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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. 10

Sekisui Plastics, 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: Pyromellitic dianhydride
Notifier: Sekisui Plastics, Ltd.
Manufacturer: Sekisui Plastics, Ltd.
Intended Use: As a modifier for ethylene terephthalate copolymers identified in 21 CFR 177.1630(e)(4)(i), item 2, and complying with all applicable provisions of 21 CFR 177.1630
Limitations/Specifications*: The level of pyromellitic dianhydride shall not exceed 0.5% by weight of the finished copolymer. Notwithstanding the limitations in 21 CFR 177.1630(e)(4)(i) item 2, for pyromellitic dianhydride modified polymers, the polymers that are the subject of this notification may be used without time or temperature limitations.
Effective Date: Mar 29, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)