Proposal for a COUNCIL DECISION authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2011-02-07
Institutions: European Commission
Subjects: cotton, genetically modified organism, health risk, labelling, market approval

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EUROPEAN COMMISSION 

Brussels, 7.2.2011 
COM(2011) 40 final 

2011/0019 (NLE) 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation 
(EC) No 1829/2003 of the European Parliament and of the Council 

(Only the German text is authentic) 
(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

The attached proposal for a Council Decision concerns food and feed containing, consisting 
of  or  produced  from  genetically  modified  cotton  GHB614  (BCS-GHØØ2-5),  for  which  a 
request for placing on the market was submitted by Bayer Cropscience AG to the competent 
authority  of  the  Netherlands  on  18  January  2008,  under  Regulation  (EC)  No  1829/2003  on 
genetically modified food and feed. 

The attached proposal also concerns the placing on the market of products other than food and 
feed containing and consisting of GHB614 cotton for the same uses as any other cotton with 
the exception of cultivation. 

On  10  March  2009,  the  European  Food  Safety  Authority  gave  a  favourable  opinion  in 
accordance with the Articles 6 and 18 of Regulation (EC) No 1829/2003. It considered that 
GHB614 cotton is as safe as its non-genetically modified counterpart and other conventional 
cotton varieties with respect to potential effects on human and animal health or environment. 
Therefore  it  concluded  that  it  is  unlikely  that  the  placing  on  the  market  of  the  products 
containing,  consisting  of,  or  produced  from  GHB614  cotton  as  described  in  the  application 
will have any adverse effects on human or animal health or the environment in the context of 
their intended uses. 

In  its  opinion  the  European  Food  Safety  Authority  recommended  that,  within  general 
surveillance,  specific  measures  are  introduced  to  actively  monitor  the  occurrence  of  feral 
cotton plants in areas where seed spillage and plant establishment are likely to occur. 

Against this background, a draft Commission Decision authorising the placing on the Union 
market of products containing, consisting of or produced from genetically modified GHB614 
cotton was submitted to the Standing Committee on the Food Chain and Animal Health, on 
24 September  2010,  for  vote.  The  Committee  delivered  no  opinion:  13  Member  States 
(157 votes)  voted  in  favour,  9  Member  States  (106  votes)  voted  against,  4  Member  States 
(75 votes) abstained and one Member State (7 votes) was not represented. 

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in 
accordance  with  Article  5  of  Council  Decision  1999/468/EC  modified  by  Council  Decision 
2006/512/EC, the Commission is required to submit to the Council a proposal relating to the 
measures to be taken, the Council having three months in which to act by a qualified majority, 
and inform the Parliament. 

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2011/0019 (NLE) 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation 
(EC) No 1829/2003 of the European Parliament and of the Council 

(Only the German text is authentic) 
(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

Having  regard  to  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the 
Council  of  22  September  2003  on  genetically  modified  food  and  feed1,  and  in  particular 
Article 7(3) and Article 19(3) thereof, 

Whereas: 

(1) 

(2) 

On 18 January 2008, Bayer CropScience AG submitted to the competent authority of 
the  Netherlands  an  application,  in  accordance  with  Article  5  and  Article  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 GHB614 cotton ('the 
application'). 

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,  in  accordance  with  Article  5(5)  and 
Article 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 environment of 
genetically  modified  organisms  and  repealing  Council  Directive  90/220/EEC2  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.  It  also  includes  a 
monitoring  plan  for  environmental  effects  conforming  with  Annex  VII  to  Directive 
2001/18/EC. 

(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  respect  to  potential  effects  on  human  and  animal  health  or  the  environment. 

1 
2 

OJ L 268, 18.10.2003, p. 1. 
OJ L 106, 17.4.2001, p. 1.  

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Therefore it concluded that it is unlikely that the placing on the market of the 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 uses3. 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 Article 6(4) 
and Article 18(4) of that Regulation.  

In  particular,  EFSA  concluded  that  GHB614  cotton  is  compositionally  and 
agronomically  equivalent  to  its  non-genetically  modified  counterpart  and  other 
conventional  cotton  varieties  except  for  the  introduced  trait  and  that  the  molecular 
characterisation  provided  no  indication  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. 

In  its  opinion,  EFSA  also  concluded  that  the  environmental  monitoring  plan, 
consisting of a general surveillance plan, submitted by the applicant is in line with the 
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  and  plant  establishment  are  likely  to 
occur. 

