Health Canada, the regulator that oversees and enforces consumer products in Canada, recently hosted a webinar for industry to provide guidance on the interpretation and enforcement of regulations regarding infant sleep products.  


Regulation of consumer products in Canada

Consumer products, including infant sleep products, are governed by the Canada Consumer Product Safety Act (the CCPSA). The CCPSA applies to anyone who manufactures, packages, labels, tests, imports, distributes, sells or advertises consumer products in Canada.1 This includes online sales and advertisement.  

The CCPSA prohibits anyone to manufacture, import, advertise or sell a product in Canada that (i) does not comply with the regulations under the CCPSA, (ii) is a danger to human health or safety, or (iii) is otherwise the subject of a recall or unimplemented order or measure.  

Infant sleep products

The key regulations under the CCPSA that govern infant sleep products in Canada are the Cribs, Cradles and Bassinets Regulations, and the Playpens Regulations. The Playpens Regulations apply to any “sleep accessory” that is designed or advertised to be used with a playpen. However, if the playpen sleep accessory can be used for sleep in stand-alone mode when detached from the playpen, it must comply with the Cribs, Cradles and Bassinets Regulations

What is an infant sleep product?

How does Health Canada determine whether a product is an infant sleep product within the scope of the regulations? Cribs, cradles, bassinets and sleep accessories are all defined as having sides to confine a child and providing sleep accommodation for a child. In determining whether a product meets this definition, Health Canada looks to its primary function. However, the intended or stated function of the product is not the end of the analysis. In determining the product’s primary function, Health Canada will consider:

  • The name of the product. If the name of the product suggests it may be used to accommodate a child for sleep, it is likely to be considered a sleep product.
  • How the product is marketed. Even if the product is not intended to be used for sleep, if any of the promotional materials depict images showing or implying sleep, or depict the product being placed on or next to the caregiver’s bed, the product is likely to be considered a sleep product.
  • The recommended or listed use of the product. If the product’s recommended or listed functions include accommodating sleep, even briefly, the product is likely to be considered a sleep product. 
  • The appearance of the product. If the product looks like a traditional or non-traditional baby sleep product, it is likely to be considered a sleep product.
  • The reasonably foreseeable use of the product. If consumers perceive the product as being suitable for sleep and are likely to use it to accommodate a sleeping child, the product is likely to be considered a sleep product. 

It is important for industry to holistically consider all of the above-noted factors when determining whether a product is required to comply with the requirements under the Cribs, Cradles and Bassinets Regulations or the Playpens Regulations.

Chemical and Flammability Requirements

In addition to the specific chemical and flammability requirements set out under the Cribs, Cradles and Bassinets Regulations and the Playpens Regulations, industry should be aware of the following requirements that apply to infant sleep products: 

  • Products that fall within the scope of the Playpens Regulations, to the extent they contain any toxic substances, must comply with the toxic substance requirements outlined in section 25 of the Toys Regulations, under the CCPSA. 
  • Any “child care article,” which is defined to include a product that is intended to facilitate the relaxation or sleep of a child under four years of age, must comply with the Phthalates Regulations, which limit the amount of phthalate permissible in vinyl product components.   

Information and Labelling Requirements 

Both the Cribs, Cradles and Bassinets Regulations and the Playpens Regulations set out the information that must be permanently affixed to, or included with, an infant sleep product, including safety warnings, assembly and use instructions, product model information, and manufacturing information. The required information must be provided in English and French and follow the prescribed standards for durability and legibility as well as font size, type, and colour. 

In addition to these requirements, industry should be aware of, and comply with, Canada’s Consumer Packaging and Labelling Act, and Consumer Packaging and Labelling Regulations, which set out the packaging and labelling requirements for pre-packaged consumer products. 

Product safety testing

Health Canada’s Product Safety Laboratory carries out testing and research on consumer products to ensure compliance with the CCPSA, identify potential hazards, and develop new safety standards and regulations. While the specific test methods used by the Product Safety Laboratory are not mandatory for industry to follow, they provide insight into how Health Canada assesses products for compliance with applicable regulations. As a result, Health Canada makes the Product Safety Laboratory’s testing methods available to industry here.



Contacts

Senior Associate
Global Co-Head of Life Sciences and Healthcare; Partner

Recent publications

Subscribe and stay up to date with the latest legal news, information and events . . .