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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. 491

Clariant GmbH

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: Sodium sulfate salt of ethoxylated (7 moles of ethylene oxide) - and iso-undecyl alcohol (C11) (CAS Reg. No. 219756-63-5).
Notifier: Clariant GmbH
Manufacturer: Clariant GmbH
Intended Use: For use as an emulsifier in the production of adhesives, pressure-sensitive adhesives, and in adhesives for laminate structures intended for use at temperatures of 250°F and above.
Limitations/Specifications*: The finished emulsifier may be used in adhesives held at temperatures not to exceed 120°F. The adhesives used must comply with 21 CFR 175.105, 175.125, or be the subject of an effective food contact notification. The finished emulsifier may also be used in laminating adhesives when separated from the food by a functional barrier in compliance with 21 CFR 177.1390(c)(2)(ii).
Effective Date: May 31, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo/Categorical Exclusion Supplement