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Rapid Response Mechanism Alternaria Toxins

Mobilising PARC’s Rapid Response Mechanism to address data gaps on Alternaria toxins

The Rapid Response Mechanism (RRM) implemented within PARC has been activated for the third time since its establishment in November 2023. This request, submitted by the European Food Safety Authority (EFSA) on 17 September 2025, addresses specific data gaps related to certain Alternaria toxins.

The data requested are essential for updating EFSA’s Scientific Opinion on Alternaria toxins, as mandated by the European Commission (EFSA-Q-2024-00285). EFSA identified three priority needs:

  • In vitro dose-response studies in oesophageal cells for tenuazonic acid (TeA);
  • Hepatic metabolism studies in primary human and rat hepatocytes for TeA, altertoxin II (ATX-II) and alternariol monomethyl ether (AME);
  • Assessment of transepithelial transport, metabolism and effects on intestinal barrier function for TeA and AME, using pig small intestinal cells in a transwell system.

This urgent request is being addressed through the RRM process. PARC will respond by launching a new project under the work package dedicated to hazard assessment. Several ongoing projects are already addressing related data gaps on Alternaria toxins, and their results will also contribute to EFSA’s ongoing risk assessment.

PARC partners involved in this new project – namely ANSES (the French Agency for Food, Environmental and Occupational Health & Safety) and the University of Vienna (UNIVIE) – are committed to delivering the requested data to EFSA by February 2026, enabling its evaluation and use in the hazard characterisation of these substances.

The activation of the RRM in this case illustrates PARC’s capacity to respond rapidly to emerging regulatory needs, complementing its regular work programme and reinforcing its role in supporting timely, evidence-based chemical risk assessment.

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