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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. 204

Asahi Denka Kogyo K.K.

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: A mixture of the lithium salts of stearic acid (69.5 weight percent), palmitic acid (25.8 weight percent), myristic acid (1.6 weight percent), arachidonic acid (1 weight percent), and other carboxylic acids (2.1 weight percent).
Notifier: Asahi Denka Kogyo K.K.
Manufacturer: Asahi Denka Kogyo K.K.
Intended Use: The FCS will be used as a stabilizer in polypropylene and olefin copolymers for use in food containers.
Limitations/Specifications*: 1) The FCS will be used at levels not to exceed 0.1 percent by weight of polypropylene and olefin copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2. 2) The FCS will be used in contact with aqueous and acidic food types I, II, IV(B), VI(B), VII(B), and VIII as listed in Table 1 under Conditions of Use B through H as described in Table 2. 3) The FCS will be used in contact with alcoholic and fatty food types III, IV(A), V, VI(A and C), VII(A) and IX as listed in Table 1 under Conditions of Use C through G as described in Table 2.
Effective Date: May 28, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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