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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. 2004

MOL-LUB Kft

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: Carbamodithioic acid, N,N-dibutyl-, C,C'-methylene ester (CAS Reg. No. 10254-57-6).
Notifier: MOL-LUB Kft
Manufacturer/Supplier: MOL-LUB Kft
Intended Use: The FCS is for use as a component of lubricants with incidental food contact, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a maximum concentration of 0.5 weight percent of the lubricant in contact with all food types under Conditions of Use A through H, as described in Table 2. The FCS is not intended 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: Oct 9, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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