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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000320

Date: May 1, 2003

 

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

 

Subject: FCN No. 320- Divergan HM for the Removal of Heavy Metal Ions and Sulfides from Alcoholic Beverages Including Beer and Wine

 

Notifier: BASF Corporation
N-MEN 3000 Continental Drive
Mount Olive, NJ 07828

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Mark A. Hepp, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

 

 

Attached is the Finding of No Significant Impact (FONSI) for this food contact notification. When this notification becomes effective, this FONSI and the notifier's environmental assessment, dated March 7, 2003, 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. 320), submitted by BASF Corporation to provide for the safe use of copolymer of 2-imidazolidinone, 1,3-diethenyl-, polymer with 1-ethenyl-1H-imidazole and 1-ethenyl-2-pyrrolidinone for the removal of heavy metal ions and sulfides from alcoholic beverages, including beer and wine.

 

The polymer is intended to be added directly to alcoholic beverages during the maturation process at levels not to exceed 80 grams per 100 liters of beverage, and is completely removed from the beverage by filtration. This polymer is referred to as Divergan HM throughout the notifier=s environmental assessment.

 

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 March 7, 2003.

 

 

 

Prepared by_____________________________________________ Date: May 1, 2003
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: May 1, 2003
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