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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. 1142


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: 1H-imidazolium, 3-ethyl-1-methyl, ethyl sulfate (1:1) (CAS Reg. No. 342573-75-5).
Notifier: BASF
Manufacturer/Supplier: BASF
Intended Use: As an antistatic agent for repeated-use, food-contact articles, such as flexible transporting tubes in the food industry.
Limitations/Specifications: For use at a level not to exceed 2 weight-percent in polyurethane resins compliant with 21 CFR 177.1680, and 177.2600. The finished food-contact articles containing FCS will contact dry solids (i.e., food types VIII and IX) at the maximum temperature of 60°C (140°F), as described in Tables 1 and 2.
Effective Date: Mar 13, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo