Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, December 30, 2014

CPSC issues proposal on phthalate restrictions

By Joe Bichl

The Consumer Product Safety Commission (CPSC) has issued a proposed rule that would prohibit children’s toys and childcare articles sold in the United States from containing specified phthalates. Phthalates are chemical plasticizers that are often used in the production of many types of plastics, certain inks, paints, and other products, including children’s toys and child care articles.

Background. Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) required CPSC to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives other than those already permanently prohibited should be prohibited. Based on the panel’s findings, the CPSC is required to issue a final rule on the chemicals. CPSC’s proposal for the rule followed the CHAP recommendations.

Currently, CPSIA permanently prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of any “children’s toy or child care article” that contains concentrations of more than 0.1 percent of di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl phthalate (BBP). In addition, section 108(b)(1) of the CPSIA prohibits on an interim basis (i.e., until the Commission promulgates a final rule), the manufacture for sale of “any children’s toy that can be placed in a child’s mouth’ or “child care article’ containing concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DNOP).

CHAP report. The CHAP reviewed all of the potential health effects of phthalates. Although phthalates are associated with a number of adverse health effects, the CHAP considered effects on male reproductive development to be the most relevant for human risk assessment. The panel determined that exposures to multiple phthalates at lower doses act in concert to produce the same effect as a higher dose of a single phthalate. The CHAP also indicated that several studies found associations between prenatal or neonatal exposure and neurobehavioral effects in children. Based on this information, the CHAP concluded that there is a growing body of studies reporting associations between phthalate exposure and human health.

Proposed rule. The proposed rule would lift the interim prohibitions for two of the three phthalates (DIDB and DNOP) and would permanently prohibit children’s toys and child care articles containing more than 0.1 percent of the third phthalate (DINP). The proposed rule would also prohibit children’s toys and child care articles containing more than 0.1 percent of any of four specified phthalates that were not prohibited by the CPSIA (DIBP, DPENP, DHEXP, and DCHP).

The proposed rule would also prohibit children’s toys and childcare articles containing four additional phthalates: DIBP, DPENP, DHEXP, and DCHP. The prohibition on the use of these additional phthalates is not expected to have a significant impact on a substantial number of manufacturers because the CHAP found that three of these phthalates (DPENP, DHEXP, and DCHP) are not currently used in children’s products and that although the fourth (DIBP) has been found in some toys, it “is not widely used in toys and child care articles.’

Under the proposed rule, manufacturers of children’s toys that can be placed in a child’s mouth and child care articles would need to continue to test to ensure that their products do not exceed concentrations of more than 0.1 percent for DINP.

The proposal would also require that manufacturers certify children’s toys and child care articles do not contain DIBP, DPENP, DHEXB, and DCHP in concentrations of greater than 0.1 percent based on third-party tests. However, these manufacturers are already subject to third-party testing for DEHP, DBP, and BBP.

Small businesses would be subject to the proposed rule if they manufacture or import children’s toys or child care articles that contain phthalates. These companies are already subject to the restrictions imposed by the CPSIA on children’s toys and child care articles containing certain phthalates. The proposed rule would neither increase, nor decrease, the number of small entities to which the phthalate restrictions apply.

Comments on the proposal must be submitted on or before March 16, 2015.

MainStory: TopStory ProposedRules CPSCNewsStory

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.