Environmental Risk Assessment (ERA) of the application of nanoscience and nanotechnology in the food and feed chain | EXTERNAL SCIENTIFIC REPORT

Clear guidance on conducting Environmental Risk Assessment (ERA) of nanomaterials is becoming more and more relevant as new applications of nanomaterials in the food and feed chain are developed. Upon request from EFSA, this report compiles and structures the relevant information for ERA of nanomaterials. This should support EFSA in preparing future guidance aimed at ERA of the application of nanoscience and nanotechnology in the food and feed chain. Existing ERA guidance documents were analysed for their adequacy to cover issues that are specific for nanomaterials, e.g. related to nanospecific behaviour. Each nanospecific issue was addressed by briefly reviewing the existing methods to address the issue in each separate step of ERA. In exposure assessment adaptations are needed in current approaches because nanomaterial behaviour and fate are not described by equilibrium partitioning and certain nanomaterial specific fate processes are not included in existing modelling tools and derivation of default values. In hazard and risk characterisation the main adaptations are needed in metrology and dose metrics by adequately describing the fate and behaviour of nanomaterials in exposure media. These adaptations are needed to address the issue of specific uptake mechanisms and bioavailability of nanomaterials, and the impact of nanospecific behaviour on the outcome of (chronic) toxicity studies. Furthermore, relevance of test species should be considered in relation to expected fate of a nanomaterial application in the environment. Overall, collaboration with other EU agencies (e.g. ECHA, EMA) and organisations on method developments (e.g. OECD, ISO) is advised to avoid duplication of work and contradictory recommendations in ERA guidance for nanomaterials.

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