Environment and Climate Change Canada (ECCC) and Health Canada have published the Final Framework for the Risk Assessment of Nanomaterials under the Canadian Environmental Protection Act (CEPA), released on Mars 5, 2026. This document follows the consultation process launched in 2021 and incorporates stakeholder input received during that period.
A preliminary review indicates that the final framework largely maintains the approach outlined in earlier drafts. Importantly, it reinforces the principle that existing risk assessment methodologies under CEPA are generally appropriate for nanomaterials, as noted in the plain-language summary: “The assessment of nanomaterials follows the same general principles and approaches as for bulk substances.” It was very good to see this key consideration highlighted in the final framework. Cosmetics Alliance Canada and other stakeholder’s key considerations appear to be well reflected.
The framework applies to both existing nanomaterials on the Domestic Substances List (DSL) and new nanomaterials notified under CEPA regulations, naturally occurring nano-sized particles are exempt. The definition being used for Nanomaterials is a substance with at least one dimension in the 1–100 nanometer range or exhibiting nanoscale properties, including agglomerates and aggregates containing nanoscale primary particles. Risk assessments will follow traditional chemical evaluation principles, adapted to account for nanomaterial-specific properties such as size, shape, surface chemistry, and potential transformations over the lifecycle. Both human health and ecological risks are considered, incorporating exposure, hazard data, bioavailability, environmental transformations, and potential impacts on vulnerable populations. Data for assessments may come from experimental studies, predictive models such as read-across and QSARs, and international databases, with uncertainty managed through a Weight of Evidence approach and case-by-case evaluation.
Cosmetics Alliance will continue to review the publication in more detail and keep members informed of any developments. Members with questions or comments about the framework are encouraged to reach out to the CA Regulatory Team at regulatory@cosmeticsalliance.ca.
