Order 2024-87-24-01 Amending the Domestic Substances List: SOR/2025-81

Canada Gazette, Part II, Volume 159, Number 7

Registration
SOR/2025-81 March 6, 2025

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substance set out in the annexed Order is specified on the Domestic Substances List ^{footnote a};

And whereas the Minister of the Environment and the Minister of Health suspect that the information concerning a significant new activity in relation to the substance may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 ^{footnote b};

Therefore, the Minister of the Environment makes the annexed Order 2024-87-24-01 Amending the Domestic Substances List under subsection 87(3)^{footnote c} of the Canadian Environmental Protection Act, 1999^{footnote b}.

Ottawa, March 3, 2025

Steven Guilbeault
Minister of the Environment

Order 2024-87-24-01 Amending the Domestic Substances List

Amendments

1 Part 1 of the Domestic Substances List ^{footnote a} is amended by deleting the following:

• 25155-23-1

2 Part 2 of the List is amended by adding the following in numerical order:

Column 1 Substance

Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act

25155-23-1 S′

1 The use of the substance phenol, dimethyl-, phosphate (3:1) in the manufacture of (a) a consumer product to which the Canada Consumer Product Safety Act applies if it contains the substance at a concentration (i) greater than 2% by weight, in the case of a lubricant or grease product, or (ii) equal to or greater than 0.1% by weight, in the case of any other product; or (b) a cosmetic as defined in section 2 of the Food and Drugs Act if it contains the substance at a concentration equal to or greater than 0.1% by weight. 2 The importation of the substance phenol, dimethyl-, phosphate (3:1) in any of the following products if the total quantity imported in all such products in a calendar year is greater than 10 kg: (a) a consumer product to which the Canada Consumer Product Safety Act applies if it contains the substance at a concentration (i) greater than 2% by weight, in the case of a lubricant or grease product, or (ii) equal to or greater than 0.1% by weight, in the case of any other product; or (b) a cosmetic as defined in section 2 of the Food and Drugs Act if it contains the substance at a concentration equal to or greater than 0.1% by weight. 3 Despite sections 1 and 2, an activity is not a significant new activity if (a) the substance is a research and development substance or a site-limited intermediate substance as those terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers); or (b) the substance, or the product that contains the substance, is intended only for export. 4 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the activity begins: (a) a description of the significant new activity in relation to the substance; (b) the anticipated annual quantity of the substance to be used; (c) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers); (d) the information specified in item 2 and paragraphs 8(f) and (g) of Schedule 5 to those Regulations; (e) a description of the consumer product or cosmetic that contains the substance, the intended use and method of application of that consumer product or cosmetic and the function of the substance in that consumer product or cosmetic; (f) the total quantity of the consumer product or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity; (g) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the anticipated quantity by site; (h) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance; (i) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency; (j) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and (k) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf. 5 The information referred to in section 4 is to be assessed within 90 days after the day on which it is received by the Minister.

Coming into Force

3 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 Chemicals Management Plan (CMP) is a Government of Canada initiative through which the risks of exposure of people in Canada and the environment to substances^{footnote 1} are assessed and managed. As part of the CMP, the Minister of the Environment (the Minister) may apply the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) to certain substances to request information to assess the potential for environmental and human health risks when the substance is used in a significant new activity. A significant new activity is an activity that results in the entry of a substance in the environment in a different quantity or concentration, or in different circumstances, than those in which the substance previously entered the environment, which could affect the environmental or human exposure to that substance in Canada. If risks are identified, the Government of Canada may recommend risk management measures to mitigate them.

In accordance with subsection 87(3) of CEPA, the Minister is issuing the Order 2024-87-24-01 Amending the Domestic Substances List (DSL)^{footnote 2} to apply the SNAc provisions of CEPA to phenol, dimethyl-, phosphate (3:1) (CAS RN^{footnote 3} 25155-23-1), also known as “trixylyl phosphate.”

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 from exposure to activities that involve them (e.g., industrial releases from manufacturing) or products that contain them (e.g., consumer products use and disposal). As part of the CMP, government officials from the Department of the Environment and the Department of Health (the departments) conduct assessments under the authority of CEPA to analyze the available information on substances (e.g., hazardous properties and uses) in order to identify existing and potential environmental and human health risks posed by exposure to these substances. The Minister of the Environment and the Minister of Health (the ministers) may recommend the development of risk management measures to mitigate these risks wherever identified, under the authority of a broad suite of federal laws, including CEPA, the Canada Consumer Product Safety Act, the Food and Drugs Act, the Pest Control Products Act, and the Fisheries Act.

