FSA, FSS confirm safety of Bayer’s GM soybean for feed and food

UK – The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have confirmed the safety of the genetically modified (GM) soybean MON 87705 x MON 87708 x MON 89788 for food and feed uses. 

This conclusion follows a comprehensive safety assessment, the results of which have been published in FSA Research and Evidence.

The assessment follows an application (RP2149) submitted by Bayer CropScience Ltd. on behalf of Bayer CropScience LP for authorisation under assimilated Regulation (EC) No. 1829/2003. 

The application seeks approval for importing, processing, and using the GM soybean in food and feed, though it does not cover cultivation in the UK.

The FSA and FSS conducted their review using evidence provided by the applicant, publicly available information, and the European Food Safety Authority’s (EFSA) scientific opinion. 

This included a 2020 EFSA opinion and a 2024 statement that finalised the risk assessment following a 90-day feeding study and a post-market monitoring proposal.

Genetic modification and intended traits

The soybean MON 87705 x MON 87708 x MON 89788 was developed through the conventional crossing of three single soybean events:

• MON 87705: Downregulates endogenous FAD2 and FATB enzymes to alter the fatty acid profile, increasing oleic acid content.
  
• MON 87708: Expresses dicamba mono-oxygenase (DMO) for tolerance to dicamba-based herbicides.
  
• MON 89788: Expresses CP4 EPSPS protein for glyphosate tolerance.
  

The resulting three-event stack soybean is designed to improve fatty acid composition while providing resistance to common herbicides.

Safety assessment findings

The safety review found no concerns for human or animal health or environmental safety. The EFSA concluded that the newly expressed proteins (CP4 EPSPS and DMO) and RNA interference (RNAi) elements did not raise toxicity or allergenicity concerns. 

Bioinformatics analyses showed no evidence of harmful effects, and studies on protein stability confirmed safety under digestion and environmental conditions.

Comparative assessments revealed that the only significant differences between the GM soybean and its conventional counterpart were related to Gly m 3 levels and total fat content, neither of which poses safety or nutritional concerns. The change in the fatty acid profile aligns with the intended trait modifications.

The FSA and FSS confirmed that the assessment followed relevant GB (Great Britain) guidance and regulatory standards, concluding that GM soybeans are as safe as their non-GM counterparts. 

The agencies also reviewed the applicant’s post-market monitoring (PMM) plan and found it aligned with EFSA recommendations.

Regulatory and market implications

With this assessment, the FSA and FSS confirm that no additional risk assessment activities are necessary. The genetic modification does not impact any existing soybean production or manufacturing processes. 

While the application allows for import, processing, and use in food and feed, it does not include cultivation, meaning this GM soybean will not be grown in the UK.

The safety assessment by FSA and FSS represents the official position of both agencies, reinforcing that soybean MON 87705 x MON 87708 x MON 89788 poses no additional risks compared to conventional soybeans. 

This conclusion supports continued regulatory approvals and market access for the GM soybean within the UK food and feed industries.

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