EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10070/2016 CIS 
(POOL/E2/2016/10070/10070 -EN 
CIS.doc)  
[…](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 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 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 Counci l Regulation ( EC) No 1601/91 , 
Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/131, 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 flavourings2, and in particular Article7( 5) 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 872/20123 adopted a 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 c ommon 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 co ntains a number of substances for 
which the European Food Safety Authority ( 'the Authority' ) has requested additional 
scientific data to be provided for completion of the evaluation before the deadlines 
established in Part A of Annex I to Regulation (EC) N o 1334/2008.  
(5) In the case of the substances  belonging to the Fla vouring Group Evaluation 
('FGE  203') rev.1 : the deadline of 31 December 2012 was established in the Union list 
for the submission of requested additional scientific data . The substances belongi ng to 
this FGE203 rev.1 are: deca-2,4-dien-1-ol (FL  no. 02.139), hepta -2,4-dien-1-ol (Fl no. 
                                                 
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 Pa rliament 
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 02.153), hexa -2,4-dien-1-ol (FL  no. 02.162), nona -2,4-dien-1-ol (FL  no. 02.188), 
hexa -2(trans),4(trans) -dienal (FL  no. 05.057), trideca -2(trans),4(cis),7(cis) -trienal 
(FL no. 05.064), nona -2,4-dienal (FL  no. 05.071), 2,4-decadienal (FL  no. 05.081), 
hepta -2,4-dienal (FL  no. 05.084), penta -2,4-dienal (FL  no. 05.101),  undeca -2,4-dienal 
(FL no. 5.108), dodeca -2,4-dienal (FL  no. 05.125),  octa-2(trans),4(trans) -dienal 
(FL no. 05.127), deca -2(trans),4(trans) -dienal (FL  no. 05.140),  deca-2,4,7 -trienal 
(FL no. 05.141), nona -2,4,6 -trienal (FL  no. 5.173),  2,4-octadienal (FL  no. 05.186),  
tr-2,tr-4-nonadienal (FL  no. 05.194), tr-2,tr-4-undecadienal (FL  no. 05.196), and hexa -
2,4-dienyl acetate (FL  no. 09.573) . Such data has been  submitted by the applicant.  
(6) That chemical group includes hexa -2(trans),4(trans) -dienal (FL-no: 05.057 ) and deca -
2(trans),4(trans) -dienal (FL-no: 05.140 ) which w ere used as representative substance s 
for the group and for which toxicity data were submitted.  
(7) The Authority has evaluated the genotoxicity of these  two representative substances in 
its sc ientific opinion of 26 March 2014 .4  
(8) For hexa -2(trans),4(trans) -dienal (FL -no: 05.057) it confirmed safety concern s based 
on the evidence from publications reporting the induction of DNA adducts in different 
systems in vitro and in vivo, the IARC classification as possible carcinogen to 
humans, considering the conclusion drawn by IARC that mechanistic da ta provide 
additional support for the relevance of the animal carcinogenicity data to humans and 
that there is a moderate evidence that tumour induction occurs via a genotoxic 
mechanism.  
(9) For deca-2(trans),4(trans) -dienal (FL -no: 05.140)  it came to the con clusion that a non -
threshold mechanism of genotoxicity cannot be excluded  on the basis that  there is 
some indication for genotoxicity in vivo and considering the evidence from in vitro 
studies for the induction of different types of DNA damage (oxidised DN A bases and 
bulky adducts).  
(10) Overall, the Authority concluded that the safety concern regarding genotoxicity cannot 
be ruled out for both representative substances of the group and that this conclusion is 
likewise applicable to the other substances of the FGE group 203 . 
(11) The parties  concerned have indicated that they are undertaking  a variety of toxicity 
studies on the substances in FGE group 203 responding  to the concerns expressed  by 
the Authority . In addition, the Commission has requested further informat ion in order 
to fully evaluate the safety of th ose substances.  
(12) The supporting parties submitted  the studies and  information  on 26 September 2016 . 
(13) Pending the evaluation by the Authority of the substances in group FGE , the eventual 
full evaluation of these  substances according to the EFSA CEF panel procedure  and 
the completion of the subsequent regulatory process , it is appropriate  to limit the 
conditions of use of those su bstances to  their current  use. 
(14) Due to technical reasons, transitional periods should be laid down to cover food not 
complying with the conditions set out in the Annex , which has been placed on the 
Union market or dispatched from third countries for the Union before the entry into 
force of this Regulation . 
                                                 
4 Scientific Opinion on Flavouring Group Evaluation 203 Rev 1 (FGE.203 Rev1):  alpha,beta -unsaturated 
aliphati c aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double -
bonds and with or without additional non -conjugated double -bonds. EFSA Journal 2014;12(4):3626, 31 pp. 
doi:10.2903/j.efsa.2014.3626 . Available online: www.efsa.europa.eu/efsajournal .  
EN 4   EN (15) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended 
accordingly.  
(16) 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  
1. Foods to which any of the flavouring substances listed  in the Annex to this 
Regulation have been added  which do not comply with the conditions set out  in that 
Annex and which have been lawfully placed on the market  before the entry into force 
of this Regulation, may be marketed until their date of minimum durability or use by 
date.  
2. Foods to which any of the flavouring substances  listed  in the Annex  to this 
Regulation have been added , and which do not comply with the conditions set out in 
that Annex and which have been imported into the Union from a third country may 
be marketed until their date of minimum durability or use by date where the importer 
of such food s can demonstrate that they were dispatched from the third country 
concerned and were en route  to the Union before the entry into force of this 
Regulation.  
3. The transitional periods provided in paragraphs 1 and 2 shall not apply to mixtures o f 
flavourings.  
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