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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. 2440

Milliken Chemical

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: 5-[[[cis-4-(1,1-Dimethylethyl)cyclohexyl]carbonyl]amino]-N1,N3-bis[cis-4-(1-methylethyl)cyclohexyl]-1,3-benzenedicarboxamide (CAS Reg. No. 2649373-38-4).
Notifier: Milliken Chemical
Manufacturer/Supplier: Milliken Chemical
Intended Use: As a clarifying agent in polypropylene homopolymers and copolymers, including infant formula and human milk.
Limitations/Specifications: For use at levels not to exceed 0.08 weight percent of the finished polymer that may contact all food types, except for those containing more than 15% alcohol, under Conditions of Use A through H and J (microwave-only, excluding susceptor applications), as described in Tables 1 and 2. The FCS may be used in repeated-use articles (other than baby bottle nipples) intended for the feeding of infants (e.g., baby bottles).
Effective Date: Jul 31, 2025
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 221 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 103 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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