Order 2025-112-08-01 Amending the Domestic Substances List: SOR/2025-173
Canada Gazette, Part II, Volume 159, Number 19
Registration
SOR/2025-173 August 29, 2025
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the Minister of the Environment has been provided with information under section 106footnote a or 107footnote b of the Canadian Environmental Protection Act, 1999 footnote c, and any additional information or test results required under subsection 109(1) of that Act, in respect of each living organism referred to in the annexed Order;
Whereas the Minister of the Environment and the Minister of Health are satisfied that those living organisms have been manufactured in or imported into Canada by the person who provided the information prescribed under the New Substances Notification Regulations (Organisms) footnote d;
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 those living organisms are in effect;
Therefore, the Minister of the Environment makes the annexed Order 2025-112-08-01 Amending the Domestic Substances List under subsection 112(1) of the Canadian Environmental Protection Act, 1999 footnote c.
Ottawa, August 27, 2025
Julie Dabrusin
Minister of the Environment
Order 2025-112-08-01 Amending the Domestic Substances List
Amendments
1 Part 5 of the Domestic Substances List footnote 1 is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:
- Human CD34+ hematopoietic stem cells prime edited ex vivo to correct delGT genetic mutations on the NCF1 gene (PM359) N
| 19786-4 N | Human T-cells transduced with a replication-deficient lentiviral vector encoding a chimeric antigen receptor targeting a human B-cell surface antigen (CLIC-2201) |
|---|
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 orders.)
Issues
The Minister of the Environment and the Minister of Health (the ministers) assessed information on six substances (four chemicals and polymers and two living organisms) 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 six substances to the Domestic Substances List.
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) [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, in which substances are divided based on
- substance type (chemicals and polymers or inanimate products of biotechnology and living organisms);
- confidentiality; and
- whether the significant new activity provisions of the Act have been applied.
Adding substances to the Domestic Substances List
A substance 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:
- the Minister has been provided with the regulatory information regarding the substance. The information to be provided is set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms);
- the period prescribed under section 83 or 108 of the Act for the assessment of the information submitted for the substance has expired;
- the substance is not subject to any conditions imposed under paragraph 84(1)(a) or 109(1)(a) of the Act on its import or manufacture; and
- for additions under subsection 87(1), the ministers are satisfied that the substance has already been manufactured in, or imported into Canada in excess of the prescribed quantity by the person who provided the information; for additions under subsection 112(1), the ministers are satisfied that the substance has already been manufactured in, or imported into Canada by the person who provided the information.
Adding six substances to the Domestic Substances List
The ministers assessed information on six substances new to Canada (four chemicals and polymers and two living organisms) 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 six 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), nor to the New Substances Notification Regulations (Organisms).
Objective
The objective of Order 2025-87-08-01 Amending the Domestic Substances List is to add four chemicals and polymers to the Domestic Substances List.
The objective of Order 2025-112-08-01 Amending the Domestic Substances List is to add two living organisms to the Domestic Substances List.
Order 2025-87-08-01 and Order 2025-112-08-01 (the orders) are expected to facilitate access to six substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of the Act.
Description
Order 2025-87-08-01 is made under subsection 87(5) of the Act to add four chemicals and polymers to the Domestic Substances List:
- four substances identified by their masked names and their confidential accession number (CAN) are added to Part 3 of the Domestic Substances List.
Order 2025-112-08-01 is made pursuant to subsection 112(1) of the Act to add two living organisms to the Domestic Substances List:
- one living organism identified by its specific name is added to Part 5 of the Domestic Substances List; and
- one living organism identified by its masked names and its CAN is added to Part 7 of 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 2025-87-08-01 and Order 2025-112-08-01 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
Costs and benefits
Adding substances to 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.
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 by email at substances@ec.gc.ca, or by telephone at 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