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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000750

Date:September 11, 2007
From:Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 750 - Acetylated monoglyceride of hydrogenated castor oil for use as a plasticizer or colorant carrier.
Notifier:Danisco A/S
565 Taxter Road - Suite 590
Elmsford, NY 10523
To:Division of Food Contact Notifications (HFS-275)
Attention: Mark A. Hepp, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT


 

Attached is the Finding of No Significant Impact (FONSI) for FCN 750. The food contact substance is octadecanoic acid, 1-(12-acetyloxy)-, 2,3-bis(acetyloxy) propyl ester; 1-(12-acetoxystearoyl)-2,3-diacetyl glycerol. After this notification becomes effective, this FONSI and the notifier's EA, dated June 19, 2007, may be made available to the public in response to a FOIA request, and we will post redacted copies of 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


 

Finding of No Significant Impact

A food contact notification (FCN No. 750), submitted by Danisco A/S, to provide for the safe use of octadecanoic acid, 1-(12-acetyloxy)-, 2,3-bis(acetyloxy) propyl ester; 1-(12-acetoxystearoyl)-2,3-diacetyl glycerol for use as (1) a plasticizer at levels up to 34 percent by weight in polyvinylchloride bottle cap sealing rings, (2) a plasticizer at levels up to 3 percent by weight in polymers used to manufacture articles intended for repeated-use, and (3) a colorant carrier or dispersant at levels up to 0.5 percent by weight in polymers used to manufacture articles intended for repeated-use.

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 submitted by the notifier in an environmental assessment (EA), dated June 19, 2007, and in a confidential section to the notification.

Prepared by __________________________________________Date: September 11, 2007
William H. Lamont, Chemist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: September 11, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
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.