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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. 285

The Chemours Company FC, LLC

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-Oxepanone, polymer with 1,4-butanediol (CAS Reg. No. 31831-53-5).
Notifier: The Chemours Company FC, LLC
Manufacturer: The Chemours Company FC, LLC
Intended Use: 2-Oxepanone, polymer with 1,4-butanediol is intended for use as a processing aid in all polyolefins for single and repeat use food-contact applications.
Limitations/Specifications*: 2-Oxepanone, polymer with 1,4-butanediol is intended for use at levels not to exceed 0.1 percent of the finished polymer. The copolymer is intended to contact all food types under conditions of Use A through H as described under Tables 1 and 2 depending on the clearance of the base polyolefin used to manufacture the food-contact article.
Effective Date: Jan 9, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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