2008/730/EC: Commission Decision of 8 September 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2008) 4735) (Text with EEA relevance)
Date: 2008-09-08
Institutions: European Commission
Subjects: animal nutrition, food safety, foodstuff, genetically modified organism, labelling, market approval, soya bean

L 247/50

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Official Journal of the European Union

16.9.2008

COMMISSION DECISION

of 8 September 2008

authorising the placing on the market of products containing, consisting of, or produced from
to Regulation (EC) No
genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant

1829/2003 of the European Parliament and of the Council

(notified under document number C(2008) 4735)

(Only the German text is authentic)

(Text with EEA relevance)

(2008/730/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 Articles 7(3) and 19(3) thereof,

Whereas:

(1)

(2)

On 1 July 2005, Bayer CropScience AG 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,
consisting of, or
produced from A2704-12 soybean (‘the application’).

and feed containing,

The application also covers the placing on the market of
other products containing or consisting of A2704-12
soybean for the same uses as any other soybean with
the exception of cultivation. Therefore,
in accordance
with the provisions of Articles 5(5) and 17(5) of Regu­
lation (EC) No 1829/2003, it includes the data and infor­
mation required by Annexes III and IV to Directive
the
2001/18/EC of
Council of 12 March 2001 on the deliberate release
into the environment of genetically modified organisms
and repealing Council Directive 90/220/EEC (2) and
information and conclusions about the risk assessment
carried out in accordance with the principles set out in
Annex II to Directive 2001/18/EC.

the European Parliament and of

(3)

On 10 August 2007,
gave
Authority

(EFSA)

(1) OJ L 268, 18.10.2003, p 1.
(2) OJ L 106, 17.4.2001, p. 1.

the European Food Safety
in
a

favourable

opinion

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 A2704-12 soybean as
described in the application (‘the products’) will have any
adverse effects on human or animal health or the envi­
ronment in the context of their intended uses (3). In its
opinion, EFSA considered all the specific questions and
concerns raised by the Member States in the context of
the consultation of the national competent authorities as
provided for by Articles 6(4) and 18(4) of that Regu­
lation.

(4)

In particular, EFSA concluded that after considering all
the data available in the application on the molecular
characterisation, compositional analysis and agronomic
performance, A2704-12 soybean is equivalent
to its
non-genetically modified counterpart and, as a conse­
quence, that no further animal safety studies with the
whole food/feed (e.g. a 90-day toxicity study in rats)
are needed.

(5)

In its opinion, EFSA also concluded that the environmen­
tal monitoring plan, consisting of a general surveillance
plan, submitted by the applicant
is in line with the
intended use of the products.

(6)

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

(7)

organism (GMO)
Regulation

A unique identifier should be assigned to each genetically
in
modified
Commission
of
14 January 2004 establishing a system for the develop­
ment and assignment of unique identifiers for genetically
modified organisms (4).

as
(EC) No

for
65/2004

provided

(3) http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_

1178620785771.htm
(4) OJ L 10, 16.1.2004, p. 5.

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L 247/51

(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
A2704-12 soybean. However,
in order to ensure the
use of the products within the limits of the 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
including post-market moni­
for the use and handling,
toring requirements, or of specific conditions for the
protection of particular ecosystems/environment and/or
geographical areas, as provided for
(e) of
and 18(5) of Regulation (EC) No
Articles 6(5)
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.

of

Parliament

(11) Article 4(6) of Regulation (EC) No 1830/2003 of the
European
of
and
22 September 2003 concerning the traceability and
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.

Council

the

(12)

(13)

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 Articles 9(1) and 15(2)(c), of Regulation (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;
to the Council on
therefore submitted a proposal
28 April 2008 in accordance with Article 5 of
the
Council Decision 1999/468/EC (3),
the Council being
required to act within three months.

(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.

(14) 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 soybean (Glycine max) A2704-12, as
is
specified in point
assigned the unique identifier ACS-GMØØ5-3, as provided for
in Regulation (EC) No 65/2004.

the Annex to this Decision,

(b) of

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 ACS-GMØØ5-3 soybean;

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

GMØØ5-3 soybean;

(c) products other than food and feed containing or consisting
of ACS-GMØØ5-3 soybean for the same uses as any other
soybean with the exception of cultivation.

Article 3

Labelling

For the purposes of the labelling requirements laid down
1.
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 ‘soybean’.

The words ‘not for cultivation’ shall appear on the label of
containing or
in

2.
and in documents accompanying products
of ACS-GMØØ5-3
consisting
Article 2(b) and (c).

soybean

referred

to

Article 4

Monitoring for environmental effects

1.
The authorisation holder 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.

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

Article 7

Validity

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

Article 5

Community register

Article 8

Addressee

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.

This Decision is addressed to Bayer CropScience AG, Alfred-
Nobel-Straße 50, D-40789 Monheim am Rhein, Germany.

Done at Brussels, 8 September 2008.

Article 6

Authorisation holder

The authorisation holder shall be Bayer CropScience AG.

For the Commission

Androulla VASSILIOU
Member of the Commission

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L 247/53

ANNEX

(a) Applicant and authorisation holder:

Name:

Bayer CropScience AG.

Address:

Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein, Germany.

(b) Designation and specification of the products:

1. Foods and food ingredients containing, consisting of, or produced from ACS-GMØØ5-3 soybean.

2. Feed containing, consisting of, or produced from ACS-GMØØ5-3 soybean.

3. Products other than food and feed containing or consisting of ACS-GMØØ5-3 soybean for the same uses as any

other soybean with the exception of cultivation.

The genetically modified ACS-GMØØ5-3 soybean, as described in the application, expresses the PAT protein which
confers tolerance to the glufosinate-ammonium herbicide.

(c) Labelling:

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

or consisting of ACS-GMØØ5-3 soybean referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection:

— event specific real-time PCR-based method for the quantification of ACS-GMØØ5-3 soybean,
— validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003,

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

— reference material: AOCS 0707-A, AOCS 0707-B and AOCS 0707-C accessible via the American Oil Chemists

Society at http://www.aocs.org/tech/crm/bayer_soy.cfm

(e) Unique identifier:

ACS-GMØØ5-3.

(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.

(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 time. Those modifications will be made available to the
public via the updating of the Community register of genetically modified food and feed.