Proposal for a COUNCIL DECISION authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2011-10-12
Institutions: European Commission
Subjects: animal nutrition, cotton, food safety, human nutrition, labelling, market approval, transgenic plant

EUROPEAN COMMISSION 

Brussels, 12.10.2011 
COM(2011) 620 final 

2011/0264 (NLE) 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the English 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  281-24-236x3006-210-23  (DAS-24236-
5xDAS-21Ø23-5),  for  which  a  request  for  placing  on  the  market  was  submitted  by  Dow 
AgroSciences Europe to the competent authority of the Netherlands on 22 June 2005, 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  281-24-236x3006-210-23  cotton  for  the  same  uses  as  any 
other cotton with the exception of cultivation. 

On  15  June  2010,  the  European  Food  Safety  Authority  gave  a  favourable  opinion  in 
accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It considered that 281-
24-236x3006-210-23 cotton is as safe as its non-genetically modified counterpart 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 281-24-236x3006-210-23 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. 

Against this background, a draft Commission Decision authorising the placing on the Union 
market of products containing, consisting of or produced from genetically modified 281-24-
236x3006-210-23 was submitted to the Standing Committee on the Food Chain and Animal 
Health on 9 February 2011, for vote. The Committee delivered no opinion: 14 Member States 
(192 votes) voted in favour, 10 Member States (87 votes) voted against and 3 Member States 
(66 votes) abstained. 

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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2011/0264 (NLE) 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the English 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, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

On 22 June 2005, Dow AgroSciences Europe 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  of,  or  produced  from  281-24-236x3006-210-23  cotton  ('the 
application'). 

The application also covers the placing on the market of products other than food and 
feed containing or consisting of 281-24-236x3006-210-23 cotton for the same uses as 
any  other  cotton  with  the  exception  of  cultivation.  Therefore,  in  accordance  with 
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.  It  also 
includes  a  monitoring  plan  for  environmental  effects  conforming  with  Annex  VII  to 
Directive 2001/18/EC. 

1 
2 

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

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

On  15  June  2010,  the  European  Food  Safety  Authority  ('EFSA’)  gave  a  favourable 
opinion  in  accordance  with  Articles  6  and  18  of  Regulation  (EC)  No  1829/2003.  It 
considered  that  cotton  281-24-236x3006-210-23  is  as  safe  as  its  non-genetically 
modified counterpart with respect to potential effects on human and animal health or 
the  environment.  Therefore  it  concluded  that  it  is  unlikely  that  the  placing  on  the 
market of the products containing, consisting of, or produced from 281-24-236x3006-
210-23  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 Articles 6(4) and 18(4) of that Regulation.  

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  its  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 Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to 
be  necessary  for  foods,  food  ingredients  and  feed  containing,  consisting  of,  or 
produced from 281-24-236x3006-210-23 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 

3 
4 

http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2010-00863 
OJ L 10, 16.1.2004, p. 5. 

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modified  organisms  and  amending  Directive  2001/18/EC5,  lays  down  in  Article  4(6) 
labelling  requirements  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)  281-24-236x3006-210-23,  as  specified  in 
point (b) of the Annex to this Decision, is assigned the unique identifier DAS-24236-5xDAS-
21Ø23-5, as provided for in Regulation (EC) No 65/2004. 

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6 
7 

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 DAS-24236-
5xDAS-21Ø23-5 cotton; 

feed  containing,  consisting  of,  or  produced  from  DAS-24236-5xDAS-21Ø23-5 
cotton; 

products  other  than  food  and  feed  containing  or  consisting  of  DAS-24236-5xDAS-
21Ø23-5  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  DAS-24236-5xDAS-21Ø23-5 
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 Dow AgroSciences Europe, United Kingdom, representing 
Mycogen Seeds, United States. 

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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 Dow AgroSciences Europe, European Development Centre, 3 
Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom. 

Done at Brussels, 

For the Council  
The President 

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ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

Dow AgroSciences Europe,  

Address:  European  Development  Centre,  3  Milton  Park,  Abingdon,  Oxon  OX14 

4RN, United Kingdom 

(b) 

Designation and specification of the products:  

(1)  Foods and food ingredients containing, consisting of, or produced from DAS-

24236-5xDAS-21Ø23-5 cotton; 

(2)  Feed containing, consisting of, or produced from DAS-24236-5xDAS-21Ø23-5 

cotton; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  DAS-24236-
5xDAS-21Ø23-5  cotton  for  the  same  uses  as  any  other  cotton  with  the 
exception of cultivation. 

The genetically modified DAS-24236-5xDAS-21Ø23-5 cotton (Gossypium hirsutum), 
as  described  in  the  application,  expresses  the  Cry1Ac  and  Cry1F  proteins  which 
confer protection against certain lepidopteran pests and expresses PAT protein, used 
as  a  selectable  marker,  which  confers  tolerance  to  the  glufosinate-ammonium 
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  DAS-24236-5xDAS-
21Ø23-5 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  DAS-
24236-5xDAS-21Ø23-5 cotton; 

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

1829/2003, 

published 

No 

at 

Reference  Material:  ERM®-BF422  accessible  via  the  Joint  Research  Centre 
(JRC)  of  the  European  Commission,  Institute  for  Reference  Materials  and 
Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue 

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(e) 

Unique identifier: 

DAS-24236-5xDAS-21Ø23-5  

(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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