Order 2024-87-08-01 Amending the Domestic Substances List: SOR/2024-206
Canada Gazette, Part II, Volume 158, Number 23
Registration
SOR/2024-206 October 15, 2024
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the Minister of the Environment has been provided with information under paragraph 87(1)(a) or (5)(a) of the Canadian Environmental Protection Act, 1999 footnote a in respect of each substance referred to in the annexed Order;
Whereas, in respect of the substance being added to the Domestic Substances List footnote b under subsection 87(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that the substance has been manufactured in or imported into Canada by the person who provided the information in excess of the quantity prescribed under the New Substances Notification Regulations (Chemicals and Polymers) footnote c;
Whereas the period for assessing the information under section 83 of that Act has expired;
And whereas no conditions specified under paragraph 84(1)(a) of that Act in respect of the substances referred to in the annexed Order are in effect;
Therefore, the Minister of the Environment makes the annexed Order 2024-87-08-01 Amending the Domestic Substances List under subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999 footnote a.
Ottawa, October 11, 2024
Steven Guilbeault
Minister of the Environment
Order 2024-87-08-01 Amending the Domestic Substances List
Amendments
1 Part 1 of the Domestic Substances List footnote b is amended by adding the following in numerical order:
- 102782-61-6 N-P
- 178462-89-0 N-P
- 3034480-18-4 N-P
19733-1 N-P | Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,4-cyclohexanedimethanol, dimethyl non-metallate, 1,6-hexanediol, 1,1’-methylenebis[4-isocyanatocyclohexane] and 2-methyl-1,5-pentanediamine, compd. with N,N-diethylethanamine |
---|---|
19734-2 N-P | Siloxanes and silicones, di-Me, hydrogen-terminated, polymers with di-Me, Me substituted siloxanes and vinyl group-terminated di-Me siloxanes |
19735-3 N-P | 2-Propenoic acid, 2-methyl-, methyl ester, polymer with N-(1,1-dimethyl-3-oxobutyl)-2-propenamide and 1-methylalkyl 2-propenoate |
19737-5 N-P | 2-Propenoic acid, 2-methyl-, alkyl esters, polymers with N-[alkylaminoalkyl]-2-methyl-2-propenamide, alkyl methacrylate, alkyl methacrylate and alkyl methacrylate |
19738-6 N | Decanedioic acid, polymer with alkanediol and methylenebis[isocyanatobenzene] |
19741-9 N-P | Isocyanic acid, polyalkylenepolycarbomonocycle ester, polymer with alkanepolyol |
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 nine substances (chemicals and polymers) 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 section 87 of CEPA, the Minister of the Environment (the Minister) is adding these nine 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 21 substances by moving them from Part 3 of the Domestic Substances List to Part 1 under the authority of section 66 of CEPA.
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 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 dRegistry Numbersfootnote b 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 1 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 subsections 87(1), 87(5) or 112(1) of CEPA 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 sections 83 or 108 of CEPA 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 CEPA 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 9 substances to the Domestic Substances List and updating 21 substances on this List
The ministers assessed information on nine chemicals and polymers new to Canada and determined that they meet the criteria for addition to the Domestic Substances List, under subsections 87(1) or 87(5) 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).
The Minister contacted persons responsible for confidentiality requests concerning substance identity that were made prior to 2004. In response, written consent for unmasking was provided regarding 17 substances on the Domestic Substances List. In addition, persons responsible for confidentiality requests concerning 4 additional substances contacted the Department of the Environment, requesting these 4 substances be unmasked. In total, industry indicated that the identity of 21 substances is no longer considered confidential business information. As a result, these substances are now identified by their CAS Registry Numbers on the Domestic Substances List.
Therefore, under subsection 66(1), the Minister is updating 21 substances on the Domestic Substances List.
Objective
The objective of Order 2024-66-08-01 Amending the Domestic Substances List (Order 2024-66-08-01) is to move 21 substances from Part 3 of the Domestic Substances List to Part 1.
Order 2024-66-08-01 will increase transparency for 21 substances identities.
The objective of Order 2024-87-08-01 Amending the Domestic Substances List (Order 2024-87-08-01) is to add nine substances to the Domestic Substances List.
Order 2024-66-08-01 and Order 2024-87-08-01 (the orders) are expected to facilitate or continue to facilitate access to 30 substances for businesses, as the substances are no longer masked or subject to requirements under subsection 81(1) of CEPA.
Description
Order 2024-66-08-01 is made under subsection 66(1) of CEPA to update 21 substances on the Domestic Substances List. These 21 substances identified by their CAS Registry Numbers are added to Part 1 of the Domestic Substances List; and the corresponding masked names and CANs are deleted from Part 3 of the Domestic Substances List.
Order 2024-87-08-01 is made under subsections 87(1) and 87(5) of CEPA to add nine chemicals and polymers to the Domestic Substances List:
- three substances identified by their CAS Registry Numbers are added to Part 1 of the Domestic Substances List; and
- six substances identified by their masked names and their CANs are added to Part 3 of 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 Order 2024-87-08-01 was deemed necessary.
The disclosure of the explicit chemical identity for substances in Order 2024-66-08-01 is 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 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 9 substances to the Domestic Substances List and updating 21 substances that are already 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 sections 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.
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 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 by email at substances@ec.gc.ca, or by phone at 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.
Contacts
Joliane Lavigne
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