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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. 1952

Eastman Chemical Company

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: 1,4-benzenedicarboxylic acid, 1,4-dibutyl ester (CAS Reg. No. 1962-75-0).
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: As a plasticizer for PVC polymers intended for repeated use applications, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: For use at a level not to exceed 14 percent by weight of finished plasticized vinyl chloride polymer formulations. Articles containing the FCS are for repeat-use and may contact all food types, except alcoholic foods, at temperatures not to exceed 100°C. 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: Apr 19, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

679662  

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