Canada Gazette, Part I, Volume 159, Number 10: Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999

60-day consultation (until May 7, 2025 11:59pm EST)

March 8, 2025

Statutory authority
Canadian Environmental Protection Act, 1999

Sponsoring departments
Department of the Environment
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

General Comment

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Issues

The Chemicals Management Plan (CMP) is a Government of Canada initiative through which the risks of exposure of people in Canada and the environment to substancesfootnote 1 are assessed and managed. As part of the CMP, the classfootnote 2 of per- and polyfluoroalkyl substances (PFAS), excluding fluoropolymers, was assessed under section 68 of the Canadian Environmental Protection Act, 1999 (the Act) to determine whether the substances meet one or more of the criteria for a toxic substance as set out in section 64 of the Act.footnote 3,footnote 4 It was concluded that the class of PFAS, excluding fluoropolymers, meets the ecological and human health criteria set out in paragraphs 64(a) and 64(c) of the Act. In accordance with subsection 90(1) of the Act, the Minister of the Environment and the Minister of Health (the Ministers) are recommending that the Governor in Council make an order to add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Act.

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Background

The Chemicals Management Plan

In 2006, the Government of Canada launched the CMP, a federal program with the objective of reducing the risks posed by certain substances to people in Canada and the environment through sources of exposure such as food and food products, consumer products, cosmetics, drugs, drinking water and industrial releases. As part of the CMP, government officials from the Department of the Environment and the Department of Health (the Departments) conduct assessments under the Act to analyze information (for example hazardous properties and uses) on substances to identify existing or potential environmental and human health risks posed by exposure to those substances. When such risks are identified, the Ministers may recommend the development of risk management measures to mitigate them, under the authority of a broad suite of federal legislation, including the Act, the Canada Consumer Product Safety Act, the Food and Drugs Act, the Pest Control Products Act, and the Fisheries Act.

As part of the CMP, the Ministers assessed the class of PFAS, excluding fluoropolymers, under section 68 of the Act.

Description, uses, sources of release and exposure

Description and uses

PFAS consist of thousands of human-made substances and encompass a very broad range of chemical structures.footnote 5 PFAS are compounds that contain at least one fully fluorinated methyl or methylene carbon atom (without any hydrogen, chlorine, bromine or iodine atoms bonded to it). Substances identified in this document, such as perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA), fall within this definition. The common chemical characteristic of PFAS is their perfluoroalkyl moiety, which is extremely stable, rendering them resistant to degradation. As a result of this stability, PFAS have often been termed “forever chemicals” due to their long persistence in the environment.

Globally, the properties of PFAS (including their oil and water repellency, high resistance to chemical, physical and thermal degradation, and low surface tension) have led to their use in a wide range of products and in commercial and industrial applications, including in certain firefighting foams, food packaging, surfactants, lubricants, certain drugs and natural health products, medical devices, cosmetics, pesticides, textiles, vehicles, repellents and electronics. An overview of the uses of PFAS published in 2020 in Environmental Science: Processes & Impacts, a journal of the Royal Society of Chemistry, identified more than 200 uses for more than 1 400 PFAS.footnote 6

In Canada, uses of PFAS have been informed by data gathered from surveys issued pursuant to section 71 of the Act, information received under the New Substances Notification Regulations (Chemicals and Polymers) and under the Cosmetic Regulations of the Food and Drugs Act, and voluntary submissions received by the Department of Health related to food packaging materials. Uses of PFAS in Canada include products available to consumers and in commercial and industrial applications, such as

The annual quantity of PFAS used in Canada is unknown, as the information required to estimate this parameter (for example type and concentrations of PFAS in products available to consumers and in commercial and industrial applications) was not identified at the time of this analysis. On July 27, 2024, a mandatory survey issued pursuant to section 71 of the Act was published.footnote 7 The survey is anticipated to provide insight on annual quantities of PFAS used in Canada.

Sources of release and exposure

There are many potential sources of PFAS releases into the environment and pathways that can lead to human and environmental exposure to the substances in Canada.

Canadian risk management activities

The federal government

There are several proposed and current federal risk management activities that apply to certain PFAS in Canada.

Provincial / territorial governments

Several provincial and territorial risk management activities on certain PFAS have been initiated or are under development.

International risk management activities

There are several proposed and current risk management activities that apply to PFAS internationally.

Summary of the State of PFAS Report

On March 8, 2025, the Ministers published the State of PFAS Report (or the Report) on the Canada.ca (Chemical substances) website.footnote 19 The Report provides an assessment to determine whether the class of PFAS, excluding fluoropolymers, meets one or more of the criteria for a toxic substance as set out in section 64 of the Act.

