Order Adding Toxic Substances to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2025-27

Canada Gazette, Part II, Volume 159, Number 5

Registration
SOR/2025-27 February 14, 2025

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

P.C. 2025-97 February 14, 2025

Whereas, under subsection 332(1)footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on June 29, 2019, a copy of the proposed Order Adding Toxic Substances to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, under the title Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, under subsection 90(1)footnote c of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, makes the annexed Order Adding Toxic Substances to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 under subsection 90(1)footnote c of the Canadian Environmental Protection Act, 1999 footnote b.

Order Adding Toxic Substances 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, 1999 footnote b 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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The two substances listed below were assessed under the Canadian Environmental Protection Act, 1999 (CEPA) in 2019. The two substances meet the ecological criterion set out in paragraph 64(a) of CEPA. In accordance with subsection 90(1) of CEPA, the Minister of the Environment and the Minister of Health (the Ministers) recommended that the Governor in Council make an Order adding the two substances to Part 2 of Schedule 1 to the Act (the List of Toxic Substances). The two substances are

Background

Strengthening Environmental Protection for a Healthier Canada Act

On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act received royal assent. It amended various provisions of CEPA and, for that reason, some provisions referenced throughout this document have since been repealed or replaced and are no longer in force. Particular to additions of substances to Schedule 1 to CEPA, it divided Schedule 1 into two parts. Toxic substances added to Part 1 require the Ministers to prioritize the total, partial, or conditional prohibition of activities involved with those substances when managing their risks. Adding toxic substances to Part 2 requires the Ministers to prioritize pollution prevention actions, which may include total, partial or conditional prohibition, when managing their risks.

Chemicals Management Plan

The Chemicals Management Plan (CMP) is a federal program that assesses and manages chemical substances and living organisms that may be harmful to the environment or human health. As part of the CMP, the Ministers assessed DBDPE and DP under the Certain Organic Flame Retardants Substance Grouping in accordance with section 68 of CEPA, as it read before the coming into force of the Strengthening Environmental Protection for a Healthier Canada Act. The grouping includes 10 organic substances that have a similar function to slow the ignition and spread of fire. The final screening assessments of DBDPE and DP found that these substances meet the ecological criteria set out in paragraph 64(a) of CEPA. The final screening assessments and final state of the science reports for 5 of the 10 substances found that none meet any of the criteria for a toxic substance under section 64 of CEPA. The updated draft screening assessments for the remaining three substances in the grouping were published in October 2020, which propose to conclude that those three substances are toxic to human health.

Description, uses and sources of release

DBDPE and DP do not occur naturally in the environment. The Department of the Environment and the Department of Health (the departments) issued a mandatory survey pursuant to section 71 of CEPAfootnote 2 encompassing the substance (reporting years 2011 and 2016) to obtain information on its use in Canada. Information reported by industry, as well as data from New Substances Notifications for DBDPE and information from a socio-economic study on DP and DBDPE in the Canadian marketplace commissioned by the Department of the Environment, indicated that the two substances were not reported to be manufactured in Canada above the reporting thresholds, but they were reported to be imported annually into the country within the following quantity ranges:

DBDPE has been used as a flame retardant since the early 1990s and has been one of the alternative flame retardants to Decabromodiphenyl ether (DecaBDE), which has been restricted both domestically in 2016footnote 3 and internationallyfootnote 4 in 2017. DBDPE is used in various applications such as plastic and rubber materials, electrical and electronic equipment, automotive, aircraft and other transportation applications and adhesives and sealants. It is also used in basic organic chemical manufacturing.

Releases of DBDPE into the environment are expected to occur, most likely during industrial processing activities. These releases would be geographically dispersed, primarily through wastewater treatment systems, with some release to water directly from industrial sites. Releases from products available to consumers are also expected to occur, which would be geographically dispersed and spread out over the duration of the service life and end-of-life of these products.

DP has been produced for at least 40 years, although not in Canada and has also been identified as an alternative to DecaBDE. In Canada, DP is used as a flame retardant in several applications and may include flame-retardant applications in products such as wire and cable jacketing, electrical and electronic equipment parts, automotive parts, aircraft and other transportation-related parts, hard plastic connectors and plastic roofing materials, similarly to known international uses.

Releases of DP to the environment are most likely to occur during the manufacturing, formulation or industrial use stages of these sectors. Releases into the environment are expected to occur primarily through wastewater, with some release to water directly from industrial sites. Since DP is added rather than reacted in products, this suggests that diffuse emissions may occur from consumer or commercial products and, although there are uncertainties, the rate is assumed to be low in comparison to industrial point sources during incorporation of DP into products. Overall, releases from products are expected to be geographically dispersed and spread out over the duration of the service life and end-of-life of these products.

Current risk management activities

National level

A substance not on the Domestic Substances List (e.g. DBDPE) is considered new to Canada and is subject to the Substances and Activities New to Canada provisions under Part 5 of CEPA. These ensure that no new substance can be imported into, or manufactured in Canada above a prescribed threshold before an assessment of its potential impacts on human health and the environment has been performed. Reporting obligations for new substances, including premarket notification requirements, are set out in the New Substances Notification Regulations (Chemicals and Polymers) [NSNR]. The first version of the NSNR, effective July 1, 1994, also required the notification of substances imported and manufactured between January 1, 1987, and July 1, 1994 (referred to as the transitional period). One company notified DBDPE as a substance imported or manufactured during the transitional period (referred to as a transitional substance) and concerns were identified during the risk assessment. As a result, DBDPE was not added to the Domestic Substances List. However, no risk management measures were developed at the time. In accordance with the NSNR, other companies later submitted premarket notifications for DBDPE and, based on environmental concerns, ministerial conditions were imposed on these companies. These ministerial conditions limit the use of DBDPE as a flame retardant component in the manufacture of wire and cable coatings, thermoplastic parts, thermoplastic coatings, thermoset parts and thermoset coatings. However, the ministerial conditions do not apply to all companies equally and controls for DBDPE are not consistent across different industry sectors. It should also be noted that manufactured items are excluded from the definition of substance for the purposes of the Substances and Activities New to Canada provisions of CEPA, such that importers of manufactured items containing DBDPEfootnote 5 are not subject to the NSNR.

DP is listed on the Domestic Substances List under CEPA, but is not subject to any substance-specific risk management in Canada. The Domestic Substances List is an inventory of substances manufactured in or imported into Canada on a commercial scale. It currently contains more than 28 000 substances.

The Government of Canada has proposed to amend the Prohibition of Certain Toxic Substances Regulations, 2012 to prohibit DBDPE and DP and products containing these substances. The existing ministerial conditions for DBDPE would be rescinded upon the amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 coming into force.

International level

In the United States (U.S.), DBDPE is listed as a new chemical under their Toxic Substances Control Act (TSCA) chemical substance inventory. Individuals and firms are required to submit a significant new use notice to the U.S. Environmental Protection Agency (EPA) at least 90 days before manufacturing or processing DBDPE for that use. Moreover, DBDPE is a chemical subject to the Export Notification Requirements under paragraph 12(b) of TSCA and is subject to a Final Health and Safety Data Reporting rule pursuant to the Toxic Substances Control Act as part of a grouping of 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC). Furthermore, DBDPE is restricted in some consumer products under general flame-retardant restrictions in some states, such as California, Maine, New Hampshire and Rhode Island.

In Europe, DBDPE was identified in 2012 for immediate evaluation as part of its Community Rolling Action Plan under its Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations. The evaluation recommended that additional testing information be submitted by industry and that an in-depth evaluation was required, as DBDPE and its transformation productsfootnote 6 were suspected of being persistent, bioaccumulative and inherently toxic. As of August 1, 2024, the substance was still under assessment by the European Chemicals Agency (ECHA). In March 2023, the European Union also published their regulatory strategy for flame retardants, which has a focus on brominated flame retardants and their prioritization for restriction, as indicated in their Restrictions Roadmap, including DBDPE. It should also be noted that the strategy indicates that available data, including field studies, appear to confirm the persistence, bioaccumulative and toxic (PBT) properties of the substance.

Australia’s 2021 DBDPE Assessment (PDF) indicated that, on the basis of the current hazard information available, DBDPE could pose an unreasonable risk to the environment and recommended that DBDPE be prioritized for scheduling and the application of appropriate risk management measures under the Industrial Chemicals Environmental Management (Register) Act 2021.

DBDPE is also listed as a high production volume (HPV) chemical under the Organisation for Economic Co-operation and Development (OECD) Cooperative Chemicals Assessment Programme, through which “member countries shall cooperatively investigate HPV chemicals in order to identify those which are potentially hazardous to the environment and/or to the health of the general public or workers.”

In the U.S., DP is listed under TSCA and as an HPV chemical under their HPV Challenge Program, through which manufacturers and processors of DP are “challenged” to publish data on the health and environmental effects of the chemicals produced in or imported into the U.S.

The European Union has identified DP as very persistent and very bioaccumulative and published a proposal to restrict the manufacture, use and sale of DP (whether alone as a substance, in a mixture or in an article).

Australia’s 2023 DP Assessment (PDF) indicated that, on the basis of the current hazard information available, DP could pose an unreasonable risk to human health and to the environment. DP has been added to Schedule 6 of the Industrial Chemicals Environmental Management (Register) Act 2021, which includes a prohibition on the import, manufacture and export of DP with limited exceptions.

At the eleventh meeting of the Conference of the Parties to the Stockholm Convention (SC COP-11), held from May 1 to May 12, 2023, DP was listed to Annex A (elimination) with specific time-limited exemptions for use in aerospace, space and defence applications; medical imaging and radiotherapy devices and installations; and in replacement parts for and repair of articles in applications such as aerospace, motor vehicles, and stationary industrial machines.

Summary of the screening assessments

In May 2019, the Ministers published a screening assessment of DBDPE and a screening assessment of DP on the Canada.ca (Chemical Substances) website. The screening assessments were conducted to determine whether either of the two substances meet one or more of the criteria for a toxic substance as set out in section 64 of CEPA.

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

The departments collected and considered information from multiple sources (e.g. literature reviews, internal and external database searches, research and monitoring and surveillance programs under the Chemicals Management Plan, modelling, data from mandatory surveys issued pursuant to section 71 of CEPA and, where warranted, data from targeted follow-ups with stakeholders) to inform the screening assessment conclusion. The ecological and human health portions of both screening assessments have undergone external peer review and consultation with academics and other relevant stakeholders.

The screening assessments concluded that DBDPE and DP meet the ecological criterion for a toxic substance as set out in paragraph 64(a) of CEPA and thus, constitute a risk to the environment in Canada.

Summary of the ecological assessment
DBDPE

DBDPE releases to the environment are most likely to occur during the formulation or industrial use. DBDPE is found mainly in sediment and soil, where it may persist for long periods of time. DBDPE release and persistence are contributing to DBDPE build-up as seen by rapid-doubling times (size or volume) with respect to levels in sediment in the Great Lakes.

To determine if DBDPE may pose an ecological risk, a weight of evidence approach was used, which included a risk quotient analysis that calculated the ratio between predicted environmental concentration (PEC) and predicted no-effect concentration (PNEC). When PEC values are greater than PNEC values, there is potential for ecological harm. The results of this risk quotient (PEC/PNEC) analysis of the sediment and soil media, as well as for wildlife, indicate that there is low potential for ecological harm in Canada directly from DBDPE. However, there is concern when the potential formation of lower brominated diphenyl ethanes in the environment are considered.

The screening assessment concluded that DBDPE meets the ecological criterion for a toxic substance set out in paragraph 64(a) of CEPA, but does not meet the criterion set out in paragraph 64(b). The assessment also determined that DBDPE meets the criteria for persistence, but does not meet the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations. However, upon transformation, DBDPE may contribute to the formation of persistent, bioaccumulative and inherently toxic substances, such as lower brominated diphenyl ethanes, in the environment.

DP

Releases of DP to the environment are most likely to occur during industrial processing activities and are expected to occur primarily through wastewater treatment systems, with some releases directly from industrial sites. Releases from products available to consumers are also expected to occur and be geographically dispersed and spread out over the service life and end-of-life stages. Based on measurements of DP in air and biota in remote regions and modelling results, DP also has long-range transport potential. DP is expected to be persistent in water, soil and sediment. Published bioaccumulation and biomagnification studies, as well as widespread measurements of DP in biota, indicate that DP may be highly bioaccumulative and may biomagnify in organisms occupying at different trophic levels in a foodweb.

A weight of evidence approach, which included a risk quotient analysis, integrating conservative estimates of exposure with toxicity information, was performed for sediment and soil, as well as for wildlife, to determine whether there is potential for ecological harm. The results of this risk quotient (PEC/PNEC) analysis for the sediment indicate that there is potential for ecological harm to organisms residing in sediment in Canada. However, the result of the risk quotient analysis for wildlife and soil are not indicative of ecological harm to organisms residing in these environmental media in Canada.

The screening assessment concluded that DP meets the ecological criterion for a toxic substance set out in paragraph 64(a) of CEPA, but does not meet the criterion set out in paragraph 64(b). The assessment also determined that DP meets the persistence criteria and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

Summary of the human health assessment
DBDPE

People living in Canada are potentially exposed to DBDPE from environmental media and food, mainly from household dust and soil, as well as from products available to consumers, specifically children’s toys. However, no adverse effects were observed in experimental studies where animals were exposed to levels of DBDPE that are more than one to 10 million times greater than what humans are estimated to be exposed to through use of products available to consumers or environmental media and food. Based on the low potential of DBDPE to cause harm to human health and based on current levels of exposure, the screening assessment concluded that the substance does not meet the human health criterion for a toxic substance set out in paragraph 64(c) of CEPA.

DP

People living in Canada are potentially exposed to DP from environmental media (e.g. air, water, household dust) and food, including human milk. DP may also be found in manufactured items, such as electrical wires, hard plastic computer and TV connectors, and from vehicles. However, potential exposures to DP for the general population of Canada from these uses are low and expected to be accounted for indirectly through indoor air and household dust. No adverse effects were observed in experimental animals. Based on the low potential of DP to cause harm to human health and on current levels of exposure, the screening assessment concluded that the substance does not meet the human health criterion for a toxic substance as defined in paragraph 64(c) of CEPA.

Objective

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

Description

The Order adds DBDPE and DP to Part 2 of Schedule 1 to CEPA.

Regulatory development

Consultation

On October 8, 2016, the Ministers published a Notice with a summary of the draft screening assessment for 10 organic flame retardants in the Canada Gazette, Part I, followed by a 60-day public comment period. Comments on DBDPE were received from three industry, health and academic stakeholders during that period. These comments were considered during the development of the final screening assessment, but did not result in a change to the conclusion that DBDPE meets the ecological criterion for a toxic substance set out under paragraph 64(a) of CEPA. A table summarizing the complete set of comments received for DBDPE and the responses to these comments are available on the Canada.ca (Chemical Substances) website. As for DP, no comments were received for this substance.

On June 29, 2019, the proposed Order recommending the addition of DBDPE and DP to Schedule 1 to CEPA was published in the Canada Gazette, Part I, followed by a 60-day public comment period. During this period, comments were received from six industry stakeholders and one non-governmental organization (NGO). Several of the comments related to the availability of substitutes, the socio-economic impacts of restricting DP and DBDPE and transitioning to substitutes and the recycling of waste containing these substances. A summary of the comments received is found below and a table summarizing the complete set of comments received and the responses to these comments is available on the Canada.ca (Chemical Substances) website.

The NGO that provided comments signalled support for the proposal to add DBDPE and DP to Schedule 1 to CEPA and commented that consideration should be given to treating organic flame retardants as a class to improve assessment efficiency and avoid regrettable substitutions.footnote 7 They requested that strong measures be designed to end the use of these substances and to collaborate with other jurisdictions in our regulatory system to limit non-essential uses of these substances, in order to protect human health and the environment from contamination. Officials responded that flame retardants were and will be assessed as groups and/or as classes under the CMP where appropriate. As for proposed measures to manage DBDPE and DP, the Government of Canada has proposed to repeal the Prohibition of Certain Toxic Substances Regulations, 2012 and replace them with the Prohibition of Certain Toxic Substances Regulations, 2022. The proposed Regulations would prohibit the manufacture, import, use, sale and offer for sale of these substances and products containing these substances.

Industry stakeholders presented considerations and caveats that the Government of Canada should consider for the Schedule 1 Order listing as well as in the development of any risk management measures for these substances. Some stakeholders indicated that hazard and risk assessment of DBDPE and DP in manufactured items and polymers should be performed before proceeding to future risk management measures. Others commented that measures developed to manage DBDPE and DP should be harmonized with international initiatives and that the measure could have negative international implications, in particular in relation to recycling and misclassification of e-waste as being hazardous waste. Officials responded that socio-economic factors, international risk management measures and other factors were being considered in the development of risk management measures for these substances. Alternative chemical flame retardants, technologies and non-chemical-based technologies may also be used to meet performance-based flammability requirements and harmonize with international initiatives. Officials clarified that transboundary movement of hazardous waste and hazardous recyclable materials is regulated under separate regulations.footnote 8 Classification of hazardous waste for the purpose of management at the domestic level is a provincial and territorial responsibility.

The departments informed the provincial and territorial governments about all publications through CEPA’s National Advisory Committeefootnote 9 via a letter and provided them with an opportunity to comment. No comments were received from CEPA’s National Advisory 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 of CEPA do not introduce any new regulatory requirements and, therefore, do not result in any impact on modern treaty rights or obligations. As a result, specific engagement and consultations with Indigenous peoples were not undertaken. However, the prepublication comment period is an opportunity for Indigenous peoples to provide feedback on the proposed Order, which was open to all Canadians.

Instrument choice

When a substance meets one or more of the criteria for a toxic substance, as set out in section 64 of CEPA, the Ministers shall propose one of the following options under subsection 77(2) of CEPA:

Toxic substances that pose the highest risk are added to Part 1 of Schedule 1. These are prioritized for total, partial, or conditional prohibition. Other toxic substances are added to Part 2 of Schedule 1 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 have been found to meet the criteria in the existing Persistence and Bioaccumulation Regulations will be added to Part 1. Should additional criteria be specified in regulation, some substances initially considered for addition to Part 2 of Schedule 1 may instead be considered for addition to Part 1 of Schedule 1. The two substances are being added to Part 2 of Schedule 1 to CEPA.

Regulatory analysis

Benefits and costs

The addition of DBDPE and DP to Part 2 of Schedule 1 to CEPA does not, on its own, impose any regulatory requirements on businesses and, therefore, does not result in any incremental compliance costs for stakeholders or enforcement costs for the Government of Canada. The Order grants the Ministers the authority to develop risk management instruments under CEPA for these substances. The Government of Canada will consult stakeholders on any future risk management instruments for DBDPE and DP before implementation and will consider their potential impacts.footnote 10

Small business lens

Analysis under the small business lens concluded that the Order will not impact Canadian small businesses, as it does not impose any administrative or compliance costs on businesses. In the event that the Ministers propose risk management measures for DBDPE or DP, the departments would assess any associated impact on small businesses during the development of such measures.

One-for-one rule

The one-for-one rule does not apply, as the Order does not result in a change in administrative burden imposed on businesses. In the event that the Ministers propose risk management measures for DBDPE or DP, the departments would assess any associated administrative burden during the development of such measures.

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g. the United States Environmental Protection Agency, the European Chemicals Agency and the Organization for Economic Co-operation and Development) and is party to several multilateral environmental agreements in the area of chemicals and waste.footnote 11 While the Order does not on its own relate to any international agreements or obligations, it enables 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, a Strategic Environmental Assessment was completed for the CMP, inclusive of orders adding substances to Schedule 1 to CEPA. The assessment concluded that the CMP is expected to have a positive effect on the environment and human health.

Gender-based analysis plus

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

Implementation, compliance and enforcement, and service standards

As no specific risk management measures are recommended as part of the 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