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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. 2355

Wacker Chemie AG

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: Siloxanes and silicones, di-Me, 3-aminopropyl group-terminated, polymers with 1,1'-methylenebis[4-isocyanatocyclohexane] (CAS Reg. No. 167883-16-1).
Notifier: Wacker Chemie AG
Manufacturer/Supplier: Wacker Chemie AG
Intended Use: As a slip agent in polypropylene films, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at levels not to exceed 12 µg/in2 (or 0.0186 g/m2) of the finished multilayer film. The finished film may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS 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 substance in the FCN.
Effective Date: Aug 29, 2024
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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