Order 2024-87-03-01 Amending the Domestic Substances List: SOR/2024-58
Canada Gazette, Part II, Volume 158, Number 9
Registration
SOR/2024-58 April 11, 2024
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the Minister of the Environment has been provided with information under paragraph 87(5)(a) of the Canadian Environmental Protection Act, 1999 footnote a in respect of each substance referred to in the annexed Order;
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 those substances are in effect;
Therefore, the Minister of the Environment makes the annexed Order 2024-87-03-01 Amending the Domestic Substances List under subsection 87(5) of the Canadian Environmental Protection Act, 1999 footnote a.
Gatineau, April 9, 2024
Steven Guilbeault
Minister of the Environment
Order 2024-87-03-01 Amending the Domestic Substances List
Amendments
1 Part 1 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:
- 1662679-55-1 N-P
19700-8 N | Naphtha, biowastes and petroleum-based oils, treated |
---|---|
19701-9 N | Amines, polyalkylenepoly-, reaction products with substituted heteromonocycle and succinic anhydride polyisobutenyl derivs. |
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 seven substances (three chemicals and polymers and four 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 seven substances to the Domestic Substances List.
Also, under the authority of section 66 of CEPA, the Minister is updating the identifiers of 134 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 criteria.
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 and its current structure was established in 2001 (Order 2001-87-04-01 Amending the Domestic Substances List [PDF] [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
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:
- 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 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 7 substances and updating 134 substances on the Domestic Substances List
The ministers assessed information on seven substances (three chemicals and polymers and four 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 seven 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 145 reduced regulatory requirement polymers was published on September 16, 2023. 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 134 polymers under subsection 66(1) of CEPA.
Objective
The objective of Order 2024-66-03-01 Amending the Domestic Substances List (Order 2024-66-03-01) is to add the letter “P” to the identifiers of 134 polymers on the Domestic Substances List.
Order 2024-66-03-01 specifies that 134 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 2024-87-03-01 Amending the Domestic Substances List (Order 2024-87-03-01) is to add three substances to the Domestic Substances List.
The objective of Order 2024-112-03-01 Amending the Domestic Substances List (Order 2024-112-03-01) is to add four living organisms to the Domestic Substances List.
Order 2024-87-03-01 and Order 2024-112-03-01 are expected to facilitate or keep facilitating access to seven substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA.
Description
Order 2024-66-03-01 is made under subsection 66(1) of CEPA to update the identifiers of 134 polymers on the Domestic Substances List:
- the letter “P” is added following the CAS Registry Numbers of 108 polymers in Part 1 of the Domestic Substances List; and
- the letter “P” is added following the CANs of 26 polymers in Part 3 of the Domestic Substances List.
Order 2024-87-03-01 is made under subsection 87(5) of CEPA to add three chemicals and polymers to the Domestic Substances List:
- one substance identified by its CAS Registry Number is added to Part 1 of the Domestic Substances List; and
- two substances identified by their masked names and their CANs are added to Part 3 of the Domestic Substances List.
Order 2024-112-03-01 is made pursuant to subsection 112(1) of CEPA to add four living organisms to the Domestic Substances List:
- three living organisms identified by its specific substance name is added to Part 5 of the Domestic Substances List.
- one living organism identified by its masked name and its CAN is added to Part 7 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 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 seven substances 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 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
Korian Soumano
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