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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. 2178

Chang Chun Plastics Co., 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: 1,4-Benzenedicarboxylic acid, polymer with 1,2-ethanediol and octahydro-4,7-methano-1H-indene5,?-dimethanol (CAS Reg. No. 106127-84-8), optionally cross-linked with ≤0.15 wt.-% glycerin.
Notifier: Chang Chun Plastics Co., Ltd.
Manufacturer/Supplier: Chang Chun Plastics Co., Ltd.
Intended Use: The FCS is intended to be used as a basic resin in the fabrication of food-contact articles, except for use in contact with infant formula and human milk (see Limitations and Specifications).
Limitations/Specifications: Food-contact articles containing the FCS may contact all types of food at temperatures up to and including 100°C for repeat use applications. The FCS is not intended 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 13, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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