Notice of intent to amend the Toys Regulations

Health Canada is proposing changes to the Toys Regulations (the regulations). This notice outlines the proposed changes and includes a questionnaire for people in Canada to provide feedback.

On this page

Introduction

As part of ongoing efforts to review the existing regulations under the Canada Consumer Product Safety Act (CCPSA), Health Canada has identified an opportunity to modernize the regulations. We are considering proposed changes that would:

These changes would also support the Minister of Health's mandate letter commitment to introduce legislation to end animal testing by reducing reliance on animal testing in toys.

Background

Canadian legislation

Toys are products that are intended for use by a child under 14 years of age in learning or play. The Hazardous Products (Toys) Regulations were introduced in 1970 under the Hazardous Products Act (HPA) to help protect children in Canada from a wide range of hazards when they interact with toys. On June 20, 2011, the CCPSA came into force and replaced certain parts of the HPA. The Hazardous Products (Toys) Regulations and other prohibited items from Part I of Schedule I to the HPA were transferred under the CCPSA and renamed as the Toys Regulations. While the Hazardous Products (Toys) Regulations, and subsequent Toys Regulations, have been amended over time, many of the chemical and toxicity requirements that were introduced in 1970 remain.

Issues

Toxic, corrosive, irritant and sensitizing substances

The Toys Regulations include requirements to minimize exposure to known harmful chemicals. The requirements for toxic, corrosive, irritant and sensitizing substances refer to data obtained through animal testing. Advancements in science, however, increasingly enable the use of new approach methods (NAMs) to help reduce animal testing while ensuring protection of human health and the environment. As such, Health Canada is now considering modernizing the regulations by:

These changes would result in a reduced reliance on animal testing.

Boric acid and salts of boric acid

Boric acid and salts of boric acid are prohibited in toys if:

These requirements don't consider the scientific data published since 1970 which shows that a very small amount of boric acid in a toy shouldn't present a health risk to children. Health Canada uses an enforcement policy to allow total concentrations of boric acid or salts of boric acid up to 0.91% or 9100 parts per million (ppm). The international toy safety standards limit elemental boron instead of boric acid. Health Canada is considering changing the regulations to modify the prohibition into a maximum concentration of elemental boron or boric acid.

Additional hazards

There is an opportunity to modernize the regulations to:

Health Canada is considering adding requirements in the regulations for:

International standards and legislation

The issues identified in this notice are addressed in several international requirements, either in the United States, in the European Union (EU) or in ISO standards. This section features some of these requirements.

The United States Consumer Product Safety Improvement Act (CPSIA) of 2008 made the provisions of the ASTM International Standard ASTM F963 Consumer Safety Specifications for Toy Safety (ASTM F963) mandatory under certain conditions. In addition, the United States Consumer Product Safety Commission codified its policy on animal testing, indicating that the regulations under the Federal Hazardous Substances Act don't require animal testing and allow alternatives to animal testing, whenever possible. Health Canada reviewed the latest edition of ASTM F963, ASTM F963-17. We found that it addresses hazards related to the migration of certain elements and those related to the cleanliness of liquids, pastes, putties, gels, powders and items of avian feather origin that aren't adequately addressed by the regulations. Health Canada is considering the adoption of a similar policy regarding animal testing for toys.

The Directive2009/48/CE of the European Parliament and of the Council of 18 June 2009 on the Safety of Toys (Toy Safety Directive) sets out the safety criteria that toys must meet before they can be marketed in the EU. The EN 71 series of standards are used to determine conformity to the Toy Safety Directive. The EN 71-3:2019+A1:2021 Safety of toys Part 3: Migration of certain elements (EN 71-3) standard specifies requirements and test methods for the migration of certain elements from toy materials and from parts of toys. These elements are aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin and zinc. Health Canada has reviewed this standard and found it addresses several hazards not currently captured by the regulations.

The ISO 8124 series of standards on toy safety address different hazards for toys, including chemical and toxicological hazards.

The ISO 8124-3:2020 Safety of toys Part 3: Migration of certain elements (ISO 8124-3) standard specifies maximum acceptable levels and methods of sampling, extraction and determination for the migration of certain elements from toy materials and from parts of toys. These elements are antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium. Health Canada has reviewed this standard and found it addresses several hazards not currently captured by the regulations.

The ISO 8124-7:2015 Safety of toys Part 7: Requirements and test methods for finger paints (ISO 8124-7) standard (in conjunction with ISO 8124-7:2015/Amd 1:2020) specifies requirements for the substances and materials used in finger paints. Health Canada has reviewed this standard and found it addresses several hazards not currently captured by the regulations.

The ISO 8124-11:2019 Safety of toys Part 11: Chemical toys (sets) other than experimental sets (ISO 8124-11) standard specifies requirements and test methods for the substances and materials used in chemical toys (sets) other than experimental sets. Health Canada has reviewed this standard and found it addresses several hazards not currently captured by the regulations.

Proposed requirements

The changes to the regulations being considered cover 7 different aspects:

  1. toxic substances
  2. corrosive, irritant or sensitizing substances
  3. specific toxic substances (boric acid and salts of boric acid)
  4. migration of certain elements
  5. finger paints
  6. liquids, pastes, putties, gels, powders and items of avian feather origin
  7. chemical toys (sets) other than experimental sets

This section outlines the proposals under consideration.

1. Proposed changes to the requirements for toxic substances

Health Canada is considering amending the requirements in the Toys Regulations addressing toxic substances (Section 25) and stuffing materials (Section 29), which refer to Schedule 2: Permissible Limits of Toxicity. Despite advances in testing methodology, Schedule 2 doesn't currently allow for other sources of data or NAMs. This means that only results from tests performed on animals may be used.

Health Canada proposes to include additional sources of toxicity data in Schedule 2, including:

NAMs for toxicity assessment are developed globally to reduce the reliance on animal testing. When applicable NAMs are published under the OECD Test Guidelines, they would automatically be allowed for toxicity assessments of substances under the regulations.

Health Canada is also evaluating the option to repeal Schedule 2 and instead refer to good scientific practices and to the hazard categories in the Globally Harmonized System (GHS). With this approach, we would consider substances that aren't classified for the acute toxicity health hazard class in the GHS to be acceptable in toys.

2. Proposed changes to the requirements for corrosive, irritant or sensitizing substances

Health Canada is considering amending the requirement for corrosive, irritant or sensitizing substances in toys (Section 26), and for irritant substances in stuffing (Section 29), both of which refer to Schedule 3. Schedule 3 defines criteria for determining if a substance is irritant, corrosive or sensitizing when judged on human experience or assessed by the prescribed animal test methods. Health Canada no longer encourages suppliers to conduct these types of tests on animals. Many substances have irritation, corrosivity or sensitization data already available. It is preferable to use a weight of evidence approach, whereby an assessment could include:

The OECD Guidelines for the Testing of Chemicals list many NAMs that could be used for irritation, corrosivity and skin sensitization in toy testing.

3. Proposed changes to the requirements for boric acid and salts of boric acid

Health Canada is considering the following options:

Health Canada's enforcement policy applies to all toys and not only to slimes, putties and modelling clays. In addition, this limit is for total boric acid and not only for its migration. Similarly, the EN 71-3 standard sets limits for all types of toys. The ISO 8124-3 standard only regulates boron in slimes, modelling clays and putties.

4. Proposed changes to add requirements for the migration of certain elements

The Toys Regulations currently address exposure to several heavy metals, such as lead and mercury, in stickers, films or other similar materials that can be removed, or in surface coating materials, that are applied to an accessible part of a toy. However, many other heavy metals and exposure scenarios aren't currently addressed by the regulations. In addition, toy materials other than surface coating materials aren't covered by these requirements. Health Canada is not considering amending the requirements for total lead at this time. These requirements are addressed by the Consumer Products Containing Lead Regulations, which aren't currently being changed.

While the ISO 8124-3 and ASTM F963 standards set limits for all toy materials, they only restrict the migration of certain elements, and they don't set limits for total concentrations. The Toys Regulations have a 1000 ppm limit for the migration of antimony, arsenic, barium, cadmium and selenium. The ISO 8124-3 and ASTM F963 standards have migration limit values of:

Health Canada is proposing the incorporation of ISO 8124-3, ASTM F963 or EN 71-3 by ambulatory reference to address these hazards.

Health Canada is considering the following options for the Toys Regulations:

  1. adopting the ISO 8124-3 and ASTM F963 migration limits (all substrates, including finger paints and modelling clays) for antimony, arsenic, barium, cadmium, chromium and selenium
  2. adopting the EN 71-3 migration limits (all substrates, including finger paints and modelling clays) for aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin and zinc or
  3. modifying the total limit for mercury by:
    • maintaining the limit for total mercury and adopting the ISO 8124-3 and ASTM F963 migration limits for substrates other than stickers, films or other similar materials that can be removed, or surface coating materials
    • maintaining the limit for total mercury and adopting the EN 71-3 migration limits for substrates other than stickers, films or other similar materials that can be removed, or surface coating materials
    • changing the limit for total mercury to the migration limit of the ISO 8124-3 and ASTM F963 standards for all substrates, or,
    • changing the limit for total mercury to the migration limit of the EN 17-3 standard for all substrates

5. Proposed changes to the requirements for finger paints

Health Canada is considering amending the requirements for finger paints. The only requirement specific to finger paints in the Toys Regulations is for them to be water-based (Section 39 of the regulations).

Health Canada is considering the following options:

  1. determining whether the proposed toxicity, irritation, sensitization and corrosivity requirements (see sections 1 and 2) are adequate for finger paints
  2. adopting the requirements from the ISO 8124-7 standard that prohibit finger paints that are classified under the GHS for acute toxicity, skin corrosion or irritation, serious eye damage or irritation, respiratory or skin sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity (single exposure and repeated exposure) and aspiration hazards
  3. adopting the requirements from the ISO 8124-7 standard for the colourants, preservatives and impurities finger paints might contain. Under that standard, these products cannot be sweetened, flavoured or fragranced, and an embittering agent shall be added to discourage and minimize the ingestion of paint
  4. adopting the requirements from the ISO 8124-7 standard for binding agents, extenders, humectants, surfactants and N-nitrosamines contained in finger paints
  5. adopting the requirements from the ISO 8124-7 standard for the containers, so they aren't mistaken with containers of foodstuffs or drinks
  6. adopting the requirements from the ISO 8124-3 standard regarding the migration limits for antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium that apply to finger paints or
  7. adopting a limit for total mercury in finger paints, in addition to requiring compliance to the ISO 8124-7 standard

6. Proposed changes to add requirements for liquids, pastes, putties, gels, powders and items of avian feather origin

The Toys Regulations require that stuffing material be clean and free from vermin (Section 29 of the regulations). However, other products like liquids, pastes, putties, gels, powders and items of avian feather origin (for example, "marabou" items derived from poultry feathers) also present risks associated with a potential lack of cleanliness, shelf-life degradation and contamination in use.

Health Canada is considering adding requirements to the Toys Regulations regarding these issues through the incorporation of ASTM F963 by ambulatory reference.

7. Proposed changes to add requirements for chemical toys (sets) other than experimental sets

Science education sets are covered under the Science Education Sets Regulations. However, chemical toys (sets) that don't meet the definition of a science education set aren't covered under these regulations. While the basic toxicity, irritation, corrosivity and sensitization requirements under the Toys Regulations apply to these chemical toys (sets), these products also present additional hazards. The ISO 8124-11 standard:

Health Canada is considering adding requirements to the Toys Regulations for chemical toys (sets) other than experimental sets in alignment with what is covered under ISO 8124-11, through an ambulatory incorporation by reference.

Considerations

Ambulatory incorporation by reference

In this proposal, Health Canada is considering the incorporation of documents by ambulatory reference.

An ambulatory reference refers to an incorporation by reference of a document into a regulation as it is changed over time. When a document is incorporated using the words "as amended from time to time," any change to that document becomes part of the regulation. As the document is changed, the new version would become part of the regulation without needing to amend the regulations.

Transition period

In this proposal, Health Canada is considering a transition period of 180 days for future changes to documents incorporated by ambulatory reference, as regulated parties would benefit from clarity regarding when they must comply with new editions of the referenced documents.

For example, 1 type of transition period Health Canada is considering would set a time during which products can comply with either the new edition of the document, or the previous edition. At the end of the transition period, all products would have to comply with the new edition of the document.

Privacy Notice

The personal information you provide to Health Canada will be collected by the Consumer and Hazardous Products Safety Directorate under the Canada Consumer Product Safety Act and handled in accordance with the Privacy Act.

Why are we collecting your personal information? Your personal information is being collected as part of a consultation relating to this proposal to amend the Toys Regulations, and will be used by Health Canada to help inform the proposal.

Will we use or share your personal information for any other reason? Your contact information may be used by a representative of the Consumer and Hazardous Products Safety Directorate to contact you should they need to clarify any of your responses. Your personal information may be added to a stakeholder list to be used for further communication and consultation. A report using aggregate data and quotes may be shared within the Healthy Environments and Consumer Safety Branch, however no names will be included in the report.

What happens if you don't want to provide your personal information? Participation in this questionnaire is voluntary, and there are no consequences for declining to respond in whole or in part. If you choose not to provide the requested information, we will be unable to contact you to further explore your needs and opportunities for collaboration.

What are your rights? You have the right to access and request a correction and/or notation to your personal information. You also have a right to complain to the Privacy Commissioner of Canada if you feel your personal information has been handled improperly. For more information about these rights, or about how we handle your personal information, please contact the Consumer and Hazardous Products Safety Directorate at ccpsa-lcspc@hc-sc.gc.ca.

For more information: The collection of your personal information is described in Info Source at infosource.gc.ca. Refer to the personal information bank (PIB) PSU 938 - Outreach Activities.

Questionnaire

Contact information

Stakeholder interest information

Please provide your answers to the following questions. Please add the information you think is necessary to support your choice or to explain why another option should be chosen. Note that Health Canada won't provide responses to feedback received from this notice. We will use your responses to the questionnaire to direct our action on the issues identified in this notice.

Question 1

Health Canada is considering amending the requirements addressing toxic substances (Section 25) and stuffing materials (Section 29) with 1 of these options:

  1. By including additional sources of toxicity data in Schedule 2, including human experience data, and data from tests conducted using the product in accordance with the OECD Test Guidelines, which would include NAMs that are published in these guidelines, or
  2. By repealing Schedule 2 and only allow substances that aren't classified for the acute toxicity health hazard class in the GHS

Do you prefer 1 of these options for the requirements addressing toxic substances? Please include information to support your opinion.

Question 2

Health Canada is considering amending the requirement for corrosive, irritant or sensitizing substances in Sections 26 and 29 with 1 of these options:

  1. By amending Schedule 3 to allow for specific corrosive, irritant or sensitizing substances testing methods, or
  2. By repealing Schedule 3 and replacing it with a requirement that the corrosive, irritant or sensitizing substances assessment be performed in accordance with good scientific practices

Do you prefer 1 of these options for the requirements addressing corrosive, irritant or sensitizing substances? Please include information to support your opinion.

Question 3

Health Canada is considering amending the requirements addressing boric acid and salts of boric acid with 1 of these options:

  1. By establishing requirements in the regulations consistent with the current enforcement policy (0.91%)
  2. By adopting the requirements from the EN 71-3 standard for liquid or sticky materials, dry, brittle, powder-like or pliable toy materials, and scraped-off toy materials, or
  3. By adopting the requirements from the ISO 8124-3 standard for slimes, putties and modelling clays

Do you prefer 1 of these options for the requirements addressing boric acid and salts of boric acid? Please include information to support your opinion.

Question 4

Health Canada is considering amending the requirements for mercury with 1 of these options:

  1. By maintaining the limit for total mercury in stickers, films or other similar materials that can be removed, or surface coating materials, and requiring compliance to the ISO 8124-3 migration limits for other substrates by an ambulatory incorporation by reference
  2. By maintaining the limit for total mercury in stickers, films or other similar materials that can be removed, or surface coating materials, and requiring compliance to the ASTM F963 migration limits, for other substrates by an ambulatory incorporation by reference
  3. By maintaining the limit for total mercury in stickers, films or other similar materials that can be removed, or surface coating materials, and requiring compliance to the EN 71-3 migration limits, for other substrates by an ambulatory incorporation by reference
  4. By changing the limit for total mercury to a migration limit for all substrates through the incorporation by ambulatory reference of the ISO 8124-3 migration limit for all substrates
  5. By changing the limit for total mercury to a migration limit for all substrates through the incorporation by ambulatory reference of the ASTM F963 migration limit for all substrates, or
  6. By changing the limit for total mercury to a migration limit for all substrates through the incorporation by ambulatory reference of the EN 17-3 migration limit for all substrates

Do you prefer 1 of these options for the requirements addressing the migration of certain elements? Please include information to support your opinion.

Question 5

Health Canada is considering amending the requirements addressing the migration of certain elements with 1 of these options:

  1. By amending the requirements for antimony, arsenic, barium, cadmium and selenium, and adding new requirements for chromium by requiring compliance to the ISO 8124-3 migration limits, by an ambulatory incorporation by reference
  2. By amending the requirements for antimony, arsenic, barium, cadmium and selenium, and adding new requirements for chromium by requiring compliance to the ASTM F963 migration limits, by an ambulatory incorporation by reference, or
  3. By amending the requirements for antimony, arsenic, barium, cadmium and selenium, and adding new requirements for aluminium, boron, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, strontium, tin, organic tin and zinc, by requiring compliance to the EN 71-3 migration limits

Do you prefer 1 of these options for the requirements addressing the migration of certain elements? Please include information to support your opinion.

Question 6

Health Canada is considering amending the requirements addressing finger paints with 1 of the following options:

  1. By adopting the proposed toxicity, irritation, sensitization and corrosivity requirements (see sections 1 and 2) for finger paints and by requiring compliance to the ISO 8124-7 standard
  2. By adopting the requirements from the ISO 8124-7 standard that prohibit finger paints that are classified under the GHS for acute toxicity, skin corrosion/irritation, serious eye damage/irritation, respiratory or skin sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity (single exposure and repeated exposure) and aspiration hazards
  3. By adopting the requirements from the ISO 8124-7 standard for the colourants, preservatives, and impurities finger paints might contain. Under that standard, these products cannot be sweetened, flavoured or fragranced, and an embittering agent shall be added to discourage and minimize the ingestion of paint
  4. By adopting the requirements from the ISO 8124-7 standard for binding agents, extenders, humectants, surfactants, and N-nitrosamines contained in finger paints
  5. By adopting the requirements from the ISO 8124-7 standard for the containers, so they are not mistaken with containers of foodstuffs or drinks
  6. By adopting a limit for total mercury in finger paints, in addition to requiring compliance to the ISO 8124-7 standard, or
  7. By adopting the requirements from the ISO 8124-3 standard regarding the migration limits for antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium that apply to finger paints

Do you prefer 1 of these options for the requirements addressing finger paints? Please include information to support your opinion.

Question 7

Health Canada is considering adding requirements for liquids, pastes, putties, gels, powders and items of avian feather origin by requiring compliance to ASTM F963.

Do you agree with these additional requirements for liquids, pastes, putties, gels, powders and items of avian feather origin? Please include information to support your opinion.

Question 8

Health Canada is considering adding requirements for chemical toys (sets) other than experimental sets by requiring compliance to ISO 8124-11.

Do you agree with these additional requirements for chemical toys (sets) other than experimental sets? Please include information to support your opinion.

Page details

Date modified: