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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. 001120

Date:November 9, 2011
From:Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Office of Food Additive Safety (HFS-255)
Subject:FCN No. 1120 – Ethylene/1-butene copolymer used as a component of articles used in contact with all types of food.
Notifier:Mitsui Chemicals, Inc.
Shiodome City Center 1-5-2
Tokyo, Japan 105-7117
To:Division of Food Contact Notifications (HFS-275)
Attention: Donna J. Robie, Ph.D.
Through: Annette M McCarthy, PhD, Lead Environmental Review Scientist

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 1120 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 1120. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 1, 2011, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

Please let us know if there is any change in the identity or use of the food-contact substance.

 

Hoshing W. Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1120), submitted by Mitsui Chemicals, Inc., to provide for the safe use of ethylene/1-butene copolymer used as a component of articles used in contact with all types of food.

The Office of Food Additive Safety 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, including an environmental assessment, dated September 1, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: November 9, 2011
Hoshing W. Chang, Ph.D.
Regulatory Team 2
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: November 9, 2011
Annette M. McCarthy, Ph.D.
Lead Environmental Review Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration