Earlier this year EFSA undertook a thorough revision of its 2011 guidance on the risk assessment of nanomaterials (NMs) used in food and feed production. Final guidance on Part 1 has now been issued and provides an overview of the information requirements and steps needed to perform health risk assessments for humans and other animals. Key topics include the following:

  • unambiguous identification and detailed characterisation of NMs (their components, including surface constituents, as well as any impurities)
  • hazard identification/characterisation, including the suitability (or not) of existing in vitro and in vivo assays
  • potential changes in properties and biokinetics of NMs compared with corresponding non-NMs, leading to altered toxicological effects
  • exposure assessment
  • risk characterisation, including where the use of NM-specific uncertainty factors may be appropriate
  • circumstances under which requirements for NM-specific data could be waived or grouping/read-across could be applied
  • ongoing developments in alternative testing approaches, mode of action and adverse outcome pathways

European Food Safety Authority (2018). Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health. https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5327


The above items were taken from the August 2018 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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