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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. 2330

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 up to 10 weight percent 4-hydroxybutanoic acid.
Notifier: CJ CheilJedang Corporation
Manufacturer/Supplier: CJ CheilJedang Corporation
Intended Use: As polymers or components of polymers used in articles that may contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all food, except alcoholic food, under Conditions of Use B through H, and in contact with alcoholic food containing no more than 15% alcohol under Conditions of Use D through G, as 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: Jan 26, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 130 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 134 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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