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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. 1313

Riken Vitamin 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: Ethoxylated alcohols, C12-C13 (CAS Reg. No. 66455-14-9).
Notifier: Riken Vitamin Co., Ltd.
Manufacturer: Riken Vitamin Co., Ltd.
Intended Use: As an antifogging agent for use in linear low density polyethylene (LLDPE) films.
Limitations/Specifications*: For use in LLDPE films with a maximum thickness of 15um at levels not to exceed 0.7 weight percent in contact with food under Conditions of Use E through G as described in Table 2.
Effective Date: Oct 17, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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