Order 2021-87-13-01 Amending the Domestic Substances List: SOR/2021-251

Canada Gazette, Part II, Volume 156, Number 1

Registration
SOR/2021-251 December 17, 2021

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 the 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 under paragraph 84(1)(a) of that Act in respect of the substance are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(3) and (5) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2021-87-13-01 Amending the Domestic Substances List.

Gatineau, December 15, 2021

Steven Guilbeault
Minister of the Environment

Order 2021-87-13-01 Amending the Domestic Substances List

Amendments

1 (1) Part 2 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:

Column 1

Substance

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

1661012-65-2 N-S

1 (1) The use, during the period beginning on the day on which this section comes into force and ending on March 20, 2022, of 100 kg or more of the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate) in the manufacture of any of the following products, if the substance is present in the product in a concentration greater than or equal to 0.1% by weight:

  • (a) a toy or child care article as defined in section 1 of the Phthalates Regulations; or
  • (b) a cosmetic as defined in section 2 of the Food and Drugs Act.

(2) The importation, during the period beginning on the day on which this section comes into force and ending on March 20, 2022, of 100 kg or more of the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate) in a cosmetic, as defined in section 2 of the Food and Drugs Act, if the substance is present in the product in a concentration that is greater than or equal to 0.1% by weight.

2 Despite section 1, a use of the substance is not a significant new activity if the substance is used

  • (a) as a research and development substance or site-limited intermediate substance as those terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers); or
  • (b) in the manufacture of a toy, child care article or cosmetic that is for export only.

3 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the activity begins:

  • (a) a description of the significant new activity in relation to the substance and the intended use of the toy, child care article or cosmetic;
  • (b) the anticipated annual quantity of the substance to be used;
  • (c) the information specified in paragraphs 7(c) and (d) of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
  • (d) the information specified in paragraphs 8(f) and (g) of Schedule 5 to those Regulations;
  • (e) the function of the substance;
  • (f) the quantity of the toy, child care article or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity;
  • (g) the data and report from a study in respect of the substance, that is conducted in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Test No. 416: Two-Generation Reproduction Toxicity, that is current at the time the study is conducted;
  • (h) in the case of a significant new activity described in paragraph 1(1)(a), the data and report from an oral migration study in respect of the substance, that is conducted in accordance with the methodology described in the Standard Operation Procedure for the Determination of Release of Di-Isononylphthalate (DINP) in Saliva Simulant from Toys and Childcare Articles Using a Head Over Heels Dynamic Agitation Device, published by the European Commission’s Joint Research Centre, that is current at the time the study is conducted;
  • (i) in the case of a significant new activity described in paragraph 1(1)(b) or subsection 1(2), the data and report from the following:
    • (i) a toxicity study of at least 24 hours in duration in respect of the substance, that is conducted in accordance with the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 428: Skin Absorption: In Vitro Method, that is current at the time the study is conducted, using rat skin,
    • (ii) a toxicity study of at least 24 hours in duration in respect of the substance, that is conducted in accordance with the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 428: Skin Absorption: In Vitro Method, that is current at the time the study is conducted, using human skin, and
    • (iii) a toxicity study of at least 24 hours in duration in respect of the substance, that is conducted in accordance with the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 427: Skin Absorption: In Vivo Method, that is current at the time the study is conducted, using rats;
  • (j) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance;
  • (k) the name of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
  • (l) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and
  • (m) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.

4 The studies referred to in paragraphs 3(g) to (i) must be conducted in accordance with the Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the OECD on May 12, 1981, that are current at the time the studies are conducted.

5 The information provided under section 3 is to be assessed within 90 days after the day on which it is received by the Minister.
(2) The portion of subsection 1(1) before paragraph (a) in column 2 of Part 2 of the List, opposite the reference to the substance “1661012-65-2 N-S” in column 1, is replaced by the following:

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

1 (1) The use of the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate) in the manufacture of any of the following products, if the substance is present in the product in a concentration greater than or equal to 0.1% by weight:
(3) Subsection 1(2) in column 2 of Part 2 of the List, opposite the reference to the substance “1661012-65-2 N-S” in column 1, is replaced by the following:

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

(2) The importation in a quantity greater than or equal to 1 kg in a calendar year of the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate) in a cosmetic, as defined in section 2 of the Food and Drugs Act, if the substance is present in the product in a concentration that is greater than or equal to 0.1% by weight.

(3) For the purpose of subsection (2), a calendar year does not include the period beginning on January 1, 2022 and ending on March 20, 2022.

Coming into Force

2 (1) This Order, except subsections 1(2) and (3), comes into force on the day on which it is registered.

(2) Subsections 1(2) and (3) come into force on March 21, 2022.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The Minister of the Environment and the Minister of Health (the ministers) assessed information on one substance (chemical) new to Canada and determined that it meets 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 CEPA, the Minister of the Environment (the Minister) is adding this substance to the Domestic Substances List.

The ministers identified potential human health concerns if the substance 1,2-cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate) (Chemical Abstracts Service registry number [CAS] Registry Number footnote 2 1661012-65-2) was to be used in certain new activities. In order to continue addressing these potential human health concerns, the Minister is maintaining the existing requirements under the Significant New Activity (SNAc) provisions of CEPA applied to this substance.

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 CAS Registry Numbers, 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 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 (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:

Criteria for adding, varying or rescinding SNAc requirements for substances on the Domestic Substances List

Amendments to the Domestic Substances List may also add, vary or rescind reporting obligations imposed under the SNAc provisions of CEPA. If the ministers assess a substance and available information suggests that certain new activities related to that substance may pose a risk to human health or the environment, the Minister may add that substance to the Domestic Substances List with reporting obligations under the SNAc provisions of CEPA (subsection 87(3) or 112(3)). The SNAc provisions of CEPA establish a requirement for any person considering undertaking a significant new activity in relation to the substance to submit a Significant New Activity Notification (SNAN) to the Minister containing certain required information. Upon receipt of the complete information, the ministers would conduct further assessment of the substance, and, if necessary, implement risk management measures before the activity is undertaken. To see the substances subject to SNAc provisions of CEPA, please visit the Canada.ca Open Data Portal.

Adding one substance to the Domestic Substances List

The ministers assessed information on one substance new to Canada (CAS Registry Number 1661012-65-2) and determined that it meets the criteria for addition to the Domestic Substances List, under subsection 87(1) of CEPA. This substance is therefore being added to the Domestic Substances List and, as a result, is no longer subject to the New Substances Notification Regulations (Chemicals and Polymers).

The SNAc provisions of CEPA were applied to this substance prior to its addition to the Domestic Substances List, pursuant to the Significant New Activity Notice No. 20521, published in March 2021. The SNAc provisions of CEPA were applied to address potential human health concerns if the substance was to be used in certain new activities involving toys, childcare articles or cosmetics. Potential human health concerns were identified because the substance may cause developmental toxicity effects.

Therefore, the SNAc requirements on the substance are being maintained, and thus, are being added with the substance to the Domestic Substances List.

Objective

The objective of Order 2021-87-13-01 Amending the Domestic Substances List (the order) is to add one substance (CAS Registry Number 1661012-65-2) to the Domestic Substances List and to continue contributing to the protection of human health by maintaining the SNAc provisions of CEPA applied to this substance. The order maintains the requirement that the Minister be notified of any significant new activity involving this substance so that further assessment of the substance is conducted, and, if necessary, risk management measures are implemented before the activity is undertaken.

The order is expected to facilitate access to this substance for businesses as the substance is no longer subject to requirements under subsection 81(1) of CEPA.

Description

The order is made pursuant to subsection 87(3) and 87(5) of CEPA to add one substance (chemical) identified by its CAS Registry Number along with SNAc requirements to Part 2 of the Domestic Substances List.

The SNAc provisions of CEPA apply to the substance identified by the CAS Registry Number 1661012-65-2. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using this substance for a significant new activity as defined in the order.

SNAc applicability and reporting requirements

Under the order, any person wishing to engage in a significant new activity in relation to the substance identified by the CAS Registry Number 1661012-65-2 is required to submit a SNAN to the Minister. The SNAN must contain all of the information prescribed in the order, and must be submitted at least 90 days prior to the manufacture, import or use of the substance for the proposed significant new activity. The ministers will use the information submitted to conduct further assessment of the substance, and, if necessary, implement risk management measures before the activity is undertaken.

Activities subject to notification requirements

The notification requirements apply to

and to

Transitional provision

The SNAc provisions of CEPA are applied to the substance with a transitional period phasing in the requirements.

