Canada Regulatory News

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.

Environment and Climate Change Canada (ECCC) has launched a public consultation on proposed amendments to the Export of Substances on the Export Control List Regulations. The consultation will runs fr...

Environment and Climate Change Canada (ECCC) has launched a public consultation on proposed amendments to the Export of Substances on the Export Control List Regulations. The consultation will runs from December 16, 2024, to March 1, 2025, and seeks feedback on changes to improve regulatory clarity, reduce administrative burdens, and enhance Canada’s compliance with international agreements.

Background and Regulatory Evolution

First introduced in 2013 under the Canadian Environmental Protection Act, 1999 (CEPA), the regulations were designed to fulfill obligations under international conventions such as the Rotterdam Convention, the Stockholm Convention, and the Minamata Convention. Incremental amendments were made in 2017 to incorporate mercury controls and in 2018 to regulate asbestos exports. However, a comprehensive review in 2024 revealed areas for improvement, prompting the current proposed amendments.

Key Objectives of the Proposed Amendments

The proposed amendments aim to address three primary issues identified during the review process: a lack of clarity and readability in the regulations, the administrative burden associated with export notifications, and challenges in effectively implementing Canada’s obligations under international conventions. To address these issues, ECCC has published a consultation document to gather feedback from stakeholders and the public on how to effectively modernize and streamline the regulatory framework.

Structure and Scope of the Export Control List

The Export Control List (ECL), which forms the basis of the regulations, categorizes substances into three parts.

• Part 1 substances are prohibited for use in Canada and may only be exported for destruction or under specific ministerial direction.

• Part 2 substances require notification or consent from importing countries under agreements such as the Rotterdam Convention.

• Part 3 substances are subject to domestic restrictions but may still be exported under certain conditions.

The regulations aim to ensure that exports comply with Canada’s domestic and international commitments.

Proposed Changes to Improve Clarity and Readability

One significant focus of the amendments is to improve the clarity and readability of the regulations. This includes reorganizing the text to group similar provisions together, simplifying the language, and ensuring that exporters can easily identify prohibited activities. For instance, provisions related to the Minamata Convention, which currently appear later in the regulations, would be moved earlier for better visibility. The proposed changes also include standardizing terminology across provisions, such as those related to laboratory use exemptions.

Simplifying the Export Notification Process

Another key area of reform is the simplification of the notification process for exporting substances. The current system requires exporters to submit detailed notices of proposed export, including estimated quantities, which can be burdensome, especially for substances found in multiple products. The ECCC proposes to allow exporters to submit a single notice for multiple shipments within a calendar year and to remove the requirement to estimate quantities for certain scenarios. These changes are intended to reduce the administrative burden while maintaining the necessary oversight to meet regulatory objectives.

Modernization Efforts

Modernization is also a priority in the proposed amendments. The ECCC seeks to integrate electronic submission systems and update definitions to align with other federal regulations. These efforts are designed to make compliance more efficient and user-friendly for stakeholders.

Strengthening Compliance with International Conventions

The amendments also focus on strengthening Canada’s compliance with international conventions. Under the Stockholm Convention, for example, the proposals include the collection of additional information for exports of persistent organic pollutants (POPs) intended for destruction, such as details about the disposal facility and method. For the Rotterdam Convention, the ECCC suggests streamlining the permitting process to ensure that all exports requiring prior informed consent are adequately monitored. Similarly, the amendments propose stricter controls on mercury-containing products under the Minamata Convention to align with domestic regulations and international obligations.

How to Submit Feedback

The ECCC is inviting stakeholders to provide feedback on these proposals, including suggestions for further improvements. Specific questions have been raised regarding the clarity of the regulatory language, the challenges faced in submitting notices, and additional scenarios where regulatory requirements could be streamlined. The input gathered during this consultation will be used to inform the final amendments, which are expected to be published in the Canada Gazette after March 2025.

Submissions can be made via email or phone, and stakeholders are encouraged to review the accompanying guidance documents for detailed information. This consultation is an important opportunity to shape the future of Canada’s export control regulations to ensure they remain effective, efficient, and aligned with international best practices.

The Government of Canada has officially amended the Pest Control Products Regulations (SOR/2024-259) under the Pest Control Products Act. Effective from the date of publication in the Canada Gazette, ...

The Government of Canada has officially amended the Pest Control Products Regulations (SOR/2024-259) under the Pest Control Products Act. Effective from the date of publication in the Canada Gazette, December 9, 2024, these amendments update the labeling requirements for sodium hypochlorite (CAS No 7681-52-9) and calcium hypochlorite (CAS No 7778-54-3) to strengthen public safety measures.

Key Changes in Labeling Requirements

1. Updated Signal Words:

   • Sodium Hypochlorite: Updated from "Warning - Corrosive" to "Danger - Corrosive to Eyes and Skin".

   • Calcium Hypochlorite: Updated from "Caution - Corrosive" to "Danger - Corrosive to Eyes and Skin".

2. Revised Precautionary Symbols:

   • Sodium Hypochlorite: Symbol shape changes from diamond to octagon.

   • Calcium Hypochlorite: Symbol shape changes from triangle to octagon.

These changes are consistent with the re-evaluation decision (RVD2023-14) to enhance hazard communication and reduce health risks.

Background and Regulatory Context

Health Canada conducted a comprehensive re-evaluation of sodium hypochlorite and calcium hypochlorite in June 2021. The findings emphasized the need for updated labels to reflect the higher level of risk associated with these chemicals. This decision followed 62 reports of incidents involving humans and domestic animals.

The Pest Control Products Act mandates pre-and post-market evaluations to assess environmental and human health risks. The updated regulations ensure consistency between product labels and scientific standards.

Consultation and Stakeholder Feedback

A public consultation was conducted between December 14, 2022 and March 14, 2023. Feedback primarily highlighted the effectiveness of these chemicals in pool and sanitation applications. No changes to the proposed amendments were required based on stakeholder input.

Objectives of the Amendments

• Improve clarity and consistency in hazard communication.

• Align regulations with the results of the re-evaluation.

• Reduce confusion among stakeholders regarding labeling standards.

• Enhance user safety by specifying body parts at risk.

Impact Assessment

• Environmental Impact: No significant environmental impacts identified.

• Economic Impact: No additional costs for stakeholders as label updates were already mandated by the re-evaluation decisions.

• Small Business Impact: No significant impact on Canadian small businesses.

• Gender and Diversity Impact: No disproportionate impact identified.

International Alignment

The amendments bring Canada’s labeling standards closer to those of the United States, the European Union and Australia. While minor differences remain, these differences are not expected to have a significant impact on trade.

Implementation and Compliance

The amendments take effect immediately upon registration. Stakeholders must comply with the updated labeling standards outlined in RVD2023-14.

Conclusion

These regulatory amendments underscore Canada’s commitment to public health and safety. By aligning labels with current scientific standards, they that ensure users are better informed about potential hazards and promote the safe handling and use of sodium hypochlorite and calcium hypochlorite products.

The governments of Canada and the United States use different regulatory frameworks for managing hazardous products in the workplace. Canada’s Hazardous Products Regulations (HPR) under the Hazardou...

The governments of Canada and the United States use different regulatory frameworks for managing hazardous products in the workplace. Canada’s Hazardous Products Regulations (HPR) under the Hazardous Products Act (HPA) and the U.S. Hazard Communication Standard (HCS) outline specific labeling, classification, and safety data sheet (SDS) requirements. While both systems follow the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), there are notable differences. The following is a detailed comparison of these differences.

1. Supplier Identifier

• Canada: The SDS and label must include the Canadian supplier’s name, address, and telephone number. Exemptions apply for importers who use hazardous products only in their workplaces or who list their own information instead.

• U.S.: The SDS and label must include the contact information of the U.S. manufacturer, importer or responsible party without exceptions.

2. Water-Activated Toxicants

• Canada: Labels and SDSs must include an additional hazard statement for products that release toxic gases upon contact with water.

• U.S.: A supplemental hazard statement is required if the workplace contains substances that release toxic gases under normal or emergency conditions.

3. Toxicological Information in SDSs

• Canada: Requires detailed descriptions of toxicological effects, including symptoms, routes of exposure, and acute toxicity estimates (ATEs). Additional toxicological data may be included if not misleading.

• U.S.: Includes similar requirements, but also requires information on interactive effects and potential carcinogenic classifications by the National Toxicology Program (NTP) or the International Agency for Research on Cancer (IARC).

4. Confidential Business Information (CBI)

• Canada: Allows use of prescribed concentration ranges for trade secrets without requiring the narrowest range possible.

• U.S.: Mandates that the narrowest possible range be disclosed. Combined ranges may be used under specific conditions.

5. Labeling Multi-Container Shipments

• Canada: Labels are required for each container unless exemptions apply for small or outer containers.

• U.S.: Only the innermost container needs labeling; outer containers are exempt.

6. Small Package Labeling

• Canada: Containers ≤100 mL may omit precautionary and hazard statements, and containers ≤3 mL may omit labels if they interfere with use.

