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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. 2211

Milliken Chemical, Division of Milliken & Co.

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: Calcium tert-butylphosphonate (CAS Reg. No. 81607-35-4).
Notifier: Milliken Chemical, Division of Milliken & Co.
Manufacturer/Supplier: Milliken Chemical, Division of Milliken & Co.
Intended Use: As a nucleating agent in the manufacture of polyolefin food contact materials and articles, including for use in contact with infant formula and human milk.
Limitations/Specifications: The FCS will be used at a maximum level of 0.15 weight percent in polyolefins in contact with all food types under Conditions of Use A through H and J (microwave only, excluding susceptor applications). The FCS may be used in articles intended to contact infant formula and human milk.
Effective Date: Apr 8, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 804 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 193 kB)

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