Health Canada's Regulatory Stock Review Plan: 2023 to 2025

Enabling act

Canada Consumer Product Safety Act

Rationale

This review is expected to help reduce the number of injuries to children by adding mechanical, informational and warning requirements to address hazards that arose after the current regulations came into force. These hazards include strangulation, entrapment and the integrity of car seat attachments. The objective of conducting the review is to also help prevent harmful health effects in children by addressing phthalates hazards in carriages and strollers.

Narrative

Health Canada is proposing to repeal and replace the Carriages and Strollers Regulations to address hazards that arose after the regulations came into force in 1985 and to update and clarify terminology.

The proposed regulations would incorporate mechanical requirements of international standards by ambulatory reference, where appropriate, and introduce phthalates requirements aligned with other Canadian regulations. The proposed regulations would also update the requirements for information and warnings.

Review process

Stakeholders had the opportunity to provide comments on the regulatory proposal during a public consultation in spring 2021 and during the Canada Gazette, Part I public comment period, which lasted 70 days following publication on June 11, 2022.

Date of last review or amendment

An internal review of the regulations was completed in 2015.

No significant updates have been made since the regulations came into force in 1985.

Targeted start for review

2020

Stakeholder feedback

A total of nine stakeholders provided comments during the consultation: 4 consumers and 5 industry stakeholders. The consumer stakeholders had generally supportive feedback. All 5 industry stakeholders were supportive of the proposal to align the mechanical requirements with those from international standards.

The major concerns raised by industry stakeholders regarded the process and requests for additional time for transitioning to the new regulations and for transitioning when a new version of a standard is published.

Outcomes

The review is complete.

Health Canada plans to publish the Carriages and Strollers Regulations (proposed regulations) in the Canada Gazette, Part II in spring 2023.

The proposed regulations are expected to help reduce the number of injuries in children by addressing known hazards that arose after the current Carriages and Strollers Regulations came into force. Hazards include strangulation, entrapment and the integrity of car seat attachments. The proposed regulations add warning, information and mechanical requirements to address these hazards. The proposed regulations will also help prevent harmful health effects in children by addressing phthalates hazards in carriages and strollers.

The proposed regulations are expected to achieve the following outcomes:

• align Canadian requirements more closely with those in other jurisdictions, including the United States and the European Union
• add requirements to address head entrapment, car seat attachment and wheel attachment
• align chemical and toxicological requirements with other Canadian regulations
• include a transition period following future updates to the standards

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Enabling act

Canada Consumer Product Safety Act

Rationale

Health Canada reviewed the Surface Coating Materials Regulations to increase the protection to infants and children from exposure to lead, improve alignment with major trading partners and reduce regulatory burden on industry.

Health Canada also explored opportunities during the review to improve alignment with the United States requirements for lead in surface coating materials and applied surface coating materials.

Narrative

The key objective of the review was to increase the protection to infants and children from exposure to lead, improve alignment with major trading partners and reduce regulatory burden on industry.

Review process

Health Canada pre-published the proposed regulations in Canada Gazette, Part I on April 24, 2021, with a 70-day public comment period.

Date of last review or amendment

An internal review of the regulations was completed in 2016.

These regulations were last amended in 2011.

Targeted start for review

2019

Stakeholder feedback

Several comments were received from stakeholders who voiced their general support for the proposal. One stakeholder communicated that the changes would align with international requirements and will have a positive economic impact, while still maintaining safety. Several comments included requests to clarify terms used in the regulations.

Some stakeholders communicated their concerns that the proposal did not apply to inaccessible parts and the potential effect of this on human health or the environment. Comments related to testing and alignment with existing voluntary industry standards were also received.

Public comments were made available in the Canada Gazette, Part II publication.

Outcomes

The review is complete.

The Regulations Amending Certain Regulations Made Under the Canada Consumer Product Safety Act (Surface Coating Materials) were published in Canada Gazette, Part II on June 22, 2022. The amendments came into force on December 19, 2022.

The amendments to the Surface Coating Materials Regulations increase protection to infants and children from exposure to lead in a broader range of products. The consequential amendments aligned limits on lead, mercury and certain other harmful elements in applied coating materials. The amendments also better aligned and clarified requirements across the implicated regulations.

The amendments are expected to achieve the following outcomes:

• reducing the potential for exposure to lead, mercury and certain other harmful elements
• improving alignment with the United States
• reducing compliance burden on industry

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Food and Drug Regulations to enable the implementation of an agile, modern licensing scheme for drugs (prescription and over-the-counter) in Canada.

Specifically, the proposed amendments would:

• implement agile regulations that support timely access to innovative drugs
• enable regulatory oversight based on risk and evolving evidence
• harmonize and align internationally
• improve transparency about the risks, benefits and uncertainties of drugs

Aspects of this regulatory initiative were identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap and the Agri-food and Aquaculture Regulatory Review Roadmap.

The following items from Health Canada’s Forward Regulatory Plan are a result of this review:

• Regulations Amending the Food and Drug Regulations (Agile Licensing: Precision Regulation and Use of Foreign Decisions)
• Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

Narrative

The proposed amendments would apply to health and biosciences industries (human and veterinary) conducting business in Canada.

Health Canada would expect potential impacts to include:

• improved risk-based regulation of drugs, both before and after they are on the market
• increased support for better decision-making by patients, health care practitioners and provinces/territories
• increased encouragement for businesses to bring innovative, safe, high-quality drugs on to the Canadian market

Date of last review or amendment

Food and Drug Regulations: 2019

Targeted start for review

2019

Stakeholder feedback

In 2020 and 2021, Health Canada consulted stakeholders on aspects of this initiative relating to temporary regulations (interim orders) and the transition of those aspects to a permanent regulatory framework. Components of the temporary and permanent regulatory proposals are similar to regulatory approaches in this proposal:

• Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
• Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19)

As part of the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) initiative, Health Canada launched in July 2021 a notice of intent proposing targeted amendments to the Food and Drug Regulations and Medical Devices Regulations.

Stakeholder feedback on the proposed amendments was generally positive. Particular support was expressed for Health Canada’s efforts towards regulatory modernization in general to reduce regulatory irritants, improve access to therapeutic products and enhance post-market oversight throughout the lifecycle of a drug or device.

The feedback from stakeholders was taken into consideration as part of the regulatory package development for Canada Gazette, Part I.

Outcomes

This initiative is complete.

Health Canada published the following proposal:

• Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) in Canada Gazette, Part I on December 17, 2022

Any further regulatory proposals resulting from this review will be reported through the Forward Regulatory Plan.

For further information

Related information can be found on:

• Improving the regulatory review of drugs and devices
• Regulatory innovation for health products: Agile licensing for drugs
• Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders
• Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
• Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19)

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Medical Devices Regulations to enable the implementation of an agile, modern licensing scheme to regulate medical devices throughout the lifecycle of devices. Specifically, the proposed amendments would: improve and maintain medical device safety, enable access to new innovations and help support economic growth.

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

The following item from Health Canada’s Forward Regulatory Plan is a result of this review:

• Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

To ensure regulatory consistency, some components of this initiative will be incorporated into the Regulations Amending Certain  Regulations Made Under the Food and Drugs Act (Agile Licensing). These were formerly referred to as Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs).

Narrative

The proposed amendments would apply to businesses involved in the sale of medical devices in Canada.

Health Canada would expect potential impacts to include:

• improved risk-based regulation of medical devices, both before and after they are on the market
• increased support for better decision-making by patients, health care practitioners and provinces/territories
• reduced pre- and on-market costs for lower risk medical devices
• increased encouragement for businesses to bring innovative, safe, high-quality medical devices on to the Canadian market

Date of last review or amendment

2019

Targeted start for review

2019

Stakeholder feedback

In 2020 and 2021, Health Canada consulted stakeholders on aspects of this initiative relating to temporary regulations (interim orders) for the importation and sale of medical devices for use in relation to COVID-19 pandemic. Stakeholders were generally supportive of the interim orders.

Outcomes

This initiative is complete.

Health Canada published the following proposal:

• Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) in Canada Gazette, Part I on December 17, 2022

Any further regulatory proposals resulting from this review will be reported through the Forward Regulatory Plan.

For further information

Related information can be found on:

• Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality
• Regulatory innovation for health products: Agile licensing for medical devices
• Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada has reviewed the Food and Drug Regulations to modernize the regulation of food to encourage businesses to bring safe and innovative products to market in Canada.

As a result of this review, Health Canada  proposed amendments to:

• create a regulatory framework to enable continued use of human milk fortifiers (complete)
• modernize the regulations for microbiological safety criteria and methods of analysis for timelier and more efficient revisions to respond to advancing science and technology
• streamline food additive rules
• establish a new regulatory framework for foods supplemented to contain added ingredients like vitamins or caffeine to safely allow them on the Canadian market (complete)

These priority areas are the first steps to implement a modernized and redesigned architecture for food regulations under the Food and Drugs Act.

This regulatory initiative was identified by Health Canada in the Agri-food and Aquaculture Sector Regulatory Review Roadmap.

This initiative is linked to the Health Canada/Canadian Food Inspection Agency Joint Policy Statement on Food Labelling Coordination.

The following item from Health Canada’s Forward Regulatory Plan is a result of this review:

• Regulations Amending the Food and Drug Regulations (Modernize food regulations to enable innovative and safe foods for Canadians)

Narrative

The proposed amendments would apply to businesses involved in the sale of regulated food products in Canada.

It is anticipated that the proposal would provide greater clarity and predictability for businesses to allow them to bring food products to market in a timely manner. This impact would in turn provide people in Canada with greater, faster access to safe and innovative food products.

Date of last review or amendment

Food and Drug Regulations: 2022

Targeted start for review

2019

Stakeholder feedback

Between 2011 and 2020, Health Canada held several targeted consultations on the proposed approach for human milk fortifiers, including on the draft regulations. Health professionals and industry stakeholders were supportive of the overall development of a regulatory framework for these products.

Health Canada engaged stakeholders on the future of food, and on how the entire sector can work collaboratively to provide people in Canada with healthy and safe food. The Consultation Summary – Food and Nutrition Stakeholder Engagement Session was published on May 7, 2019.

Health Canada received a number of stakeholder submissions representing a wide range of views on the supplemented foods proposal following the publication of proposed changes related to supplemented foods in the Canada Gazette, Part l on June 26, 2021.

Outcomes

Two aspects of this initiative are now complete.

Health Canada published the following regulatory amendments:

• Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) in the Canada Gazette, Part II on April 14, 2021
• Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) in the Canada Gazette, Part II on July 20, 2022

Any further regulatory proposals resulting from this review will be reported through the Forward Regulatory Plan.

For further information

Related information can be found on:

• Consultation summary - Food and nutrition stakeholder engagement session, May 7, 2019
• Event summary: Health Canada's 2021 stakeholder update on food and nutrition, May 6, 2021
• Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers)
• Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods)

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing to amend the Cosmetic Regulations to enhance regulatory oversight for cosmetics.

The amended regulations would inform consumers about the presence of certain fragrance allergens, outside of the term “parfum”, that are present in the product. This would allow consumers to avoid products containing fragrance allergens to which they may be sensitive.

