COMMISSION REGULATION (EU) No 545/2013 of 14 June 2013
of 14 June 2013 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene.
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No
2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Article 11(3) 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(6) thereof,
Whereas:
(1) Commission Implementing Regulation (EU) No 872/2012 (3) has adopted a list of flavouring substances and has introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.
(2) That list may be updated in accordance with the common procedure referred to in Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application by a Member State or by an interested party.
(3) The flavouring substance 3-acetyl-2,5-dimethylthiophene (FL-no 15.024) is included in the list as a flavouring substance under evaluation for which additional scientific data must be submitted. Such data has been submitted by the applicant.
(4) The European Food Safety Authority has evaluated the submitted data and concluded on 15 May 2013 that 3- acetyl-2,5-dimethylthiophene is mutagenic both in vitroand in vivo and that therefore its use as flavouring substance raises a safety concern (4).
(5) Accordingly the use of 3-acetyl-2,5-dimethylthiophene does not comply with the general conditions of use for flavourings set out in Article 4(a) of Regulation (EC) No 1334/2008. Consequently, that substance should be removed from the list without delay in order to protect human health.
