Proposal for a Council Decision authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) N° 258/97 of the European Parliament and of the Council
Date: 2004-01-28
Institutions: European Commission
Subjects: biotechnology, food inspection, genetically modified organism, maize, market approval, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.1.2004 
COM(2004) 10 final 

Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of sweet corn from genetically modified maize line 
Bt11 as a novel food or novel food ingredient under Regulation (EC) N° 258/97 of the 
European Parliament and of the Council 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

On 11 February 1999, Novartis (in the meantime Syngenta) submitted a request under Article 
4  of  the  Novel  Food  Regulation  (EC)  N°  258/97  to  the  competent  authorities  of  the 
Netherlands for placing sweet maize from genetically modified maize line Bt11 on the market 
as a novel food or as a novel food ingredient. 

Following the transmission of the Dutch initial assessment report, which concluded that Bt11 
sweet maize is as safe as conventional sweet maize, to all Member States, reasoned objections 
to the marketing of the product were raised. 

Therefore,  a  Community  Decision  was  required  under  Article  7,  paragraph  1  of  Regulation 
(EC)  No  258/97  and  the  Commission  requested  an  opinion  of  the  Scientific  Committee  on 
Food as there might be an effect on public health. On 17 April 2002, the Scientific Committee 
on  Food  delivered  its  opinion  that  Bt11  sweet  maize  is  as  safe  for  human  food  use  as  its 
conventional counterparts.  

In order to grant a Community authorisation, a draft Commission Decision was submitted to 
the  Standing  Committee  on  Food  Chain  and  Animal  Health  on  8  December  2003.  This 
Committee  did  not  deliver  its  opinion  on  the  draft  submitted  by  the  Commission,  since  no 
qualified majority was reached. 

The results of the vote were: 

In favour: 33 (Spain, Ireland, The Netherlands, Finland, Sweden, United Kingdom) 

Against: 29 (Denmark, Greece, France, Luxembourg, Austria, Portugal) 

Abstention: 25 (Belgium, Germany, Italy)  

Some  Member  States,  in  particular  France,  claimed  that  scientific  questions  had  not  been 
addressed adequately in the assessment. However, the data provided by the applicant and the 
safety  assessment  of  the  product  followed  the  criteria  and  requirements  laid  down  in  the 
Commission Recommendation 618/97/EC1. The methodology used for the safety assessment 
of  Bt11  was  also  in  line  with  the  recent  guidelines  prepared  by  the  Scientific  Steering 
Committee concerning the assessment of GMOs, GM food and GM feed2 and with the Codex 
Principles and Guidelines on Foods Derived from Biotechnology3. 

The  concerns  raised  in  the  opinion  of  the  “Agence  française  de  sécurité  sanitaire  des 
aliments”  (AFSSA)  of  26  November  2003  do  not  bring  any  new  scientific  elements  in 
addition to the initial assessment of sweet maize Bt11 carried out by the competent authorities 
of the Netherlands. In fact these concerns were also expressed in two AFSSA opinions of 21 

1 

2 

3 

“Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation 
of information necessary to support applications for the placing on the market of novel foods and novel 
food ingredients and the preparation of initial assessment reports under Regulation EC No 258/97 of the 
European Parliament and of the Council (OJ L 253 of 16.09.97). 
“Guidance Document  for  the  Risk  Assessment  of Genetically  Modified Plants  and  Derived  Food  and 
Feed” Joint Working Group on Novel foods and GMOS, 6-7 March 2003. 
http://europa.eu.int/comm/food/fs/sc/ssc/out327_en.pdf 
Codex  Alimentarius  Commission,  2003.  Codex  Principles  and  Guidelines  on  Foods  Derived  from 
Biotechnology.  Joint  FAO/WHO  Food  Standards  Programme,  Food  and  Agriculture  Organisation: 
Rome. ftp://ftp.fao.org/codex/standard/en/CodexTextsBiotechFoods.pdf 

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July 2000 and 20 March 2001 and were duly considered by the Scientific Committee on Food 
(SCF) in its opinion of 17 April 2002, which confirmed the findings of the initial assessment 
that Bt11 sweet maize is as safe for human food use as conventional maize. 

Pursuant to Article 13, paragraph 4 b) of Regulation (EC) No 258/97 and in accordance with 
the  Regulatory  Committee  procedure  of  Article  5,  and  in  particular  paragraph  4,  of  the 
Council Decision 1999/468/EC, the Commission must now submit a proposal to the Council. 

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 and as requested by the Member States at 
the meeting of the Standing Committee on Food Chain and Animal Health of 10 November 
2003, the Commission proposal includes also the particulars required by Article 6, paragraph 
5 and Article 7, paragraph 2 of Regulation (EC) No 1829/2003. 

The  proposed  authorisation  is  to  take  effect  from  18  April  2004,  date  of  application  of 
Regulation (EC) No 1829/2003, and to be valid for a period of 10 years. 

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Proposal for a 

COUNCIL DECISION 

authorising the placing on the market of sweet corn from genetically modified maize line 
Bt11 as a novel food or novel food ingredient under Regulation (EC) N° 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 ingredients4, (hereinafter referred 
to as the Regulation), and in particular Article 7 thereof, 

Having regard the proposal of the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

4 

5 

6 

7 

Consent has been granted on 22 April 1998 for the placing on the market of grains of 
genetically modified maize line Bt11 to be used for feed, processing and importing5, in 
accordance  with  Council  Directive  90/220/EEC  of  23  April  1990  on  the  deliberate 
release into the environment of genetically modified organisms.6 

Food and food ingredients derived from the original transformant Bt11 and any inbred 
and hybrid lines derived from it and containing the introduced genes may be placed on 
the  market  in  the  Community  following  a  notification7  pursuant  to  Article  5  of 
Regulation (EC) N° 258/97. 

On  11  February  1999,  Novartis  (in  the  meantime:  Syngenta),  submitted  a  request  to 
the competent authorities of the Netherlands for placing sweet maize from genetically 
modified maize line Bt11 on the market as a novel food or as a novel food ingredient. 

In  their  initial  assessment  report  of  12  May  2000,  the  Netherlands’  competent  food 
assessment  body  came  to  the  conclusion  that  Bt11  sweet  maize  is  as  safe  as 
conventional sweet maize. 

The Commission forwarded the initial assessment report to all Member States on 15 
June  2000.  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. 

OJ L43, 14.02.1997, p.1 
Commission Decision 98/292/EC, OJ L131/28, 05.05.1998, p.28 
OJ L 117, 08.05.1990, p.15 
OJ C 181, 26.06.1999, p.22 

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(6) 

(7) 

(8) 

(9) 

On  13  December  2000,  the  Commission  requested  an  opinion  from  the  Scientific 
Committee  on  Food,  in  accordance  with  Article  11  of  the  Regulation.  On  17  April 
2002, the Scientific Committee on Food delivered its opinion that Bt11 sweet maize is 
as safe for human food use as its conventional counterparts. This opinion focused, as 
requested by the Commission, on the issues raised in the comments made by Member 
States’  authorities,  including  molecular  characterisation  and  toxicity  studies.  The 
concerns  raised  in  the  opinion  of  the  “Agence  française  de  sécurité  sanitaire  des 
aliments” (AFSSA) of 26 November 2003 do not bring any new scientific elements in 
addition to the initial assessment of sweet maize Bt11.  

The data provided by the applicant and the safety assessment of the product carried out 
followed the criteria and requirements laid down in the Commission Recommendation 
618/97/EC8  concerning  the  scientific  aspects  and  the  presentation  of  applications 
under the Novel Food Regulation. The methodology used for the safety assessment of 
Bt11  was  also  in  line  with  the  recent  guidelines  prepared  by  the  Scientific  Steering 
Committee concerning the assessment of GMOs, GM food and GM feed and with the 
Codex Principles and Guidelines on Foods Derived from Biotechnology. 

Article  46(1)  of  Regulation  (EC)  No  1829/2003  on  genetically  modified  food  and 
feed9 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 (JRC) of the European Commission, in collaboration with 
the European Network of GMO Laboratories (ENGL), 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 Bt11 transformation 
event  in  sweet  maize.  The  method  validated  had  been  developed  by  the  National 
Veterinary Institute of Norway and INRA, France. The materials needed in the study 
(GM  and  non-GM  DNA  as  well  as  the  method-specific  reagents)  had  been  provided 
by  Syngenta.  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. 

(10)  Reference  material  for  sweet  maize  from  genetically  modified  maize  line  Bt11  has 
been produced by the Joint Research Centre (JRC) of the European Commission. 

