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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. 2476

Kisuma Chemicals BV

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: Aluminum magnesium carbonate hydroxide (quintinite), surface-treated with cis-1,2-cyclohexanedicarboxylic acid.
Notifier: Kisuma Chemicals BV
Manufacturer/Supplier: Kisuma Chemicals BV
Intended Use: As a nucleating agent and acid scavenger in polyolefins, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may contain up to 9 percent by weight of cis-1,2-cyclohexanedicarboxylic acid and may be used at levels not to exceed 2,000 ppm in polyolefins that may contact all foods 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: Feb 12, 2026
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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