EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1083 
(POOL/E2/2023/1083/1083 -EN.docx) 
D091962/02  
[…](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 removal of certain flavouring substances from the Union list  
 
(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 removal of certain flavouring substances from the Union list  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on t he 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 amendin g 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 Decem ber 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 materi als 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.  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 .  
(3) The Union list of  flavourings 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 th at list by Regulation (EU) No 872/2012, the 
European Food Safety Auth ority (‘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, 
therefore, considered that additional data was necessary to complete their evaluation. 
Those substances were inclu ded in the Union list of flavouring substances 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 
 
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 Regulation (EC) No 1334/2008. Howe ver, the operators responsible for placing the  
following eight substances  on the market as flavouring substances, for which the 
Authority requested additional scientific data, did not submit the required data and 
withdrew their respective applications : 2-Phenylpent -2-enal (FL No 05.175); 2-
Phenyl -4-methyl -2-hexenal  (FL No 05.222); 2-(sec-Butyl) -4,5-dimethyl -3-thiazoline  
(FL No 15 .029); 4,5-Dimethyl -2-ethyl -3-thiazoline  (FL No 15.030); 2,4-Dimethyl -3-
thiazoline   (FL No 15.060); 2 -Isobutyl -3-thiazoline (FL N o 15.119);  5-Ethyl -4-
methyl -2-(2-methylpropyl) -thiazoline  (FL No 15.130); 5 -Ethyl -4-methyl -2-(2- butyl) -
thiazoline (FL No 15.131)  (‘substances  concerned ’).The  substances concerned should 
therefore be removed from the Union list of flavouring substances .  
(4) Regulation (EC) No 1334/2008 should therefore be amended accordingly . 
(5) Foods 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 w ere 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 s ubstances concerned has been added and which are not intended to be 
consumed as such, as the manufacturers of food products that use those preparations as 
ingredients know their composition when they use them . 
(6) The measures provided for in this Regulation a re in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
 Amendments for 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 has been added and which were lawfully placed on the market before the 
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 which any of the flavouring substances listed in the 
Annex to this Regulation has been added may be marketed until their date of 
minimum durabil ity or use -by date, if the importer of such food 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 paragrap hs 1 and 2 shall not apply to 
preparations, not intended to be consumed as such, to which any of the flavouring 
substances listed in the Annex to this Regulation has been added .   
EN 3  EN 4. For the purposes of this Regulation, preparations shall be understood as mixt ures of 
one or more flavourings to which other food ingredients such as food additives, 
enzymes or carriers may be also incorporated to facilitate their storage, sale, 
standardisation, dilution or dissolution . 
Article 3  
Entry into force  
This Regulation sha ll 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 the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN