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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. 891

Process Technologies, Inc.

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: Fluorocarbon cured elastomer produced by copolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3) and propylene (CAS Reg. No. 115-07-01) and subsequent curing of the copolymer with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,2'-bis(t-butylperoxy)diisopropylbenzene (CAS Reg. No 25155-25-3).
Notifier: Process Technologies, Inc.
Manufacturer: Process Technologies, Inc.
Intended Use: In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function primarily in sealing applications.
Limitations/Specifications*: The fluorocarbon base polymer shall contain no less than 65 weight percent (wt-%) of polymer units derived from tetrafluoroethylene and no less than 25 wt-% of polymer units derived from propylene. The uncured elastomer shall be composed of no more than 6 wt-% of triallylisocyanurate and no more than 5 wt-% of 2,2'-bis(t-butylperoxy)diisopropylbenzene, and no more than 15 wt-% carbon black (produced by the furnace combustion process) (CAS Reg. No. 1333-86-4). The PCE must comply with the provisions of 21 CFR 177.2600 (d) and (g) and the extractive limitations prescribed in 21 CFR 177.2600(e) and (f), and 21 CFR 177.2400(d)(2). The finished copolymers are for use in contact with Food Types I, II,III, IV-A, IV-B, V, VI-A, VI-B, and VI-C under Conditions of Use A through C, as described in Table 1 and Table 2.
Effective Date: Jul 23, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo