In the U.S., as of February 2009, three phthalates were permanently prohibited at concentrations greater than 0.1 percent in toys and child care articles. Three phthalates (DINP, DIDP and DnOP) were temporarily restricted in toys that can be placed in a child’s mouth and child care articles and have been referred to an advisory panel for further study.
The decision to restrict the use of phthalates in children’s products, however, is not based on science. In September 2012, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) of the Australian Government Department of Health and Ageing joined regulatory bodies in the United States and Europe that have found that current uses of DINP in consumer products are not expected to pose a risk to human health.
NICNAS performed a comprehensive review of the available scientific literature on the phthalate DINP, including the report to the U.S. Consumer Product Safety Commission (CPSC) by the Chronic Hazard Advisory Panel (CHAP) on DINP in 2001 and the most recent publicly available U.S. assessment, the 2010 CPSC staff toxicity report on DINP.
Consumer Product Safety Improvement Act: Phthalates Provision for Toys
In August 2008, President Bush signed into law the Consumer Product Safety Improvement Act (CPSIA), (H.R. 4040). The CPSIA overhauled the Consumer Product Safety Act, and responded, in part, to public concerns about imported toys containing lead. Among the CPSIA’s provisions are restrictions on six phthalates in toys and children’s products. These restrictions became effective February 10, 2009.
The phthalates restrictions of the CPSIA apply to specified phthalates in particular products:
DEHP, DBP and BBP: There were permanent restrictions, effective February 10, 2009, on the sale of children’s toys and child care articles with concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) or benzyl butyl phthalate (BBP).
DINP, DIDP and DnOP: CPSIA placed temporary (interim) restrictions, effective February 10, 2009, on the sale of children’s toys that can be placed in a child’s mouth, and on child care articles that contain more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) or di-n-octyl phthalate (DnOP). Toys that can be put in the mouth are defined to include toys or parts smaller than five centimeters in one dimension. Toys that cannot be put in the mouth, but can be licked, are not included.
For the three interim-restriction phthalates (and for other phthalates and plasticizers), the Consumer Product Safety Commission (CPSC) must convene a scientific study conducted by a Chronic Hazard Advisory Panel (CHAP). After the CHAP is completed, CPSC must decide whether to lift the interim restriction or make it permanent.
What You Need to Know
The CPSIA sets specific standards on the presence of certain phthalates in toys and child care articles. However, unlike lead, where prior to the passage of CPSIA there had been numerous, highly publicized recalls of children’s products by CPSC, there had been no equivalent activity by the CPSC with regard to phthalates. It is also important to note that:
Of the six phthalates restricted by the CPSIA, DINP had been typically used in toys in recent years; this phthalate has not been permanently restricted by CPSIA. Instead, it has been referred for further study. DINP was found safe in a previous review by CPSC.
A CHAP convened in 2001 to review the safety of DINP concluded that, “For the majority of children, the exposure to DINP from DINP-containing toys would be expected to pose a minimal to nonexistent risk of injury.”
The CHAP 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; however, mouthing experiments showed that children kept toys in their mouths for less than two minutes a day.
CPSC has never expressed immediate concerns about phthalates used in toys and child care articles, therefore, consumers should not be alarmed or concerned that some children’s products may still contain phthalates.
The industry voluntarily removed DEHP and DINP from teethers, rattles and pacifiers and, as a result, these products are made from plastics that are not expected to contain phthalates. The CPSIA simply put this voluntary agreement into law.
Past Scientific Reviews
1998: CPSC Review of DINP
In 1998, after being petitioned to ban vinyl toys, the U.S. 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.”
CPSC, nevertheless, requested that the industry voluntarily remove phthalates from soft rattles and teethers “as a precaution while more scientific work is done.” Despite the lack of a scientific basis, the industry complied with the request. CPSC also established 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.
1999: Former Surgeon General Led Review of DINP
In June 1999, under the auspices of the American Council on Science and Health (ACSH), a panel led by former Surgeon General Dr. C. Everett Koop examined the safety of DINP in vinyl toys. After a review of the scientific data and exposure for DINP, Dr. Koop’s panel concluded that, “DINP in flexible toys is unlikely to pose a health risk to children.” Dr. Koop also stated that, “Consumers can be confident that vinyl toys … are safe.” The Koop Panel did recommend some further evaluation, which was completed by the CPSC CHAP and, in 2001, likewise found little reason for concern.
2000: National Toxicology Program Conducted Risk Assessments
An expert panel of the National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) reviewed the data for several phthalates and concluded in 2000 that there was low concern for reproductive or developmental toxicity in children who mouth toys containing DINP and minimal concern for DINP, DIDP, or DnOP exposure in reproductive toxoicty to humans. On the basis of the NTP-CERHR final report on DINP, published April 2003, CPSC lowered the concern level to “minimal.”
2001: Chronic Hazard Advisory Panel Finding
After the initial CPSC review of DINP in 1998, to reduce uncertainty, CPSC convened a Chronic Hazard Advisory Panel (CHAP). The CHAP reviewed the wealth of existing research on the effects of DINP. In 2001, the CHAP found “minimal to nonexistent 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.”
In 2007, the CPSC sent a letter to California Senator George Runner regarding children’s toys and PVC. In this letter, the CPSC reinforced its 2002 decision and indicated “that the CPSC staff has kept abreast of the new research and has not seen anything that would cause a change in the staff’s position on this issue.”
2003: Assessment by EU’s European Chemicals Bureau
The European Union (EU) conducted risk assessments on a number of phthalates, including DINP, over the years. The final risk-assessment report on DINP, completed in 2003 and published in 2006 by the EU’s European Chemicals Bureau, stated 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.
View this PDF for an independent analysis of how the European ban came about.
U.S. State Legislation on Phthalates
In October 2007, California passed legislation banning the manufacture and sale of toys and child care products that contain levels of six specific phthalates of more than one-tenth of 1%. The law went into effect on January 1, 2009. In signing the California law, Governor Arnold Schwarzenegger stated, “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.”
In Washington, Governor Chris Gregoire signed into law a regulation to limit the use of phthalates to 1,000 parts-per-million in toys, cosmetics and jewelry for children under the age of 12, and car seats that are made and sold in the state, effective July 1, 2009.
With the enactment of the CPSIA and its express preemption provision, state laws that address phthalates are now being called into question. In November 2008, the Washington State Department of Ecology (DOE) formally withdrew agency rulemaking on the proposed Children’s Safe Products Rule, including provisions related to phthalates in children’s products.