FDA Clears Naphthalate in Food and Beverage Containers
Naphthalate-based polymers provide a combination of glass-like properties, including high clarity, gas impermeability, and thermal stability. They also block ultraviolet light. BP Amoco is betting they could replace glass beer bottles.
The FDA clearance covers polymers made with BP Amoco's NDC dimethyl-2,6-naphthalene dicarboxylate (NDC), 2,6-naphthalene dicarboxylic acid (NDA), or combinations of the two. It includes both polyethylene naphthalate (PEN) polymers and polyethylene terephthalate-naphthalate copolymers (PET/N).
Eastman's 1996 clearance covered only 100% PEN polymers made from NDA. According to BP Amoco spokesperson Greg E. Schmidt, BP Amoco also received permission for broader conditions of use, including retorts for cook-in-bag fatty foods.
BP Amoco describes the clearance as "proprietary," and says it covers its NDC and NDA-based polymers exclusively. FDA will allow the company to extend the clearance to resin producers and their customers.
Producers
BP Amoco produces both monomers at a 100 million lb/yr plant in Decatur, AL. It supplies monomer to Shell Chemical Co., which manufacturers naphthalate polymers at plants in West Virginia and Europe. Shell received FDA clearance for its products shortly after the BP Amoco decision.
Industry analysts consider naphthalates a growth area, and several producers have rushed into the business. The DuPont-Teijin joint venture produces PET and PEN films. Allied Signal Performance Fibers, a division of Honeywell International, manufacturers PEN fibers for textiles and tire cordage.
Markets
"For industries trying to reduce shipping weight and breakage without sacrificing shelf life, PET/N and PEN provide the answer," says BP Amoco packaging/film sales/marketing director Uduak Udofia. "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."
BP Amoco currently produces a PET resin blended with its Amosorb oxygen absorber for beer. This retains beer freshness by reducing oxidation. PEN's thermal stability, however, makes it more attractive to brewers who Pasteurize beer at high temperatures.
The clearances permit PET/N and PEN packaging for all food types under all conditions of use. This ranges from foods that undergo high- temperature sterilization in the container to frozen foods reheated in the container.
Expedited Clearance
The approval comes under FDA's expedited Food Contact Notification program, which began in late 1999. The program reduces FDA 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.
BP Amoco expects the FDA decision to influence markets outside the United States "that look to the FDA for regulatory guidance," says BP Amoco global NDC business manager Dan Leonardi.
Recycling
Recycling work led by the Naphthalate Polymers Council (NPC), a subcommittee of the National Association for PET Container Resources (NAPCOR), proved essential in gaining the clearances. NPC members include DuPont Films, Eastman Chemical Co., and Shell Chemical Co., as well as BP Amoco Chemicals.
NPC investigated the compatibility of recycling naphthalate-based containers with existing PET containers. The two-year study helped FDA determine that its clearances will not have a significant impact on environmental quality.
"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," says NAPCOR president Luke Schmidt.
By Alan S. Brown