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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. 1148

ADEKA 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: 1,2-Benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (CAS Reg. No. 128-44-9).
Notifier: ADEKA Corporation
Manufacturer/Supplier: ADEKA Corporation
Intended Use: As a nucleating agent in the manufacture of polyethylene phthalate polymers otherwise complying with 21 CFR 177.1630.
Limitations/Specifications: To be used at levels not to exceed 0.1 percent in polyethylene phthalate polymers intended to contact all types of foods under the conditions of use described for such polymers in 21 CFR 177.1630.
Effective Date: May 25, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.26 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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