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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. 2209

Chang Chun Plastics Company, Ltd.

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: Butanedioic acid, hydroxy-, polymer with butanedioic acid, 1,4-butanediol and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (CAS Reg. No. 864132-20-7), optionally reacted with 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0).
Notifier: Chang Chun Plastics Company, Ltd.
Manufacturer/Supplier: Chang Chun Plastics Company, Ltd.
Intended Use: The FCS is intended for use in coatings, films, molded articles, and thermoformed articles, except for use in contact with alcoholic foods, infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For contact with all food types, except alcoholic foods, under Conditions of Use B through H 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: Mar 24, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 284 kB)
FDA Decision: Finding of No Significant Impact (FONSI) & EA Revision Sheet (in PDF, 240 kB)

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