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EFSA Opinion: once again, no safety risk for GM maize MON863


(7 April 2010) Additional authorisations of food and feed products derived from genetically modified maize can be expected in the EU. According to an opinion recently published by EFSA, there is no scientifically based concern for safety – that also applies to MON863 which has been the subject of much controversy over the past two years.

Following conclusion of the risk assessment carried out by the GMO Panel of the European Food Safety Authority (EFSA), it can be expected that the EU Commission will be preparing relevant authorisation decisions. Should it happen – as is often the case – that the Council of Ministers reaches no qualified majority of Member States for or against an authorisation, the EU Commission will step in as provided for by European legislation, implement its recommendations and grant authorisation.

Up for authorisation are food and feed products derived from maize MON89034 x MON88017, a cross of two varieties of genetically modified maize which create a total of three types of Bt protein. This makes the maize plants resistant to various pests, including the larvae of the European corn borer and the Western corn rootworm, a beetle. Additionally, the maize plants are tolerant of herbicides containing glyphosate (Roundup).

Just as for products derived from MON89034 x MON88017 maize, the EFSA GMO Panel also determined that GM maize MON863 presents no scientifically based cause for concern. The authorisation permits only the sale of food and feed products derived from MON863, which also creates a Bt protein against the Western corn rootworm, but not its commercial cultivation in the EU.

MON863 products had already been authorised in the EU based on previous legislation. Monsanto’s reapplication, submitted in accordance with current EU biotechnology legislation, was under assessment.

The opinion delivered by EFSA’s GMO Panel shows that additional data was requested from the applicant for the new risk assessment. This data was taken into consideration during the assessment as well as the latest scientific knowledge published. The EFSA experts upheld an earlier conclusion of the results of MON863 feeding trials on mice. In 2007, French scientist Gilles-Eric Séralini criticised Monsanto’s analysis of the feeding trials. He interpreted the difference found in mice growth and other biological parameters not as "natural, biological variation", but as an indication of possible health risks posed by MON863.

EFSA and French institutes have since been repeatedly concerned with the feeding trials and Séralini’s interpretation of them. Former results have been upheld in the current EFSA opinion.

MON863 maize has been cultivated on a large scale primarily in the USA for the past several years.

 

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