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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. 168

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: An approximately 1:1 ratio mixture of hydroxymethyl-5,5-dimethylhydantoin (MMDMH) (CAS Reg. No. 27636-82-4) and 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMDMH) (CAS Reg. No. 6440-58-0), containing up to 8.5 percent by weight dimethylhydantoin.
Notifier: Lonza, Inc.
Manufacturer/Supplier: Lonza, Inc.
Intended Use: As adjuvants in the bleaching of recycled paper and paperboard.
Limitations/Specifications*: 1. A mixture of MMDMH and DMDMH containing up to 8.5 percent dimethylhydantoin will be applied to process water during the bleaching of recycled paper at a maximum rate of 180 parts per million (ppm) combined hydantoins. 2. Recycled paper and paperboard manufactured with MMDMH and DMDMH containing up to 8.5 percent dimethylhydantoin can be used in contact with all types of food under Conditions of Use D through H , as described in Tables 1 and 2 respectively.
Effective Date: Nov 28, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (830 kB)
FDA Decision: Finding of No Significant Impact (FONSI)