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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

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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.
Effective Date:  05/24/2002
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.
Environmental Impact Decisions:  Environmental Decisions Site