Under section 64 of the Act, a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

The Departments considered multiple lines of evidence based on information from a variety of sources (for example literature searches of journal articles, review papers, electronic databases, and reports from international jurisdictions), including available information on subpopulations who may have greater susceptibility or greater exposure and considerations of cumulative effects, and incorporated a weight of evidence approach and precaution to reach assessment conclusions under section 64 of the Act. The Report has undergone external review and public consultation. Comments were received from the public, academia, municipal / provincial / territorial governments, other federal government departments, Indigenous groups, labour unions, environmental and other non-governmental organizations (ENGOs/NGOs), and industry representatives (including industry associations).

The Report concluded that the class of PFAS, excluding fluoropolymers, meets the ecological and human health criteria for a toxic substance as set out in paragraphs 64(a) and 64(c) of the Act. In the Report, PFAS and fluoropolymers have the following definitions:

Fluoropolymers that meet the OECD definition of PFAS used in the State of PFAS Report, were excluded from consideration in the Report, as they may have significantly different exposure and hazard profiles when compared with other PFAS. Therefore, it was determined that additional work on fluoropolymers is warranted, and they are planned for consideration in a separate assessment.

Below is a summary of the assessment provided in the State of PFAS Report of the potential impacts of the class PFAS, excluding fluoropolymers, on the environment and human health:

Considering the multiple lines of evidence presented in the State of PFAS Report, owing to the extreme persistence of PFAS and their potential to cause adverse effects, impacts on the environment are expected to increase if entry to the environment continues. Owing to the widespread use of PFAS combined with their ubiquitous presence in the environment, humans are continuously exposed to multiple PFAS, which has the potential to cause effects of concern. On the basis of what is known about well-studied PFAS, the potential for other PFAS to behave similarly, and the expectation that combined exposures to multiple PFAS increase the likelihood of detrimental impacts, it is concluded that the class of PFAS, excluding fluoropolymers, meets the criteria under paragraph 64(a) and 64(c), but not paragraph 64(b) of the Act, as these substances are entering or may enter the environment in a quantity or concentration or under conditions that have or may have immediate or long-term harmful effects on the environment or its biological diversity and that constitute or may constitute a danger in Canada to human life or health. Therefore, in accordance with subsection 90(1) of the Act, the Ministers are recommending that the Governor in Council make an order to add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Act.

Objective

The objective of the proposed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (the proposed Order) is to enable the Ministers to propose risk management instruments for toxic substances under the Act that prioritize pollution prevention actions, which may include prohibitions, when managing potential environmental and human health risks associated with those substances.

Description

The proposed Order would add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Act.

Regulatory development

Consultation

On May 20, 2023, the Ministers published a notice with a summary of the Draft State of PFAS Report (or the Draft Report) in the Canada Gazette, Part I, initiating a 60-day public comment period for the Draft Report. The notice also indicated that the Ministers released a Risk Management Scope document for PFAS to initiate discussion with interested parties on the development of risk management options. Over 370 submissions were received on the two publications from a wide range of interested parties including members of the public, academia, industry (including companies and industry associations from the chemical manufacturing, paints and coatings, automotive, construction, refrigeration, textiles and apparel, and pharmaceutical sectors), other government departments, municipal and provincial governments, and NGOs. A summary of the public comments received and the government responses to these comments is available on the Canada.ca (Chemical substances) website. As a result of these comments, the Draft State of PFAS Report and Risk Management Scope document were updated.

On July 13, 2024, the Ministers published a notice with a summary of the Updated Draft State of PFAS Report (or the Updated Draft Report) in the Canada Gazette, Part I, initiating a 60-day public comment period for the Updated Draft Report. The notice also indicated that the Ministers released a Revised Risk Management Scope document for PFAS to continue discussion with interested parties on the development of risk management options. Over 75 submissions were received on the two publications from a similar range of interested parties to those who submitted comments previously, as well as from Indigenous groups and labour unions. A summary of the public comments received and the government responses to these comments is available on the Canada.ca (Chemical substances) website.

Below is an overview of the comments received and government responses to these comments on the Draft State of PFAS Report and on the Updated Draft State of PFAS Report.footnote 20

Draft State of PFAS Report

Comments from members of the public, academia, municipal, provincial or other federal government departments, and NGOs expressed support for consideration of PFAS as a class and for the proposed conclusion outlined in the Draft Report. Members of the public, academia, and NGOs further noted that, with careful consideration of the definition of the class of PFAS, the class-based approach may avoid “regrettable substitutions” (that is, replacing managed substances with other substances that may be found to be equally or more hazardous than the replaced substances).

Industry (for example chemical manufacturing and automative) was generally opposed to the class-based approach used in the Draft Report, expressing concern over the broadness of the OECD definition for PFAS that was used, and commenting that not all PFAS possess the same properties and hazard profiles. Industry also stated the need for a precise definition on Schedule 1 to the Act. Government officials responded that a class-based approach would better address situations where exposure to multiple PFAS occurs at the same time, that it is a way to prevent “regrettable substitution”, and that a precautionary class-based approach to addressing PFAS is needed to adequately protect the environment and human health. Officials also noted that the definition was developed by a working group of international regulatory authorities and other experts under the auspices of the OECD, that it is coherent and comprehensive, and that it represents the growing and increasingly diverse inventory of PFAS chemicals. Officials further noted that, to be protective of the environment and human health and to apply precaution when addressing gaps in information, it is reasonable to anticipate that the concerns identified for well-studied PFAS may also be inherent in other substances in the class.

Industry (for example construction, refrigeration and automotive) opposed the inclusion of hydrofluoroolefins (HFOs) in the definition of the class of PFAS, stating that they do not persist, but rather degrade in many cases into trifluoroacetic acid (TFA), which is persistent but not of concern. Government officials noted that the Updated Draft Report acknowledges this avenue of degradation but stated that there are concerns about the cumulative effects of combined exposures to multiple PFAS, and that TFA meets the definition of a PFAS.

Industry (for example chemical manufacturing, construction and automotive) similarly opposed the inclusion of fluoropolymers, stating that they pose low risk to human health and the environment, and that fluoropolymers have different characteristics from other PFAS. Government officials noted that, based on consideration of information from a range of sources, fluoropolymers that meet the OECD definition of PFAS used in the State of PFAS Report are planned for consideration in a separate assessment. Officials stated that their exclusion from further consideration in the Updated Draft Report should not be interpreted as meaning that fluoropolymers are or are not of concern.

Industry (for example chemical manufacturing and automotive) expressed concern over the process followed with the Draft Report, describing a divergence from the CMP assessment process including that it did not follow a scientific, risk-based approach that identifies critical exposure scenarios. Government officials stated that the Departments followed the same general process as with other assessments conducted under the CMP. This included information gathering (including some completed during previous assessments and through other PFAS-related initiatives), synthesis and analysis of the information gathered, discussion on the limitations in the availability of data and, based on consideration of multiple lines of evidence, inclusion of a proposed conclusion under section 64 of the Act. Government officials also noted the publication of a notice of intent to address the broad class of PFAS on April 24, 2021, and the Supporting document: Ecological state of the science report on Short-chain (C4-C7) Perfluorocarboxylic Acids (SC-PFCAs) Short-chain (C4-C7) Perfluorosulfonic Acids (SC-PFSAs) Long-chain Perfluorosulfonic Acids (LC-PFSAs) published alongside the Draft State of PFAS Report on May 20, 2023.

Updated Draft State of PFAS Report

NGOs, academia, labour unions, and members of the public reiterated their support for a class-based approach but expressed concern regarding the exclusion of fluoropolymers from the conclusion of the Updated Draft Report. Government officials responded that, while they are considered part of the PFAS definition set out in the Updated Draft Report, information from a range of sources suggests differences between fluoropolymers and other PFAS, warranting additional work on fluoropolymers. Commenters also requested more information on the future fluoropolymers assessment, including the proposed publication timelines. Government officials noted that fluoropolymers have been proposed to be included in an upcoming Plan of Priorities to be published under section 73 of the Act. They also noted that data collection (including a notice under section 71 of the Act) is in progress to collect additional information on fluoropolymers.

NGOs also expressed concern that a listing on Part 2, instead of Part 1, of Schedule 1 to the Act will not sufficiently address the impacts associated with the class of PFAS with respect to risk management actions that may follow the listing of the substances. Government officials noted that while PFAS meet the criteria for persistence set out in Persistence and Bioaccumulation Regulations, the bioaccumulation potential for PFAS cannot reasonably be determined according to these Regulations. They further noted that substances listed on Part 2 can still be prohibited.

Industry expressed support for the exclusion of fluoropolymers and requested the exclusion of other PFAS (such as HFOs and other fluorinated polymers). They further requested that these PFAS be assessed separately, similarly to fluoropolymers. As mentioned in the Summary of State of PFAS Report section, fluoropolymers were excluded from consideration in the Report as they may have significantly different exposure and hazard profiles when compared with other PFAS. Government officials responded that these PFAS (for example HFOs and other fluorinated polymers) were determined to contribute to the cumulative risk of the class of PFAS, and that the potential for cumulative exposure and effects are important considerations as most wildlife and human exposures involve an unknown mixture of PFAS.

These comments were considered in the finalization of the State of PFAS Report, which in some cases resulted in additions or revisions to the Report, but did not change the conclusion proposed in the Updated Draft Report that the class of PFAS, excluding fluoropolymers, meets the ecological and human health criteria for a toxic substance as set out in paragraphs 64(a) and 64(c) of the Act and thus has the potential to constitute a risk to the environment and human health in Canada.

The Departments informed the provincial and territorial governments about these publications through the Act’s National Advisory Committeefootnote 21 via a letter and provided them with an opportunity to comment. No comments were received from the Committee.

Modern treaty obligations and Indigenous engagement and consultation

An assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders adding substances to Schedule 1 to the Act do not introduce any new regulatory requirements, and therefore do not result in any impact on modern treaty rights or obligations. As such, specific engagement and consultations with Indigenous Peoples were not undertaken.

Instrument choice

Following an assessment conducted under section 68 of the Act, the publication of the assessment conclusion under section 77 of the Act must propose one of the following measures:

Toxic substances that pose the highest concern are recommended for addition to Part 1 of Schedule 1 to the Act. These substances would be prioritized for total, partial, or conditional prohibition. Other toxic substances are recommended for addition to Part 2 of Schedule 1 to the Act and are prioritized for pollution prevention actions, which may include total, partial or conditional prohibition. Until regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic, or toxic to reproduction are developed, toxic substances that are determined to be persistent and bioaccumulative as per the criteria under the Persistence and Bioaccumulation Regulations are recommended for addition to Part 1 of Schedule 1 to the Act. Should additional criteria be specified in regulation, some substances initially considered for addition to Part 2 of Schedule 1 to the Act may instead be considered for addition to Part 1 of Schedule 1 to the Act. PFAS, excluding fluoropolymers, were determined to be persistent, but the bioaccumulation potential of PFAS cannot be reasonably determined according to the criteria in the Persistence and Bioaccumulation Regulations.

The measure being proposed by the Ministers is recommending that the class of PFAS, excluding fluoropolymers, be added to Part 2 of Schedule 1 to the Act.

Regulatory analysis

Benefits and costs

Orders adding substances to Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), as they do not impose any regulatory requirements on businesses. Therefore, the proposed Order would not result in incremental impacts. These orders grant the Ministers the authority to develop risk management instruments for a toxic substance under the Act for those substances. The Government of Canada will consult interested parties on any future risk management instruments for those substances before implementation and will consider their potential impacts.footnote 22

Small business lens

Since orders adding substances to Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), the assessment of the small business lens concluded that the proposed Order would not impact Canadian small businesses.footnote 23

One-for-one rule

Since orders adding substances to Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), the assessment of the one-for-one rule concluded that the proposed Order would not have impacts that would need to be addressed under the rule.footnote 24

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (for example the United States Environmental Protection Agency, European Chemicals Agency, and the OECD), and is party to several international multilateral environmental agreements in the area of chemicals and waste.footnote 25 While the Order will not on its own relate to any international agreements or obligations, it will enable the Ministers to propose risk management measures that may align with actions undertaken by other jurisdictions.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment (SEEA), a SEEA is required for proposals that are expected to have important effects (positive or negative, direct or indirect) on the environment and the economy. Since orders adding substances to Part 2 of Schedule 1 to the Act do not result in incremental impacts (benefits and costs), a SEEA was not required for the proposed Order. The proposed Order would grant the Ministers the authority to develop risk management instruments for PFAS under the Act. The Government of Canada will evaluate whether a SEEA may be required on any future risk management instruments for PFAS.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for this proposal.footnote 26

Implementation, compliance and enforcement, and service standards

As no specific risk management instruments are recommended as part of the proposed Order, developing an implementation plan and a compliance and enforcement strategy as well as establishing service standards are not necessary at this time.

Contacts

Thomas Kruidenier
Executive Director
Substance Prioritization, Assessment and Coordination Division
Environment and Climate Change Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Email: substances@ec.gc.ca

Andrew Beck
Director
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613‑266‑3591
Email: andrew.beck@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given, under subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999 footnote b, that the Governor in Council proposes to make the annexed Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 under subsection 90(1)footnote c of that Act.

Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333footnote d of that Act and stating the reasons for the objection. Persons filing comments are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website. Persons filing comments by any other means, and persons filing a notice of objection, should cite the Canada Gazette, Part I, and the date of publication of this notice, and send the comments or notice of objection to the Executive Director, Substance Prioritization, Assessment and Coordination Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (email: substances@ec.gc.ca; Environment and Climate Change Canada’s Single Window: https://ec.ss.ec.gc.ca/).

A person who provides information to the Minister may submit with the information a request for confidentiality under section 313footnote e of that Act.

Ottawa, February 27, 2025

Janna Rinaldi
Acting Assistant Clerk of the Privy Council

Order Adding a Toxic Substance to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999

Amendment

1 Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999footnote 27 is amended by adding the following in numerical order:

Coming into Force

2 This Order comes into force on the day on which it is registered.

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