Proposal for a Council Decision authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
Date: 2005-07-29
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.7.2005 
COM(2005)346 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of foods and food ingredients produced from 
genetically modified Roundup Ready maize line GA21 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 

The  attached  draft  Council  Decision  concerns  foods  and  food  ingredients  produced  from 
genetically  modified  maize  line  GA21,  for  which  a  request  for  placing  on  the  market  was 
submitted  by  Monsanto  to  the  competent  authorities  of  the  Netherlands  on  24  July  1998, 
under Regulation (EC) No 258/97.  

Following the initial assessment report from the Netherlands, who considered GA21 maize as 
safe as conventional maize, reasoned objections were raised by some Member States. These 
objections were referred to the  Scientific Committee  on Foods which delivered the opinion, 
on  27  February  2002,  that  GA21  maize  is  as  safe  as  conventional  maize.  The  detection 
method was validated and published by the Joint Research Centre (JRC) on 17 January 2005. 

The  original  application  of  Monsanto  concerned  food  and  food  ingredients  derived  from 
genetically  modified  organisms.  On  24  April  2002,  Monsanto  asked  to  limit  the  request  to 
food and food ingredients produced from genetically modified organisms.  

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  GA21  on  the  Community  market  was  submitted  to  the 
Standing  Committee  on  Food  Chain  and  Animal  Health,  on  27  April  2005,  for  vote.  Nine 
Member States voted in favour, five Member States  voted  against  and  eight Member States 
abstained. Three Member States were 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 
The European Parliament was informed on 28 April 2005. 

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Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of foods and food ingredients produced from 
genetically modified Roundup Ready maize line GA21 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 24 July 1998, Monsanto submitted to the competent authorities of the Netherlands 
a request, in accordance with Article 4 of Regulation (EC) No 258/97, for placing on 
the  market  foods  and  food  ingredients  derived  from  genetically  modified  maize  line 
GA21 as novel foods or novel food ingredients. 

In its initial assessment report of 21 December 1999, the Netherlands’ competent food 
assessment  body  came  to  the  conclusion  that  GA21  maize  and  foodstuffs  and  food 
ingredients made from it are as safe to eat as maize and maize products that have not 
been genetically modified. 

The Commission forwarded the initial assessment report to all Member States on 18 
February 2000. Within the 60-day period laid down in Article 6 (4) of Regulation (EC) 
No  258/97,  reasoned  objections  to  the  marketing  of  the  product  were  raised  in 
accordance with that provision. 

On  18  May  2000,  the  Commission  requested  an  opinion  from  the  Scientific 
Committee  on  Foods  (SCF)  in  accordance  with  Article  11  of  Regulation  (EC)  No 
258/97. On 27 February 2002 the SCF delivered its opinion that from the point of view 
of consumer health, GA21 maize and derived products are as safe as grain and derived 
products from conventional maize lines. In delivering its opinion the SCF considered 
all specific questions and concerns raised by the Member States. 

1 

OJ L 43, 14.2.1997, p. 1 

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(5) 

On 24 April 2002, Monsanto asked to limit the request to food and  food ingredients 
produced from genetically modified organisms. 

(6)  With  respect  to  the  use  of  the  product  as  or  in  feed,  Monsanto  submitted,  on  12 
December  1997,  a  notification  under  Part  C  of  Directive  90/220/EEC2.  The  opinion 
adopted on 22 September 2000 by the Scientific Committee on Plants concluded that 
there is no evidence to indicate that the placing on the market of GA21 maize for this 
use  is  likely  to  cause  any  adverse  effects  on  human  health  and  the  environment. 
However, the application was withdrawn for commercial reasons. 

(7) 

(8) 

Article  46(1)  of  Regulation  (EC)  No  1829/2003  on  genetically  modified  food  and 
feed3  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)  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. 

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 GA21 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 GA21 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 published by the JRC. 

(9) 

Reference material for GA21 maize has been produced by the JRC. 

(10)  Food  and  food  ingredients  from  GA21  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  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/EC4. 

(11) 

(12) 

In accordance with Commission Regulation (EC) No 65/20045, 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 produced from GA21 maize, including the validated detection method and 

2 
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OJ L 117, 08.5.1990, p. 15-27 
OJ L268, 18.10.2003, p. 1 
OJ L268, 18.10.2003, p. 24 
OJ L10, 16.1.2004, p. 5 

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the reference material, should be retrievable from the Register referred to in Article 28
 of Regulation (EC) No 1829/2003. 

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

opinion, 

HAS ADOPTED THIS DECISION: 

Article 1 

Foods and food ingredients produced from genetically modified maize line GA21 (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 

Article 4 

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

ANNEX  

(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 produced from genetically modified maize (Zea mays L.) 
line  GA21  with  increased  tolerance  to  the  herbicide  glyphosate  and  from  all  its 
crosses  with  traditionally  bred  maize  lines.  GA21  maize  contains  the  modified  5-
enolpyruvylshikimate-3-phosphate  synthase  (mEPSPS)  coding  sequence  under  the 
regulation of the rice actin 1 promoter (r-act) and an optimised transit peptide (OPT) 
sequence based on chloroplast transit peptide sequences from Helianthus annuus and 
the RuBisCo gene from Zea mays L. 

(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 GA21. 

–  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-414 produced by the Joint Research Centre (JRC) of 

the European Commission. 

(5) 

Unique identifier: 

MON- ØØØ21-9 

(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 

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(8) 

Post market monitoring requirements: 

Not applicable 

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