Proposal for a Council Decision 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
Date: 2008-04-30
Institutions: European Commission
Subjects: animal nutrition, cotton, genetically modified organism, health policy, human nutrition, labelling, market approval

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.4.2008 
COM(2008) 226 final 

Proposal for a 

COUNCIL DECISION 

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 

(Only the German text is authentic) 

(presented by the Commission) 

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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 LLCotton25, for which a request for placing on the 
market  was  submitted  by  Bayer  CropScience  AG  to  the  competent  authority  of  the 
Netherlands on 3 March 2005, under Regulation (EC) No 1829/2003 on genetically modified 
food and feed.  

The attached proposal also concerns 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 
cultivation. 

On  16  April  2007,  the  European  Food  Safety  Authority  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  application  will  have  adverse  effects  on  human  or 
animal health or the environment. 

Against  this  background,  a  draft  Commission  Decision  authorising  the  placing  on  the 
Community  market  of  products  containing,  consisting  of,  or  produced  from  genetically 
modified  LLCotton25  was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and 
Animal Health, on 12 February 2008, for vote. The Committee delivered no opinion: fourteen 
Member  States  (168  votes)  voted  in  favour,  nine  Member  States  (109  votes)  voted  against, 
three  Member  States  (65  votes)  abstained  and  one  Member  State  (3  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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Proposal for a 

COUNCIL DECISION 

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 

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

THE COUNCIL OF THE EUROPEAN UNION,k 

Having regard to the Treaty establishing the European Community, 

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 
Articles 7(3) and 19(3) thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

On 3 March 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,  and  feed 
containing, consisting or produced from LLCotton25 ('the application'). 

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 
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 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. 

(3) 

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  application  ('the 

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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). 
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).  

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

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 Articles 6(4) and 18(4) of that 
Regulation. 

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  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 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. 

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

(10)  Similarly, 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,  or  of  specific 
the  protection  of  particular  ecosystems/environment  and/or 
conditions 
geographical  areas,  as  provided  for  in  point  (e)  of  Articles  6(5)  and  18(5)  of 
Regulation (EC) No 1829/2003. 

for 

(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. 

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http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785856.htm 
OJ L 10, 16.1.2004, p. 5. 

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(12)  Article 4(6) of 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  modified  organisms  and  amending  directive  2001/18/EC5,  lays  down 
labelling requirements for products consisting or containing GMOs. 

(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 organisms6. 

(14)  The Standing Committee on the Food Chain and Animal Health has not delivered an 
opinion within the time-limit laid down by its Chairman and the measures provided for 
in this Decision must therefore be adopted by the Council, 

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 
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 (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; 

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OJ L 268, 18.10.2003, p. 24. 
OJ L 287, 5.11.2003, p. 1. 

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(b) 

(c) 

1. 

2. 

1. 

2. 

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

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. 

Article 3 
Labelling 

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)  n° 
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  ACS-GHØØ1-3  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 the 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 activities. 

Article 5 
Community register 

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. 

Article 6 
Authorisation holder 

The authorisation holder shall be Bayer Cropscience AG. 

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

Article 7 
Validity 

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 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) n° 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 
http://gmo-
Regulation 
crl.jrc.it/statusofdoss.htm 

1829/2003, 

published 

(EC) 

No 

at 

Reference  Material:  AOCS  0306-A  and  AOCS  0306-E  accessible  via  the 
at 
Oil 
American 
http://www.aocs.org/tech/crm/bayer_cotton.cfm 

Chemists 

Society 

(e) 

Unique identifier: 

ACS-GHØØ1-3 

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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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