Order 2018-66-05-01 Amending the Domestic Substances List: SOR/2018-165
Canada Gazette, Part II, Volume 152, Number 16
Registration
July 24, 2018
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 2018-66-05-01 Amending the Domestic Substances List.
Gatineau, July 18, 2018
Catherine McKenna
Minister of the Environment
Order 2018-66-05-01 Amending the Domestic Substances List
Amendment
1 In Part 1 of the Domestic Substances List footnote 1, the reference to “745070-61-5 N-P’’ is replaced by “745070-61-5 N”.
Coming into Force
2 This Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the orders.)
Issues
The Government of Canada (the Government) assessed information on 22 substances new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL).Therefore, the Government added 22 substances to the DSL, 3 of which are added under the Order 2018-112-05-01 Amending the Domestic Substances List (Order 2018-112-05-01) and 19 substances under the Order 2018-87-05-01 Amending the Domestic Substances List (Order 2018-87-05-01).
The Government also updated the identifier of one substance already on the DSL under the Order 2018-66-05-01 Amending the Domestic Substances List (Order 2018-66-05-01).
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 109 of the Canadian Enrivonmental Protection Act, 1999 (CEPA), as well as in the New Substances Notification Regulations (Chemicals and Polymers) footnote 2 and the New Substances Notification Regulations (Organisms). footnote 3 These Regulations are administered by the New Substances Program and were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds footnote 4 are risk assessed to identify potential hazards to the environment and human health, and that appropriate control measures are taken, if deemed necessary.
Domestic Substances List
The DSL is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994. footnote 5 The current structure of the DSL was established in July 2001 footnote 6 and it includes 8 Parts defined as follows:
- Part 1 footnote 7 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 footnote 8 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; and
- Part 8 sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked name and their CAN.
The DSL is amended on average 10 times a year to add or delete substances. A substance must be added to the DSL under section 66 of CEPA if it was manufactured or imported into Canada by any person in a quantity greater than 100 kg in any one calendar year, or if it was in Canadian commerce, or used for commercial manufacturing purposes in Canada between January 1, 1984, and December 31, 1986.
A living organism must be added to the DSL under section 105 of CEPA if it was manufactured or imported in Canada by any person between January 1, 1984, and December 31, 1986, 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, a substance must be added to the DSL under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days once all of the following criteria are met:
- the Minister of the Environment has been provided with information regarding the substance; footnote 9
- 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 accordance with the conditions set out in subsection 87(1) or 112(1) of CEPA by the person who provided the information;
- the period prescribed for the assessment of the information submitted for the substance has expired; and
- the substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture.
Adding 22 substances to the DSL
The Government assessed information on 22 new substances (3 organisms and 19 chemicals and polymers) reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL, under subsections 112(1) [3 substances] and 87(1) and 87(5) [19 substances] of CEPA. These 22 substances were therefore added to the DSL, and are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA.
Objectives
Order 2018-112-05-01 is made pursuant to section 112(1) of CEPA to add three substances (living organisms) to the DSL.
Order 2018-66-05-01 updates the identifier of one substance on the DSL.
Order 2018-87-05-01 is made pursuant to subsections 87(1) and (5) of CEPA to add 19 substances (chemicals and polymers) to the DSL.
By adding 22 substances to the DSL, these substances are no longer subject to the notification and assessment requirements under sections 81, 83, 106 and 108 of CEPA. This is expected to facilitate access to these substances.
Description
The Order 2018-112-05-01 adds three substances (living organisms) to Part 7 of the DSL, all of which are identified by their masked name and their CAN.
The Order 2018-66-05-01 updates the identifier of one substance listed on Part 1 of the DSL.
The Order 2018-87-05-01 adds 19 substances (chemicals and polymers) to the DSL. Six substances identified by their CAS RN are added to Part 1 of the DSL and 13 substances identified by their masked name and their CAN are added to Part 3 of the DSL.
An Order adding a substance to the DSL does not constitute an endorsement from the Department of the Environment or the Government of Canada of the substance to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.
Consultation
As the orders are administrative in nature, no consultation was deemed necessary.
Rationale
Substances new to Canada are subject to notification and assessment requirements before they can be manufactured or imported over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). These regulations were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds are risk assessed to identify potential hazards to the environment and human health, and that appropriate control measures are taken, if deemed necessary.
The Government assessed information on 22 substances new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL and, therefore, they are exempt from notification and assessment requirements under sections 81 and 83 of the Act.
“One-for-One” Rule and small business lens
The orders do not trigger the “One-for-One” Rule, as they do not add any additional costs to business. Also, the small business lens does not apply to the orders as they do not add any administrative or compliance burden to 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.
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