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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. 362


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: Siloxanes and silicones, di-methyl, 3-(4-hydroxy-3-methoxyphenyl)propyl group-terminated, polymers with bisphenol A, carbonic dichloride and 4-(1-methyl-1-phenylethyl)phenol (CAS Reg. No. 202483-49-6; also known as siloxane-modified polycarbonate) where the siloxane-modified portion of the FCS is approximately 22 percent by weight of the FCS.
Notifier: SABIC Innovative Plastics
Manufacturer/Supplier: SHPP US LLC
Intended Use: As a resin blended with conventional polycarbonate.
Limitations/Specifications: The FCS is intended to be blended with conventional polycarbonate for use in articles or components of articles designed for single or repeat use in contact with all food types identified in Table 1 under Conditions of Use B through H as described in Table 2, but limited to levels not to exceed 33 percent by weight of currently regulated or effective polycarbonate.
Effective Date: Jan 7, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 194 kB)
FDA Decision: Finding of No Significant Impact (FONSI)