HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 160/90
EN
Official Journal of the European Union
18.6.2011
COMMISSION DECISION
of 17 June 2011
authorising the placing on the market of products containing, consisting of, or produced from
genetically modified cotton GHB614 (BCS-GH2-5) pursuant to Regulation (EC) No 1829/2003
of the European Parliament and of the Council
(notified under document C(2011) 4177)
(Only the German text is authentic)
(Text with EEA relevance)
(2011/354/EU)
THE EUROPEAN COMMISSION,
principles set out in Annex II to Directive 2001/18/EC. It
also includes a monitoring plan for environmental effects
conforming with Annex VII to Directive 2001/18/EC.
Having regard to the Treaty on the Functioning of the European
Union,
(3) On
10
March
2009,
the
European
Food
Safety
Authority
(‘EFSA’) gave a favourable opinion in accordance with
Article 6 and Article 18 of Regulation (EC) No
1829/2003. It considered that cotton GHB614 is as
safe as its non-genetically modified counterpart with
Having regard to Regulation (EC) No 1829/2003 of the
respect to potential effects on human and animal
European Parliament and of the Council of 22 September
health or the environment. Therefore it concluded that
2003 on genetically modified food and feed ( 1 ), and in
it is unlikely that the placing on the market of the
particular Article 7(3) and Article 19(3) thereof,
products containing, consisting of, or produced from
GHB614 cotton as described in the application (‘the
products’) will have any adverse effects on human or
animal health or the environment in the context of
their intended uses ( 3 ). In its opinion, EFSA considered
Whereas:
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
Article 6(4) and Article 18(4) of that Regulation.
(1) On
18
January
2008,
Bayer
CropScience
AG
submitted
to the competent authority of the Netherlands an appli
cation, in accordance with Article 5 and Article 17 of
(4) In
particular,
EFSA
concluded
that
GHB614
cotton
is
Regulation (EC) No 1829/2003, for the placing on the
compositionally and agronomically equivalent to its
market of foods, food ingredients, and feed containing,
non-genetically modified counterpart and other conven
consisting of, or produced from GHB614 cotton (‘the
tional cotton varieties except for the introduced trait and
application’).
that the molecular characterisation provided no indi
cation of unintended effects of the genetic modification
and as a consequence, that animal safety studies with the
whole food/feed (e.g. a 90-day toxicity study in rats) are
not needed.
(2) The
application
also
covers
the
placing
on
the
market
of
products other than food and feed containing or
consisting of GHB614 cotton for the same uses as any
other cotton with the exception of cultivation. Therefore,
(5) In
its
opinion,
EFSA
also
concluded
that
the
environ
in accordance with Article 5(5) and Article 17(5) of
mental monitoring plan, consisting of a general
Regulation (EC) No 1829/2003, it includes the data
surveillance plan, submitted by the applicant is in line
and information required by Annexes III and IV to
with the intended use of the products. However due to
Directive 2001/18/EC of the European Parliament and
the physical characteristics of cotton seeds and methods
of the Council of 12 March 2001 on the deliberate
of transportation, EFSA recommended that, within
release into the environment of genetically modified
general surveillance, specific measures are introduced to
organisms and repealing Council Directive
actively monitor the occurrence of feral cotton plants in
90/220/EEC ( 2 ) and information and conclusions about
areas where seed spillage and plant establishment are
the risk assessment carried out in accordance with the
likely to occur.
( 1 ) OJ L 268, 18.10.2003, p. 1.
( 3 ) http://registerofquestions.efsa.europa.eu/roqFrontend/
( 2 ) OJ L 106, 17.4.2001, p. 1.
questionLoader?question=EFSA-Q-2006-020

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EN
18.6.2011 Official
Journal
of
the
European
Union L
160/91
(6) In
order
to
better
describe
the
monitoring
requirements
into the environment of genetically modified organisms,
and to comply with the EFSA recommendation, the
as or in products, for the purpose of placing on the
monitoring plan submitted by the applicant has been
market, pursuant to Directive 2001/18/EC of the
modified. Specific measures to limit losses and spillage
European Parliament and of the Council ( 3 ). The EFSA
and to eradicate adventitious cotton populations have
opinion does not justify the imposition of specific
been introduced.
conditions or restrictions for the placing on the market
and/or specific conditions or restrictions for the use and
handling, including post-market monitoring requirements
for the use of the food and feed, or of specific conditions
for the protection of particular ecosystems/environment
(7) Taking
into
account
those
considerations,
authorisation
should be granted for the products.
and/or geographical areas, as provided for in point (e) of

