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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. 000916

 

Date: August 11, 2009
From: Acting Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 916 - Aliphatic-aromatic copolyester for coatings or single-use films and molded articles.
Notifier: BASF SE
KT/KS - E100
Ludwigshafen 67056, Germany
To: Division of Food Contact Notifications (HFS-275)
Attention: Elizabeth S Furukawa, Ph.D.

The food contact substance (FCS) notified for use is 1,4-benzenedicarboxylic acid, (or dimethyl ester), polymer with 1,4-butanediol, sebacic acid, hexamethylene diisocyanate, and not more than one percent by weight of the polyhydric alcohol described in the notification. One notified use of the FCS is for coatings, which ordinarily may not require the preparation of an environmental assessment to address whether the use or disposal from use of the FCS may significantly affect the environment. The notifier chose to prepare an environmental assessment that encompassed all the proposed uses without special distinction for any one use.

Attached is the Finding of No Significant Impact (FONSI) for FCN 916. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated May 7, 2009, 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.

 

William H Lamont

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 916), submitted by BASF SE, to provide for the safe use of 1,4-benzenedicarboxylic acid, (or dimethyl ester), polymer with 1,4-butanediol, sebacic acid, hexamethylene diisocyanate, and not more than one percent by weight of the polyhydric alcohol described in the notification, for use as coatings or single use films and molded 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 in the notification, including an environmental assessment, dated May 7, 2009, submitted by the notifier and other information known to the agency.

 

Prepared by __________________________________________Date: August 11, 2009
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration