The U.S. Consumer Product Safety Commission (CPSC) has released the risk assessment on phthalates conducted for the CPSC by a congressionally mandated Chronic Hazard Advisory Panel (CHAP). In the Consumer Product Safety Improvement Act, Congress charged the CHAP with making recommendations on whether the use of additional phthalates or phthalate alternatives in children’s toys and child care articles should be restricted as banned hazardous substances. The CHAP made the following specific recommendations in its assessment of the risks of 14 phthalates and six phthalate alternatives:

• The interim ban on the use of diisononyl phthalate (DINP) in children’s toys and child care articles at levels greater than 0.1% be made permanent because DINP “induces antiandrogenic effects in animals, although with lesser potency than other active phthalates, and therefore can contribute to the cumulative risk from other antiandrogenic phthalates.”
• The current interim bans on di-n-octylphthalate (DNOP) and diisodecyl phthalate (DIDP) be lifted because they do not appear to possess antiandrogenic potential but that U.S. agencies responsible for dealing with DNOP and DIDP exposures from food and child care products conduct the necessary risk assessments with a view to supporting risk management steps given other toxicological endpoints of concern.

• Diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) should be permanently banned from use in children’s toys and child care articles at levels greater than 0.1% even though they “individually do not indicate a high level of concern” but citing to their contribution “to the cumulative risk from other antiandrogenic phthalates.”
• No action be taken on dimethyl phthalate (DMP) or diethyl phthalate (DEP) but further recommends that U.S. agencies responsible for dealing with DEP exposures from food, pharmaceuticals, and personal care products conduct the necessary risk assessments with a view to supporting risk management steps.
• It is unable to make a recommendation on di(2-propylheptyl) phthalate (DPHP) despite its use in some children’s toys because of the general lack of publically available information on DPHP.
• Diisooctyl phthalate (DIOP) be subject to an interim ban from use in children’s toys and child care articles at levels greater than 0.1% until sufficient toxicity and exposure data are available to assess the potential risks given that antiandrogenic effects are possible.
• No action be taken on the phthalate alternatives at this time because there “is no evidence that any of the alternatives considered by the CHAP presents a hazard to infants or toddlers from mouthing toys or child care articles” but the CHAP recommends that the appropriate U.S. agencies obtain the necessary exposure and hazard data to estimate total exposure to and assess the potential health risks of:
  • 2,2,4-trimethyl-1,3 pentanediol diisobutyrate (TPIB);
  • Di(2-ethylhexyl) adipate (DEHA);
  • Di(2-ethylhexyl) terephthalate (DEHT);
  • Acetyl tributyl citrate (ATBC);
  • Diisononyl hexahydrophthalate (1,2-cyclohexanedicarboxylic acid, diisononyl ester) (DINX); and
  • Tris(2-ethylhexyl) trimellitate (TOTM).

Congress charged the CHAP with making recommendations on whether the use of additional phthalates or phthalate alternatives in children’s toys and child care articles should be restricted as “banned hazardous substances,” and, interestingly, not whether interim or permanent bans should be issued. No specific action has been or will be taken by the CPSC on the CHAP’s recommendations for some time, and there will be time for industry comment before any restrictions on additional phthalates go into effect.