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CFSAN/Office of Food Additive Safety
March 15, 2006
Note: Material that is not releasable under the Electronic Freedom of Information Act (EFOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks.
Date: March 15, 2006
From: Chemist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 556 - | | | | | | | | | | | | | | | | | for use as an antioxidant/stabilizer at levels not to exceed 1100 ppm (0.11 weight percent) in polyesters.
Notifier: Ciba Specialty Chemicals Corp.
540 White Plains Road
Tarrytown, NY 10591
To: Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
Attached is the Finding of No Significant Impact (FONSI) for FCN 556. The food contact substance is phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester. After this notification becomes effective, this document and the notifier's environmental assessment, dated December 20, 2005, may be made available to the public, and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.
Please let us know if there is any change in the identity or use of the food contact substance.
Attachment
A food contact notification (FCN No. 556), submitted by Ciba Specialty Chemicals Corporation, to provide for the safe use of phosphonic acid, [[3,5 bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester as an antioxidant/stabilizer at levels not to exceed 1100 ppm (0.11 weight percent) in polyesters.
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 December 20, 2005.
Prepared by __________________________________________Date: March 15, 2006
William H. Lamont, Chemist
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: March 15, 2006
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
