Introduction: Diisononyl phthalate, or DINP, is the plasticizer most used for making children’s vinyl toys soft, flexible, and durable—and, use of DINP in vinyl toys has been supported by thorough scientific reviews by government agencies on two continents.
A thorough risk assessment performed by French scientist under the aegis of the European Union’s European Chemicals Bureau found no reason to impose any risk reduction rules on use of the substance, specifically including their uses in toys and childcare items. In the United States, a six-year review by the Consumer Products Safety Commission (CPSC) found no demonstrated health risk to children from playing with and mouthing vinyl toys containing DINP. And it found good reason to continue its use, stating: “If DINP is to be replaced in children’s products…the potential risks of the substitutes must be considered. Weaker or more brittle plastics might break and result in a choking hazard. Other plasticizers might not be as well studied as DINP.”
Despite the overwhelming evidence testifying to DINP’s benefits and safety profile, politics sometimes prevails over science. Europe has banned its use in toys, and a copycat proposal has been introduced in the California legislature.
Safety data: Concerns over the use of DINP in toys and children’s articles, particularly those intended for the mouth, were raised in a petition from an activist group to the CPSC in 1998. The concerns were based on negative health effects seen in some rats and mice fed high doses of DINP over extended periods. To be ultraconservative, the CPSC suggested that manufacturers stop using phthalates in soft rattles and teething rings—article intended for the mouth (as CPSC noted, phthalates are not used in pacifiers and baby bottles). American manufacturers complied. In 1999, the European Union imposed a temporary three-month ban, and periodically renewed it.
Since then, DINP has been extensively studied and has earned high points. Data generated by American regulatory and scientific agencies indicate that human exposure to DINP is far below safety levels established by the government. In fact, biomonitoring tests performed by the Centers for Disease Control and Prevention on more than 5,000 human subjects couldn’t even detect its presence in most cases. In tests of a small number of infants, CDC researchers got the same result—although they tested for DINP, they could not detect its presence.
And after years of work, including review by a specially convened panel of independent scientists, CPSC denied the petition against DINP. The CPSC review included original research on the mouthing habits of children, literally counting the minutes in a day when any toy, vinyl or not, resided in the mouth of the observed children. The results were crystal clear: even if every toy, including pacifiers, were made from DINP-bearing vinyl, exposure from mouthing would be far below the conservative safety level set by the CPSC. Said commissioner Mary Sheila Gall in a statement: “…consumers may have a high level of assurance that soft plastic products pose no risk to children."
In Europe, the results were similar. The final conclusion of the scientific assessment of DINP was that exposures from consumer products, including toys, “are unlikely to pose a risk to adults, infants, or newborns.” Nevertheless, on the political side, the European Commission extended the temporary ban 19 times. Finally, in what appears to have been a decision to resolve an increasingly awkward situation, permanent restrictions on use were agreed to by the European Parliament.
A final point: further research has led to the scientific consensus that DINP does not pose a cancer risk to humans because the process leading to the formation of tumors in rodents is not relevant to humans.
