Order 2024-87-20-01 Amending the Domestic Substances List: SOR/2025-59

Canada Gazette, Part II, Volume 159, Number 6

Registration
SOR/2025-59 February 28, 2025

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

The Minister of the Environment makes the annexed Order 2024-87-20-01 Amending the Domestic Substances List under subsection 87(4.1)footnote a of the Canadian Environmental Protection Act, 1999 footnote b.

Ottawa, February 25, 2025

Steven Guilbeault
Minister of the Environment

Order 2024-87-20-01 Amending the Domestic Substances List

Amendment

1 The portion of column 2 of Part 2 of the Domestic Substances List footnote 1, opposite the reference to the substance “106-89-8 S′”, in column 1 is replaced by the following:

Column 2

Significant new activity for which substance is subject to subsection 81(3) of the Act

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 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 2 is assessed and managed. As part of the CMP, the Minister of the Environment (the Minister) may vary the requirements applied to certain substances under the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA). 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 the substance in Canada.

As part of the CMP, a review of SNAc orders and notices determined that the requirements applied in 2012 to the substance oxirane, (chloromethyl)- (CAS RNfootnote 3 106-89-8), also known as “epichlorohydrin”, under the SNAc provisions of CEPA do not align with current information on the substance, policies and approaches. As a result of this review and in accordance with subsection 87(4.1) of CEPA, the Minister is issuing the Order 2024-87-20-01 Amending the Domestic Substances List (DSL)footnote 4 to vary the requirements applied to epichlorohydrin under the SNAc provisions of CEPA.

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 those 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 the Canadian Environmental Protection Act, 1999

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 those 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 SNAc provisions of CEPA, please visit the Canada.ca Open Data Portal.

Description, uses, and sources of release and exposure

Epichlorohydrin does not occur naturally in the environment. The substance is a versatile chemical used as an intermediate in the production of a wide variety of chemical products. The main use of epichlorohydrin is in the production of epoxy and phenoxy resins, which are primarily used in protective coatings (e.g. lining of food and beverage cans, printed circuit board laminates, flooring, and adhesives) and thermoplastic polymers (e.g. polyethylene, acrylic, nylon, and polytetrafluoroethylene). The substance may also be used in the production of synthetic glycerol used to make personal care products (e.g. cosmetics and toiletries), drugs (e.g. syrups and eyewash solutions), food and beverages. In personal care products, it is often used as a means of improving smoothness, providing lubrication, and preserving moisture. In food and beverages, it helps preserve moisture and acts as a solvent, sweetener, and preservative.

The information obtained for epichlorohydrin, as part of the review of SNAc orders and notices, identified current uses in Canada in the production of concrete sealer, epoxy adhesives, thermal chemical bonder, and epoxy resins. Based on the reported uses, and other available information (e.g. assessment and risk management actions), exposure of people in Canada and the environment to the substance could occur from industrial emissions from manufacturing and the use of consumer products that contain epichlorohydrin. However, current exposure from these sources has been determined to present no or limited risk. Industrial emissions are considered low to constitute a concern and current exposure to epichlorohydrin from consumer products is also expected to be very low or negligible. If present, epichlorohydrin is primarily only found as a residual in products.

Summary of the assessment and risk management measures

As part of the CMP, in January 2009, the ministers published a screening assessment for epichlorohydrin on the Canada.ca (Chemical Substances) website. The assessment was conducted to determine whether the substance meets one or more of the criteria for a toxic substance as set out in section 64 of CEPAfootnote 5 (i.e. to determine if the substance could pose a risk to the environment or human health in Canada). The assessment of epichlorohydrin concluded that the substance meets the human health criteria for a toxic substance as set out in paragraph 64(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 epichlorohydrin were to increase from its use in a significant new activity in Canada.

Following the publication of the assessment conclusion, risk management measures were put in place including, under CEPA, the application of the SNAc provisions to epichlorohydrin in 2012, and, under the Food and Drugs Act, describing epichlorohydrin as a prohibited ingredient on the Cosmetic Ingredient Hotlist and the removal of epichlorohydrin from the list of permitted starch-modifying agents.

Review of SNAc orders and notices

Since publication of the first SNAc notice in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAc orders and notices, as well as the wording used to define a significant new activity. As part of the Significant New Activity orders and notices of the Chemical Management Plan initiative, the review of SNAc orders and notices is being undertaken to ensure that current SNAc requirements applied to certain substances under CEPA are in step with current information about those substances, policies and approaches. The SNAc review will apply all elements of the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 (published in December 2013).

