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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. 1539

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/hexene copolymers containing up to 50 weight percent polymer units derived from hexene (CAS Reg. No. 25213-02-9).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: The FCS will be used as food contact articles or component of food contact articles, except for use in contact with infant formula and breast milk (see Limitations and Specifications).
Limitations/Specifications*: The FCS may contact all food types under Conditions of Use A through H, as described in Table 2. Ethylene/hexene copolymers having a density between 0.85 - 0.93 and either a wide distribution polymer with a minimum number - average molecular weight of 14,000 Daltons or a narrow distribution polymer with 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 or 3.2 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 19, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (534 kb)
FDA Decision: Finding of No Significant Impact (FONSI)