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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. 980

Nisseki Plasto Company, 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: 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7).
Notifier: Nisseki Plasto Company, Ltd
Manufacturer/Supplier: Nisseki Plasto Company, Ltd
Intended Use: For use as a cross-linking agent for high density polyethylene (HDPE) in the production of fibers that are laminated with low density polyethylene (LDPE) to produce non-woven fabric.
Limitations/Specifications: The FCS may be used at a level not to exceed 90 parts per million by weight of authorized HDPE. Articles containing the FCS may be used in contact with unprocessed produce and dry food.
Effective Date: Jul 21, 2010
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 314 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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