Proposal for a Council Decision authorising the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2004-06-25
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.6.2004 
COM(2004) 439 final 

. 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of foods and food ingredients derived 
from genetically modified maize line NK 603 as novel foods or novel food ingredients 
under Regulation (EC) No 258/97 of the European Parliament and of the Council  

. 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

On 24 April 2001, Monsanto submitted, under Article 4 of the Novel Food Regulation (EC) 
N°  258/97,  a  request  to  the  competent  authorities  of  the  Netherlands  for  the  placing  on  the 
market of foods and food ingredients derived from genetically modified maize line NK 603 as 
novel foods or as novel food ingredients. 

The initial assessment report from the Netherlands concluded that foods and food ingredients 
derived  from  genetically  modified  maize  line  NK  603  were  as  safe  as  foods  and  food 
ingredients derived from conventional maize and may be used in the same manner but other 
Member  States  raised  reasoned  objections  to  their  placing  on  the  market.  Therefore  an 
authorisation  Decision  via  comitology  procedure  was  required  in  accordance  with  Article  7 
(1) of Regulation (EC) No 258/97. In view of the Member States’ objections, the Commission 
requested an opinion from the European Food Safety Authority, which was delivered on 25 
November  2003  and  concluded  that  NK  603  maize  is  as  safe  as  conventional  maize  and 
therefore  its  placing  on  the  market  for  food  or  feed  or  processing  is  unlikely  to  have  an 
adverse effect on human and animal health and, in that context, the environment1. 

Against  this  background,  a  draft  Commission  Decision  to  place  food  and  food  ingredients 
derived  from  genetically  modified  maize  line  NK  603  on  the  Community  market  was 
submitted to the Standing Committee on Food Chain and Animal Health, on 30 April 2004, 
for vote. The result of the vote was as follows: 

50 votes in favour: (BE, FR, IE, IT, NL, FI, SE, UK) 

19 votes against: (DK, EL, LU, AT, PT) 

18 votes through abstention: (DE, ES)  

The Committee failed to deliver, by qualified majority, an opinion on the draft submitted by 
the Commission. 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 
must without delay 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 European 
Parliament, which may consider appropriate to take a position in accordance with Article 8 of 
the above Decision. 

In accordance with Article 46 of Regulation (EC) No 1829/2003 on genetically modified food 
and feed, the authorisation in case must be granted under the provisions of Regulation (EC) 
No  258/97.  However,  in  order  take  into  account  the  new  legislative  framework  for  the 
authorisation of  genetically modified food  and feed,  the  Commission proposal includes also 
the  particulars  required  by  Article  6,  paragraph  5  and  Article  7,  paragraph  2  of  Regulation 
(EC) No 1829/2003. 

1  

The EFSA Journal (2003) 9, 1-14. 

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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 NK 603 as novel foods or novel food ingredients 
under Regulation (EC) No 258/97 of the European Parliament and of the Council  

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 ingredients 2 (hereinafter referred 
to as the Regulation), and in particular Article 7 thereof, 

Having regard to the proposal of the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

On 24 April 2001, Monsanto submitted to the competent authorities of the Netherlands 
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  NK  603  as 
novel foods or as novel food ingredients. 

In  their  initial  assessment  report  of  5  November  2002,  the  Netherlands’  competent 
food assessment body came to the conclusion that foods and food ingredients derived 
from  maize  NK603  are  as  safe  as  foods  and  food  ingredients  derived  from 
conventional maize and may be used in the same manner. 

The  Commission  forwarded  the  initial  assessment  report  to  all  Member  States  on  6 
January 2003. Within the 60 days period laid down in Article 6 (4) of the Regulation, 
reasoned  objections  to  the  marketing  of  the  product  were  raised  in  accordance  with 
that provision. 

On  27  August  2003,  the  Commission  requested  an  opinion  from  the  European  Food 
Safety  Authority  (EFSA),  in  accordance  with  Article  11  of  the  Regulation.  On  25 
November  2003,  EFSA  delivered  its  opinion  that  NK  603  maize  is  as  safe  as 
conventional maize and therefore the placing on the market of NK603 maize for food 
or feed or processing is unlikely to have an adverse effect on human and animal health 
and, in that context, the environment3. In delivering its opinion, the EFSA considered 
all specific questions and concerns raised by the Member States. 

2 
3 

OJ L 43, 14.2.1997, p. 1. 
The EFSA Journal (2003) 9, 1-14. 

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(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

Article  46(1)  of  Regulation  (EC)  No  1829/2003  on  genetically  modified  food  and 
feed4 provides that 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)  of  Regulation  (EC)  No  258/97  has  been  transmitted  to 
the Commission before the date of application of Regulation (EC) No 1829/2003. 

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 the NK603 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  NK603  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  aimed 
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. 

Reference  material  for  maize  from  genetically  modified  maize  line  NK603  has  been 
produced by the Joint Research Centre (JRC) of the European Commission. 

Food  and  food  ingredients  from  genetically  modified  maize  line  NK  603  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 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. 

In accordance with Commission Regulation (EC) No 65/2004, 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  genetically  modified  maize  line  NK603,  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)  The  Standing  Committee  on  the  Food  Chain  and  Animal  Health  has  not  given  a 

favourable opinion. 

4 
5 

OJ L 268, 18.10.2003, p. 1. 
OJ L 268, 18.10.2003, p. 24. 

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HAS ADOPTED THIS DECISION:  

Article 1 

Foods and food ingredients derived from genetically modified maize line NK603 (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) N° 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 

Article 4 

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

(a) 

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. 

(b) 

Designation and specification of the products:  

Foods and food ingredients derived from genetically modified maize (Zea maize L.) 
line  NK603  with  increased  tolerance  to  the  herbicide  glyphosate  and  from  all  its 
crosses with traditionally bred maize lines. Maize line NK 603 contains the following 
DNA sequences in two intact cassettes: 

–  A  5-enolpyruvylshikimate-3-phosphate  synthase  (epsps)  gene  derived  from 
Agrobacterium  spec.  strain  CP  (CP4  EPSPS),  which  imparts  tolerance  to 
glyphosate,  under  the  regulation  of  the  rice  actin  1  gene  promoter,  terminator 
sequence  from  Agrobacterium  tumefaciens  and  the  chloroplast  transit  peptide 
sequence from the epsps gene of Arabidopsis thaliana. 

–  A  5-enolpyruvylshikimate-3-phosphate  synthase  (epsps)  gene  derived  from 
Agrobacterium  spec.  strain  CP  (CP4  EPSPS),  which  imparts  tolerance  to 
glyphosate,  under  the  regulation  of  an  enhanced  35S  promoter  derived  from 
cauliflower  mosaic  virus,  terminator  sequence  from  Agrobacterium  tumefaciens 
and  the  chloroplast  transit  peptide  sequence  from  the  epsps  gene  of  Arabidopsis 
thaliana. 

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

(c) 
maize” 

(d)  Method for detection: 

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

NK 603 maize. 

–  Validated  by  the  Joint  Research  Centre  (JRC)  of  the  European  Commission,  in 
collaboration  with  the  European  Network  of  GMO  Laboratories  (ENGL),  to  be 
published at http://engl.jrc.it/crl/oj/nk603.pdf. 

–  Reference Material: IRMM-415 produced by the Joint Research Centre (JRC) of 

the European Commission. 

(e) 

Unique identifier: MON-00603-6 

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(f) 

Information required under Annex II to the Cartagena Protocol: 

Not applicable 

g) 

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

Not applicable 

(h) 

Post market monitoring requirements 

Not appropriate 

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