COMMISSION REGUL ATION (EU) 2016/1244 
of 28 July 2016 
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the 
Council as regards certain flavour ing subst ances from a group related with an alpha beta 
unsaturation structure 
(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 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 author isation procedure for food additives, food enzymes and food flavourings (2), and in 
particular Article 7(5) 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) adopt ed a list of flavouri ng 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 (‘the Author ity’) has requeste d additional scientifi c data to be provided for compl etion of the 
evaluation before specifi c deadlines established in the Annex I Part A to Regulation (EC) No 1334/2008. 
(5)  In the case of the five following substances belonging to the Flavouring Group Evaluation FGE 208rev .1: 
p-mentha-1,8-dien-7-ol (FL No 02.060), myrtenol (FL No 02.091), myrtenal (FL No 05.106), p-mentha-1,8-dien- 
7-yl acetat e (FL No 09.278) and myrtenyl acetate (FL No 09.302), the deadline of 31 December 2012 was 
established in the Union list for the submission of request ed additional scientific data. Such data has been 
submitte d by the applicant. 
(6) That chemical group includes substance p-mentha-1,8-dien-7-al (FL No 05.117) which was used as a representa ­
tive substance for the group and for which the toxicity data were submitt ed. 
(7)  The Author ity has evaluated the submitted data and concluded in its scientifi c opinion of 24 June 2015 (4) 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 (5). 29.7.2016 L 204/7 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). 
(4)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 . 
(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 regar ds 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). (8)  In that opinion, the Auth ority also concluded that since p-mentha-1,8-dien-7-al (FL No 05.117) is a representative 
for the group, there is a potential safet y concer n for the other substances in that group. 
(9)  In order to further evaluate the safet y of those five substances, the suppor ting parties concer ned were formally 
request ed to provide additional toxicity studies by 30 Apr il 2016 to enable EFSA to finalise their assessment. 
(10)  The suppor ting parties concer ned submitte d the request ed new studies before 30 Apr il 2016. 
(11)  It is also appropr iate, pending the evaluation by EFSA of the new scientific data, the eventual full evaluation of 
these substances according to the EFSA CEF panel procedure if appropr iate and the compl etion of the subsequent 
regulatory process, to amend the conditions of use of those five substances to bette r reflect the current real uses 
of those substances. 
(12)  Due to technical reasons, transitional periods should be laid down to cover food to whic h any of the five 
flavouring substances have been added, which has been placed on the mark et or dispatched from third countr ies 
for the Union, before the entr y into force of this Regulation. 
(13)  Part A of Annex I to Regulation (EC) No 1334/2008 should theref ore be amended according ly. 
(14)  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 any of the five flavouring substances have been added: p-mentha-1,8-dien-7-ol (FL No 02.060), 
myrtenol (FL No 02.091), myrtenal (FL No 05.106), p-mentha-1,8-dien-7-yl acetate (FL No 09.278) and myrtenyl acetat e 
(FL No 09.302) whic h do not compl y with the conditions set out in the Annex to this Regulation and were lawfully 
placed on the market before the entr y into force of this Regulation, may be mark eted until their date of minimum 
durability or use by date . 
2. Foods impor ted into the Union to whic h any of the flavouring substances refer red to in paragraph 1 have been 
added and whic h do not compl y with the conditions set out in the Annex to this Regulation may be market ed until 
their date of minimum durability or use by date where the impor ter of such foods can demonstrate that they were 
dispatche d from the third countr y concer ned and were en route to the Union before the entr y into force of this 
Regulation. 
3. The transitional periods provided in paragraphs 1 and 2 shall not apply to mixtures of flavourings. 
Article 3 
This Regulation shall enter into force the twentieth day following that of its publication in the Official Journal of the 
European Union. 29.7.2016 L 204/8 Official Jour nal of the European Union EN     This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 28 July 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  29.7.2016 L 204/9 Official Jour nal of the European Union EN     ANNEX 
Table 1 of Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows: 
(a)  the entr y concer ning FL No 02.060 is replaced by the following: 
‘02.060 p-Mentha-1,8-dien-7-ol 536-59-4 974 2024  In catego ries 1, 3, 4.2, 5 (except catego ­
ry 5.3), 6, 7, 14.1, 14.2 and 16 1 EFSA ’  
(b)  the entr y concer ning FL No 02.091 is replaced by the following: 
‘02.091 Myr tenol 515-00-4 981 10285  In catego ries 1, 3, 5, 6, 14.1, 14.2, 15 
and 16 1 EFSA ’  
(c)  the entr y concer ning FL No 05.106 is replaced by the following: 
‘05.106 Myr tenal 564-94-3 980 10379  In cate gories 1, 2, 3, 4.2, 5, 6, 7, 8, 9, 
10, 11, 12, 14.1, 14.2, 15, and 16 1 EFSA ’  
(d)  the entr y concer ning FL No 09.278 is replaced by the following: 
‘09.278 p-Mentha-1,8-dien-7-yl acetate 15111-96-3 975 10742  In catego ries 1, 3, 5, 6, 7, 8, 14.1, 14.2 
and 16 1 EFSA ’  
(e)  the entr y concer ning FL No 09.302 is replaced by the following: 
‘09.302 Myr tenyl acetate 1079-01-2 982 10887  In catego ries 1, 3, 4.2, 5, 6, 7, 14.1, 
and 14.2 1 EFSA ’   29.7.2016 L 204/10 Official Jour nal of the European Union EN