Download PDF
July 5, 2018

EFSA Publishes New Guidance on Nanotechnologies in Food and Feed

Lynn L. Bergeson Carla N. Hutton

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011.  Potential future developments suggested in the scientific literature include nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides, and food contact materials.  Therefore, EFSA states, the guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment, and hazard characterization of nanomaterials.  It specifically elaborates on the physicochemical characterization of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterization of nanomaterials, and their determination in complex matrices.  The guidance also details the aspects relating to exposure assessment and hazard identification and characterization.  In particular, the guidance discusses nanospecific considerations relating to in vivo/in vitro toxicological studies, and outlines a tiered framework for toxicological testing.  It describes in vitro degradation, toxicokinetics, and genotoxicity, as well as general issues relating to testing of nanomaterials.  Depending on the initial tier results, EFSA states that studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome, and endocrine activity.  The guidance also discusses 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.  The guidance proposes approaches to risk characterization and uncertainty analysis, and provides recommendations for further research in this area.  EFSA notes that the guidance is intended for all interested parties — in particular risk assessors, risk managers, and applicants.  According to EFSA, the guidance will now enter a pilot phase, with a final guidance envisioned by the end of 2019.  EFSA will develop a second guidance in 2019 focusing on the environmental risk assessment of nanoscience and nanotechnology applications in the food and feed chain.