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Canada Gazette, Part 2, Volume 153, Number 3: Order 2019-66-01-01 Amending the Domestic Substances List
Order 2019-66-01-01 Amending the Domestic Substances List: SOR/2019-20
SOR/2019-20 January 24, 2019
Whereas the Minister of the Environment is satisfied that the substance referred to in the annexed Order was, between January 1, 1984 and December 31, 1986, imported into Canada by a person in a quantity of not less than 100 kg in any one calendar day, meeting the requirement set out in paragraph 66(1)(a) of the Canadian Environmental Protection Act, 1999 footnote a;
Therefore, the Minister of the Environment, pursuant to subsection 66(3) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2019-66-01-01 Amending the Domestic Substances List.
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The Government of Canada (the Government) assessed information on 10 substances (chemicals and polymers) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government is adding 10 substances to the DSL. The Government is also adding a Chemical Abstracts Service Registry Number (CAS RN or CAS number) to the DSL as proposed by industry regarding a substance that is meeting the requirement set out in paragraph 66(1)(a) of the Canadian Environmental Protection Act, 1999 (CEPA).
Substances (chemicals and polymers) that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements set out in sections 81 and 83 of the Canadian Environmental Protection Act, 1999, as well as in the New Substances Notification Regulations (Chemicals and Polymers). These Regulations ensure that new substances introduced to the Canadian marketplace over certain quantities are assessed to identify potential risks to the environment and to human health, and that appropriate control measures are taken, if deemed necessary.
For more information on the thresholds and scope of the above-mentioned Regulations, please see section 1 in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.
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), published in the Canada Gazette, Part II, in July 2001, which establishes the structure of the DSL, 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 Abstracts 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 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 in 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 DSL under subsections 87(1) or 87(5) 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);
For substances added pursuant to subsection 87(1) or 87(5) 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 by the person who provided the information;
Adding the 11 substances to the DSL
The Government assessed information on 10 new substances (chemicals and polymers) and determined that they meet the criteria for their addition to the DSL, under subsection 87(5) of CEPA. These 10 substances are therefore being added to the DSL and are no longer subject to the notification and assessment requirements under sections 81 and 83 of CEPA.
The industry has communicated information on a substance that meets the requirement set out in paragraph 66(1)(a) of CEPA. Therefore, the Government is now adding the CAS number of one substance to the DSL under subsection 66(3) of CEPA.
The Order 2019-87-01-01 Amending the Domestic Substances List (Order 2019-87-01-01) adds 10 substances to the DSL, and the Order 2019-66-01-01 Amending the Domestic Substances List (Order 2019-66-01-01) adds the CAS number of one substance to the DSL. These amendments to the DSL are expected to facilitate access to the 11 substances for businesses by reducing cost and administrative burden, such as notifications and assessment requirements.
Order 2019-87-01-01 is made pursuant to section 87(5) of CEPA to add 10 substances (chemicals and polymers) to the DSL:
Two substances identified by their CAS RN are added to Part 1 of the DSL; and
Eight 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 2019-66-01-01 is made pursuant to subsection 66(3) of CEPA to add one CAS number of one chemical substance to the DSL:
One CAS RN is added to Part 1 of the DSL.
As CEPA does not prescribe any public comment period before adding a substance to the DSL, no consultation period for orders 2019-87-01-01 and 2019-66-01-01 was deemed necessary.
The Government assessed information on 10 new substances to Canada that were subject to notification and assessment requirements, as set out in sections 81 and 83 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers). The assessment determined that the 10 substances do not pose risks to the environment or to 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 and 83 of CEPA.
In addition, the Government adds the CAS number of one substance to the DSL since it is satisfied that the substance was, between 1984 and 1986, manufactured in or imported into Canada in a quantity greater than or equal to 100 kilograms in any one calendar year. This substance meets the criteria for addition to the DSL.
Since the orders 2019-87-01-01 and 2019-66-01-01 decrease administrative burden by removing notification and information requirements on the 11 substances, the “One-for-One” Rule and the small business lens do not apply to these orders, as they do not impose any new administrative or compliance cost on small businesses.
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 (PNC), 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 11 substances to which they relate, 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 2019-87-01-01 and 2019-66-01-01 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.