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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. 759

International Specialty Products

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: International Specialty Products
Manufacturer: International Specialty Products
Intended Use: 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 100oC.
Effective Date: Dec 7, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo