2007/703/EC: Commission Decision of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2007) 5142) (Text with EEA relevance)
Date: 2007-10-24
Institutions: European Commission
Subjects: animal nutrition, food inspection, foodstuff, genetically modified organism, labelling, maize, market approval

31.10.2007

EN

Official Journal of the European Union

L 285/47

COMMISSION DECISION

of 24 October 2007

authorising the placing on the market of products containing, consisting of, or produced from
genetically modified maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation
(EC) No 1829/2003 of the European Parliament and of the Council

(notified under document number C(2007) 5142)

(Only the French, Dutch and English texts are authentic)

(Text with EEA relevance)

(2007/703/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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) and Article 19(3) thereof,

Whereas:

the United Kingdom an application,

On 27 September 2004, Pioneer Overseas Corporation,
on behalf of Pioneer Overseas Corporation and Dow
AgroSciences Europe, submitted to the competent autho-
rities of
in
accordance with Articles 5 and 17 of Regulation (EC)
No 1829/2003,
the placing on the market of
foods, food ingredients, and feed containing, consisting
of, or produced from 1507xNK603 maize (‘the appli-
cation’).

for

(1)

(2)

On 12 May 2006, the European Food Safety Authority
(‘EFSA’) gave a favourable opinion in accordance with
Articles 6 and 18 of Regulation (EC) No 1829/2003
and concluded that it is unlikely that the placing on
the market of the products containing, consisting of, or
produced from 1507xNK603 maize as described in the
application (the products) will have adverse effects on
human or animal health or the environment (3). In its
opinion, EFSA concluded that it was acceptable to use
the data for the single events in support of the safety of
the products and considered all specific questions and
concerns raised by the Member States in the context of
the consultation of the national competent authorities
provided for by Article 6(4) and 18(4) of that Regulation.

(4)

(5)

In October 2006, upon request of the Commission, EFSA
published detailed clarifications on how the comments of
the competent authorities of the Member States had been
taken into account
It also published
in its opinion.
further information on the different elements considered
on Genetically Modified
by
Organisms of EFSA and the reason why some specific
additional studies such as a 90-day toxicology study in
rats were not considered as necessary.

Scientific

Panel

the

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

consisting of

a

The application also covers the placing on the market of
other products containing or consisting of 1507xNK603
maize for the same uses as any other maize with the
in accordance with
exception of cultivation. Therefore,
the provision of Article 5(5) and 17(5) of Regulation
(EC) No 1829/2003, it includes the data and information
required by Annexes III and IV to Directive 2001/18/EC
of the European Parliament and of the Council of 12
March 2001 on the deliberate release into the envir-
onment of genetically modified organisms (2) and infor-
mation and conclusions about the risk assessment carried
out in accordance with the principles set out in Annex II
to Directive 2001/18/EC.

(6)

Taking into account those considerations, authorisation
should be granted for the products.

(7)

A unique identifier should be assigned to each GMO 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 (4).

(1) OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission
Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).
(2) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(3) http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178620784648.htm

(4) OJ L 10, 16.1.2004, p. 5.

L 285/48

EN

Official Journal of the European Union

31.10.2007

(8)

(9)

On the basis of the EFSA opinion, no specific labelling
requirements other than those provided for in Articles
13(1) and 25(2) of Regulation (EC) No 1829/2003
appear to be necessary for the foods, food ingredients,
and feed containing, consisting of, or produced from
1507xNK603 maize. However,
in order to ensure the
use of the products within the limits of authorisation
the
provided by
feed
labelling of
containing or
the GMO and other
products than food and feed containing or consisting
of
requested
should be complemented by a clear indication that the
products in question must not be used for cultivation.

the GMO for which authorisation is

this Decision,
consisting of

Similarly, the EFSA opinion does not justify the impo-
sition of specific conditions or restrictions for the placing
on the market and/or specific conditions or restrictions
for the use and handling,
including post-market moni-
toring requirements, or of specific conditions for the
protection of particular ecosystems/environment and/or
(e) of
geographical areas, as provided for
Articles 6(5)
and 18(5) of Regulation (EC) No
1829/2003.

in point

(10) All relevant

information on the authorisation of

the
products should be entered in the Community register
of genetically modified food and feed as provided for in
Regulation (EC) No 1829/2003.

(11) Article 4(6) of Regulation (EC) No 1830/2003 of the
the Council of 22
European Parliament
and of
September 2003 concerning
and
traceability
the
labelling of genetically modified organisms and the trace-
ability of
food and feed products produced from
genetically modified organisms and amending Directive
2001/18/EC (1),
lays down labelling requirements for
products consisting or containing GMOs.

(12)

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

12 July 2007 in accordance with Article 5 of the Council
Decision 1999/468/EC (3), the Council being required to
act within three months.

