EU Proposes Updates to Food-Related Risk Assessment

Under new changes proposed by the European Commission, companies would be responsible for reporting all safety studies which were conducted on food-related products [including food contact materials (FCMs)] when submitting them for authorization to European Food Safety Authority (EFSA). Currently, companies applying for authorization for FCMs from EFSA only submit a dossier which summarizes necessary studies (as per EFSA guidance) which were conducted on the materials for review. According to the Commission, these changes are being proposed to ensure companies submit all relevant information for review, and do not withhold unfavorable studies.

In an effort to promote transparency, EFSA will make all submitted safety-related information accessible to the public. The proposed changes would also:

  • Require companies claiming confidential business information (CBI) to submit two different dossiers (one public and one confidential);
  • Create an EFSA managed register of industry studies for the EU;
  • Require that the decision of product authorization requests be made with the consultation of the public and stakeholders;
  •  Grant EFSA, with permission from the Commission, the power to request additional studies (funded by the EU).

The proposal will be submitted by The Commission to the European Parliament with hopes of implementation by mid-2019.