Order 2025-112-07-01 Amending the Domestic Substances List: SOR/2025-179

Canada Gazette, Part II, Volume 159, Number 19

Registration
SOR/2025-179 August 29, 2025

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment has been provided with information under paragraph 112(1)(a) of the Canadian Environmental Protection Act, 1999 footnote a in respect of the living organism referred to in the annexed Order;

Whereas the Minister of the Environment and the Minister of Health are satisfied that the living organism has been manufactured in or imported into Canada by the person who provided the information prescribed under the New Substances Notification Regulations (Organisms) footnote b;

Whereas the period for assessing the information under section 108 of that Act has expired;

And whereas no conditions specified under paragraph 109(1)(a) of that Act in respect of the living organism are in effect;

Therefore, the Minister of the Environment makes the annexed Order 2025-112-07-01 Amending the Domestic Substances List under subsection 112(1) of the Canadian Environmental Protection Act, 1999 footnote a.

Ottawa, August 27, 2025

Julie Dabrusin
Minister of the Environment

Order 2025-112-07-01 Amending the Domestic Substances List

Amendment

1 Part 5 of the Domestic Substances List footnote 1 is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:

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 orders.)

Issues

The Minister of the Environment and the Minister of Health (the ministers) assessed information on 10 substances (9 chemicals and polymers and 1 living organism) and determined that they meet the criteria for addition to the Domestic Substances List, as set out in the Canadian Environmental Protection Act, 1999 (the Act). Therefore, under the authority of sections 87 and 112 of the Act, the Minister of the Environment (the Minister) is adding these 10 substances to the Domestic Substances List.

Furthermore, it was determined that one chemical on the Domestic Substances List is no longer considered to have ecological or health effects of concern, and therefore, the Minister is rescinding the Significant New Activity (SNAc) requirements concerning this substance.

Also, after communicating with the persons responsible for the requests for confidentiality and obtaining their written consent, the Minister is disclosing the explicit chemical identity of three substances by moving them from Part 3 to Part 1 of the Domestic Substances List under the authority of section 66 of the Act. The Minister is also updating the masked name of one substance on Part 3 under the authority of section 66 of the Act.

Background

Assessment of substances new to Canada

Substances that are not on the Domestic Substances List are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 108 of the Act, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). The Act and these regulations ensure that new substances introduced to the Canadian marketplace are assessed to identify potential risks to the environment and human health, and that appropriate control measures are taken if deemed necessary.

For more information on the thresholds and scope of these regulations, please see section 1 in the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers) and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms.

Domestic Substances List

The Domestic Substances List (SOR/94-311) provides an inventory of substances in the Canadian marketplace. It was originally published in the Canada Gazette, Part II, in 1994 and its current structure was established in 2001 (Order 2001-87-04-01 Amending the Domestic Substances List (PDF, 2.11MB) (PDF) [SOR/2001-214]). The Domestic Substances List is amended, on average, 14 times per year to add, update or delete substances.

The Domestic Substances List includes eight parts.

Part 1
Sets out chemicals and polymers, except those referred to in Part 2, 3 or 4, that are identified by their Chemical Abstracts Service (CAS) Registry Numbersfootnote 2 or their Substance Identity Numbers assigned by the Department of the Environment and the names of the substances.
Part 2
Sets out chemicals and polymers subject to SNAc requirements that are identified by their CAS Registry Numbers.
Part 3
Sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked namesfootnote 3 and their Confidential Substance Identity Numbers (also referred to as Confidential Accession Numbers [CANs]) assigned by the Department of the Environment.
Part 4
Sets out chemicals and polymers subject to SNAc requirements that are identified by their masked names and their CANs.
Part 5
Sets out inanimate biotechnology products and living organisms, except those referred to in Part 6, 7 or 8, that are identified by their American Type Culture Collection (ATCC) numbers, International Union of Biochemistry and Molecular Biology (IUBMB) numbers or specific substance names.
Part 6
Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their ATCC numbers, IUBMB numbers or specific substance names.
Part 7
Sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked names and their CANs.
Part 8
Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked names and their CANs.

Adding substances to the Domestic Substances List

New substances must be added to the Domestic Substances List under subsection 87(1), 87(5) or 112(1) of the Act within 120 days after the following criteria have been met:

Criteria for adding, varying or rescinding SNAc requirements for substances on the Domestic Substances List

Amendments to the Domestic Substances List may also add, vary or rescind notification obligations imposed under the SNAc provisions of the Act. If the ministers assess a substance and available information suggests that certain new activities related to that substance may pose a risk to human health or the environment, the Minister may add that substance to the Domestic Substances List with notification obligations under the SNAc provisions of the Act (subsection 87(3) or 112(3)). The SNAc provisions of the Act establish a requirement for any person considering undertaking a significant new activity in relation to the substance to submit a Significant New Activity Notification (SNAN) to the Minister containing certain required information. Upon receipt of the complete information, the ministers would conduct further assessment of the substance and, if necessary, implement risk management measures before the activity is undertaken. To see the substances subject to SNAc provisions of the Act, please visit the Canada.ca Open Data Portal.

Adding 10 substances to the Domestic Substances List

The ministers assessed information on 10 substances new to Canada (9 chemicals and polymers and 1 living organism) and determined that they meet the criteria for addition to the Domestic Substances List, under subsection 87(5) or 112(1) of the Act. These 10 substances are therefore being added to the Domestic Substances List and, as a result, are no longer subject to the New Substances Notification Regulations (Chemicals and Polymers), or to the New Substances Notification Regulations (Organisms).

Rescinding SNAc requirements for one substance

In 2013, it was determined that the substance 1,2-oxathiolane, 2,2-dioxide (CAS RN 1120-71-4) had properties of concern that could pose a risk to the environment or human health if exposure levels were to increase from their use in a significant new activity in Canada.footnote 4 Accordingly, the SNAc provisions of the Act were applied to this substance the same year.footnote 5

In 2024, a significant new activity notification was received for this substance. The ministers have assessed this information and have determined that, when the substance is used in industrial applications in electric vehicle battery manufacturing or for other potential uses, such as an intermediate in chemical and polymer synthesis, it is not anticipated to enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, constitute or may constitute a danger to the environment on which life depends, or constitute or may constitute a danger in Canada to human life or health.footnote 6 Therefore, the ministers no longer suspect that the information concerning a significant new activity in relation to this substance may contribute to determining the circumstances in which this substance is toxic or capable of becoming toxic within the meaning of section 64 of that Act.

Disclosing the identity of three substances and updating the masked name of one substance

The Minister contacted persons responsible for confidentiality requests concerning substance identity that were made prior to the year 2004. In response, written consent to disclose the information was provided for three substances. Therefore, the Minister is updating the identifier of these three substances on the Domestic Substances List under subsection 66(1) of the Act. These substances are now identified by their CAS Registry Numbers on the Domestic Substances List.

The masked name for one substance is also updated on the Domestic Substances List to correct an administrative oversight. The Minister is updating the masked name of this substance on the Domestic Substances List under subsection 66(1) of the Act.

Objective

The objective of Order 2025-66-07-01 Amending the Domestic Substances List is to move three substances from Part 3 of the Domestic Substances List to Part 1 and update the masked name of one substance listed on Part 3 of the Domestic Substances List.

Order 2025-66-07-01 will increase transparency for three substances.

The objective of Order 2025-87-07-01 Amending the Domestic Substances List is to add nine substances to the Domestic Substances List. Another objective of Order 2024-87-07-01 is to rescind the SNAc requirements concerning one substance, as these requirements are no longer warranted.

The objective of Order 2025-112-07-01 Amending the Domestic Substances List is to add one living organism to the Domestic Substances List.

Order 2025-66-07-01, Order 2025-87-07-01 and Order 2025-112-07-01 are expected to facilitate or continue to facilitate access to 13 substances for businesses, as the substances are no longer masked or no longer subject to requirements under subsection 81(1), 81(3) or 106(1) of the Act.

Description

Order 2025-66-07-01 is made under subsection 66(1) of the Act to update four substances on the Domestic Substances List:

Order 2025-87-07-01 is made under subsections 87(4.1) and 87(5) of the Act to add nine chemicals and polymers to the Domestic Substances List and to rescind SNAc requirements for one substance:

Order 2025-112-07-01 is made pursuant to subsection 112(1) of the Act to add one living organism to the Domestic Substances List:

Regulatory development

Consultation

As the Act does not prescribe any public comment period before adding a substance to the Domestic Substances List, no consultation period for Order 2025-87-07-01 and Order 2025-112-07-01 was deemed necessary.

On February 22, 2025, the Minister published a Notice of intent to amend the Domestic Substances List under subsection 87(4.1) of the Canadian Environmental Protection Act, 1999 with the proposed rescission of the SNAc requirements for one substance. The notice of intent was published in the Canada Gazette, Part I, for a 60-day comment period. The Minister received no comments.

Disclosing the identity of substances in Order 2025-66-07-01 is made after obtaining written consent from the persons responsible for the request for confidentiality; therefore, no consultation period was deemed necessary.

Modern treaty obligations and Indigenous engagement and consultation

The assessment of modern treaty implications made in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation concluded that orders amending the Domestic Substances List do not introduce any new regulatory requirements, and therefore, do not result in any impact on modern treaty rights or obligations.

Instrument choice

Under the Act, the Minister is required to add a substance to the Domestic Substances List when it is determined to meet the criteria for addition. Orders amending the Domestic Substances List are the only regulatory instruments that allow the Minister to comply with these obligations.

Regulatory analysis

Benefits and costs

Adding substances, updating substance identifiers and rescinding SNAc requirements on the Domestic Substances List is administrative in nature. The orders do not impose any regulatory requirements on businesses, and therefore, do not result in any incremental compliance costs for stakeholders or enforcement costs for the Government of Canada. Adding substances to the Domestic Substances List is a federal obligation under section 87 or 112 of the Act that is triggered once a substance meets the criteria for addition.

Small business lens

The assessment of the small business lens concluded that the orders have no impact on small businesses, as they do not impose any administrative or compliance costs on businesses.

One-for-one rule

The assessment of the one-for-one rule concluded that the rule does not apply to the orders, as there is no impact on industry.

Regulatory cooperation and alignment

There are no international agreements or obligations directly associated with the orders.

International obligations

There are no agreements or obligations directly associated with the orders.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment, a preliminary scan of additions to the Domestic Substances List concluded that a strategic environmental and economic assessment is not required for the orders.

Gender-based analysis plus

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

Implementation, compliance and enforcement, and service standards

Implementation

The orders are now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List. The orders do not constitute an endorsement from the Government of Canada of the substances to which they relate, nor an exemption from any other laws or regulations that are in force in Canada and that may apply to these substances or to activities involving them.

Compliance and enforcement

Where a person has questions concerning their obligation to comply with an order, believes that they may be out of compliance, or would like to request a pre-notification consultation, they are encouraged to contact the Substances Management Information Line at substances@ec.gc.ca (email), 1‑800‑567‑1999 (toll-free in Canada), or 819‑938‑3232 (outside of Canada).

The orders are made under the authority of the Act, which is enforced in accordance with the Canadian Environmental Protection Act: compliance and enforcement policy. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, effectiveness in achieving compliance with the Act and its regulations, and consistency in enforcement when deciding which enforcement measures to take. Suspected violations can be reported to the Enforcement Branch of the Department of the Environment by email at enviroinfo@ec.gc.ca.

Contact

Marc Demers
Acting Director
Regulatory Operations, Policy and Emerging Sciences Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1‑800‑567‑1999 (toll-free in Canada)
819‑938‑3232 (outside of Canada)
Fax: 819‑938‑5212
Email: substances@ec.gc.ca