Canada Requests Input on Proposed CCPSA Requirements for Consumer Chemical Products

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Health Canada has released a notice of intent requesting comments on proposed regulatory requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA).  The Department says it will use the comments and information received to shape a potential regulatory initiative that would mandate information disclosure and other requirements for certain human health hazards of concern (HHHOCs) in consumer products.

The 2001 Consumer Chemicals and Containers Regulations use restrictions on dangerous consumer chemical products, information disclosure requirements, and container requirements to address acute human health and physical hazards, such as acute toxicity and corrosivity.  However, the 2001 regulations do not include requirements to mitigate risks from HHHOCs, which include carcinogenicity, germ cell mutagenicity, reproductive toxicity, specific organ toxicity, and respiratory/skin sensitization.

The initiative would implement hazard classification criteria for HHHOCs consistent with the United Nations Globally Harmonized System (GHS), establish disclosure requirements for HHHOCs based on GHS label elements (including hazard symbols, signal words, hazard statements, precautionary statements, and ingredient disclosure requirements), and institute additional prohibitions, restrictions, or child-resistant container requirements where deemed necessary.

The proposal applies to consumer products within the scope of the CCPSA that are supplied in containers and classified in an HHHOC category or sub-category according to GHS classification criteria.  Health Canada clarified that the initiative would not apply to consumer products that cannot expose the user to any of its hazardous ingredients during reasonably foreseeable use or vaping products covered under the Tabacco and Vaping Products Act.  The comment period ends on October 9, 2023.

Environment Canada Issues Mandatory Information Request for 850 Chemical Substances

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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 Bans Many Single-Use Plastics

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Canada has enacted the Single-use Plastics Prohibition Regulations, SOR/2022-138, prohibiting the manufacture, import, export, and sale of many single-use plastics (SUPs).  The ban will cover the following six types of SUPs by the end of 2025:

  • Checkout bags;
  • Cutlery;
  • Foodservice ware containing expanded polystyrene foam, extruded polystyrene foam (commonly known by the trademark Styrofoam), polyvinyl chloride (PVC), carbon black, or an oxo-degradable plastic;
  • Ring carriers (defined as plastic items “formed in the shape of a series of deformable rings or bands that are designed to surround beverage containers in order to carry them together”);
  • Stir sticks; and
  • Straws.

For ring carriers, the prohibition on manufacture and import takes effect on June 20, 2023, and sale will be prohibited on June 20, 2024.  Manufacture and import of the other five types of SUPs will be prohibited on December 20, 2023, and sale of these items will be prohibited on December 20, 2023.

All six types of SUPs are subject to a temporary exemption for manufacture, import, and sale for the purpose of export; this exemption will be repealed on December 20, 2025.  In the meantime, the regulations institute recordkeeping requirements for persons who manufacture or import SUPs for the purpose of export.

Flexible SUP straws are not subject to the manufacture and import prohibitions for SUP straws, but alternative provisions apply.  For example, retail stores will only be allowed to sell flexible SUP straws if a customer requests straws and the straws are “not displayed in a manner that permits the customer to view the package without the help of a store employee.”

The regulations are the latest in a series of steps taken by Canada to move away from the use of SUPs.  In 2020, Environment and Climate Change Canada (ECCC) released a report on the sources, environmental fate, occurrence, and health effects of plastic pollution, which concluded by stating that “action is needed to reduce macroplastics and microplastics that end up in the environment” in accordance with the precautionary principle.  In 2021, manufactured plastic items were added to the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act.

More information on the regulations can be found in an ECCC guidance document.

Canada Overhauls Assessment of Toxic Substances in CEPA Update

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On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act received royal assent.  The act, which revises Canada’s toxic substances law and enshrines a right to a healthy environment, is the first significant revision to the Canadian Environmental Protection Act (CEPA) since its passage in 1999.

The act implements some, but not all, of the 87 recommendations made by the House of Commons Committee on Environmental and Sustainable Development in 2017.  Key provisions of the act, including a new chemical management plan and implementation of the right to a healthy environment, are unspecified and will be determined by future regulations.

Revisions to Toxic Substances Law

One of the most important changes in the act is the requirement that the government develop a new chemical management plan within the next two years.  The plan must identify substances that should be prioritized for assessment, specify initiatives that should be prioritized by Parliament to control risks posed by substances, promote alternatives to vertebrate testing, and be reviewed at least once every eight years.  To avoid harmful substitutions—when a problem chemical is replaced by a chemical that itself becomes a problem—the ministers are instructed to consider whether it would be more advantageous to assess substances by class than individually.

In 1999, CEPA required the prioritization of substances in commerce for assessment.  According to a backgrounder by Environment and Climate Change Canada, the “resulting process to assess these substances has largely been completed.”  However, a new plan will address “new chemicals being developed, new uses for existing chemicals, increasingly complex supply chains, and emerging science about risks.”

The act also institutes a new classification system for assessed chemicals.  CEPA originally contained two lists of hazardous chemicals: a List of Toxic Substances in Schedule 1 and a Virtual Elimination List.  The act scraps the Virtual Elimination List, which was almost never used, and divides Schedule 1 into Parts 1 and 2.  Part 1 contains 19 chemicals prioritized for total, partial, or conditional prohibition, including PFOS and DDT.  Part 2 contains all other substances deemed toxic, which will be prioritized for pollution prevention.  The 132 substances initially placed in Part 2 include asbestos and manufactured plastic items.

As an alternative to Parts 1 and 2 in Schedule 1, the act creates a watch list for “substances that the ministers have reason to suspect are capable of becoming toxic or that have been determined to be capable of becoming toxic.”  The backgrounder states that the list “will help importers, manufacturers, and Canadian consumers to select safer alternatives and avoid [harmful] substitutions.”  Any person can file a request that the ministers assess a substance’s toxicity or capability to become toxic.

Other changes introduced in the act include requiring the ministers to consider “whether exposure to the substance in combination with exposure to other substances has the potential to cause cumulative effects” and “whether there is a vulnerable population or environment in relation to the substance” when interpreting the results of an assessment; requiring a rationale to support requests for the confidential treatment of business information; and requiring that an explanation be provided if an assessment has not been completed after two years.

Right to a Healthy Environment

Also included in the act, for the first time in Canadian legislative history, is a “right to a healthy environment.”  The government has two years to “develop an implementation framework to set out how the right to a healthy environment will be considered in the administration of this Act.”  The framework must “elaborate on” the act’s principles, such as environmental justice, non-regression, and intergenerational equity.  However, the right is not absolute.  The implementation framework must “determine[e] the reasonable limits to which it is subject.”

Canadian representatives have questioned whether the right to a healthy environment will be enforceable.  The act does not amend section 22 of CEPA, which allows individuals to bring an “environmental protection action” in limited circumstances against persons who commit an offence under CEPA.  The Senate Committee on Energy, the Environment, and Natural Resources stated that “the right to a healthy environment cannot be protected unless it is made truly enforceable,” noting concern that Section 22 “contains too many procedural barriers and technical requirements that must be met to be of practical use” when it comes to enforcement.

Canada imposes new reporting requirements for nanoscale substances.

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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.

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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.

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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

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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

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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.