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FDA Acknowledges Abandonment of Polycarbonate Resins

FDA Issues Final Rule on BPA in Baby Bottles and Cups

July, 20 2012


The U.S. Food and Drug Administration (FDA) has amended its food additive regulations, issuing a final rule that infant feeding bottles and spillproof cups, including their closures and lids, should no longer include polycarbonate (PC) resins because these uses have been abandoned.

PC resins are formed by the condensation of bisphenol A (BPA), and carbonyl chloride or diphenyl carbonate.

The action is in response to a petition filed by the American Chemistry Council. Because the petition was based on an assertion of abandonment, any comments addressing the safety of PC resins were not considered in the Agency’s evaluation of the petition. Separate from FDA’s consideration of this petition, FDA is assessing the safety of BPA.

The rule is effective July 17, 2012. Electronic or written objections and requests for a hearing must be submitted by August 16, 2012, and identified by Docket No. FDA–2012–F–0031. Electronic objections may be filed via the Federal eRulemaking Portal: http://www.regulations.gov. Written objections may be submitted via fax at 301–827–6870 or mailed/hand delivered/courier to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.


Why It Matters

BPA has been used since the 1950s to make polycarbonate plastics and epoxy resins. These hard, clear plastics are often used in containers that store food and beverages, such as some water bottles. The resins are also used to protect foods from microbial and other contamination by coating the inside of metal products, such as some food cans.

Pointing to dozens of studies in rats and other animals, some researchers say ingesting the chemical can interfere with development of the reproductive and nervous systems in babies and young children.

Additional research has shown that BPA can migrate into food and beverages and reports from some animal studies have raised potential concerns that BPA exposure may cause multiple health problems, including reproductive disorders, diabetes and cardiovascular disease.

How UL-STR Can Help

UL-STR’s material identification services use Fourier Transform Infrared Spectroscopy (FTIR) to ensure that PC resins are not being used.

To learn more about how UL-STR can help you achieve the highest standards of product safety and quality and verify that your products meet federal testing and labeling regulations, submit the short form below. A UL-STR representative will follow up with you soon.

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