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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. 2281

CJ CheilJedang Corporation

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: Butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid (CAS Reg. No. 125495-90-1), containing from 25 to 35 weight percent 4-hydroxybutanoic acid.
Notifier: CJ CheilJedang Corporation
Manufacturer/Supplier: CJ CheilJedang Corporation
Intended Use: For use in blends with polyesters used in the manufacture of food contact materials, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used:
  1. at levels not to exceed 20 weight percent in the food contact polymer that may contact all food types, except those containing more than 15% alcohol, under Conditions of Use B and H,
  2. at levels not to exceed 30 weight percent in the food contact polymer that may contact all food types, except those containing more than 15% alcohol, under Condition of Use C,
  3. and at levels not to exceed 40 weight percent in the food contact polymer that may contact all food types under Conditions of Use D through G. Conditions of Use are described in Table 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: May 3, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 2.4 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 226 kB)

*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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