Vol. 150, No. 7 — April 6, 2016

Registration

SOR/2016-47 March 16, 2016

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2016-66-04-01 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 2016-66-04-01 Amending the Domestic Substances List.

Gatineau, March 9, 2016

Catherine McKenna
Minister of the Environment

Order 2016-66-04-01 Amending the Domestic Substances List

Amendments

1 Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:

2 Part 3 of the List is amended by deleting the following:

17918-8 N-P

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with 1,3-alkyl, and alkyl 2-propenoates

2-Méthyl-2-propénoate d’alkyle polymérisé avec un 1,3-alkyle et des 2-propénoates d’alkyle

Coming into Force

3 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), 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.

The Government of Canada (the Government) assessed information on 24 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). These substances have therefore been added to the DSL.

The Government determined that due to human health and environmental concerns, specific information on new activities associated with one of these 24 substances (listed on the DSL under the confidential accession number 18923-5) must be submitted prior to the commencement of such activities in Canada. The Significant New Activity (SNAc) provisions under CEPA have therefore been applied for this substance.

In addition, new information provided to the Government indicates that the identity of a substance currently on the confidential portion of the DSL is no longer considered confidential business information. Therefore, the substance identifier has been updated, and the substance was moved from the confidential to the public portion of the DSL.

Background

Addition of 24 substances to the DSL

The DSL is an inventory of substances found in the marketplace in 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. The notification and assessment 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) and the New Substances Notification Regulations (Organisms). These notification and assessment requirements do not apply to substances listed on the DSL.

The DSL was published in the Canada Gazette, Part II, in May 1994 (see footnote 2) and is amended on average 10 times a year. 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 within 120 days once all of the following conditions are met:

Environment Canada and Health Canada assessed information on 24 new substances reported to the New Substances Program and determined that they meet the criteria for addition to the DSL.

SNAc requirements on the substance bearing confidential accession number 18923-5

The assessment of this substance identified potential human health concerns related to oral toxicity, reproductive toxicity, and potential mutagenic/genotoxic effects, as well as potential environmental concerns related to toxicity for aquatic species. For these reasons, the significant new activity provisions of CEPA were applied to the substance before its addition to the DSL, pursuant to a notice published in the Canada Gazette, Part I, in October 2015. (see footnote 4) This substance later became eligible for addition and was added to the DSL under the current amendments. In order to maintain the reporting obligations, the SNAc requirements were also added to the DSL.

Amendments to a substance identifier

To protect confidential business information, a substance bearing the Chemical Abstracts Service Registry Number (CAS RN) 29896-67-1 was added to the DSL in 2008 under the confidential accession number 17918-8. (see footnote 5) In 2015, industry submitted new information indicating that the substance’s identity was no longer considered confidential business information. As a result, the substance identifier has been updated on the DSL, and the substance moved from the confidential portion of the DSL to the public portion.

Objectives

The objectives of the Order 2016-87-04-01 Amending the Domestic Substances List (the Order 2016-87-04-01) are to

The objective of the Order 2016-66-04-01 Amending the Domestic Substances List (the Order 2016-66-04-01) is to update a substance identifier on the DSL. The substance is no longer identified on the DSL by a confidential accession number and a masked chemical name, but rather by its Chemical Abstracts Service Registry Number.

Description

Addition of 24 substances to the DSL

The Order 2016-87-04-01 added 24 substances to the DSL. To protect confidential business information, 12 of the 24 substances have masked chemical names. Masked names are allowed by CEPA if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. (see footnote 6) Substances with a masked name are added on 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.

SNAc requirements on the substance bearing confidential accession number 18923-5

As noted above, the SNAc was originally published in the Canada Gazette, Part I, in October 2015. The substance was not on the DSL at that time. The substance later became eligible and, as a result, the Order 2016-87-04-01 added this substance to Part 4 of the DSL. The Order also indicated that the substance is subject to the SNAc provisions under CEPA. (see footnote 7) This Order has been registered and is in force. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substance for a significant new activity, as defined in this Order.

The SNAc requirements apply to any person who intends to use, manufacture or import the substance for a significant new activity. Any person intending to use, manufacture or import the substance for a significant new activity with the substance must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to the beginning of the significant new activity.

The activities associated with this substance requiring a SNAN submission involve any use in quantities greater than 1 000 kg in a calendar year, other than its use as a component of

The requirements of subsection 81(3) of CEPA do not apply to uses of the substance that are regulated under any of the following Acts of Parliament listed in Schedule 2 of CEPA: the Pest Control Products Act, the Fertilizers Act and the Feeds Act. They also do not apply to transient reaction intermediates that are not isolated and not likely released, impurities, contaminants or partially unreacted materials related to the preparation of a substance or, in some circumstances, to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be notifiable under subsection 81(3) of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 8)

Information must be provided to the Minister of the Environment 90 days prior to the beginning of the significant new activity. Environment Canada and Health Canada will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

Amendments to a substance identifier

The Order 2016-66-04-01 updated a substance’s identifier by removing the confidential accession number 17918-8 and associated masked chemical name from Part 3 of the DSL, and by adding the CAS RN 29896-67-1 to Part 1 of 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 do not contain any information expected to generate comments or objections by stakeholders, no consultation is deemed necessary.

Rationale

The Government assessed information on 24 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the DSL. These substances have therefore been added to the DSL.

The Government determined that due to human health and environmental concerns, specific information on new activities associated with one of these 24 substances (listed on the DSL under the confidential accession number 18923-5) must be submitted prior to the commencement of such activities in Canada. The SNAc provisions under CEPA have therefore been applied for this substance.

In addition, new information provided to the Government indicated that the identity of a substance currently on the confidential portion of the DSL was no longer considered confidential business information. Therefore, the substance identifier has been updated and the substance moved from the confidential to the public portion of the DSL.

The orders will benefit Canadians by enabling industry to have better access to larger quantities of these substances, which is expected to reduce costs associated with their use in products consumed by Canadians.

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

Addition of 24 substances to the DSL and amendments to a substance identifier

The DSL identifies substances that, for the purposes of CEPA, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). Developing an implementation plan and a compliance strategy or establishing a service standard is not required when adding substances to the DSL or updating a substance identifier on the DSL.

SNAc requirements on the substance bearing confidential accession number 18923-5

When assessing whether or not a particular activity meets the definition of significant new activities on the DSL, a person is expected to make use of information in their possession or to which they ought to have access. (see footnote 9) The phrase “to which they ought to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product, are expected to have access to import records, usage information and the relevant Safety Data Sheet (SDS).

Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. In this regard, an SDS may not list all substances that may be subject to SNAc provisions due to public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact his or her supplier.

If any information becomes available that reasonably supports the conclusion that the substance is toxic or capable of becoming toxic, the person who obtains the information and is involved in activities with the substance is obligated, under section 70 of CEPA, to provide that information to the Minister of the Environment without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of the substance from another person, he or she may not be required to submit a SNAN, under certain conditions, if his or her activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999, provides more detail on this subject. (see footnote 10)

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the New Substances Program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

Individuals who have questions concerning their obligations to comply with the Order, who believe they may be out of compliance or who would like to request a PNC are encouraged to contact the Substances Management Information Line. (see footnote 11) The Program will work with the individuals to help them comply with the Order.

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 12) In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent and history of compliance.

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: eccc.substances.eccc@canada.ca