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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. 1347

EcoSynthetix, 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: Starch, reaction products with glycerol and glyoxal (CAS Reg. No. 338797-73-2).
Notifier: EcoSynthetix, Inc.
Manufacturer/Supplier: EcoSynthetix, Inc.
Intended Use: (1) As a component of mineral (e.g., clay or ground calcium carbonate) coatings for paper and paperboard complying with 21 CFR 176.170 and 176.180 in contact with all food types and all conditions of use technically suitable for paper; (2) As a component of adhesives complying with 21 CFR 175.105(a)(2) in contact with all food types and all conditions of use.
Limitations/Specifications: When used in coatings for paper and paperboard, the maximum use level will not exceed 2.5 lbs. FCS per 1,000 square feet of paper. Permitted uses in contact with food for infants 0-6 months of age: the FCS may be used in composite cans for the holding or packaging of dry powder infant formula.
Effective Date: Feb 14, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 164 kB)
FDA Decision: Finding of No Significant Impact (FONSI)