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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. 519

Arkema Inc.

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: Phenol,4-(1,1-dimethylethyl)-, polymer with sulfur chloride (CAS Reg. No. 60303-68-6).
Notifier: Arkema Inc.
Manufacturer: Arkema Inc.
Intended Use: As an antioxidant/stabilizer in the processing of rosins and rosin esters for use as components of adhesives complying with 21 CFR 175.105.
Limitations/Specifications*: For use at a level not to exceed 0.3 percent by weight of the adhesive formulation. The finished food-contact articles containing the adhesives may contact all food types under Conditions of Use E through G as described in Table 2.
Effective Date: Sep 1, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo