Proposal for a COUNCIL DECISION authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11xMIR604 (SYN-BTØ11-1xSYN-IR6Ø4-5) 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, food safety, human nutrition, labelling, maize, market approval, transgenic plant

EUROPEAN COMMISSION 

Brussels, 12.10.2011 
COM(2011) 622 final 

2011/0266 (NLE) 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize Bt11xMIR604 (SYN-BTØ11-1xSYN-IR6Ø4-5) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the French text is authentic) 

(Text with EEA relevance) 

 
 
  
 
EXPLANATORY MEMORANDUM 

The attached proposal for a Council Decision concerns food and feed containing, consisting 
of  or  produced  from  genetically  modified  maize  Bt11xMIR604  (SYN-BTØ11-1xSYN-
IR6Ø4-5),  for  which  a  request  for  placing  on  the  market  was  submitted  by  Syngenta  Seeds 
S.A.S.  to  the  competent  authority  of  the  United  Kingdom  on  31  October  2007,  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 Bt11xMIR604 maize for the same uses as any other maize 
with the exception of cultivation. 

On  18  May  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 
Bt11xMIR604  maize  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  Bt11xMIR604  maize  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 
Bt11xMIR604  maize  was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and 
Animal  Health,  on  9  February  2011,  for  vote.  The  Committee  delivered  no  opinion: 
13 Member States (180 votes) voted in favour, 11 Member States (99 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. 

EN 

2 

   EN 

 
2011/0266 (NLE) 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize Bt11xMIR604 (SYN-BTØ11-1xSYN-IR6Ø4-5) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the French 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 31 October 2007, Syngenta Seeds S.A.S. submitted to the competent authority of 
the  United  Kingdom  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 Bt11xMIR604 maize 
('the application'). 

The application also covers the placing on the market of products other than food and 
feed containing or consisting of Bt11xMIR604 maize for the same uses as any other 
maize 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. 

1 
2 

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

EN 

3 

   EN 

 
                                                 
(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

On  18  May  2010,  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  maize  Bt11xMIR604  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  Bt11xMIR604  maize  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  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. 

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  Bt11xMIR604  maize.  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.  

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  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. 

(10)  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 

3 
4 
5 

http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2010-00833 
OJ L 10, 16.1.2004, p. 5. 
OJ L 268, 18.10.2003, p. 24. 

EN 

4 

   EN 

 
                                                 
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. 

(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. 

(12)  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. 

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

(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, 

HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically  modified  maize  (Zea  mays  L.)  Bt11xMIR604,  as  specified  in  point  (b)  of  the 
Annex  to  this  Decision,  is  assigned  the  unique  identifier  SYN-BTØ11-1xSYN-IR6Ø4-5,  as 
provided for in Regulation (EC) No 65/2004. 

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) 

foods and food ingredients containing, consisting of, or produced from SYN-BTØ11-
1xSYN-IR6Ø4-5 maize; 

feed  containing,  consisting  of,  or  produced  from  SYN-BTØ11-1xSYN-IR6Ø4-5 
maize; 

6 
7 

OJ L 275, 21.10.2009, p. 9. 
OJ L 287, 5.11.2003, p. 1. 

EN 

5 

   EN 

 
                                                 
(c) 

products other than food and feed containing or consisting of SYN-BTØ11-1xSYN-
IR6Ø4-5  maize  for  the  same  uses  as  any  other  maize  with  the  exception  of 
cultivation. 

Article 3 
Labelling 

1. 

2. 

1. 

2. 

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 ’maize’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  SYN-BTØ11-1xSYN-IR6Ø4-5 
maize 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 the 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 Syngenta Seeds S.A.S. France, representing Syngenta Crop 
Protection AG, Switzerland. 

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

Article 7 
Validity 

EN 

6 

   EN 

 
Article 8 
Addressee 

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de l'Hobit 12, BP 27 – F-31790 
Saint-Sauveur - France.  

Done at Brussels, 

For the Council, 
The President  

EN 

7 

   EN 

 
 
 
ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

Syngenta Seeds S.A.S. 

Address: 

Chemin de l'Hobit 12, BP 27 – F-31790 Saint-Sauveur – France 

On behalf of Syngenta Crop Protection AG - Schwarzwaldallee 215 - CH 4058 Basle 
- Switzerland  

(b) 

Designation and specification of the products:  

(1) 

(2) 

foods and food  ingredients containing, consisting of, or produced from SYN-
BTØ11-1xSYN-IR6Ø4-5 maize; 

feed containing, consisting of, or produced from SYN-BTØ11-1xSYN-IR6Ø4-
5 maize; 

(3)  products  other  than  food  and  feed  containing  or  consisting  of  SYN-BTØ11-
1xSYN-IR6Ø4-5  maize  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

The  genetically  modified  SYN-BTØ11-1xSYN-IR6Ø4-5  maize,  as  described  in  the 
application,  is  produced  by  crosses  between  maize  containing  SYN-BTØ11-1  and 
SYN-IR6Ø4-5  events  and  expresses  the  Cry1Ab  protein  which  confers  protection 
against  certain  lepidopteran  pests,  the  PAT  protein  which  confers  tolerance  to 
glufosinate-ammonium herbicides and the Cry3A protein which provides protection 
against certain coleopteran pests. A pmi gene, which allows transformed maize cells 
to  utilize  mannose  as  a  sole  carbon  source,  was  used  as  a  selectable  marker  in  the 
genetic modification process for SYN-IR6Ø4-5 event.  

(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 ’maize’; 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  SYN-BTØ11-1xSYN-
IR6Ø4-5 maize referred to in Article 2(b) and (c) of this Decision. 

(d) 

Method for detection: 

– 

– 

Event  specific  real-time  quantitative  PCR  based  methods  for  genetically 
modified  maize  SYN-BTØ11-1  and  SYN-IR6Ø4-5  maize  validated  on  SYN-
BTØ11-1xSYN-IR6Ø4-5 maize; 

Validated  on  seeds  by  the  European  Union  Reference  Laboratory  established 
under  Regulation 
at  http://gmo-
crl.jrc.ec.europa.eu/statusofdoss.htm; 

(EC)  No  1829/2003,  published 

EN 

8 

   EN 

 
– 

Reference  Material:  ERM®-BF412  (for  SYN-BTØ11-1)  and  ERM®-BF423 
(for  SYN-IR6Ø4-5)  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. 

(e) 

Unique identifier: 

SYN-BTØ11-1xSYN-IR6Ø4-5. 

(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. 

EN 

9 

   EN