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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. 770

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-bis(2-ethylhexyl) benzenedicarboxylate (CAS Reg. No. 6422-86-2).
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: (1) At a level not to exceed 35 percent by weight of finished plasticized vinyl chloride polymer formulations used in repeated-use food contact applications at temperatures no greater than 100°C; (2) As a component of a paper or paperboard, or coatings for such paper and paperboard intended for use in contact with dry foods with no free surface fats or oil in compliance with 21 CFR 176.180 Components of Paper and paperboard in contact with dry food; (3) As a component of adhesives complying with the provisions of 21 CFR 175.105 Adhesives; and, (4) As a component of pressure sensitive adhesives complying with the provisions of 21 CFR 175.125 Pressure-sensitive adhesives.
Limitations/Specifications: SEE INTENDED USE
Effective Date: Jan 12, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j) and Environmental Assessment (in PDF, 315 kB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)