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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. 804

E. I. du Pont de Nemours and Company, Inc.

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: Trimethylolpropane (CAS Reg. No. 77-99-6).
Notifier: E. I. du Pont de Nemours and Company, Inc.
Manufacturer: E. I. du Pont de Nemours and Company, Inc.
Intended Use: As a milling aid and dispersant for titanium dioxide used as a light stabilizer in food contact articles.
Limitations/Specifications*: For use at levels not to exceed 2.4 percent by weight of titanium dioxide. The titanium dioxide containing the food-contact substance will be used at levels not to exceed 5 percent by weight of the food-contact article. The final articles may contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: May 18, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo