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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. 563

Wellman Incorporated

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: Dimethyl sulfoisophthalate, sodium salt (DMSIP) (CAS Reg. No. 3965-55-7). [The CAS nomenclature is 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt.]
Notifier: Wellman Incorporated
Manufacturer/Supplier: Wellman Incorporated
Intended Use: For use as a modifier in polyethylene terephthalate (PET).
Limitations/Specifications: The FCS may be used at a maximum level of 1.0 mole percent based on total diacids (diesters), or 0.5 mole percent based on the finished PET, where the modified PET may be blended with up to 30 percent of hexanedioic acid polymer with 1,3 benezenedimethanamine (MXD-6) at levels not exceeding those specified in 21 CFR 177.1630(e)(4)(v). The finished blend is intended to be used in contact with all food types under Conditions of Use C through G, as described in Table 2.
Effective Date: Apr 28, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 509 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement