EFSA publishes Guidance on nanoscience and nanotechnologies risk assessment

The European Food Safety Authority (EFSA) has produced Guidance for risk assessment of nanoscience and nanotechnology applications in the food chain. It covers novel foods, food contact materials, food/feed additives and pesticides.

As well as elaborating on whether a material is a nanomaterial, the Guidance details exposure assessment, hazard identification and characterization. In particular, nanospecific considerations relating to in vivo/in vitro toxicological studies are discussed and a tiered framework for toxicological testing is outlined.

It describes in vitro degradation, toxicokinetics, genotoxicity as well as general issues relating to testing of nanomaterials. Depending on the initial tier results, studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity.
The possible use of read‐across to fill data gaps as well as the potential use of integrated testing strategies and the knowledge of modes/mechanisms of action are also discussed. The Guidance proposes approaches to risk characterization and uncertainty analysis, and provides recommendations for further research in this area.

The Guidance takes account of new developments since publication of the previous Guidance in 2011. Potential future developments are also suggested in the scientific literature for nanoencapsulated delivery systems and nanocomposites, so the Guidance has taken account of new scientific studies that provide more insights to physicochemical properties, exposure assessment and hazard characterisation of nanomaterials.