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