Chemical Substances
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Frequently Asked Questions
Batch 6 Draft Screening Assessments
1.What are phthalates?
Phthalates refers to a family of chemicals commonly used in the making of plastics.
2.What products contain phthalates?
Phthalates are found in a number of products, including medical devices such as blood bags and intravenous tubing, nail polish and soft vinyl toys and child care articles.
3.Why are phthalates a concern?
There is concern in the scientific community that some phthalates found in soft vinyl children's toys and child care articles may pose a risk to health. Animal studies show that certain phthalates may cause reproductive and developmental abnormalities in young children when soft vinyl toys and child care articles containing phthalates are sucked or chewed for extended periods.
4.Why does the Government's draft assessment propose two phthalates (DMEP and DHNUP) do not pose a risk to human health?
The Government conducted a science-based evaluation, called a screening assessment, for DMEP and DHNUP. DMEP is not used, manufactured or imported into Canada. The production of DHNUP appears to have been phased out in Canada since 2006, and annual imports of DHNUP are estimated to have declined by over 95% since 2006. Since Canadians' exposure to both of these substances is expected to be very low, the Government's draft screening assessment concludes they do not pose a risk to human health. DHNUP may be entering the environment through cleaning of shipping containers and may pose a risk to the environment. The Government is recommending a code of practice be developed for the handling of these containers to reduce the impact to the environment.
5.Are DMEP and DHNUP used in soft vinyl children's toys or child care articles?
No. Industry was required to provide information on these substances following publication of a Notice in Canada Gazette, Part I in May 2008. From the information received, DMEP is not used, manufactured or imported into Canada. Health Canada has also tested for DMEP in over 70 children's products. The chemical was not detected in any of the products tested.
The production of DHNUP appears to have been phased out in Canada since 2006, and annual imports of DHNUP are estimated to have declined by over 95% since 2006. Its primary use is for plasticization of electrical and communication wire insulation.
6.What is the Government doing to protect Canadians from exposure to phthalates?
The Government is drafting regulations to prohibit the use of six phthalates (DEHP, DBP, BBP, DINP, DIDP and DNOP) in soft vinyl children's toys and child care articles. These regulations are expected to come forward in the coming months.
To ensure levels of DMEP remain very low, the Government is recommending the application of a Significant New Activity (SNAc) provision so that the Government is notified of any new manufacture, import or use of the substance and that ecological and human health risk assessments are done prior to any new use. The Government is also recommending a code of practice be developed for the handling of containers (i.e., tanker trucks, rail cars) that transport or store DHNUP to minimize its impact on the environment.
7.Why doesn't the Government ban the use of all phthalates?
The use of some phthalates, such as in medical devices including blood bags and intravenous tubing, is necessary for the proper functioning of devices that provide many health benefits to Canadians. Canadians need access to devices that are medically necessary and for which there are no suitable substitutes.
8.Can adults and children continue to use personal care products such as shampoo or consumer products such as machine dishwashing detergent containing benzyl chloride?
Yes. Benzyl chloride is not intentionally added to products and Canadians are only exposed to trace amounts in consumer and personal care products and pharmaceuticals. Consumers can continue to use these products and should not be concerned about the effects on their health.
9.If benzyl chloride poses a risk to human health, why isn't the Government introducing a ban similar to the one it announced for baby bottles made with bisphenol A?
The health risks associated with a chemical depend on the hazard (its potential to cause health effects) and the dose (the amount of chemical to which you are exposed).
Because Canadians are only exposed to trace amounts of benzyl chloride, they should not be concerned about health effects. To ensure the levels of benzyl chloride remain very low, however, the Government is recommending regulations be introduced so that Canadians' exposure does not increase.
10.What happens next?
The Government published the draft screening assessments in Canada Gazette, Part I on May 29, 2009. The public has 60 days to comment on all draft screening assessments released as part of Batch 6. Anyone with information on the substances assessed in Batch 6 is encouraged make a submission before July 29, 2009. This information will be considered before we finalize the assessments, and in the development of any risk management options.
