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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. 221

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 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 residual 5,5-dimethylhydantoin on a dry basis (DMH)(CAS Reg. No. 77-71-4) or up to 5.5 percent in the formulated product.
Notifier: Lonza, Inc.
Manufacturer: Lonza, Inc.
Intended Use: As a preservative for mineral (pigment) slurries (clay, kaolin clay, calcium carbonate or titanium dioxide) that are used as paper fillers and/or components of paper coatings used 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 1100 mg/kg in the mineral slurry. (2) Paper and paperboard manufactured with the FCS may be used in contact with all types of food under Conditions of Use A through H as described in Tables 1 and 2, respectively.
Effective Date: May 24, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (3.14 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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