Proposal for a Council Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Only the French and Dutch texts are authentic)
Date: 2007-12-18
Institutions: European Commission
Subjects: animal nutrition, cereal product, consumer information, food safety, foodstuff, genetically modified organism, health policy, labelling, maize, market approval

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 18.12.2007 
COM(2007) 815 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of products containing, consisting of, or produced 
from genetically modified maize MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-6) 
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council 

(Only the French and Dutch texts are authentic) 

(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 maize MON863xMON810, for which a request for 
placing on the market was submitted by Monsanto Europe S.A. to the competent authorities 
of Germany on 24 June 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 or 
consisting  of  maize  MON863xMON810  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

On 31 Mars 2006, 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 maize MON863xMON810 as described in the application will have adverse effects on 
human or animal health or the environment1. 

In  October  2006,  EFSA  published  detailed  clarifications  on  how  the  comments  of  the 
competent authorities of the Member States had been taken into account in its opinion. 

On 13 April 2007, EFSA reconfirmed that the use of the nptII gene as a selectable marker in 
GM plants does not pose a risk to human or animal health or the environment.  
On 28 June 2007, following a scientific publication regarding a re-analysis of the MON 863 
90-day  rat  study  and  questioning  the  safety  of  MON  863,  EFSA  confirmed  its  earlier 
favourable safety assessment on MON 863 maize. 

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  MON863xMON810  was  submitted to the Standing Committee on the Food 
Chain  and  Animal  Health,  on  10  October  2007,  for  vote.  The  Committee  delivered  no 
opinion:  twelve  Member  States  (149  votes)  voted  in  favour,  eleven  Member  States  (119 
votes) voted against and four Member States (77 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. 

1 

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620784282.htm 

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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 MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-6) 
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  feed2,  and  in  particular 
Article 7(3) and Article 19(3) thereof, 

Whereas: 

(1) 

(2) 

On  24  June  2004,  Monsanto  Europe  S.A.,  submitted  to  the  competent  authorities  of 
Germany  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  MON863xMON810  maize  ('the 
application').  

The application also covers the placing on the market of other products containing or 
consisting of MON863xMON810 maize for the same uses as any other maize with the 
exception of cultivation. Therefore, in accordance with the provision of 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  organisms3  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. 

(3) 

On 31 March 2006, 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  MON863xMON810  maize  as  described  in  the 

2 

3 

OJ  L  268,  18.10.2003,  p  1.  Regulation  as  amended  by  Commission  Regulation  (EC)  No  1981/2006 
(OJ L 368, 23.12.2006, p. 99). 
OJ  L  106,  17.4.2001,  p.  1.  Directive  as  last  amended  by  Regulation  (EC)  No  1830/2003  (OJ  L  268, 
18.10.2003, p. 24).  

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application ('the products') will have adverse effects on human or animal health or the 
environment4. In its opinion, EFSA concluded that it was acceptable to use the data for 
the  single  events  in  support  of  the  safety  of  the  products  and  considered  all  specific 
questions and concerns raised by the Member States in the context of the consultation 
of the national competent authorities provided for by Articles 6 (4) and 18 (4) of that 
Regulation. 

In  October  2006,  upon  request  of  the  Commission,  EFSA  published  detailed 
clarifications on how the comments of the competent authorities of the Member States 
had been taken into account in its opinion and also published further information on 
the  different  elements  considered  by  the  Scientific  Panel  on  Genetically  Modified 
Organisms of EFSA. 

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. 

On 25 January 2007, following comments from the public and a report published by 
the World Health Organisation listing kanamycin and neomycin as 'critically important 
antibacterial  agents  for  human  medicine  and  for  risk  management  strategies  of  non-
human  use',  the  Commission  consulted  the  European  Medicines  Agency  (EMEA) 
regarding  the  therapeutic  relevance  in  human  and  veterinary  medicine  of  antibiotics 
for  which  nptII  gene  allows  resistance.  Upon  reception  of  the  answer  of  EMEA,  the 
Commission consulted EFSA regarding the safety assessments of nptII gene and GM 
plants comprising the nptII gene. On 13 April 2007, EFSA confirmed its earlier safety 
assessments of GM plants comprising the nptII gene concluding that the presence of 
the nptII gene in GM plants for food and feed uses does not pose a risk to human or 
animal health or to the environment. 

On  15  March  2007,  following  a  scientific  publication  regarding  a  re-analysis  of  the 
MON  863  90-day  rat  study  and  questioning  the  safety  of  MON  863  maize,  the 
Commission  consulted  EFSA  on  what  impact  this  analysis  study  might  have  on  its 
earlier  opinion  on  MON  863  maize.  On  28  June  2007,  EFSA  indicated  that  the 
publication does not raise new issues which are toxicologically relevant and confirmed 
its earlier favourable safety assessment on MON 863 maize. 

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 organisms5. 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10)  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  the  foods,  food  ingredients,  and  feed  containing,  consisting  of,  or 
produced from MON863xMON810 maize. However, in order to ensure the use of the 
products within the limits of authorisation provided by this Decision, the labelling of 

4 
5 

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620784282.htm 
OJ L 10, 16.1.2004, p. 5. 

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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.  

(11)  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 
the  protection  of  particular  ecosystems/environment  and/or 
conditions 
geographical  areas,  as  provided  for  in  point  (e)  of  Articles  6(5)  and  18(5)  of 
Regulation  (EC)  No  1829/2003.  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. 

for 

(12)  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/EC6,  lays  down 
labelling requirements for products consisting of or containing GMOs. 

(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 uses, other than food and feed, which were authorised for the same GMO under 
Decision  2006/478  as  well  as  equivalent  conditions  for  placing  on  the  market  and 
monitoring  are  included  in  this  Decision  and  are  therefore  regulated  only  by  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 and the measures provided for 
in this Decision must therefore be adopted by the Council, 

6 
7 
8 

OJ L 268, 18.10.2003, p. 24. 
OJ L 287, 5.11.2003, p. 1. 
OJ L 26, 31.1.2006, p. 17. 

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HAS ADOPTED THIS DECISION: 

Article 1 
Genetically modified organism and unique identifier 

Genetically modified maize (Zea mays L.) MON863xMON810 produced by crosses between 
maize containing MON-ØØ863-5 and MON-ØØ81Ø-6 events, as specified in point (b) of the 
Annex to this Decision is assigned the unique identifier MON-ØØ863-5xMON-ØØ81Ø-6, as 
provided for in Regulation (EC) No 65/2004. 

Article 2 
Authorisation and placing on the market 

The  following  products  are  authorised  for  the  purposes  of  Articles  4(2)  and  16(2)  of 
Regulation (EC) No 1829/2003, according 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  MON-
ØØ863-5xMON-ØØ81Ø-6 maize; 

feed  containing,  consisting  of,  or  produced  from  MON-ØØ863-5xMON-ØØ81Ø-6 
maize; 

products,  other  than  food  and  feed,  containing  or  consisting  of  MON-ØØ863-
5xMON-ØØ81Ø-6 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 MON-ØØ863-5xMON-ØØ81Ø-
6 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 the 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.  

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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 

Article 8 
Addressee 

This Decision is addressed to Monsanto Europe S.A., Scheldelaan 460, Haven 627 – B 2040 
Antwerp - 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: 

Scheldelaan 460, Haven 627 – B 2040 Antwerp – 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-

ØØ863-5xMON-ØØ81Ø-6 maize; 

(2)  Feed  containing,  consisting  of,  or  produced  from  MON-ØØ863-5xMON-

ØØ81Ø-6 maize; 

(3)  Products  other  than  food  and  feed  containing  or  consisting  of  MON-ØØ863-
5xMON-ØØ81Ø-6  maize  for  the  same  uses  as  any  other  maize  with  the 
exception of cultivation. 

The  genetically  modified  maize  MON-ØØ863-5xMON-ØØ81Ø-6,  as  described  in 
the  application,  is  produced  by  crosses  between  maize  containing  MON-ØØ863-5 
and  MON-ØØ81Ø-6  events  and  expresses  the  CryBb1  protein  which  confers 
protection against certain coleopteran insect pests (Diabrotica spp.) and the Cry 1 Ab 
protein  which  confers  protection  against  certain  lepidopteran  insect  pests  (Ostrinia 
nubilalis, Sesammia spp.). An nptII gene, conferring kanamycin resistance, was used 
as a selectable marker in the genetic modification process. 

(c) 

Labelling: 

(1)  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’. 

(2)  The words ‘not for cultivation’ shall appear on the label of and in documents 
accompanying  products  containing  or  consisting  of  MON-ØØ863-5xMON-
ØØ81Ø-6 maize referred to in Article 2(b) and (c). 

(d) 

Method for detection: 

– 

– 

Event  specific  real-time  quantitative  PCR  based  methods  for  genetically 
modified  maize  MON-ØØ863-5  and  MON-ØØ81Ø-6  validated  on  MON-
ØØ863-5xMON-ØØ81Ø-6 maize. 

Validated by the Community reference laboratory established under Regulation 
(EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm 

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– 

Reference  Material:  ERM®-BF416  (for  MON-ØØ863-5)  and  ERM®-BF413 
(for  MON-ØØ81Ø-6)  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 

(e) 

Unique identifier: 

MON-ØØ863-5xMON-ØØ81Ø-6 

(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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