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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. 460

Lonza, Inc.

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: Benzenemethanaminium, N,N-dimethyl-N-(2-(2-(4-(1,1,3,3,-tetramethylbutyl)phenoxy)ethoxy)-ethyl)-,chloride (CAS Reg. No. 121-54-0) also known as Benzethonium Chloride USP
Notifier: Lonza, Inc.
Manufacturer: Lonza, Inc.
Intended Use: As an antimicrobial agent in no-rinse hand sanitizers for food handlers.
Limitations/Specifications*: Benzethonium Chloride USP may be used at levels not to exceed 0.2 percent by weight of the finished hand sanitizer formulations.
Effective Date: Dec 7, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (205 kB)
FDA Decision: Finding of No Significant Impact (FONSI)