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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. 215

Cryovac, 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: Poly(ethylene-methyl acrylate-cyclohexenylmethyl acrylate) (CAS Reg. No. 223503-47-7).
Notifier: Cryovac, Inc.
Manufacturer: Cryovac, Inc.
Intended Use: As a component of articles used in contact with dry food containing no surface fat or oil (i.e. food type VIII as described in Table 1) and as a component of multi-layer articles in contact with food as specified.
Limitations/Specifications*: (1) The polymer is produced by the transesterification of ethylene-methyl acrylate copolymer complying with 21 CFR 177.1340 with cyclohexenyl methanol (CAS Reg. No. 1679-51-2). (2) The polymer shall contain a minimum of 65 weight percent ethylene, no more than 28 weight percent cyclohexenylmethyl acrylate, with the remainder being methyl acrylate units. (3) The layer containing the polymer may contain up to 0.1 percent benzolylated triphenylbenzene (CAS Reg. No. 227099-60-7). For use only: (1) As a component of articles in contact with dry food containing no surface fat or oil (i.e., food type VIII as described in Table 1). (2) As a non-food contact layer of laminate structures. The multi-layer articles shall be flexible films, containers made of paper and paperboard, or rigid containers, except for bottles consisting primarily of polyethylene phthalate polymers complying with 21 CFR 177.1630, 177.1315, or effective food contact substance notifications or bottles consisting primarily of polyethylene complying with 21 CFR 177.1520 having a density greater than 0.94 grams per cubic centimeter. The food-contact substance will be separated from the food by one or more polymeric layers permitted for this use that have a total thickness no less than 0.25 mil (0.00025 in): (a) aqueous, acidic and low alcohol-content food (food types I, II, IV-B, VI-A, VI-B, VII-B, as described in Table 1), under Conditions of Use C through G, as described in Table 2, provided that the FCS layer does not exceed 1.5 mil (0.0015 inch) in thickness. (b) fatty and high alcohol-content food (food types III, IV-A, V, VI-C, VII-A, and IX, as described in Table 1), under Conditions of Use E through G, as described in Table 2, provided that the FCS layer does not exceed 0.75 mil (0.00075 inch) in thickness.
Effective Date: Apr 30, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (10.5 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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