Overall goal/objectives:
The goal of this EFSA-funded project was to assess the capacity of NAMs for addressing the gaps identified in risk assessments for nanofibers used in the food/feed area, particularly nanocellulose. Complements a parallel OECD activity on “Integrated in vitro approach for intestinal fate of orally ingested nanomaterial” that focuses on metallic nanoparticles. The project aimed to 1) design and conduct a set of NAM-based studies for assessing the uptake and potential crossing of the intestinal barrier by different nanocellulose fibres and crystals after their thorough physicochemical characterisation, 2) explore the capacity of advanced in vitro models for the assessment of local effects of nanocellulose, including inflammation and genotoxicity, on the gastrointestinal epithelia, 3) assess if any digestion or degradation of nanocellulose by the human microbiome occurs, 4) integrate the results in regulatory risk assessment of nanocellulose covering different uses linked to consumer exposure via food. A parallel, smaller project led by CNR-IT (coordinator: Barbara Cassani) focused on exploring gut-on-a-chip approaches for assessing nanocellulose hazards.
Case Study Leader:
ISS-IT (Francesco Cubadda)
Collaborators:
ISS-IT, ANSES-FR, Sciensano-BE, INRAE-FR, EU-JRC
Status: Completed
- Critical gaps for the safety assessment of nanocellulose identified
- Selection of nanocellulose test materials and design of IATA and study protocols finalized
- Experimental work finalized
- Final report issued
Presentations or publications that have been publicly released:
- Vincentini O, Blier AL, Bogni A, Brun M, Cecchetti S, De Battistis F, Denis S, Etienne-Mesmin L, Ferraris F, Sirio Fumagalli F, Hogeveen K, Iacoponi F, Moracci G, Raggi A, Siciliani L, Stanco D, Verleysen E, Fessard V, Mast J, Blanquet-Diot S, Bremer-Hoffmann S, Cubadda F, 2023. EFSA Project on the use of New Approach Methodologies (NAMs) for the hazard assessment of nanofibres. Lot 1, nanocellulose oral exposure: gastrointestinal digestion, nanofibres uptake and local effects. EFSA Supporting publication 20(9):EN-8258. 49 pp. https://www.efsa.europa.eu/en/supporting/pub/en-8258