Canada Regulatory News

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 14, 2025, Canada published SOR/2025-27, officially listing decabromodiphenyl ethane (DBDPE) and dechlorane plus (DP) under Part 2 of Schedule 1 of the Canadian Environmental Protection Act...

On February 14, 2025, Canada published SOR/2025-27, officially listing decabromodiphenyl ethane (DBDPE) and dechlorane plus (DP) under Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). This action follows detailed risk assessments and public consultations and is part of Canada’s ongoing commitment to strengthen environmental protection through the Chemicals Management Plan (CMP).

Why Are DBDPE and Dechlorane Plus Considered Toxic?

Both DBDPE and DP were evaluated under the ecological and human health criteria set out in section 64(a) of CEPA. The final screening assessments concluded that while human health risks are minimal, environmental exposure and persistence of both substances pose significant ecological risks.

• DBDPE: Identified as persistent in the environment, especially in sediments, and has the potential to break down into bioaccumulative compounds.

• Dechlorane Plus: Shows long-range transport capability and is highly bioaccumulative, found in wildlife and remote environments.

These findings led to their classification as toxic under CEPA and listing in Part 2, which focuses on pollution prevention strategies.

CEPA Schedule 1 – What Does Part 2 Mean?

Under amendments introduced by the Strengthening Environmental Protection for a Healthier Canada Act (2023), CEPA Schedule 1 is now divided into two parts:

• Part 1 contains high-risk substances that require immediate or full prohibition.

• Part 2, where DBDPE and DP are now listed, requires risk management through pollution prevention measures such as controlled use, import limitations, or eventual bans.

The designation allows federal authorities to develop regulatory tools to mitigate the risks posed by these substances.

Industrial Use, Environmental Release, and Exposure in Canada

While neither substance is manufactured in Canada, industry data shows significant import volumes:

• DBDPE: 1,000 to 10,000 tonnes/year

• DP: 10 to 100 tonnes/year

Both are used as flame retardants in sectors including:

• Plastics and electronics

• Automotive and aerospace parts

• Construction materials and adhesives

Releases to the environment occur primarily during manufacturing, industrial use, and through waste streams over the lifecycle of products containing these chemicals.

International Regulation and Alignment

Canada's actions are aligned with global regulatory trends:

• United States: Both substances are listed under the Toxic Substances Control Act (TSCA).

• European Union: Under assessment by the European Chemicals Agency (ECHA), with DBDPE and DP included in restriction strategies for brominated flame retardants.

• Australia: Both substances are listed for environmental regulation under the Industrial Chemicals Environmental Management (Register) Act 2021.

• Stockholm Convention: DP is listed in Annex A for global phase-out with specific exemptions.

Stakeholder Consultation and Public Input

The federal government engaged with industry, non-governmental organizations, and the public during consultations in 2016 and 2019. Industry feedback included concerns about:

• Substitute availability and socio-economic impact

• Consistency with international regulations

• Potential for  misclassification of waste

NGOs supported the listing and called for class-based regulation of flame retardants to prevent regrettable substitution.

Next Steps in Regulatory Development

While this listing does not impose immediate regulatory obligations, it allows the government to propose risk management tools under CEPA, such as:

• Amendments to the Prohibition of Certain Toxic Substances Regulations

• Import or manufacturing restrictions

• Pollution prevention programs

Future regulatory proposals will be subject to further public and industry consultation.

Impact on Businesses and Small Enterprises

The Order SOR/2025-27 does not introduce direct compliance costs or administrative burdens. Analyses under the small business lens and one-for-one rule confirmed no impact on small businesses or reporting requirements. Economic implications will be assessed if further restrictions are developed.

Environmental and Health Implications

Although current human health exposure levels are low, the ecological risk posed by the substances - especially their persistence and bioaccumulation - warrants proactive management. The federal Strategic Environmental Assessment concluded that the listing of these substances supports Canada’s broader goals for environmental and human health protection.

On January 25, 2025, the Government of Canada published regulatory updates in the Canada Gazette, Part I, Volume 159, Number 4, regarding the management of chemical substances, specifically addressing...

On January 25, 2025, the Government of Canada published regulatory updates in the Canada Gazette, Part I, Volume 159, Number 4, regarding the management of chemical substances, specifically addressing trisiloxane and a group of terpene and terpenoid substances.

Significant New Activity Notice for Trisiloxane

The Department of the Environment has issued a Significant New Activity (SNAc) Notice under the Canadian Environmental Protection Act, 1999 (CEPA) for trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl- (CAS RN 17861-60-8). This notice requires that any significant new activities involving this substance, particularly in cosmetic applications, require prior notification to the Minister of the Environment.

Key Restrictions

• Cosmetics Use Limits: The substance cannot be used in cosmetics beyond prescribed limits, such as 5% in hair dyes and 10% in rinse-off cosmetics.

• Advance Notification: New significant activities involving the substance must be notified 90 days in advance.

• Exemptions: Use of the substance in manufacturing for export only is exempt from these regulations.

These measures are intended to prevent potential environmental and health risks associated with excessive use of trisiloxane in consumer products.

Assessment of Terpene and Terpenoid Substances

The Department of the Environment and the Department of Health have conducted a draft assessment of 14 terpene and terpenoid substances and proposed 12 of them be added to Part 2 of Schedule 1 of CEPA due to health risks.

Key Findings

• Substances of concern include cade oil, verbena officinalis extract, ginkgo biloba extract, and sage oil.

• Potential health risks: Identified concerns include carcinogenicity, reproductive toxicity, and effects on the nervous system.

• Public consultation period: A 60-day public comment period is open from January 25, 2025, to March 26, 2025, during which stakeholders are invited to submit comments and scientific data to support further assessments.

These findings reinforce the Canadian Government’s commitment to consumer safety and regulatory oversight in the management of chemical substances.

For detailed information and to participate in the consultation process, stakeholders are encouraged to consult the official publications in the Canada Gazette here.

On February 13, 2025, the Government of Canada launched a consultation on risk management measures for short-chain chlorinated alkanes (SCCAs), medium-chain chlorinated alkanes (MCCAs), and long-chain...

On February 13, 2025, the Government of Canada launched a consultation on risk management measures for short-chain chlorinated alkanes (SCCAs), medium-chain chlorinated alkanes (MCCAs), and long-chain chlorinated alkanes (LCCAs) with up to 20 carbon atoms. A screening assessment found  that these substances meet the toxicity criteria under the Canadian Environmental Protection Act, 1999 (CEPA). The objectives of this consultation are to:

1. Inform stakeholders and obtain comments on the proposed prohibition of MCCAs and LCCAs up to 20 carbon atoms under the Prohibition of Certain Toxic Substances Regulations, 2012.

2. Gather information on concentration thresholds for SCCAs and MCCAs.

3. Propose the addition of SCCAs, MCCAs, and LCCAs to the Export Control List (ECL) in Schedule 3 of CEPA.

Background

Chlorinated alkanes, also known as chlorinated paraffins, are hydrocarbons with carbon chain lengths ranging from 10 to 38 atoms. SCCAs (10-13 carbon atoms) have been prohibited in Canada since 2013, while MCCAs (14-17 carbon atoms) and LCCAs (18-20 carbon atoms) continue to be used in industrial applications such as metalworking fluids, plastics, rubber, paints, coatings, adhesives, and sealants.

Assessments by Environment and Climate Change Canada (ECCC) and Health Canada concluded that chlorinated alkanes up to 20 carbon atoms are harmful to the environment and human health, resulting in their inclusion in Schedule 1 of the CEPA in 2011.

International Risk Management

Chlorinated alkanes are under global regulatory scrutiny due to their persistence and potential harm to human health and the environment. Various international agreements and national regulations have restricted or prohibited their use and trade.