In order to better describe the monitoring requirements and to comply with the EFSA 
recommendation,  the  monitoring  plan  submitted  by  the  applicant  has  been  modified. 
Specific  measures  to  limit  losses  and  spillage  and  to  eradicate  adventitious  cotton 
populations have been introduced. 

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 organisms4. 

On the basis of the EFSA opinion, no specific labelling requirements other than those 
provided  for  in  Article  13(1)  and  Article  25(2)  of  Regulation  (EC)  No  1829/2003, 
appear to be necessary for foods, food ingredients and feed containing, consisting of, 
or produced from GHB614 cotton. However, in order to ensure the use of the products 
within  the  limits  of  the  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  requested  should  be 
complemented by a clear indication that the products in question must not be used for 
cultivation.  

(10)  Regulation  (EC)  No  1830/2003  of  the  European  Parliament  and  of  the  Council  of 
22 September  2003  concerning  the  traceability  and  labelling  of  genetically  modified 
organisms  and  the  traceability  of  food  and  feed  products  produced  from  genetically 

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http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2006-020 
OJ L 10, 16.1.2004, p. 5. 

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modified  organisms  and  amending  Directive  2001/18/EC5,  lays  down  labelling 
requirements  in  Article  4(6)  for  products  containing  or  consisting  of  GMOs. 
Traceability  requirements  for  products  containing  or  consisting  of  GMOs  are  laid 
down in paragraph (1) to (5) of Article 4 and for food and feed produced from GMOs 
are laid down in Article 5 of that Regulation. 

(11)  The authorisation holder should submit annual reports on the implementation and the 
results of the activities set out in the monitoring plan for environmental effects. Those 
results should be presented in accordance with Commission Decision 2009/770/EC of 
13 October 2009 establishing standard reporting formats for presenting the monitoring 
results  of  the  deliberate  release  into  the  environment  of  genetically  modified 
organisms,  as  or  in  products,  for  the  purpose  of  placing  on  the  market,  pursuant  to 
Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council6.  The  EFSA 
opinion  does  not  justify  the  imposition  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 monitoring requirements for the use of the food and 
feed, or of specific conditions for the protection of particular ecosystems/environment 
and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) 
of Regulation (EC) No 1829/2003. 

(12)  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. 

(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 Article 9(1) and Article 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 organisms7. 

(14)  The applicant has been consulted on the measures provided for in this Decision. 

(15)  The Standing Committee on the Food Chain and Animal Health has not delivered an 

opinion within the time-limit laid down by its Chairman, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically  modified  cotton  (Gossypium  hirsutum)  GHB614,  as  specified  in  point  (b)  of  the 
Annex to this Decision, is assigned the unique identifier BCS-GHØØ2-5, as provided for in 
Regulation (EC) No 65/2004. 

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OJ L 268, 18.10.2003, p. 24. 
OJ L 275, 21.10.2009, p. 9. 
OJ L 287, 5.11.2003, p. 1. 

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Article 2 
Authorisation  

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

(a) 

(b) 

(c) 

1. 

2. 

1. 

2. 

foods  and  food  ingredients  containing,  consisting  of,  or  produced  from  BCS-
GHØØ2-5 cotton; 

feed containing, consisting of, or produced from BCS-GHØØ2-5 cotton; 

products other than food and feed containing or consisting of BCS-GHØØ2-5 cotton 
for the same uses as any other cotton with the exception of cultivation. 

Article 3 
Labelling 

For  the  purposes  of  the  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’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  BCS-GHØØ2-5  cotton  referred 
to in Article 2(b) and (c). 

Article 4 
Monitoring for environmental effects 

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

The  authorisation  holder  shall  submit  to  the  Commission  annual  reports  on  the 
implementation  and  the  results  of  the  activities  set  out  in  the  monitoring  plan  in 
accordance with Commission Decision 2009/770/EC.  

Article 5 
Community register 

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 holder 

The authorisation holder shall be Bayer Cropscience AG. 

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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.  

Done at Brussels, 

For the Council  
The President 

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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 BCS-

GHØØ2-5 cotton; 

(2)  Feed containing, consisting of, or produced from BCS-GHØØ2-5 cotton; 

(3)  Products other than food and feed containing or consisting of BCS-GHØØ2-5 

cotton for the same uses as any other cotton with the exception of cultivation. 

The  genetically  modified  BCS-GHØØ2-5  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-GHØØ2-5  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-
GHØØ2-5 cotton; 

Validated  on  seeds  by  the  Community  reference  laboratory  established  under 
http://gmo-
(EC) 
Regulation 
crl.jrc.ec.europa.eu/statusofdoss.htm; 

1829/2003, 

published 

No 

at 

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-GHØØ2-5 

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(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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