FCN No. 2243

Kaneka North America

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 2069
• Notifier: Kaneka North America
• Manufacturer/Supplier: Kaneka North America
• Intended Use: As a nucleating agent in the manufacture of poly((R)-3-hydroxybutyric acid-co-(R)-3-hydroxyhexanoic acid) (PHBH, CAS Reg. No. 198007-37-3) authorized under FCN 1835¹ for use in the manufacture of food contact materials, except for use in contact with infant formula and human milk (see Limitations/Specifications).
• Limitations/Specifications:
  1. For use at levels not to exceed 1.5 weight percent in PHBH, in contact with aqueous, acidic, fatty, and dry foods (Food Types I-V, VIB, and VII-IX) under Conditions of Use C through G, as described in Tables 1 and 2;
  2. For use at levels not to exceed 1.0 weight percent in PHBH, in contact with alcoholic beverages containing up to 8 percent of alcohol (Food type VIA) under Conditions of Use E 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: Oct 4, 2022
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 201 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 257 kB)

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*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.

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