Proposal for a COUNCIL DECISION authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
Date: 2011-02-01
Institutions: European Commission
Subjects: animal nutrition, consumer information, genetically modified organism, health policy, human nutrition

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EUROPEAN COMMISSION 

Brussels, 1.2.2011 
COM(2011) 28 final 

2011/0010 (NLE) 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-
88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of 
the Council 

(Only the French and Dutch texts are 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 maize MON 89034 × MON 88017  (MON-89Ø34-
3xMON-88Ø17-3), for which a request for placing on the market was submitted by Monsanto 
Europe  S.A.  to  the  competent  authority  of  the  Netherlands  on  6  February  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 MON 89034 × MON 88017 maize for the same uses as any 
other maize with the exception of cultivation. 

On  30  March  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 
MON 89034 × MON 88017 maize 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  MON 89034 × MON 88017  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 
MON 89034 × MON 88017 was submitted to the Standing Committee on the Food Chain and 
Animal  Health  on  15 November  2010,  for  vote.  The  Committee  delivered  no  opinion: 
12 Member States (154 votes) voted in favour, 10 Member States (138 votes) voted against, 
5 Member States (53 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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2011/0010 (NLE) 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-
88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of 
the Council 

(Only the French and Dutch texts are 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 of the European Commission,  

Whereas: 

(1) 

(2) 

On 6 February 2007, Monsanto Europe S.A. 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, 
from 
MON 89034 × MON 88017 maize ('the application'). 

containing, 

consisting 

produced 

feed 

and 

of, 

or 

The application also covers the placing on the market of products other than food and 
feed containing or consisting of MON 89034 × MON 88017 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. 

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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) 

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On 30 March 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  MON 89034 × MON 88017  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 
from 
market  of 
MON 89034 × MON 88017 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.  

consisting  of,  or  produced 

the  products 

containing, 

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 MON 89034 × MON 88017 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. 

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 

http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2007-056 
OJ L 10, 16.1.2004, p. 5. 
OJ L 268, 18.10.2003, p. 24. 

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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. 

(10)  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. 

(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 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. 

(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.) MON 89034 × MON 88017, as specified in point 
(b)  of  the  Annex  to  this  Decision,  is  assigned  the  unique  identifier  MON-89Ø34-3xMON-
88Ø17-3, 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  MON-
89Ø34-3xMON-88Ø17-3 maize; 

feed  containing,  consisting  of,  or  produced  from  MON-89Ø34-3xMON-88Ø17-3 
maize; 

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

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(c) 

products other than food and feed containing or consisting of MON-89Ø34-3xMON-
88Ø17-3  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 MON-89Ø34-3xMON-88Ø17-3 
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 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  Monsanto  Europe  S.A.,  Belgium,  representing  Monsanto 
Company, United States. 

Article 7 
Validity 

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

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 
Brussels – Belgium.  

Article 8 
Addressee 

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Done at Brussels, 

For the Council  
The President 

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ANNEX 

(a) 

Applicant and Authorisation holder: 

Name: 

Monsanto Europe S.A. 

Address: 

Avenue de Tervuren 270-272, B-1150 Brussels - Belgium 

On  behalf  of  Monsanto  Company  -  800  N.  Lindbergh  Boulevard  -  St.  Louis, 
Missouri 63167 - United States of America. 

(b) 

Designation and specification of the products:  

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

89Ø34-3xMON-88Ø17-3 maize; 

(2)  Feed  containing,  consisting  of,  or  produced  from  MON-89Ø34-3xMON-

88Ø17-3 maize; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  MON-89Ø34-
3xMON-88Ø17-3  maize  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

The genetically modified MON-89Ø34-3xMON-88Ø17-3 maize, as described in the 
application,  is  produced  by  crosses  between  maize  containing  MON-89Ø34-3  and 
MON-88Ø17-3  events  and  expresses  the  Cry1A.105  and  Cry2Ab2  proteins  which 
confer protection against certain lepidopteran pests, Cry3Bb1 protein which confers 
protection  against  certain  coleopteran  pests  and  the  CP4  EPSPS  protein  which 
confers tolerance to 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 
’maize’; 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  MON-89Ø34-3xMON-
88Ø17-3 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 MON-89Ø34-3 and MON-88Ø17-3 maize validated on MON-
89Ø34-3xMON-88Ø17-3 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 

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– 

Reference Material: AOCS 0406-A and AOCS 0906-E (for MON-89Ø34-3) 
and AOCS 0406-A and AOCS 0406-D (for MON-88Ø17-3) accessible via the 
American Oil Chemists Society at http://www.aocs.org/tech/crm  

(e) 

Unique identifier: 

MON-89Ø34-3xMON-88Ø17-3. 

(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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