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13.11.2012 Official
Journal
of
the
European
Union
L
313/9
COMMISSION REGULATION (EU) No 1056/2012
of 12 November 2012
amending Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food
enzymes with regard to transitional measures
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
on food enzymes
( 5 ). It also adopted a scientific
opinion on 25 May 2011 updating the guidance for
the risk assessment of genetically modified micro-
Having regard to the Treaty on the Functioning of the European
organisms and their products intended for food and
Union,
feed use ( 6 ).
Having regard to Regulation (EC) No 1332/2008 of the
European Parliament and of the Council of 16 December
(5) The
detailed
requirements
set
out
in
Regulation
(EU)
No
2008 on food enzymes and amending Council Directive
234/2011, by the Authority’s guidance documents and
83/417/EEC, Council Regulation (EC) No 1493/1999,
explanatory note were adopted later than Regulation (EC)
Directive 2000/13/EC, Council Directive 2001/112/EC and
No 1332/2008.
Regulation (EC) No 258/97 ( 1 ), and in particular Article 17(5)
thereof,
(6) The
experience
gained
in
the
meantime
shows
that
the
initial deadline for submitting applications is insufficient
Whereas:
in order to allow stakeholders and in particular small and
medium sized enterprises to produce all necessary data
within that period. More time than originally foreseen is
(1) Pursuant
to
Article
17(2)
of
Regulation
(EC)
No
required for the submission of the applications to
1332/2008 the deadline for submitting enzyme appli
enhance the smooth transition from the present legal
cations is 24 months after the date of application of
situation to the system established by Regulation (EC)
the implementing measures to be laid down in
No 1332/2008. Therefore, the 24-month period estab
accordance with Article 9(1) of Regulation (EC) No
lished by Regulation (EC) No 1332/2008 for submitting
1331/2008 of the European Parliament and of the
enzyme applications should be extended.
Council of 16 December 2008 establishing a common
authorisation procedure for food additives, food enzymes
and food flavourings ( 2 ).
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health, and
(2) Commission
Regulation
(EU)
No
234/2011
of
10
March
2011 implementing Regulation (EC) No 1331/2008 (
neither the European Parliament nor the Council has

3 ) is
applicable from 11 September 2011.
opposed them,

(3) The
establishment
of
the
Union
list
of
food
enzymes HAS ADOPTED THIS REGULATION:
should take place smoothly and should not disturb the
existing food enzyme market, in particular small and
medium sized enterprises. If necessary, any appropriate
Article 1
transitional measures for the purposes of the estab
In Article 17(2) of Regulation (EC) No 1332/2008, the second
lishment of this list may be adopted in accordance
subparagraph is replaced by the following:
with the procedure referred to in Article 17(5) of Regu
lation (EC) No 1332/2008.
"The deadline for submitting such applications shall be 42
months after the date of application of the implementing
(4) Pursuant
to
Article
5(3)
of
Regulation
(EU)
No
measures laid down in accordance with Article 9(1) of Regu
234/2011, the applicants shall take into account latest
lation (EC) No 1331/2008 establishing a common authori
guidance concerning the data required for risk assessment
sation procedure for food additives, food enzymes and food
established by the European Food Safety Authority ("the
flavourings."
Authority") that is available at the time of the submission
of the application. The Authority adopted a scientific
opinion on 23 July 2009 providing guidance on data
Article 2
requirements for the evaluation of food enzyme appli
cations ( 4 ) and issued on 8 July 2011 an explanatory
This Regulation shall enter into force on the twentieth day
note for the guidance on the submission of a dossier
following that of its publication in the Official Journal of the
European Union.
( 1 ) OJ L 354, 31.12.2008, p. 7.
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 5 ) Supporting Publication 2011:177. http://www.efsa.europa.eu/en/
( 3 ) OJ L 64, 11.3.2011, p. 15.
supporting/doc/177e.pdf
( 4 ) The EFSA Journal (2009) 1305, p. 1. http://www.efsa.europa.eu/en/
( 6 ) EFSA Journal 2011;9(6):2193. http://www.efsa.europa.eu/en/
scdoc/doc/1305.pdf
efsajournal/doc/2193.pdf

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L 313/10
EN
Official Journal of the European Union
13.11.2012
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 November 2012.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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