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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000631

Date: May 24, 2006

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

FCN No. 631 - 2,5-Furanedione, polymer with 1 propene.

Mitsui Chemicals, Inc.
Shiodome City Center 1-5-2, Higashi-Shimbashi
Minato-ku, Tokyo, Japan

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

Attached is the Finding of No Significant Impact (FONSI) for FCN 631. After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated April 21, 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. 631), submitted by Mitsui Chemicals, Inc., to provide for the safe use of 2,5-furandione, polymer with 1-propene, as a component in blends with polypropylene (homopolymers and copolymers) intended for use in contact with all food types under conditions of use A through H. The food contact substance is used such that its level of concentration (fraction by weight of polypropylene) multiplied by the thickness, in micrometers (µm), of the polypropylene layer containing it does not exceed 3.7 in numerical value.

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 21, 2006.

Prepared by __________________________________________Date: May 24, 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 24, 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.