COMMISSION IMPLEMENTING REGULATION (EU) No 796/2013  
of 21 August 2013  
concerning the denial of authorisation of the substance 3-acetyl-2,5-dimethylthiophene as a feed 
additive  
(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 1831/2003 of the 
European Parliament and of the Council of 22 September 
2003 on additives for use in animal nutrition (  1 ), and in 
particular Article 9(2) thereof,  
Whereas:  
(1) Regulation (EC) No 1831/2003 provides for the auth ­
orisation of additives for use in animal nutrition and 
for the grounds and procedures for granting or denying 
such authorisation. Article 10 of that Regulation provides 
for the re-evaluation of additives authorised pursuant to 
Council Directive 70/524/EEC (  2 ). 
(2) The substance 3-acetyl-2,5-dimethylthiophene was auth ­
orised without a time limit in accordance with Directive 
70/524/EEC as a feed additive for use on all animal 
species as part of the group ‘Flavouring and appetising 
substances — All natural products and corresponding 
synthetic products’. That substance was subsequently 
entered in the European Union Register of Feed 
Additives as an existing product, in accordance with 
Article 10(1) of Regulation (EC) No 1831/2003, with 
CAS number 2530-10-1 and Flavis number 15.024.  
(3) In accordance with Article 10(2) of Regulation (EC) No 
1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the re-evaluation of this 
substance as a feed additive for all animal species, 
requesting that additive to be classified in the additive 
category ‘sensory additives’ and in the functional group 
‘flavouring compounds’. That application was accom ­
panied by the particulars and documents required 
under Article 7(3) of Regulation (EC) No 1831/2003.  
(4) The substance 3-acetyl-2,5-dimethylthiophene was also 
included in the list of flavouring substances in Part A 
of Annex I 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, Regu ­
lations (EC) No 2232/96 and (EC) No 110/2008 and 
Directive 2000/13/EC (  3 ), as a flavouring substance 
under evaluation for which additional scientific data 
had to be submitted. Such data was submitted.  
(5) The European Food Safety Authority (‘the Authority’) 
concluded in its opinion of 15 May 2013 (  4 ) about the 
use of this substance as a flavouring substance in food 
that this substance is mutagenic  in vitro  and  in vivo  and 
that its use as a flavouring substance in food raises a 
safety concern.  
(6) This assessment indicates that 3-acetyl-2,5-dimethyl ­
thiophene is very likely to be mutagenic also for 
animals consuming feed containing this substance as a 
sensory additive. Consequently, it has not been estab ­
lished that this substance does not have an adverse 
effect on animal health, when used as a feed additive 
under the proposed conditions of use.  
(7) The conditions for authorisation, as provided for in 
Article 5 of Regulation (EC) No 1831/2003, are 
therefore not satisfied. Accordingly, the authorisation of 
3-acetyl-2,5-dimethylthiophene as a feed additive should 
be denied.  
(8) Since further use of 3-acetyl-2,5-dimethylthiophene as a 
feed additive may cause a risk to animal health, it should 
be withdrawn from the market as soon as possible.  
(9) Taking into account practical reasons, a transitional 
period should be laid down to address the situation of 
existing stocks of feed containing the flavouring 
substance 3-acetyl-2,5-dimethylthiophene already in the 
market before the entry into force of this Regulation.  
(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  
Authorisation of 3-acetyl-2,5-dimethylthiophene as an additive 
in animal nutrition is denied.EN L 224/4 Official Journal of the European Union 22.8.2013  
( 1 ) OJ L 268, 18.10.2003, p. 29.  
( 2 ) OJ L 270, 14.12.1970, p. 1.  ( 3 ) OJ L 354, 31.12.2008, p. 34.  
( 4 ) EFSA Journal 2013 ; 11(5):3227.Article 2  
Existing stocks of 3-acetyl-2,5-dimethylthiophene and premixtures containing it shall be withdrawn from 
the market as soon as possible and at the latest by 11 October 2013. Compound feed produced containing 
3-acetyl-2,5-dimethylthiophene before the date of entry into force of this Regulation may be used up until 
stocks are exhausted and at the latest by 11 October 2013.  
Article 3  
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 is binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 21 August 2013.  
For the Commission  
The President  
José Manuel BARROSOEN 22.8.2013 Official Journal of the European Union L 224/5