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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. 436

Degussa Corporation

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-Dioxa-8-azaspiro[4.5]decane, 7,7,9,9-tetramethyl- (CAS Reg. No. 36793-27-8)
Notifier: Degussa Corporation
Manufacturer: Degussa Corporation
Intended Use: As a catalyst in the manufacture of pulp used to manufacture food-contact paper.
Limitations/Specifications*: This notification extends the present authorized use of the FCS as an oxidation catalyst under FCN 339 to include use levels greater than 2.0 mg but not more than 13.9 mg FCS per kg of dry pulp, and to include use in contact with all types of food. The FCS may be used under Conditions of Use E through G, as described in Table 2.
Effective Date: Nov 20, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (312 kB)
FDA Decision: Finding of No Significant Impact (FONSI)