EFSA News Item, 9 June 2005
On 12 April 2005 the European Food Safety Authority (EFSA) released a statement on the lack of data available to assess the risks of Bt10 [see * below] following the inadvertent release in the United States of a non-authorised genetically modified (GM) maize line called Bt10 and its unintended export as Bt11 to the European Union (EU).
EFSA has received a confirmation from Syngenta (the company which developed the genetically modified maize Bt10 maize) that the material subjected to safety studies described in the application for the use of Bt11 maize in cultivation [see ** below] was indeed Bt11 maize that had not been compromised by the presence of Bt10 maize. Hence the GMO Panel could conclude its risk assessment and finalised its opinion on the safety of Bt11 maize which was adopted on 20 April 2005 and published on 20 May 2005 [see *** below].
As apparently Bt10 was not intended to be further developed for commercial market purposes, Syngenta did not provide sufficiently comprehensive data for performing a full risk assessment of Bt10. It is therefore not possible to conclude on the safety of Bt10 itself. However, information on the newly inserted genetic material and the protein characterisation confirmed the presence in Bt10 of a gene (blaTEM) conferring resistance to the antibiotic ampicillin (see EFSA statement1 of 12 April 2005 for more information on the antibiotic resistance marker gene). It also showed that the two new proteins, found in Bt 10 and Bt11 maize, Cry1Ab and PAT, are identical. These characteristics were addressed in the EFSA Bt11 risk assessment.
Syngenta has estimated that the overall contribution of Bt 10 to all maize imported from the United States to the European Union (EU) is extremely low. This estimation is based on the amount of Bt10 seeds distributed and the area which could potentially have been planted with Bt10 maize (relative to the total maize cultivation area). The low potential contamination level of maize grain imported into the EU with Bt10 would therefore imply a very low exposure to Bt10 maize and derived products. In addition, the applicant has confirmed that Bt10 maize has not been used in sweet corn varieties used for human consumption.
Given that the two new proteins found in Bt11 and Bt10 are identical, and on the basis that information provided by Syngenta is correct – which EFSA cannot independently verify-- it is not considered likely that the inadvertent contamination of the imported maize grain with Bt10 poses a safety concern to animals and consumers. In light of the remaining uncertainties, and given the impossibility of carrying out a full risk assessment on Bt10 maize, the European Commission has taken an emergency measure requiring imports from the US of maize gluten feed and brewers grain used as animal feed to be certified as free of Bt10 [see **** below].
[**] EFSA-Q-2004-012, application under Directive 2001/18/EC.
[***] Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/F/96/05.10) for the placing on the market of insect resistant genetically modified maize Bt11, for cultivation, feed and industrial processing, under Part C of Directive 2001/18/EC from Syngenta Seeds, The EFSA Journal (2005) 213, 1-33 http://www.efsa.eu.int/science/gmo/gmo_opinions/922_en.html