Environment Canada Issues Mandatory Information Request for 850 Chemical Substances

On June 24, 2023, the Science and Risk Assessment Directorate of Environment Canada published a notice in the Canada Gazette, the Canadian equivalent of the United States Federal Register, that enumerated a mandatory information request for 850 chemical substances for the purpose of assessing whether these substances are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control or the manner in which to control the listed substances under the  Chemicals Management Plan — 2023. The notice details the information that manufacturers, importers, and users of the identified substances will be required to submit.

These 850 substances at issue are divided into four categories:

  • Part 1: Substances for which reporting is required if manufacture, import, or use is 100 kg or more;
  • Part 2: Substances for which reporting is required if manufacture, import, or use is 1,000 kg or more;
  • Part 3: Substances for which reporting is required if import and use for a specific application(s) is 100 kg or more; and
  • Part 4: Substances for which reporting is required if manufacture, import, and use “with additional use activity” is 100 kg or more.

In the notice, Environment Canada grouped reporting requirements by threshold, concentration, and intended use. Reporting is required for substances present at a concentration greater than or equal to 0.1 percent in a mixture or product. In addition, reporting is required for substances present in certain manufactured items (defined as items that are formed into a specific physical shape or design during manufacture and have, for their final use, a function or functions dependent in whole or in part on its shape or design) including products:

  • Intended to be used by or for children under the age of 14 years;
  • Intended to come into contact with the mucosa of an individual other than eyes;
  • Intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual;
  • Present in cookware or cooking or serving utensils;
  • Present in food packaging material;
  • Present in clothing or footwear;
  • Present in bedding, sleeping bags, or towels;
  • Present in some furniture, mattresses, cushions, or pillows; and
  • Present in some flooring materials.

Reporting is not required for substances covered by other regulations, including substances that is or is contained in:

  • A pest control product registered under the Pest Control Products Act
  • A fertilizer or supplement registered under the Fertilizer Act
  • A feed registered under the Feeds Act

Additionally, there are exemptions for tetrachloroethylene used in specific situations, such as solvent degreasing and used in dry cleaning. Substances solely in transit through Canada will also be exempt.

Information required includes the concentration, or range of concentrations, of the substance by in goods, where applicable; substance functions; information on commercial and consumer, including use by children; and the title(s) of any unpublished data or studies related to the substance that has not already been provided to the Government of Canada.

Responses are due by January 17, 2024, and must be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window.

Canada imposes new reporting requirements for nanoscale substances.

Canada’s Minister of the Environment is requiring manufacturers and importers of certain nanoscale substances to report information for “the development of a list of nanomaterials in commerce in Canada and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities.”

A notice published in the Canada Gazette on July 25 lists 206 substances by CAS number. A listed substance is reportable if it “has a size of between 1 and 100 nanometres in at least one external dimension, or internal or surface structure.” The Minister of Environment intends to use the reported data to assess whether the listed substances “are toxic or are capable of becoming toxic,” or to assess whether and how to control the substances.

The reporting requirements apply to any person who manufactured or imported more than 100 kg of a listed nanoscale substance in calendar year 2014, including imports of substances in mixtures and products, at any concentration. However, the notice does not apply to listed nanoscale substances that are in transit through Canada, are naturally occurring, were incidentally produced, or are covered by various other laws, such as the Fertilizers Act or Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations.

Reportable information includes total quantities manufactured or imported, end uses (commercial, consumer, or use by children under 14 years of age) and studies or data on physical-chemical properties, bioaccumulation, persistence, toxicity, metabolism, degradation, and release or disposal from the final mixture or product. The reporting deadline is February 23, 2016.

Canada begins phase-in of GHS with Hazardous Products Regulation.

Earlier this month, Canada published final regulations implementing the Globally Harmonized System (GHS) for Classification and Labeling of Chemicals. The Hazardous Products Regulation (HPR) aligns closely with the United States’ Hazard Communication Standard and the United Nations’ fifth revision of the GHS. The HPR harmonizes criteria for hazard classification, labels, and safety data sheets, but will not otherwise change the roles and responsibilities for suppliers, employers and workers. A goal of GHS is to allow chemical suppliers to use “a single label and SDS for each hazardous product.”

Adoption of the HPR marks the beginning of Canada’s three-phase transition to GHS, similar to the U.S. approach to implementing GHS. Canada’s transition is scheduled to be completed by December 1, 2018.

U.S.-Canada joint consultation process for new substances in the works.

Last week, Chemical Watch reported that the U.S. EPA and Environment Canada are developing a joint process that will allow “companies planning to introduce a new substance in both countries to approach both governments simultaneously.” The joint consultation process, called the North American Notification Consultation (Nan-C), was described by an Environment Canada official on October 8 at a conference in Mississauga, Canada. Although it is still in an early stage of development, the official described it as based on the OECD’s “Parallel Process” standard operating procedures for new substance notifications. One company is already participating in the Nan-C process, and other companies interested in trying it are encouraged to contact Environment Canada through their substances management information line.

The idea for the process reportedly emerged from a nanotechnology workshop held earlier this year by the US-Canada Regulatory Cooperation Council. However, Environment Canada representatives stressed that Nan-C is not meant to replace the OECD parallel process, but is simply a more streamlined and bilateral version specific to the U.S. and Canada. Nan-C is also not a wholly new process, since bilateral consultation is already an option – instead, it is a response to a perceived need among stakeholders for a more formalized version of a pre-existing mechanism.

Upcoming Event: Chemical Regulation in Canada – Lessons for U.S. Reforms

TSCA/CEPA:

Readers attending the ABA’s meeting in Toronto in August may be interested in the following event concerning the Canadian system for regulating industrial chemicals and lessons that system may offer the United States as it debates TSCA Reform.  A short description is embedded below, and more information about the annual meeting is available here.  The list of speakers is impressive, so the event should prove worth the time investment. 

3:45 p.m. to 5:15 p.m.

Chemical Regulation in Canada—Lessons for U.S. Reforms

Room 801A, 800 Level, MTCC, South Building

Everyone agrees that chemical regulation in the US needs to be updated. Industry, NGOs and the EPA all find fault with TSCA, the 1976 law that still governs the process. The EU and Canada are both implementing new, ambitious programs that provide models and cautionary experiences for US reforms. The EU’s REACH program has been widely criticized for needless expense and complexity and for producing slow results. The Canadian Environmental Protection Act, by contrast, is frequently cited by stakeholders as a better approach. This program will focus on features of CEPA that make it apparently more efficient and productive, and explore how compatible those processes would be with US law and expectations regarding transparency, participation and due process.

Moderator:

James Conrad, Washington, D.C.

Panelists:

Joseph Castrilli, Toronto, Ontario, Canada

Mark Duvall, Washington, D.C.

Robert Fishlock, Toronto, Ontario, Canada

Karen Levins, Mississauga, Ontario, Canada

Additional Sponsor:

Section of Environment, Energy, and Resources

 

Health Canada Publishes FAQs on Canada Consumer Product Safety Act

Consumer Products:

On May 17, 2011, Health Canada published a Frequently Asked Questions (FAQ) document concerning the Canada Consumer Product Safety Act (CCPSA).  The CCPSA enters into force on June 20, 2011, and many questions remain unanswered.  Industry and other stakeholders have been waiting for more detailed instructions from the agency.  A copy of the CCPSA is available here, and the FAQ is available here.

A broad range of products and associated packaging are covered by the CCPSA.  Under the Act, a “consumer product” is defined as a product, including its components, parts or accessories that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging. Section 4 of the Act outlines the consumer products to which the CCPSA does not apply, including those listed in Schedule I. These include products that are covered under other legislation such as food, cosmetics, medical devices, drugs, natural health products, pest control products, fertilizers and vehicles.

The FAQ includes a fairly comprehensive set of questions.  The following examples are provided for the reader’s convenience:

Q. Does my product fall under the Canada Consumer Product Safety Act (CCPSA)?

Q. Is Health Canada considering adding certain products to the list of products to which the Canada Consumer Product Safety Act (CCPSA) does not apply?

Q. The definition of “consumer product” contains terms such as “obtained” and “non-commercial purposes” which are not defined in the Act. Is Health Canada going to provide definitions or guidance on these terms?

Q. Will there be a transition period for the implementation of the Canada Consumer Product Safety Act (CCPSA) and regulations, and if so, how long will it be?

Q. What does it mean in practice for the Minister to have the authority to order a recall?

Q. What is Mandatory Reporting?

Q. How do I determine what is considered as a reportable incident?

Q. Will the Canada Consumer Product Safety Act (CCPSA) Mandatory Reporting requirements be retroactive? For example, at the time that the Act comes into force on June 20th, 2011, will manufacturers, importers and retailers be required to report incidents that happened prior to that date?

Q. If a product falls under the purview of both the Canada Consumer Product Safety Act (CCPSA) and another statute, such as a provincial one, will Health Canada be the primary reporting body that will distribute the incident report information to the other regulatory body?

Q. Does a recall undertaken in another country need to be reported in Canada as well?

Q. Is Health Canada planning to require traceability of components of consumer products?

Q. When can we expect to see new regulations under the Canada Consumer Product Safety Act (CCPSA)?

Q. When will the regulations for Administrative Monetary Penalties be developed?

Q. Will certain organizations be exempt from the Canada Consumer Product Safety Act (CCPSA)?

Q. What safeguards are in place to protect Confidential Business Information submitted to Health Canada?

Readers interested in consumer product safety should continue to follow Canada’s implementation of this important new law.