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15.6.2013 Official
Journal
of
the
European
Union L
163/15
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,
(6) The
Commission
should
use
the
urgency
procedure
for
the removal of a substance which raises a safety concern
Having regard to the Treaty on the Functioning of the European
from the Union list.
Union,
(7) Pursuant
to
Article
30
of
Regulation
(EC)
No
1334/2008
Having regard to Regulation (EC) No 1334/2008 of the
flavouring substances not included in the Union list may
European Parliament and of the Council of 16 December
be placed on the market as such and used in or on food
2008 on flavourings and certain food ingredients with
until 22 October 2014. That transitional period should
flavouring properties for use in and on foods and amending
not apply to 3-acetyl-2,5-dimethylthiophene.
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,
(8)
Due to very low use levels and the low total amount that
3-acetyl-2,5-dimethylthiophene has been added yearly to
Having regard to Regulation (EC) No 1331/2008 of the
foods in the European Union, the presence of that
European Parliament and of the Council of 16 December
substance in food does not raise immediate safety
2008 establishing a common authorisation procedure for
concerns. Therefore, taking into account also technical
food additives, food enzymes and food flavourings ( 2 ), and in
and economic reasons, transitional periods should be
particular Article 7(6) thereof,
laid down to cover food containing the flavouring
substance 3-acetyl-2,5-dimethylthiophene, which has
Whereas:
been placed on the market or dispatched from third

countries for the Union, before the date of entry into
force of this Regulation.
(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
(9) Regulation
(EC)
No
1334/2008
should
therefore
be
Regulation (EC) No 1334/2008.
amended accordingly.
(2) That
list
may
be
updated
in
accordance
with
the
common procedure referred to in Regulation (EC) No
(10) The
measures
provided
for
in
this
Regulation
are
in
1331/2008, either on the initiative of the Commission
accordance with the opinion of the Standing
or following an application by a Member State or by an
Committee on the Food Chain and Animal Health,
interested party.
HAS ADOPTED THIS REGULATION:
(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
Article 1
data must be submitted. Such data has been submitted by
the applicant.
Part A of Annex I to Regulation (EC) No 1334/2008 is
amended in accordance with the Annex to this Regulation.
(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
Article 2
and in vivo and that therefore its use as flavouring
1. The
placing
on
the
market
of
3-acetyl-2,5-dimethyl
substance raises a safety concern ( 4 ).
thiophene as a flavouring substance and the use of that
substance in or on foods shall be prohibited.
(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
2. The
placing
on
the
market
of
food
containing
the
1334/2008. Consequently, that substance should be
flavouring substance 3-acetyl-2,5-dimethylthiophene shall be
removed from the list without delay in order to protect
prohibited.
human health.
3. The import of 3-acetyl-2,5-dimethylthiophene as a
( 1 ) OJ L 354, 31.12.2008, p. 34.
flavouring substance and the import of food containing the
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 3 ) OJ L 267, 2.10.2012, p. 1.
flavouring substance 3-acetyl-2,5-dimethylthiophene shall be
( 4 ) EFSA Journal 2013; 11(5):3227.
prohibited.

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L 163/16
EN
Official Journal of the European Union
15.6.2013
Article 3
thiophene where the importer of such food can demonstrate
that they have been dispatched from the third country
1. By
way
of
derogation
to
Article
2(2),
foods
containing
the concerned and were en route to the Union before the date of
flavouring substance 3-acetyl-2,5-dimethylthiophene which have
entry into force of this Regulation.
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.
Article 4
2. Article
2
shall
not
apply
to
consignments
of
food
This Regulation shall enter into force on the day following that
containing the flavouring substance 3-acetyl-2,5-dimethyl
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’

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Document Outline

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