DIFFERING ACTIONS ON PHTHALATES
U.S. group allows continued use of phthalate in toys, EU seeks bans
The regulation of phthalates and the use of polyvinyl chloride (PVC) in children's toys and medical devices continue to be beset by conflicting actions.
On Feb. 21, the U.S. Consumer Product Safety Commission voted unanimously to allow the continued use of PVC and its primary plasticizer diisononyl phthalate (DINP) in toys for children ages five and under. CPSC voted in response to a petition from the National Environmental Trust and 11 other organizations that sought to ban PVC in all toys and other products intended for young children.
In making this decision, the commission accepted the conclusions of a CPSC-commissioned report that says exposure to DINP from toys "would be expected to pose a minimal to nonexistent risk of injury for the majority of children." The study concludes that young children mouth toys for an average of 1.9 minutes per day, and the amount of DINP that leaches from the toys would be far below an unsafe level.
However, in contrast, a recent proposal prepared under the European Union Existing Substances Regulation states that several groups are exposed to unacceptable levels of di-2-ethylhexyl phthalate (DEHP) in PVC. The groups are children in contact with vinyl toys containing DEHP, workers in industries manufacturing or using DEHP, and patients under long-term hemodialysis with vinyl medical devices containing DEHP. The proposal suggests amendments to a large number of existing European Commission directives.
Also, on Feb. 21, a bill was introduced in the California Assembly that would ban the sale and distribution of DEHP-plasticized medical devices except when there is no alternative device approved by FDA. Last year, FDA proposed voluntary restrictions on DEHP-plasticized devices used for long periods of time on newborn infants and pregnant women.