How safe is polycarbonate as a design engineering material for food-contact applications?
A new report from the U.S. Department of Health and Human Services (HHS) and the Federal Drug Administration makes this statement: ”At this interim stage, FDA shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.”
The response from the American Chemistry Council is this: “The HHS statement today confirms that exposure to BPA in food contact products has not been proven harmful to children or adults. However, the agency suggests that more research needs to be done and provided guidance on how parents can choose to limit infant exposures.
“Regulatory agencies around the world, which have recently reviewed the research, have reached conclusions that support the safety of BPA. Extensive scientific studies have shown that BPA is quickly metabolized and excreted and does not accumulate in the body. BPA is one of the most thoroughly tested chemicals in commerce today. ”
The design of products for infants is most immediately affected by concerns that bisphenol A used in the production of polycarbonate and epoxy could leach into milk or food. The FDA is supporting actions to stop producing BPA-containing bottles and infant feeding cups for the U.S. market. The FDA is also facilitating the development of alternatives to BPA for the linings of infant formula cans.
What about myriad medical applications for polycarbonate?
“The greatest risk of BPA leaching into a drug formulation is most likely to occur with liquid and suspension formulations that are packaged in (i.e., direct contact with) polycarbonate container-closures or metal canisters with epoxy lining,” according to the FDA, which launched a study on BPA used in the medical market last year. The FDA’s Center for Drug Evaluation and Research (CDER) is assessing the potential for exposure to BPA from use of these products.
In the meantime, it was clear at last week’s Medical Design & Manufacturing exhibition in Anaheim, CA that some suppliers are already targeting potential BPA sources in medical applications.
Eastman Chemical, for example, showed its medical grades of Eastman TritanTM copolyester, which were launched into the medical market during MD&M West in February 2009. They are said to provide outstanding lipid and chemical resistance; higher heat stability; excellent long-term clarity; added durability and toughness; and are made without bisphenol-A (BPA) or halogens.