Order 2021-66-10-01 Amending the Domestic Substances List: SOR/2021-262

Canada Gazette, Part II, Volume 156, Number 1

Registration
SOR/2021-262 December 21, 2021

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment is satisfied that the substance referred to in the annexed Order was, between January 1, 1984, and December 31, 1986, imported into Canada by a person in a quantity of not less than 100 kg in any one calendar year, meeting the requirement set out in paragraph 66(1)(a) of the Canadian Environmental Protection Act, 1999 footnote a;

Therefore, the Minister of the Environment, pursuant to subsection 66(3) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2021-66-10-01 Amending the Domestic Substances List.

Gatineau, December 17, 2021

Steven Guilbeault
Minister of the Environment

Order 2021-66-10-01 Amending the Domestic Substances List

Amendment

1 Part 1 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:

  • 1318-02-1

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 (nine chemicals and polymers, and four living organisms) new to Canada 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 66, 87 and 112 of CEPA, the Minister of the Environment (the Minister) is adding these 13 substances to the Domestic Substances List.

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 Notification and Testing of New 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, 12 times per year to add, update or delete substances.

The Domestic Substances List includes eight parts defined as follows:

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 Numbers, footnote 2 or their Substance Identity Numbers assigned by the Department of the Environment and the names of the substance.
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 names and their 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 kilograms 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 ministers are satisfied that the substance has already been manufactured in, or imported into, Canada in the prescribed quantity or conditions by the person who provided the information;
  • The period prescribed under section 83 or 108 of CEPA for the assessment of the information submitted for the substance has expired; and
  • The substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture.

Adding 13 substances to the Domestic Substances List

The ministers assessed information on 12 substances (8 chemicals and polymers, and 4 living organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List, under subsection 87(1), 87(5) or 112(1) of CEPA. These 12 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).

In addition, the Minister is adding one substance to the Domestic Substances List since this substance was manufactured or imported in Canada in a quantity greater than or equal to 100 kg in any one calendar year between 1984 and 1986. This substance therefore meets the criteria for addition to the Domestic Substances List.

Objective

The objective of Order 2021-66-10-01 Amending the Domestic Substances List is to add one substance to the Domestic Substances List.

The objective of Order 2021-87-10-01 Amending the Domestic Substances List is to add eight substances to the Domestic Substances List.

The objective of Order 2021-112-10-01 Amending the Domestic Substances List is to add four living organisms to the Domestic Substances List.

Order 2021-66-10-01, order 2021-87-10-01 and order 2021-112-10-01 (the orders) are expected to facilitate access to 13 substances for businesses, as the substances are no longer subject to requirements under subsection 81(1) or 106(1) of CEPA.

Description

The order 2021-66-10-01 is made pursuant to subsection 66(1) of CEPA to add one chemical to the Domestic Substances List:

  • one substance identified by its CAS Registry Number is added to Part 1 of the Domestic Substances List.

The order 2021-87-10-01 is made pursuant to subsections 87(1) and 87(5) of CEPA to add eight substances (chemicals and polymers) to the Domestic Substances List:

  • five substances identified by their CAS Registry Numbers are added to Part 1 of the Domestic Substances List; and
  • three substances identified by their masked names and their CANs are added to Part 3 of the Domestic Substances List. Masked names are regulated under the Masked Name Regulations and are created to protect confidential business information.

The order 2021-112-10-01 is made pursuant to subsection 112(1) of CEPA to add four living organisms to the Domestic Substances List:

  • two substances identified by their specific substance names are added to Part 5 of the Domestic Substances List;
  • two substances identified by their masked names and their CANs are 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 13 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 66, 87 or 112 of CEPA that is triggered once a substance meets the criteria for addition.

Small business lens

The small business lens analysis concluded that the orders have no associated impact on small businesses, as they do not impose any administrative or compliance costs on businesses.

One-for-one rule

The one-for-one rule does not apply to the orders, as there are no incremental changes in administrative burden imposed 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

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement 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