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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. 1351

Milliken & 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: Oxirane, 2-methyl-, polymer with oxirane, ether with 2,2',2'',2'''-[sulfonylbis[4,1-phenylene-2,1-diazenediyl(3-methyl-4,1-phenylene)nitrilo]]tetrakis[ethanol] (4:1) (CAS Reg. No. 927432-39-1).
Notifier: Milliken & Company
Manufacturer/Supplier: Milliken & Company
Intended Use: As a colorant in high density polyethylene and polypropylene homopolymers and copolymers, at concentrations not to exceed 0.3 percent by weight of the finished polymers, except for use in packaging of infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: Use of the colorant is subject to the provisions and definitions set forth in paragraphs a and b of 21 CFR 178.3297, Colorants for Polymers. Finished articles containing the FCS are intended to contact all types of food under Conditions of Use B through H and J (microwave-only container applications), as described in Tables 1 and 2. The FCS may be used in repeat use articles in contact with infant formula or breast milk (other than baby bottle nipples) intended for the feeding of infants (e.g., baby bottles). The FCS is not for use in packaging of infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 15, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo