Order 2020-87-01-01 Amending the Domestic Substances List: SOR/2020-16
Canada Gazette, Part II, Volume 154, Number 4
Registration
SOR/2020-16 January 30, 2020
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 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 2020-87-01-01 Amending the Domestic Substances List.
Gatineau, January 28, 2020
Jonathan Wilkinson
Minister of the Environment
Order 2020-87-01-01 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 |
Column 2 |
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262299-63-8 N-S |
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(2) The portion of section 1 before paragraph (a) in column 2 of Part 2 of the List, opposite the reference to the substance “262299-63-8 N-S” in column 1, is replaced by the following:
| Column 2 |
|---|
1 The use of the substance 2-propenoic acid, 2-methyl-, 3-[1,1-bis[[dimethyl[2-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]ethyl]silyl]oxy]-3,3-dimethyl-3-[2-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]ethyl]-1-disiloxanyl]propyl ester, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate in the manufacture of any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight: |
(3) The portion of section 2 before paragraph (a) in column 2 of Part 2 of the List, opposite the reference to the substance “262299-63-8 N-S” in column 1, is replaced by the following:
| Column 2 |
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2 The use, in a quantity greater than or equal to 10 kg in a calendar year, of the substance 2-propenoic acid, 2-methyl-, 3-[1,1-bis[[dimethyl[2-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]ethyl]silyl]oxy]-3,3-dimethyl-3-[2-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]ethyl]-1-disiloxanyl]propyl ester, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate in any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight: |
(4) The portion of column 2 of Part 2 of the List, opposite the reference to the substance “262299-63-8 N-S” in column 1, is amended by adding the following after section 2:
| Column 2 |
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2.1 For the purpose of section 2, a calendar year does not include the period beginning on January 1, 2020 and ending on March 20, 2020. |
Coming into Force
2 (1) This Order, except for subsections 1(2) to (4), comes into force on the day on which it is registered.
(2) Subsections 1(2) to (4) come into force on March 21, 2020.
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, 2-propenoic acid, 2-methyl-, 3-[1,1-bis[[dimethyl[2-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]ethyl]silyl]oxy]-3,3-dimethyl-3-[2-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]ethyl]-1-disiloxanyl]propyl ester, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate (Chemical Abstracts Service Registry Number [CAS registry number] 262299-63-8) 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, under the authority of subsection 87(5) of CEPA, the Minister of the Environment (the Minister) is adding the 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, 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 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 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 May 1994. The current structure of the Domestic Substances List was established in 2001 (Order 2001-87-04-01 Amending the Domestic Substances List (PDF) [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 number, 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 registry number. |
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. |
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 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 sections 83 and 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.
Criteria for adding, varying or rescinding SNAc requirements for substances on the Domestic Substances List
Amendments to the Domestic Substances List may also allow the addition, the variation or the rescission of reporting obligations imposed under the SNAc provisions of CEPA, the application guidelines of which are defined in the Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999. If a substance has been assessed and available information suggests that there may be a risk to human health or the environment from the use of the substance in certain new activities, the Minister may add the substance to the Domestic Substances List with reporting obligations under subsection 87(3) of CEPA. The SNAc provisions of CEPA establish a requirement for any person proposing to import, manufacture or use the substance for a significant new activity to provide the required information as part of a notification to the Minister. Upon receipt of the complete information, an assessment of the substance relating to the proposed significant new activity is conducted before the new activity is undertaken in Canada. To see the substances subject to SNAc provisions of CEPA, please consult the Significant New Activity Publications under the Canadian Environmental Protection Act, 1999 on the Government of Canada's Open Data Portal.
Adding one substance to the Domestic Substances List
The ministers assessed information on one substance new to Canada (CAS registry number 262299-63-8) 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, as a result, 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 pursuant to the Significant New Activity Notice No. 19788, published in March 2019. The SNAc provisions were applied to address potential human health concerns if the substance is used in certain new activities involving consumer spray applications. Potential human health concerns were identified because the substance, an acrylate silicone copolymer with high molecular weight and water-insoluble components, has the potential to cause pulmonary complications if inhaled. Therefore, the SNAc requirements are being maintained and, as a result, they are being added with the substance to the Domestic Substances List.
Objective
The first objective of Order 2020-87-01-01 Amending the Domestic Substances List (the Order) is to add one substance to the Domestic Substances List. The Order is expected to facilitate access to the substance for businesses, as it is no longer subject to requirements under subsection 81(1) of CEPA. The second objective of the Order is to contribute to the protection of human health by maintaining the application of the SNAc provisions of CEPA to the substance. The Order requires that the Minister be notified of any significant new activity involving the substance so that an assessment of the substance relating to the proposed significant new activity is conducted before the activity is undertaken in Canada and, if necessary, risk management measures are implemented.
