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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000806

Date:March 12, 2008
From:Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 806 - Ethylene, 1-butylene polymer for use as a component of articles in contact with all food types under Conditions of Use B - H.
Notifier:Mitsui Chemicals, Inc.
Shiodome City Center
Japan
To:Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam


 

 

The above referenced notification contains two proposed uses for the food contact substance (FCS). The notifier submitted a claim categorical exclusion under 21 CFR 25.32 (j) for use as component of repeat-use articles and an environmental assessment for the use of the FCS in single-use articles.

We have reviewed the claim of categorical exclusion for FCN 806 and have concluded that the categorical exclusion is warranted. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32 (j), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that would require the submission of an environmental assessment.

Attached is the Finding of No Significant Impact (FONSI) for FCN 806. When this notification becomes effective, the FONSI and the notifier's EA, dated February 4, 2008, may be made available to the public in response to a Freedom of Information Act 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.

Kiros Hailemariam, Ph.D.

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 806), submitted by Mitsui Chemicals, Inc., to provide for the safe use of ethylene, 1-butylene polymer with high butane-1 content (up to 34% by weight) for use as a component of articles in contact with all food types under Conditions of Use B - H.

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 the notification, including an environmental assessment, dated February 4, 2008.

Prepared by __________________________________________Date: March 12, 2008
Kiros Hailemariam, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

I have reviewed this document and accept it as final:

__________________________________Date: March 12, 2008
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.