(14) However, the Council has not acted within the required
adopted by the
a Decision should be

time-limit;
Commission,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

(Zea mays L.) 1507xNK603
Genetically modified maize
produced by crosses between maize containing DAS-Ø15Ø7-
1 and MON-ØØ6Ø3-6 events, as specified in point (b) of the
Annex to this Decision, is assigned the unique identifier DAS-
Ø15Ø7-1xMON-ØØ6Ø3-6 as provided for in Regulation (EC)
No 65/2004.

Article 2

Authorisation

The following products are authorised for the purposes of
Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003, in
accordance with the conditions set out in this Decision:

(a)

foods and food ingredients containing, consisting of, or
produced from DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize;

(b) feed containing, consisting of, or produced from DAS-

Ø15Ø7-1xMON-ØØ6Ø3-6 maize;

(c) products, other than food and feed, containing or consisting
of DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize for
the same
uses as any other maize with the exception of cultivation.

Article 3

Labelling

1.
For the purposes of the labelling requirements laid down
in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003
and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name
of the organism’ shall be ‘maize’.

(13)

The Standing Committee on the Food Chain and Animal
Health has not delivered an opinion within the time-limit
the Commission has
laid down by its Chairman;
to the Council on
therefore submitted a proposal

The words ‘not for cultivation’ shall appear on the label of
2.
containing or
and in documents accompanying products
consisting of DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize referred
to in Article 2(b) and (c).

(1) OJ L 268, 18.10.2003, p. 24.
(2) OJ L 287, 5.11.2003, p. 1.

(3) OJ L 184, 17.7.1999, p. 23. Decision as last amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

31.10.2007

EN

Official Journal of the European Union

L 285/49

Article 4

Monitoring for environmental effects

1.
The authorisation holders shall ensure that the monitoring
plan for environmental effects, as set out in the point (h) of the
Annex, is put in place and implemented.

Both authorisation holders

for
2.
fulfilling the duties imposed on authorisation holders by this
Decision and Regulation (EC) No 1829/2003.

responsible

shall be

Article 7

Validity

2.
The authorisation holders shall submit to the Commission
annual reports on the implementation and the results of the
activities set out in the monitoring plan.

This Decision shall apply for a period of 10 years from the date
of its notification.

Article 5

Community register

Article 8

Addressees

This Decision is addressed to:

The information set out 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

1.

The authorisation holders shall be:

(a) Pioneer Overseas Corporation, Avenue des Arts 44, B-1040

Brussels, Belgium;

and

(b) Dow AgroSciences Europe Ltd., European Development
Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN,
United Kingdom.

(a) Pioneer Overseas Corporation,

Belgium,
Pioneer Hi-Bred International, United States;

representing

Done at Brussels, 24 October 2007.

and

(b) Dow AgroSciences Europe Ltd, United Kingdom, repre-

senting Mycogen Seeds, United States.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 285/50

EN

Official Journal of the European Union

31.10.2007

ANNEX

(a) Applicants and Authorisation holders:

Name:

Pioneer Overseas Corporation

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

On behalf of Pioneer Hi-Bred International, Inc., 7250 NW 62nd Avenue, P. O. Box 552, Johnston, IA 50131-0552,
United States

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.

(b) Designation and specification of the products:

1. Foods and food ingredients containing, consisting of, or produced from DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize;

2. Feed containing, consisting of, or produced from DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize;

3. Products, other than food and feed, containing or consisting of DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize for the

same uses as any other maize with the exception of cultivation.

The genetically modified maize DAS-Ø15Ø7-1xMON-ØØ6Ø3-6, as described in the application,
is produced by
crosses between maize containing DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 events and expresses the Cry1F protein which
confers protection against certain lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and species
belonging to the genus Sesamia, the PAT protein which confers tolerance to the glufosinate-ammonium herbicide, and
the CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.

(c) Labelling:

1. For the purposes of

the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC)
No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘maize’.

2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing

or consisting of DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize referred to in Article 2(b) and (c).

(d) Method for detection:

— Event specific real-time quantitative PCR based methods for genetically modified maize DAS-Ø15Ø7-1 and MON-

ØØ6Ø3-6 maize validated on DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize,

— Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at

http://gmo-crl.jrc.it/statusofdoss.htm

— Reference Material: ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) 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-Ø15Ø7-1xMON-ØØ6Ø3-6

(f)

Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological
Diversity:
Biosafety Clearing House, Record ID: see [to be completed when notified]

31.10.2007

EN

Official Journal of the European Union

L 285/51

(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: plan published on the Internet]

(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 the time. Those modifications will be made available to

the public via the updating of the Community register of genetically modified food and feed.