Order 2023-112-11-01 Amending the Domestic Substances List: SOR/2023-252

Canada Gazette, Part II, Volume 157, Number 25

Registration
SOR/2023-252 November 24, 2023

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 organisms 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 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 those living organisms are in effect;

Therefore, the Minister of the Environment makes the annexed Order 2023-112-11-01 Amending the Domestic Substances List under subsection 112(1) of the Canadian Environmental Protection Act, 1999 footnote a.

Gatineau, November 23, 2023

Steven Guilbeault
Minister of the Environment

Order 2023-112-11-01 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”:

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 nine substances (seven 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 (CEPA). Therefore, under the authority of sections 87 and 112 of CEPA, the Minister of the Environment (the Minister) is adding these nine substances to the Domestic Substances List. Also, the Minister is updating the description of the “P” flag on the Domestic Substances List for the purpose of administrative correction.

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 CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). CEPA 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. The current structure of the Domestic Substances List was established in 2001 (Order 2001-87-04-01 Amending the Domestic Substances List [PDF, 2.1 MB] [SOR/2001-214]), and amended in 2012 (Order 2012-87-09-01 Amending the Domestic Substances List [SOR/2012-229]). The Domestic Substances List is amended, on average, 14 times per year to add, update or delete substances.

The Domestic Substances List includes the following 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)footnote 2 Registry Numbers 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

Chemicals or polymers must be added to the Domestic Substances List under section 66 of CEPA if they were manufactured in, or imported into, Canada by any person (individual or corporation) between January 1, 1984, and December 31, 1986, in a quantity greater than or equal to 100 kg in any one calendar year or, if during this period, they were in Canadian commerce or used for commercial manufacturing purposes in Canada.

Living organisms must be added to the Domestic Substances List under section 105 of CEPA if they were manufactured in, or imported into, Canada by any person between January 1, 1984, and December 31, 1986, and if, during this period, they entered or were released into the environment without being subject to conditions under an Act of Parliament or the legislature of a province.

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

Adding nine substances to the Domestic Substances List

The ministers assessed information on nine substances (seven chemicals and polymers and two living organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List, under subsection 87(5) or 112(1) of CEPA. These nine 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).

Updating the “P” flag description on the Domestic Substances List

The description of the “P” flag in subsection (6) of section 2 of the Domestic Substances List is updated for the purpose of administrative correction. The letter “P” after a substance identifier indicates that the substance is a polymer that meets the Reduced Regulatory Requirement (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.

Objective

The objective of Order 2023-87-11-01 Amending the Domestic Substances List (Order 2023-87-11-01) is to add seven substances to the Domestic Substances List and to update the definition of the “P” flag to better align with the definition of RRR polymers set out in the New Substances Notification Regulations (Chemicals and Polymers).

The objective of Order 2023-112-11-01 Amending the Domestic Substances List (Order 2023-112-11-01) is to add two living organisms to the Domestic Substances List.

Order 2023-87-11-01 and Order 2023-112-11-01 (the orders) are expected to facilitate access to nine substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA.

Description

Order 2023-87-11-01 is made under subsection 87(5) of CEPA to add seven chemicals and polymers to the Domestic Substances List and update the “P” flag definition:

Order 2023-112-11-01 is made pursuant to subsection 112(1) of CEPA to add two living organisms to the Domestic Substances List:

Regulatory development

Consultation

As CEPA does not prescribe any public comment period before adding a substance to the Domestic Substances List, no consultation period for the orders 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 CEPA, 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 nine 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 CEPA 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.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan of additions to the Domestic Substances List concluded that a strategic environmental 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 CEPA, 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 CEPA 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

Michel Lortie
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