Ad Hoc meeting with GMO industry representatives

Ad Hoc meeting with GMO industry representatives
The ad hoc meeting with GMO industry representatives (GMO applicants) was organized by EFSA on 19 March 2025. The meeting was held online.

The following topics were discussed:

Updates on submission of new and renewal GMO applications. EFSA provided an overview of the elements that were updated in the Administrative guidance for the preparation of applications on genetically modified plants and the Administrative guidance for the preparation of renewal applications on genetically modified food and feed, published on 4 April in EFSA’s website. The relevance of the services available to GMO applicants in EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products was also highlighted. 

Correspondence during the life cycle of a GMO dossier. EFSA presented the main steps of the Risk Assessment workflow via ESFC, and an overview of the public information displayed in OpenEFSA.

post-TR Confidentiality Assessment Process. EFSA presented the main lessons learnt and best practice regarding the submission of Confidentiality Requests and provided information on how GMO applicants can contribute to speed up the Confidentiality Assessment processing time.

Risk Assessment of stacks CropLife Europe [CLE] presented a proposal for a streamlined risk assessment of GM plant stacked events obtained by conventional crossing. CLE advocated for a fit-for-purpose, science-driven approach to the Risk Assessment of GM plant stacked events. EFSA took note of the CLE position and indicated that the GMO Panel and its Working Groups are currently assessing the data requirements for GM plant stacked events applications.

Protein Safety CropLife Europe [CLE] presented a summary of its comments to the Draft Scientific Opinion Protein safety assessment_for public consultation. CLE stated its support to the weight-of-evidence approach, combined with a stepwise methodology, as it provides a robust framework for evaluating protein safety.
EFSA shared the following updates: the Public Consultation closed on March 12 2025; the GMO Panel aims at adopting the Scientific Opinion on Protein Safety Assessment in the coming months (indicatively by September 2025); upon its publication, EFSA will organise a webinar to present the contents of the Scientific Opinion on Protein Safety Assessment. 

Food consumption data and dietary exposure estimations for GMO risk assessment. EFSA presented how dietary exposure assessment is currently conducted for the GMO risk assessments, making use of summary statistics of consumption published in the EFSA website GMO applications: Tools and the methodology published in the 2019 EFSA statement Human dietary exposure to GMO food. EFSA highlighted the advantages and disadvantages of the current approach and detailed its future plans to estimate dietary exposure to newly expressed proteins and for nutritional intake assessment in nutritionally altered crops.

The next ad hoc meeting with GMO industry representatives will be held in as on-site (Parma, Italy) hybrid meeting on October 30 [p.m.] and October 31 [a.m.] 2025.