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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. 104

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 (DMDMH) (CAS Reg. No. 27636-82-4), mixture with 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (MMDMH) (CAS Reg. No. 6440-58-0).
Notifier: Lonza, Inc.
Manufacturer: Lonza, Inc.
Intended Use: As preservatives for mineral (pigment) slurries (clay, kaolin clay, calcium carbonate or titanium dioxide) that are used as components of paper coatings used in the manufacture of food-contact paper and paperboard and as preservatives in mineral slurries of calcium carbonate or titanium dioxide that are used as fillers in the manufacture of food-contact paper and paperboard.
Limitations/Specifications*: 1. The subject methylhydantoins may be used as intended, at a combined level not to exceed 1200 parts per million (ppm) in the slurry. 2. Paper and paperboard manufactured with DMDMH and MMDMH can be used under Conditions of Use D through H as described in Table 2.
Effective Date: Feb 27, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.06 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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