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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. 633

Eka Chemicals Inc., an AkzoNobel 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: Aluminum hydroxide magnesium hydroxide carbonate (Hydrotalcite) (CAS Reg. No. 12304-65-3).
Notifier: Eka Chemicals Inc.
Manufacturer: Eka Chemicals Inc., an AkzoNobel Company
Intended Use: The FCS will be used as a processing aid in the manufacture of paper and paperboard intended to contact food.
Limitations/Specifications*: The FCS will be used at a maximum level of 2 kg per ton of dry paperboard. The finished paperboard containing the FCS will be used in paperboard coated with a regulated polymeric film or polymeric film/aluminum foil which will contact only food types I, II, IV-B at room temperature or below (i.e., 120°F or below).
Effective Date: Aug 30, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (791 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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