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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. 1927

Addivant

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, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5). REPLACES FCN 1800
Notifier: Addivant
Manufacturer/Supplier: Addivant
Intended Use: As an antioxidant in styrene block polymers and repeat use elastomers, including use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS may be used at levels up to 0.5 percent by weight in styrene block polymers and repeat use elastomers authorized for use in contact with all food types under Conditions of Use A through H. The FCS may be used in styrene block polymers authorized for use as packaging for powdered infant formula, as well as in styrene block polymers and elastomers authorized for use in repeat use articles in contact with infant formula and human milk. The FCS may be used in conjunction with triisopropanolamine (CAS Re. No 122-20-3) at a maximum use level of 0.75 percent by weight of the FCS.
Effective Date: Mar 15, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF)

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