On August 7, Health Canada published a technical update to its Science Approach Document (SciAD) on the Bioactivity-Exposure Ratio (BER). The SciAD was originally published for consultation in March 2021. The Technical Update describes modifications to the BER approach, reflecting public comments, updated databases and tools, and advances in the interpretation of in vitro bioactivity data.
The BER approach combines in vitro bioactivity data with in vitro-to-in vivo extrapolation (IVIVE) and human exposure estimates to support quantitative, risk-based chemical prioritization and screening-level risk assessment. The 2026 update includes changes to the ToxCast database and toxicokinetic modelling tools, revised assay-filtering criteria, additional consideration of cytotoxicity and data curation, and consideration of chemical distribution in in vitro test systems.
The BER approach is part of the government’s broader shift toward New Approach Methodologies (NAMs) and non-animal approaches to chemical risk assessment. The Technical Update indicates that the approach continues to evolve as new data, modelling tools and scientific information become available. Of particular interest, Health Canada continues to consider a BER below 100 as an indicator that a substance may warrant higher priority for further action, where there is adequate confidence in the exposure estimate. The Government states that the approach is currently considered fit for priority setting and rapid risk-based screening.
Your CA Regulatory Team is reviewing the technical update in further detail and will provide members with new information as needed. For more information or questions, please contact the Substances Management Information Line at substances@ec.gc.ca. Members may also contact the CA Regulatory Team at regulatory@cosmeticsalliance.ca.