The SNAc provisions of CEPA

Following the assessments of substances, the Minister may apply the SNAc provisions of CEPA to certain substances that are determined to have properties of concern, to request information to assess the environmental and human health risks of increased exposure to these substances in the event of their use in a significant new activity in Canada. The SNAc provisions establish a requirement for any person (individual or corporation) considering manufacturing, importing, or using a substance for a significant new activity to submit a Significant New Activity Notification (SNAN) to the Minister containing the prescribed information for that substance. Upon receipt of the complete information, government officials would conduct further assessment of that substance before the activity is undertaken, to determine whether exposure to that substance from that activity could pose a risk to the environment or human health and whether further risk management considerations may be required to mitigate those risks.

To see the substances subject to the SNAc provisions of CEPA, please visit the Canada.ca Open Data Portal.

Description, uses, sources of release and exposure, and risk management activities

Trixylyl phosphate does not occur naturally in the environment. Trixylyl phosphate has an overall long environmental persistence. Data in the assessment report shows that trixylyl phosphate has a moderate potential to cause negative effects in the environment and is considered to have a health effect of concern on the basis of its potential to cause reproductive effects. However, on the basis of current use patterns, trixylyl phosphate is unlikely to be causing environmental or human health harm in Canada. Globally, due to trixylyl phosphate’s physical and chemical properties, the substance may be used as a flame retardant, as a plasticizer or as/in hydraulic fluids, for wire and cabling insulation, in lubricants and greases, in power generation fluids, in metal working fluids and in various plastics including polyvinyl chloride, rigid and flexible polyurethane, ethylene propylene diene monomer rubber, copolymer of polycarbonate and acrylonitrile-butadiene-styrene and phenolic resins.

The Minister issued a mandatory survey under section 71 of CEPA^{footnote 4} that included the substance. Information received from industry for the 2008 reporting year indicated no reports of the manufacture of trixylyl phosphate in Canada above the reporting threshold of 100 kilograms (kg), though 100 000 kg to 1 000 000 kg of the substance was reported to have been imported into the country. The reported uses of trixylyl phosphate in Canada include as a flame retardant and in lubricants and greases, and it may also be used in food packaging materials, as a plasticizer, in hydraulic fluids, and for wire and cabling insulation.

People in Canada may be exposed to trixylyl phosphate as a result of its presence in dust and through a limited number of consumer products. Internationally, trixylyl phosphate is included on the list of Substances of Very High Concern (SVHC) and in the Community Rolling Action Plan (CoRAP) in Europe. Inclusion on the SVHC list is based on the substance’s classification as a reproductive toxicant. This substance has also been reviewed by Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS). No other risk management actions are in place in Canada or internationally.

Summary of the assessment

As part of the CMP, in December 2020, the ministers published an assessment report on the Phosphoric Acid Derivatives Group, which assessed trixylyl phosphate along with two other substances^{footnote 5}, on the Canada.ca (Chemical Substances) website.

The assessment concluded that trixylyl phosphate does not meet the environmental or human health criteria for a toxic substance as set out in paragraphs 64(a), (b) or (c) of CEPA.^{footnote 6} The assessment also determined that the substance has properties of concern that could pose a risk to the environment or human health if exposure levels to trixylyl phosphate were to increase from its use in a significant new activity in Canada. As a result, the Minister decided to apply the SNAc provisions of CEPA to trixylyl phosphate.

Objective

The objective of Order 2024-87-24-01 Amending the Domestic Substances List (the Order) is to apply the SNAc provisions of CEPA to trixylyl phosphate in accordance with subsection 87(3) of CEPA. As part of the CMP, the Order contributes to the protection of the environment and human health by reducing the risks associated with increased exposure of people in Canada and the environment to trixylyl phosphate in the event of its use in a significant new activity in Canada.

Description

Pursuant to subsection 87(3) of CEPA, the Order applies the SNAc provisions under subsection 81(3) of CEPA to trixylyl phosphate. For a description of the significant new activities associated with this substance, please see the regulatory text in the Order.

Applicability

The Order does not impose any regulatory requirements on existing activities involving trixylyl phosphate in Canada, which have been determined to present no risk, to present limited risk or as being adequately managed.

The SNAc provisions of CEPA target potential significant new activities involving a substance that could result in a new or increased exposure to that substance in Canada. A significant new activity is an activity that results in the entry of the substance into the environment in a different quantity or concentration, or under different circumstances, than those in which the substance previously entered the environment.^{footnote 7} For details on the significant new activities associated with trixylyl phosphate, please see the regulatory text in the Order.

Should a person (individual or corporation) choose to engage with a substance, they would be required to comply with any regulations associated with that substance. In the same manner, if a person chooses to engage in a significant new activity in relation to a substance subject to the SNAc provisions of CEPA, they would be required to submit a SNAN to the Minister. The SNAN must contain all the information prescribed in an order and must be submitted in the prescribed period before the day on which the significant new activity begins. The prescribed information to complete a SNAN is specific to each substance and is described in the order that applied the SNAc provisions of CEPA to that substance.^{footnote 8} For details on the information that would be required to be submitted in a SNAN for trixylyl phosphate, please see the regulatory text in the Order.

Notification requirements

Below is a summary of the notification requirements for trixylyl phosphate. For specific details, please see the regulatory text in the Order.

Activities subject to notification requirements

The notification requirements apply to

• the use of the substance phenol, dimethyl-, phosphate (3:1) in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies, or in the manufacture of a cosmetic as defined in section 2 of the Food and Drugs Act if the product or cosmetic contains the substance at a concentration equal to or greater than 0.1% by weight, except in cases where notification requirements do not apply (outlined below); and
• the importation of the substance phenol, dimethyl-, phosphate (3:1) in any consumer product to which the Canada Consumer Product Safety Act applies or in any cosmetic as defined in section 2 of the Food and Drugs Act, that contains the substance at a concentration equal to or greater than 0.1% by weight if the total quantity imported in all such products in a calendar year is greater than 10 kg, except in cases where notification requirements do not apply (outlined below).

Activities not subject to notification requirements

The notification requirements do not apply

• to the use of the substance phenol, dimethyl-, phosphate (3:1) in the manufacture of a lubricant or grease product to which the Canada Consumer Product Safety Act applies, or its importation if the total quantity imported in all such products in a calendar year is greater than 10 kg and the lubricant or grease product contains the substance at a concentration less than or equal to 2% by weight;
• if the substance is a research and development substance, site-limited intermediate substance, or export-only substance;^{footnote 9}
• to any use of the substance that is regulated under the Acts of Parliament listed in Schedule 2 to CEPA, including the Pest Control Products Act, the Fertilizers Act, and the Feeds Act; and
• if the substance is exempt or excluded from notification requirements under CEPA (i.e., as a transient reaction intermediate, impurity, contaminant, partially unreacted material, or incidental reaction product, and, under certain circumstances, in mixtures, manufactured items, or wastes).^{footnote 10}

Information requirements

Below is a summary of the information requirements for the notification of a proposed significant new activity in relation to trixylyl phosphate. For specific details, please see the regulatory text in the Order.

The Order requires the submission of

• a description of the proposed significant new activity;
• relevant information in Schedules 4 and 5 to the New Substances Notification Regulations (Chemicals and Polymers) (SOR/2005-247);
• a description of the product that contains the substance, the intended use and the method of application of that product, and the function of the substance within that product; and
• other information in respect of the substance, including additional details surrounding use and exposure information.

Regulatory Development

Consultations

As part of the CMP, on December 19, 2020, the Minister published a Notice of Intent (NOI) to apply the SNAc provisions of CEPA to trixylyl phosphate in the Canada Gazette, Part I, for a 60-day public comment period. The Department received no comments during this period.

The departments also informed the provincial and territorial governments about the Order through the CEPA National Advisory Committee (CEPA NAC)^{footnote 11} 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 consultations

An assessment of modern treaty implications conducted in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in any impact on modern treaty rights or obligations, as they do not impose regulatory requirements (see Applicability section) that could result in incremental impacts (see Benefits and costs section) that would warrant specific engagement and consultation with Indigenous Peoples separate from the 60-day public comment period that followed the publication of the NOI.

Instrument choice

The decision to use the SNAc provisions of CEPA is risk-based. The SNAc provisions will be considered for use where there is reasonable suspicion that certain new activities with respect to a substance may result in new or increased risks to the environment or human health. That suspicion could be based on factors such as the specific properties of that substance, the function of that substance and the presence of that substance in markets in other jurisdictions.^{footnote 12}

As part of the CMP, the assessment informed the determination that applying the SNAc provisions of CEPA to trixylyl phosphate is the most appropriate instrument to mitigate the risks of increased exposure of people in Canada and the environment to the substance in the event of use in a significant new activity in Canada.

Regulatory analysis

Benefits and costs

Orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs). The SNAc provisions aid in the protection of the environment and human health through their contribution to the main objective of the CMP. These orders usually do not apply to current activities identified at the time of the analysis involving those substances, as they are not considered to pose an environmental or human health risk, or their risk is adequately managed. These orders apply to the potential use of those substances in a significant new activity that could result in a new or increased exposure to those substances. Should a person (individual or corporation) choose to engage in a significant new activity involving a substance subject to the SNAc provisions of CEPA, they would be required to comply with all the regulations in place associated with that activity and that substance, including the requirement to submit a SNAN to the Minister. Therefore, the costs associated with a submission of a SNAN are not considered incremental to the SNAc provisions for a substance, but rather costs of conducting business and/or complying with federal laws and regulations in Canada.

Small business lens

Since orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs), the assessment of the small business lens concluded that these orders do not have impacts on small businesses.^{footnote 13}

One-for-one rule

Since orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs), the assessment of the one-for-one rule concluded that these orders do not have impacts on businesses that would need to be addressed under the rule.^{footnote 14}

Regulatory cooperation and alignment

Canada cooperates with other international organizations and regulatory agencies for the management of chemicals (e.g., United States Environmental Protection Agency, European Chemicals Agency, and the Organisation for Economic Co-operation and Development) and is party to several international multilateral environmental agreements in the area of chemicals and waste.^{footnote 15} The CMP is administered in cooperation and alignment with these agreements.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a Strategic Environmental Assessment was completed for the CMP, which includes orders amending the DSL to apply the SNAc provisions of CEPA to certain substances. The assessment concluded that the CMP is expected to have a positive impact on the environment and human health.

Gender-based analysis plus

Since orders amending the DSL to apply the SNAc provisions of CEPA to certain substances do not result in incremental impacts (benefits and costs), gender-based analysis plus does not apply.^{footnote 16}

Implementation, compliance, enforcement, and service standards

Implementation

Orders amending the DSL are in force on the day that they are registered. Compliance promotion activities conducted as part of the implementation of those orders will include developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements in those orders in the event a substance subject to the SNAc provisions of CEPA is used in a significant new activity in Canada.

Compliance

When assessing whether the use of a substance subject to the SNAc provisions of CEPA may be considered a significant new activity, a person (individual or corporation) is expected to make use of information in their possession or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheet.^{footnote 17}

Where a person involved in activities with the substance obtains information that reasonably supports the conclusion that that substance is toxic or capable of becoming toxic, the person is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

Under section 87.1 of CEPA, any person who transfers the physical possession or control of a substance subject to an order to another shall notify that person of their obligation to comply with that order, including the obligation to notify the Minister of any significant new activity and to provide all the required prescribed information specified in that order.

In cases where a person receives physical possession or control of a substance subject to the SNAc provisions of CEPA from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the supplier on behalf of its clients.

A pre-notification consultation (PDF) (PNC) is available for notifiers who wish to consult during the planning or preparation of a SNAN to discuss any questions or concerns they have about the prescribed information and test plans. Where a person has questions concerning their obligations to comply with an order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to contact the Substances Management Information Line.^{footnote 18}

Enforcement

Orders amending the DSL to apply the SNAc provisions of CEPA to certain substances are enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act. In instances of non-compliance, deciding which enforcement measure to take will consider factors such as the nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations and consistency in the application of enforcement measures. Suspected violations under CEPA can be reported to the Enforcement Branch by email at enviroinfo@ec.gc.ca.

Service standards

In the event that a SNAN is submitted to the Minister in relation to trixylyl phosphate, government officials will assess the information received within the prescribed timelines set out in the Order.

Contacts

Marc Demers
Acting Director
Regulatory Operations, Policy and Emerging Sciences Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
Telephone: 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada)
Email: substances@ec.gc.ca

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