HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 163/52
EN
Official Journal of the European Union
23.6.2011
COMMISSION DECISION
of 17 June 2011
amending Decision 2006/197/EC as regards the renewal of the authorisation to place on the market
existing feed produced from genetically modified maize line 1507 (DAS-157-1) pursuant to
Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document C(2011) 4159)
(Only the Dutch, English and French texts are authentic)
(Text with EEA relevance)
(2011/365/EU)
THE EUROPEAN COMMISSION,
opinions of the EFSA GMO Panel on maize line 1507 ( 3 )
do not require changes of the previous scientific opinions
on maize line 1507. Furthermore, EFSA reiterated the
Having regard to the Treaty on the Functioning of the European
previous conclusions that 1507 maize is unlikely to
Union,
have an adverse effect on human and animal health or
the environment in the context of its proposed uses. This
includes the use of feed produced from maize line
1507 (
Having regard to Regulation (EC) No 1829/2003 of the

4 ).
European Parliament and of the Council of 22 September
2003 on genetically modified food and feed ( 1 ), and in
(5) In
its
opinion,
EFSA
considered
all
the
specific
questions
particular Articles 7(3) and 19(3) thereof,
and concerns raised by the Member States in the context
of the consultation of the national competent authorities
as provided for by Article 18(4) of that Regulation.
Whereas:
(6) By
letter
of
21
January
2010,
the
applicant
confirmed
(1) Commission
Decision
2006/197/EC
of
3
March
2006
that he is aware of the fact that renewing the authori
authorising the placing on the market of food containing,
sation of existing feed produced from maize line 1507
consisting of, or produced from genetically modified
by extending the scope of Decision 2006/197/EC so as
maize line 1507 (DAS-157-1) pursuant to Regulation
to include such product, would imply this category of
(EC) No 1829/2003 of the European Parliament and of
products to be subject to the legal provisions of that
the Council ( 2 ) does not cover the placing on the market
Decision.
of feed produced from maize line 1507 (DAS-157-1)
(hereafter ‘maize line 1507’).
(7) On
the
basis
of
the
EFSA
opinion,
no
specific
labelling
requirements other than those provided for in
Article 25(2) of Regulation (EC) No 1829/2003 appear
(2) Feed
produced
from
maize
line
1507
has
been
placed
on
the market before the date of application of Regulation
to be necessary for feed produced from maize line 1507.
(EC) No 1829/2003 and notified in accordance with
Article 20(1)(b) of that Regulation.
(8) The
EFSA
opinion
does
not
justify
the
imposition
of
specific conditions or restrictions for the placing on the
market and/or specific conditions or restrictions for the
(3) On
12
April
2007
Pioneer
Overseas
Corporation
on
use and handling, including post-market monitoring
behalf of Pioneer Hi-bred International and Dow AgroS
requirements for the use of the feed, as provided for in
ciences on behalf of Mycogen Seeds jointly submitted to
point (e) of Article 18(5) of Regulation (EC)
the Commission an application, in accordance with
No 1829/2003.
Article 23 of Regulation (EC) No 1829/2003, for
renewal of the authorisation for continued marketing
(
of existing feed produced from maize line 1507.

3 ) EFSA opinions published on:

— 24 September 2004 for the placing on the market of maize
1507 for import and processing;
http://registerofquestions.efsa.europa.eu/roqFrontend/
(4) On
11
June
2009,
the
European
Food
Safety
Authority
questionLoader?question = EFSA-Q-2004-011
— 19 January 2005 for the placing on the market of maize 1507
(‘EFSA’) gave a favourable opinion in accordance with
for import, feed and industrial processing and cultivation;
Article 18 of Regulation (EC) No 1829/2003 and
http://registerofquestions.efsa.europa.eu/roqFrontend/
concluded that the new information provided in the
questionLoader?question = EFSA-Q-2004-072
application and the review of the scientific literature
— 19 January 2005 for the placing on the market of maize 1507
that has been published since the previous scientific
for food use;
http://registerofquestions.efsa.europa.eu/roqFrontend/
questionLoader?question = EFSA-Q-2004-087
( 1 ) OJ L 268, 18.10.2003, p. 1.
( 4 ) http://registerofquestions.efsa.europa.eu/roqFrontend/
( 2 ) OJ L 70, 9.3.2006, p. 82.
questionLoader?question = EFSA-Q-2007-144

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EN
23.6.2011 Official
Journal
of
the
European
Union L
163/53
(9)
For the sake of transparency, the applicant has been
the unique identifier DAS-157-1, as provided for in
consulted on the measures provided for in this Decision.
Regulation (EC) No 65/2004.
(10) Taking
into
account
these
considerations,
renewal
of
the
Article 2
authorisation to place on the market existing feed
produced from maize line 1507 should be granted.
Placing on the market
The placing on the market of the products, according to the
conditions specified in this Decision and its Annex, is auth
(11) Since it is general practice to authorise the placing on the
orised for the purposes of Articles 4(2) and 16(2) of Regu
market of food and feed in the same decision, the
lation (EC) No 1829/2003.
renewal of the authorisation to place on the market
feed produced from maize line 1507 should be
included in Decision 2006/197/EC. Decision
2006/197/EC should therefore be amended accordingly.
Article 3
Labelling
(12) The
Standing
Committee
on
the
Food
Chain
and
Animal
For the purposes of the specific labelling requirements
Health has not delivered an opinion within the time limit
provided for in Articles 13(1) and 25(2) of Regulation
laid down by its Chair and the Commission therefore
(EC) No 1829/2003, the “name of the organism” shall be
submitted to the Council a proposal relating to these
“maize”.’;
measures. Since, at its meeting on 17 March 2011, the
Council was unable to reach a decision by qualified
majority either for or against the proposal and the
(3) the Annex is amended as follows:
Council indicated that its proceedings on this file were
concluded, these measures are to be adopted by the
Commission,
(a) Section (b) is replaced by the following:
HAS ADOPTED THIS DECISION:
‘(b) Designation and specification of the products:
Article 1
Amendments
(i) foods and food ingredients containing,
consisting of, or produced from DAS-157-
Decision 2006/197/EC is amended as follows:
1 maize;
(1) the title is replaced by the following:
(ii) feed produced from DAS-157-1 maize.
‘Commission Decision of 3 March 2006 authorising the
placing on the market of food containing, consisting of,
The genetically modified DAS-157-1 maize,
or produced from genetically modified maize line 1507
as described in the application, is resistant to
(DAS-157-1) and renewing the authorisation to place
the European corn borer (Ostrinia nubilalis) and
on the market feed produced from such maize, pursuant
certain other lepidopteran pests and is tolerant
to Regulation (EC) No 1829/2003 of the European
to the herbicide glufosinate-ammonium. The
Parliament and of the Council’;
genetically modified DAS-157-1 maize
contains the following DNA sequences in two
(2) Articles 1, 2 and 3 of Decision 2006/197/EC are replaced
cassettes:
by the following:
‘Article 1
— cassette 1:
Products
A synthetic version of the truncated cry1F
This Decision covers foods and food ingredients containing
gene from Bacillus thuringiensis subsp.
and consisting of, or produced from genetically modified
aizawai, which confers resistance to the
maize (Zea mays L.) line 1507 and feed produced from
European corn borer (Ostrinia nubilalis) and
such maize (the products).
certain other lepidopteran pests, under the
regulation of the ubiquitin promoter
ubiZM1(2) from Zea mays L. and the
Genetically modified maize (Zea mays L.) line 1507 as
ORF25PolyA terminator from Agrobacterium
further specified in the Annex to this Decision is assigned
tumefaciens pTi15955,

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L 163/54
EN
Official Journal of the European Union
23.6.2011
— cassette 2:
Article 2
Addressees
A synthetic version of the pat gene from
This Decision is addressed to:
Streptomyces viridochromogenes strain Tü494,
which confers tolerance to the herbicide
glufosinate-ammonium, under the regu
lation of the 35S promoter and terminator
(a) Pioneer Overseas Corporation, Avenue des Arts 44, 1040
sequences from Cauliflower Mosaic Virus.’;
Brussels, Belgium; and
(b) Section (c) is replaced by the following:
(b) Dow AgroSciences Europe, European Development Centre,
3 Milton Park, Abingdon, Oxon OX14 4RN, United
‘(c) Labelling:
Kingdom.
No specific requirements other than those provided
for in Articles 13(1) and 25(2) of Regulation (EC)
Done at Brussels, 17 June 2011.
No 1829/2003.
For the Commission
For the purpose of Articles 13(1) and 25(2) of
Regulation (EC) No 1829/2003, the “name of
John DALLI
organism” shall be “maize”.’.
Member of the Commission

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