Order 2019-87-08-01 Amending the Domestic Substances List: SOR/2019-235

Canada Gazette, Part II, Volume 153, Number 14

Registration

SOR/2019-235 June 24, 2019

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 that is added to the Domestic Substances List footnote b pursuant to subsection 87(5) of that Act;

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 substances 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 2019-87-08-01 Amending the Domestic Substances List.

Gatineau, June 18, 2019

Catherine McKenna
Minister of the Environment

Order 2019-87-08-01 Amending the Domestic Substances List

Amendment

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

42844-93-9 N-S

1 The use of the substance nickel, [1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthalenyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]-, (SP-4-2)-, in a quantity greater than or equal to 10 kg in a calendar year, in the manufacture of any of the following products such that the substance is present in a concentration that is greater than or equal to 0.1% by weight:

  • (a) a consumer product to which the Canada Consumer Product Safety Act applies and that is intended to be sprayed; or
  • (b) a cosmetic, as defined in section 2 of the Food and Drugs Act, that is intended to be sprayed.

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 a product that is referred to in that section and is intended only for export.

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;
  • (b) the anticipated annual quantity of the substance to be used for the significant new activity;
  • (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) a description of the consumer product or cosmetic that contains the substance, the intended use of that consumer product or cosmetic and the function of the substance in that consumer product or cosmetic;
  • (f) the total quantity of the consumer product or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity;
  • (g) the test data and the test report from a repeated dose inhalation test 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. 412, entitled Subacute Inhalation Toxicity: 28-Day Study, that is current at the time the test is conducted, including a satellite (reversibility) study performed for all tissues and organs, as well as a bronchoalveolar lavage fluid analysis;
  • (h) the analytical information that is necessary to determine the primary and secondary particle size (i.e., its length, width and thickness) and the particle size distribution of the substance administered in the test referred to in paragraph (g);
  • (i) the information that is necessary to determine the agglomeration and aggregation state, shape, surface area and surface charge of the primary and secondary particles of the substance administered in the test referred to in paragraph (g);
  • (j) all other information or test data in respect of the substance that are in the possession of the person who is proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the substance;
  • (k) the name of every government department or government 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 imposed by the department or agency in relation to the substance;
  • (l) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person who is 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 who is 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 tests and studies referred to in paragraph 3(g) 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 tests are conducted. Furthermore, the tests referred to in that paragraph must be conducted in accordance with the principles described in the OECD Series on the Safety of Manufactured Nanomaterials Publication No. 36, entitled Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, that are current at the time the tests are conducted.

5 The information referred to in paragraphs 3(h) and (i) must be determined in accordance with the principles described in the OECD Series on the Safety of Manufactured Nanomaterials, Publication No. 41, entitled Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines, that is current at the time of the determination.

6 The information provided under section 3 will be assessed within 90 days after the day on which it is received by the Minister.

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 Order.)

Issues

The Minister of the Environment and the Minister of Health (the Ministers) assessed information on one substance new to Canada, nickel, [1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthalenyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]-, (SP-4-2)- (Chemical Abstract Service Registry Number (CAS RN) 42844-93-9 footnote 2), 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, the Minister of the Environment (the Minister) is adding this substance to the Domestic Substances List. In addition, to address potential human health concerns, the Minister is maintaining the existing requirements under the Significant New Activity (SNAc) provisions of CEPA on the 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 and 83 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers). CEPA and these Regulations ensure that new substances introduced to the Canadian marketplace over certain quantities 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 the Regulations, please see section 1 in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

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 May 1994. The current structure of the Domestic Substances List was established in 2001 and amended in 2012. For more details, please refer to the Order 2001-87-04-01 Amending the Domestic Substances List (PDF) (SOR/2001-214), which established the structure of the Domestic Substances List, and to the Order 2012-87-09-01 Amending the Domestic Substances List (SOR/2012-229), which amended the Domestic Substances List. The Domestic Substances List is amended, on average, 10 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 RN, or their Substance Identity Number assigned by the Department of the Environment and the name of the substance;

Part 2

Sets out chemicals and polymers subject to SNAc requirements that are identified by their CAS RN;

Part 3

Sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked name and their Confidential Accession Number (CAN) assigned by the Department of the Environment;

Part 4

Sets out chemicals and polymers subject to SNAc requirements that are identified by their masked name and their CAN;

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) number, International Union of Biochemistry and Molecular Biology (IUBMB) number or specific substance name;

Part 6

Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their ATCC number, IUBMB number or specific substance name;

Part 7

Sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked name and their CAN;

Part 8

Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked name and their CAN.

Criteria for addition of substances to the Domestic Substances List

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

In addition, new substances must be added to the Domestic Substances List under subsection 87(1) or 87(5) 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. When available information suggests that a substance may pose a risk to human health or the environment from its use in a new activity, the substance can be added to the Domestic Substances List under subsection 87(3) of CEPA with reporting obligations. The SNAc provisions of CEPA establish a requirement for any person considering a significant new activity in relation to the substance subject to these provisions to provide the required information as part of a notification to the Minister. Upon receipt of the complete information, a risk assessment will be conducted, and, if necessary, risk management measures will be implemented, before the new activity is undertaken in Canada. To see the substances subject to SNAc provisions of CEPA, please visit the Government of Canada’s Canada.ca Open Data Portal.

Adding one substance to the Domestic Substances List

The Ministers assessed information on one new substance (CAS RN 42844-93-9) and determined that it meets the criteria for addition to the Domestic Substances List, under subsection 87(5) of CEPA. This substance is therefore being added to the Domestic Substances List and is no longer subject to the New Substances Notification Regulations (Chemicals and Polymers).

The SNAc provisions of CEPA were applied to the substance before its addition to the Domestic Substances List according to the Significant New Activity Notice No. 19477, published in June 2018. As the substance contains nickel, a known human carcinogen, potential human health concerns were identified if it is used in certain new activities involving consumer products intended for spray application. To keep addressing these potential concerns, the SNAc requirements are being maintained, and thus, are being added with the substance to the Domestic Substances List.

Objectives

Order 2019-87-08-01 (the Order) is made pursuant to subsections 87(3) and 87(5) of CEPA to add one substance to the Domestic Substances List, and to maintain the SNAc requirements associated with the substance. This Order is expected to facilitate access to the substance for businesses as the substance is no longer subject to requirements under section 81.

Description

The Order is a legal instrument made by the Minister pursuant to subsections 87(3) and (5) of CEPA to add one substance identified by the CAS RN 42844-93-9 to Part 2 of the Domestic Substances List.

The application of the SNAc provisions of CEPA on the substance is maintained. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substance for a significant new activity, as defined in the Order. For more information, please consult the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999.

SNAc applicability and reporting requirements

Under the Order, any person wishing to engage in a significant new activity in relation to the substance is required to submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to using the substance for the activity. The Ministers will conduct risk assessments after the complete information is received within the prescribed timelines set out in the Order.

Activities subject to notification requirements

The notification requirements apply to the use of the substance in the manufacture of the following products such that the substance is present in a concentration that is greater than or equal to 0.1% by weight:

For example, a notification is required if a person plans to use the substance in the manufacture of a product for consumer uses such as a lubricant, grease or fluid product intended to be sprayed, where the concentration of the substance in the product is greater or equal to 0.1% by weight.

Activities not subject to notification requirements

This Order does not apply to uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act. The Order also does not apply to any use of the substance that is exempt or excluded from notification requirements under CEPA (i.e. transient reaction intermediate, impurity, contaminant, partially unreacted material, or incidental reaction product, and under certain circumstances, manufactured items, wastes or substances carried through Canada). For more information on these terms, including definitions, please see section 3.2 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers. Please note that according to section 3 and subsection 81(6) of CEPA, individual components of a mixture may be subject to the notification requirements under certain circumstances.

Activities involving the use of the substance as a research and development substance or a site-limited intermediate substance or in the manufacture of an export-only product are also excluded from notification under the Order. For more information on these terms, including definitions, please see section 3.5 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Information requirements

The information required under the Order relates to general information in respect of the substance, details surrounding its use, 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, which maintains the application of the SNAc provisions of CEPA on the substance. For guidance on preparing a SNAN, please see sections 1.3 and 4 of the Guidelines for the Notification and Testing of New Substances: 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 Order is not expected to have any impact on Indigenous groups. Therefore, no modern treaty obligations and associated Indigenous engagement and consultation were identified.

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. An order amending the Domestic Substances List is the only regulatory instrument available to comply with this obligation.

Regulatory analysis

Costs and benefits

The Order does not have any impact (costs or benefits) as it is administrative in nature and is a federal obligation under subsection 87(1) or 87(5) of CEPA that is triggered once a substance meets the criteria for addition to the Domestic Substances List.

Small business lens

An assessment under the small business lens concluded that this Order does not have any impact on small businesses.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this Order, as it does not impose any administrative or compliance costs on businesses.

Regulatory cooperation and alignment

There are no international agreements or obligations directly associated with this Order.

Strategic environmental assessment

In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan on additions to the Domestic Substances List concluded that a strategic environmental assessment is not required for the Order since the addition of a substance to the Domestic Substances List is administrative in nature and is an obligation under CEPA.

Gender-based analysis plus (GBA+)

The Order is not expected to have any impact on specific groups based on factors such as sex, gender identity, ethnicity, ability, age, religion, language, geography, culture, income, sexual orientation or education.

Implementation, compliance and enforcement, and service standards

Implementation

The Order 2019-87-08-01 is now in force. Developing an implementation plan or a compliance strategy is not required when adding substances to the Domestic Substances List or when SNAc requirements are maintained. This 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 activities involving it.

Compliance

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, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets (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. 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 the substance added to the Domestic Substances List through this Order is toxic or capable of becoming toxic, under section 64 of CEPA, the person who is in possession of, or has the knowledge of 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. For example, 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. The Substances Management Advisory Note “Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999” provides more detail on this subject.

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 obligations 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 eccc.substances.eccc@canada.ca (email), 1‑800‑567‑1999 (toll-free in Canada), or 819‑938‑3232 (outside of Canada).

Enforcement

The Order is made under the authority of CEPA, which is enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. 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. Suspected violations can be reported to the Enforcement Branch by email at ec.enviroinfo.ec@canada.ca.

Service standards

In the event that a SNAN is submitted to the Minister, the Ministers will assess the information after the complete information is received, within the prescribed timelines set out in the Order.

Contact

Nicole Davidson
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: eccc.substances.eccc@canada.ca