Article 6(5) and Article 18(5) of Regulation (EC) No
1829/2003.
(8) A
unique
identifier
should
be
assigned
to
each
GMO
as
provided for in Commission Regulation (EC) No
(12) All
relevant
information
on
the
authorisation
of
the
65/2004 of 14 January 2004 establishing a system for
products should be entered in the Community register
the development and assignment of unique identifiers for
of genetically modified food and feed, as provided for in
genetically modified organisms ( 1 ).
Regulation (EC) No 1829/2003.
(9)
On the basis of the EFSA opinion, no specific labelling
(13) This
Decision
is
to
be
notified
through
the
Biosafety
requirements other than those provided for in
Clearing-House to the Parties to the Cartagena Protocol
Article 13(1) and Article 25(2) of Regulation (EC) No
on Biosafety to the Convention on Biological Diversity,
1829/2003, appear to be necessary for foods, food
pursuant to Article 9(1) and Article 15(2)(c) of Regu
ingredients and feed containing, consisting of, or
lation (EC) No 1946/2003 of the European Parliament
produced from GHB614 cotton. However, in order to
and of the Council of 15 July 2003 on transboundary
ensure the use of the products within the limits of the
movements of genetically modified organisms ( 4 ).
authorisation provided for by this Decision, the labelling
of feed containing or consisting of the GMO and
products other than food and feed containing or
consisting of the GMO for which authorisation is
(14) The applicant
has been consulted on the measures
requested should be complemented by a clear indication
provided for in this Decision.
that the products in question must not be used for culti
vation.
(15) The
Standing
Committee
on
the
Food
Chain
and
Animal
Health has not delivered an opinion within the time limit
(10) Regulation (EC) No 1830/2003 of the European
laid down by its Chair and the Commission therefore
Parliament and of the Council of 22 September 2003
submitted to the Council a proposal relating to these
concerning the traceability and labelling of genetically
measures. Since, at its meeting on 17 March 2011 the
modified organisms and the traceability of food and
Council was unable to reach a decision by qualified
feed products produced from genetically modified
majority either for or against the proposal and the
organisms and amending Directive 2001/18/EC ( 2 ), lays
Council indicated that its proceedings on this file were
down labelling requirements in Article 4(6) for products
concluded, these measures are to be adopted by the
containing or consisting of GMOs. Traceability
Commission,
requirements for products containing or consisting of
GMOs are laid down in paragraphs (1) to (5) of
Article 4 and for food and feed produced from GMOs
are laid down in Article 5 of that Regulation.
HAS ADOPTED THIS DECISION:
(11) The
authorisation
holder
should
submit
annual
reports
Article 1
on the implementation and the results of the activities set
Genetically modified organism and unique identifier
out in the monitoring plan for environmental effects.
Those results should be presented in accordance with
Genetically modified cotton (Gossypium hirsutum) GHB614, as
Commission Decision 2009/770/EC of 13 October
specified in point (b) of the Annex to this Decision, is
2009 establishing standard reporting formats for pres
assigned the unique identifier BCS-GH2-5, as provided for
enting the monitoring results of the deliberate release
in Regulation (EC) No 65/2004.
( 1 ) OJ L 10, 16.1.2004, p. 5.
( 3 ) OJ L 275, 21.10.2009, p. 9.
( 2 ) OJ L 268, 18.10.2003, p. 24.
( 4 ) OJ L 287, 5.11.2003, p. 1.

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L 160/92
EN
Official Journal of the European Union
18.6.2011
Article 2
2. The
authorisation
holder
shall
submit
to
the
Commission
annual reports on the implementation and the results of the
Authorisation
activities set out in the monitoring plan in accordance with
The following products are authorised for the purposes of
Decision 2009/770/EC.
Article 4(2) and Article 16(2) of Regulation (EC) No
1829/2003 in accordance with the conditions set out in this
Article 5
Decision:
Community register
(a) foods and food ingredients containing, consisting of, or
The information set out in the Annex to this Decision shall be
produced from BCS-GH2-5 cotton;
entered in the Community register of genetically modified food
and feed, as provided for in Article 28 of Regulation (EC) No
(b) feed containing, consisting of, or produced from BCS-
1829/2003.
GH2-5 cotton;
Article 6
(c) products other than food and feed containing or consisting
Authorisation holder
of BCS-GH2-5 cotton for the same uses as any other
cotton with the exception of cultivation.
The authorisation holder shall be Bayer Cropscience AG.
Article 3
Article 7
Labelling
Validity
1. For the purposes of the labelling requirements laid down
This Decision shall apply for a period of 10 years from the date
in Article 13(1) and Article 25(2) of Regulation (EC) No
of its notification.
1829/2003 and in Article 4(6) of Regulation (EC) No
1830/2003, the ‘name of the organism’ shall be ‘cotton’.
Article 8
Addressee
2. The
words
‘not
for
cultivation’
shall
appear
on
the
label
of
and in documents accompanying products containing or
This Decision is addressed to Bayer CropScience AG, Alfred-
consisting of BCS-GH2-5 cotton referred to in Article 2(b)
Nobel-Strae 50, 40789 Monheim am Rhein, Germany.
and (c).
Article 4
Done at Brussels, 17 June 2011.
Monitoring for environmental effects
For the Commission
1. The
authorisation
holder
shall
ensure
that
the
monitoring
plan for environmental effects, as set out in point (h) of the
John DALLI
Annex, is put in place and implemented.
Member of the Commission

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EN
18.6.2011 Official
Journal
of
the
European
Union L
160/93
ANNEX
(a) Applicant and authorisation holder
Name: Bayer
CropScience
AG
Address: Alfred-Nobel-Strae 50, 40789 Monheim am Rhein, Germany
(b) Designation and specification of the products
(1) Foods and food ingredients containing, consisting of, or produced from BCS-GH2-5 cotton;
(2) Feed containing, consisting of, or produced from BCS-GH2-5 cotton;
(3) Products other than food and feed containing or consisting of BCS-GH2-5 cotton for the same uses as any
other cotton with the exception of cultivation.
The genetically modified BCS-GH2-5 cotton (Gossypium hirsutum), as described in the application, expresses the
2mEPSPS protein which confers tolerance to the glyphosate herbicide.
(c) Labelling
(1) For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 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 BCS-GH2-5 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 BCS-GH2-5 cotton,
— Validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003,
published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm,
— Reference Material: AOCS 1108-A and 0306-A accessible via the American Oil Chemists society at http://www.
aocs.org/tech/crm/
(e) Unique identifier
BCS-GH2-5
(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 the time. Those modifications will be made available to
the public via the updating of the Community register of genetically modified food and feed.

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