Canada Releases Final State of PFAS Report and Proposed Risk Management Approach

On March 5, 2025, Environment and Climate Change Canada (ECCC) announced the availability of its final State of Per- and Polyfluoroalkyl Substances (PFAS) Report (State of PFAS Report) and proposed risk management approach for PFAS, excluding fluoropolymers. The State of PFAS Report concludes that the class of PFAS, excluding fluoropolymers, is harmful to human health and the environment. To address these risks, on March 8, 2025, Canada published a proposed order that would add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). ECCC states in its March 5, 2025, press release that it will prioritize the protection of health and the environment while considering factors such as the availability of alternatives. Phase 1, starting in 2025, will address PFAS in firefighting foams to protect better firefighters and the environment. Phase 2 will focus on limiting exposure to PFAS in products that are not needed for the protection of human health, safety, or the environment. ECCC notes that this will include products like cosmetics, food packaging materials, and textiles. ECCC states that it will publish a final decision on the proposed addition of 131 individual PFAS to the National Pollutant Release Inventory (NPRI) with reporting to take place by June 2026 for PFAS releases that occurred during the 2025 calendar year. ECCC states that these data will improve its understanding of how PFAS are used in Canada, help it evaluate possible industrial PFAS contamination, and support efforts to reduce environmental and human exposure to harmful substances. Comments on the proposed risk management approach and the proposed order to add the class of PFAS, excluding fluoropolymers, to CEPA Schedule 1 Part 2 are due May 7, 2025.

State of PFAS Report

The State of PFAS Report provides a qualitative assessment of the fate, sources, occurrence, and potential impacts of PFAS on the environment and human health to inform decision-making on PFAS in Canada. The term PFAS refers to the Organisation for Economic Co-operation and Development’s definition, which is: “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it), that is, with a few noted exceptions, any chemical with at least a perfluorinated methyl group (–CF3) or a perfluorinated methylene group (–CF2–) is a PFAS.” The class of PFAS is comprised of substances meeting this definition. ECCC states that the definition captures substances with a wide range of structures and properties, from discrete chemicals, such as perfluorocarboxylic acids, perfluorosulfonic acids, and fluorotelomer alcohols, to side-chain fluorinated polymers, perfluoropolyethers, and fluoropolymers. According to ECCC, some PFAS on the market also possess structural attributes other than perfluoroalkyl chains (for example, inclusion of ether linkages or chlorine atoms in the fluorinated hydrocarbon chains).

The State of PFAS Report notes that there is evidence to suggest that fluoropolymers may have significantly different exposure and hazard profiles when compared with other PFAS in the class. ECCC defines fluoropolymers as “polymers made by polymerization or copolymerization of olefinic monomers (at least 1 of which contains fluorine bonded to 1 or both of the olefinic carbon atoms) to form a carbon-only polymer backbone with fluorine atoms directly bonded to it.” According to ECCC, given information suggesting their differences from the other PFAS in the class, additional work on fluoropolymers is warranted. ECCC does not address PFAS meeting the definition of fluoropolymers within the State of PFAS Report. ECCC plans to consider them in a separate assessment.

According to the State of PFAS Report, the following is known on the basis of current information:

• The broad use of PFAS, their transport in the environment, and their ubiquitous presence have resulted in continuous environmental and human exposure to multiple PFAS, a finding that is supported by both environmental monitoring and human biomonitoring studies, including higher exposures in certain human subpopulations;
• Given that PFAS are extremely persistent and have a broad range of uses leading to continued releases to the environment, the amount of PFAS in the environment is expected to increase;
• Exposure to well-studied PFAS can affect multiple systems and organs in both humans and wildlife. Recent information demonstrates that effects on human health occur at lower levels than indicated by previous studies;
• Some well-studied PFAS have demonstrated the potential to bioaccumulate and biomagnify in food webs to an extent that can cause adverse effects in biota, even at low environmental concentrations; and
• Potential for cumulative exposure and effects are important considerations as most humans and wildlife exposures occur to unknown mixtures of PFAS.

On the basis of what is known about well-studied PFAS and the potential for other PFAS to behave similarly, and on the expectation that combined exposures to multiple PFAS increase the likelihood of detrimental impacts, ECCC states that it concludes that the class of PFAS, excluding fluoropolymers, meets the criteria under CEPA Section 64(a) 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. ECCC concludes that the class of PFAS, excluding fluoropolymers, does not meet the criteria under CEPA Section 64(b), however, as these substances are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends.

According to the State of PFAS Report, on the basis of what is known about well-studied PFAS and the potential for other PFAS to behave similarly, and on the expectation that combined exposures to multiple PFAS increase the likelihood of detrimental impacts, ECCC concludes that the class of PFAS, excluding fluoropolymers, meets the criteria under CEPA Section 64(c) as these substances are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

ECCC therefore concludes that the class of PFAS, excluding fluoropolymers, meets one or more of the criteria set out in CEPA Section 64.

