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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. 001135

Date: February 6, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Office of Food Additive Safety (HFS-255)
Subject: FCN No. 1135 – 1,4-Benzenedicarboxylic acid, polymer with 1,2- ethanediol and beta, beta ,beta', beta', tetramethyl - 2,4,8,10 - tetraoxaspiro [5.5] undecane-3,9- diethanol.
Notifier: Mitsubishi Gas Chemical Co.
Mitsubishi Bldg. 5-2, Marunouchi 2-chome, Chiyoda-ku
Tokyo, Japan 100-8324
To: Division of Food Contact Notifications (HFS-275)
Attention: Hui Chen Chang, Ph.D.
Through: Annette M McCarthy, PhD, Senior Science and Policy Staff

The FCS is for use as a basic polymer in the manufacture of films, coatings, and molded articles having a maximum thickness of 5 mm for single-use and repeated-use food-contact applications.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1135. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated December 21, 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.

 

Leah D. Proffitt

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food-contact notification (FCN No. 1135), submitted by Mitsubishi Gas Chemical Co., to provide for the safe use of 1,4-Benzenedicarboxylic acid, polymer with 1,2- ethanediol and beta, beta ,beta', beta', tetramethyl - 2,4,8,10 - tetraoxaspiro [5.5] undecane-3,9- diethanol as a basic polymer in the manufacture of films, coatings, and molded articles having a maximum thickness of 5 mm for single-use and repeated-use food-contact applications.

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 December 21, 2011, in the notification submitted by the notifier, and other information known to the agency.

 

Prepared by __________________________________________Date: February 6, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: February 6, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration