2006/197/EC: Commission Decision of  3 March 2006  authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2006-03-03
Institutions: European Commission
Subjects: animal nutrition, food inspection, foodstuff, genetically modified organism, labelling, maize, market approval

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COMMISSION DECISION

of 3 March 2006

authorising the placing on the market of
food containing, consisting of, or produced from
genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003
of the European Parliament and of the Council

(2006/197/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1829/2003 of
European Parliament and of
the Council of 22 September
2003 on genetically modified food and feed (1), and in
particular Article 7(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

On 15 February 2001, Pioneer Overseas Corporation and
Dow AgroSciences Europe jointly submitted to the
competent authorities of the Netherlands a request,
in
accordance with Article 4 of Regulation (EC) No
258/97 of the European Parliament and of the Council
of 27 January 1997 concerning novel foods and novel
food ingredients (2), for the placing on the market of
foods and food ingredients derived from genetically
modified maize line 1507 as novel foods or as novel
food ingredients (the products).

In their initial assessment report of 4 November 2003,
food assessment body
the Netherlands
concluded that the products are just as safe as foods
and food ingredients derived from conventional maize
lines and may be used in the same manner.

competent

The Commission forwarded the initial assessment report
to all Member States on 10 November 2003. Within the
60-day period laid down in Article 6(4) of Regulation
(EC) No 258/97, reasoned objections to the placing on
the market of the products were raised in accordance
with that provision. As a consequence, an additional
assessment report was required.

referred to as

Article 46(1) of Regulation (EC) No 1829/2003 (here-
inafter
that
requests submitted pursuant to Article 4 of Regulation
(EC) No 258/97 before the date of application of the

the Regulation) provides

Regulation,
i.e. 18 April 2004, shall be transformed
into applications pursuant to Chapter II, Section 1 of
the Regulation in cases where an additional assessment
report is required in accordance with Article 6(3) or (4)
of Regulation (EC) No 258/97.

The scope of Regulation (EC) No 258/97 is limited to the
placing on the market, within the Community, of novel
foods or novel
food ingredients. Consequently the
present decision does not cover the placing on the
market of
feed containing, consisting of or produced
from maize line 1507.

In particular, the placing on the market of genetically
modified maize line 1507 as or
in some products
including feed containing or consisting of this maize is
subject
to Commission Decision 2005/772/EC of 3
November 2005 concerning the placing on the market,
in accordance with Directive 2001/18/EC of
the
European Parliament and of
the Council, of a maize
product (Zea mays L.,
line 1507) genetically modified
for
resistance to certain lepidopteran pests and for
tolerance to the herbicide glufosinate-ammonium (3).

Feed produced from maize line 1507 has been placed on
the market before the date of application of the Regu-
lation, i.e. 18 April 2004. As a consequence, it is subject
to the requirements provided for in Article 20 of the
Regulation and may be placed on the market and used
in accordance with the conditions laid down in the
Community Register of genetically modified food and
feed.

On 3 March 2005, the European Food Safety Authority
(Authority) gave its opinion in accordance with Article 6
of the Regulation that there is no evidence to indicate
that the placing on the market of the products is likely to
cause adverse effects on human or animal health or the
environment (4).
the Authority
In giving its opinion,
considered all specific questions and concerns raised by
the Member States.

(5)

(6)

(7)

(8)

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

(3) OJ L 291, 5.11.2005, p. 42.
(4) http://www.efsa.eu.int/science/gmo/gm_ff_applications/more_info/

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

503/op_gm07_ej182_1507_opinion_nl_doc2_en1.pdf

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(9)

(10)

restrictions

the Authority advised that no specific
Accordingly,
labelling requirements other than those provided for in
the Regulation are necessary. The
Article 13(1) of
conditions
Authority also advised that no specific
the market
or
and/or specific conditions or restrictions for the use
post-market monitoring
and
requirements,
the
protection of particular ecosystems/environment and/or
(e) of
geographical areas, as provided for
Article 6(5) of the Regulation, are required.

and no specific

conditions

including

handling,

in point

placing

the

for

for

on

In its opinion, the Authority concluded that the environ-
mental monitoring plan,
general
surveillance plan, submitted by the applicant is in line
with the intended use of the products.

consisting of

a

(11)

In the light of the above considerations, authorisation
should be granted.

(17) However, the Council has not acted within the required
time limit; a Decision should now be adopted by the
Commission,

HAS DECIDED AS FOLLOWS:

Article 1

Products

This Decision covers foods and food ingredients containing,
consisting of, or produced from the genetically modified
maize (Zea mays L.) line 1507 further specified in the Annex
to this Decision (the products) and assigned the unique iden-
tifier DAS-Ø15Ø7-1, as provided for in Regulation (EC) No
65/2004.

Article 2

Placing on the market

(12) A unique identifier should be assigned to maize line
1507 as provided for in Commission Regulation (EC)
No 65/2004 of 14 January 2004 establishing a system
for the development and assignment of unique identifiers
for genetically modified organisms (1).

The placing on the market of the products, according to the
conditions
is
authorised for the purposes of Article 4(2) of Regulation (EC)
No 1829/2003.

specified in this Decision and its Annex,

(13) All information contained in the Annex to this Decision
on the authorisation of the products should be entered in
the Community Register of genetically modified food and
feed as provided for in the Regulation.

(14)

In accordance with Article 4(2) of the Regulation, the
conditions for authorisation of
the product bind all
persons placing it on the market.

(15)

This Decision should be notified through the Biosafety
Clearing House to the Parties to the Cartagena Protocol
on Biosafety to the Convention on Biological Diversity,
pursuant to Articles 9(1) and to point 2(c) of Article 15
of Regulation (EC) No 1946/2003 of
the European
the Council of 15 July 2003 on
Parliament and of
genetically modified
transboundary movements
organisms (2).

of

Article 3

Labelling

For the purposes of the specific labelling requirements provided
for in Article 13(1) of Regulation (EC) No 1829/2003, the
‘name of the organism’ shall be ‘maize’.

Article 4

Monitoring for environmental effects

1.
Authorisation holders shall ensure that the monitoring
plan for environmental effects, as specified in the Annex to
this Decision, is put in place and implemented.

Authorisation holders shall submit

to the Commission
2.
annual reports on the implementation and the results of the
monitoring activities.

(16) No opinion was delivered by the Standing Committee on
the Food Chain and Animal Health; the Commission has
therefore submitted a proposal
to the Council on 5
October 2005 in accordance with Article 5(4) of
Council Decision 1999/468/EC (3),
the Council being
required to act within three months.

The reports shall clearly state those parts of the reports which
are considered to be confidential,
together with a verifiable
justification for confidentiality in accordance with Article 30
of Regulation (EC) No 1829/2003.

(1) OJ L 10, 16.1.2004, p. 5.
(2) OJ L 287, 5.11.2003, p. 1.
(3) OJ L 184, 17.7.1999, p. 23.

Confidential parts of such reports shall be submitted in separate
documents.

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Article 5

Community Register

both of which are responsible for fulfilling the duties of author-
isation holders provided for in this Decision and in Regulation
(EC) No 1829/2003.

The information in the Annex to this Decision shall be entered
in the Community Register of genetically modified food and
feed, as provided for in Article 28 of Regulation (EC) No
1829/2003.

Article 6

Authorisation holders

The authorisation holders are:

(a) Pioneer Overseas Corporation,

representing
Pioneer Hi-Bred International, United States of America;
and

Belgium,

(b) Dow AgroSciences Europe, United Kingdom, representing

Mycogen Seeds, United States of America;

Article 7

Validity

This Decision shall be valid for a period of 10 years from the
date of its adoption.

Done at Brussels, 3 March 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

(a) Applicants and authorisation holders:

Name:

Pioneer Overseas Corporation

Address: Avenue des Arts 44, B-1040 Brussels.

On behalf of Pioneer Hi-Bred International, Inc., 400 Locus Street, Suite 800, Des Moines, IA50309, United States of
America

and

Name: Dow AgroSciences Europe Ltd

Address: European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom.

On behalf of Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United
States of America.

(b) Designation and specification of the products:

Foods and food ingredients containing, consisting of, or produced from genetically modified maize (Zea mays L.) line
1507 as described in the application, unique identifier DAS-Ø15Ø7-1, with resistance to the European corn borer
(Ostrinia nubilalis) and certain other lepidopteran pests and with tolerance to the herbicide glufosinate-ammonium. The
genetically modified maize DAS-Ø15Ø7-1 contains the following DNA sequences in two cassettes:

(a) cassette 1:

A synthetic version of the truncated cry1F gene from Bacillus thuringiensis subsp. aizawai, which confers resistance
to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests, under the regulation of the
ubiquitin promoter ubiZM1(2) from Zea mays L. and the ORF25PolyA terminator from Agrobacterium tumefaciens
pTi15955;

(b) cassette 2:

A synthetic version of the pat gene from Streptomyces viridochromogenes strain Tü494, which confers tolerance to
the herbicide glufosinate-ammonium, under the regulation of the 35S promoter and terminator sequences from
Cauliflower Mosaic Virus.

(c) Labelling:

No specific requirements other than those provided pursuant to Article 13(1) of Regulation (EC) No 1829/2003.

For the purpose of Article 13(1) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘maize’.

(d) Method for detection:

— Event specific real-time quantitative PCR based method for genetically modified maize DAS-Ø15Ø7-1.

— Validated by the Community reference laboratory established pursuant

to Regulation (EC) No 1829/2003,

published at http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf

— Reference Material: ERM®-BF418 accessible via the Joint Research Centre (JRC) of the European Commission, the
Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_
catalogue/index.htm

(e) Unique identifier:

DAS-Ø15Ø7-1

(f)

Information required in accordance with Annex II to the Cartagena Protocol on Biosafety to the Convention
on Biological Diversity:

Biosafety Clearing House, Record ID: see Decision 2006/197/EC.

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(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC

(Link: http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf)

(i) Post market monitoring requirements for the use of the food for human consumption:

Not required.

Note:

links to relevant documents may need to be modified over time. Those modifications will be made available to the
public via the updating of the Community Register of genetically modified food and feed.