On February 5, 2025, the Government of Canada registered SOR/2025-17, officially amending the Domestic Substances List (DSL) under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA). This amendment, entitled Order 2024-87-21-01, applies the Significant New Activity (SNAc) provisions of CEPA to the substance ethanol, 2-[(2-aminoethyl)amino]- (CAS RN 111-41-1), commonly known as AEEA.

Why Was This Order Issued?

The amendment results from Canada’s ongoing efforts under the Chemicals Management Plan (CMP), a federal initiative to assess and manage the risks posed by chemicals to human health and the environment. While AEEA was not found to be “toxic” under CEPA’s section 64 criteria during its 2016 screening assessment, it was identified as a substance of concern due to properties that could pose risks if its use increases in new applications.

To ensure that future uses of AEEA do not result in unanticipated environmental or health effects, the SNAc provisions will now be triggered if the substance is used in ways that are significantly different from those previously assessed.

What Is AEEA and How Is It Used?

AEEA does not occur naturally in the environment and is used in various industrial and commercial applications, including:

• Food packaging adhesives and inks (non-direct food contact)

• Paper manufacturing agents

• Closed-loop cooling systems

• Epoxy adhesives and corrosion inhibitors

• Asphalt paving and patching materials

• Pigments for fibers such as carpets

The substance is primarily used as a chemical intermediate and curing agent in the production of resins and sealants. In previous surveys, it was reported that over 500,000 kg of AEEA was imported into Canada, although domestic production was negligible or non-existent.

Internationally, AEEA is used in epoxy hardeners, personal care products, and industrial chemicals, particularly in the United States, Europe, Japan, and Switzerland.

What Are the New Requirements?

The SNAc provisions of CEPA require that any person (individual or corporation) who plans to engage in a significant new activity involving AEEA must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment at least 90 days prior to the proposed activity.

Activities That Trigger Notification:

1. Manufacture or import of AEEA in concentrations ≥0.1% by weight in:

   • Consumer products (under the Canada Consumer Product Safety Act) sold in containers >250 ml

   • Cosmetics (as defined in the Food and Drugs Act)

2. Importing any of the above products containing AEEA if the total annual import exceeds 10 kg.

Activities Exempt from Notification:

• Use in research and development or as a site-limited intermediate

• Products intended solely for export

• Uses regulated under other Acts such as the Pest Control Products Act, Fertilizers Act, or Feeds Act

• Incidental presence in products, or substances formed as impurities or contaminants

Required Information for SNAN Submission:

Notifiers must provide detailed information about the activity and product, including:

• Description and function of the product

• Anticipated annual quantity

• Method of application and use

• Toxicological and environmental data

• Previous notifications to other government agencies

• Contact information and certification of accuracy

Once received, the Minister has 90 days to assess the submission before the activity may proceed.

Impact on Stakeholders and Industry

This Order does not affect currently authorized uses of AEEA in Canada. It only applies to new or modified uses that may increase the risk of exposure. Businesses using AEEA in previously assessed activities are not subject to any new regulatory obligations under this amendment.

For new uses, the SNAN process ensures pre-market review to prevent environmental or public health risks. This requirement is consistent with similar policies in international jurisdictions and supports Canada's alignment with global chemical management practices, including cooperation with the U.S. EPA and the European Chemicals Agency (ECHA).

Regulatory Context and Consultation Process

This regulatory change follows previous Notices of Intent published in the Canada Gazette, Part I in 2016 and 2020, which allowed for public and industry consultation. A stakeholder submission in 2016 resulted in refinements in the scope of what constitutes a significant new activity. No objections were received during the second public consultation.

Compliance, Enforcement, and Guidance

The Order is effective from the day of registration (February 15, 2025). Compliance promotion efforts will include direct outreach, guidance materials, and the availability of pre-notification consultations (PNCs) to help notifiers understand and meet their obligations.

Enforcement of this Order falls under the Compliance and Enforcement Policy for CEPA, which allows for a range of measures from warnings to legal action, depending on the severity and nature of the violation.

Broader Impacts and Benefits

This regulatory action is designed to prevent potential environmental and health risks from new uses of AEEA without disrupting current, low-risk uses. The application of the SNAc provisions reflects Canada's precautionary approach to chemical safety, allowing for proactive intervention before risks arise.

A Strategic Environmental and Economic Assessment concluded that this initiative supports the objectives of the CMP and will have a positive impact on human health and the environment. No adverse impacts were identified under Gender-based Analysis Plus (GBA+) or modern treaty obligations.

On March 8, 2025, the Government of Canada published two regulatory proposals in the Canada Gazette to list boric acid, its salts and precursors, as well as certain substances in the benzotriazoles and benzothiazoles group, specifically 2-mercaptobenzothiazole (MBT) and its precursors, under Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). The proposals follow updated risk assessments that identified potential risks to the environment and, in the case of boric acid, to human health,. The public consultations are now open, providing stakeholders with an opportunity to submit comments and additional information by May 7, 2025.

1. Boric Acid, Its Salts and Precursors: Proposed Addition to Schedule 1

Background and Scope:

The updated assessment focuses on boric acid, a common substamce of concern. It includes any boron-containing substance that can release boric acid through environmental or physiological transformation pathways. Boric acid is found naturally and is widely used in industrial and consumer applications.

Between 2017 and 2020, Canada imported 54,810 to 65,795 tonnes of boric acid-related substances annually, with significant domestic use in sectors such as:

• Insulation and engineered wood manufacturing

• Agriculture and fertilizers

• Consumer and self-care products

• Oil and gas extraction

• Waste and water treatment

Environmental Risk:

A weight of evidence approach indicates that boric acid poses a low ecological risk in most sectors. However, the metal ore processing industry presents a localized environmental risk due to aquatic releases of boric acid. A predicted no effect concentration (PNEC) of 1.5 mg B/L has been established based on Canadian Water Quality Guidelines.

Boric acid is persistent in the environment but not considered bioaccumulative or biomagnifying.

Risk to Human Health:

Canadians are exposed to boric acid from natural sources (e.g. fruits, vegetables, drinking water) and products such as cleaning agents, cosmetics, and DIY materials. Urine and blood biomonitoring data were used to assess population-level exposure.

Key findings include:

• Higher boron levels in young children and women,

• Exposure margins in some products (e.g. toys, self-care items, flame retardants) may be insufficient to protect against health risks such as reproductive toxicity (e.g., reduced testicular weight)

Conclusion:

The assessment suggests that boric acid and its related substances:

• Meet CEPA section 64(a): harmful to the environment

• Meet CEPA section 64(c): pose a risk to human health

• Do not meet section 64(b): not a threat to life-supporting environmental systems

• Meet persistence but not bioaccumulation criteria under CEPA regulati

2. Benzotriazoles and Benzothiazoles Group (Including MBT)

Overview:

The government also published its final assessment of the benzotriazoles and benzothiazoles group, which includes:

• 9 benzotriazole substances (used in UV stabilizers, lubricants, cosmetics).

• 6 benzothiazole substances (including MBT and its precursors, used in rubber and automotive products).

Key Findings:

• Benzotriazoles: Do not meet CEPA section 64 criteria; no significant environmental or health risks identified.

• Benzothiazoles (MBT and precursors):

  • Meet section 64(a): pose environmental risks.

  • Do not meet section 64(b): no threat to environmental systems.

  • Do not meet section 64(c): no current threat to human health but remain substances of concern.

MBT is identified as a Group 2A carcinogen (probably carcinogenic to humans) by the IARC. Exposure scenarios - especially in rubber manufacturing and metalworking fluids – indicate a risk to the aquatic environment. While current public exposures are not of concern, elevated levels in the future could pose health risks.

Proposed Actions:

The Ministers recommend that MBT, its salts, and chemical derivatives be added to Part 2 of Schedule 1 of CEPA. A risk management approach document is available for public comment.

How to Participate in the Consultations

For both the boric acid and MBT proposals, interested stakeholders can provide input during the open public comment period. Comments should reference the Canada Gazette, Part I, the date of publication, and include any requests for confidentiality under section 313, of CEPA if applicable.

Regulatory Implications and Follow-up

These proposals do not impose any immediate new obligations, but allow for future risk management measures, such as pollution prevention plans, restrictions, or monitoring. Substances associated with health risks but currently at safe exposure levels may be tracked to monitor commercial use and emerging risks.

The Government will use the data collected through these consultations to:

• Inform future regulatory development,

• Track trends in chemical use.

• Evaluate the effectiveness of current and proposed risk management measures.