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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. 1171

Japan Chemtech Ltd.

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: Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS Reg. No. 13170-05-3).
Notifier: Japan Chemtech Ltd.
Manufacturer/Supplier: Japan Chemtech Ltd.
Intended Use: As an additive to increase rigidity and impact modulus in polypropylene homopolymer and high-propylene olefin copolymers.
Limitations/Specifications: For use at a level not to exceed 0.1 percent by weight of the finished polymer. The finished polymers may be used in the form of molded articles in contact with all types of foods under Conditions of Use A through H as described in Table 2.
Effective Date: Jun 22, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo