EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11979/2015 Rev. 3 
(POOL/E7/2015/11979/11979R3-
EN.doc) D042554/03 […](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annex I to Re gulation (EC) No 1334/2008 of th e European Parliament and of 
the Council as regards removal from the Un ion list of certain flavouring substances 
(Text with EEA relevance) 
  
EN 2   EN 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 Un ion 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 am ending Council Regulation (EEC) No 1601/91, 
Regulations (EC) No 2232/96 and (E C) 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 co mmon authorisation procedure for food 
additives, food enzymes and food flavourings2, and in particular Article 7(4) thereof, 
Whereas: (1) Annex I to Regulation (EC) No 1334/2008 lays down a Uni on list of flavourings and 
source materials approved for use in and on foods and their conditions of use. 
(2) Commission Implementing Re gulation (EU) No 872/2012
3 adopted the list of 
flavouring substances and intr oduced that list in Part A of  Annex I 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 mate rials contains a number of substances for 
which the European Food Safety Authority (‘Authority’) has requested additional 
scientific data to be provided for completion of the evaluation before specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008.  
(5) In case of the following four substances  belonging to chemical subgroup 2.2 of 
FGE.19: 2,6,6-trimethyl-1-cyclohexen-1- carboxaldehyde (FL no. 05.121), myrtenyl 
formate (FL no. 09.272), myrtenyl-2-methyl butyrate (FL no. 09.899), and myrtenyl-3-
methylbutyrate (FL no. 09.900), the deadline of  31 December 2012 was established in 
                                                
 
1 OJ L 354, 31.12.2008, p. 34.  
2 OJ L 354, 31.12.2008, p. 1. 
3 Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of 
flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament 
and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission 
Decision 1999/217/EC. OJ L 267, 2.10.2012, p. 1.  
EN 3   EN the Union list for the submission of requested  additional scientific data. Such data has 
been submitted by the applicant.  
(6) This chemical group includes also the substance p-mentha-1,8-dien-7-al (FL no. 
05.117) which was used as representative substance for the group and for which the 
toxicity data were submitted.  
(7) The Authority has evaluated the submitted data and concluded in its scientific opinion 
of 24 June 20154 that the substance p-mentha-1,8-dien-7-al (FL no. 05.117) is 
genotoxic in vivo  and therefore its use as a fla vouring substance raises a safety 
concern. That substance has already been re moved from the Union list by Commission 
Regulation (EU) 2015/17605.  
(8) In that opinion, the Authority also concluded that since p-mentha-1,8-dien-7-al (FL no. 
05.117) is representative for the substances in this group, there is a potential safety 
concern for such substances. 
(9) Therefore, 2,6,6-trimethyl-1-cyclohexen- 1-carboxaldehyde (FL no. 05.121), myrtenyl 
formate (FL no 09.272), myrtenyl-2-methyl butyrate (FL no. 09.899), and myrtenyl-3-
methylbutyrate (FL no. 09.900) should be removed from the Union list. 
(10) Taking into account te chnical reasons, tran sitional periods should be laid down to 
cover food to which one of the four flavour ing substances has been added, which has 
been placed on the market or dispatched fr om third countries for the Union, before the 
date of entry into force of this Regulation. 
(11) Part A of Annex I to Regulation (EC)  No 1334/2008 should therefore be amended 
accordingly. 
(12) The measures provided for in this Regulati on 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 Regula tion (EC) No 1334/2008 is ame nded in accordance with the 
Annex to this Regulation. 
Article 2 
1. Foods to which one of the flavouring subs tances listed in the Annex to this 
Regulation has been added and were lawfully  placed on the market before the date of 
entry into force of this Regulation, ex cluding mixtures of flavourings, may be 
marketed until their date of mi nimum durability or use by date. 
2. Foods imported into the Union to which one of  the flavouring substances listed in the 
Annex to this Regulation has been added, excluding mixtures of flavourings, may be 
marketed until their date of minimum durability or use by date where the importer of 
                                                 
4 Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of 
genotoxicity data on representatives for 10 alicyclic aldehydes with the α,β-unsaturation in ring / side-
chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2015;13(7):4173, 28 pp. 
doi:10.2903/j.efsa.2015.4173 Available on line: www.efsa.europa.eu/efsajournal. 
5 Commission Regulation (EU) 2015/1760 of 1 October 2015 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 the 
flavouring substance p-mentha-1,8-dien-7-al (OJ L 257, 2.10.2015, p. 27).  
EN 4   EN such food can demonstrate that they we re dispatched from the third country 
concerned and were en route to the Union befo re the date of entry into force of this 
Regulation.  
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