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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. 2116

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: Pentaerythritol (CAS Reg. No. 115-77-5).
Notifier: Meredian, Inc.
Manufacturer/Supplier: Meredian, Inc.
Intended Use: As a nucleating agent in polymers of 3-hydroxybutyric acid with up to 25% 3-hydroxyvaleric acid, 3-hydroxyhexanoic acid, 3-hydroxyoctanoic acid, and/or 3-hydroxydecanoic acid authorized under FCN 1398, except for polymers used in contact with infant formula and man milk (see Limitations/Specifications).
Limitations/Specifications: The use level of the FCS will not exceed 1.5% by mass relative to the finished polymer. The FCS may be used in polymers that contact all food types, except alcoholic foods, under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not for use in polymers that contact infant formula and human milk, as such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 24, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 874 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 155 kB)

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