EFSA publishes new guidance on nanotechnologies in food and feed
The European Food Safety Authority (EFSA) have published guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance gives practical suggestions on the types of testing that are needed and the methods that can be applied.
Reinhilde Schoonjans, a risk assessment scientist at EFSA, said: “This guidance is very timely because it gives applicants the tools they need to prepare complete nanotechnology applications and equips risk assessors such as EFSA with the appropriate tools to evaluate their safety”.
It covers areas such as novel foods, food contact materials, food and feed additives, and pesticides and is intended for all interested parties – in particular risk assessors, risk managers and applicants.
This document, which focuses on the safety assessment for human and animal health, underwent a three-month public consultation and takes into account all comments received.
The guideline has taken 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.
EFSA states the guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment, and hazard characterisation of nanomaterials. It specifically elaborates on the physicochemical characterisation 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 characterisation of nanomaterials, and their determination in complex matrices.
The guidance also details the aspects relating to exposure assessment and hazard identification and characterisation. 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 will now enter a pilot phase, with finalisation envisaged by the end 2019.
A second guidance will be developed in 2019 focusing on environmental risk assessment of nanoscience and nanotechnology applications in the food and feed chain.