COMMISSION REGUL ATION (EU) 2016/637 
of 22 Apr il 2016 
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the 
Council as regards remo val from the Union list of certain flavour ing subst ances 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d 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 flavouri ng proper ties 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 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 author isation 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 flavouri ngs and source mater ials appro ved 
for use in and on foods and their conditions of use. 
(2)  Commission Implementing Regulation (EU) No 872/2012 (3) adop ted the list of flavouring substances and 
introduced 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 refer red 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 mat erials contains a number of substances for which the European Food 
Safety Author ity (‘Auth ority’) has request ed additional scientifi c data to be provided for completion of the 
evaluation before specifi c 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-tr imethyl -1- 
cyclohexen -1-carbo xaldeh yde (FL No 05.121), myrtenyl formate (FL No 09.272), myrtenyl-2-meth ylbutyrate (FL 
No 09.899), and myrtenyl-3-meth ylbutyrate (FL No 09.900), the deadline of 31 December 2012 was established 
in the Union list for the submission of requested additional scientifi c data. Such data has been submitt ed 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 rep­
resentative substance for the group and for which the toxicity data were submitte d. 23.4.2016 L 108/24 Official Jour nal of the European Union EN     
(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 Octo ber 2012 adopt ing 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). (7)  The Author ity has evaluated the submitted data and concluded in its scientifi c opinion of 24 June 2015 (1) that 
the substance p-mentha-1,8-dien-7-al (FL No 05.117) is genoto xic in vivo and theref ore its use as a flavouri ng 
substance raises a safety concer n. That substance has already been remo ved from the Union list by Commission 
Regulation (EU) 2015/1760 (2). 
(8)  In that opinion, the Author ity 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 poten tial safety concer n for such substances. 
(9)  Theref ore, 2,6,6-tr imethyl-1-cy clohexen -1-carbo xaldehyde (FL No 05.121), myrtenyl formate (FL No 09.272), 
myrtenyl-2-meth ylbutyrate (FL No 09.899), and myrtenyl-3-methylbutyrat e (FL No 09.900) should be remo ved 
from the Union list. 
(10)  Taking into account technical reasons, transitional periods should be laid down to cover food to whic h one of the 
four flavouri ng substances has been added, whic h has been placed on the mark et or dispatched from third 
countr ies for the Union, before the date of entr y into force of this Regulation. 
(11)  Part A of Annex I to Regulation (EC) No 1334/2008 should theref ore be amended according ly. 
(12)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
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 
1. Foods to whic h one of the flavouri ng substances listed in the Annex to this Regulation has been added and were 
lawfully placed on the market before the date of entr y into force of this Regulation, excluding mixtures of flavourings, 
may be mark eted until their date of minimum durability or use by date . 
2. Foods imported into the Union to which one of the flavouri ng substances listed in the Annex to this Regulation 
has been added, excluding mixtures of flavouri ngs, may be mark eted until their date of minimum durability or use by 
date where the importer of such food can demonstrate that they were dispatched from the third countr y concer ned and 
were en route to the Union before the date of entr y 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. 23.4.2016 L 108/25 Official Jour nal of the European Union EN     
(1)Scientific Opinion on Flav ouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on represen ­
tatives for 10 alicy clic 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 online: www .efsa.europa.eu/efsajournal 
(2)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 remo val from the Union list of the flavouring substance p-mentha-1,8-dien-7-al (OJ L 257, 
2.10.2015, p. 27). This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 22 Apr il 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  23.4.2016 L 108/26 Official Jour nal of the European Union EN     ANNEX 
In Part A of Annex I to Regulation (EC) No 1334/2008, the following entr ies are delet ed: 
‘05.121 2,6,6- Trimethyl-1-cy clohexen -1-carbo xaldehyde 432-25-7 979 2133   2 EFSA 
09.272 Myr tenyl format e 72928-52-0 983 10858   2 EFSA 
09.899 Myr tenyl-2-methylbutyrat e 138530-44-6     2 EFSA 
09.900 Myr tenyl-3-methylbutyrat e 33900-84-4     2 EFSA ’   23.4.2016 L 108/27 Official Jour nal of the European Union EN