Vol. 151, No. 14 — July 12, 2017

Registration

SOR/2017-150 June 23, 2017

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2017-112-05-01 Amending the Domestic Substances List

Whereas the Minister of the Environment has been provided with information under paragraph 112(1)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) in respect of the living organism referred to in the annexed Order;

Whereas, in respect of the living organism being added to the Domestic Substances List (see footnote b) pursuant to subsection 112(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that the living organism has been manufactured in or imported into Canada by the person who provided the information prescribed under the New Substances Notification Regulations (Organisms) (see footnote c);

Whereas the period for assessing the information under section 108 of that Act has expired;

And whereas no conditions under paragraph 109(1)(a) of that Act in respect of the living organism are in effect;

Therefore, the Minister of the Environment, pursuant to subsection 112(1) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2017-112-05-01 Amending the Domestic Substances List.

Gatineau, June 20, 2017

Catherine McKenna
Minister of the Environment

Order 2017-112-05-01 Amending the Domestic Substances List

Amendment

1 Part 5 of the Domestic Substances List (see footnote 1) is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:

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

Under the Canadian Environmental Protection Act, 1999 (CEPA), substances (i.e. chemicals, polymers, nanomaterials, and living organisms) new to Canada are subject to notification and assessment 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.

The Domestic Substances List (DSL) is an inventory of substances in the Canadian marketplace. When substances new to Canada meet the criteria for addition to the DSL, they must be added to this List. A substance on the DSL can be used by industry in larger quantities than a substance that is not on this List. Adding substances to the DSL is expected to reduce costs associated with products consumed by Canadians.

When substances are suspected of posing a risk to human health or the environment if used in certain new activities, they can be added to the DSL with requirements under the significant new activity (SNAc) (see footnote 2) provisions of CEPA. This provides industry with access to substances while protecting human health and the environment in Canada. When new information shows that substances on the DSL subject to SNAc requirements are no longer suspected of posing a risk to human health or the environment if used in certain new activities, these requirements can be varied or rescinded.

Under the authority of CEPA, the Government of Canada (the Government) assessed information on 19 substances new to Canada and added them to the DSL. Furthermore, based on new information, the Government rescinded SNAc requirements concerning 33 substances and updated the identifiers of 4 substances on the DSL.

Background

Substances new to Canada

Substances that are not on the DSL are considered new to Canada 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, as well as in the New Substances Notification Regulations (Chemicals and Polymers) (see footnote 3) and the New Substances Notification Regulations (Organisms). (see footnote 4)

Substances on the DSL

The DSL is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994. (see footnote 5) The DSL is amended on average 10 times a year to add or delete substances. These amendments may also include additions, variations, or rescissions of SNAc requirements on the DSL.

The current structure of the DSL was established in July 2001; (see footnote 6) it includes eight parts defined as follows:

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:

Adding 19 substances to the DSL

The Government assessed information on 19 new substances (18 chemicals and polymers and one living organism) reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL. These substances were therefore added to the DSL. This will facilitate their import or manufacture by removing the notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).

Rescinding SNAc requirements on 33 substances

Under subsection 87(3) or 112(3) of CEPA, reporting obligations may be imposed, varied and rescinded in relation to significant new activities associated with substances on the DSL, if the Government deems it necessary based on available information. The information submitted enables the Government to assess risks associated with proposed new uses of substances and determine whether additional risk management may be required.

The Government reviewed the SNAc requirements for 33 substances already on the DSL. Reporting obligations were imposed on these substances because they were considered to present an ecological risk based on available information at the time. The SNAc provisions of CEPA were applied to the substances in June 2008 (see footnote 10) and September 2009. (see footnote 11) The 33 substances were not considered to present a human health risk.

The 33 substances were re-evaluated as part of the Aromatic Azo and Benzidine-based Substance Grouping under the Chemicals Management Plan. (see footnote 12) The final assessment published in March 2017 (see footnote 13) indicated that these 33 substances are no longer considered to have ecological effects of concerns, nor considered as having health effects of concerns under CEPA. As a result, the SNAc requirements on these substances were no longer warranted and were thus removed from the DSL.

Updating the identifiers for four substances

To protect confidential business information, four substances were added to the DSL in 2011 (see footnote 14) and 2012 (see footnote 15) under their masked name and CANs (18325-1; 18324-0; 18323-8; and 18356-5). In 2017, industry submitted new information indicating that the identity of these substances was no longer considered confidential business information. As a result, the substance identifiers have been updated on the DSL. They are now identified by their CAS RNs (848301-65-5; 848301-66-6; 848301-67-7; and 848301-69-9) and were moved from Part 3 to Part 1 of the DSL.

Objectives

The objectives of Order 2017-87-05-01 Amending the Domestic Substances List are to (a) comply with subsection 87(5) of CEPA by adding 18 substances to the DSL and (b) rescind the SNAc requirements concerning 33 substances, as the assessment conclusions regarding these substances have been updated.

The objective of Order 2017-112-05-01 Amending the Domestic Substances List is to comply with subsection 112(1) of CEPA by adding one living organism to the DSL.

The objective of Order 2017-66-05-01 Amending the Domestic Substances List is to update identifiers of four substances on the DSL.

Description

Order 2017-87-05-01 added 18 substances to the DSL. Fourteen substances identified by their CAS RN were added to Part 1 of the DSL and four substances identified by their masked name and their CAN were added to Part 3. This Order also rescinded the SNAc requirements concerning 33 substances by moving the substances from Part 2 to Part 1 of the DSL.

Order 2017-112-05-01 added one living organism identified by its specific substance name to Part 5 of the DSL.

Order 2017-66-05-01 updated the identifiers of four substances by removing CANs 18325-1; 18324-0; 18323-8; and 18356-5 and associated masked names from Part 3 of the DSL, and adding CAS RNs 848301-65-5; 848301-66-6; 848301-67-7; and 848301-69-91 to Part 1 of the DSL.

Consultation

As these orders do not contain any information expected to generate comments by stakeholders, no consultation is deemed necessary.

Rationale

Under CEPA, substances new to Canada are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate.

The Government assessed information on 19 substances (18 chemicals and polymers and one living organism) new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL.

The Government reviewed the SNAc requirements concerning 33 substances on the DSL. The review concluded that these substances are no longer considered to be of concern. Therefore, the SNAc requirements on these substances were removed from the DSL.

Based on new information, identifiers of four substances have been updated on the DSL.

The orders will benefit Canadians by enabling industry to have access to larger quantities of these substances while managing potential human health or environmental risks associated with them where appropriate. This is expected to reduce costs associated with products consumed by Canadians. It is also expected that there will be no incremental costs to the public, industry, or governments associated with these orders.

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

The orders do not trigger the “One-for-One” Rule, as it does 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, rescinding SNAc requirements, or updating substance identifiers.

Contact

Jake Sanderson
Acting 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