BPA Labeling in California Begins May 10

April 21, 2016 | Bisphenol-A (BPA) is one of the latest chemicals to be named under California’s Proposition 65 law, which requires that products (or buildings) that contain substances “known to the State of California” to be potentially harmful bear a warning label indicating as much.  BPA was listed as a reproductive toxin in 2015 under California Proposition 65 and the labeling date will begin on May 10, 2016 for products that present an exposure level to BPA above an acceptable level as set by the State.  

“The traces of unreacted residual BPA found in fully formed plastics are so low that it appears that labeling of typical toy parts will not be necessary,” said Al Kaufman, Toy Industry Association (TIA) senior vice president of Technical Affairs. He added that residual BPA may be found in polycarbonate plastics, a material specifically selected for its safety attributes because it is shatter- and heat-resistant.

“Children’s mouthing behavior makes oral exposure the primary route of relevance when we are talking about toys, while other routes like skin contact and inhalation are typically negligible pathways for exposure,” Kaufman noted. 

However, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) set a dermal exposure maximum allowable dose level (MADL), or “safe harbor” of 3 ug per day. No MADL for oral exposure has been established by OEHHA.

A review of experimental studies on both mouthing behavior and on BPA reveals that the calculated BPA exposure from mouthing of polycarbonate toys is significantly lower than the lowest No Observable Adverse Effect Level (NOAEL) for reproductive toxicity in published studies. It is also lower than a calculated “unofficial” MADL (derived by dividing the NOAEL by a 1,000-fold safety factor). This is further validated by the European Food Safety Authority, which in 2015 issued a statement taking the position that exposure to BPA from polycarbonate parts does not pose a risk, and estimating daily exposure from toys to be several orders of magnitude lower than the calculated “unofficial” MADL (these estimates are in the single-digit nanogram range).   

Manufacturers are encouraged to make individual determinations of potential exposure from their products and reach a decision regarding necessity of labeling, but labeling is not expected to be required for the vast majority of toy products.