According to the State of PFAS Report, well-studied PFAS meet the persistence criteria set out in the Persistence and Bioaccumulation Regulations of CEPA. Based on available information and structural similarities, ECCC expects that other substances within the class of PFAS are also highly persistent or transform to persistent PFAS. ECCC states that it therefore determines that the class of PFAS meets the persistence criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA. ECCC notes that given that fluoropolymers have been excluded from this assessment, they are also excluded from this determination with regard to the Persistence and Bioaccumulation Regulations of CEPA.

ECCC states that there is a high concern identified for the biomagnification (BMF) and trophic magnification (TMF) potential of well-studied PFAS in air-breathing organisms; the numeric criteria for bioaccumulation, outlined in the Persistence and Bioaccumulation Regulations, however, are based on bioaccumulation data for freshwater aquatic species that do not account for biomagnification potential. Therefore, application of the criteria would not reflect the concern for dietary-based biomagnification, the primary route of food web exposure identified for well-studied PFAS. As a result, according to ECCC, the bioaccumulation potential of PFAS cannot reasonably be determined according to the regulatory criteria set out in the Persistence and Bioaccumulation Regulations of CEPA.

Proposed Risk Management Approach

ECCC concludes that the class of PFAS, excluding fluoropolymers, meet the criteria under CEPA Sections 64(a) and (c), 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.

For the purpose of CEPA Section 77(6)(c)(i), ECCC proposes the following new risk management actions through a phased prohibition under CEPA:

• Phase 1: Prohibition of the use of PFAS, excluding fluoropolymers, not currently regulated in firefighting foams, due to high potential for environmental and human exposure.
• Phase 2: Prohibition of the uses of PFAS, excluding fluoropolymers, not needed for the protection of health, safety, or the environment, which includes consumer applications. ECCC states that prioritization of uses for prohibition is based on, and will take into account, costs and benefits, availability of suitable alternatives, and other socio-economic considerations. Proposed uses to be regulated in Phase 2 include:

   

  • Cosmetics;

     

  • Natural health products and non-prescription drugs;

     

  • Food packaging materials, food additives, and non-industrial food contact products such as paper plates, bowls, and cups;

     

  • Paint and coating, adhesive and sealant, and other building materials available to consumers;

     

  • Consumer mixtures such as cleaning products, waxes, and polishes;

     

  • Textile uses (including in personal protective equipment (PPE) such as firefighting turnout gear); and

     

  • Ski waxes.

     

• Phase 3: Prohibition of the uses of PFAS, excluding fluoropolymers, requiring further evaluation of the role of PFAS for which currently there may not be feasible alternatives and taking into consideration socio-economic factors, including:

   

  • Fluorinated gas applications;

     

  • Prescription drugs (human and veterinary);

     

  • Medical devices;

     

  • Industrial food contact materials;

     

  • Industrial sectors such as mining and petroleum; and

     

  • Transport and military applications.

ECCC states that at each phase of risk management it will consider exemptions, when necessary, with attention to feasible alternatives and socio-economic factors. To inform ECCC’s risk management decision-making, information on the following topics should be provided by May 7, 2025):

• Availability of alternatives to PFAS, or lack thereof, in products and applications in which they are currently used;
• Estimated timeframe to transition to alternatives to PFAS, including any challenges;
• Socio-economic impacts of replacing PFAS, including costs and feasibility of elimination or replacement; and
• Quantities and concentrations of PFAS (including Chemical Abstracts Service Registry Number^® (CAS RN^®), units of measurement, and applications) in products manufactured in, imported into, and sold in Canada (if not already provided through the July 27, 2024, Section 71 notice).

Commentary

Canada’s release of the State of PFAS Report, proposed risk management approach, and proposed order to add PFAS, excluding fluoropolymers, to Part 2 of CEPA Schedule 1 follows soon after the January 29, 2025, deadline for mandatory reporting for 312 PFAS. In its July 27, 2024, Canada Gazette notice, Canada stated that it required information for the purpose of assessing whether the 312 PFAS listed in the notice “are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances.” The March 8, 2025, proposed order acknowledges that “[t]he 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.” Canada states that it anticipates that the mandatory survey will “provide insight on annual quantities of PFAS used in Canada,” but it may be more likely that the survey will highlight the complexity of the supply chain and the difficulty in obtaining information from suppliers.

Stakeholders should carefully review the proposed risk management approach. Canada requests information on the availability of PFAS alternatives, the estimated timeframe to transition to alternatives, the costs and feasibility of elimination or replacement, and the quantities and concentrations of PFAS in products manufactured in, imported into, and sold in Canada (if not already reported through the mandatory survey). It is unlikely many entities will volunteer such specific information on PFAS in their products and companies that were not subject to the mandatory survey may not know. Yet without evidence on the critical use of PFAS in products and the lack of alternatives, Canada may begin prohibiting uses.

Most agree that ultimately the proposal will succeed, and PFAS will be deemed CEPA toxic and listed on Part 2 of CEPA Schedule 1. Given the PFAS risk evaluations of many other authoritative bodies, it is more likely than not that ECCC’s scientific determination is defensible. That the proposal seeks to exempt fluoropolymers is noteworthy, however, and stakeholders may wish to support the exemption.