Infant Formula Packaging Now Free from BPA Coating
A final rule which changed the existing food additive regulations on the use of BPA has been published by the U.S. Food and Drug Administration (FDA). It states that the use of bisphenol A (BPA)-based epoxy resins to coat packaging of infant formula will no longer be allowed, as the practice has been abandoned by manufacturers.
This action by the FDA has taken place only because of abandonment, it is not linked to any safety concerns around BPA. The safety review which is currently in effect backs the safety of BPA when used to manufacture containers that have food contact, as noted in the food additive regulations.
The Food and Drug Administration chose to take action because of a petition relating to food additives submitted by Massachusetts Representative, Edward Markey. The petition argued that the industry has stopped using BPA in the production of infant formula packaging. It requested, therefore, that the FDA change the current food additive regulations, halting this type of BPA use in infant formula packaging, to match current industry practices.
What is BPA?
BPA (bisphenol-A) is a synthetically produce chemical. Due to its strength and resilience, it is added to food containers, baby bottles and cans to prevent corrosion. BPA produces two kinds of polymer, each used in food packaging, these are epoxy-based coatings and polycarbonate polymers. The U.S FDA acknowledge that residual amounts of BPA can transfer to food when the product is used, but they believe that dietary exposure is so low that it could not be harmful to health. However, the FDA confirms that BPA usage is reviewed regularly and some studies reported significantly higher levels of transfer.
Use of BPA Abandoned in Infant Food Package Manufacturing
The FDA announced in July 2012 that Representative Edward J. Markey had filed a petition suggesting that BPA use was halted in infant formula packaging. Under regulations laid out in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the FDA noted a petition could suggest this kind of change to a food additive regulation if there are clear “old uses abandoned” indications for the specific additive.
As such, Representative Markey’s petition gathered information available to the public and fresh data from US companies which make infant formula. The data backed his claim that the use of BPA-based epoxy resins as coatings in infant formula had been abandoned by all manufacturers of infant formula in the USA, and, that no more of this packaging was being put on the US market.
Is BPA Safe?
Over 7,200 individuals were represented by eighteen comments regarding the potential threat to health posed by BPA exposure. However, as the petition was not based on safety, but rather abandonment, the FDA considered that safety concerns were not relevant here. They mentioned the safety of BPA would be assessed in separate studies.
Has BPA Been Abandoned in Infant Packaging Manufacture?
Three comments were received from trade associations arguing that BPA-based epoxy resins in packaging for infant formula, had not been completely abandoned. Furthermore, they claimed some manufacturers still wanted it as a possible future coating for infant formula. The FDA requested more information from the petitioner. Representative Edward J. Markey responded with a new study including all four main U.S infant formula producers. Of these, three agreed the use was abandoned, but one reserved the right to use BPA in future. The FDA decided this proved abandonment, and the single manufacturer that may want to use BPA in future could seek permission through the food contact notification process if necessary.
What Impact Will the New Ruling Have?
One commenter proposed that consumer confidence could be affected and some people in the U.S.A may even lose their jobs if the ruling was agreed. The FDA felt that as the use of BPA in infant formula packaging was already abandoned, it was unlikely to impact jobs or confidence retrospectively.
Are There Alternatives?
Some comments expressed concern over what products could be used as an alternative to BPA-based epoxy resins. The FDA explained that this was not relevant to this ruling on abandonment, though they were aware of alternatives, and these were listed in regulation § 175.300.
How Wide Should the Ban be?
One of the commenters suggested the ruling did not go far enough, calling for a blanket ban on BPA-containing packages. As it was beyond their scope in this particular case, the FDA decided it would not be appropriate to address the idea of a total BPA ban, although as stated previously, other studies are ongoing.
The Issue of BPA Labelling
The FDA received one comment which advised consumer packaging should be clearly labelled to show it contained BPA. Again, it was not considered relevant to this particular ruling and the comment was not addressed.
The Presence of BPA in Future Infant Formula Packaging
Concerns were raised about environmental contamination, i.e., the transfer of BPA to infant formula packaging in future, despite a ban. The FDA felt that cross-contamination at any significant level was highly unlikely when the ban comes into place. However, they said if BPA-based epoxy resins were identified in infant formula packaging when the resolution is passed, they will investigate whether it contravenes the FD&C Act.
The FDA’s Conclusion
Having looked at the information available in the petition, along with other relevant data, the FDA established that BPA-based epoxy resins were not used in infant formula packaging anymore and so they were, in effect, abandoned. Therefore, regulation § 175.300 was amended and infant formulas can no longer be manufactured using a coating of BPA-based epoxy resins in their packaging.