Ad hoc meeting with GMO industry representatives - 30-31 October 2025
The ad hoc meeting with GMO industry representatives (GMO applicants) was organized by EFSA on 30-31st of October 2025. The meeting was hybrid.
The following topics were discussed:
Scientific Opinion on protein safety and next steps. This topic has been discussed during several meetings. This time EFSA and the applicants discussed the next steps and pending questions so that the scientific opinion is implemented in practice in the future. EFSA informed of the planned webinar to present the contents of the Scientific Opinion on Protein Safety Assessment.
Explanatory Note on Newly Expressed Proteins (NEPs). EFSA informed the GMO applicants of the intention to update the Explanatory Note on NEPs considering it was published in 2018. The purpose is to clarify points where a high number of risk assessment questions has been addressed throughout the years to the applicants.
Good Laboratory Practices (GLP) studies. EFSA and CropLife Europe (CLE) exchanged views on the acceptance of GLP studies in application dossiers. EFSA presented the GLP requirements, and the verification of the GLP status of studies that EFSA performs during the completeness check. CLE asked in that regard for further clarifications on the process of study audits that EFSA may request to a national monitoring authority when the GLP status of submitted studies needs to be verified.
Communications on agronomic and phenotypic assessment. EFSA provided clarifications on the use of marker genes conferring herbicide tolerance and on the relevant endpoints to be considered by the applicants. Questions and a discussion followed the presentation.
Risk Assessment of stacks. EFSA informed on the discussions and progress made by the GMO Panel and its Working Groups. EFSA committed to keep the GMO applicants updated on the progress and decision of the EFSA GMO Panel.
Administrative and procedural issues. EFSA presented updates on the risk assessment and publication process and tools. EFSA also clarified aspects on the confidentiality assessment related to antibody information and sequence information based on the assessment of recent dossiers. Finally, EFSA provided clarifications on several aspects encountered during the intake phase of the dossier. CLE presented their questions on the topic and received answers by EFSA.
EFSA shared the following updates under AOB: a) on the request to provide scientific and technical assistance for a regular horizon scanning to assess new scientific data on plants, animals and microorganisms and products thereof obtained by new genomic techniques, and b) on the completeness of data for the submission of animal dietary exposure.
For further details and updates on administrative procedures, refer to the Administrative guidance for the preparation of renewal applications on genetically modified food and feed.
The next ad hoc meeting with the GMO industry representatives will be held remotely on the 17th of March 2026.