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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. 1803

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: Maleic anhydride, polymer with ethene and 1-hexene (CAS Reg. No. 86286-09-1).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a component of coatings on food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The level of maleic anhydride used to produce the FCS may not exceed 1.6 percent by weight of the FCS. The FCS may be used at a level not to exceed 20 percent by weight of coating solids in high-density polyethylene (HDPE) coatings on paper and paperboard for use in contact with all food under Conditions of Use A through H, as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 29, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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