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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. 408

BASF Corporation

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: C16 - 18 fatty acid esters of a branched C20 alcohol as described in the notification.
Notifier: COGNIS Deutschland GmbH & Co KG
Manufacturer: BASF Corporation
Intended Use: To be used as a lubricant/release agent in the manufacture of repeat-use, food-contact polycarbonate.
Limitations/Specifications*: The FCS may be used at a maximum rate of 5 mg/g polycarbonate. The finished polycarbonate food-contact articles will have a maximum thickness of 3 mm and may contact all food types at temperatures not to exceed 100°C.
Effective Date: Jun 22, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo