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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. 1798

Danxia Chemicals Factory 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: 2,2'-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one] (CAS Reg. No. 18600-59-4). REPLACES FCN 1652
Notifier: Danxia Chemicals Factory Co., Ltd.
Manufacturer/Supplier: Danxia Chemicals Factory Co., Ltd.
Intended Use: As an ultraviolet (UV) light stabilizer in ethylene phthalate (PET) polymers, complying with 21 CFR 177.1630 (Polyethylene phthalate polymers), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The substance will be used at levels not to exceed 1.0% by weight in PET polymers for single and repeat use in contact with all food types under Conditions of Use C through G, as described in Tables 1 and 2. The PET polymers will comply with 21 CFR 177.1315, 177.1630, or effective FCNs. The finished food contact articles will not be used in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Sep 1, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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