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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. 99

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: Hydroxymethyl-5,5-dimethylhydantoin (MMDMH)(CAS Reg. No. 27636-82-4), mixture with 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMDMH) (CAS Reg. No. 6440-58-0).
Notifier: Lonza, Inc.
Manufacturer/Supplier: Lonza, Inc.
Intended Use: As adjuvants in the bleaching of recycled paper and paperboard intended to contact food.
Limitations/Specifications*: 1. A mixture of MMDMH and DMDMH will be applied to process water during the bleaching of recycled paper at a maximum rate of 200 parts per million (ppm) combined hydantoins. 2. Paper and paperboard manufactured with MMDMH and DMDMH can be used under conditions of use D through H as described in Table 2.
Effective Date: Dec 9, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (564 kB)
FDA Decision: Finding of No Significant Impact (FONSI)