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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. 2204

ADEKA Corporation

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: Phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester (CAS Reg. No. 80693-00-1).
Notifier: ADEKA Corporation
Manufacturer/Supplier: ADEKA Corporation
Intended Use: For use as an antioxidant in polypropylene homopolymers and copolymers that contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels of up to 0.075 percent by weight of the polymer. The finished polypropylene homopolymers and copolymers may be used in contact with all food types under Condition of Use A as described in Table 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: May 12, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 864 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 235 kB)
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