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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. 632

Katsuta Kako K.K.

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: Magnesium(2+) 12-hydroxyoctadecanoate (CAS Reg. No. 91697-37-9).
Notifier: Katsuta Kako K.K.
Manufacturer: Katsuta Kako K.K.
Intended Use: As a processing aid during extrusion and molding of polymer articles in contact with food.
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.5 percent by weight in the finished articles in contact with all food types and Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Aug 25, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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