Order 2026-112-11-01 Amending the Domestic Substances List: SOR/2026-192

Canada Gazette, Part II, Volume 160, Number 19

Registration
SOR/2026-192 September 8, 2026

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 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 by 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 the living organism are in effect;

Therefore, the Minister of the Environment makes the annexed Order 2026-112-11-01 Amending the Domestic Substances List under subsection 112(1) of the Canadian Environmental Protection Act, 1999 footnote c.

Ottawa, September 8, 2026

Julie Dabrusin
Minister of the Environment

Order 2026-112-11-01 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”:

Recombinant human T-cells transduced with a replication-deficient lentiviral vector containing an anti-BCMA/4-1BB/CD3zeta chimeric antigen receptor (KITE-772) N

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.

Also, under the authority of section 66 of the Act, the Minister is updating the identifiers of 204 polymers on the Domestic Substances List with the addition of the letter “P”. These substances were added to the Domestic Substances List while meeting the reduced regulatory requirements (RRR) polymer criteriafootnote 2.

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 provides an inventory of substances in the Canadian marketplace. It was originally published in the Canada Gazette, Part II, in 1994 and is amended, on average, 12 times per year to add, update or delete substances.

The Domestic Substances List includes eight parts, in which substances are divided based on

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:

Reduced regulatory requirement polymers

Polymers that meet the RRR criteria set out in the New Substances Notification Regulations (Chemicals and Polymers) are considered to pose low concern. However, the same polymers may be synthesized into forms that do not meet the RRR criteria, and in such cases, their toxicological properties are unknown. RRR polymers are added to the Domestic Substances List with a “P” flag. This flag signals that any form of the polymer not meeting the RRR polymer criteria is subject to notification under the regulations prior to import or manufacture.

Adding 10 substances to the Domestic Substances List and updating 204 substances on 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(1), 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), nor to the New Substances Notification Regulations (Organisms).

The Government identified substances assessed as RRR polymers and added to the Domestic Substances List prior to the introduction of the RRR criteria and the letter “P” in 2003. Therefore, a Notice of intent to amend the Domestic Substances List, adding the letter “P” to the identifiers of 220 reduced regulatory requirement polymers was published on February 14, 2026. The letter “P” after a substance identifier indicates that the substance is a polymer that meets the RRR polymer criteria set out in the New Substances Notification Regulations (Chemicals and Polymers). Any form of the polymer that does not meet the RRR polymer criteria is subject to notification under the regulations prior to import or manufacture. After taking into consideration responses to the notice of intent, the Minister adds the letter “P” to the identifiers of 204 polymers under subsection 66(1) of the Act.

Objective

The objective of Order 2026-66-11-01 Amending the Domestic Substances List (Order 2026-66-11-01) is to add the letter “P” to the identifiers of 204 polymers on the Domestic Substances List.

Order 2026-66-11-01 specifies that 204 polymers on the Domestic Substance List are RRR polymers. Any form of these polymers that does not meet the RRR polymer criteria is subject to notification under the regulations prior to import or manufacture.

The objective of Order 2026-87-11-01 Amending the Domestic Substances List (Order 2026-87-11-01) is to add 9 chemicals and polymers to the Domestic Substances List.

The objective of Order 2026-112-11-01 Amending the Domestic Substances List (Order 2026-112-11-01) is to add 1 living organism to the Domestic Substances List.

Order 2026-87-11-01 and Order 2026-112-11-01 are expected to facilitate access to 10 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of the Act.

Description

Order 2026-66-11-01 is made under subsection 66(1) of the Act to update the identifiers of 204 polymers on the Domestic Substances List:

Order 2026-87-11-01 is made under subsection 87(1) and 87(5) of the Act to add 9 chemicals and polymers to the Domestic Substances List:

Order 2026-112-11-01 is made pursuant to subsection 112(1) of the Act to add 1 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 2026-87-11-01 and Order 2026-112-11-01 was deemed necessary.

In February 2026, a Notice of intent to amend the Domestic Substances List, adding the letter “P” to the identifiers of 220 reduced regulatory requirement polymers was published in the Canada Gazette, Part I, for a 120-day comment period. After taking into consideration responses to the notice of intent, the letter “P” is added to 204 polymers in Order 2026-66-11-01.

Indigenous engagement, consultation and modern treaty obligations

The Government of Canada has a duty to consult and, where appropriate, accommodate Indigenous groups when it is contemplating conduct that could have an adverse impact on Aboriginal or treaty rights. The duty to consult can arise in relation to established historical or modern treaty rights, and in relation to rights not yet determined, often referred to as asserted or potential rights. The United Nations Declaration on the Rights of Indigenous Peoples Act states that the Government of Canada is committed to taking effective measures, including legislative and policy measures, in consultation and cooperation with Indigenous peoples, to achieve the objectives of the United Nations Declaration on the Rights of Indigenous Peoples. Orders amending the Domestic Substances List do not result in any incremental impacts (benefits and costs), and therefore, do not result in any impact on modern treaty rights or obligations. Therefore, specific engagement and consultations with Indigenous Peoples were not undertaken.

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 and updating their identifiers 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 statutory obligation under sections 87 and 112 of the Act that is triggered once a substance meets the criteria for addition.

Small business lens

As described in the “Benefits and costs” subsection, the orders will not result in any incremental impacts. Therefore, they will not impact Canadian small businesses.

One-for-one rule

Since the orders do not impose any regulatory requirements (see the “Benefits and costs” subsection), they do not impose new administrative burden on business and the one-for-one rule does not apply.

Regulatory cooperation and alignment, and international obligations

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 (SEEA Directive), a strategic environmental and economic assessment is required for proposals that are expected to have important effects (positive or negative, direct or indirect) on the environment and economy. Since orders amending the Domestic Substances List to add or update the identifiers of substances do not result in incremental impacts (benefits and costs), a strategic environmental and economic assessment is not required.

Right to a healthy environment

The Government of Canada has a duty, in the administration of the Act, to protect the right to a healthy environment as provided for under the Act, subject to reasonable limits. An implementation framework sets out considerations to protect this right and uphold the principles described in the framework.

Many of the elements included in the framework were considered to inform the orders. In line with the framework, an initial screening and review of the best available science submitted for new substances under the regulations prior to their importation or manufacture into Canada was conducted to determine whether these substances may pose a risk to the environment and human health. Furthermore, the addition of substances to the Domestic Substances List aligns with the framework’s non-regression principle, as this is not expected to lead to a decrease in environmental and/or human health protection, since the assessment of the substances concluded they are not suspected of being toxic or capable of becoming toxic.

Other relevant factors that were considered include the statutory framework and regulatory timelines for assessing new substances.

Gender-based analysis plus

No gender-based analysis plusfootnote 6 (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 phone at 1‑800‑567‑1999 (toll-free in Canada), or at 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

Pascal Roberge
Director
Regulatory Operations 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)
Email: substances@ec.gc.ca