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Council of the European Union Brussels, 24 March 2015 (OR. en) 7498/15 DLEG 43 AGRI 154 SAN 84 COVER NOTE From: European Commission date of receipt: 24 March 2015 To: No. Cion doc.: D038008/02 Subject: General Secretariat of the Council COMMISSION REGULATION (EU) / of XXX amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances Delegations will find attached document D038008/02. Encl.: D038008/02 7498/15 JS/pm DGB 3B

EUROPEAN COMMISSION Brussels, XXX SANCO/11995/2014 Rev. 2 (POOL/E7/2014/11995/11995R2-.doc) D038008/02 [ ](2015) XXX draft COMMISSION REGULATION (EU) / of XXX amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (Text with EEA relevance)

COMMISSION REGULATION (EU) / of XXX amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (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 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 (EC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13 1, and in particular Articles 11(3) and 25(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(4) thereof, Whereas: (1) Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use. (2) Commission Implementing Regulation (EU) No 872/2012 3 of 1 st October 2012 adopted the list of flavouring substances and introduced it in Annex I Part A to Regulation (EC) No 1334/2008. (3) That list 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 submitted by a Member State or by an interested party. (4) The Union list of flavourings and source materials contains a number of substances for which the European Food Safety Authority ('EFSA') has requested additional scientific data to be provided for completion of the evaluation before specific deadlines established in the Annex I Part A to Regulation (EC) No 1334/2008. 1 2 3 OJ L 354, 31.12.2008, p. 34. OJ L 354, 31.12.2008, p. 1. OJ L 267, 2.10.2012, p. 1. 2

(5) In the case of the five following substances: 1-methylnaphthalene [FL No. 01.014], furfuryl methyl ether [FL No. 13.052], difurfuryl sulphide [FL No. 13.056], difurfuryl ether [FL No. 13.061] and ethyl furfuryl ether [FL No. 13.123], the deadline of 31 December 2013 was established in the Union list for the submission of requested additional scientific data. (6) Where the necessary information is not provided by the time requested, the flavouring substance in question will be removed from the Union list. (7) Additional scientific data following specific EFSA Opinions 4 relating to these substances have not been submitted by 30 June 2014. Therefore, these flavouring substances should be removed from the Union list. (8) Regulation (EC) No 1334/2008 should therefore be amended accordingly. (9) Article 1 of Commission Regulation (EU) No 873/2012 5 lays down transitional measures for food containing flavouring substances which are lawfully placed on the market or labelled prior to 22 October 2014. Those transitional measures may not be sufficient for foods containing flavouring substances to be removed from the Union list after 22 October 2014. Therefore, an additional transitional period should be provided for food containing the five flavouring substances in order to enable food business operators to adapt to the requirements laid down in this Regulation. (10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION: Article 1 Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation. Article 2 Foods containing the five flavouring substances mentioned in the Annex to this Regulation which are lawfully placed on the market or labelled prior to 9 months after the entry into force of this Regulation which do not comply with Part A of Annex I to Regulation No 1334/2008 may be marketed until their date of minimum durability or use by date. 4 5 Scientific Opinion on Flavouring Group Evaluation 78 (FGE.78), The EFSA Journal (2009) 931, 1-59; Scientific Opinion on Flavouring Group Evaluation 67, Revision 1 (FGE.67Rev.1), EFSA Journal 2011; 9(10):2315; Scientific Opinion on Flavouring Group Evaluation 65 (FGE.65), EFSA Journal 2010; 8(7):1406. Commission Regulation (EU) No 873/2012 of 1 October 2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (OJ L 267, 2.10.2012, p. 162). 3

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, For the Commission The President Jean-Claude JUNCKER 4