Vol. 151, No. 26 — December 27, 2017

Registration

SOR/2017-281 December 11, 2017

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment is satisfied that the substances referred to in the annexed Order were, 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 year, meeting the requirement set out in paragraph 66(1)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) ;

Therefore, the Minister of the Environment, pursuant to subsection 66(3) of the Canadian Environmental Protection Act, 1999 (see footnote b), makes the annexed Order 2017-66-10-01 Amending the Domestic Substances List.

Gatineau, December 7, 2017

Catherine McKenna

Minister of the Environment

Order 2017-66-10-01 Amending the Domestic Substances List

Amendment

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

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

The Government of Canada (the Government) assessed information on 11 substances new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government added nine substances to the DSL under the Order 2017-87-10-01 Amending the Domestic Substances List (Order 2017-87-10-01) and two substances under the Order 2017-66-10-01 Amending the Domestic Substances List (Order 2017-66-10-01).

The Government identified potential human health concerns if one of the 11 substances (CAN 18563-5) is used in certain new activities. For this reason, reporting obligations under the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) were also added to the DSL under Order 2017-87-10-01 with regards to this substance.

Background

Assessment of substances new to Canada

Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 109 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) (see footnote 2) and the New Substances Notification Regulations (Organisms). (see footnote 3) Both regulations are administered by the New Substances Program and were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds (see footnote 4) are risk assessed to identify potential hazards to the environment and human health, and that appropriate control measures are taken, if deemed necessary.

Domestic Substances List

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

The DSL is amended on average 10 times a year to add or delete substances. A substance must be added to the DSL under section 66 of CEPA if it was manufactured or imported into Canada by any person in a quantity greater than 100 kg in any one calendar year, or if it was in Canadian commerce, or used for commercial manufacturing purposes in Canada between January 1, 1984, and December 31, 1986.

In addition, 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:

Amendments to the DSL may also add, vary or rescind reporting obligations imposed under the SNAc provisions of CEPA. 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 reporting obligations under subsection 87(3) or 112(3) of CEPA. The information submitted enables the Government to assess risks associated with proposed new uses of substances before they are undertaken in Canada and determine whether additional risk management may be required. (see footnote 10)

Adding 11 substances to the DSL

The Government assessed information on 11 new substances reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL, under section 87 of CEPA (nine substances) and section 66 (two substances). These 11 substances were therefore added to the DSL and are no longer subject to the notification and assessment requirements under sections 81 and 83 of CEPA.

The Government identified potential human health concerns if one of the 11 substances (CAN 18563-5) is used in certain new activities. For this reason, the SNAc provisions under CEPA were applied to this substance in June 2013, (see footnote 11) before its addition to the DSL. In order to maintain the reporting obligations associated with the substance, SNAc requirements were also added to the DSL under Order 2017-87-10-01.

Objectives

Order 2017-87-10-01 is made in compliance with subsection 87(1), (3) and (5) of CEPA by adding nine substances to the DSL and maintaining the SNAc requirements associated with the substance CAN 18563-5.

Order 2017-66-10-01 is made in compliance with subsection 66(3) of CEPA by adding two substances to the DSL.

Description

Order 2017-87-10-01 Amending the Domestic Substances List

This Order adds nine substances to the DSL. Five substances identified by their CAS RN are added to Part 1 of the DSL and three substances identified by their masked name and their CAN are added to Part 3 of the DSL.

One substance identified by its masked name and its CAN is added to Part 4 of the DSL. This substance (CAN 18563-5) is subject to the SNAc provisions under CEPA. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substances for a significant new activity as defined in this Order.

According to subsection 81(3) of CEPA, any person who intends to use, manufacture or import the substance for a significant new activity must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order. Information must be provided to the Minister of the Environment 90 days prior to the beginning of the significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

Significant New Activities requiring a SNAN submission

A transitional period for the SNAc requirements is included in the Order to facilitate compliance by persons who would already have imported or manufactured up to 1 000 kg of the substance CAN 18563-5 and would have started activities with it. Until January 24, 2019, the significant new activities requiring a SNAN submission are defined as

  1. The use, in the manufacture of coatings or adhesives that are consumer products to which the Canada Consumer Product Safety Act applies, of the substance in a quantity greater than 1 000 kg in a calendar year and in such a manner that the substance is present in the coating or adhesive.
  2. The use, in a quantity greater than 1 000 kg in a calendar year, of the substance in coatings or adhesives that are consumer products to which the Canada Consumer Product Safety Act applies.

As of January 24, 2019, the significant new activities requiring the submission of a SNAN will be re-defined as follows:

  1. The use, in the manufacture of coatings or adhesives that are consumer products to which the Canada Consumer Product Safety Act applies, of the substance in such a manner that the substance is present in those products in a concentration that is greater than or equal to 1% by weight.
  2. The use, in a quantity greater than 10 kg in a calendar year, of the substance in a coating or an adhesive that are consumer products to which the Canada Consumer Product Safety Act applies, in which the substance is present in a concentration that is greater than or equal to 1% by weight.
Activities not subject to the SNAc requirements

The following activities with substance CAN 18563-5 do not require the submission of a SNAN:

  1. The substance is used as a research and development substance, i.e. it is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, whose primary objective is any of the following:
    • a. to create or improve a product or process;
    • b. to determine the technical viability or performance characteristics of a product or process; or
    • c. to evaluate the substance prior to its commercialization, by pilot plant trials, production trials, including scale-up, or customer plant trials, so that technical specifications can be modified in response to the performance requirements of potential customers.
  2. The substance is a site-limited intermediate, i.e. it is consumed in a chemical reaction used for the manufacture of another substance and that is
    • a. manufactured and consumed at the site of manufacture;
    • b. manufactured at one site and transported to a second site where it is consumed; or
    • c. imported and transported directly to the site where it is consumed.
  3. The substance is used in a consumer product, as described in the Order, that is for export only.
  4. The substance is used in activities regulated under the Acts of Parliament listed in Schedule 2 of CEPA, namely the Pest Control Products Act, the Fertilizers Act and the Feeds Act.
  5. The substance is a transient reaction intermediate that is not isolated and is not likely released, an impurity, a contaminant, or a partially unreacted material related to the preparation of a substance or in some circumstances an item such as waste, mixture or manufactured item. 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 12)
Order 2017-66-10-01 Amending the Domestic Substances List

This Order adds two substances identified by their CAS RN to Part 1 of the DSL.

Consultation

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

Rationale

Substances new to Canada are subject to notification and assessment requirements before they can be manufactured or imported over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). These regulations were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds are risk assessed to identify potential hazards to the environment and human health and that appropriate control measures taken, if deemed necessary.

The Government assessed information on 11 substances new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL and therefore they are exempt from notification and assessment requirements under sections 81 and 83 of the Act.

Due to potential human health concerns, SNAc requirements for the substance CAN 18563-5 have been maintained and added to the DSL. This will enable the Government to assess the risks associated with significant new activities involving this substance before they are undertaken.

“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.

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 or maintaining SNAc requirements.

When assessing whether or not a particular activity meets the definition of significant new activity 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 13) 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 a 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. Therefore, a 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 their 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, they may not be required to submit a SNAN, under certain conditions, if their 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 14)

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. Where a person/notifier has questions concerning their obligations to comply with the order or believes they may be out of compliance, or, would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line. (see footnote 15)

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 16) 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

Julie Thompson
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