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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. 694

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)-polyethyleneimine copolymer (CAS Reg. No. 124578-12-7).
Notifier: Lubrizol, Ltd.
Manufacturer: Lubrizol, Ltd.
Intended Use: As a colorant dispersant for use in all food-contact polymers.
Limitations/Specifications*: For use at levels not to exceed 0.1 percent by weight of the finished polymer, in contact with all types of food under Conditions of Use A through H as described in Table 2.
Effective Date: Apr 17, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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