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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. 2321

GCH Technology 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: 1,2-Cyclohexanedicarboxylic acid, calcium salt (1:1), (1R, 2S)-rel- (CAS Reg. No. 491589-22-1).
Notifier: GCH Technology Co. Ltd.
Manufacturer/Supplier: GCH Technology Co. Ltd.
Intended Use: As a nucleating or clarifying agent in polyolefins, except for use in contact with infant formula and human milk.
Limitations/Specifications: The FCS will be used at levels not to exceed 0.25 weight percent in polyolefins that may contact all food types under Conditions of Use A 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: Dec 2, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 111 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 153 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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