HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 224/4
EN
Official Journal of the European Union
22.8.2013
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,
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
Having regard to the Treaty on the Functioning of the European
under evaluation for which additional scientific data
Union,
had to be submitted. Such data was submitted.
Having regard to Regulation (EC) No 1831/2003 of the
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
European Parliament and of the Council of 22 September
concluded in its opinion of 15 May 2013 ( 4 ) about the
2003 on additives for use in animal nutrition (
use of this substance as a flavouring substance in food

1 ), and in
particular Article 9(2) thereof,
that this substance is mutagenic in vitro and in vivo and
that its use as a flavouring substance in food raises a
safety concern.
Whereas:
(6) This
assessment
indicates
that
3-acetyl-2,5-dimethyl
thiophene is very likely to be mutagenic also for
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
animals consuming feed containing this substance as a
orisation of additives for use in animal nutrition and
sensory additive. Consequently, it has not been estab
for the grounds and procedures for granting or denying
lished that this substance does not have an adverse
such authorisation. Article 10 of that Regulation provides
effect on animal health, when used as a feed additive
for the re-evaluation of additives authorised pursuant to
under the proposed conditions of use.
Council Directive 70/524/EEC ( 2 ).
(7) The
conditions
for
authorisation,
as
provided
for
in
(2) The
substance
3-acetyl-2,5-dimethylthiophene
was
auth
Article 5 of Regulation (EC) No 1831/2003, are
orised without a time limit in accordance with Directive
therefore not satisfied. Accordingly, the authorisation of
70/524/EEC as a feed additive for use on all animal
3-acetyl-2,5-dimethylthiophene as a feed additive should
species as part of the group ‘Flavouring and appetising
be denied.
substances — All natural products and corresponding
synthetic products’. That substance was subsequently
entered in the European Union Register of Feed
(8)
Since further use of 3-acetyl-2,5-dimethylthiophene as a
Additives as an existing product, in accordance with
feed additive may cause a risk to animal health, it should
Article 10(1) of Regulation (EC) No 1831/2003, with
be withdrawn from the market as soon as possible.
CAS number 2530-10-1 and Flavis number 15.024.
(9) Taking
into
account
practical
reasons,
a
transitional
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
period should be laid down to address the situation of
1831/2003 in conjunction with Article 7 thereof, an
existing stocks of feed containing the flavouring
application was submitted for the re-evaluation of this
substance 3-acetyl-2,5-dimethylthiophene already in the
substance as a feed additive for all animal species,
market before the entry into force of this Regulation.
requesting that additive to be classified in the additive
category ‘sensory additives’ and in the functional group
‘flavouring compounds’. That application was accom
(10) The
measures
provided
for
in
this
Regulation
are
in
panied by the particulars and documents required
accordance with the opinion of the Standing
under Article 7(3) of Regulation (EC) No 1831/2003.
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
(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
Article 1
European Parliament and of the Council of 16 December
2008 on flavourings and certain food ingredients with
Authorisation of 3-acetyl-2,5-dimethylthiophene as an additive
flavouring properties for use in and on foods and
in animal nutrition is denied.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 3 ) OJ L 354, 31.12.2008, p. 34.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 4 ) EFSA Journal 2013; 11(5):3227.

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EN
22.8.2013 Official
Journal
of
the
European
Union L
224/5
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 BARROSO

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Document Outline

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