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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 001150

 

June 12, 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: Paul Honigfort, PhD
 
This memo supersedes the memo dated April 10, 2012.
 
Subject:  FCN No. 1150 – 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7) as a mineral pigment dispersant for calcium carbonate or kaolin pigments in the manufacture of food-contact paper and paperboard.
 
Notifier: BASF SE, Germany
For the requested use as a mineral pigment dispersant in the kaolin or calcium carbonate coating of paper and paperboard to be used in contact with food, we have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that the categorical exclusion is warranted. The claim of categorical exclusion cites the section, 21 CFR 25.32 (i), under which the categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment
For the use as a dispersant for mineral fillers in the ‘wet-end’ during the manufacture of food-contact paper and paperboard, attached is the Finding of No Significant Impact (FONSI) for FCN 1150. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 13, 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. 1150), submitted by BASF SE, to provide for the safe use of 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7) as a mineral pigment dispersant for calcium carbonate or kaolin pigments in the manufacture of food-contact paper and paperboard.
 
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 February 13, 2012, in the notification submitted by the notifier, and other information known to the agency.
 
Prepared by     __________________________________________Date: June 12, 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: June 12, 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