Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 2268
Unitika Ltd.
Asahi Kasei 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: | Copolymer of 2-propenoic acid, 2-hydroxyethyl ester 1,1-dichloroethene, methyl 2-propenoate, and 2-propenenitrile (CAS Reg. No. 245118-21-2). |
---|---|
Notifier: | Unitika Ltd. |
Manufacturer/Supplier: |
Unitika Ltd. Asahi Kasei Corporation |
Intended Use: | As a gas barrier coating on food-contact Nylon 6 films, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
Limitations/Specifications: | The FCS will be used at a thickness not to exceed 1.5µm on Nylon 6 films in contact with all food types under Conditions of Use A through H and J, as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN. |
Effective Date: | Feb 14, 2023 |
National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
FDA Decision: | Categorical Exclusion Memo |
-