COMMISSION REGULATION (EU) No 545/2013  
of 14 June 2013  
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council 
as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene  
(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 (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) thereof,  
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 flavourings (  2 ), and in 
particular Article 7(6) thereof,  
Whereas:  
(1) Commission Implementing Regulation (EU) No 
872/2012 (  3 ) has adopted a list of flavouring substances 
and has introduced that list in Part A of Annex I to 
Regulation (EC) No 1334/2008.  
(2) That list may be updated in accordance with the 
common procedure referred to in Regulation (EC) No 
1331/2008, either on the initiative of the Commission 
or following an application by a Member State or by an 
interested party.  
(3) The flavouring substance 3-acetyl-2,5-dimethylthiophene 
(FL-no 15.024) is included in the list as a flavouring 
substance under evaluation for which additional scientific 
data must be submitted. Such data has been submitted by 
the applicant.  
(4) The European Food Safety Authority has evaluated the 
submitted data and concluded on 15 May 2013 that 3- 
acetyl-2,5-dimethylthiophene is mutagenic both  in vitro  
and in vivo  and that therefore its use as flavouring 
substance raises a safety concern (  4 ). 
(5) Accordingly the use of 3-acetyl-2,5-dimethylthiophene 
does not comply with the general conditions of use for 
flavourings set out in Article 4(a) of Regulation (EC) No 
1334/2008. Consequently, that substance should be 
removed from the list without delay in order to protect 
human health.  (6) The Commission should use the urgency procedure for 
the removal of a substance which raises a safety concern 
from the Union list.  
(7) Pursuant to Article 30 of Regulation (EC) No 1334/2008 
flavouring substances not included in the Union list may 
be placed on the market as such and used in or on food 
until 22 October 2014. That transitional period should 
not apply to 3-acetyl-2,5-dimethylthiophene.  
(8) Due to very low use levels and the low total amount that 
3-acetyl-2,5-dimethylthiophene has been added yearly to 
foods in the European Union, the presence of that 
substance in food does not raise immediate safety 
concerns. Therefore, taking into account also technical 
and economic reasons, transitional periods should be 
laid down to cover food containing the flavouring 
substance 3-acetyl-2,5-dimethylthiophene, which has 
been placed on the market or dispatched from third 
countries for the Union, before the date of entry into 
force of this Regulation.  
(9) 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 the Food Chain and Animal Health,  
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. The placing on the market of 3-acetyl-2,5-dimethyl ­
thiophene as a flavouring substance and the use of that 
substance in or on foods shall be prohibited.  
2. The placing on the market of food containing the 
flavouring substance 3-acetyl-2,5-dimethylthiophene shall be 
prohibited.  
3. The import of 3-acetyl-2,5-dimethylthiophene as a 
flavouring substance and the import of food containing the 
flavouring substance 3-acetyl-2,5-dimethylthiophene shall be 
prohibited.EN 15.6.2013 Official Journal of the European Union L 163/15  
( 1 ) OJ L 354, 31.12.2008, p. 34.  
( 2 ) OJ L 354, 31.12.2008, p. 1.  
( 3 ) OJ L 267, 2.10.2012, p. 1.  
( 4 ) EFSA Journal 2013; 11(5):3227.Article 3  
1. By way of derogation to Article 2(2), foods containing the 
flavouring substance 3-acetyl-2,5-dimethylthiophene which have 
been legally placed on the market before the date of entry into 
force of this Regulation may be marketed until their ‘use by’ 
date or their date of minimum durability.  
2. Article 2 shall not apply to consignments of food 
containing the flavouring substance 3-acetyl-2,5-dimethyl ­thiophene where the importer of such food can demonstrate 
that they have been dispatched from the third country 
concerned and were en route to the Union before the date of 
entry into force of this Regulation.  
Article 4  
This Regulation shall enter into force on the 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, 14 June 2013.  
For the Commission  
The President  
José Manuel BARROSO  
ANNEX  
In Part A of Annex I to Regulation (EC) No 1334/2008, the following entry for FL 15.024 is deleted: 
‘15.024  3-Acetyl-2,5-dimethylthiophene  2530-10-1  1051  11603  2  EFSA’EN L 163/16 Official Journal of the European Union 15.6.2013