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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. 1348

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, methyl-, polymer with oxirane, ether with 5-[[4-[bis(2-hydroxyethyl)amino]-2-methylphenyl]azo]-3-methyl-2,4-thiophenedicarbonitrile (2:1) (CAS Reg. No. 515857-23-5).
Notifier: Milliken & Company
Manufacturer/Supplier: Milliken & Company
Intended Use: As a colorant in high density polyethylene and polypropylene homopolymers and copolymers, in compliance with 21 CFR 178.3297.
Limitations/Specifications: The FCS may be used at concentrations not to exceed 0.1% in the finished copolymers that may contact all food types under Conditions of Use B through H and J (microwave-only container applications), as described in Tables 2. Permitted uses in contact with infant formula and breast milk: the FCS may be used in repeated use articles (other than baby bottle nipples) intended for the feeding of infants (e.g., baby bottles and sippy cups).
Effective Date: Feb 18, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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