• U.S.: Similar exemptions apply, but a statement is required directing users to complete the label information on the outer package.

7. Bulk Shipments

• Canada: Labels are not required, but the same information must be provided on SDSs.

• U.S.: Labels may accompany shipments as electronic documents or appear on  shipping papers or the immediate container.

8. Bilingual Labeling

• Canada: Labels and SDSs must be in both English and French.

• U.S.: Labels and SDSs are only required in English.

9. Explosives and Desensitized Explosives

• Canada: Excludes explosives from the HPR as they fall under the jurisdiction of the Explosives Act.

• U.S.: Includes explosives and desensitized explosives in the HCS framework.

10. Combustible Dusts

• Canada: Labels and SDSs are only required for products in dust form that present a combustible hazard.

• U.S.: Classification and labeling are required for products that may create combustible dust hazards when processed or used.

11. Carcinogen Labeling in Mixtures

• Canada: Mixtures containing carcinogens at ≥0.1% must have both labels and SDSs.

• U.S.: Labels are required only for mixtures containing Category 1 carcinogens ≥0.1% or Category 2 carcinogens ≥1%.

12. Hazards Not Otherwise Classified (HNOC)

• Canada: Requires labeling for Physical Hazards Not Otherwise Classified (PHNOC) and Health Hazards Not Otherwise Classified (HHNOC).

• U.S.: Does not require labeling for HNOCs but allows optional pictograms with the designation "HNOC".

13. Biohazardous Infectious Materials (BIM)

• Canada: Includes a specific BIM hazard class with labeling requirements and an SDS appendix.

• U.S.: Does not regulate BIM under the HCS.

Summary

While Canada’s HPR and the U.S. HCS share common objectives, these key differences reflect different approaches to workplace hazardous material safety. Employers, manufacturers and importers operating in both jurisdictions should ensure compliance with the unique requirements of each regulatory framework.

On November 9, 2024, the Government of Canada announced a proposed amendment to the Domestic Substances List (DSL) under the Canadian Environmental Protection Act, 1999 (CEPA) to apply Significant New...

On November 9, 2024, the Government of Canada announced a proposed amendment to the Domestic Substances List (DSL) under the Canadian Environmental Protection Act, 1999 (CEPA) to apply Significant New Activity (SNAc) provisions to four substances: Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7. This amendment aims to address environmental and human health concerns associated with these substances.

Key Details of the Proposed Order

1. Targeted Substances:

   • Basic Violet 3 (CAS RN 548-62-9)

   • Malachite Green (CAS RN 569-64-2)

   • Basic Violet 4 (CAS RN 2390-59-2)

   • Basic Blue 7 (CAS RN 2390-60-5)

2. Purpose:
   The proposed amendment requires that any significant new activity (such as manufacturing or import) involving these substances be reported to the Minister of the Environment. This will ensure that their potential risks are evaluated in accordance with CEPA guidelines before activities proceed.

3. Scope of Notification:

   • Manufacturing: Notification is required if a consumer product contains any of the substances in a concentration greater than 0.1% by weight, except for specific exemptions.

   • Importation: Notification is required if a consumer product contains the substances above 0.1% by weight and exceeds an annual import threshold of 10 kg.

4. Exemptions:
   The proposed order does not apply to:

   • Components in commercial printing inks or dyes in paper products.

   • Research and development substances or site-limited intermediate substances.

   • Substances intended for export only.

Reasons for the Amendment

The targeted substances were identified in the Final Screening Assessment (published in October 2020) as posing potential risks to the environment and human health:

• Environmental Impact: All four substances were found to be harmful to ecosystems or biodiversity.

• Human Health Concerns: Malachite Green also poses a risk to human health, particularly through exposure in consumer products.

This initiative aligns with Canada’s commitment to protect public health and the environment by ensuring a robust risk management framework.

Public Consultation Period

The Government is seeking public feedback on the proposed amendment. Comments will be accepted until 60 days after the notice’s publication in the Canada Gazette, Part I, dated November 9, 2024 (until January 8, 2025).

Compliance and Enforcement

Organizations with significant activities involving these substances must comply with the notification requirements outlined in CEPA. Non-compliance may result in enforcement action under the CEPA Compliance and Enforcement Policy.

Next Steps

Upon reviewing the public comments, the finalized order will be published in the Canada Gazette, Part II, along with details on its implementation. The information provided in the Significant New Activity Notification (SNAN) will be subject to a comprehensive assessment to determine any potential risks associated with new activities involving these substances.