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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. 916


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-benzenedicarboxylic acid, (or dimethyl ester), polymer with 1,4-butanediol, sebacic acid, hexamethylene diisocyanate and further reacted with no more than 1 percent by weight of the polyhydric alcohol described in the notification.
Notifier: BASF SE
Manufacturer/Supplier: BASF SE
Intended Use: As a single use polyester film, coating, and molded articles.
Limitations/Specifications*: To be used in contact with all food types under Conditions of Use C through G, as described in Table 1.
Effective Date: Sep 18, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (466 kB)
FDA Decision: Finding of No Significant Impact (FONSI)