Assessment of genetically modified soybean MON 87769 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21253)

TL;DR

This paper assesses the safety of genetically modified soybean MON 87769 for food and feed use renewal, finding no new risks.

Contribution

The paper provides a scientific evaluation of new data for the renewal of authorization of MON 87769 soybean.

Findings

No new hazards were identified in the renewal dossier for MON 87769.

The original risk assessment conclusions remain valid based on the new data.

Environmental and post-market monitoring reports did not reveal new uncertainties.

Abstract

Following the submission of dossier GMFF‐2023‐21253 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 stearidonic acid producing genetically modified soybean MON 87769, 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, post‐market monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. 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 sequence of the event in soybean MON 87769 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2023‐21253 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87769.