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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. 1997

Evonik Resource Efficiency GmbH

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: Polycyclooctene (CAS Reg. No. 25267-51-0), used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0) REPLACES FCN 1896
Notifier: Evonik Resource Efficiency GmbH
Manufacturer/Supplier: Evonik Resource Efficiency GmbH
Intended Use: As an oxygen scavenger in blends with low-density polyethylene or polypropylene as a non-food contact layer in multilayer food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: Polycyclooctene may be used at levels up to 10 weight-percent (wt.-%) with up to 0.03 wt.-% cobalt stearate in blends with low-density polyethylene or polypropylene. The FCS/polymer blends will be used only as a non-food contact layer in multilayer films. The thickness of the FCS-containing layer will not exceed 10 microns (μm). The FCS-containing layer will be separated from food by not less than 10 μm of low-density polyethylene, or one or more authorized polymers having equivalent or better barrier properties. The FCS may comprise up to 5 wt.-% of the food contact article. The FCS may be used in packaging that contacts all food types under Conditions of Use E through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and/or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 5, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo