Order 2019-66-02-01 Amending the Domestic Substances List: SOR/2019-34

Canada Gazette, Part II, Volume 153, Number 4

Registration

SOR/2019-34 January 31, 2019

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 ^{footnote a}, the Minister of the Environment is required to maintain the Domestic Substances List ^{footnote b};

Therefore, the Minister of the Environment, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 ^{footnote a}, makes the annexed Order 2019-66-02-01 Amending the Domestic Substances List.

Gatineau, January 28, 2019

Catherine McKenna
Minister of the Environment

Order 2019-66-02-01 Amending the Domestic Substances List

Amendments

1 The English description of substance “19279-7 N-P” set out in column 2 of Part 3 of the Domestic Substances List ^{footnote 1} for that substance is replaced by the following:

• 1,3-Benzenedicarboxylic acid, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, heteromonocycledione, hexanedioic acid, 1,6-hexanediol, α-(2-methyl-1-oxo-2-propen-1-yl)-ω-methoxypoly(oxy-1,2-ethanediyl) and 2-propenoic acid, tert-Bu 2-ethylhexaneperoxoate-initiated, compds. with 2-(dimethylamino)ethanol

2 In column 1 of Part 3 of the List, the reference to “16451-8 N” is replaced by “16451-8 N-P”.

Coming into Force

3 This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the orders.)

Issues

The Government of Canada (the Government) assessed information on 21 substances (16 chemicals and polymers, and 5 organisms) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government is adding 21 substances to the DSL. The Government is also updating one confidential accession number and one masked name of two substances already listed on the DSL.

Background

Assessment of substances new to Canada

Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 108 of the Canadian Environmental Protection Act, 1999 (CEPA), as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). 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 DSL (SOR/94-311) provides an inventory of substances in the Canadian marketplace and was originally published in the Canada Gazette, Part II, in May 1994. The current structure of the DSL was established in June 2001. For more details, please refer to the Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214) (pdf), which establishes the structure of the DSL, published in the Canada Gazette, Part II, in July 2001, and to the Order 2012-87-09-01 Amending the Domestic Substances List (SOR/2012-229), published in the Canada Gazette, Part II, in November 2012, which amended the DSL. The DSL 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 Abstract Service Registry Number (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 Significant New Activity (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 DSL

The DSL is amended, on average, 10 times per year to add, update or delete substances. Chemicals or polymers must be added to the DSL 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 kg in any one calendar year, or if they were in Canadian commerce or used for commercial manufacturing purposes in Canada.

A living organism must be added to the DSL under section 105 of CEPA if, between January 1, 1984, and December 31, 1986, it was manufactured or imported into Canada by any person (individual or corporation) and if, during this period, it entered or was released into the environment without being subject to conditions under an Act of Parliament or of the legislature of a province.

In addition, new substances must be added to the DSL under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days after all of the following criteria have been met:

• The Minister of the Environment has been provided with the most comprehensive package of information requirements regarding the substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms);
• For substances added pursuant to subsection 87(1) or 112(1) of CEPA, the Minister of the Environment and the Minister of Health 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 for the assessment of the information submitted for the substance under sections 83 and 108 of CEPA 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 the 21 substances to the DSL

The Government assessed information on 21 new substances (16 chemicals and polymers, and 5 organisms) and determined that they meet the criteria for their addition to the DSL, under subsection 87(5) and 112(1) of CEPA. These 21 substances are therefore being added to the DSL and are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.

Also, two substances meet the requirement set out in subsection 66(1) of CEPA. Therefore, the Government is now amending the CAN of one substance and the English masked name of another one that are both on the DSL.

Objectives

Order 2019-87-02-01 adds 16 substances to the DSL, Order 2019-112-02-01 adds 5 substances to the DSL, and Order 2019-66-02-01 corrects the CAN for one substance and the English masked name for another substance that are on the DSL. These amendments to the DSL are expected to facilitate access to the substances that are added to the DSL for businesses by reducing cost and administrative burden, such as notifications and assessment requirements.

Description

Order 2019-87-02-01 is made pursuant to subsection 87(5) of CEPA to add 16 substances (chemicals and polymers) to the DSL.

• Seven substances identified by their CAS RN are added to Part 1 of the DSL.
• Nine substances identified by their masked name and their CAN are added to Part 3 of the DSL. Masked names are regulated under the Masked Name Regulations and are created to protect confidential business information.

Order 2019-112-02-01 is made pursuant to subsection 112(1) of CEPA to add five substances (organisms) to the DSL.

• Five substances identified by their masked name and their CAN are added to Part 7 of the DSL.

Order 2019-66-02-01 is made pursuant to subsection 66(1) of CEPA to correct the CAN and the masked name of two substances on the DSL.

Consultation

As CEPA does not prescribe any public comment period before adding a substance to the DSL, no consultation period for orders 2019-87-02-01, 2019-112-02-01 and 2019-66-02-01 was deemed necessary.

Rationale

The Government assessed information on 21 new substances to Canada that were subject to notification and assessment requirements, as 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). The assessment determined that the 21 substances do not pose risks to the environment or human health. These substances meet the criteria for addition to the DSL and, therefore, are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.

In addition, the government corrects the identifiers of two substances on the DSL, since it is satisfied that these changes will better reflect the identification of the two substances that are already on the DSL.

“One-for-One” Rule and small business lens

Since the orders 2019-87-02-01 and 2019-112-02-01 decrease administrative burden by removing notification and information requirements on the 21 substances, and Order 2019-66-02-01 does not modify administrative burden, the “One-for-One” Rule and small business lens do not apply to these orders, as they do not impose any new administrative or compliance costs on small businesses.

Implementation, enforcement and service standards

Developing an implementation plan, a compliance strategy, or establishing a service standard is not required when adding substances to the DSL.

Where a person has questions concerning their obligations to comply with these orders, believes that they may be out of compliance, or would like to request a pre-notification consultation, this person is encouraged to discuss their particular circumstances with the program by contacting 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).

These orders do not constitute an endorsement from the Government of the 23 substances to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to these substances or activities involving them.

The orders 2019-87-02-01, 2019-112-02-01 and 2019-66-02-01 are now in force. CEPA 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, as well as the potential harm, intent, and history of compliance.

Contact

Julie Thompson
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