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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1318

Unitika, Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: 1,4-Benzendicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-butanediol and α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl) (aka PBT/PTMG copolymer) (CAS Reg. No. 9078-71-1).
Notifier: Unitika, Ltd.
Manufacturer: Unitika, Ltd.
Intended Use: As an additive in authorized poly(ethylene terephthalate) (PET) films.
Limitations/Specifications*: At levels not to exceed 20 percent by weight of the finished PET films (no greater than 25 μm thick) in contact with all food types under the Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Oct 24, 2013
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (222 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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