The European Parliament’s committees are currently busy discussing the Commission proposal for a revision of the general food law regulation.German MEP Renate Sommer is responsible for steering the proposal through the Parliament. She has proposed 63 amendments to the Commission proposal that would improve transparency in risk management and in particular one of her amendments (25) requires that the pre-submission process provided for by the Commission in its proposal allow for applicants to discuss the design and requirements of clinical trials with the European Food Safety Authority (EFSA). The extent to which data submitted by applicants can be published is a very controversial issue amongst MEPs dating back to the controversy on EFSA’s safety assessment of glyphosate.The Commission and EFSA are clearly not supportive of pre-submission meetings involving detailed discussions on clinical trials and EHPM will be working to increase MEP support for this requirement as otherwise any pre-submission process will be meaningless.
Positive EHPM Relevant Points made by MEPs
MEP Marco Zullo (IT/EFDD) raised some points referring explicitly to the concerns of SME’s producing natural products on whether ESFA approach is up to the task of assessing such ingredients and whether EFSA panels members’ have the required level of expertise in the subject they are assessing.
Mr Zullo also highlighted the need of a dialogue between EFSA and SME’s prior to the submission of an authorisation request.
MEP Giovanni La Via (IT/EPP) queried whether the disclosure of confidential information for the sake of transparency may, in the long term, undermine competitiveness by making companies withdraw their dossier to maintain the control over their confidential information.
On EFSA’s Scientific Opinion on HADs, Mr La Via expressed concern that EFSA negative assessment contradicted previous assessments by national authorities and queried whether the methodology used was appropriate .
Mr La Via pleaded for EFSA’s risk assessments to be accurate and based on the actual ingredients under assessment rather than synthetic equivalents. He said that otherwise he was concerned about EFSA becoming a “Market Management tool”. A short video documenting MEP La Via making presenting his points is available below