The Food and Drug Administration will ban the use of bisphenol A (BPA)-based epoxy resins in coatings for baby formula packaging after determining the industry has abandoned use of the substance, according to a final rule published July 12 (78 Fed. Reg. 41,840).
According to FDA, all U.S. infant formula manufacturers have abandoned the use of BPA-based epoxy resins as coatings in packing and have no plans to introduce the resins into the market.
FDA did not address the safety of using BPA in baby formula packaging, only whether its use had been abandoned my manufacturers. Regulations under the Federal Food, Drug, and Cosmetic Act at 21 C.F.R. 171.130 (a) allow FDA to amend a food additive regulation on the basis of evidence that the additive is no longer used in a particular application if, for example, the marketplace has abandoned that application.
FDA said it defined BPA-based epoxy resins as coatings used to provide a barrier between the formula and the metal or other packaging layer.
The move comes in response to a March 2012 petition from then-Rep. Edward Markey (D-Mass.), who was recently elected to the Senate representing Massachusetts (36 CRR 783, 7/23/12).
“With viable alternatives available for BPA, I urge all companies to abandon the use of this toxic chemical, and I will continue my work in the Senate to ensure our entire food supply is free from this damaging chemical,” Markey said in a July 11 statement.
BPA is used primarily to make polycarbonate plastic for use in electronics, automobiles, CDs and DVDs, and food and drink containers. It exhibits hormone-like properties and has raised concern specifically about its suitability in consumer products and food containers.
The American Chemistry Council said amending the food additive regulations to remove BPA from the list of approved substances will alleviate any confusion from customers.
“As stated in the petition, BPA is no longer used in infant formula packaging,” Steven G. Hentges from the American Chemistry Council's Polycarbonate/BPA Global Group said in a statement. “We believe this action by FDA will bring clarity for consumers and will eliminate any lingering confusion about the presence of BPA in infant formula packaging. As noted by FDA, their action is not based on any finding or conclusion that packaging containing BPA is unsafe.”
FDA is studying the potential health effects of BPA exposure as part of a separate action. The administration in 2010 sought comment on four documents addressing evaluations by FDA of recently published toxicological studies on bisphenol A. The studies included research on the low-dose effects of bisphenol A, dietary exposure estimates, and biomonitoring data.
At the time, FDA said it had “some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children” (75 Fed. Reg. 17,145).
FDA's final rule on BPA-based epoxy resins in baby formula packaging is available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-16684.pdf.
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