• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 001163

 

March 29, 2012
From: Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff ____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D.
 
Subject:  FCN No. 1163 – Montmorillonite (CAS Reg. No.1318-93-0) surface treated with quaternary ammonium compounds bis(hydrogenated tallow alkyl)dimethyl, chlorides (CAS Reg. No. 61789-80-8) to be used in polymeric films intended for food contact applications, where the film layer containing the FCS has a maximum thickness of 2 mils and may contain up to 15% of the FCS.
 
Notifier: PolyOne Corporation, Nanocor® Inc.
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1163. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 26, 2012, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.
 
Please let us know if there is any change in the identity or use of the food-contact substance.
 
 
Jeremy J. Mihalov
 
 
Attachment:
Finding of No Significant Impact
 


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1163), submitted by PolyOne Corporation, Nanocor® Inc., to provide for the safe use of Montmorillonite (CAS Reg. No.1318-93-0) surface treated with quaternary ammonium compounds bis(hydrogenated tallow alkyl)dimethyl, chlorides (CAS Reg. No. 61789-80-8) to be used in polymeric films intended for food contact applications, where the film layer containing the FCS has a maximum thickness of 2 mils and may contain up to 15% of the FCS.
 
The Office of Food Additive Safety 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, including an environmental assessment, dated January 26, 2012, in the notification submitted by the notifier, and other information known to the agency.
 
Prepared by     __________________________________________Date:  March 29, 2012
Jeremy J. Mihalov
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: March 29, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration