USA: FDA Clears Use of Naphthalate for Food and Beverage Containers
Two clearances allow blending of naphthalate in PET (polyethylene terephthalate) at any composition from zero to 100 percent. Under the terms of the clearances, granted exclusively to polymers made with BP Amoco's NDC (dimethyl-2,6-naphthalene dicarboxylate), NDA (2,6-naphthalene dicarboxylic acid) or both, the company may extend the privilege for use to resin producers and their customers.
PET/N and PEN (polyethylene naphthalate) offer food and beverage manufacturers a long-awaited alternative to glass. "For industries trying to reduce shipping weight and breakage without sacrificing shelf life, PET/N and PEN provide the answer," says Uduak Udofia, BP Amoco's Director of Marketing and Sales for Packaging/Film. "The beer industry in particular is ready for a lightweight, shatter resistant bottle that is gas impermeable and able to withstand the high temperatures of tunnel pasteurization."
New Markets Open for PET/N and PEN
The clearances permit all food types to be packaged in PET/N and PEN under all conditions of use, from foods that undergo high-temperature sterilization in the container to frozen foods reheated in the container. As Dan Leonardi, BP Amoco's Global Business Manager for NDC, explains, "FDA clearance for the use of BP Amoco naphthalates in PET/N copolymers and PEN homopolymer the market in the U.S. for these high performance resins. And it does the same in markets outside the U.S. that look to the FDA for regulatory guidance."
Recycling Leads the Way
Recycling work led by the Naphthalate Polymers Council proved essential in gaining the clearances. A subcommittee of the National Associatio n for PET Container Resources, the NPC investigated the impact of naphthalate-based containers on existing PET recycling infrastructure, their compatibility with PET, and how effectively they can be recycled. This two-year study supported the FDA's assessment of the environmental impact of naphthalate polymers and helped it determine that the clearances will not have a significant impact on the quality of the human environment. According to Luke Schmidt, president of NAPCOR, "The research conducted by the NPC clearly indicates that naphthalate copolymer and blend bottles, at anticipated market levels, won't have an adverse effect on post consumer PET bottles or other products, such as polyester carpet, that are made with recycled PET."
Improving the Regulatory Process for New Materials
In late 1999 the FDA received funding for and began implementing its new Food Contact Notification program. This program is designed to reduce the FDA's review time for food packaging materials to as little as 120 days. The two naphthalate petitions, originally filed in 1995 through the joint efforts of Shell Polyester and BP Amoco Chemicals, were converted to the new program on November 22, 1999. The FDA's outstanding support and guidance during the conversion process accelerated the clearance of the naphthalate materials.
For more information about the FDA clearances
A list of effective Food Contact Notifications can be viewed at FDA's Internet site at www.cfsan.fda.gov.
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