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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. 464

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: C.I. Pigment Yellow 163 (CAS Reg. No. 68186-92-5).
Notifier: BASF Corporation
Manufacturer: BASF Corporation
Intended Use: As a colorant in single- and repeat-use polymeric, food-contact articles.
Limitations/Specifications*: For use at levels not to exceed 2 percent by weight of the finished polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2. The maximum thickness of the polymers containing the food contact substance should not exceed 0.5 cm.
Effective Date: Dec 17, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo