EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1469  
(POOL/E2/2023/1469/1469 -EN.docx) 
D091974/02  
[…](2023) 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 the introduction of restrictions on the use 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 the introduction of restrictions on the use 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 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 Council 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 Decembe r 2008 establishing a common authorisation procedure for food 
additives, food enzymes and food flavourings2, and in particular Article 7(5) thereof,  
Whereas:  
(1) Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and 
source material s approved for use in and on foods and their conditions of use.  
(2) By Commission Implementing Regulation (EU) No 872/20123 the list of flavouring 
substances was adopted and introduce d in Part A of Annex I to Regulation (EC) 
No 1334/2008.  
(3) That list 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 list of fla vourings and source materials laid down in Annex I to Regulation 
(EC) No 1334/2008 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 the consumer on the basis of the data available and had, 
 
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 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 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 
condition that safety data addressing the concerns 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.  
(5) Among the substances included in the Union list of flavourings and source materials 
but identified by way of a footnote reference requiring the Authority to complete the 
evaluation, there are the following three substances of the Flavouring Group 
Evaluation 216 (FGE.216): 2 -Phenyl -2-butenal (FL No 05.062), 5 -Methyl -2-phenyl -2-
hexenal (FL No 05.099) and 4 -Methyl -2-phenyl -2-pentenal (FL No 05.100). For those 
substances the Authority requested additional scientific data that were subsequently 
submitted by the applic ants. 
(6) In its scientific opinion of 29 June 20224, the Authority evaluated the submitted data 
and concluded that the representative substance of the group, 2 -Phenyl -2-butenal (FL 
No 05.062) , induced an aneugenicity mode of action. As the available in -vivo 
micronucleus studies were inconclusive, an in vivo potential aneugenicity cannot be 
ruled out for 2 -Phenyl -2-butenal (FL No 05.062) , 5-Methyl -2-phenyl -2-hexenal (FL 
No 05.099) and 4 -Methyl -2-phenyl -2-pentenal (FL No 05.100).  
(7) Following this opinion  and in o rder to further evaluate the safety of those three 
substances  the interested business operators committed to provide further data that 
would allow a thorough assessment of the in vivo aneugenicity for these three 
substances5. 
(8) It is also appropriate , pending the re-evaluation by the Authority of the  additional data 
from the interested business operators and following on from the scientific opinion of 
29 June 2022, to limit the conditions of use of 2-Phenyl -2-butenal (FL No 05.062), 5 -
Methyl -2-phenyl -2-hexenal (FL No 05.099) and 4 -Methyl -2-phenyl -2-pentenal (FL 
No 05.100)  to their current use .  
(9) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended 
accordingly.  
(10) Foods not complying with the new conditions set out , to which any of the  substances 
concerned have been added and which have been placed on the market in the Union or 
which have been dispatched from third countries and were in transit to the Union 
before the entry into force of this Regulation should be allowed to be marketed in the 
Union until their date of minimum durability or use -by date. This transitional measure 
should not apply to preparations to which any of the substances concerned has been 
added and which are not intended to be consumed as such, as the manufacturers o f 
food products that use those preparations as ingredients know their composition when 
they use them . 
 
4 Scientific Opinion on Flavouring Group Evaluation 216 Revision 2 (FGE.2 16Rev2): Scientific opinion 
on Flavouring group evaluation 216 revision 2 (FGE.216Rev2): consideration of the genotoxicity 
potential of α,β‐un saturated 2‐phenyl‐2‐alkenals from subgroup 3.3 of FGE.19 . EFSA Journal 
2022;20(8):7420 ,  doi:10.2903/j.efsa.2022.7420 . Available online: 
https://www.efsa.europa.eu/en/efsajournal/pub/7420  
5 IOFI EFFA Letter DG Sante - EFSA Opinion 216 Rev2 (EFSA Journal (2022; 20(8) 7420)) - follow -up 
IOFI/EFFA letter: confirmation of follow -up testing and anticipated timings. Ares(2022)8489668   
EN 3  EN (11) For reasons of harmonisation with Regulation (EC) No 1333/2008 of the European 
Parliament and the Council6 and in order to account for the restrictions that correspond 
to the food categories used by the Authority during the exposure assessment, the food 
categories listed in Section 1  of Part A of Annex I  to Regulation (EC) No 1334/2008 
should be replaced by th e food categories listed in Part D of Annex II to Regulation 
(EC) No 1333/2008.  
(12) A new footnote should be added to column 8 in the Union list, under Section 1  of Part 
A of Annex I to Regulation (EC) No 1334/2008 to indicate the need for additional data 
where additional data are expected in order to fully complete the assessment of the 
Authority.   
(13) The measures provided for in this Regulation are in accordance with the opini on of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to Regulation (EC) No  1334/2008  
Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
Transitional measures  
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 i nto 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,  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 useby date where the importer of 
such foods can demonstrate that they were dispatched from the third country 
concerned and  were   in transit  to the Union before the entry into force of this 
Regulation.  
3. The transitional measures provided for in paragraphs 1 and 2 shall not apply to 
preparations, not intended to be consumed as such, to which any of the flavouring 
substances list ed in the Annex to this Regulation has been added .  
4. For the purposes of this Regulation, preparations shall be understood as mixtures of 
one or more flavourings to which other food ingredients such as food additives, 
enzymes or carriers may be also incorpo rated to facilitate their storage, sale, 
standardisation, dilution or dissolution . 
 
 
6 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on 
food additives  (OJ L 354, 31.12.2008, p. 16 ).  
EN 4  EN Article 3  
Entry into force  
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