SOR/2015-48 February 23, 2015
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2015-66-01-01 Amending the Domestic Substances List
Whereas, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote a), the Minister of the Environment is required to maintain the Domestic Substances List (see footnote b);
Therefore, the Minister of the Environment, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2015-66-01-01 Amending the Domestic Substances List.
Gatineau, February 18, 2015
Minister of the Environment
ORDER 2015-66-01-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. In Part 1 of the Domestic Substances List (see footnote 1), the reference to “57635-48-0 N-P” is replaced by “57635-48-0 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.)
Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), substances (chemicals, polymers, and living organisms) “new” to Canada are subject to reporting requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed, where appropriate.
Environment Canada and Health Canada assessed the information on 22 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). Under CEPA 1999, the Minister of the Environment must add a substance to the DSL within 120 days after the criteria listed in section 87 have been met.
In addition, Environment Canada and Health Canada have reviewed new information for one substance on the DSL subject to significant new activity (SNAc) provisions under CEPA 1999. The assessment concluded that the substance is not of concern to human health or the environment and, thus, the SNAc provisions requirements for the substance are no longer warranted.
The Domestic Substances List
The DSL is a list of substances (chemicals, polymers, and living organisms) that are considered “existing” in Canada for the purposes of CEPA 1999. “New” substances are not on the DSL and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in subsections 81(1) and 106(1) of CEPA 1999, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).
The DSL was published in the Canada Gazette, Part II, in May 1994. (see footnote 2) The DSL is amended 10 times a year, on average; these amendments may add or remove substances or make corrections to the DSL.
The Non-domestic Substances List
The Non-domestic Substances List (NDSL) is a list of substances “new” to Canada that are subject to reduced notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year. The NDSL only applies to chemicals and polymers.
The United States and Canada have similar new substances programs to assess new chemicals’ impact on human health and the environment prior to manufacture in or import into the country. Substances are eligible for listing on the United States Toxic Substances Control Act (TSCA) Inventory once they have undergone a new substances assessment in the United States. Substances that have been listed on the public portion of the TSCA Inventory for a minimum of one calendar year and that are not subject to risk management controls in either country are eligible for listing on the NDSL. On a semi-annual basis, Canada subsequently updates the NDSL based on amendments to the United States TSCA Inventory.
While chemicals and polymers on the DSL are not subject to the New Substances Notification Regulations (Chemicals and Polymers), those on the NDSL remain subject to them but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States. This protects human health and the environment by ensuring that NDSL substances will undergo risk assessments in Canada, but leverages assessments conducted in the United States to lessen the reporting requirements imposed on industry.
Once substances are added to the DSL, they must be deleted from the NDSL, as a substance cannot be on both the DSL and the NDSL simultaneously because these lists involve different regulatory requirements.
Rescission of significant new activity provisions requirements
In the current Order 2015-87-01-01 Amending the Domestic Substances List, the SNAc provisions under CEPA 1999 for the substance with the Chemical Abstracts Service Registry Number 1871-22-3 is proposed to be removed. The SNAc provisions were applied to the aforementioned substance and 144 other substances on June 10, 2008, in the Order 2008-87-01-01 Amending the Domestic Substances List. The SNAc provisions were applied as the substances were not in commerce in Canada and, based on the available information at the time, were considered to be persistent, bioaccumulative and inherently toxic to non-human organisms (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/pbit145-eng.php). The SNAc provisions require notification of these substances prior to their re-introduction into the Canadian marketplace at quantities greater than 100 kg per calendar year. Should notification occur, it would trigger additional assessment to determine if further risk management consideration is required.
In 2014, the aforementioned substance was reassessed as part of an evaluation of an Aromatic Azo and Benzidine-based Substance Grouping. The final assessment concluded that this substance is no longer of concern to human health or the environment (http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=6A3D4735-1). As a result, the SNAc provisions for this substance are no longer warranted, and it is henceforth included for addition to Part 1 of the DSL (non-confidential public portion) in the current Order 2015-87-01-01 Amending the Domestic Substances List.
As part of a broader review exercise (http://chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php), Environment Canada and Health Canada are considering reviewing Order 2008-87-01-01 Amending the Domestic Substances List relating to the SNAc provisions on the remaining 141 of the original 145 substances based on the availability of new data. Should stakeholders have new information or commercial interest in any of these substances, they are encouraged to contact the program or request a pre-notification consultation or to submit the new information through the Substances Management Information Line: email@example.com (email), 1-800-567-1999 (toll-free in Canada), 819-938-3232 (outside of Canada).
The objectives of the Order 2015-87-01-01 Amending the Domestic Substances List and the Order 2015-66-01-01 Amending the Domestic Substances List (hereafter referred to as the orders) are to comply with the requirements of CEPA 1999 and facilitate access to and use of 22 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture. Furthermore, additional objectives of the orders are to modify the description of one substance identifier in Part 1 of the DSL to better reflect the substance identity, and cancel the obligations under the SNAc provisions of CEPA 1999 concerning one substance.
The orders add 22 substances to the DSL. To protect confidential business information, 14 of the 22 substances being added to the DSL will have masked chemical names.
Furthermore, as substances cannot be on both the DSL and the NDSL simultaneously, the Order 2015-87-01-02 Amending the Non-domestic Substances List will delete 2 of the 22 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.
Additions to the Domestic Substances List
A substance must be added to the DSL under subsections 87(1) or (5) of CEPA 1999 within 120 days once all of the following conditions are met:
- the Minister of the Environment has been provided with information regarding the substance; (see footnote 3)
- the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada under the conditions set out in section 87 of CEPA 1999 by the person who provided the information;
- the period prescribed for the assessment of the submitted information for the substance has expired; and
- the substance is not subject to any conditions imposed on its import or manufacture.
Modifications to the Domestic Substances List
The Order 2015-66-01-01 Amending the Domestic Substances List modifies the description of one substance identifier in Part 1 of the DSL to make the information reflected by this identifier more accurate.
Rescission of significant new activity provisions requirements for substances on the Domestic Substances List
The Order 2015-87-01-01 Amending the Domestic Substances List rescinds the obligations under the SNAc provisions of CEPA 1999 concerning one substance (Chemical Abstracts Service Registry Number 1871-22-3) from Part 2 of the DSL. This substance is to be moved to Part 1 of the DSL.
Publication of masked names
The orders mask the chemical name of 14 of the 22 substances being added to the DSL. Masked names are allowed by CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under CEPA 1999. Substances with a masked name are added under the confidential portion of the DSL. Anyone who wishes to determine if a substance is on the confidential portion of the DSL must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.
“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 it is not expected to add any administrative or compliance burden to small businesses. Rather, the orders provide industry with better access to the 22 substances being added to the DSL.
As the orders are administrative in nature and do not contain any information that would be subject to comment or objection by the general public, no consultation is required.
Twenty-two substances have met the necessary conditions for addition to the DSL. The orders add these substances to the DSL to exempt them from assessment and reporting requirements under subsection 81(1) of CEPA 1999.
The orders will benefit Canadians by enabling industry to use these substances in larger quantities. The orders will also benefit industry by reducing the administrative burden associated with the current regulatory status of these substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the orders. However, the Government of Canada may still decide to assess any substance on the DSL under the existing substances provisions of CEPA 1999 (section 68 or 74).
Implementation, enforcement and service standards
The DSL identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). As the orders only add substances to the DSL, developing an implementation plan or a compliance strategy or establishing a service standard is not required.
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
- Footnote a
S.C. 1999, c. 33
- Footnote b
- Footnote c
S.C. 1999, c. 33
- Footnote 1
- Footnote 2
The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the Domestic Substances List. For more information, please visit http://publications.gc.ca/gazette/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf.
- Footnote 3
The most comprehensive package, with information about the substances, depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) under CEPA 1999.