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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000721

Date:July 18, 2007
From:Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 721 - 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid as a component of non-food-contact layers of multilayer articles.
Notifier:EMS-Chemie AG
CH-7013 Domat/Ems
Switzerland
To:Division of Food Contact Notifications (HFS-275)
Attention: Anita Chang, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT



 

Attached are the Finding of No Significant Impact (FONSI) and our confidential supplement to the notifier's environmental assessment (EA) for FCN 721. After this notification becomes effective, this FONSI and the notifier's EA (in PDF, 818Kb), dated March 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

Attachments:
Finding of No Significant Impact
Confidential Supplement to the Environmental Record for Food Contact Notification No. 721


 

Finding of No Significant Impact

A food contact notification (FCN No. 721), submitted by EMS Chemie AG/EMS Chemie (North America) Inc., to provide for the safe use of 1,3 benzenedicarboxylic acid, polymer with 1,3 benzenedimethanmine and hexanedioic acid, as a component of non-food-contact layers of multilayer articles.

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) (in PDF, 818Kb), dated March 19, 2007, confidential business information, and other information known to the agency.

Prepared by__________________________________________Date: July 18, 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: July 18, 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



 

 

Confidential Supplement to the Environmental Record
For Food Contact Notification No. 721

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the document.

This document incorporates by reference the notifier's environmental assessment (EA)(in PDF, 818Kb), dated March 17, 2007, and Attachment 13 to food contact notification (FCN) 721 entitled, "Confidential market data and environmental information."

The purpose of this confidential supplement is to ensure the accuracy and completeness of the environmental record as a basis for preparing a finding of no significant impact (FONSI).


The remaining portion of the supplement contains confidential
business information and was not placed on the web.


*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.