• Stockholm Convention: SCCAs were listed for elimination in 2017; MCCAs are recommended for inclusion in 2025.

• Rotterdam Convention: SCCAs were listed in 2017, requiring prior informed consent for international trade.

• United States: MCCAs and LCCAs are subject to Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA).

• European Union: MCCAs are classified as Substances of Very High Concern (SVHCs) under REACH and are subject to strict regulatory controls.

Proposed Risk Management Measures

To protect human health and the environment, Canada proposes to ban certain chlorinated alkanes, set concentration limits, and restrict exports.

1. Prohibition of MCCAs and LCCAs

The Government of Canada proposes to amend the Prohibition of Certain Toxic Substances Regulations, 2012 to prohibit the manufacture, use, sale, and import of MCCAs and LCCAs with up to 20 carbon atoms. Temporary exemptions may be considered for:

• Metalworking fluids

• Plastics and rubbers

• Adhesives and sealants

• Automotive parts

2. Establishment of Concentration Thresholds

Proposed incidental presence thresholds for regulatory alignment:

• SCCAs: 1% by weight for substances, 0.15% for manufactured items

• MCCAs: 0.1% by weight for all products

• LCCAs: Further data required

3. Addition to the Export Control List (ECL)

In order to comply with international obligations, SCCAs, MCCAs, and LCCAs with up to 20 carbon atoms may be added to Part 2 and Part 3 of the ECL under CEPA, thereby restricting exports.

Information Gathering

Stakeholders are invited to submit information on:

• Product use and industry applications.

• Available alternatives and transition timelines.

• Socio-economic impacts of prohibition.

• Data on incidental presence thresholds.

Next Steps

The Government of Canada is inviting industry stakeholders, manufacturers, and environmental groups to provide feedback by April 14, 2025. Stakeholder feedback will help refine the regulatory amendments and inform Canada’s position at the Stockholm Convention in April/May 2025.

On February 12, 2025, the Government of Canada officially added 2,4,11,13-tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) and its salts to Part 2 of Schedule 1 ...

On February 12, 2025, the Government of Canada officially added 2,4,11,13-tetraazatetradecanediimidamide, N,N″-bis(4-chlorophenyl)-3,12-diimino-(chlorhexidine) and its salts to Part 2 of Schedule 1 under the Canadian Environmental Protection Act, 1999 (CEPA) through Order SOR/2025-13. This regulatory action, published in the Canada Gazette, follows scientific assessments that identified environmental risks associated with chlorhexidine compounds, prompting the government to prioritize pollution prevention actions for these substances.

Why is Chlorhexidine Now Considered Toxic?

In 2019, a screening assessment conducted by Environment and Climate Change Canada (ECCC) and Health Canada concluded that chlorhexidine (CAS no 55-56-1) and its salts meet the environmental toxicity criteria outlined in paragraph 64(a) of CEPA. Key findings highlighted that:

• Chlorhexidine persists in aquatic environments and poses long-term risk to aquatic and benthic organisms, with algae being particularly sensitive.

• Although its bioaccumulation potential is low, the substance remains in water, sediment, and soil for prolonged periods of time.

• Releases primarily come from consumer use, wastewater discharge, and industrial formulation processes.

Despite these environmental concerns, the assessment found no significant risks to human health at current exposure levels from products such as antiseptics, cosmetics, and disinfectants.

Regulatory Impact and Next Steps

The addition of chlorhexidine and its salts to Part 2 of Schedule 1 allows the government to develop pollution prevention measures, which may include restrictions or prohibitions on certain uses. Unlike substances listed in Part 1 of Schedule 1, which require immediate bans or severe restrictions, substances listed in Part 2 are managed through targeted risk reduction strategies.

Canada’s Chemicals Management Plan (CMP) will now oversee the development of risk management measures, with stakeholder consultations expected before any final regulations come into effect. The government has also taken steps to:

• Include chlorhexidine in the National Pollutant Release Inventory (NPRI), which requires industry to report its environmental releases.

• Establish an Environmental Performance Agreement (EPA) with industrial formulators to limit chlorhexidine discharges to wastewater.

International and Domestic Context

While Canada has now classified chlorhexidine and its salts as toxic to the environment, regulatory actions vary worldwide:

• United States: Chlorhexidine digluconate is under review by the U.S. Environmental Protection Agency (EPA) for its safety as an antiseptic.

• European Union: Chlorhexidine is registered under REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) to monitor its effects on human health and the environment.

• Canada: The country will now prioritize pollution prevention strategies while continuing to allow the use of chlorhexidine in medical and personal care products.

What Happens Next?

The Canadian government is expected to initiate consultations with industry stakeholders, environmental groups, and health agencies to develop risk management tools. These measures could range from manufacturing and disposal guidelines to specific restrictions in industrial applications.

The full regulatory order can be accessed in the Canada Gazette here, and stakeholders have until April 14, 2025, to submit comments on future risk management plans.

The Canadian Environmental Protection Act 1999 (CEPA 1999) remains Canada’s most important chemical control law, requiring assessments of new substances placed on the market after 1994. It mandates ...

The Canadian Environmental Protection Act 1999 (CEPA 1999) remains Canada’s most important chemical control law, requiring assessments of new substances placed on the market after 1994. It mandates reviews of substances introduced before 1994, ensuring their safety for human health and the environment. Substances not on the Domestic Substances List (DSL) cannot be manufactured or imported without prior government approval, reinforcing Canada’s commitment to regulating hazardous chemicals effectively.

Bill S-5, known as the Strengthening Environmental Protection for a Healthier Canada Act, was adopted in 2023, marking a major amendment to CEPA for the first time in over two decades. It enhances protection for vulnerable communities, advances Indigenous reconciliation, strengthens chemical management strategies, and reduces reliance on animal testing. The government has until June 2025 to develop a comprehensive new plan for managing chemicals and integrating the right to a healthy environment into CEPA.

Canada has also begun transitioning to the seventh revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS7), replacing the fifth edition previously in use. This transition will occur over three years to allow industry stakeholders time to comply with updated classification and labeling standards.

Key News from 2024

Modernizing Canada's Environmental Protection: The Journey of Bill S-5

The modernization of the Canadian Environmental Protection Act (CEPA) is underway, embedding the right to a healthy environment into law. The government has launched a public consultation schedule to strengthen CEPA, focusing on chemicals management, environmental monitoring, and reducing vertebrate animal testing. The initiative aligns with global best practices and aims to improve environmental health standards. Read more here.

Health Canada and Environment and Climate Change Canada (ECCC) Announce New Regulatory Developments under Updated CEPA

Following the passage of Bill S-5, Health Canada and ECCC have initiated new regulations focusing on high-risk substances and toxic chemical restrictions. A series of public consultations will take place in 2024–2025 to shape new frameworks for environmental protection, including a watch list approach for hazardous chemicals and strategies to minimize animal testing.Read more here.

Canada Amends Domestic Substances List to Enhance Environmental Protection and Public Health

The Canadian government has amended the Domestic Substances List to regulate three chemicals—AGE, o-CGE, and TGIC—introducing new Significant New Activity (SNAc) requirements. The move ensures that any significant new uses of these substances undergo thorough risk assessment before approval, aligning with the country's Chemicals Management Plan. Read more here.

Government of Canada Publishes Notice on Amendments to the Domestic Substances List Under CEPA

The government plans to unmask the identities of 198 substances currently listed under Part 3 of the Domestic Substances List to improve transparency. Public consultations are open for stakeholders to provide feedback on confidentiality and regulatory impacts, with changes expected to align with Bill S-5’s amendments. Read more here.

Government of Canada Publishes Notice on Amendments to the Domestic Substances List under CEPA

The government plans to unmask the identities of 198 substances currently listed under Part 3 of the Domestic Substances List to improve transparency. Public consultations are open for stakeholders to provide feedback on confidentiality and regulatory impacts, with changes expected to align with Bill S-5’s amendments. Read more here.

Key Dates for 2025

Health Canada amended the Hazardous Products Regulation (HPR) to align with GHS 7 and introduce a new "Chemicals Under Pressure" hazard class from GHS 8. A three-year transition period has been set, requiring full compliance by December 15, 2025.

The Canadian Environmental Protection Act, 1999 (CEPA) governs the assessment and management of substances that may pose a risk to human health or the environment. On December 7, 2024, the Minister of...

The Canadian Environmental Protection Act, 1999 (CEPA) governs the assessment and management of substances that may pose a risk to human health or the environment. On December 7, 2024, the Minister of the Environment and the Minister of Health issued Significant New Activity (SNAc) Notice No. 21862, under Section 85 of CEPA for phosphoric acid, mixed decyl and octyl esters, potassium salts (CAS no: 70879-47-9). The Notice outlines specific conditions of use to ensure that potential risks are effectively managed.

Key Highlights of the SNAc Notice

Substance Details

The substance regulated under this Notice is:

• Name: Phosphoric acid, mixed decyl and octyl esters, potassium salts

• CAS RN: 70879-47-9

This substance is not currently listed on the Domestic Substances List (DSL) and significant new activities involving it may result in risks to the environment or human health as defined in Section 64 of CEPA.

Purpose of the Notice

The purpose of this Notice is to:

• Identify activities that may require further risk assessment before proceeding.

• Outline mandatory information requirements for proposed new uses.

• Ensure compliance with CEPA’s precautionary approach to chemical safety.

Significant New Activities Defined

Activities Requiring Notification

The Notice specifies that a Significant New Activity (SNA) includes:

1. Manufacture or Distribution of Cosmetics:

   • Use of the substance in cosmetics in concentrations greater than 1% by weight.

   • Quantities of 10 kg or more per calendar year in products intended for sale.

2. Excluded Uses:

   • Research and development or use as a site-limited intermediate.

   • Manufacture of products intended solely for export.

Information Requirements

Individuals or organizations intending to conduct a significant new activity must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment. Required information includes:

• Description of the Proposed Activity: A detailed outline of the significant new activity involving the substance.

• Anticipated Annual Quantities: Estimated volume of the substance to be used or distributed.

• Toxicological Data: Information on eye and skin irritation, dermal penetration, and any other relevant toxicity assessments.

• Environmental and Human Health Impact: Documentation identifying potential adverse effects and assessing exposure risks.

• Contact Details: Name, address, and contact information of the notifier and its Canadian representative (if applicable).

• Certification Statement: A signed declaration confirming the accuracy and completeness of the information provided.

Review Process

The SNAN will be reviewed by the Department of the Environment and the Department of Health within 90 days of a complete submission.

Transitional Provisions

To facilitate compliance, transitional provisions are in place until December 7, 2025. During this period, significant new activity thresholds are as follows:

• Manufacturing or Distribution Threshold: Quantities of up to 100 kg per year may be used in cosmetics in concentrations greater than 1% by weight.

From December 8, 2025, the threshold will revert to 10 kg per year for similar activities.

Compliance and Enforcement

Reporting Obligations

Entities engaging in activities involving the substance must comply with reporting requirements, including:

• Submitting timely and accurate SNANs.

• Reporting new information that indicates the substance is toxic or may become toxic under Section 70 of CEPA.

Transfers of Possession Obligations

Those who transfer physical possession or control of the substance must inform recipients of compliance requirements, including obligations under the SNAc Notice.

Pre-Notification Consultation (PNC)

Organizations or individuals are encouraged to consult with the regulatory authorities during the planning phase of their activities to clarify data requirements and regulatory expectations.