2007/702/EC: Commission Decision of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2007) 5141) (Text with EEA relevance)
Date: 2007-10-24
Institutions: European Commission
Subjects: animal nutrition, food inspection, foodstuff, genetically modified organism, labelling, maize, market approval

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COMMISSION DECISION

of 24 October 2007

authorising the placing on the market of products containing, consisting of, or produced from
genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of
the European Parliament and of the Council

(notified under document number C(2007) 5141)

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

(Text with EEA relevance)

(2007/702/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 Articles 7(3) and 19(3) thereof,

Whereas:

(1)

(2)

On 24 January 2005, Pioneer Overseas Corporation, on
behalf of Pioneer Overseas Corporation and Dow AgroS-
ciences Europe, submitted to the competent authority of
the Netherlands an application,
in accordance with
Articles 5 and 17 of Regulation (EC) No 1829/2003,
for the placing on the market of foods, food ingredients,
and feed containing, consisting of, or produced from
59122 maize (‘the application’).

The application also covers the placing on the market of
other products containing or consisting of 59122 maize
the same uses than any other maize with the
for
exception of cultivation. Therefore,
in accordance with
the provision of Articles 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
and
repealing Council Directive 90/220/EEC (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.

genetically modified

organisms

of

(4)

(5)

(6)

(7)

On 2 April 2007, 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 59122 maize as described in the appli-
cation (‘the products’) will have adverse effects on human
or animal health or the environment (3). In its opinion,
EFSA considered all the specific questions and concerns
raised by the Member States in the context of the consul-
tation of the national competent authorities, as provided
for by Articles 6(4) and 18(4) of that Regulation.

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

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

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).

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
59122 maize. However,
in order to ensure the use of
the products within the limits of authorisation provided
for by this Decision, the labelling of feed containing or
consisting of the GMO and other products than food and
feed containing or consisting of the GMO for which
authorisation is requested should be complemented by
a clear indication that the products in question must
not be used for cultivation.

(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-
1178620753816_1178620785273.htm

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

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(8)

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
geographical areas, as provided for
(e) of
Articles 6(5)
and 18(5) of Regulation (EC) No
1829/2003.

in point

identifier DAS-59122-7, 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 1829/2003, in accordance
with the conditions set out in this Decision:

(9)

information on the authorisation of

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

(a)

foods and food ingredients containing, consisting of, or
produced from DAS-59122-7 maize;

(10) 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 of or containing GMOs.

(11)

(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).

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;
therefore submitted a proposal
to the Council on 9
July 2007 in accordance with Article 5 of the Council
Decision 1999/468/EC (3), the Council being required to
act within three months.

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

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier
Genetically modified maize (Zea mays L.) 59122, as specified in
point (b) of the Annex to this Decision, is assigned the unique

(b) feed

containing,

consisting

of,

or

produced

from

DAS-59122-7 maize;

(c) products, other than food and feed, containing or consisting
of DAS-59122-7 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’.

The words ‘not for cultivation’ shall appear on the label of
2.
and in documents accompanying products
containing or
consisting of DAS-59122-7 maize referred to in Article 2(b)
and (c).

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.

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.

Article 5

Community register

(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).

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.

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Article 6

Authorisation holders

Article 8

Addressees

1.

The authorisation holders shall be:

This Decision is addressed to:

(a) Pioneer Overseas Corporation,

Belgium,
Pioneer Hi-Bred International, United States;

representing

and

(b) Dow AgroSciences Europe, United Kingdom, representing

Mycogen Seeds, United States.

Both authorisation holders

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

responsible

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.

Done at Brussels, 24 October 2007.

Article 7

Validity

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

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, 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-59122-7 maize;

(2) Feed containing, consisting of, or produced from DAS-59122-7 maize;

(3) Products other than food and feed containing or consisting of DAS-59122-7 maize for the same uses as any

other maize with the exception of cultivation.

The genetically modified maize DAS-59122-7, as described in the application, expresses Cry34Ab1 and Cry35Ab1
proteins which confer protection against certain coleopteran pests such as corn rootworm larvae (Diabrotica spp.) and
the PAT protein, used as a selectable marker, which confers tolerance to the glufosinate-ammonium 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-59122-7 maize referred to in Article 2(b) and (c).

(d) Method for detection:

— Event specific real-time quantitative PCR based method for genetically modified maize DAS-59122-7.,

— 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®-BF424 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-59122-7

(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]

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

Not required.

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(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.