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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. 597

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: 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate (CAS Reg. No. 6846-50-0).
Notifier: Eastman Chemical Company
Manufacturer: Eastman Chemical Company
Intended Use: As a plasticizer for repeat-use vinyl chloride polymers that may contact food, including vinyl chloride polymer-based gloves used in processing food and as a component of coatings for paper and paperboard intended to contact dry food.
Limitations/Specifications*: The FCS will be used at a level not to exceed 10 percent by weight of the finished, repeat-use vinyl chloride polymers and at temperatures not to exceed 100°C. The FCS will also be used in coatings for paper and paperboard that may contact Food Type VIII (dry solids with the surface containing no free fat or oil) as described in Table 1.
Effective Date: Apr 29, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i), (j), and Environmental Assessment (309 kB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)