Health Canada seeks consultation on proposed amendments to Toys Regulations

On June 23, 2023, Health Canada published a Notice of Intent to Amend the Toys Regulations. The goal of the amendments is to improve the health and safety of Canadians and to modernize the regulations by aligning them with advancements in science, increasing alignment with Canada’s major trading partners, reducing reliance on animal testing, and addressing known stakeholder concerns.

Health Canada is inviting comments on the proposed amendments from stakeholders in the toy industry, consumer groups, health professionals and organizations, Indigenous groups, members of the public and other interested parties. Anyone seeking to provide comments on the proposed amendments is invited to respond to Health Canada by September 21, 2023 by completing a questionnaire and providing written feedback.

Toxic, corrosive, irritant and sensitizing substances

Health Canada is considering amendments to the provisions in the Toys Regulations that govern toxic, corrosive, irritant and sensitizing substances, as well as stuffing materials.  The proposed amendments would introduce additional sources of data and new approach methods for the determination of toxic, corrosive, irritant and sensitizing substances that are less reliant on animal testing.  New sources of data include human experience data, data from tests conducted in accordance with Organization for Economic Cooperation and Development (OECD) Test Guidelines, and a weight of evidence approach.  The introduction of new data sources and new approach methods aligns with Health Canada’s goal of reducing reliance on animal testing.  

As it relates to toxic substances, Health Canada is also considering repealing the existing Schedule 2, which sets out permissible limits of toxicity, and instead incorporating “good scientific practices” and the hazard categories identified in the Global Harmonized System. 

Boric acid and salts

The current Toys Regulations do not permit a toy to contain any level of boric acid if it could, under reasonably foreseeable circumstances, become accessible to a child or, if used as a filling, could be released on breakage or leakage. However, new scientific data shows that a very small amount of boric acid in a toy should not present a health risk to children.  As a result, Health Canada’s enforcement policy permits total concentrations of boric acid or boric salts up to 0.91% or 9,100 parts per million.  Current scientific research also shows that elemental boron, rather than boric acid, should be the focus of restrictions.  

Health Canada is considering amendments to the regulations governing boric acid that would more closely align with the current state of science and Health Canada’s enforcement policy. Health Canada is considering the following options:

• Regulations that reflect its current enforcement policy, which limits total boric acid in all types of toys to 0.91%; 
• Adopting the EN 71-3 standard, which sets out safety standards for toys in the European Union.  This standard limits total boron concentration in all toys and limits migration of boron in liquid or sticky material, dry, brittle, powder-like or pliable toy material, and scrapped-off toy material; and
• Adopting the ISO 8124-3:2020 /Amd 1:2023 standard, which would limit migration of boron in slimes, putties and modelling clay.

Stakeholders are invited to provide feedback on which of these options they prefer. 

Migration of certain elements

The current Toys Regulations address exposure to certain heavy metals in removable stickers and films and surface coating materials.  However, they do not address other heavy metals of concern, certain exposure scenarios, or materials other than surface coating materials or removable stickers and films.  Health Canada is considering several options to address these hazards:  

• adopting the migration limits set out in ISO 8124-3 and ASTM F963 for antimony, arsenic, barium, cadmium, chromium and selenium present in all substrates, including finger paints and modelling clays;
• adopting the migration limits set out in EN 71-3 for aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin and zinc, present in all substrates, including finger paints and modelling clays; and
• various alternatives for modifying the total permissible limit for mercury, including:
  • maintaining the limit for total mercury and adopting the migration limits for substrates other than surface coating materials and removable stickers and films set out in either (i) the ISO 8124-3 and ASTM F963 standards or (ii) the EN 71-3 standard; or
  • changing the limit for total mercury for all substrates to the migration limits set out in either (i) the ISO 8124-3 and ASTM F963 standards, or (ii) the EN 71-3 standard. 

Stakeholders are invited to provide feedback on which of these options they prefer.

Finger paints

Under the current Toys Regulations, finger paints are subject only to the requirement that they be water-based.  Health Canada is considering a range options to introduce limits on other substances present in finger paints, including:

• adopting and applying the proposed requirements for determining toxicity, irritation, sensitization and corrosivity requirements set out above for finger paints;
• adopting the requirements from ISO 8124-7 that: 
  • prohibit finger paints that are subject to certain toxicity, irritation, sensitization and corrosivity classifications under the Global Harmonized System; 
  • limit the presence of sweeteners, flavours and fragrances and that require the addition of an embittering agent;
  • prescribe standards for binding agents, extenders, humectants, surfactants and N-nitrosamines; and
  • prescribe requirements for finger paint containers to limit mistaken confusion with edible items; 
• 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; and
• adopting a limit for total mercury in finger paints.

Stakeholders are invited to provide feedback on which of these options they prefer. 

Liquids, pastes, putties, gels, powders and items of avian feather origin

Health Canada is considering adopting the requirements of ASTM F963 that restrict or limit the presence of liquids, pastes, putties, gels, powders and items of avian feather origin in stuffing material, due to concerns regarding lack of cleanliness, shelf-life degradation and contamination in use.

Toy chemical sets

Health Canada is considering amendments that would address a gap in the legislation governing toy chemical sets.  While science education sets are governed by the Science Education Sets Regulations, some of the hazards presented by toy chemical sets that do not meet the definition of scientific education sets are not adequately addressed by the Toys Regulations. 

Health Canada is considering adopting the ISO 8124-11 standard, which sets requirements for moulding sets, PVC modelling sets and adhesives, paints, lacquers, thinners and cleaning agents used with model sets.  The standard also contains labelling requirements and mandates that certain first aid information and safety rules accompany the product.

Transition Period

Under Health Canada’s proposed changes, the amended regulations will incorporate by ambulatory reference certain external standards, such as ASTM, ISO and EN standards, as well as OECD scientific practices.  As a result, as these standards are changed, those changes will become part of the regulations.  Health Canada proposes a 180-day transition period from the date a standard is revised. At the end of the 180-day transition period, all products governed by the regulations must comply with the revised standard.