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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. 1310

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'-[[3-methyl-4-[(4-methyl-2-benzothiazolyl)azo]phenyl]imino]bis[ethanol] (2:1) (CAS Reg. No. 229306-55-2).
Notifier: Milliken & Company
Manufacturer/Supplier: Milliken & Company
Intended Use: The FCS will be used as a colorant in high density polyethylene and polypropylene homopolymers and copolymers at concentrations not to exceed 0.3% by weight in the finished 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 repeated use articles intended for the feeding of infants (e.g., baby bottles and sippy cups). Not for use in infant formula packaging. 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").

Effective Date: Oct 8, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo