Canada Regulatory News

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.

On October 4, 2024, Canada released a draft plan for the Watch List under the Canadian Environmental Protection Act (CEPA). The Watch List will monitor substances that are potentially harmful to human...

On October 4, 2024, Canada released a draft plan for the Watch List under the Canadian Environmental Protection Act (CEPA). The Watch List will monitor substances that are potentially harmful to human health or the environment, even if they do not currently meet toxicity criteria under CEPA. Public consultations on the draft will be open for feedback for 60 days before the Watch List is finalized by the end of 2025.

What is the Watch List?

In June 2023, Canada strengthened its environmental protection laws by amending the Canadian Environmental Protection Act, 1999 (CEPA) through Bill S-5. A key element of this amendment is the creation of the Watch List, which is designed to increase transparency and provide the public with insight into substances that may pose a risk to human health or the environment. The Watch List allows for the identification of substances that may become toxic over time, even though they do not currently meet the criteria for toxicity under CEPA, thus allowing for proactive management. Unlike substances listed in Schedule 1 of CEPA, substances on the Watch List are not subject to immediate regulatory restrictions. However, the list provides increased transparency and allows stakeholders to stay informed about substances of concern.

How the Watch List Works

The proposed Watch List approach outlines the processes for adding or removing substances from the Watch List. Environment and Climate Change Canada (ECCC) and Health Canada (HC) are responsible for compiling the list based on scientific data and evaluations. Substances may be added to the Watch List following an assessment or review under Part 5 of CEPA or based on decisions by other jurisdictions that are relevant to Canada.

Substances that may be included on the Watch List are those that do not meet the current definition of toxic under CEPA, but may become harmful if use, exposure or hazard characteristics change in the future. Examples of considerations include:

• The severity or type of health or the environmental effect the substances may have.

• Physical or chemical properties of the substance.

• Potential changes in exposure or use patterns that could increase risks.

• Environmental fate and behavior of the substance in the ecosystem.

Adding Substances to the Watch List

Substances can be added to the Watch List based on several criteria, including:

• A recommendation following an assessment under Part 5 of CEPA.

• A review of decisions by other jurisdictions suggesting that a substance may become toxic.

• Evaluation of new or emerging data that indicate potential risks.

Each addition to the Watch List will go  through a public consultation process to ensure transparency and stakeholder participation.

Removal of Substances from the Watch List

A substance will be removed from the Watch List if:

• It is added to Schedule 1 of CEPA as a toxic substance

• The Ministers of Environment and Health no longer have reason to believe that the substance may become toxic

Public Engagement and Transparency

The Watch List is designed to be a transparent tool for informing the public and stakeholders about substances of potential concern. Information about each substance added to the list, including its Chemical Abstracts Service Reference Number (CAS RN), name, and reason for inclusion, will be made available to the public. This information will be searchable and accessible through the CEPA Registry, ensuring easy access to details of substances on the Watch List.

The proposed Watch List will not impose any legal or regulatory obligations on the substances listed, but will serve as an early warning mechanism for stakeholders, manufacturers, and importers to monitor these substances and consider safer alternatives.

Example Follow-Up Activities for Watch List Substances

While the Watch List does not impose new restrictions, the ECCC and HC may pursue additional activities to monitor and gather information on substances of concern. Examples of such activities include:

• Significant New Activity (SNAc) Provisions: If there is a significant change in the use of a substance, the SNAc provisions may require stakeholders to inform the government of these changes, allowing for further risk assessment.

• Environmental and Biomonitoring: Monitoring the presence of substances in wildlife, air, water, or humans to track trends and potential exposures.

• Section 71 Notices: Mandatory information-gathering notices used to collect data on substance usage, toxicity, and commercial activity.

Public Comment Period and Watch List Finalization

The proposed Watch List approach will be open for public comment for a period of days. Interested parties, including the general public, industry stakeholders, and environmental organizations, are invited to provide feedback. Comments may be submitted through the CEPA Registry and must cite "Proposed Watch List Approach" in the subject line.

Once finalized, the Watch List Approach will be published by the end of 2025, with substances added to the list shortly thereafter. The goal is to provide an early warning system to ensure that potential risks are identified and managed before they become a greater threat to human health or the environment.

A recent study by Health Canada introduced a new metric called Cumulative Health Risk from Exposure Load (CHREL), which provides insight into the cumulative health risks posed by multiple chemical exp...

A recent study by Health Canada introduced a new metric called Cumulative Health Risk from Exposure Load (CHREL), which provides insight into the cumulative health risks posed by multiple chemical exposures. This metric is based on data from the Canadian Health Measures Survey (CHMS) and uses Human Biomonitoring Health-Based Guidance Values (HB2GVs) as thresholds to evaluate the potential health risks from chemical exposures in a population. The findings suggest that a significant portion of the Canadian population may be exposed to chemicals at levels potentially above the HB2GVs, raising concerns about cumulative health risks.

Understanding CHREL: A New Approach to Chemical Exposure

CHREL builds on the concept of Exposure Load (EL), which identifies how many chemicals an individual is exposed to at levels above a certain threshold. CHREL takes this further by integrating HB2GVs, which are exposure thresholds derived from toxicological studies, to evaluate the health risks of chemical mixtures.

By applying HB2GVs, the CHREL metric indicates the number of chemicals detected in an individual that exceeds the health-protective guidance values. The study focused on 18 chemicals measured in CHMS cycles 3 and 4 (2012–2013 and 2014–2015), including mercury, benzene, acrylamide and triclosan. These chemicals have been linked to adverse health effects on the liver, nervous system, and cancer risk.

Key Findings: Chemical Exposures in Canada

The CHREL analysis revealed that more than half of the Canadian population had a CHRELTOTAL score of 1 or higher, indicating exposure to one or more chemicals at levels above the health-based thresholds. Certain subgroups were found to be at higher risk:

• Males had significantly higher CHREL scores compared than females.

• Smokers had notably higher CHREL scores than non-smokers, indicating increased exposure to harmful chemicals.

• Younger age groups (12–19 years) had lower CHREL scores compared to older age groups, especially those aged 40–59.

Small segments of the population also showed higher CHRELLIVER and CHRELNERV scores, which assess risks to the liver and nervous system, respectively. For cancer risk, the study introduced CHRELCANC, based on six chemicals linked to cancer endpoints. Most of the population had an estimated CHRELCANC score of 3, indicating potential exposure to multiple chemicals above negligible cancer risk levels.

Chemicals Driving Health Risks

The study identified several key chemicals that contribute significantly to health risks in the Canadian population:

• Inorganic arsenic was the leading contributor to elevated CHREL scores in the population.

• Mercury, acrylamide, benzene and xylenes were also notable contributors to the overall chemical burden.

• For smokers, the most critical chemicals were inorganic arsenic, benzene, and cadmium, which drove the higher CHREL scores in this group.

Public Health and Policy Implications

The CHREL metric provides a novel way to assess the cumulative health risks of chemical exposures in a population. This information can help guide risk management and regulatory decisions by identifying chemicals that pose the greatest threats to public health. For instance, reducing exposure to inorganic arsenic and other high-risk chemicals could have a significant impact on reducing overall health risks.

The findings underscore the importance of continued biomonitoring efforts, as well as research on how chemical exposures interact to affect human health. Additionally, the study highlights the need for targeted interventions to reduce chemical exposures in vulnerable subpopulations, such as smokers and the elderly.

Limitations and Future Research

While CHREL provides valuable insights, the study has several limitations. The metric relies on available data for a limited number of chemicals, and further research is needed to expand the range of chemicals analyzed. Additionally, the HB2GVs used in the analysis may vary depending on the methods used to derive them, and more work is needed to standardize these values across different chemicals.

Moreover, CHREL does not indicate the level of exposure for each chemical, only whether the exposure exceeds the health-based threshold. As research on chemical interactions and cumulative risk advances, future updates to the CHREL methodology may provide even more refined insights into population-level chemical exposures.

Conclusion: A Step Toward Better Chemical Risk Management

CHREL represents a significant step forward in understanding the cumulative health risks posed by multiple chemical exposures. By integrating biomonitoring data with health-based guidance values, CHREL provides a clearer picture of the chemical exposures of the Canadian population. This metric can serve as a valuable tool for public health officials, researchers, and policy makers to assess and manage the risks associated with chemical exposures, ultimately contributing to improved health outcomes and stronger environmental protection.

The full study can be found here.