Following the review process, there may be no changes needed for certain SNAc orders and notices or, for others, rescissions or amendments may be warranted. Under this initiative, resulting changes to SNAc requirements are expected to provide greater clarity of scope and improved ease of compliance, while protecting people in Canada and their environment.

Review of the SNAc requirements applied to epichlorohydrin in 2012

In 2012, the Minister applied the SNAc provisions to epichlorohydrin to require that the Minister be notified of any significant new activity involving, in any one calendar year, more than 100 kg of the substance so that further assessment of epichlorohydrin is conducted before the activity is undertaken and, if necessary, risk management measures are implemented. As part of the review of SNAc orders and notices under the CMP, the departments completed a review of the requirements applied to epichlorohydrin under the SNAc provisions of CEPA. The review considered information included in multiple SNAN submissions received for the substance pertinent to industrial and commercial uses and an analysis to identify whether new or increased use of epichlorohydrin in consumer products should require notification to the Minister.

The departments evaluated the SNAN submissions and concluded that exposure to epichlorohydrin from the notified industrial and commercial uses of the substance are not likely to present a significant risk to human health or the environment and therefore the submission of a SNAN for those activities should no longer be required. The analysis determined that, due to epichlorohydrin’s potential for carcinogenicity, new or increased use of the substance in consumer products could constitute a risk in Canada and therefore notification to the Minister for those activities should be required. As a result, the review determined that the requirements applied to epichlorohydrin in 2012 need to be varied to align with current information on the substance, policies and approaches.

Objective

As part of the Significant New Activity orders and notices of the Chemical Management Plan initiative, the objective of Order 2024-87-20-1 Amending the Domestic Substances List (the Order) is to vary the requirements applied to epichlorohydrin under the SNAc provisions of CEPA to align with current information on the substance, policies and approaches, in accordance with subsection 87(4.1) of CEPA. Under this initiative, resulting changes to SNAc requirements applied to certain substances under CEPA are expected to provide greater clarity of scope and improved ease of compliance, while protecting people in Canada and their environment.

Description

Pursuant to subsection 87(4.1) of CEPA, the Order varies the SNAc requirements applied to epichlorohydrin under the SNAc provisions of CEPA. This includes variation of the significant new activity definition and prescribed notification information requirements for the substance (see Tables 1 and 2 below).

Applicability

Variation of the significant new activity definition

The review of the SNAc requirements applied to epichlorohydrin under CEPA determined that the activities previously defined as significant new activities involving the substance are not expected to result in exposure to the general population in Canada. As shown in Table 1, these include activities that were previously defined as significant new activities but are not limited to: industrial and commercial uses of the substance over 100 kg in a calendar year and its use as a research and development substance, a site-limited intermediate substance and an export-only substance. It was also determined that increased exposure to epichlorohydrin from its use in consumer products could constitute a human health concern. As a result, the Order varies the significant new activity definition to target the potential use of the substance in a significant new activity (i.e. manufacture, import, and use) in consumer products to which the Canada Consumer Product Safety Act applies.

Table 1: Variation of the significant new activity definition for epichlorohydrin under the Order
Significant new activity definition applied to epichlorohydrin in 2012 Significant new activity definition applied to epichlorohydrin under the Order
1. Any activity involving, in any one calendar year, more than 100 kg of the substance oxirane, (chloromethyl)-.
  1. The use of the substance oxirane, (chloromethyl)- in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies if the product contains the substance at a concentration equal to or greater than 0.1% by weight.
  2. The importation of the substance oxirane, (chloromethyl)- in any consumer product to which the Canada Consumer Product Safety Act applies 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.
  3. Despite items 1 and 2, an activity is not a significant new activity if:

Notification requirements

Variation of the prescribed notification information requirements

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. The SNAN must contain all the information prescribed in an order and must be submitted at least 180 days 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 a substance.footnote 7 Table 2 shows information requirements described in the Order that is required to be submitted in a SNAN, should a person choose to engage in a significant new activity in relation to epichlorohydrin.

The review of the SNAc requirements applied to epichlorohydrin under CEPA determined that the prescribed notification information requirements for the substance need to be varied to align with current information on the substance, polices and approaches. The application of the SNAc provisions of CEPA to epichlorohydrin in 2012 included a total of 10 prescribed notification information requirements in the event of its use in a significant new activity in Canada. Under the Order, out of the 10 prescribed notification information requirements, 2 were removed (information no longer required), 2 were amended (changes to information required), and 6 did not change (information required). The Order also adds 2 new notification information requirements. Table 2 shows the variation of the prescribed notification information requirements for epichlorohydrin.

Table 2: Variation of the prescribed notification information requirements for epichlorohydrin under the Order
Prescribed notification information requirements for epichlorohydrin in 2012 Prescribed notification information requirements for epichlorohydrin under the Order
If known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site. Removed
The information specified in item 11 of Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers). Removed
The information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers). Amended – The information specified in items 3 to 6 and paragraphs 7(a) and (b) of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers).
The information specified in paragraphs 2(d) to (f) and paragraphs 8(a) to (g) of Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers). Amended – The information specified in paragraphs 2(d) to (f) and 8(f) and (g) of Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers).
A description of the significant new activity in relation to the substance. No change
The anticipated annual quantity of the substance to be used for the significant new activity. No change
A summary of all other information or test data concerning the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the substance. No change
The identification of every other government agency, either outside or within Canada, that the person has notified of the significant new activity in relation to the substance and, if known, the agency’s file number and the outcome of the assessment and, if any, the risk management actions in relation to the substance imposed by the agency. No change
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 any, the person authorized to act on behalf of that person. No change
A certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are a resident in Canada or, if not, by the person authorized to act on their behalf. No change
- New – A description of the consumer product that contains the substance and, if known, of the end-use product that is anticipated to contain the substance, the intended use and method of application of that consumer product, the concentration of the substance in that consumer product and the function of the substance in that consumer product.
- New – The total quantity of the consumer product expected to be sold in Canada in a calendar year by the person proposing the significant new activity.

Regulatory development

Consultation

As part of the CMP, on January 14, 2017, the Minister published a Notice of Intent (NOI) to vary the notification requirements on significant new activities associated with 26 substances, including epichlorohydrin, in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received explicitly for epichlorohydrin; however, an overarching comment from industry was received that applies to the substance. The comment did not support the reduction of the reporting threshold, from 100 kg to 10 kg in a calendar year, for activities subject to the SNAc requirements that involve a consumer product containing the substance at a concentration equal to or greater than 0.1% by weight. Government officials responded that 10 kg is the threshold that is applied to activities involving consumer products and is appropriate to address human health concerns.

The departments also informed the provincial and territorial governments about the Order through the CEPA National Advisory Committee (CEPA NAC)footnote 8 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 vary the requirements applied to certain substances under the SNAc provisions of CEPA 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 Order is the only available instrument under CEPA to vary the requirements applied to epichlorohydrin under the SNAc provisions of CEPA.

Regulatory analysis

Benefits and costs

The Order varies the requirements applied to epichlorohydrin (see Description section). This results in certain activities involving the substance for which SNANs have been submitted to the Minister to no longer be subject to the SNAc provisions of CEPA. This is expected to reduce the administrative burden associated with the submission of a SNAN for these activities. The Order targets the use of the substance in a significant new activity (i.e. manufacture, import, and use) in consumer products to which the Canada Consumer Product Safety Act applies. It is unknown whether SNANs may be submitted to the Minister to use epichlorohydrin in a significant new activity under the Order, and so the extent of any potential reduction in administrative burden is unknown.

Small business lens

The assessment of the small business lens concluded that orders amending the DSL to vary the requirements applied to certain substances under the SNAc provisions of CEPA do not have impacts on small businesses, as these orders usually do not apply to current activities involving those substances and any use of those substances in a significant new activity under these orders is unknown.footnote 9

One-for-one rule

The assessment of the one-for-one rule concluded that orders amending the DSL to vary the requirements applied to certain substances under the SNAc provisions of CEPA do not have impacts on businesses that would need to be addressed under the rule.footnote 10

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 Organisation for Economic Cooperation and Development) and is party to several international multilateral environmental agreements in the area of chemicals and waste.footnote 11 The CMP is administered in cooperation and alignment with these agreements.

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, which includes orders amending the DSL to vary the requirements applied to certain substances under the SNAc provisions of CEPA. The assessment concluded that the CMP is expected to have a positive impact on the environment and human health.

Gender-based analysis plus

Orders amending the DSL to vary the requirements applied to certain substances under SNAc provisions of CEPA do not have impacts that would need to be addressed under gender-based analysis plus.footnote 12

Implementation, compliance and enforcement, and service standards

Implementation

Orders amending the DSL come into force on the day on which 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 13

Where a person involved in activities with the substance obtains information that reasonably supports the conclusion that the substance is toxic or is 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 (PNC) (PDF) 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 14

Enforcement

Orders amending the DSL to vary the requirements applied to certain substances under the SNAc provisions of CEPA 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 epichlorohydrin, 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

Maya Berci
Executive Director
Chemicals Management Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Email: maya.berci@ec.gc.ca

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