Safety assessment of MON810: invalidation of a Monsanto result by a European Food Safety Authority (EFSA) expert

22.10.2013

Question for written answer E-012048-13
to the Commission
Rule 117
Sandrine Bélier (Verts/ALE)

A study on the assessment of genetically modified organisms (GMOs) in the European Union has been conducted by the French association Inf’OGM[1], with a particular focus on the application for renewal of the authorisation of Monsanto’s MON810 genetically modified maize. The study casts doubt on the reliability of some of the results published by Monsanto and of some of the methods used to assess the safety of MON810 and other genetically modified plants.

Inf’OGM refers to the pepsin-resistance (or in vitro digestion) test and reports that Jean‐Michel Wal, an expert on EFSA’s GMO panel and a specialist in these matters, indicated that in conditions close to those of the physiology of digestion, the Cry1Ab protein (MON810 protein of interest) is not destroyed in simulated gastric fluid. This result totally contradicts the result presented by Monsanto in its case, yet it was validated by EFSA as part of the body of evidence for the safety of MON810.

1. Can the Commission explain why EFSA validated a result which was invalidated by one of its own experts?

2. Does the Commission consider that a test carried out in non-physiological conditions and exposed as such by at least one EFSA expert can be taken into account when assessing the safety of GMOs?

• [1] ‘GMO expertise: assessment turns its back on science’, http://infogm.org

OJ C 221, 11/07/2014