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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. 346

API Corporation

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: 2,2,5,7,8-Pentamethyl-6-chromanol (CAS Reg. No. 950-99-2) Other name: 2,2,5,7,8-Pentamethyl-6-hydroxy chroman.
Notifier: API Corporation
Manufacturer/Supplier: API Corporation
Intended Use: As a stabilizer for use in linear low-density polyethylene food-contact films, coatings and molded articles.
Limitations/Specifications: The stabilizer may be used with linear low density polyethylene not exceeding 0.008 weight percent, used in contact with all food types as described in Table 1, under Conditions of Use B through H as described in Table 2 .
Effective Date: Oct 2, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo