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Many of today's toys are made of flexible plastic such as vinyl. From dolls to rubber duckies, a popular choice is vinyl made flexible by the addition of a phthalate
plasticizer during fabrication of the material. Flexible vinyl is durable and can endure years of hard play without losing its color, its flexibility or its fun.
It is easily cleaned and is low in cost. Years after the kids have outgrown their toys, and after many non-durable toys have broken, become useless or just a hazard,
the rubber duckie and its companions can be taken from storage to be enjoyed by the grandkids.
The plasticizer most commonly used in flexible vinyl toys is DINP, diisononyl phthalate. DINP has been extensively studied for possible health effects and has a very
good safety profile. Studies showed that rats and mice fed very high doses of DINP developed liver and/or kidney tumors after exposure over a lifetime. However,
there is growing consensus that these effects are not relevant to humans. Concerns have been expressed about possible developmental effects as well as possible chronic
liver and kidney toxicity, but these effects have been associated only with very high doses in laboratory studies and, as with the tumors, are probably not relevant to
humans. Nevertheless, a number of groups aggressively lobbied governments in the United States, Canada, Japan and Europe to have DINP banned from toys. A television
news magazine addressed the issue in 1998. Numerous scare stories were reported in the media and wildly inaccurate statements still circulate through the Internet.
In December 1998, after being petitioned to have vinyl toys banned, the U.S. Consumer Product Safety Commission (CPSC) released the results of a preliminary review of
DINP in children's products. The CPSC concluded that "few if any children are at risk from the chemical because the amount that they ingest does not reach a level that
would be harmful. Generally, the amount ingested does not even come close to a harmful level."
Having reached that conclusion, CPSC nevertheless requested industry to remove phthalates from soft rattles and teethers "as a precaution while more scientific work is
done." The industry complied despite the lack of scientific basis for the request. CPSC also set a conservative acceptable daily intake level for DINP, setting it at
"100 times less than the amount found not to cause any adverse health effects in laboratory animals." Only children who mouthed toys containing DINP for long periods of
time every day could potentially exceed that very conservative acceptable daily intake level.
Review followed review. Former Surgeon General C. Everett Koop chaired a scientific panel in 1999, which concluded that "DINP in toys is not harmful for children in the
normal use of these toys." The CPSC Panel recommended further study to increase the already substantial body of knowledge and reduce uncertainty and convened the Chronic
Hazard Advisory Panel (CHAP) to do so.
The CHAP reviewed the wealth of existing research on the effects of DINP. The CHAP report, published in 2001, found "minimal to non-existent risk of injury" for the
majority of children, but also added there might be a risk to children who mouth DINP-plasticized toys for 75 minutes a day or more, day after day for an extended period
of time. Dr. Daland Juberg, a toxicologist who reviewed studies of children's mouthing behavior and the advisory panel's conclusions, stated that "to date, there are no
data to indicate that such children exist."
In September 2002, the CPSC staff issued a report concluding that children who mouth toys containing DINP face "no demonstrated health risk" and recommended denial of the
petitions calling for bans on the use of vinyl in toys. The CPSC's assessment included a new and more extensive study on the mouthing habits of children. The mouthing study
showed that children spent much less time mouthing objects such as soft toys, teethers and rattles than had been previously believed. With these new data, the revised risk
assessment study on the mouthing habits of children concluded that oral exposure to DINP from mouthing objects is "not likely to present a health hazard to children." On
February 21, 2003, the three CPSC Commissioners voted unanimously to deny the petition calling for a ban. In an accompanying statement, Commissioner Mary Sheila Gall wrote:
"…consumers may have a high level of assurance that soft plastic products pose no risk to children."
Previously, an Expert Panel of the National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) reviewed the data for DINP and concluded
in 2000 that there was low concern for reproductive or developmental toxicity in children who mouth toys containing DINP. On the basis of the newer data from the CPSC, the
NTP-CERHR final report on DINP, published April 2003, lowered the concern level to "minimal." And in its second biomonitoring report in January 2003, the Centers for Disease
Control and Prevention found that on average, urinary levels of a breakdown product of DINP metabolism were below the limits of detection - that is, below eight-tenths of a
millionth of a gram per liter.
Risk assessments on a number of phthalates, including DINP, are in varying stages of completion by the European Union (EU). The final risk assessment report on DINP,
completed in 2003 and published in 2006 by the EU's European Chemicals Bureau, states that "…the end products containing DINP (clothing, building materials, toys and baby
equipment) and the sources of exposure (car and public transport interiors, food and food packaging) are unlikely to pose a risk for consumers (adults, infants and newborns)
following inhalation, skin contact and ingestion. The full technical report may be found at the DINP Information Centre on the European Council for Plasticisers and
Intermediates (ECPI) web site. Despite the findings of the risk assessment, the EU has made the temporary ban permanent. See
http://www.phthalates.org/pdfs/WhyEUBannedPhthalates.pdf for an independent analysis of
how the European ban came about.
A number of copy-cat bills have been introduced in state legislatures in the United States. One city, San Francisco, approved such a ban with almost no discussion or
consideration. A coalition sued the City of San Francisco challenging its ordinance on the ground that the federal government preempted the City through the CPSC's prior,
comprehensive safety review. In the Fall of 2007, California Gov. Arnold Schwarzenegger signed a similar bill into law, even while observing that "I do not believe that
addressing this type of concern in the Legislature on a chemical by chemical, product by product basis is the best or most effective way to make chemical policy in California."
Instead, he called for a "systematic way to address these types of concerns…" It remains to be seen whether other states will heed his comments.
CPSC letter denying the petition can be found at: http://www.cpsc.gov/library/foia/foia03/petition/ageunder.pdf
Last Updated: 10/19/2007
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