Description
The Order is a legal instrument made by the Minister pursuant to subsections 87(3) and 87(5) of CEPA to add one substance identified by the CAS registry number 262299-63-8 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.
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 262299-63-8 is required to submit a significant new activity notification (SNAN) to the Minister containing all of the information prescribed in the Order at least 90 days prior to using the substance for the proposed activity. After the complete information is received, the ministers will conduct risk assessments of the substance in relation to the proposed significant new activity within the prescribed timelines set out in the Order.
Activities subject to notification requirements
The notification requirements apply to the use of the substance identified by the CAS registry number 262299-63-8 in the manufacture of any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:
- a consumer product to which the Canada Consumer Product Safety Act applies and that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size; or
- a cosmetic, as defined in section 2 of the Food and Drugs Act, that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size.
The notification requirements also apply to the use of the substance identified by the CAS registry number 262299-63-8 in a quantity greater than or equal to 10 kg in a calendar year in any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:
- a consumer product to which the Canada Consumer Product Safety Act applies and that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size; or
- a cosmetic, as defined in section 2 of the Food and Drugs Act, that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size.
For the year of 2020, a calendar year does not include the period beginning on January 1, 2020, and ending on March 20, 2020. During this period, a transitional provision is in effect.
Transitional provision
The SNAc provisions of CEPA that are applied to the substance identified by the CAS registry number 262299-63-8 contain a transitional period that phases in the requirements. During the period beginning on the day on which the Order comes into force and ending on March 20, 2020, the notification requirements apply to the use of 1 000 kg or more of the substance in the manufacture of any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:
- a consumer product to which the Canada Consumer Product Safety Act applies and that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size; or
- a cosmetic, as defined in section 2 of the Food and Drugs Act, that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size.
During the period beginning on the day on which the Order comes into force and ending on March 20, 2020, the notification requirements also apply to the use of 1 000 kg or more of the substance in any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:
- a consumer product to which the Canada Consumer Product Safety Act applies and that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size; or
- a cosmetic, as defined in section 2 of the Food and Drugs Act, that releases or sprays the substance in airborne particles of less than or equal to 10 micrometres in size.
Activities not subject to notification requirements
The notification requirements do not apply to uses of the substance identified by the CAS registry number 262299-63-8 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 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 details surrounding uses of the substance, 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
An assessment of modern treaty obligations must be made in accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation. It was concluded that orders amending the Domestic Substances List do not result in any impact on modern treaty rights or obligations. It was also concluded that the making of an order under section 87 or 112 of CEPA does not require specific engagement and consultation with Indigenous peoples.
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.
Applying the SNAc provisions of CEPA on substances new to Canada is considered when there is suspicion that activities other than those notified may pose a risk. 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
The addition of a 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. Applying the SNAc provisions of CEPA to the substance identified by CAS registry number 262299-63-8 contributes to the protection of human health by requiring that potential significant new activities involving the substance undergo an assessment to determine whether they could pose a risk to human health or the environment before they are undertaken, and that, if necessary, risk management measures are implemented.
The SNAc provisions of CEPA do not target current activities involving the substance identified by the CAS registry number 262299-63-8 and would only target significant new activities involving the substance, 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 assume costs associated with generating data and supplying the required information, as well as potential costs associated with tracking used quantities to determine whether the SNAc provisions apply to any substance that the notifier uses. 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 assessments of the substance relating to the proposed significant new activity. The Department of the Environment will incur negligible costs for conducting compliance promotion and enforcement activities associated with the Order.
Small business lens
An assessment under the small business lens concluded that the Order does not have any impact on small businesses, as it does not impose any administrative or compliance costs on small businesses related to current activity.
One-for-one rule
The one-for-one rule does not apply to the Order, as it does not impose any administrative or compliance costs on small businesses related to current activity.
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 of additions to the Domestic Substances List concluded that a strategic environmental assessment is not required for the Order.
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 is now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List or when SNAc requirements are maintained. 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
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 sheet (SDS).
Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the SDS mainly serves to protect the health of workers in the workplace from specific hazards of a chemical product, and may not include all the information on these hazards. Therefore, an SDS may not list all the product ingredients or substances that could 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 in accordance with section 64 of CEPA, a person who is in possession of or has 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.
Any person who transfers the physical possession or control of a substance subject to the SNAc provisions of CEPA to another should notify them of their obligation to comply with the Order, including the obligations to notify the Minister of any significant new activity and to provide all the required information specified in the 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 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 (CEPA, 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 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 ec.enviroinfo.ec@canada.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 262299-63-8, the ministers will assess the information within the prescribed timelines set out in the Order once the regulatory information is received.
Contact
Andrea Raper
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