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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. 1211

Riken Vitamin Co., Ltd.
Tianjin Rikevita Food Co., 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: A mixture of linear saturated aliphatic esters produced from C16-C18 alcohols and C14-C20 fatty acids.
Notifier: Riken Vitamin Co., Ltd.
Tianjin Rikevita Food Co., Ltd.
Manufacturer: Riken Vitamin Co., Ltd.
Tianjin Rikevita Food Co., Ltd.
Intended Use: As a friction reduction additive in polycarbonate (PC) resins for use in the production of food contact articles.
Limitations/Specifications*: For use at levels not to exceed 0.5% by weight of repeat-use polycarbonate food-contact articles in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Nov 6, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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