BT 11 Mais. Ein Dossier

BACKGROUND INFORMATION ON SYGENTAS GM MAIZE BT 11

Zur Ergänzung der heutigen Nachricht, daß die EU-Kommission bt11 für den Verzehr (Import) aber nicht für die Freisetzung (Anbau) zugelassen hat.
Links und Infos zur Zulassung, den wissenschaftlichen Bedenken und Syngenta.

1) EU decision making:

Official dossiers submitted to the European Union:

PDF-Dokument gmoinfo.jrc.it/csnifs/C-FR-96-05-10.pdf
PDF-Dokument gmoinfo.jrc.it/csnifs/C-FR-96-05-10_RiskAssessment.pdf

Opinion of the Scientific Committee on Food on a request to place genetically modified sweet maize line Bt11 on the market
PDF-Dokument europa.eu.int/comm/food/fs/sc/scf/out129_en.pdf

EU Commissions 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
PDF-Dokument foodlaw.rdg.ac.uk/pdf/com2004_0010.pdf

Vote in the Standing Committee on GMOs, December 2003:
Voting by experts on the EU’s regulatory committee for the food chain and animal health resulted in an even 6-6 split with three abstentions on whether to allow Bt-11, a strain of genetically modified sweetcorn developed by Swiss firm Syngenta, onto the market. Finland, Sweden, Ireland, UK, Netherlands, Spain voted in favour carrying 33 votes, and Greece, Denmark, France, Austria, Luxembourg, Portugal against with 29 votes. With 25 votes, Belgium, Italy and Germany abstained.

Vote in the Council of Ministers 27.April 2004 Finland, Sweden, Ireland, UK, Netherlands, Italy voted in favour, Greece, Denmark, France, Austria, Luxembourg, Portugal against, Belgium, Spain and Germany abstained.

2) Scientific Concerns:

Belgian Biosafety authority:
Report of the molecular characterisation of the genetic map of event Bt11 (June 2003)
PDF-Dokument biosafety.be/TP/MGC_reports/Report_Bt11.pdf

French Food Safety Authority:
AFSSA Does not Approve a GMO Which Brussels Wants to Authorise Article from Le Monde (France). Date: 24 April 2004, Herve Kempf.

French experts want Bt11 maize to be tested on animals before giving approval.

The progress of GM is still suffering from successive halts: two scientific evaluation committees, in France and Belgium, have just refused to give their approval to a transgenic maize. On April the 22nd, AFSSA (French Agency of Food Sanitary Security) opposed the authorization of Bt11 sweetcorn, commercialised by Syngenta.
This cereal had already been twice refused by AFSSA, in 2000 and 2003, as the experts had concluded that the scientific results were insufficient. In 2003, AFSSA already opposed an approval delivered by the European Scientific Committee, in April 2002. At the same time, the French government were joining the countries opposed to this approval during a meeting on December the 8th 2003. In the brief note published last Thursday, AFSSA declared that it "maintains its previous opinion which concluded that to rigorously evaluate the impact of regular consumption of a maize carrying the Bt11 event, toxicity / tolerance experiments on rats must be carried out".
Implicitly replying to the European Commission, who wrote on February the 5th that "the results supplied by Syngenta [...] are in accordance with the criteria and rules defined in the recommendation 618/97/EC", AFSSA
specifies: " Such toxicity / tolerance experiments are not required by the actual regulation, though they might be advisable [...] because the sweetcorn is the only one to be consumed by humans".
The opposition between the European Commission and AFSSA is due to the fact that another maize - used as feed - had been authorised before the moratorium took place, in 1999. According to the firm, because the genetic sequence introduced in the Bt11 maize is the same as the one introduced in the previous cereal (used as feed), a complete toxicological experiment is not necessary. French experts did not agree with this point of view, nor the did the Belgian experts. On April the 1st, the Belgian Council for Biosafety therefore refused to give its approval for the Bt11 maize.
Syngenta did not supply data showing that the introduced genetic sequence - or transgene - was perfectly identical and stable. Those two positions must affect the decision of the European Council of Agricultural Ministers which will be held on April the 26th. The council must give its opinion on this
Bt11 maize. Its authorisation would mean the end of the 1999 "de facto"
moratorium on new GMOs.
This controversy takes place while another transgenic maize, MON863, is profoundly dividing the experts. Speaking on air on RMC, the new french Minister for Ecology, Serge Lepeltier, explained : "There is no way for authorising anything in the next few days or weeks".

Austrian Government’s report on Bt11 application attacks safety research and
concludes:
o there was no toxicological testing with the whole plant
o there were no tests on the long terms effects of eating the novel protein
o the test for allergic reactions are insufficient and many assumptions
argued by Syngenta are false
o the safety of Bt 11 is based on theoretical argument rather than evidence.)
PDF-Dokument umweltbundesamt.at/publikationsdetail.html?&pub_id=1066

Greenpeace technical comments on insect resistant Bt11 maize, a compilation
PDF-Dokument saveourseeds.org/downloads/gp_bt11_oct_2003.pdf

Other background:

Syngenta fact sheet on Bt 11
PDF-Dokument syngenta.com/en/downloads/Bt_sweet_corn_update_3-04_final.pdf