Into the Mouths of Babes – Toxic Toys

 Into the mouths of babes – Phthalates Regulations soon in force in Canada – U.S. to follow?

(The following article was written by Dr. Dianne Saxe and Ms. Jackie Campbell – see below for information on the authors – used by permission.  Please note that the picture of the baby biting on a teething ring is by Jamie Grill and is part of the Tetra Collection, Getty Images. All rights reserved.)

 Phthalates are chemicals used to make plastic toys, as well as soothers and other products, soft and flexible.  Often these products end up in the mouths of infants, who may suck or chew on them for prolonged periods.  Phthalates, which may enter the bloodstream via saliva in these infants, have been linked to reproductive and developmental toxicities in animals.

In 1998, Canadian industry voluntarily removed the two main phthalates used in teethers and pacifiers, but as most of these products are manufactured off-shore, the impact has not been significant.   As well, there are many other products that are likely to be mouthed by infants, bath toys (e.g., rubber ducks), squeeze and inflatable ones, which may contain phthalates. 

New regulations restricting the concentration of phthalates in some products used by infants and children will soon be in place.  These regulations are consistent with measures taken by the United States and European Union.  This is a positive step in minimizing exposure to these chemicals in our most vulnerable population –  infants and young children.

Below, we highlight some concerns about these chemicals, and briefly summarize the new regulations.

Health concerns – phthalates 

The six phthalates that have been identified as potential concerns for human health are as follows:

        – Di(2-ethylhexyl) Phthalate (DEHP)
        – Dibutyl Phthalate (DBP)
        – Benzyl Butyl Phthalate (BBP)
        – Diisononyl Phthalate (DINP)
        – Diisodecyl Phthalate (DIDP)
        – Di-n-octyl Phthalate (DNOP)

DEHP, DBP and BBP have been linked to reproductive and developmental toxicity, as well as liver and kidney effects, in rodents.  Of particular concern to regulators is that the estimated average daily intake of DEHP, by children under 4 years of age, may slightly exceed the tolerable daily intake.  Assessments under the Canadian Environmental Protection Act, 1999 (CEPA) concluded that the average daily intake of DBP and BBP will not cause adverse health effects in humans. 

As for DNOP, data are insufficient to determine an appropriate tolerable daily intake or whether this agent affects human life or health. DINP and DIDP have not been assessed under CEPA.  However, a 1998 Health Canada risk assessment (and recent re-calculation) of DINP-containing soft vinyl children’s products concluded that there is a potential health risk for those under 3 years old who suck or chew on such products for prolonged periods.   A 2001 US Consumer Product Safety Commission report also concluded that there may be a concern for children up to 18 months of age who mouth DINP-containing soft vinyl toys for 75 minutes or more per day.  The US Center for the Evaluation of Risks to Human Reproduction has reported rodent studies showing the DINP and DIDP pose developmental hazards to rodents.

The Phthalates Regulations 

 The Phthalates Regulations under Canada’s Hazardous Products Act (HPA) were registered on December 10 2010, and will come into force after 6 months, in June 2011.  The regulations restrict advertising, sale and import of toys and child care articles made of vinyl that contains phthalates.  “Toys” means products intended for use by children under 14 years of age in learning or play; “child care articles” are those intended to help a child under 4 years of age relax, sleep, feed, suck or teethe.

Soft vinyl products may contain up to 1000 mg/kg (0.1% w/w) of DEHP, DBP or BBP.   As well, any part of a product containing vinyl that could “in a reasonably foreseeable manner” be placed in in the mouth of a child under 4 years of age may contain up to 1000 mg/kg of DINP, DIDP or DNOP. 

The regulations set out how one identifies if such a product can be “placed in the mouth” of a child: if any part of the product can be brought to the child’s mouth to be sucked or chewed AND if one of its dimensions (in its deflated state, where applicable) is less than 5 centimetres.   Vinyl-containing products that exceed 5 cm in all dimensions or that can only be licked, are not considered a concern, as these cannot be placed in the child’s mouth, and licking is not a concern regarding phthalate absorption.

As of December 2010, toys and child care articles composed of phthalate-containing vinyl were added as restricted products under the HPA and the Hazardous Products (Toys) Regulations were amended – both as a consequence of the Phthalates Regulations.  However until the Phthalates Regulations actually come into force later this year, it is doubtful that regulators will enforce these provisions.   Enforcement will range from product recall to criminal prosecution, and those found guilty of contravening the HPA or its regulations are liable to significant fines and/or imprisonment.

Useful Links:
Phthalates Regulations – SOR/2010-298

Regulatory Impact Analysis Statement

Order amending Schedule I to the Hazardous Products Act (Phthalates)

Health Canada. Preventing the use of six phthalates in soft vinyl children’s toys and child-care articles.  June 2009

A recent US report on chemical additives in toys highlights the concerns about hazardous substances in children’s toys:  See
Center for Health, Environment & Justice (CHEJ) and Teamsters Office of Consumer Affairs.  Toxic Toys R Us: PVC toxic chemicals in toys and packaging.  A Report to the National Commission of Inquiry into Toxic Toys. November 2010

About the Authors

The foregoing article forms part of a series of monthly columns by Environmental Law Specialists Dr. Dianne Saxe  and Ms. Jackie Campbell.

Dianne Saxe is one of the world’s top 25 Environmental Lawyers, according to Euromoney‘s Best of the Best, 2008. Best Lawyers named Dianne: Toronto’s Environmental Lawyer of the Year for 2011. Lexpert recognizes her as one of the best in Canada. Corporate Intl Magazine said their law firm was the 2010 “Environmental Law Firm of the Year in Canada

Dianne Saxe

Jackie Campbell is Canada’s only environmental lawyer who is also a practicing health professional: a pharmacist. Their law firm is the first Canadian environmental boutique on Lexology, and the only Canadian environmental firm honoured to be a member of the very prestigious International Network of Boutique Law Firms. The INBLF is an organization of the most highly credentialed and pre-eminent single-discipline law firms in North America, and top full-service firms on other continents.


Jackie Campbell



About Sandra Bell Kirchman

My passion is for fiction, especially fantasy fiction. I have been writing nearly all my life, since the age of 7 when I produced a 5-page novel called "Angus the Ant" - self-illustrated. My most recent novel WITCHCANERY is not about an ant and is available at most online booksellers. "Witchcanery" has won several awards and has met with modest, although enthusiastic, acclaim from readers around the world. I've also edited and published an anthology for the writers at my site, called "Birth of a Unicorn and Other Stories." Both books are available on Kindle; the latter is also available on Nook. Both books are sold as hard copies at most major online outlets as well as being available as paperbacks. One of my later ventures was horror stories; surprisingly, since horror stories scare me, I find I have a special affinity for them, especially in flash fiction format (under 1000 or less words). Currently, I am working on two WIPs, one a sequel to "Witchcanery," which several readers have made me promise to write; the other an apocalyptic novel called "The Road to the End of the World." There are several examples of this latter novel in my blog "Fantasyfic," formerly known as "Wizards and Ogres and Elves - Oh My!" Fantasyfic is on hold temporarily, while I work on my other two sites--"News, Views, and Gurus," and the said "Fantasyfic.". My other blogs keep me hopping. One is a roundup of news and some fun pieces from around the world. It is listed under the name of "News, Views, and Gurus." My blog "Puppy Dog Tales" is an ongoing sometimes humorous account of my adventures as an avid pet parent and animal lover. My little Shih-Tzu Ling Ling and my long-haired Mexican chihuahua are the joys of my life...and so is my husband, but I don't write about him. Anyhow, my blog "Puppy Dog Tales" is a work of love, featuring my doggies and other pets around the world. I'm a devoted advocate of animal rights and especially backing the cause of animal rescue shelters. My wonderful husband and I live in a very small town in southeastern Saskatchewan on the south side in a rustic, cedar-sided home. Our property is almost a whole acre, and is gracious and pretty (which is not easy to be in one package). All four of us are happy here.

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