Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) 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)
Date: 2008-10-22
Institutions: European Commission
Subjects: animal nutrition, food safety, foodstuff, genetically modified organism, labelling, market approval, soya bean

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.10.2008 
COM(2008) 669 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified soybean MON89788 (MON-89788-1) 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) 

(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  soybean  MON89788,  for  which  a  request  for 
placing on the market was submitted by Monsanto Europe S.A. to the competent authority of 
the  Netherlands  on  31  October  2006,  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 soybean MON89788 for the same uses as any other soybean, with the exception 
of cultivation. 

On  11  July  2008,  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 soybean MON89788 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 soybean MON89788 was submitted to the Standing Committee on the Food Chain 
and  Animal  Health,  on  29  September  2008,  for  vote.  The  Committee  delivered  no  opinion: 
twelve  Member  States  (160  votes)  voted  in  favour,  six  Member  States  (69  votes)  voted 
against, seven Member States (106 votes) abstained and two Member States (10 votes) were 
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, 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 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 soybean MON89788 (MON-89788-1) 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 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) 

(3) 

On 31 October 2006, Monsanto Europe S.A. 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 MON89788 soybean ('the application'). 

The application also covers the placing on the market of other products containing or 
consisting  of  MON89788  soybean  for  the  same  uses  as  any  other  soybean  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. 

On  11  July  2008,  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  MON89788  soybean  as  described  in  the  application 
('the  products')  will  have  any  adverse  effects  on  human  or  animal  health  or  the 

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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) 

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. 

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  MON89788  soybean.  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,  or  of  specific 
conditions 
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. 

for 

(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://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620787358.htm 
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  soybean  (Glycine  max)  MON89788,  as  specified  in  point  (b)  of  the 
Annex  to  this  Decision,  is  assigned  the  unique  identifier  MON-89788-1,  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 MON-89788-
1 soybean; 

feed containing, consisting of, or produced from MON-89788-1 soybean; 

products other than food and feed containing or consisting of MON-89788-1 soybean 
for the same uses as any other soybean 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 ’soybean’. 

The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying products containing or consisting of MON-89788-1 soybean 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  Monsanto  Europe  S.A.,  Belgium,  representing  Monsanto 
Company, United States of America. 

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

Article 7 
Validity 

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Article 8 
Addressee 

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

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-

89788-1 soybean; 

(2)  Feed containing, consisting of, or produced from MON-89788-1 soybean; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  MON-89788-1 
soybean  for  the  same  uses  as  any  other  soybean  with  the  exception  of 
cultivation. 

The  genetically  modified  MON-89788-1  soybean,  as  described  in  the  application, 
expresses  the  CP4  EPSPS  protein  which  confers  tolerance  to  the  glyphosate 
herbicide.  

(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 ’soybean’; 

(2)  The  words  'not  for  cultivation'  shall  appear  on  the  label  of  and  in  documents 
accompanying  products  containing  or  consisting  of  MON-89788-1  soybean 
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  MON-
89788-1 soybean; 

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

1829/2003, 

published 

No 

at 

Reference  Material:  AOCS  0906-A  and  AOCS  0906-B  accessible  via  the 
American Oil Chemists Society at http://www.aocs.org/tech/crm/soybean.cfm. 

(e) 

Unique identifier: 

MON-89788-1 

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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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