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EFSA Publishes Timelines for Submitting Additional Information during Risk Assessments

February 20, 2014

The European Food Safety Authority (EFSA) released a set of indicative timelines specifying when additional documentation requested by the Authority should be submitted for risk assessments of regulated products. EFSA does not have an overarching regulation that governs the risk-assessment process for all products, but has instead relied on sector-specific regulations which vary depending on the regulated entity. In an effort to streamline the risk assessment process, and to create more efficient reporting mechanisms, EFSA worked with sector-specific panels to design cross-sector timelines for conducting risk-assessments.

The report includes a table of recommended response times for submission of supplemental information upon EFSA's request, which is broken down by the regulated product areas, including food contact materials, and by the type of additional information being requested for the risk assessment. Examples of the type of supplemental information that may be requested by EFSA for a food-contact material assessment and the corresponding timelines within which a petitioner must respond include (among others):

  • Migration test data (6 months);
  • In vitro genotoxicity assays (6 months); and
  • Sub-chronic 90-day oral toxicity studies (12 months).

EFSA suggested that the timelines will increase efficiency by giving sector-specific panels a clearer perspective of the type of data needed to conduct the assessment, create more uniformity across sectors, and provide applicants with a better sense of the time needed to conduct the risk assessments. The timelines were released on January 31, 2014 and are scheduled to take effect three months after the date of publication.