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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. 2230

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). REPLACES FCN 2116
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 use in contact with infant formula and human 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 food types VI-A and VI-C (up to 15% alcohol) under Condition of Use E through G, as described in Tables 1 and 2, and food types I, II, III, IV-A, IV-B, V, VI-B, VII-A, VII-B, VIII, and IX under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 29, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 813 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 209 kB)
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