The US FDA announced that it will publish a final rule that will disallow the use of bisphenol-A (BPA)-based epoxy resins as coatings in infant formula packaging(1). The agency’s decision is based solely upon the fact that BPA has been abandoned by all of the US manufacturers of infant formula, and is not to be taken as a statement of the safety of BPA. This rule amended 21 CFR 175.300(2) which deals with resinous and polymeric coatings for food contact purposes, and went into effect on 12 July 2013. BPA-based resins and coatings may still be used for articles “intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food” (3). This would include metal containers which almost always use some kind of polymeric coating, though not necessarily BPA-based. Previously, in June of 2012, the FDA had also disallowed BPA-based polycarbonate resins for the use of infant feeding bottles (baby bottles) and spill-proof cups (sippy cups)(4).
Bisphenol A in Other Juvenile Products
As with the baby bottles and sippy cups, the FDA exercised its authority under 21 CFR 171.130 to amend a regulation based upon “an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that … old uses abandoned … [that] may justify its amendment or repeal.” (5) The abandonment must be complete, and through a survey of all manufacturers of infant formula that are registered in the US, the FDA found they had all abandoned the use of BPA-based epoxy resins in their containers. Furthermore, the FDA was presented with no evidence that any of these manufacturers had definite plans to reintroduce BPA in any future production of infant formula packaging.
US FDA was careful to point out in its final rule that this change is strictly based upon abandonment and is not a statement one way or another on the safety of BPA. Furthermore, consideration of any other type of packaging was beyond the scope of the ruling, and the FDA had not received any evidence of the complete abandonment of BPA-based packaging materials in any other type of container. The FDA also declined to specify a minimum acceptable amount of BPA in infant formula containers due to environmental contamination. They stated that in the highly unlikely event that the presence of BPA-based epoxy resins in infant formula packaging is identified in the future, it is then that the agency will decide whether the infant formula is adulterated under the Food, Drugs, and Cosmetics Act and would require a regulatory limit.
References:
(1) “Indirect Food Additives: Adhesives and Components of Coatings”, Federal Register (https://www.federalregister.gov/articles/2013/07/12/2013-... )
(2) FDA Code of Federal Regulations (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/C... )
(3) SGS SafeGuard NO. 119/12 July 2012 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/0...);,
(4) US FDA Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2012-07-17/pdf/2012-17366.pdf )
(5) Code of Federal Regulations (http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol3/xml/CFR-2012-title21-vol3-sec171-130.xml)
About SGS BPA Testing Services
Throughout a global network of laboratories, SGS is able to provide a range of services, including analytical testing and consultancy for BPA in food-contact (http://www.sgs.com/en/Consumer-Goods-Retail/Hardgoods/Home-Furnishings-and-Houseware/Testing/Food-Contact-Tests.aspx) and other consumer products for the US and international markets.
Please do not hesitate to contact the SGS experts for further information.
Contact details:
SGS Consumer Testing Services
Paul Milne, Ph.D.
Technical Manager, Restricted Substances Testing Services
SGS – North America
291 Fairfield Avenue
Fairfield, NJ 07004
t: +1 973-461-1512
Email: cts.media@sgs.com
Website: http://www.sgs.com/en/Consumer-Goods-Retail/Hardgoods.aspx
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75 000 employees, SGS operates a network of over 1 500 offices and laboratories around the world.
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