ARCHIVED — Vol. 150, No. 1 — January 13, 2016

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Registration

SOR/2015-256 December 23, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-66-13-01 Amending the Domestic Substances List

Whereras, 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 2015-66-13-01 Amending the Domestic Substances List.

Gatineau, December 17, 2015

Catherine McKenna
Minister of the Environment

Order 2015-66-13-01 Amending the Domestic Substances List

Amendment

1 The description of substance “11079-0” in Part 3 of the Domestic Substances List (see footnote 1) is replaced by the following:

11079-0 N 9,10-Anthracenedione, substituted alkoxyalkoxyalkylamino-
[(((Alcoxy)alcoxy)alkyl)amino]anthracène-9,10-dione

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

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 (i.e. chemicals, polymers, nanomaterials, 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. Adding substances to the Domestic Substances List (DSL) under CEPA 1999 provides better market access.

The Government of Canada assessed information on 10 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the 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 or 112 have been met.

Furthermore, to comply with the Masked Name Regulations under CEPA 1999, an updated masked name for one substance currently on the confidential portion of the DSL was provided to the Government of Canada. Therefore, the Minister of Environment, keeping the substance on the DSL, will update its masked name under section 66 of CEPA 1999.

Background

The Domestic Substances List

The DSL is a list of substances 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.

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.

Environment Canada and Health Canada assessed information on 10 new substances reported to the New Substances Program and determined that they meet the criteria for their addition 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 lesser 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 helps to protect 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.

Objectives

Adding 10 substances to the DSL

The objectives of the Order 2015-87-13-01 Amending the Domestic Substances List are to comply with the requirements under CEPA 1999 and facilitate the import or manufacture of 10 substances by removing reporting requirements under the New Substances Notification Regulations (Chemicals and Polymers).

Modifying the DSL to update one substance’s masked name

The objective of the Order 2015-66-13-01 Amending the Domestic Substances List is to update the masked name of one substance currently on the confidential portion of the DSL to comply with the Masked Name Regulations under CEPA 1999.

Amending the NDSL

The objective of the Order 2015-87-13-02 Amending the Non-domestic Substances List is to delete from the NDSL three substances being added to the DSL. The other seven substances being added to the DSL were not listed on the NDSL.

Description

The Order 2015-87-13-01 Amending the Domestic Substances List adds 10 substances to the DSL. To protect confidential business information, 6 of the 10 substances will have masked chemical names. 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.

The Order 2015-66-13-01 Amending the Domestic Substances List updates the masked name of the substance 9,10-Anthracenedione, substituted alkoxyalkoxyalkylamino-, DSL confidential accession number 11079-0, which is currently on the confidential portion of the DSL. New information indicates that an updated chemical name is available for this substance and therefore the masked name included on the DSL is updated pursuant to the Masked Name Regulations under CEPA 1999. No changes are made to the current status of this substance in the DSL.

“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.

Consultation

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.

Rationale

Ten substances have met the necessary conditions for addition to the DSL. One order adds these substances to the DSL, which exempts them from assessment and reporting requirements under subsection 81(1) of CEPA 1999. Another order updates the masked name of one substance currently listed on the confidential portion of the DSL.

The orders will benefit Canadians by enabling industry to use these substances in larger quantities. The orders will also benefit industry by removing the administrative burden associated with the New Substances Notification Regulations (Chemicals and Polymers) for 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.

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 and update the masked name of one substance currently listed, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

Contact

Greg Carreau
Executive Director
Program Development and Engagement Division
Environment Canada
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: ec.substances.ec@canada.ca

  • Footnote a
    S.C. 1999, c. 33
  • Footnote b
    SOR/94-311
  • Footnote c
    S.C. 1999, c. 33
  • Footnote 1
    SOR/94-311
  • Footnote 2
    SOR/94-311 and the Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establish 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) under CEPA 1999.