May 20, 2026
New Amendments to the Human Pathogens and Toxins Act
Amendments to the Human Pathogens and Toxins Act (Act), as part of the Budget 2025 Implementation Act, No. 1, received Royal Assent on March 26, 2026, marking the first major update to the Act since 2015. These changes strengthen Canada’s biosafety and biosecurity framework and support a modern, risk-based approach to regulating human pathogens and toxins in Canada. The clean, amended Act will be posted online in the coming weeks, once available.
To support implementation, the Centre for Biosecurity has developed several resources to help you understand and comply with the changes:
- How the Public Health Agency Implements the Human Pathogens and Toxins Act – outlines the key changes and updated guidance
- the Training Portal’s Amendments to the Human Pathogens and Toxins Act main page – provides new and updated training materials aligned with the amended requirements.
Additional guidance and resources will continue to be released. Please refer to these pages regularly for the most up-to-date information.
The Centre for Biosecurity presented a webinar providing an overview of the amendments on March 31, 2026. The recording, transcript, and presentation materials are now available on the PHAC Training Portal. Licence holders, licence holder representatives, biological safety officers, and other interested parties are encouraged to view the recording to understand the amendments and support implementation and compliance with the amended Act.
Do all amendments come into effect immediately?
While many provisions came into force upon Royal Assent, others will require regulatory development before taking effect. Amendments to the Human Pathogens and Toxins Regulations will follow the Government of Canada’s standard regulatory process.
Anyone to which the Act applies must also comply with the existing Human Pathogens and Toxins Regulations and the Canadian Biosafety Standard, Third Edition. Risk Group 4 licenced facilities must also comply with the Biosecurity Addendum to the Canadian Biosafety Standard, Third Edition, which came into effect on January 5, 2026, as a condition of their licence.
It is your legal responsibility to remain up to date and comply with the requirements of the Act. Failure to meet your obligations may result in enforcement actions in accordance with the Centre for Biosecurity’s Compliance and Enforcement Policy.
If you have any questions, please do not hesitate to contact us at Centre for Biosecurity Engagement, cb.engagement-mobilisation.cb@phac-aspc.gc.ca.