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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. 368

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/1-butene copolymers (CAS Reg. No. 25087-34-7).
Notifier: The Chemours Company FC, LLC & The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a component of articles used in contact with all types of food.
Limitations/Specifications: Limitations: Ethylene-butene copolymers may contain up to 40 weight percent polymer units derived from 1-butene. For use as a component of articles in contact with all foods under Conditions of Use C through G, as described in Table 2. Adjuvants substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), item 3.1 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met. Specifications: 1) Density: 0.85-0.91 g/cm3 2) Melt Index (190°C/2.16kg): ≤42 g/10 minutes.
Effective Date: Dec 17, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 352 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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