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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. 1751


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: Carbonic dichloride, polymer with 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-1-H-isoindol-1-one and 4,4-(1-methylethylidene)bis[phenol], bis[4-(1-methyl-1-phenylethyl)phenyl] ester (CAS Reg. No. 503834-43-3).
Notifier: SABIC Innovative Plastics
Manufacturer/Supplier: SHPP US LLC
Intended Use: As a component in the manufacture of articles intended to contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used under conditions of use A through H and J, as described in Table 2. Adjuvant substances permitted for use in polycarbonate resin complying with 21 CFR 177.1580 may be used in the polymer that is the subject of this notification, subject to any limitations in the authorizing regulation or notification. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 7, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 6.1 MB)
FDA Decision: Finding of No Significant Impact (FONSI)