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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. 1266

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: Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, ethoxylated, salts with [29H,31H-phthalocyanine-C,C-disulfonato(4-)-N29,N30,N31,N32] cuprate (2-) (2:1) (CAS Reg. No. 1140527-05-4).
Notifier: Milliken & Company
Manufacturer: Milliken & Company
Intended Use: As a colorant in high density polyethylene and polypropylene homopolymers and copolymers.
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.3 percent by weight of the finished polymer that may contact all food types, including food intended for infants, under Conditions of Use B through H and J (microwave only) as described in Table 2.
Effective Date: May 29, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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