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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 1022

Date:November 17, 2010
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1022– Fatty acids, C14-18 and C16-18-unsatd., polymers with adipic acid and triethanolamine, dimethyl sulfate-quaternized, as a flotation agent for purification of calcite.
Notifier:Cognis GmbH
Henkelstrasse 67
Duesseldorf, D-40551, Germany
To:Division of Food Contact Notifications (HFS-275)
Attention: Helen Lee, Ph.D.
Through: William H Lamont, Acting Supervisor, ERT

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 1022. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 2, 2010, and our supplement to the environmental record for FCN1022 may be made available to the public. We will post digital transcriptions of the FONSI, the environmental assessment, and the supplement to the environmental record for FCN1022 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.

 

Hoshing W Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 1022


Finding of No Significant Impact

A food-contact notification (FCN No. 1022), submitted by Cognis GmbH, to provide for the safe use of fatty acids, C14-18 and C16-18-unsaturated, polymers with adipic acid and triethanolamine, dimethyl sulfate-quaternized, for use as a flotation agent in the purification of calcite, used as a filler in the manufacture of food-contact paper and paperboard.

The Environmental Review Team 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 August 2, 2010, in the notification submitted by the notifier, our supplement to the environmental record for FCN1022, confidential information attached to the notification, and other information known to the agency.

 

Prepared by __________________________________________Date: November 17, 2010
Hoshing W Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: November 17, 2010
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 1022

This document incorporates by reference the notifier's environmental assessment (EA), dated August 2, 2010.

The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI).

The approval of the action poses a potential environmental impact from isopropanol because it is a concomitant component providing rheological modification of the active agent, which is the food-contact substance notified for use. However, isopropanol is presently used in flotation processes for calcite, and such processes are environmentally regulated. Furthermore, the impact, if any, posed by introduction of isopropanol is very small due to its ready biodegradation and its very low level of ecotoxicity (2-Propanol, SIDS Initial Assessment Profile, Organisation for Economic Co-operation and Development, United Nations Environment Programme, Geneva, Switzerland, March 1997).

 

Prepared by __________________________________________Date: November 17, 2010
Hoshing W. Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration