Canada Regulatory News

In an effort to combat Canada’s growing opioid crisis, Health Canada under the Government of Canada, has proposed significant regulatory changes to tighten controls over precursor chemicals and desi...

In an effort to combat Canada’s growing opioid crisis, Health Canada under the Government of Canada, has proposed significant regulatory changes to tighten controls over precursor chemicals and designated devices such as pill presses and encapsulators. The proposed changes to the Precursor Control Regulations (PCR) and Schedule IX of the Controlled Drugs and Substances Act (CDSA) were officially published in the Canada Gazette, Part I, on June 28, 2025, and are open for public consultation until August 12, 2025. 

The amendments are designed to disrupt the supply chain for illegally produced fentanyl, which continues to be the primary contributor to overdose deaths nationwide. 

What Are Precursor Chemicals and Designated Devices? 

• Precursor chemicals are chemical substances that can be used to produce controlled substances such as synthetic opioids like fentanyl. 

• Designated devices refer to equipment used in drug production, such as pill presses and encapsulators. The proposed rules would also regulate certain component parts such as 
   dies,  punches, and  molds. 

While these items often are used in legal manufacturing contexts, are increasingly being diverted for illegal drug production in clandestine labs operated by organized crime. 

Summary of Proposed Amendments 

According to the documents published in the Canada Gazette, the following regulatory changes are being proposed: 

1. Expanded Import Registration Requirements 

Currently, importers of designated devices (like pill presses) must register their importation with Health Canada. Under the new proposal component parts suitable for use in pill presses and encapsulators such as  dies, molds, punches, would also be subject to registration.  
Importers would be required to provide proof of registration at the time of import. 
 

2. New Definitions and Classification 

• The definition of "designated device" would be updated to include interchangeable or individual components. 
   

• Precursor chemicals would be categorized by risk level, allowing more focused regulatory control of high-risk substances (e.g. those commonly linked to fentanyl synthesis). 
   

3. Enhanced Compliance and Inspection Powers 

• Health Canada would be granted broader powers to inspect premises, collect records, and seize non-compliant materials,  
  including the right to audit production documentation, examine inventory logs, and issue compliance orders. 
   

4. Improved Regulatory Flexibility 

• The proposed changes would enable faster regulatory response to emerging synthetic drugs, and  
  allow provisional controls over new substances or equipment pending formal classification. 
   

Why Are These Changes Necessary? 

Canada is experiencing one of the worst public health crises in its history due to the opioid epidemic. According to national statistics: 

• Illegally produced fentanyl is involved in over 80 percent of opioid-related deaths in Canada. 
   

• Organized crime groups are increasingly using domestic labs to produce fentanyl using imported precursors and unregulated drug manufacturing equipment. 
   

• Law enforcement agencies have reported an increase in the illegal importation and diversion of precursor chemicals and components for designated devices. 
   

The regulatory framework aims to: 

• Prevent the diversion of legally traded materials into illicit drug manufacturing. 
   

• Disrupt domestic production capabilities of illegal fentanyl. 
   

• Protect communities from the devastating impact of synthetic opioids. 
   

Stakeholder Responsibilities 

If adopted, the new regulations would affect: 

Importers 

• Must register both designated devices and their components prior to import. 
   

• Provide proof of registration to border officers. 
   

• Maintain detailed records of sales and storage locations. 
   

Distributors and Manufacturers 

• Ensure compliance with handling and security protocols. 
   

• Participate in inspection procedures by Health Canada. 
   

• Report any suspicious orders or diversion risks. 
   

Timeline and Consultation 

• Publication Date: June 28, 2025 
   

• Public Consultation Ends: August 12, 2025 
   

• Expected Final Publication: Fall 2025 in Canada Gazette, Part II 
   

• Date of Entry into Force: Upon final publication 

Access Official Regulatory Texts 

For full details, consult the following Canada Gazette links: 

• Regulations Amending the Precursor Control Regulations (English) 
   

• Order Amending Schedule IX to the CDSA (English) 
   

Conclusion: Strengthening Canada’s Response to the Opioid Crisis 

Canada’s proposed amendments reflect an urgent, evidence-based strategy to combat synthetic opioid trafficking and reduce overdose-related deaths. By extending oversight to chemical precursors and the components of pill-making equipment, the government seeks to disrupt a critical link in the supply chain for illegal fentanyl production. 

Proactive stakeholder involvement during the consultation phase is essential to shaping a balanced regulatory framework that is both enforceable and aligned with legitimate industry needs. 

Keywords: Canada precursor chemical regulation, pill press import rules, Health Canada precursor oversight, CDSA amendments 2025, Canada Gazette, fentanyl regulation Canada, opioid crisis Canada, precursor control regulations 

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 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.