Narrative

Health Canada is proposing amendments to the Cosmetic Regulations to:

• introduce a requirement to disclose certain fragrance allergens on the labels of cosmetics
• add greater flexibility for the disclosure of ingredients for cosmetics sold in small packages
• improve the oversight of cosmetics by:
  • clarifying terminology and improving the level of detail in the information submitted in a cosmetic notification
  • enhancing compliance and enforcement tools through additional authorities and expanded responsibilities of importers
• address administrative changes

For fragrance allergens, the proposal would align Canada’s requirements with other international regimes (for example, European Union).

Review process

People in Canada had an opportunity to provide comments on the proposed changes to the regulatory proposal through a:

• 45-day public comment period when the notice to interested parties (pre-consultation) was published on July 16, 2021
• 70-day public comment period when the regulatory proposal was pre-published in the Canada Gazette, Part I on February 11, 2023

Date of last review or amendment

These regulations were significantly amended in 2004 (ingredient disclosure on product labels).

Targeted start for review

2021

Stakeholder feedback

A total of 65 responses were received during the pre-consultation, including from industry, non-governmental organizations (for example, subject-matter experts in dermatology), trade associations and the public. There was unanimous support for the disclosure of fragrance allergens on the labels of cosmetics, and general support for the other proposed amendments.

This proposal was pre-published in Canada Gazette, Part I on February 11, 2023, followed by a 70-day comment period.

Public comments will be made available in the closed consultations section on Canada Gazette.

Outcomes

The review is complete.

The next step is to review the comments received during the consultation in Canada Gazette, Part I.

Health Canada plans to publish the Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredient (proposed regulations) in the Canada Gazette, Part II in winter or spring 2024.

The proposed regulations are expected to introduce a requirement to disclose certain fragrance allergens on cosmetic labels. The disclosure of certain fragrance allergens on cosmetic labels will help people in Canada make better decisions regarding the products they use. This increased chemical transparency on cosmetic labels will help protect the health and safety of people in Canada.

Moreover, the proposed regulations would achieve the following outcomes:

• add greater flexibility for the disclosure of ingredients for cosmetics sold in small packages
• improve the regulatory oversight of cosmetics by clarifying terminology, strengthening the cosmetic notification requirement and enhancing compliance and enforcement tools
• make changes of administrative nature

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: cosmetics@hc-sc.gc.ca

Enabling acts

Food and Drugs Act
Pest Control Products Act

Rationale

Health Canada is proposing amendments to the Food and Drug Regulations, the Natural Health Products Regulations and the Pest Control Products Regulations to ensure a consistent and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers). Currently, these are regulated under separate regimes, creating challenges for industry and regulators, acutely experienced during COVID-19.

Specifically, the proposed amendments would create one comprehensive framework for the regulation of biocides, enable regulatory oversight based on risk and evolving evidence, and introduce a use of foreign decisions pathway.

Development of this initiative has been a part of broader work on modern regulations related to the Health and Biosciences Sector Regulatory Review Roadmap.

The following item from Health Canada’s Forward Regulatory Plan is a result of this review:

• Biocides Regulations
  • formerly named Regulations amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and surface sanitizers)

Narrative

The amended regulations would reduce barriers and create efficiencies for most businesses wanting to bring biocides to the Canadian market, resulting in timely access to biocides for people in Canada. Benefits may vary between companies.

Review process

The regulatory proposal was pre-published in the Canada Gazette, Part I on May 7, 2022, for a 70-day public comment.

Date of last review or amendment

N/A

Targeted start for review

2018

Stakeholder feedback

Health Canada closely collaborated with industry stakeholders throughout the COVID-19 pandemic to help increase the availability of biocides to people in Canada. Lessons learned from the pandemic will inform the proposed Biocides Regulations.

Health Canada met with industry associations in early July 2019, April 2021, January 2022 and May 2022 to discuss key components of the framework.

Outcomes

This initiative is complete.

Health Canada published the following proposal:

• Biocides Regulations in Canada Gazette, Part I on May 7, 2022

Any further regulatory proposals resulting from this review will be reported through the Forward Regulatory Plan.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Hazardous Products Act

Rationale

Health Canada published amendments to the Hazardous Products Regulations and to Schedule 2 of the Hazardous Products Act primarily to align with the seventh revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

The objectives of the amendments were to incorporate changes adopted in the sixth and seventh revised editions, and certain changes in the eighth revised edition, of the GHS, and to amend certain provisions of the regulations to provide greater clarity.

Narrative

The recent changes provide greater clarity and will have trade benefits because of common labelling and safety data sheet (SDS) requirements for workplace hazardous products and will strengthen worker health and safety protections.

Review process

The regulatory proposal was pre-published in Canada Gazette, Part I on December 19, 2020, for a 70-day public comment period.

Date of last review or amendment

Sections 4.4.1 and 4.5 of the Hazardous Products Regulations were amended in April 2018.

Targeted start for review

2018

Stakeholder feedback

The regulations and the order were published in Canada Gazette, Part II on January 4, 2023. Public comments were made available in the Canada Gazette, Part II publication.

Outcomes

The review is complete.

The resulting regulations amending the Hazardous Products Regulations and the order amending Schedule 2 to the Hazardous Products Act were published in the Canada Gazette, Part II on January 4, 2023. The amendments came into force on December 15, 2022, on which day a 3-year transition period began that will end December 14, 2025.

The amendments incorporate changes from the sixth and seventh revised editions, and certain changes from the eighth revised edition, of the GHS into the Hazardous Products Regulations.

The amendments are expected to achieve the following outcomes:

• provide trade benefits for suppliers because of common labelling and SDS requirements for workplace hazardous products
• protect workers by requiring more comprehensive and detailed health and safety information on product labels and SDS
• benefit employers designing educational and training programs and selecting control measures for their workers

The amendments will enable Canada to meet its international commitment under the Canada-U.S. Regulatory Cooperation Council Joint Forward Plan.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Lynn Berndt-Weis
Director
Workplace Hazardous Materials Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email address: whmis-simdut@hc-sc.gc.ca

Enabling act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing amendments to the Tents Regulations to replace the flammability and labelling requirements with the ambulatory incorporation by reference of a National Standard of Canada developed by the Canadian General Standards Board.

Although modern tents made of synthetic materials are less flammable than traditional cotton canvas tents, they are not fireproof. Proposed amendments to the Tents Regulations would continue to help protect people in Canada from injuries and deaths caused by tent fires.

Narrative

Health Canada is proposing to replace the flammability and labelling requirements under the Tents Regulations through ambulatory incorporation by reference of a new national standard developed by the Canadian General Standards Board (CGSB). The standard is entitled CAN/CGSB-182.1-2020, Flammability and Labelling Requirements for Tents.

Health Canada is proposing to add flammability and labelling requirements under the Toys Regulations to continue regulating play tents not intended to be used as outdoor shelters.

Amendments to the Textile Flammability Regulations are proposed to continue to exclude products covered by the Tents Regulations and the Toys Regulations.

Review process

People in Canada will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2023.

Date of last review or amendment

An internal review of the regulations was completed in 2017.

• significant updates have been made since the regulations came into force in 1988

Targeted start for review

2019

Stakeholder feedback

A notice to interested parties was published on January 22, 2019, with a 60-day public comment period. At that time, people in Canada were also invited to provide technical comments on the draft of CAN/CGSB-182.1 to the CGSB.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Enabling act

Canadian Environmental Protection Act, 1999

Rationale

Health Canada is proposing amendments to the Formaldehyde Emissions from Composite Wood Products Regulations to clarify quality control testing requirements and the Declaration of Certification record-keeping requirements.

Narrative

Health Canada is proposing amendments to section 17 of the Formaldehyde Emissions from Composite Wood Products Regulations to clarify quality control testing requirements and to review the Declaration of Certification record-keeping provisions of the regulations.

Review process

Health Canada is holding discussions with key stakeholders. People in Canada will have the opportunity to provide comments on the proposed regulatory amendment during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2023.

Date of last review or amendment

The Formaldehyde Emissions from Composite Wood Products Regulations were published in Canada Gazette, Part II on July 7, 2021.

Targeted start for review

2022

Stakeholder feedback

Following publication of the final Formaldehyde Emissions from Composite Wood Products Regulations, stakeholders raised concerns that requirements for manufacturer testing to be conducted by an accredited laboratory is more onerous than necessary and infeasible for manufacturers. Stakeholders also raised concerns that record-keeping requirements for Declarations of Certification are unnecessarily complex and burdensome, particularly for importers and retailers of finished goods.

Outcomes

In consideration of stakeholder concerns, an amendment to the Formaldehyde Emissions from Composite Wood Products Regulations is under development. The amendment will aim to clarify testing requirements for manufacturers and to simplify Declaration of Certification record-keeping requirements. Some small modifications to better align with the U.S., and minor clarifications are also being considered.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Andrew Beck
Director
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Email: formaldehyde-formaldehyde@hc-sc.gc.ca

Enabling act

Controlled Drugs and Substances Act

Rationale

The Canadian legislative and regulatory framework for controlled substances has evolved over decades to address emerging issues and meet international commitments under the United Nations’ drug control conventions. Some of the regulations under the Controlled Drugs and Substances Act are relatively new, while others are older. The Narcotic Control Regulations, for example, first came into force in 1961 under the Narcotic Control Act (the legislation that preceded the Controlled Drugs and Substances Act). The Benzodiazepines and Other Targeted Substances Regulations came into force in 2000 under the authority of the Controlled Drugs and Substances Act.

This evolution has resulted in a set of regulations that, while containing broadly similar provisions, also features issues, gaps and inconsistencies, causing undue burden for the administration of and compliance with these regulations.

Narrative

Health Canada had previously proposed to modernize regulations under the Controlled Drugs and Substances Act through a staged approach, built on a series of thematic regulatory proposals, including:

• licences and permits
• pharmacists
• hospitals.

Review process

The first step in this initiative was the modernization of provisions pertaining to licences and permits (under the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and Parts G and J of the Food and Drug Regulations). These provisions were modernized in 2019.

As a next step in this modernization initiative, Health Canada intends to consult on a new regulation that will consolidate the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, Parts G and J of the Food and Drug Regulations and the New Classes of Practitioners Regulations into a single new regulation for controlled substances. Health Canada also intends to repeal the Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act.

This consolidation is expected to result in a modernization of regulatory language throughout the proposed new regulation. In addition, changes to regulatory provisions pertaining to pharmacists, individuals, destruction and test kits would also be made to:

• support pharmacy innovation in Canada, and enable pharmacists to more fully use their expertise and contribute to Canada’s responses to urgent and non-urgent health-related situations, while maintaining stewardship over the movement of controlled substances
• allow individuals to travel with prescription drugs containing controlled substances for personal medical use and to return prescription drugs containing controlled substances to a pharmacy for disposal
• allow pharmacists, pharmacy technicians, practitioners and persons in charge of a hospital to destroy controlled substances or provide them to licensed dealers for the purpose of destruction
• update provisions in relation to test kits

Coordinating amendments would also be made to other federal regulations, including the Precursor Control Regulations, the Cannabis Regulations and the Food and Drug Regulations.

