EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11834/2019 
(POOL/E2/2019/11834/11834 -EN.docx)  
D067204/02  
[…](2020) 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)   EN 1  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 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 a nd 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 (E EC) No 1601/91, 
Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13 /EC1, and in 
particular Article 11(3) , 
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 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 872/20123 adopt ed the list of 
flavouring substances and introduce d that list  in Part A of Annex I to Regulation (EC) 
No 1334/2008.  
(3) Annex I to Regulation (EC) No 1334/2008 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 lis t of flavourings and source materials laid down in Annex I to Regulation 
(EC) No 1334/2 008 contains , among others, a number of flavouring substances for 
which , at the time of adoption of the list by Regulation (EU) No 872/2012 , the 
European Food Safety Authority  (‘the Authority ’) had not been able to rule out a 
safety risk to the health of t he consumer on the basis of the data available and had, 
therefore, considered that additional data was necessary to complete their evaluation.  
Those substances were included in the Union list of flavouring substances but on the 
                                                 
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 t o 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 2  EN condition that safety data a ddressing th e concern s expressed by the Authority was 
submitted before the expiry of specific deadlines  established in Part A of Annex I to 
Regulation (EC) No 1334/2008 . These substances and their deadlines were  identified 
by footnotes numbered from 1 to 4.  
(5) Among the substances  included in the Union list of flavourings and source materials 
but identified by way of a footnote reference  requiring additional scientific data to be 
submitted by 31 December 2012, there were the foll owing five substances  alpha -
Damascone (Fl no 07.134) (representative substance  of the group ), delta -Damascone 
(Fl no. 07.130), cis -1-(2,6,6 -trimethyl -2-cyclohexen -1-yl)but -2-en-1-one (Fl no. 
07.225), tr ans-1-(2,6,6 -trimethyl -2-cyclohexen -1-yl)but -2-en-1-one (Fl no. 07.226) 
and alpha -Damascenone (Fl no. 07.231)  (‘the concerned substances’) . These 
substances are part of the subgroup 2.4 of substances from Flavouring Group FGE.19, 
and were included in the Flavouring Group FGE 210. As regards these substances , the 
Authority  had indicated  in its opinion on the Flavouring Group Evaluation 210 of 
20094 that they contain a structural alert for genotoxicity in their molecular structure as 
they are alpha,  beta-unsaturated ketones , and that  additional genotoxicity data  was 
needed to rule out th e concern  on their genotoxic ity in accordance with the Authority’s 
document on the “G enotoxicity test strategy for substances belonging to subgroups of 
the Flavouring Group FGE.19 ”5. 
(6) On 28 December 2012 , data was submitted  concerning subgroup 2.4 of substances 
from Flavouring Group FGE.19 . 
(7) The Authority evaluated the submitted data in revision 1 of the Opinion on the 
genotoxic potential of the substances of Flavouring Group FGE 210  from chemical 
group 2.4 of Flavouring Group  FGE 210 published on 19  February 20146. However, 
the Authority  considered the submitted data was still insufficient to rule out the 
genotoxic potential of the concerned substances  and it requested further additional data 
on genotoxicity on the substances representative for this subgroup . 
(8) New data was submitted i n 2014. The Authority evaluated th e new data in revision 2 
of its Opinion, published on 10 July 20157. However, t he Authority considered that the 
new data was insufficient to rule out the genotoxic potential of the concerned 
substances and requested  once more  further scientific data to be submitted  on the 
genotoxicity of the concerned substances . 
(9) Further data was submitted in 2016  on the concerned substances . Following this 
submission, the Autho rity requested further information and specific  studies to be 
performed by letters of 8 November 2016, 9 February,  29 June 2017  and 8 February 
2019 . However, the  new data provided did not always correspond to the studies 
                                                 
4 Scientific Opinion on Flavouring Group Evaluation 210: alp ha, beta -unsaturated alicyclic ketones and 
precursors from chemical subgroup 2.4 of FGE.19 ; EFSA Journal (2009) ON -1030, 1 -18. 
https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2009.1030   
5 Genotoxicity Test Strategy for Substances belonging to S ubgroups of FGE.19 - Statement of the Panel 
on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) ; EFSA Journal (2008) 
854, 1 -5. :https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2008.854 . 
6 Scientific Opinion on Flavouring Group Evaluation 210, Revision 1 (FGE.210Rev1): Consideration of 
genotoxic potential for alpha,beta -unsaturated alicyclic ketones and precursors from chemical subgroup 
2.4 of FGE.19. EFSA Journal 2014;12(2):3587, 35 pp. doi:10.2903/j.efsa.2014.3587  
7 Scien tific Opinion on Flavouring Group Evaluation 210 Revision 2 (FGE.210Rev2): Consideration of 
genotoxic potential for alpha,  beta-unsaturated alicyclic ketones and precursors from chemical subgroup 
2.4 of FGE.19 . 10 July 2015. doi:10.293/j.efsa.2015.4172.  EN 3  EN requested by the Authority and  were  not suitable to answer properly  the Authority’s 
concerns . Taking into account all that additional data submitted, t he Authority  
evaluated again  the genotoxic potential  of the concerned substances in revision  3 of 
the Opinion on FGE.2108 published on  22 May 2019 . The Authority  concluded that 
the concern for genotoxicity cannot be ruled out for  the five concerned substances .  
(10) In view of the fact that neither the data submitted within the initial deadline nor the 
data submitted following the Authority’s suc cessive requests after that deadline had 
allow ed the Authority in 2019  to rule out the concerns expressed in its Opinion of 
2009, the Commission  considers that it is not established  that the concerned 
substances do not pose a safety risk to the health of t he consumer . Therefore, on the 
basis of the scientific evidence submitted within the framework set out  in Part A of 
Annex I to Regulation (EC) No 1334/2008  for the substances pending the completion 
of their eval uation , the use of the concerned substances d oes not comply with the 
general conditions of use for flavourings set out in Article 4 of Regulation (EC) No 
1334/2008 . 
(11) Consequently , the concerned  substances  should be removed from the Union list  in 
order to protect human health . 
(12) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended 
accordingly.  
(13) Due to technical reasons , transitional period s should be provided for  concerning food 
to which any of the five flavouring substances ha ve been added  and which ha ve been 
placed on the mar ket or dispatched from third countries  to the Union  and were en route 
prior to  the entr y into force of this Regulation . The transitional period should not apply 
to preparations to which any of these five flavouring substances have been added and 
which are not intended to be consumed  as such  as the composition of the se 
preparations are known by the ir manufacturer s when they prepare them.  
(14) 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 li sted in  the Annex to th is 
Regulation have been added and which were lawfully placed on the market prior to  
the date of entry into force of this Regulation may continue to be marketed until their 
date of minimum durability or ‘use by ’ date.  
2. Foods imported into the Union , to whic h one of  the flavouring substances listed in 
the Annex to this Regulation have been added may be marketed until their date of 
minimum durability or ‘use by ’ date where the importer of such food can 
                                                 
8 Scientific Opinion on Flavouring Group Evaluation 210 Revision 3  (FGE.210Rev3): Consideration of 
genotoxic potential for a lpha, beta-unsaturated alicyclic ketones and precursors from chemical subgroup 
2.4 of FGE.19 . EFSA Journal 2019;  17(5):5676 . EN 4  EN demonstrate that they were dispatched from the third country concerned and were en 
route to the Union  before the date of entry into force of this Regulation .  
3. The transitional periods provided in paragraphs 1 and 2 shall not ap ply to 
preparations not intended to be consume d as such  to which any of these five 
flavourin g substances have been added . 
4. For the purposes of this Regulation, p reparations shall be understood as mixtures of 
one or more flavourings to which other food ingredients such as food additives, 
enzymes or carr iers may be also incorporated to facilitate their storage, sale, 
standardisation, dilution or dissolution .  
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  
 Ursula VON DER  LEYEN