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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. 2207

BYK-Chemie GmbH

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: 1-Decene, homopolymer, hydrogenated (CAS Reg. No. 68037-01-4).
Notifier: BYK-Chemie GmbH
Manufacturer/Supplier: BYK-Chemie GmbH
Intended Use: As an additive in resinous and polymeric coatings complying with 21 CFR 175.300 and/or effective food contact notifications, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 0.13 weight percent in finished coatings. Coatings containing the FCS are intended for single-use applications in contact with all food types under Conditions of Use A through H as described in Table 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: Mar 17, 2022
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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