Assessment of genetically modified soybean MON 87701 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-021)

Following the submission of application EFSA-GMO-RX-021 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant genetically modified soybean MON 87701, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the event in soybean MON 87701 considered for renewal is identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-021 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701.

Automated summary

The Panel on Genetically Modified Organisms of the European Food Safety Authority evaluated the data submitted by Bayer CropScience LP for the renewal application of insect-resistant genetically modified soybean MON 87701. They found no evidence in the renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment.