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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. 424

The Dow Chemical Company

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/octene copolymers containing up to 50 weight percent polymer units derived from 1-octene (CAS Reg. No. 26221-73-8).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As articles or components of articles used in contact with all types of food under Conditions of Use A through H, as described in Table 2.
Limitations/Specifications: Ethylene/octene copolymers have a density of 0.85-0.92 g/cc and a minimum Brookfield viscosity of 6,800 centipoise at 350°F, as determined by Brookfield DVII+ viscometer (or equivalent) using a No. 31 spindle. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.
Effective Date: Oct 7, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 341 kB)
FDA Decision: Finding of No Significant Impact (FONSI)