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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. 2032

BASF SE

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, adipic or sebacic acid, hexamethylene diisocyanate and further reacted with no more than 1 percent by weight of the polyhydric alcohol described in the notification. REPLACES FCN 907 and FCN 916
Notifier: BASF Corporation
Manufacturer/Supplier: BASF SE
Intended Use: The FCS is intended for use in single-use polyester films, coatings, and molded articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Table 2. The FCS is not intended for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 29, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 641 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 87 kB)

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