Control banding tools for occupational exposure assessment of nanomaterials - Ready for use in a regulatory context?

AbstractThe development, production and application of engineered nanomaterials are becoming more and more widespread. Because researchers, developers and industrial workers are the first in line to be exposed to potentially hazardous nanomaterials, appropriate occupational exposure assessment is a key area of concern. Therefore, a number of Control Banding (CB)-based tools have been developed in order to assess and manage the potential risks associated with occupational exposure to nanomaterials.In this paper we provide a comparative analysis of different nanomaterial-specific types of control-banding/risk prioritization tools (the Control Banding Nanotool, IVAM Technical Guidance, Stoffenmanager Nano, ANSES CB Tool, NanoSafer, and the Precautionary Matrix) in order to evaluate their use-domains; types, extent, use and availability of input parameters; their output format; and finally their potential use and maturity in regard to meeting the minimum requirements for occupational exposure assessment under REACH and the conceptual source-transmission-receptor model by Schneider et al. (2011). This was done through an analysis including a literature review and use of the tools.It was found that the tools were developed for different purposes, with different application domains and inclusion criteria. The exposure assessments and derived risk levels are based on different concepts and assumptions and outputs in different formats. The use of requested input parameters for exposure assessment differ greatly among the tools. Therefore, direct inter-comparison and combination of the different models into a larger holistic framework is not immediately possible.Harmonization of input parameters and output could allow establishment of an exposure assessment framework with different levels of information requirements

Novel foods: allergenicity assessment of insect proteins

Abstract Insects represent a promising source of proteins and have been reported as a great potential for being used as novel food and feed proteins. This makes them a valuable source of nutrients to face the increasing demand of food necessitated by the growing global population. The current European food legislation on novel food (EU Reg. 2015/2283), which entered into force in 2018, provides the provisions that should be considered in the applications for the authorisation of novel foods in the European market. Insects, intended as an alternative source of food proteins for human consumption, are considered novel foods. Since food allergens are mostly proteins, the analysis and identification of the potential allergenicity of novel proteins should be a fundamental activity that enables the applicants to fulfil the requirements for the application and authorisation to bring a novel food into the European market and ensures a high level of food safety for the European consumers. The main aims of the work of the EU‐FORA fellow were to: (i) Review, assess and identify gaps in the current strategies for predicting allergenicity of novel foods and new alternative protein sources; and (ii) Familiarise, understand and perform an allergenicity assessment of a novel food protein source by: (a) Working on an allergenicity assessment case study of insect proteins from black soldier fly larva (Hermetia Illucens); and (b) Taking into consideration other risk assessment aspects of insects as novel food, including toxicological, nutritional and microbial risks. The project contributed to the continuous learning of the fellow on practical assays and methodologies for the in silico, in vitro and in vivo analysis principles and complemented personal skills related to the food risk assessment requirement for the preparation and submission of an application for authorisation of a novel food