EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10306/2015 Rev. 1 CIS 
(POOL/E7/2015/10306/10306R1 -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 ame nding 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 De cember 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 mate rials for use in food and their conditions of use.  
(2) Commission Implementing Regulation (EU) No 872/20123 adopted the 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 acc ordance 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) Part A of the Union list contains b oth evaluated flavouring substances, which are 
assig ned no footnotes , and flavouring  substances under evaluation, which are 
identified by footnote references 1 to 4 in that list.  
                                                 
1 OJ L 354, 3 1.12.2008, 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, int roducing 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 3   EN (5) The European Food Safety Authority  (EFSA) has completed the assessment of 5 
substances which are currently listed as flavouring substances under evaluation. Th ose 
flavouring substances were assessed by EFSA in the following flavouring group 
evaluations: evaluation FGE.12rev54 (substances FL -no 07.041 and 07.224), 
FGE.63rev25 (subst ances FL -no 07.099 and 07.101), and evaluation FGE.3126 
(substance FL -no 16.126). EFSA concluded that these flavouring substances do not 
give rise to safety concerns at the estimated levels of dietary intake.  
(6) As part of its  evaluation, EFSA has made commen ts on the specification s of certain of 
those substances. The comments are related to names, purity or composition of the 
substances FL -nos: 07.041, 07.224 and 07.099. Th ose comments should be introduced 
in the list.  
(7) The U nion l ist referred to in Regulation  (EC) No 1334/2008 is intended to regulate 
only the use of flavouring substances which are added to food in order to impart or 
modify odour and/or taste. Substance FL -no 16.126 could also be added to food for 
other purposes than flavouring and such uses re main subject to other rules. This 
Regulation lays down conditions of use which relate solely to its use  as a flavouring 
substance.  
(8) The flavouring substances assessed in th ose evaluations should be listed as evaluated 
substances by deleting footnote referen ces 1 to 4 in the relevant entries of the Union 
list. 
(9) Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended 
accordingly.  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Pl ants, 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  
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,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
4 EFSA Journal 201 4; 11(12):3911. 
5 EFSA Journal 201 4; 11(4):3188. 
6 EFSA Journal 2013;  11(10):3404 .