Beginning on the day this order comes into force and ending on March 20, 2022, the notification requirements apply to

and to

Activities not subject to notification requirements

The notification requirements do not apply to uses of the substance identified by the CAS Registry Number 1661012-65-2 that are regulated under any act of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act. The notification requirements also do not apply to any transient reaction intermediate, impurity, contaminant, partially unreacted material, or incidental reaction product, and under certain circumstances, to mixtures, manufactured items, wastes or substances carried through Canada. For more information on these terms, including definitions, please see section 3.2 of the Guidance Document for the Notification and Testing of New Chemicals and Polymers. Please note that individual components of a mixture may be subject to the notification requirements under certain circumstances.

Activities involving the use of the substance identified by the CAS Registry Number 1661012-65-2 as a research and development substance, site-limited intermediate substances or in the manufacture of an export-only product are also excluded from notification requirements. For more information on these terms, including definitions, please see section 3.4 of the Guidance Document for the Notification and Testing of New Chemicals and Polymers.

Information requirements

The information required under the order relates to details surrounding the significant new activities, exposure information and toxicity to human health. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

The information required to complete a SNAN is unique to each substance and is described within the order. For guidance on preparing a SNAN, please see section 1.3 and section 4 of the Guidance Document for the Notification and Testing of New Chemicals and Polymers.

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 order 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 instrument that allow the Minister to comply with this obligation.

Applying the SNAc provisions of CEPA on substances is considered when there is suspicion that new activities may pose a risk to human health or the environment. For more information, please consult the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999.

Regulatory analysis

Benefits and costs

Adding one substance to the Domestic Substances List does not have any impact (benefits or costs), as it is administrative in nature and is a federal obligation under section 87 of CEPA that is triggered once a substance meets the criteria for addition. Maintaining the SNAc provisions of CEPA on the substance identified by the CAS Registry Number 1661012-65-2 continues contributing to the protection of human health by requiring that potential significant new activities involving the substance undergo further assessment, and that, if necessary, risk management measures are implemented before the activity is undertaken. The order does not impose any regulatory requirements (and therefore, any administrative of compliance costs) on businesses related to current activities. The order would continue to only target significant new activities involving the substance identified by the CAS Registry Number 1661012-65-2, should any person choose to pursue such an activity. In the event that any person wishes to use, import, or manufacture the substance for a significant new activity, they would be required to submit a SNAN to the Minister containing the complete information referred to in the order.

While there is no notification fee associated with submitting a SNAN to the Minister in response to the order, the notifier may incur costs associated with generating data and supplying the required information. Similarly, in the event that a SNAN is received, the Department of the Environment and the Department of Health would incur costs for processing the information and conducting further assessment of the substance to which the SNAN relates. The Department of the Environment will incur negligible costs for conducting compliance promotion and enforcement activities associated with the order.

Small business lens

The assessment of the small business lens concluded that the order has no impact on small businesses, as it does not impose any administrative or compliance costs on businesses related to current activities.

One-for-one rule

The assessment of the one-for-one rule concluded that the rule does not apply to the order, as there is no impact on industry related to current activities.

Regulatory cooperation and alignment

There are no international agreements or obligations directly associated with the order.

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 order.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for the order.

Implementation, compliance and enforcement, and service standards

Implementation

The order is now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List. The order does not constitute an endorsement from the Government of Canada of the substance to which it relates, nor an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or to activities involving it.

Compliance and enforcement

When assessing whether or not a substance is subject to the SNAc provisions of CEPA, a person is expected to make use of information in their possession, or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance are expected to have access to import records, usage information and the relevant Safety Data Sheet (SDS).

Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products, and may not include all the information on these hazards. Therefore, an SDS may not list all product ingredients or substances that may be subject to the SNAc provisions of CEPA. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that a substance added to the Domestic Substances List through any order is toxic or capable of becoming toxic under section 64 of CEPA, the person who obtains the information and is involved in activities with the substance, is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. In cases where a person receives possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN.

Any person who transfers the physical possession or control of a substance subject to an order to another should notify that person of their obligation to comply with that order, including the obligation to notify the Minister of any significant new activity and to provide all the required information specified in that order.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult during the planning or preparation of a SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

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 PNC, 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 order is 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.

Service standards

In the event that a SNAN is submitted to the Minister in relation to the substance identified by the CAS Registry Number 1661012-65-2, the ministers will assess the information after the complete information is received, within the prescribed timelines set out in the order.

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