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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000221

Date: March 12, 2002

 

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

 

Subject: FCN No. 221 - Dantogard 2000TM as a preservative for mineral (pigment) slurries (clay, kaolin clay, calcium carbonate or titanium dioxide) used in manufacture of paper and paperboard

 

Notifier: Lonza, Inc.
c/o Lewis and Harrison, L.L.C.
Washington, DC 20001

 

To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Vivian Gilliam
Through: Layla Batarseh, Supervisor, ERG

 

 

Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. When this notification becomes effective, this FONSI and the notifier's environmental assessment, dated December 29, 2001, may be made available to the public.

 

Please let us know if there is any change in the identity or use of the food-contact substance.

 

 

 

Tong Zhou, Ph.D.

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 221), submitted by Lonza, Inc., to provide for the safe use of an approximately 1:1 mixture of hydroxymethyl-5,5-dimethylhydantoin (MMDMH) and 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMDMH), containing up to 8.5% by weight residual 5,5-dimethylhydantoin on a dry basis (DMH) or up to 5.5% in the formulated product 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.

 

 

The Environmental Review Group has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment dated Decemeber 29, 2001.

 

 

 

Prepared by:_________________________________________ Date: March 12, 2002
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by:_________________________________________ Date: March 12, 2002
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration