Canada to Restrict 6 Phthalates in Toys, Childcare Articles to Align with U.S.

According to Canada’s regulatory impact statement, the country has chosen to amend its regulations regarding phthalates in certain children’s toys and products in order to align them with the U.S. and Europe.

Vinyl in Toys, Child Care Articles Limited to 1,000 mg/kg of DEHP, DBP, BBP

Under the new regulations, the vinyl in a toy or child care article will not be able to contain more than 1,000 mg/kg of di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) or benzyl butyl phthalate (BBP) in order to be imported, sold, or advertized in Canada.

According to Health Canada sources, Canada’s 1,000 mg/kg is the same as the U.S.’ 0.1% limit on these same three phthalates affecting the same types of products. The limits are simply expressed differently. (Note, however, that the U.S. has slightly different definitions of toys and child care articles -- see below.)

If Can be Placed in Mouth of Child Under 4, DINP, DIDP, DNOP Also Limited to 1,000 mg/kg

In addition, the vinyl in any part of a toy or child care article that can, in a reasonably foreseeable manner, be placed in the mouth of a child under four years of age must contain not more than 1,000 mg/kg of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) or di-n-octyl phthalate (DNOP).

Health Canada sources confirm that the U.S. has the same limit on the same three phthalates in child care articles and toys that can be placed in a child’s mouth. However, Canada, like Europe, has decided to make the limit on these three phthalates permanent, while the U.S. has made it temporary, pending further study. (The U.S. also has slightly different definitions of the affected products.)

Canada’s Definitions for Child Care Articles, Toys, Placing in Mouth

Under Canada’s new regulations, the following definitions will apply:

• “Child care article” means a product that is intended to facilitate the relaxation, sleep, hygiene, feeding, sucking or teething of a child under four years of age.
• “Toy” means a product that is intended for use by a child under 14 years of age in learning or play.
• A part of a toy or child care article "can be placed in the mouth of a child under four years of age" if (a) it can be brought to the child’s mouth and kept there so that it can be sucked or chewed; and (b) one of its dimensions is less than 5 cm (if the part of the toy or child care article is inflatable, its dimensions must be determined in its deflated state.)

Products Must Be Tested in Accordance with “Good Laboratory Practices”

The products must be tested to the new limits under “good laboratory practices,” which are defined as practices that are in accordance with the principles set out in the Organization for Economic Co-operation and Development document entitled OECD Principles of Good Laboratory Practice, Number 1 of the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/MC/CHEM(98)17.

(U.S. statute requires children’s products to be tested by third-party laboratories whose accreditation has been approved by the Consumer Product Safety Commission.)

In the U.S., CPSIA Limited Same 6 Phthalates (3 Only Temporarily, Pending Further Study)

In the U.S., the Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibited the sale of “children’s toys or child care articles” containing more than 0.1% of DEHP, DBP, or BBP phthalates, beginning February 10, 2009.

It also prohibited, on an interim basis, the sale of “children’s toys that can be placed in a child’s mouth” or “child care articles” containing more than 0.1% of DINP, DIDP and DNOP phthalates, beginning February 10, 2009. For this interim ban, the CPSIA required CPSC to establish a scientific panel to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles. After receiving the panel’s report, CPSC must evaluate its findings and recommendations and decide whether to continue the interim ban and whether any other measures are needed with respect to phthalates. Six months later, it must issue a final rule on the matter.

U.S Definitions. Under U.S. phthalates statutes, the following definitions apply:

• “Children's toy'' means a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.
• ''Child care article'' means a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.
• A toy is considered a "toy that can be placed in a child's mouth" if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children's product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.

Order and Regulatory Impact Statement, dated 12/09/10, available here.

Consequential amendment, dated 12/09/10, available here.