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CFSAN/Office of Food Additive Safety
July 27, 2000
Date: July 27, 2000
From: Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)
Subject: Premarket Notification FCN No. 000076 - A modified, branched polydimethylhydrogen methylsiloxane as a crosslinking agent
Notifier: Wacker Silicones
Technology Sciences Group
Washington, DC 20036
To: Division of Petition Control (HFS-215)
Attention: Julius Smith
Through: Team Leader, ERT
Attached is the Finding of No Significant Impact (FONSI) for the above cited Premarket Notification. The Environmental Assessment (EA) dated July 11, 2000 was prepared by the notifier in accordance with the recommendations we provided. When this notification becomes effective, the EA and FONSI may be made available to the public. The confidential appendix should remain confidential. Please let us know if there is any change in the identity or use of the food contact substance that would be inconsistent with the identity and use described in the FONSI.
John L. Dennison
A Premarket Notification (FCN No. 000076), submitted by Wacker Silicones/Wacker Chemie GmbH, to provide for the safe use of a modified, branched polydimethylhydrogen methylsiloxane containing small amounts of trivinyl cyclo-hexane as a crosslinking agent and intended for use as a component of food packaging articles, in molds used to manufacture food-contact material, and as a component of release coatings (a dehesive) for use with pressure-sensitive labels.
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 an
environmental assessment submitted by the notifier.
Prepared by: ___________________________________________ Date: July 27, 2000
John L. Dennison, Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by: ___________________________________________ Date: July 27, 2000
Buzz Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration
