In 2009, we blogged about plastics that contain (and release) phthalates, plasticizers used in the manufacture of soft vinyl used in many products (https://www.siskinds.com/slow-death-by-rubber-duck/). New Phthalates Regulations under the Hazardous Products Act (HPA) were registered on December 9 2010, and will come into force on June 9, 2011. They should help reduce phthalate exposure for babies and toddlers.
Phthalates leach out of plastic, for example via the saliva from soothers during sucking and chewing (not licking), and can be absorbed into the bloodstream. Some phthalates have been linked to reproductive and developmental toxicities in animals.
The regulations restrict advertising, sale and importation of toys and child care articles (e.g., teethers) made of vinyl that contains any of six phthalates (see the full chemical names and abbreviations, below). These regulations are consistent with measures taken by the United States and European Union.
In 1998, Canadian industry voluntarily removed the 2 main phthalates used in teethers and pacifiers (DEHP, DINP), but as most of these products are manufactured off-shore, the impact has not been significant. These regulations represent a positive first step in making sure that exposure to phthalates is minimized in our most vulnerable population – infants and young children.
The regulations – they’re brief!
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 and chewed AND if one of its dimensions (in its deflated state, where applicable) is less than 5 centimetres. Of note, 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.
Health concerns – phthalates
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 children 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 six phthalates:
Di(2-ethylhexyl) Phthalate (DEHP) — CAS Number 117-81-7
Dibutyl Phthalate (DBP) — CAS Number 84-74-2
Benzyl Butyl Phthalate (BBP) — CAS Number 85-68-7
Diisononyl Phthalate (DINP) — CAS Numbers 28553-12-0 and 68515-48-0
Diisodecyl Phthalate (DIDP) — CAS Numbers 26761-40-0 and 68515-49-1
Di-n-octyl Phthalate (DNOP) — CAS Number 117-84-0
Phthalates Regulations – SOR/2010-298
Regulatory Impact Analysis Statement