People in Canada will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in fall 2023.

The licences and permits, pharmacists, and hospitals components of this modernization initiative were identified by Health Canada as part of its Health and Biosciences Sector Regulatory Review Roadmap.

Date of last review or amendment

Amendments to regulatory provisions pertaining to licences and permits (under the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and Parts G and J of the Food and Drug Regulations) were made in 2019. The amending regulations were published in the Canada Gazette, Part II on June 12, 2019, and came into force on December 9, 2019.

Targeted start for review

2015 (the review is ongoing)

Stakeholder feedback

Certain aspects of this modernization initiative have been consulted upon previously, as follows:

• A notice to interested parties seeking feedback on proposed regulatory changes pertaining to the return, destruction of and travel with controlled substances was published in the Canada Gazette, Part I on October 28, 2017, for a 60-day public comment period.
• A notice to interested parties seeking feedback on proposed regulatory changes pertaining to test kits was published in the Canada Gazette, Part I on March 31, 2018, for a 60-day public comment period.
• A notice to interested parties seeking feedback on proposed regulatory changes pertaining to pharmacists was published in the Canada Gazette, Part I on March 9, 2019, for a 60-day public comment period.

Outcomes

This regulatory modernization initiative is ongoing. The next step is expected to be the publication of the proposal for public comment.

Amendments made to the provisions pertaining to licences and permits in 2019 achieved the following outcomes:

• enhanced clarity and alignment, thereby facilitating compliance with the regulations
• reduced administrative burden for licence holders
• strengthened powers for the Minister to address issues of public health and public safety related to the diversion or problematic use of controlled substances

For further information

For further information, please consult Health Canada’s Forward Regulatory Plan, the Health and Biosciences Sector Regulatory Review Roadmap, or additional information can be requested from the departmental contact.

Departmental contact

Jennifer Pelley,
Director
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Food and Drug Regulations, Natural Health Products Regulations and Medical Devices Regulations to modernize the regulation of clinical trials conducted in Canada.

Specifically, the proposed amendments would:

• ensure that Canada remains an attractive place to conduct clinical trials, while continuing to uphold high standards for protecting the health and safety of participants
• introduce a coherent risk-based approach to the regulation of clinical trials in Canada
• afford greater flexibility in the safe development of innovative therapies and products, and innovative clinical trial designs
• streamline regulatory processes toward greater efficiency and clarity
• align with international best practices regarding clinical trial oversight and public access to information

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

The following items from Health Canada’s Forward Regulatory Plan are a result of this review:

• Enabling the Biomanufacturing and Life Sciences Strategy - Modernizing Clinical Trials to Support Innovation

Narrative

The proposed amendments would apply to health and biosciences and agri-food stakeholders involved in the conduct of clinical trials in Canada.

Health Canada would expect that this regulatory proposal would improve clarity, predictability and transparency around the regulation of clinical trials for businesses, academics and people in Canada. Improved agility of the regulatory framework is expected to benefit researchers and industry by better accommodating innovative, non-conventional clinical trial designs. This in turn could benefit people in Canada by improving access to clinical trials. The application of a risk-based approach would help reduce regulatory burden for some clinical trials conducted on marketed products.

Canadian participants in trials would benefit from improved safety monitoring. Health care professionals would be able to apply for investigational testing of medical devices (without going through a manufacturer). As well, the agri-food business would be able to conduct clinical trials for infant formula and other foods for a special dietary purpose within Canada.

Date of last review or amendment

Natural Health Products Regulations: 2018
Medical Devices Regulations: 2019
Food and Drug Regulations: 2019

Targeted start for review

2022

Stakeholder feedback

In response to stakeholder engagement and consultation undertaken in 2019, stakeholders confirmed that having a flexible framework and enabling clinical trials would draw in key companies and investments, and support research and innovation in Canada.

Additional engagement was undertaken in 2020 related to the Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19 that has similar regulatory approaches to those in this proposal. Stakeholders were generally supportive of the proposal to transition the interim order into regulations.

In spring 2021, Health Canada launched 2 related and parallel consultations. The first sought stakeholder feedback on the modernization of the clinical trial framework for drugs, devices and natural health products.

Health Canada published a What We Heard Report on February 23, 2022, on the consultations that were conducted in the spring and summer of 2021. Stakeholders provided 122 written submissions and close to 1,000 stakeholders participated in 8 interactive webinar sessions.

The second consultation sought stakeholder feedback on the design and development of regulations that would enable the authorization and conduct of human clinical trials in Canada regarding foods for a special dietary purpose.

Health Canada published the Consultation summary: Clinical trial regulations for foods for a special dietary purpose on February 23, 2022. Stakeholders provided 5 written responses and participated in an interactive webinar to clarify questions.

Overall, most stakeholders were supportive of these initiatives.

For further information

Related information can be found on:

• Regulatory innovation for health products: Modernizing clinical trial regulations
• Agile regulations for advanced therapeutic products and clinical trials
• Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
• Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
• Clinical trials modernization: Consultation paper

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is planning to advance the Modernizing the Drug Establishment Licensing (DEL) Framework in 2 phases.

Phase I began in spring 2023. The proposed amendments would include components respecting DEL, good manufacturing practices and recall reporting to take a more agile, risk-based approach to compliance and enforcement oversight for drugs and reduce regulatory and operational burden. The proposed amendments for drugs would:

• establish a regulatory framework for recalls of drugs ordered by the Minister and clarify reporting obligations for industry for voluntary recalls in a manner that is consistent with existing policy
• address outdated references in the drug establishment licence (DEL) framework to other regulatory authorities who participate in mutual recognition agreements (MRAs) with Canada and replace them with a list incorporated by reference within the regulations and housed online
• offer conditional exemptions from the requirements related to finished product testing for certain biologics (for example, gene and cell therapies) and radiopharmaceuticals in cases where alternative risk mitigation measures and safety controls have been implemented
• clarify that direct shipment to a person other than an importer (typically a health care provider) is permitted for these products

Phase II is targeting fall 2024. The proposed amendments would reduce burden associated with annual licence review and modernize provisions related to the use of compliance and enforcement tools, such as terms and conditions and suspensions. It would introduce less prescriptive and more flexible provisions that would maintain appropriate oversight of regulated activities conducted in Canada.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap under the ‘Establishment licensing scheme for drugs and medical devices’ and ‘Recall reporting expectation’ sections.

Additional notes

For regulatory consistency, Phase I amendments to the Food and Drug Regulations will proceed jointly with the Phase I amendments to the Medical Devices Regulations that are part of the Modernizing the Medical Device Establishment Licensing (MDEL) Framework initiative.

Narrative

It is anticipated that the proposal would improve regulatory decision-making efficiency and predictability in relation to DELs, allowing an opportunity for industry stakeholders to streamline compliance programs accordingly.

Review process

Health Canada has adopted a phased approach for modernizing drug establishment licensing, including the recall of drugs.

Consultations for Phase I

Health Canada pre-published the proposed amendments in Canada Gazette, Part I on April 15, 2023, with a 75-day public comment period.

Consultations for Phase II

The Phase II package is targeting pre-publication of amendments to the Food and Drug Regulations in Canada Gazette, Part I in fall 2024.

Date of last review or amendment

2018, 2021, 2022

Targeted start for review

2020

Stakeholder feedback

Drug and medical device establishment licence holders were consulted between April and June 2019.

Between December 2021 and February 2022, Health Canada consulted industry stakeholders on this proposal via a 60-day notice of intent and cost-benefit analysis survey. Industry stakeholders were generally supportive of the proposal. One industry stakeholder association raised some concern with including additional reporting requirements in the regulations. They indicated their preferred approach would be to continue to rely on guidance when it comes to establishing timelines for submission of certain information and documents to Health Canada. All respondents indicated support for clarifying the reporting timelines in the regulations (for instance, 24 hours from having made the decision to recall).

Health Canada has also held several meetings with drug manufacturers and importers to better understand the challenges of the drug industry in complying with the finished product testing requirements. One stakeholder expressed a desire to see Health Canada expand the conditional exemption from finished product testing to other products. This was out of scope of the current analysis and policy objective. However, the department will continue to assess where regulatory modernization initiatives can be leveraged to reduce the burden and barriers and to improve access to drug products.

People in Canada will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which began on April 15, 2023 (for Phase I) and is expected to take place in fall 2024 (for Phase II).

For further information

Related information on drug establishment licensing framework (DEL) can be found on Health Canada’s webpage.

Additional information can be requested from the departmental contact.

Departmental or agency contact

Danny Lepage
Acting Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email: prsd-questionsdspr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is planning to advance Modernizing the Medical Device Establishment Licensing (MDEL) Framework in 2 phases.

Phase I began in spring 2023. The proposed amendments to the Medical Devices Regulations would improve and modernize the regulatory oversight of medical devices in Canada. This would be achieved by:

• modernizing the medical device establishment licence application requirements to reflect existing practices
• providing the Minister with the ability to issue terms and conditions on a medical device establishment licence to mitigate risks to health and safety and strategically target non-compliance
• establishing a regulatory framework for recalls of medical devices ordered by the Minister, updating the definition of recall and clarifying industry-reporting obligations

Phase II is targeting fall 2024. The proposed amendments to the Medical Devices Regulations would:

• improve and modernize the regulatory oversight of the medical devices supply chain in Canada (achieved through clarifying uncertainties around importation introduced into the regulations from the last round of regulatory amendments)
• provide the Minister with additional compliance and enforcement tools to address issues in a more targeted and strategic manner and provide sufficient post-market oversight

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap under the ‘Establishment licensing scheme for drugs and medical devices’ and ‘Recall reporting expectation’ sections.

Additional notes

For regulatory consistency, Phase I amendments to the Medical Devices Regulations will proceed jointly with the Phase I amendments to the Food and Drug Regulations that are part of the Modernizing the Drug Establishment Licensing (DEL) Framework initiative.

Narrative

Phase I and II of the proposed framework would create a level playing field with other jurisdictions for Canada’s medical device sector.

It would improve the predictability and efficiency of recalls for industry and decrease the burden on industry relating to the reporting of low-risk issues for medical devices. It would also close regulatory gaps by extending regulatory oversight to facilities distributing safe medical devices to the global markets.

Review process

Health Canada has adopted a phased approach for the Modernizing Medical Device Establishment Licensing Framework, including the recall of medical devices.

Consultations for Phase I

Health Canada pre-published the proposed amendments in the Canada Gazette Part I, on April 15, 2023, with a 75-day public comment period.

Consultations on Phase II

Further targeted stakeholder consultations to inform policy development will occur prior to publication in Canada Gazette, Part I, targeted for fall 2024.

Date of last review or amendment

2018, 2021, 2022

Targeted start for review

2020

Stakeholder feedback

Industry and stakeholders were consulted in 2016.

Drug establishment licence holders and medical device establishment licence holders were consulted between April and June 2019.

On December 11, 2021, Health Canada published a notice of intent in Canada Gazette, Part I, with a 60-day consultation period, to inform stakeholders of the proposed policy direction, and to provide opportunities for comment on the proposed approach.

Health Canada held stakeholder consultations targeting MDEL holders in fall 2021 and winter 2022 on Phase I of this proposal. More than 100 industry stakeholders completed the cost-benefit analysis survey and participated in the consultation regarding the proposed amendments. Stakeholders generally supported the proposal.

People in Canada will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which began on April 15, 2023 (for Phase I) and is expected to take place in fall 2024 (for Phase II).

For further information

The Forward Regulatory Plan: Modernizing Medical Device Establishment Licensing Frameworks, the Health and Biosciences Sector Regulatory Review Roadmap or additional information can be requested from the departmental contact.

Departmental or agency contact

Danny Lepage
Acting Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email: prsd-questionsdspr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Natural Health Products Regulations and Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for self-care products. As the scope of the regulatory proposals is significant, Health Canada will no longer be advancing these amendments through a phased approach. They will be done in separate regulatory proposals.

Health Canada plans to modernize the Natural Health Products Regulations through the creation of a risk-based categorization structure and enhanced premarket quality review. Amendments would also introduce an annual notification to identify marketed products, revisions to strengthen the requirements for good manufacturing practices and a risk-based site-licensing program.

Health Canada plans to amend the Food and Drug Regulations to develop expedited pathways for lower-risk non-prescription drug products, including a class-based licensing system, appropriate pharmacovigilance requirements and establishment licensing that is commensurate with the risk of these products.

These amendments would address many recommendations made in the 2021 audit by the Commissioner of the Environment and Sustainable Development.

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

The following item from Health Canada’s Forward Regulatory Plan is a result of this review:

• Regulations Amending the Natural Health Products and the Food and Drug Regulations (Self-Care Framework)

Narrative

The proposed amendments would apply to businesses involved in the sale of natural health products and non-prescription drugs in Canada.

Proposed amendments to the Natural Health Products Regulations are anticipated to strengthen oversight and provide people in Canada with greater assurance of the quality of marketed natural health products.

Proposed amendments to the Food and Drug Regulations are anticipated to decrease regulatory burden and costs to businesses, as well as introduce greater efficiencies.

Date of last review or amendment

Natural Health Products Regulations: 2018
Food and Drug Regulations: 2019

Targeted start for review

2019

Stakeholder feedback

Since the fall of 2016, Health Canada has held a series of public consultations seeking input on modernizing the department’s approach to regulating self-care products.

Summaries of consultations can be found on:

• Report of online consultations on modernizing the regulation of self-care products in Canada
• Consulting consumers on self-care product labelling: A report on what we heard

In response to publication in the Canada Gazette, Part I on June 26, 2021, Health Canada received a number of stakeholder submissions representing a wide range of views on the regulatory amendments to improve the labeling of natural health products.

Outcomes

This regulatory modernization initiative is ongoing.

One aspect of the initiative is complete:

• Regulations Amending the Natural Health Product Regulations has been published in the Canada Gazette, Part II on July 6, 2022

Any further regulatory proposals resulting from this review will be reported through the Forward Regulatory Plan.

For further information

Related information can be found on:

• Self-care products
• Summary: What we heard on self-care product regulation
• Consultation on the regulation of self-care products
• Simplified market access to non-prescription drugs (Phase II of the Self-Care Framework)
• Non-prescription Drug Action Plan

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Pest Control Products Act

Rationale

Health Canada is undertaking the first comprehensive review of the Pest Control Products Regulations since their coming into force in 2006.

Narrative

In 2016, Health Canada developed a multi-year plan to review the Pest Control Products Regulations. The objectives of the review are to:

• ensure that the Pest Control Products Regulations are current and reflective of the Pest Control Products Act, taking into account the statutory review of the act
• ensure the Pest Control Products Regulations continue to meet policy objectives, while attempting to minimize unnecessary regulatory burden, if any, on regulatory parties
• provide recommendations on policy, program and regulatory actions required to address identified issues

This review includes the following initiatives that were identified in the Agri-food and Aquaculture Sector Regulatory Review Roadmap:

• Label modernization for pest control products: These proposed amendments would provide consistency in the way that information is presented in labels, permit the use of electronic labels and internationally aligned Globally Harmonized System standards and improve the readability of labels.
• Modernize authorization process for certain pest control products for which registration is not required: This initiative includes proposed statutory and regulatory aspects. The proposed regulatory amendments would update the current list of products that are exempt from registration under the Pest Control Products Act, while the proposed statutory elements would provide a more efficient process for authorizing low-risk products (for example, food products like baking soda).
• Exclusive rights and data compensation modernization for pest control products: These proposed amendments would clarify for regulated parties how the data compensation program works in the post-market context and would reduce the effort required to administer it.
• Modernize the post-market review process for pest control products: This review of the re-evaluation program is complete and being effected through policy. Based on the previous review, Health Canada has launched a multi-year program renewal project to build a stronger, effective and efficient pesticide regulatory program that improves health and environmental protection and leads to improved timeliness of scientific decisions through the adoption of a lifecycle and proportional effort approach.

The review of the Pest Control Products Regulations also includes the following initiatives identified in Health Canada’s Forward Regulatory Plan:

• Regulations Amending the Pest Control Products Regulations (Applications and Imports)
• Regulations Amending the Pest Control Products Regulations (Research)

Date of last review or amendment

As part of the review, the Pest Control Products Regulations were amended in 2022, with changes to certain application and importation requirements for pest control products in Canada (Regulations Amending the Pest Control Products Regulations (Applications and Imports): SOR/2022-241).

