Order 2025-112-04-01 Amending the Domestic Substances List: SOR/2025-176

Canada Gazette, Part II, Volume 159, Number 19

Registration
SOR/2025-176 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 2025-112-04-01 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 2025-112-04-01 Amending the Domestic Substances List

Amendment

1 Part 7 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:
19771-9 N A genetically modified Drosophila melanogaster strain with a single insert of a construct containing a gene expressing human Prolactin and a marker gene balanced over a chromosome balancer

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 13 substances (12 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 13 substances to the Domestic Substances List.

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 nine 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 names of 14 substances 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)[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 Significant New Activity (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:

Adding 13 substances to the Domestic Substances List

The ministers assessed information on 13 substances new to Canada (12 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 13 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).

Disclosing the identity of 9 substances and updating the masked name of 14 substances

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 nine substances. Therefore, the Minister is updating the identifier of these nine 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.

Responses also included confirmation of the initial request for confidentiality concerning the identity of 14 substances. The masked name for these substances are updated on the Domestic Substances List to improve compliance with the requirements set out in the Masked Name Regulations. The Minister is updating the masked name of these 14 substances on the Domestic Substances List under subsection 66(1) of the Act.

Objective

The objective of Order 2025-66-04-01 Amending the Domestic Substances List (Order 2025-66-04-01) is to move 9 substances from Part 3 of the Domestic Substances List to Part 1 and update the masked names of 14 substances listed on Part 3 of the Domestic Substances List.

Order 2025-66-04-01 will increase transparency for 9 substances and increase compliance with the Masked Name Regulations for 14 substances.

The objective of Order 2025-87-04-01 Amending the Domestic Substances List (Order 2025-87-04-01) is to add 12 substances to the Domestic Substances List.

The objective of Order 2025-112-04-01 Amending the Domestic Substances List (Order 2025-112-04-01) is to add one living organism to the Domestic Substances List.

Order 2025-66-04-01, Order 2025-87-04-01 and Order 2025-112-04-01 are expected to facilitate or continue to facilitate access to 22 substances for businesses, as the substances are no longer masked or no longer subject to requirements under subsection 81(1) or 106(1) of the Act.

Description

Order 2025-66-04-01 is made under subsection 66(1) of the Act to update 23 substances on the Domestic Substances List:

Order 2025-87-04-01 is made under subsection 87(5) of the Act to add 12 chemicals and polymers to the Domestic Substances List:

Order 2025-112-04-01 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 2025-87-04-01 and Order 2025-112-04-01 was deemed necessary.

Disclosing the identity of substances and updating masked names in Order 2025-66-04-01 are made after obtaining written consent from the persons responsible for the request for confidentiality and, 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 and updating their identifiers on the Domestic Substances List are 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 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 prenotification 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