(11)  Sweet  maize  from  genetically  modified  maize  line  Bt11  and  food  containing  sweet 
maize  from  genetically  modified  maize  line  Bt11  as  ingredient  shall  be  labelled  in 
accordance with the provisions of Regulation (EC) No 1829/2003 and shall 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 

8 
9 

OJ L 253 of 16.09.97 
OJ L268, 18.10.2003, p.1 

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traceability of food and feed products produced from genetically modified organisms 
and amending Directive 2001/18/EC10. 

(12) 

Information on the identification of sweet maize from genetically modified maize line 
Bt11, including the validated detection method and the reference material, contained in 
the annex, shall be retrievable from the Register to be established by the Commission 
in accordance with Article 28 of Regulation (EC) No 1829/2003. 

(13)  Genetically  modified  maize  Bt11  has  been notified  to  the  Biosafety  Clearing-House, 
pursuant to Articles 11(1) and 20(3)(c) of the Cartagena Protocol on Biosafety to the 
Convention on Biological Diversity. 

(14)  The  Standing  Committee  on  the  Food  Chain  and  Animal  Health  has  not  given  a 

favourable opinion. 

HAS ADOPTED THIS DECISION:  

Article 1 

Sweet  maize  from  genetically  modified  maize  line  Bt11  (hereinafter  referred  to  as  “the 
product”), as designated and specified in the Annex, may be placed on the Community market 
as a novel food or novel food ingredient. 

The product shall be labelled as “genetically modified sweet maize”, in accordance with the 
labelling requirements laid down in Article 13 of Regulation (EC) N° 1829/2003. 

Article 2 

The  product  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  Syngenta  Seeds  BV,  The  Netherlands,  representing  Syngenta 
Seeds AG, Switzerland. It shall take effect from 18 April 2004. It shall be valid for a period of 
10 years. 

Done at Brussels,  

10 

OJ L268, 18.10.2003, p.24 

For the Council 
The President 

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

ANNEX 

(a) 

Authorisation holder: 

Name: 

Syngenta Seeds BV 

Address:  Westeinde 62, Enkhuizen, The Netherlands 

On behalf of: Syngenta  Seeds  AG,  Schwarzwaldallee  215,  CH-4058  Basel, 
Switzerland 

(b) 

Designation and specification of the product:  

Sweet  maize,  fresh  or  canned,  that  is  progeny  from  traditionally  crosses  of 
traditionally bred maize with genetically modified maize line Bt11 that contains: 

–  a  synthetic  version  of  the  cryIA  (b)  gene  derived  from  Bacillus  thuringiensis 
kurstaki strain HD1 under the control of a 35S promoter from Cauliflower Mosaic 
Virus,  and  IVS  6  intron  from  the  maize  alcohol  dehydrogenase  gene  and  the 
nopaline synthase terminator sequence of Agrobacterium tumefaciens, and 

–  a synthetic version of the pat gene derived from Streptomyces viridochromogenes 
under  the  control  of  a  35S  promoter  from  Cauliflower  Mosaic  Virus,  an  IVS 
intron  from  the  maize  alcholdehydrogenase  gene  and  the  nopaline  synthase 
terminator sequence of Agrobacterium tumefaciens. 

(c) 

Labelling: “Genetically modified sweet maize” 

(d)  Method for detection: 

–  Event specific real-time quantitative PCR based method for genetically modified 
Bt11  sweet  maize,  published  in  European  Food  Research  and  Techonolgy,  Vol. 
216/2003, pages 347-354. 

–  Validated  by  the  Joint  Research  Centre  (JRC)  of  the  European  Commission,  in 
collaboration  with  the  European  Network  of  GMO  Laboratories  (ENGL), 
published at http://engl.jrc.it/crl/oj/bt11sm.pdf.  

–  Reference  Material:  IRMM-412R,  produced  by  the  Joint  Research  Centre  (JRC) 

of the European Commission. 

(e) 

Unique identifier: SYN-BT Ø11-1 

(f) 

Information required under Annex II to the Cartagena Protocol: 

Biosafety Clearing House, Record ID 1240  
(see: http://bch.biodiv.org/Pilot/Record.aspx?RecordID=1240) 

(g) 

Conditions or restrictions on the placing on the market of the product: 
Not applicable 

(h)  Monitoring plan for environmental effects: 

Not appropriate 

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