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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 000635

Date: May 30, 2006

From: Chemist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 635 - Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) for use in food contact applications.

Notifier: DAK Americas, LLC
5925 Carnegie Boulevard, Suite 500
Charlotte, NC 28209

To: Division of Food Contact Notifications (HFS-275)
Attention: Julie N. Mayer
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached is the Finding of No Significant Impact (FONSI) for FCN 635. After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated April 28, 2006, 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



 



 

Finding of No Significant Impact

A food contact notification (FCN No. 635), submitted by DAK Americas, LLC, to provide for the safe use of polyethylene terephthalate copolyesters (diethylene glycol - isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid with ethylene glycol and with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol. The finished polymer shall contain a total of not more than 10 mole-percent of diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole-percent of the total glycol units and the isophthalate content expressed as a mole-percent of the total isophthalate/terephthalate units.

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 (EA), dated April 28, 2006.

Prepared by __________________________________________Date: May 30, 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: May 30, 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.