Proposal for a Council Decision authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2005-07-26
Institutions: European Commission
Subjects: animal nutrition, food inspection, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.7.2005 
COM(2005) 338 final 

Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of foods and food ingredients derived from 
genetically modified maize line MON 863 as novel foods or novel food ingredients under 
Regulation (EC) No 258/97 of the European Parliament and of the Council 

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EXPLANATORY MEMORANDUM 

The  attached  draft  Council  Decision  concerns  foods  and  food  ingredients  derived  from 
genetically modified maize line MON 863, for which a request for placing on the market was 
submitted  by  Monsanto  to  the  competent  authorities  of  Germany  on  15  July  2002,  under 
Regulation (EC) No 258/97.  

Following  the  initial  assessment  report  from  Germany,  who  came  to  the  conclusion  that  an 
additional assessment was required because of the presence of an antibiotic resistance marker 
gene (nptII) used in the product concerned, reasoned objections were raised by some Member 
States. These objections were referred to the European Food Safety Authority which delivered 
the  opinion,  on  2  April  2004,  that  MON  863  maize  is  as  safe  as  conventional  maize.  The 
detection method was validated by the Joint Research Centre (JRC). 

Regulation (EC) No 1829/2003 on GM food and feed is applicable from 18 April 2004. In the 
light of Article 46(1) of this Regulation, requests submitted under Regulation (EC) No 258/97 
before 18 April 2004 and for which an additional assessment report has been transmitted to 
the Commission before that date, shall be processed under Regulation (EC) No 258/97. 

Against  this  background,  a  draft  Commission  Decision  to  place  food  and  food  ingredients 
produced from modified maize line MON 863 on the Community market was submitted to the 
Standing  Committee  on  Food  Chain  and  Animal  Health,  on  19  May  2005,  for  vote.  Ten 
Member  States  voted  in  favour,  eight  Member  States  voted  against  and  six  Member  States 
abstained. One Member State was not present.  

The Committee delivered no opinion. Consequently, pursuant to Article 13, paragraph 4 b) of 
Regulation  (EC)  No  258/97  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 a qualified majority, 
and inform the Parliament.  

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Proposal for a  

COUNCIL DECISION 

authorising the placing on the market of foods and food ingredients derived from 
genetically modified maize line MON 863 as novel foods or novel food ingredients under 
Regulation (EC) No 258/97 of the European Parliament and of the Council 

Only the French and Dutch texts are authentic 

THE COUNCIL OF THE EUROPEAN UNION,  

Having regard to the Treaty establishing the European Community, 

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council 
of  27  January  1997  concerning  novel  foods  and  novel  food  ingredients1,  and  in  particular 
Article 7 thereof, 

Having regard to the proposal of the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

On  15  July  2002,  Monsanto  submitted  to  the  competent  authorities  of  Germany  a 
request,  in  accordance  with  Article  4  of  the  Regulation,  for  placing  on  the  market 
foods  and  food  ingredients  derived  from  genetically  modified  maize  line  MON  863 
(hereinafter referred to as MON 863 maize) as novel foods or novel food ingredients, 
in accordance with Regulation (EC) No 258/97. 

In its initial assessment report of 8 April 2003, Germanys’ competent food assessment 
body came to the conclusion that an additional assessment was required because of the 
presence of an antibiotic resistance marker gene (nptII) used in the product concerned.  

The  Commission  forwarded  the  initial  assessment  report  to  all  Member  States  on 
3 June 2003 with additional comments raised by the Member States.  

On  9  December  2003  the  Commission  requested  a  scientific  opinion  from  the 
European  Food  Safety  Authority  (EFSA)  in  accordance  with  Article  11  of  the 
Regulation.  On  2  April  2004  the  EFSA  delivered  its  opinion  that  from  the  point  of 
view of consumer health, MON 863 maize and derived products are as safe as grain 
and  derived  products  from  conventional  maize  lines.  In  delivering  its  opinion  the 
EFSA addressed all specific questions and concerns raised by the Member States. 

(5) 

Article 46(1) of Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council  of  22  September  2003  on  genetically  modified  food  and  feed2  provides  that 

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OJ  L  43,  14.2.1997,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 
OJ L 268, 18.10.2003, p. 1. 

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requests  submitted  under  Article  4  of  Regulation  (EC)  No  258/97  before  the  date  of 
application  of  this  Regulation  shall  be  processed  under  the  provisions  of  Regulation 
(EC)  No 258/97,  notwithstanding  Article  38  of  Regulation  (EC)  No  1829/2003,  in 
cases where the additional assessment report required in accordance with Article 6(3) 
or 6(4) of Regulation (EC) No 258/97 has been transmitted to the Commission before 
the date of application of Regulation (EC) No 1829/2003. 

(6) 

The Joint  Research  Centre of the  European Commission (JRC) in collaboration  with 
the  European  Network  of  GMO  Laboratories  (ENGL),  has  validated  a  method  for 
detection  of  MON  863  maize.  The  JRC  has  carried  out  a  full  validation  study  (ring-
trial)  following  internationally  accepted  guidelines  to  test  the  performance  of  a 
quantitative event-specific method to detect and quantify the MON 863 transformation 
event  in  maize.  The  materials  needed  in  the  study  had  been  provided  by  Monsanto. 
The JRC has considered that the method performance was appropriate for its purpose, 
taken  into  account  the  performance  criteria  proposed  by  the  ENGL  for  methods 
submitted  for  regulatory  compliance  as  well  as  the  current  scientific  understanding 
about  satisfactory  method  performance.  Both  the  method  and  the  results  of  the 
validation have been made publicly available. 

(7) 

Reference material for MON 863 maize has been produced by the JRC. 

(8) 

(9) 

(10) 

Food  and  food  ingredients  from  MON  863  maize  should  be  labelled  in  accordance 
with  the  provisions  of  Regulation  (EC)  No  1829/2003  and  should  be  subject  to  the 
traceability requirements laid down in 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/EC3. 

In accordance with Commission Regulation (EC) No 65/20044, a unique identifier has 
been assigned to the product for the purposes of Regulation (EC) No 1830/2003. 

Information,  contained  in  the  Annex,  on  the  identification  of  foods  and  food 
ingredients  derived  from  MON  863  maize,  including  the  validated  detection  method 
and  the  reference  material,  should  be  retrievable  from  the  Register  referred  to  in 
Article 28 of Regulation (EC) No 1829/2003.  

(11)  On  the  basis  of  the  information  available,  it  is  established  that  MON  863  maize 

complies with criteria laid down in Regulation (EC) No 258/97. 

(12)  The  Standing  Committee  on  the  Food  Chain  and  Animal  Health  has  not  given  an 

opinion,  

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4 

OJ L 268, 18.10.2003, p. 24. 
OJ L 10, 16.01.2004, p. 5. 

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HAS ADOPTED THIS DECISION: 

Article 1 

Foods  and  food  ingredients  derived  from  genetically  modified  maize  line  MON  863 
(hereinafter referred to as “the products”), as designated and specified in the Annex, may be 
placed on the Community market as novel foods or novel food ingredients. 

Article 2 

The products shall be labelled as “genetically modified maize” or “produced from genetically 
modified  maize”  in  accordance  with  the  labelling  requirements  laid  down  in  Article  13  of 
Regulation (EC) No 1829/2003. 

The products and the information included in the Annex shall be entered in the Community 
Register of genetically modified food and feed. 

Article 3 

Article4 

This  Decision  is  addressed  to  Monsanto  Europe  S.A.,  Belgium,  representing  Monsanto 
Company, U.S.A. It shall be valid for a period of 10 years. 

Done at Brussels,  

For the Council 
The President 

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ANNEX  

INFORMATION TO BE ENTERED IN THE COMMUNITY REGISTER OF 
GENETICALLY MODIFIED FOOD AND FEED 

(1) 

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, 
U.S.A. 

(2) 

Designation and specification of the products 

Foods and food ingredients derived from genetically modified maize (Zea maize L.) 
line  MON  863  with  increased  protection  to  insects  and  from  all  its  crosses  with 
traditionally bred maize lines. MON 863 maize contains two cassettes:  

(a)  Cassette 1:  

A modified cry3Bb1 gene derived from Bacillus thuringiensis subsp. kumamotoensis, 
which confers resistance to the corn rootworm Diabrotica spp., under the regulation 
of  the  4AS1  promoter  derived  from  Cauliflower  Mosaic  Virus,  the  wtCAB 
translation  enhancer  from  wheat  (Triticum  aestivum),  the  transcription  enhancer 
ract1  intron  from  the  actin  1  gene  of  rice  (Oryza  sativa)  and  terminator  sequences 
tahsp 17 3’ from wheat. 

(b)  Cassette 2: 

The nptII gene from E. coli, which confers resistance to aminoglycosides comprising 
kanamycin and neomycin, under the regulation of the 35S Cauliflower Mosaic Virus 
promoter, and the NOS 3’ terminator sequences from Agrobacterium tumefaciens as 
well as the non-functional, truncated ble gene from E. coli. 

(3) 

Labelling: 

“Genetically modified maize” or “produced from genetically modified maize” 

(4)  Method for detection: 

–  Event specific real-time quantitative PCR based method for genetically modified 

maize line MON 863. 

–  Validated  by  the  Joint  Research  Centre  (JRC)  of  the  European  Commission,  in 
collaboration  with  the  European  Network  of  GMO  Laboratories  (ENGL), 
published at http://gmo-crl.jrc.it/statusofdoss.htm. 

Reference  Material:  IRMM-416  produced  by  the  Joint  Research  Centre  (JRC)  of  the 
European Commission. 

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(5) 

Unique identifier: 

MON- ØØ863-5 

(6) 

Information required under Annex II to the Cartagena Protocol: 

Not applicable 

(7) 

Conditions or restrictions for the placing on the market of the product: 

Not applicable 

(8) 

Post market monitoring requirements: 

Not applicable 

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