Targeted start for review

2016

Stakeholder feedback

Stakeholders have been engaged on each of the initiatives described above via the Treasury Board of Canada Secretariat led Targeted Regulatory Review of the Agri-food and Aquaculture Sectors and other mechanisms (for example, webinars, published consultation documents, Canada Gazette pre-publications and face-to-face meetings). Their feedback has and continues to inform work on the review and recommendations flowing from it.

Applications and imports: Health Canada sent industry stakeholders, non-governmental organizations, Indigenous organizations and federal/provincial/territorial partners a regulatory pre-consultation discussion paper pertaining to the proposed changes to certain application and importation requirements for pest control products in Canada. The consultation period lasted 75 days, and feedback was generally supportive. Health Canada subsequently pre-published the proposed amendments in the Canada Gazette, Part I on April 2, 2022, with a 70-day comment period. Comments were generally in favour of the proposed regulations. As noted above, these amendments were published in the Canada Gazette, Part II on December 7, 2022.

Research: Health Canada published a regulatory proposal document (PRO2022-01, Pre-Consultation – Proposed Regulatory Amendments to the Pest Control Products Regulations (Research)) on December 16, 2022, with a 45-day comment period. The document proposed amendments to the research provisions in the Pest Control Products Regulations. Comments are currently being analyzed and will inform the final proposal.

Proposal to modernize the authorization process for certain pest control products for which registration is not required: As part of this initiative, Health Canada consulted on the proposal to remove sodium bromide and potassium monopersulfate from Schedule 2 of the Pest Control Products Regulations to address unacceptable health risks. No comments were received, and the amended regulations were published in Canada Gazette, Part II on December 23, 2020.

Project to modernize the post-market review process for pest control products: From February to September 2020, Health Canada engaged stakeholders from across Canada on proposed changes to the pesticide evaluation program, and their feedback has informed continued development of program renewal agenda. In 2022, as part of PMRA’s transformation agenda, Health Canada consulted with key stakeholders on the design and plans to work towards implementation of lifecycle and proportional effort approach and to improve transparency.

Exclusive rights and data compensation modernization for pest control products:  Health Canada pre-published the proposed changes in the Canada Gazette, Part I on June 11, 2022, with a 75-day consultation period. Comments were generally supportive.

Outcomes

This regulatory modernization initiative is ongoing.

The regulatory amendments to change certain application and importation requirements for pest control products in Canada completes certain aspects of the review of “pre-market” provisions in the Pest Control Products Regulations.

Proposal to modernize the authorization process for certain pest control products for which registration is not required: Certain aspects of this proposal are complete and amended, with sodium bromide and potassium monopersulfate being removed from Schedule 2 of the Pest Control Products Regulations.

Project to modernize the post-market review process for pest control products: Certain aspects of this proposal are complete and are currently being effected through policy. Health Canada has implemented new internal processes to track key information for each pesticide active ingredient and planned or launched pilots to inform final design. Full implementation of all project elements is planned for 2024-2025.

For further information

For further information, please consult:

• Forward Regulatory Plan
• Re-evaluation program web page
• Targeted Regulatory Review: Agri-food and Aquaculture Roadmap

Additional information can be requested from the departmental contact.

Departmental or agency contact

Jordan Hancey
Director
Policy and Operations Directorate
Pest Management Regulatory Agency
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Enabling act

Radiation Emitting Devices Act

Rationale

Health Canada is proposing amendments to the Radiation Emitting Devices Regulations pertaining to lasers, to address health risks and injuries to people in Canada from these products.

The proposed amendments would align Canada's regulations with international standards, specifically the International Electrotechnical Commission’s IEC 60825-1, Safety of Laser Products - Part 1: Equipment classification and requirements, Ed. 3.0, 2014. Canada’s key trading partners use and reference this standard.

Narrative

The amended regulations would enhance the safety of laser products imported, sold, leased and advertised in Canada by requiring appropriate laser warning labels and establishing minimum design safety features for specific laser classes/hazard levels.

Review process:

People in Canada will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2023.

Date of last review or amendment

The Radiation Emitting Devices Regulations represents 1 regulatory title comprising a series of parts related to different devices.

Parts VII (Laser Scanners) and VIII (Demonstration Lasers) of Schedule II of the Radiation Emitting Devices Regulations were both introduced in 1977. Part VII was substantively amended in 1985. In 2018, a minor amendment was made to this regulation via miscellaneous amendment regulations (MAR) to correct a negative sign to a positive sign. Part VIII was last amended in 1981.

Targeted start for review

2020

Stakeholder feedback

Health Canada undertook an online public consultation process on this proposal from June 30, 2021, to August 30, 2021.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Tara Bower
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Email: hc.erhsdgeneral-dssergenerale.sc@canada.ca

Enabling act

Radiation Emitting Devices Act

Rationale

Heath Canada is planning a review the Radiation Emitting Devices Regulations, Schedule II, Part XIII pertaining to ultrasound therapy devices, to assess its on-going effectiveness in protecting the health and safety of people in Canada and considering impacts on stakeholders.

Narrative

The examination of the regulations will be conducted with a view to:

• identifying requirements that no longer apply due to advancement in ultrasound technologies
• identifying and mitigating any potential unintended impacts, such as barriers to trade or innovation
• verifying alignment with international equipment safety standards (for example, those of the International Electrotechnical Commission)
• identifying opportunities to reduce regulatory burden on stakeholders

Date of last review

1984

Targeted start for review

2023

For further information

For further information, please consult the departmental contact.

Departmental or agency contact

Narine Martel
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Email: erhsdgeneral-dssergenerale@hc-sc.gc.ca

Departmental contact information

For general inquiries on the stock review plan, contact Health Canada’s Departmental Regulatory Affairs Section at dra-arm@hc-sc.gc.ca.