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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000556

Date: Date: March 15, 2006
From: Chemist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 556 - Irgamod 295 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.

 

William H. Lamont

 

Attachment

 


Finding of No Significant Impact

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


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.