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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. 1024

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: Triisopropanolamine (CAS Reg. No. 122-20-3).
Notifier: Adeka Corporation
Manufacturer: Adeka Corporation
Intended Use: As a stabilizer for phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester (CAS Reg. No. 80693-00-1).
Limitations/Specifications*: The FCS will be used as a stabilizer at levels not to exceed 1 percent by weight of phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester complying with 21 CFR 178.2010 or an effective food contact notification.
Effective Date: Dec 23, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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