COMMI SSION REGUL ATION (EU) 2020/1681 
of 12 November 2020 
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 subs tances 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng 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 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), 
Havi ng 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 flavourings and source mat erials approved 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 flavouri ng substances and 
introduced 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 refer red to in 
Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or followi ng an 
application submitted by a Member State or by an inter ested party. 
(4) The Union list of flavourings and source mat erials laid down in Annex I to Regulation (EC) No 1334/2008 contains, 
among others, a number of flavouring substances for whic h, at the time of adoptio n of the list by Regulation (EU) 
No 872/2012, the European Food Safety Authority (‘the Author ity’) had not been able to rule out a safety risk to 
the health of the consumer on the basis of the data available and had, theref ore, considered that additional data was 
necessar y to compl ete their evaluation. Those substances were included in the Union list of flavouring substances 
but on the condition that safety data addressing the concer ns expressed by the Authority was submitted before the 
expir y of specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008. These substances 
and their deadlines were identified by footnot es numbered from 1 to 4. 
(5) Among the substances included in the Union list of flavourings and source mate rials but identif ied by way of a 
footnot e reference requir ing additional scientifi c data to be submitted by 31 December 2012, there were the 
follo wing five substances alpha-Damascone (Fl No 07.134) (representative substance of the group), delta- 
Damascone (Fl No 07.130), cis-1-(2,6,6-tr imethyl -2-cy clohexen -1-yl)but-2-en-1-one (Fl No 07.225), trans-1-(2,6,6- 
trimethyl -2-cy clohexen -1-yl)but-2-en-1-one (Fl No 07.226) and alpha-Damascenone (Fl No 07.231) (‘the concer ned 
substances’ ). These substances are part of the subgroup 2.4 of substances from Flavouring Group FGE.19, and were 
included in the Flav ouring Group FGE 210. As regar ds these substances, the Author ity had indicated in its opinion 
on the Flavouri ng Group Evaluation 210 of 2009 (4) that they contain a structural alert for genot oxicity in their 
(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 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). 
(4)Scientific Opinion on Flav ouring Group Evaluation 210: alpha, beta-unsaturated alicy clic ketones and precursors from chemical 
subgroup 2.4 of FGE.19; EFSA Journal (2009) ON-1030, 1-18. https://efsa.onlinelibrar y.wiley .com/doi/pdf/10.2903/j.efsa.2009.1030 EN Offi cial Jour nal of the European Union 13.11.2020                                                                                                                                       L 379/27   molecular structure as they are alpha, beta-unsaturated ketones, and that additional genoto xicity data was needed to 
rule out the concer n on their genoto xicity in accordance with the Author ity’s document on the ‘Genoto xicity test 
strateg y for substances belonging to subgroups of the Flavouring Group FGE.19’ (5). 
(6) On 28 December 2012, data was submitte d concer ning subgroup 2.4 of substances from Flav ouring Group FGE.19. 
(7) The Author ity evaluate d the submitte d data in revision 1 of the Opinion on the genoto xic poten tial of the substances 
of Flavouring Group FGE 210 from chemical group 2.4 of Flav ouring Group FGE 19 published on 19 Febr uary 
2014 (6). However , the Author ity considered the submitted data was still insuffi cient to rule out the genot oxic 
poten tial of the concer ned substances and it requeste d further additional data on genoto xicity on the substances 
representative for this subgroup. 
(8) New data was submitte d in 2014. The Auth ority evaluated the new data in revision 2 of its Opinion, published on 
10 July 2015 (7). Howe ver, the Author ity considered that the new data was insuffi cient to rule out the genot oxic 
poten tial of the concer ned substances and requeste d once more further scientific data to be submitte d on the 
genoto xicity of the concer ned substances. 
(9) Further data was submitte d in 2016 on the concer ned substances. Followin g this submission, the Author ity 
requeste d further information and specific studies to be performe d by lette rs of 8 November 2016, 9 Febr uary 
2017, 29 June 2017 and 8 Febr uary 2019. However , the new data provi ded did not alwa ys correspond to the 
studies requested by the Auth ority and were not suitable to answer properly the Author ity’s concer ns. Taking into 
account all that additional data submitted , the Auth ority evaluated again the genoto xic poten tial of the concer ned 
substances in revision 3 of the Opinion on FGE.210 (8) published on 22 May 2019. The Author ity concluded that 
the concer n for genoto xicity cannot be ruled out for the five concer ned substances. 
(10) In view of the fact that neither the data submitted within the initial deadline nor the data submitted followi ng the 
Authority’s successive requests after that deadline had allowed the Author ity in 2019 to rule out the concer ns 
expressed in its Opinion of 2009, the Commission considers that it is not established that the concer ned substances 
do not pose a safety risk to the health of the consumer . Theref ore, on the basis of the scientific evidence submitted 
within the framew ork set out in Part A of Annex I to Regulation (EC) No 1334/2008 for the substances pending the 
compl etion of their evaluation, the use of the concer ned substances does not compl y with the general conditions of 
use for flavouri ngs set out in Article 4 of Regulation (EC) No 1334/2008. 
(11) Consequently , the concer ned substances should be removed from the Union list in order to prote ct human health. 
(12) Part A of Annex I to Regulation (EC) No 1334/2008 should theref ore be amended according ly. 
(13) Due to technical reasons, transitional periods should be provid ed for concer ning food to which any of the five 
flavouring substances have been added and which have been placed on the mark et or dispatch ed from third 
countr ies 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 whic h any of these five flavouring substances have been added and which are 
not intended to be consumed as such as the compo sition of these preparations are kno wn by their manufacturers 
when they prepare them. 
(14) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
(5)Genot oxicity Test Strategy for Substances belonging to Subgroups of FGE.19 – Statement of the Panel on Food Contact Materials, 
Enzymes, Flav ourings and Processing Aids (CEF); EFSA Journal (2008) 854, 1-5. https://efsa.onlinelibrar y.wiley .com/doi/pdf/10.2903/j. 
efsa.2008.854 
(6)Scientific Opinion on Flavour ing Group Evaluation 210, Revision 1 (FGE.210Rev1): Consideration of genot oxic potential for alpha, 
beta-unsaturat ed alicy clic ketones and precursors from chemi cal subgroup 2.4 of FGE.19. EFSA Journal 2014;12(2):3587, 35 pp. 
doi:10.2903/j.efsa.2014.3587 
(7)Scientific Opinion on Flav ouring Group Evaluation 210 Revision 2 (FGE.210Rev2): Consideration of genotoxic potential for alpha, 
beta-unsaturat ed alicy clic ketones and precursors from chem ical subgroup 2.4 of FGE.19. 10 July 2015. EFSA Journal 
2015;13(7):4172.doi:10.293/j.efsa.2015.4172 
(8)Scientific Opinion on Flav ouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for alpha, 
beta-unsaturat ed alicy clic ketones and precursors from chemical subgroup 2.4 of FGE.19. EFSA Journal 2019; 17(5):5676. EN Offi cial Jour nal of the European Union L 379/28                                                                                                                                       13.11.2020   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 which any of the flavouri ng substances listed in the Annex to this Regulation have been added and which 
were lawfully placed on the market prior to the date of entr y into force of this Regulation may continue to be mark eted 
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 market ed 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. 
3. The transitional periods provided in paragraphs 1 and 2 shall not apply to preparations not intended to be consumed 
as such to which any of these five flavouri ng substances have been added. 
4. For the purposes of this Regulation, preparations shall be underst ood as mixtures of one or more flavourings to 
which other food ingredients such as food additives, enzymes or carriers may be also incor porat ed to facilitate their 
storag e, sale, standardisation, dilution or dissolution. 
Article 3 
This Regulation shall enter into force on the twentieth day followi ng 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, 12 November 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 13.11.2020                                                                                                                                       L 379/29   ANNEX 
In Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008, the follo wing entr ies are deleted:                                                                
‘07.130 delta-Damascone 57378-68-4 386    2 JECF A/EFSA 
07.134 alpha-Damascone 43052-87-5 385 11053   2 JECF A/EFSA 
07.225 cis-1-(2,6,6- Trimethyl -2-cy clohexen -1-yl) 
but-2-en-1-one 23726-94-5   At least 92 %; secondar y compo nent 4 % 
trans-isomer  2 EFSA 
07.226 trans-1-(2,6,6- Trimethyl -2-cy clohexen -1-yl) 
but-2-en-1-one 24720-09-0     2 EFSA 
07.231 alpha-Damascenone 35044-63-4     2 EFSA ’   EN Offi cial Jour nal of the European Union L 379/30                                                                                                                                       13.11.2020