Canada - Home

On May 31, 2025, Canada’s Biocides Regulations under the Food and Drugs Act officially entered into force, establishing a single regulatory framework for surface disinfectants and sanitizers—collectively referred to as biocides. These new rules replace previous authorizations granted under either the Food and Drug Regulations (FDR) or the Pest Control Products Act (PCPA).

Pre-Market Authorisation Now Mandatory

Under the new framework, all biocides must undergo a pre-market assessment by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) to obtain a market authorization. Only then can they be sold, imported, or advertised in Canada. Authorized products will carry a unique 8-digit identification number, signaling that they meet stringent standards for safety, efficacy, and quality.

Stronger Oversight for Public and Occupational Safety

This regulatory shift ensures greater consistency, improved transparency, and enhanced public and occupational safety, particularly for products used in healthcare facilities, food premises, households, schools, and veterinary settings.

Transition Deadlines for Existing Products

• Products previously authorized under the FDR or PCPA must transition to the new framework by May 31, 2029.

• Surface sanitizers used in food premises must obtain market authorization by May 31, 2031.

Post-Market Surveillance to Continue

Health Canada will continue post-market monitoring and enforcement through its Regulatory Operations and Enforcement Branch (ROEB) and Marketed Health Products Directorate (MHPD) to ensure ongoing compliance and risk management.

On March 26, 2025, Canada amended the Domestic Substances List to apply Significant New Activity (SNAc) provisions to trixylyl phosphate (CAS RN 25155-23-1). This requires prior notification before undertaking any new use that could significantly increase human or environmental exposure to the substance.

Precautionary Action Under CEPA

Based on the suspicion that information about new activities involving trixylyl phosphate could help determine its potential toxicity under Section 64 of the Canadian Environmental Protection Act (CEPA), the Environment Minister, Steven Guilbeault, and the Health Minister jointly made the decision.

The order, issued under subsection 87(3) of CEPA, serves as a preventive measure to guarantee that any future applications of the substance are thoroughly evaluated to limit risks to the environment and public health.

Further details can be found in the Canada Gazette, Part II, Volume 159, Number 7 (here), which includes the precise substance impacted and outlines the necessary regulatory requirements.

SNAc provisions to trixylyl phosphate

Order 2024-87-24-01 amends the Domestic Substances List to apply CEPA's SNAc provisions to trixylyl phosphate, also known as phenol, dimethyl-, phosphate (3:1). This action seeks to manage potential risks associated with increased exposure in Canada and the environment due to significant new activities.

Although current use levels do not pose an immediate risk, the substance is used in flame retardants, hydraulic fluids, lubricants, plastics, and possibly food packaging. It has been identified as having potential reproductive toxicity and environmental persistence.

Notification Requirements for New Activities

Under the new requirements, any individual or company proposing a significant new activity involving trixylyl phosphate, particularly in cosmetics or consumer products, must submit a Significant New Activity Notification (SNAN) containing detailed information on the proposed use, exposure levels, and safety measures, at least 90 days prior to the activity.

The regulatory amendment follows assessments under Canada’s Chemicals Management Plan (CMP) and aims to proactively protect public health and the environment from future risks associated with the increased or altered use of this substance.