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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. 1127

NOF 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: A mixture of linear saturated aliphatic esters produced from C16-C18 alcohols and C14-C20 fatty acids.
Notifier: NOF Corporation
Manufacturer: NOF Corporation
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 single-, or repeat-use polycarbonate food-contact articles in contact with all food types and under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Jan 26, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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