Next generation risk assessment in practice

There is an ongoing shift in toxicology, from the classical animal experiments to the use of new assessment methodologies (NAMs). However, no complete evidence-based framework for the use of NAMs in chemical risk assessment are available.

The project “Next Generation Risk Assessment in Practice” is designed to be a practical step-by-step approach to the development of an evidence-based framework for human health hazard assessment based on NAMs. The framework will include tools and guidance’s, and the development will be based on existing evidence-based toxicology and systematic review principles. The project will provide generic and sector-independent tools and guidance’s to make it feasible to perform chemical risk assessment based on NAMs.

As part of the gradual incorporation and transition toward the use of NAMs, a framework for evidence-based use of NAMs in toxicological research and chemical risk assessment is required. Such a framework should ultimately incorporate at least the following principles:

  • Result in identification of all relevant NAM-generated evidence relating to the research question addressed in a systematic review or risk assessment.
  • Provide for the evaluation of the internal validity of NAM studies (propensity for systematic error due to how the study is designed and conducted).
  • Provide for the evaluation of the external validity of NAM studies (the degree to which results of a study can be translated/generalised to human adverse health effects).
  • Contribute to objectivity, robustness, transparency, and reproducibility in the hazard identification and characterisation process.
  • In its approach to normalising and structuring the description and analysis of NAMs, contribute to progress in the extent to which research data conforms to FAIR (Findable, Accessible, Interoperable and Re-usable) principles of open science.

Evidence-based hazard assessment can be separated into six modules:




Systematic literature search


Critical appraisal


Certainty in the evidence


Identify the point of departure


Uncertainty in the point of departure

An overview of the planned work in this project:

Module 3

Critical appraisal

  • Tools for evaluation of external validity of new assessment methodologies (NAMs)
  • Tools for evaluation of internal validity of NAMS
  • Checklists (reporting standards) for NAMs

Module 4

Certainty in the evidence

  • Guidance for evidence synthesis and evaluation of certainty in the overall body of evidence

Module 5

Point of departure

  • Guidance on the identification of the Point of Departure from NAMs

Module 6


  • Guidance on the identification and evaluation of uncertainty in the Point of Departure