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September 18, 2020

EFSA Calls for Grant Proposals on the Use of NAMs for the Hazard Assessment of Cellulose Nanofibers

Lynn L. Bergeson Carla N. Hutton

On September 15, 2020, the European Food Safety Authority (EFSA) called for grant proposals on the use of new approach methodologies (NAM) for the hazard assessment of cellulose nanofibers.  EFSA states that the use of cellulose at the nanoscale is increasing and requires an assessment.  According to EFSA, the main concern is that the nanoscale characteristics (e.g., length/shape of the fibers) may influence the toxicokinetic and hazardous properties of cellulose nanofibers.  The main objective of the call is to design and conduct a set of NAM-based studies for addressing the current data gaps and to offer a proposal for including the results in the regulatory hazard assessment of nanocellulose for consumers exposed via food.  The studies should cover the three main areas identified by EFSA:

  • Digestion or degradation, including surface modifications, of nanocellulose by the human microbiome;
  • Assessment of nanocellulose uptake in human intestinal epithelia; and
  • Assessment of local effects, including inflammation, of nanocellulose on the gastrointestinal epithelia.

All studies should be designed using NAMs, avoiding in vivo animal studies, and should specifically address the nanoscale properties.  EFSA states that the studies should also be designed for maximizing the use of the results in the regulatory context, including internal validation protocols and a detailed level of reporting, including access to the raw data for the verification of the results during the regulatory assessment.  The call includes two lots, and applicants may apply to one or both lots:

  • Lot 1 covers the adaptation and use of human cellular models and in vitro microbial gastrointestinal tract (GIT) digestion systems; and
  • Lot 2 focuses on the use of gut-on-a-chip models replicating GIT motility.

The call is restricted to the list of competent organizations established by EFSA’s Management Board.  Proposals are due November 3, 2020.  ECHA expects to notify applicants of the outcome of the call in December 2020.