2008/837/EC: Commission Decision of 29 October 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2008) 6204) (Text with EEA relevance)
Date: 2008-10-29
Institutions: European Commission
Subjects: animal nutrition, cotton, genetically modified organism, health policy, human nutrition, labelling, market approval

L 299/36

EN

Official Journal of the European Union

8.11.2008

COMMISSION

COMMISSION DECISION

of 29 October 2008

authorising the placing on the market of products containing, consisting of, or produced from
genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of
the European Parliament and of the Council

(notified under document number C(2008) 6204)

(Only the German text is authentic)

(Text with EEA relevance)

(2008/837/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 3 March 2005, Bayer CropScience AG submitted to
the competent authority of the Netherlands an appli­
in accordance with Articles 5 and 17 of Regu­
cation,
lation (EC) No 1829/2003, for the placing on the market
of
containing,
consisting of, or produced from LLCotton25 (the
application).

ingredients,

foods,

food

feed

and

cultivation. Therefore,

it
by Annexes

The application also covers the placing on the market of
other products containing or consisting of LLCotton25
for the same uses as any other cotton with the exception
of
in accordance with the
provisions of Articles 5(5) and 17(5) of Regulation (EC)
includes the data and information
No 1829/2003,
required
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.

and
the European Parliament and of

III

On 16 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 LLCotton25 as described in the appli­
cation (the products) will have any adverse effects on
in the
human or animal health or the environment
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 Regulation.

(4)

(5)

(6)

(7)

In particular, EFSA concluded that
the comparative
compositional analysis and agronomic analyses show
that LLCottton25 is substantially equivalent to its non-
genetically modified counterpart and, as a consequence,
that no additional safety studies with laboratory animals
(e.g. a 90-day toxicity study in rats) are needed.

In its opinion, EFSA also concluded that the environmen­
tal monitoring plan, consisting of a general surveillance
is in line with the
plan, submitted by the applicant
intended use of
the products. However, due to the
physical characteristics of cotton seeds and methods of
transportation, EFSA recommended that, within general
surveillance, specific measures are introduced to actively
monitor the occurrence of feral cotton plants in areas
where seed spillage is likely to occur.

The monitoring plan submitted by the applicant has been
modified to comply with this EFSA recommendation.

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

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

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

1178620785856.htm

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L 299/37

(8)

(9)

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 (1).

therefore submitted a proposal
30 April 2008 in accordance with Article 5 of
Council Decision 1999/468/EC (4),
required to act within three months.

to the Council on
the
the Council being

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
in order to ensure the use of
LLCotton25. However,
the authorisation
the products within the limits of
feed
labelling of
the
provided by
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

(10)

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

(11) 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

(12) 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 (2),
lays down labelling requirements for
products consisting or containing GMOs.

Council

the

(15) 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 cotton (Gossypium hirsutum) LLCotton25, as
specified in point (b) of the Annex to this Decision, is assigned
the unique identifier ACS-GHØØ1-3, as provided for in Regu­
lation (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 ACS-GHØØ1-3 cotton;

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

GHØØ1-3 cotton;

(c) products other than food and feed containing or consisting
of ACS-GHØØ1-3 cotton for the same uses as any other
cotton with the exception of cultivation.

(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 (3).

(14)

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;

(1) OJ L 10, 16.1.2004, p. 5.
(2) OJ L 268, 18.10.2003, p. 24.
(3) OJ L 287, 5.11.2003, p. 1.

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 ‘cotton’.

The words ‘not for cultivation’ shall appear on the label of
2.
and in documents accompanying products
containing or
consisting of ACS-GHØØ1-3 cotton referred to in Article 2(b)
and (c).

(4) OJ L 184, 17.7.1999, p 23.

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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.

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

Article 5

Community register

Article 7

Validity

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

Article 8

Addressee

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

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.

Done at Brussels, 29 October 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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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-GHØØ1-3 cotton;

2. feed containing, consisting of, or produced from ACS-GHØØ1-3 cotton;

3. products other than food and feed containing or consisting of ACS-GHØØ1-3 cotton for the same uses as any

other cotton with the exception of cultivation.

The genetically modified ACS-GHØØ1-3 cotton, as described in the application, expresses the PAT protein which
confers tolerance to the herbicide glufosinate-ammonium.

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

or consisting of ACS-GHØØ1-3 cotton 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-GHØØ1-3 cotton,
— 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 0306-A and AOCS 0306-E accessible via the American Oil Chemists Society at

http://www.aocs.org/tech/crm/bayer_cotton.cfm

(e) Unique identifier:

ACS-GHØØ1-3.

(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.