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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. 456

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) n- 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 acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR Sections 176.170 and 176.180 in contact with all types of food.
Limitations/Specifications*: The FCS will be used at a level not to exceed 2.0 percent by weight of the acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR Sections 176.170 and 176.180.
Effective Date: Nov 25, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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