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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. 1725

Dart Industries Inc. and Affiliates

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: SiOxCyHz polymeric coatings formed by plasma enhanced chemical vapor deposition, utilizing tetramethylsilane (CAS Reg. No. 75-76-3) and oxygen as the starting materials.
Notifier: Dart Industries Inc.
Manufacturer/Supplier: Dart Industries Inc. and Affiliates
Intended Use: The FCS is applied to the food-contact surfaces of repeated-use polyolefin food containers to impart stain resistance, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The finished coating is for use at a thickness below 40 nm on linear low density polyethylene and polypropylene repeated-use food containers. The finished coating is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the finished coating in the FCN.
Effective Date: Mar 28, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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