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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. 224

Eastman Chemical Co.

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: 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate (TXIB) (CAS Reg. No. 6846-50-0).
Notifier: Eastman Chemical Co.
Manufacturer/Supplier: Eastman Chemical Co.
Intended Use: The FCS will be used as a plasticizer in vinyl chloride polymers for use in repeated-use food-contact applications and in vinyl chloride polymer-based gloves used to process food.
Limitations/Specifications: The FCS will be used at a level not to exceed 10 percent by weight of the finished plasticized vinyl chloride polymer formulation and will be used at temperatures not to exceed 40°C.
Effective Date: Jun 7, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 3.92 MB)
FDA Decision: Finding of No Significant Impact (FONSI)