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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. 1910

ProFusion Industries

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: Ethylene phthalate polymers modified with 1,2,4,5-benzenetetracarboxylic dianhydride (pyromellitic dianhydride (PMDA; CAS Reg. No. 89-32-7)) and 1,3-butadiene, homopolymer, hydroxy-terminated (PBD; CAS Reg. No. 69102-90-5) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0).
Notifier: ProFusion Industries
Manufacturer/Supplier: ProFusion Industries
Intended Use: As an oxygen scavenger in polyester polymers, complying with 21 CFR 177.1315, 21 CFR 177.1630, or effective FCNs, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level up to 5 percent by weight of the final polyester polymer. The levels of PMDA and PBD shall not exceed 0.04 percent by weight and 0.5 percent by weight, respectively, of the final polyester polymer. The FCS may be used in contact with aqueous, acidic, and alcoholic foods up to 20% alcohol content, under Conditions of Use A through H, as described in Table 2. The polyester polymers will comply with 21 CFR 177.1315, 177.1630, or effective FCNs. 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: Sep 19, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo