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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. 315

Avecia, 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: 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).
Notifier: Avecia, Inc.
Manufacturer: Avecia, Inc.
Intended Use: As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in poultry and meat processing plants.
Limitations/Specifications*: For use at levels not to exceed 0.05 percent by weight of the latex solids.
Effective Date: Apr 25, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo
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