Canada Regulatory News

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—colle...

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 un...

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.

Transport Canada has announced the publication of a new edition of its key packaging standard for dangerous goods.  Developed by the Canadian General Standards Board (CGSB), CAN/CGSB-43.150-2025, tit...

Transport Canada has announced the publication of a new edition of its key packaging standard for dangerous goods.  Developed by the Canadian General Standards Board (CGSB), CAN/CGSB-43.150-2025, titled “Design, Manufacture and Use of UN Standardized Drums, Jerricans, Boxes, Bags, Combination Packaging, Composite Packaging and Other Packagings for the Transport of Dangerous Goods, Classes 3, 4, 5, 6.1, 8, and 9” was officially released in April 2025.

The updated standard ensures that Canada’s requirements for the design, manufacture, and use of containers for dangerous goods remain aligned with international best practices.

Coming Into Force

The CAN/CGSB-43.150-2025 standard will be incorporated by reference into the Transportation of Dangerous Goods Regulations (TDGR).
Until the TDGR is amended, stakeholders must continue to comply with the following standards:

• TP14850-2010: Small Containers for Transport of Dangerous Goods, Classes 3, 4, 5, 6.1, 8, and 9 (Transport Canada Standard)

• CAN/CGSB-43.126-2019 (reaffirmed in 2024): Reconditioning, Remanufacturing and Repair of Drums for the Transportation of Dangerous Goods

Regulatory updates adopting the 2025 standard into the TDGR are anticipated in the near future.

Key Updates in the 2025 Edition

The 2025 edition introduces important changes to improve safety, harmonization, and regulatory clarity:

• Alignment with International Recommendations: Updates incorporate changes from the 23rd edition of the UN Recommendations on the Transport of Dangerous Goods, enhancing international compatibility.

• Integration of Reconditioning and Repair Requirements: The provisions from CAN/CGSB-43.126 are now being incorporated directly into CAN/CGSB-43.150, streamlining requirements for the reconditioning, remanufacturing, and repair of drums.

These updates ensure that Canadian manufacturers, reconditioners, and users of UN-standardized containers meet the most recent international safety and performance standards.

How to Access the New Standard

The CAN/CGSB-43.150-2025 standard is available free of charge here.

In March 2025, Health Canada updated its "Notification of Cosmetics: Guide for Cosmetic Notifications" to introduce new notification and labelling requirements that will apply in 2025 and 2026. The...

In March 2025, Health Canada updated its "Notification of Cosmetics: Guide for Cosmetic Notifications" to introduce new notification and labelling requirements that will apply in 2025 and 2026.

The Guide provides comprehensive instructions for manufacturers and importers on how to notify Health Canada about cosmetic products sold in Canada, as mandated by the Food and Drugs Act and the Cosmetic Regulations.

Notification Requirement

Under to Section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10 days of the first sale.

Health Canada always asks for the following information for cosmetic product notifications:

• The manufacturer

• The importer

• The person who formulated, manufactured, or processed the cosmetic on behalf of the manufacturer or importer.

New Requirements Introduced

Key updates to the Cosmetic Notification Form (CNF) include:

• As of March 5, 2025, the form mandates a Canadian address for the manufacturer or importer in section 4.

• Starting April 12, 2026, fragrance allergens must be listed on the label and CNF if they are present in concentrations exceeding 0.01% in rinse-off products and 0.001% in leave-on products.

These changes are intended to improve consumer protection and bring Canadian requirements closer to international standards.

On March 5, 2025 the Canadian government took a significant step to address the risks posed by per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals". These substances, w...

On March 5, 2025 the Canadian government took a significant step to address the risks posed by per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals". These substances, widely used for their waterproofing, oil resistance, and non-stick properties, are found in everyday products such as clothing, electronics, food packaging, and cosmetics. However, PFAS are highly persistent in the environment and harmful to both human health and wildlife.

PFAS Deemed Toxic under CEPA in New Government Report

Environment and Climate Change Canada has published the "State of Per- and Polyfluoroalkyl Substances (PFAS) Report," which concludes that PFAS, excluding fluoropolymers, are toxic under the Canadian Environmental Protection Act, 1999 (CEPA). Exposure to PFAS can adversely affect multiple organs and systems, including the liver, kidneys, thyroid, immune system, and more. In the environment, these substances can accumulate in living organisms and remain for long periods of time.

Phased Approach Will Target Key PFAS Starting in 2025

To mitigate these risks, the government plans to add PFAS (excluding fluoropolymers) to Part 2 of Schedule 1 of CEPA. A phased approach will be implemented from 2025:

1. Phase 1 will target PFAS in firefighting foams to protect firefighters and the environment.

2. Phase 2 will focus on limiting PFAS exposure in non-essential products such as cosmetics, food packaging, and textiles.

Additionally, from 2025, facilities that manufacture, import or use PFAS will be required to report their use to the National Pollutant Release Inventory (NPRI). This initiative aims to enhance the understanding of PFAS use in Canada and support efforts to reduce exposure to these harmful substances.

The government is seeking public comment on the proposed measures until May 7, 2025.

On  March 5, 2025, as part of its ongoing commitment to transparent chemical safety practices, Health Canada has published a detailed fact sheet explaining the moiety approach - a scientific methodol...

On  March 5, 2025, as part of its ongoing commitment to transparent chemical safety practices, Health Canada has published a detailed fact sheet explaining the moiety approach - a scientific methodology used to assess groups of chemical substances—under the Canadian Environmental Protection Act, 1999 (CEPA). This approach plays a key role in how the Government of Canada evaluates potential risks to both the environment and human health from substances that share a common chemical component.

What Is the Moiety Approach in CEPA Risk Assessment?

In chemical risk assessments under CEPA, the moiety approach evaluates the risk of a shared chemical structure or element - called a moiety - in a group of substances. Instead of analyzing each substance individually, assessments focus on the common moiety and its potential to cause harm. This allows for more efficient and holistic evaluations, particularly when dealing with complex families of chemicals.

For example, assessments using the moiety approach have been conducted for the benzothiazole group and for zinc and its compounds. The zinc assessment, focused on all substances capable of releasing zinc ions, whether from elemental zinc, zinc salts, organometallic compounds, or unknown/variable composition materials (UVCBs). These substances were assessed based on their ability to contribute to total zinc exposure in the environment.

How Does Health Canada Assesses Chemical Effects Using the Moiety Approach?

Ecological risk assessment under the moiety approach focuses on the toxic effects of the moiety in aquatic, sediment, and soil organisms. Health Canada and Environment and Climate Change Canada conduct targeted reviews of scientific literature and databases to determine toxicity thresholds. When sufficient reliable data are available, a Predicted No-Effect Concentration (PNEC) is established using species sensitivity distributions or assessment factors.

Environmental toxicity can vary due to factors such as pH, water hardness, and dissolved organic matter, particularly for metals. Therefore, PNECs may be adjusted to account for these conditions.

For human health assessments, scientists examine the toxicity of the moiety itself and assess whether any specific substances in the group pose higher risks. If a particular substance is found to be more hazardous than the moiety as a whole, it may be evaluated separately.

Exposure Assessment

The exposure assessment under the moiety approach considers all sources of environmental release that could lead to the presence of the moiety in air, water, soil, biota, or consumer products. This includes both anthropogenic (man-made) and natural sources. Exposure estimates are derived using both measured and modelled data, helping to quantify potential risk across the full range of environmental and human receptors.

Human biomonitoring data, such as concentrations found in blood, urine, or breast milk, are also considered. This provides a more complete picture of total exposure through all routes, including inhalation, ingestion, and skin contact.

CEPA Conclusions Based on the Moiety Approach

In assessing whether a moiety poses a potential risk, Health Canada uses all available evidence on exposure and effects. The evaluation may also consider:

• Vulnerable environments (e.g. sensitive ecosystems)

• Sensitive human subpopulations (e.g. children or pregnant women)

• Environmental and human exposure from nanomaterials, if applicable

While engineered nanomaterials are typically evaluated under a separate CEPA framework, their presence in environmental media can still be indirectly captured in moiety-based assessments if they release a relevant moiety.

Why This Approach Matters

The moiety approach enhances Canada’s ability to efficiently manage chemical risks by:

• Streamlining assessments for groups of related substances.

• Identifying shared hazards and exposure risks.

• Ensuring that regulatory action can be taken based on the core toxic component.

By grouping substances based on a common chemical identity, the Government of Canada ensures that emerging risks are addressed early, even when individual substances have not been prioritized for separate evaluation.

On February 5, 2025, the Government of Canada registered SOR/2025-17, officially amending the Domestic Substances List (DSL) under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (...

On February 5, 2025, the Government of Canada registered SOR/2025-17, officially amending the Domestic Substances List (DSL) under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA). This amendment, entitled Order 2024-87-21-01, applies the Significant New Activity (SNAc) provisions of CEPA to the substance ethanol, 2-[(2-aminoethyl)amino]- (CAS RN 111-41-1), commonly known as AEEA.

Why Was This Order Issued?

The amendment results from Canada’s ongoing efforts under the Chemicals Management Plan (CMP), a federal initiative to assess and manage the risks posed by chemicals to human health and the environment. While AEEA was not found to be “toxic” under CEPA’s section 64 criteria during its 2016 screening assessment, it was identified as a substance of concern due to properties that could pose risks if its use increases in new applications.

To ensure that future uses of AEEA do not result in unanticipated environmental or health effects, the SNAc provisions will now be triggered if the substance is used in ways that are significantly different from those previously assessed.

What Is AEEA and How Is It Used?

AEEA does not occur naturally in the environment and is used in various industrial and commercial applications, including:

• Food packaging adhesives and inks (non-direct food contact)

• Paper manufacturing agents

• Closed-loop cooling systems

• Epoxy adhesives and corrosion inhibitors

• Asphalt paving and patching materials

• Pigments for fibers such as carpets

The substance is primarily used as a chemical intermediate and curing agent in the production of resins and sealants. In previous surveys, it was reported that over 500,000 kg of AEEA was imported into Canada, although domestic production was negligible or non-existent.

Internationally, AEEA is used in epoxy hardeners, personal care products, and industrial chemicals, particularly in the United States, Europe, Japan, and Switzerland.

What Are the New Requirements?

The SNAc provisions of CEPA require that any person (individual or corporation) who plans to engage in a significant new activity involving AEEA must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment at least 90 days prior to the proposed activity.

Activities That Trigger Notification:

1. Manufacture or import of AEEA in concentrations ≥0.1% by weight in:

   • Consumer products (under the Canada Consumer Product Safety Act) sold in containers >250 ml

   • Cosmetics (as defined in the Food and Drugs Act)

2. Importing any of the above products containing AEEA if the total annual import exceeds 10 kg.

Activities Exempt from Notification:

• Use in research and development or as a site-limited intermediate

• Products intended solely for export

• Uses regulated under other Acts such as the Pest Control Products Act, Fertilizers Act, or Feeds Act

• Incidental presence in products, or substances formed as impurities or contaminants

Required Information for SNAN Submission:

Notifiers must provide detailed information about the activity and product, including:

• Description and function of the product

• Anticipated annual quantity

• Method of application and use

• Toxicological and environmental data

• Previous notifications to other government agencies

• Contact information and certification of accuracy

Once received, the Minister has 90 days to assess the submission before the activity may proceed.

Impact on Stakeholders and Industry

This Order does not affect currently authorized uses of AEEA in Canada. It only applies to new or modified uses that may increase the risk of exposure. Businesses using AEEA in previously assessed activities are not subject to any new regulatory obligations under this amendment.

For new uses, the SNAN process ensures pre-market review to prevent environmental or public health risks. This requirement is consistent with similar policies in international jurisdictions and supports Canada's alignment with global chemical management practices, including cooperation with the U.S. EPA and the European Chemicals Agency (ECHA).

Regulatory Context and Consultation Process

This regulatory change follows previous Notices of Intent published in the Canada Gazette, Part I in 2016 and 2020, which allowed for public and industry consultation. A stakeholder submission in 2016 resulted in refinements in the scope of what constitutes a significant new activity. No objections were received during the second public consultation.

Compliance, Enforcement, and Guidance

The Order is effective from the day of registration (February 15, 2025). Compliance promotion efforts will include direct outreach, guidance materials, and the availability of pre-notification consultations (PNCs) to help notifiers understand and meet their obligations.

Enforcement of this Order falls under the Compliance and Enforcement Policy for CEPA, which allows for a range of measures from warnings to legal action, depending on the severity and nature of the violation.

Broader Impacts and Benefits

This regulatory action is designed to prevent potential environmental and health risks from new uses of AEEA without disrupting current, low-risk uses. The application of the SNAc provisions reflects Canada's precautionary approach to chemical safety, allowing for proactive intervention before risks arise.

A Strategic Environmental and Economic Assessment concluded that this initiative supports the objectives of the CMP and will have a positive impact on human health and the environment. No adverse impacts were identified under Gender-based Analysis Plus (GBA+) or modern treaty obligations.