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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. 1398

Meredian, 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: Polymer of 3-hydroxybutyric acid with up to 25% 3-hydroxyvaleric acid, 3-hydroxyhexanoic acid, 3-hydroxyoctanoic acid, and/or 3-hydroxydecanoic acid.
Notifier: Meredian, Inc.
Manufacturer/Supplier: Meredian, Inc.
Intended Use: For use in the manufacture of food contact materials, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The finished articles may contact all food types under Conditions of Use B through H, as described in Tables 1 and 2, respectively. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 27, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 566 kB)
FDA Decision: Finding of No Significant Impact (FONSI)