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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. 395

Lucite International UK, Ltd.

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: Copolymer of n-butyl methacrylate and isobutyl methacrylate (CAS Reg. No. 9011-53-4).
Notifier: Lucite International UK, Ltd.
Manufacturer: Lucite International UK, Ltd.
Intended Use: As a pigment dispersant for use in all pigmented food-contact plastics.
Limitations/Specifications*: The FCS is used at levels not to exceed 10 percent by weight in pigments that are used at levels not to exceed 1 percent by weight in food-contact polymers. The finished polymers may be used in contact with all foods (I-IX) under Conditions of Use A through H.
Effective Date: Mar 18, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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