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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. 374

Lubrizol, Ltd.

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: Poly(12-hydroxystearic acid) end-capped with stearic acid (CAS Reg. No. 58128-22-6).
Notifier: Lubrizol, Ltd.
Manufacturer: Lubrizol, Ltd.
Intended Use: The FCS will be used: 1. As a colorant dispersant at levels not to exceed 0.1 percent by weight in the manufacture of food-contact polymers. 2. As a nucleating agent at levels not to exceed 0.012 weight percent in olefin polymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2. The copolymers complying with items 3.1 and 3.2 shall contain not less than 85 weight percent of polymer units derived from propylene.
Limitations/Specifications*: Finished articles containing the FCS may be used in contact with all food types and under Conditions of Use A through H as described in Table 2. Use of the colorant is subject to the provisions and definitions set forth in paragraphs a and b of 21 CFR 178.3297.
Effective Date: Dec 25, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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