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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. 1576

Addivant

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: Pentaerythritol tetra(3-dodecylthiopropionate) (CAS Reg. No. 29598-76-3).
Notifier: Addivant
Manufacturer/Supplier: Addivant
Intended Use: For use as an antioxidant in adhesive and pressure-sensitive adhesive applications, complying with 21 CFR 175.105(Adhesives) and 21 CFR 175.125 (Pressure-sensitive adhesives). Articles containing the FCS may be used in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use with all foods at levels of up to 1.0 weight percent of adhesives and pressure-sensitive adhesives.
Effective Date: Oct 30, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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