should be adopted for Neutral methacrylate copolymer (E 1206) and Anionic methacrylate copolymer (E 1207).                              The purity criteria for arsenic, lead, mercury and cadmium should follow the same approach as those for Basic methacrylate                              copolymer (E 1205) and the maximum levels should take into account that the commercial form of Neutral methacrylate copolymer                              (E 1206) and Anionic methacrylate copolymer (E 1207) is a 30 % dispersion of the dry substance in water.

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

(12)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain                              and Animal Health and neither the European Parliament nor the Council has opposed them,

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, 28 August 2013.

*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, the following entries for E 1206 and E 1207 are inserted in point 3 ‘Additives other than colours and sweeteners’,                              after the entry for E 1205 Basic methacrylate copolymer:                           

In Part E, the following entries are inserted in food category 17.1 ‘Food supplements supplied in a solid form including capsules                              and tablets and similar forms, excluding chewable forms’, after the entry for E 1205 Basic methacrylate copolymer:                           

## ANNEX IIU.K.

The Annex to Regulation (EU) No 231/2012 is amended as follows:

The purity section of the entry for E 1205 (Basic methacrylate copolymer) is replaced by the following:

The following entries for E 1206 and E 1207 are inserted after the entry for E 1205 (Basic methacrylate copolymer):

### **‘E 1206 NEUTRAL METHACRYLATE COPOLYMER**

### **E 1207 ANIONIC METHACRYLATE COPOLYMER**

1

OJ L 354, 31.12.2008, p. 16.                           

2

OJ L 354, 31.12.2008, p. 1.                           

3

OJ L 83, 22.3.2012, p. 1.                           

4

EFSA Journal 2010; 8(7):1655.

5

EFSA Journal 2010; 8(7):1656.

6

OJ L 295, 12.11.2011, p. 1.                           

7

OJ L 364, 20.12.2006, p. 5.