Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2009-10-30
Institutions: European Commission
Subjects: United Kingdom, animal nutrition, food safety, foodstuff, foodstuffs legislation, genetically modified organism, human nutrition, labelling, maize

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 30.10.2009 
COM(2009)613 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council 

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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 maize MIR604, 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  23  December  2004,  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 
and consisting of MIR604 maize for the same uses as any other maize with the exception of 
cultivation. 

On 21 July 2009, 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 MIR604 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 
Community  market  of  products  containing,  consisting  of  or  produced  from  genetically 
modified  maize  MIR604  was  submitted  to  the  Standing  Committee  on  the  Food  Chain  and 
Animal  Health,  on  19  October  2009,  for  vote.  The  Committee  delivered  no  opinion: 
11 Member States (141 votes) voted in favour, 10 Member States (96 votes) voted against and 
6 Member States (108 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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Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN COMMUNITIES, 

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 23 December 2004, Syngenta Seeds S.A.S. submitted to the competent authority of 
the  United  Kingdom  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 MIR604 maize ('the 
application'). 

The application also covers the placing on the market of other products containing or 
consisting of MIR604 maize for the same uses as any other maize 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. 

(3) 

On  21  July  2009,  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  MIR604  maize  as  described  in  the  application  ('the 
products') will have any adverse effects on human or animal health or the environment 

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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) 

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. 

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  MIR604  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  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. 

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 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 
Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003. 

(9) 

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. 

(10)  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 of, or containing GMOs. 

(11)  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 

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http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-046 
OJ L 10, 16.1.2004, p. 5. 
OJ L 268, 18.10.2003, p. 24. 

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European Parliament and of the Council of 15 July 2003 on transboundary movements 
of genetically modified organisms6. 

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

(13)  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.) MIR604, as specified in point (b) of the Annex to 
this Decision, is assigned the unique identifier SYN-IR6Ø4-5, 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) 

(b) 

(c) 

1. 

2. 

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

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

products other than food and feed containing or consisting of SYN-IR6Ø4-5 maize 
for the same uses as any other maize 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)  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-IR6Ø4-5 maize referred to 
in Article 2(b) and (c). 

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OJ L 287, 5.11.2003, p. 1. 

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Article 4 
Monitoring for environmental effects 

1. 

2. 

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.  

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. 

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 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 

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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)  Foods and food ingredients containing, consisting of, or produced from SYN-

IR6Ø4-5 maize; 

(2)  Feed containing, consisting of, or produced from SYN-IR6Ø4-5 maize; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  SYN-IR6Ø4-5 

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

The  genetically  modified  SYN-IR6Ø4-5  maize,  as  described  in  the  application, 
expresses a modified Cry3A protein which provides protection to certain coleopteran 
pests  (Diabrotica  spp.).  A  pmi  gene,  allowing  transformed  maize  cells  to  utilize 
mannose  as  a  sole  carbon  source,  was  used  as  a  selectable  marker  in  the  genetic 
modification process. 

(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)  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-IR6Ø4-5  maize 
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  SYN-
IR6Ø4-5 maize; 

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®-BF423 accessible via the Joint Research Centre 
(JRC) of the European Commission, the Institute of Reference Materials and 
Measurements (IRMM) at 
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm 

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(e) 

Unique identifier: 

SYN-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. 

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