Inventory of Environmental Impact Decisions for Food Contact Substance Notifications
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FCN No. 247
Food Contact Substance: | A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoro-2,5-dimethyl-3,6-dioxanonane vinyl ether (CAS Reg. No. 2599-84-0), and perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexene (CAS Reg. No. 106108-22-9), and subsequent curing of the terpolymer (CAS Reg. No. 106108-23-0) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7). |
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Environmental Assessment NEPA Submission: | Categorical Exclusion 25.32(j) |
FDA Decision: | Categorical Exclusion Memo |
FCN Premarket Authorization Issued: | FCN description |
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