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CFSAN/Office of Food Additive Safety
January 4, 2008
| Date: | January 4, 2008 |
| From: | Environmental Toxicologist, Environmental Review Team (ERT) Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 780- 1,4-benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol, adipic acid, hexamethylene diisocyanate for use as a polyester film or coating. |
| Notifier: | BASF Aktiengesellschaft KS/KS - E 100 67056 Ludwigshafen, Germany |
| To: | Division of Food Contact Notifications (HFS-275) Attention: Paul Honigfort, Ph.D. Through: Layla I. Batarseh, Ph.D., Supervisor, ERT |
Attached is the Finding of No Significant Impact (FONSI) for FCN 780. When this notification becomes effective, the FONSI and the notifier's EA, dated October 17, 2007, 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
A food contact notification (FCN No. 780), submitted by BASF Aktiengesellschaft, to provide for the safe use of 1,4-benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol, adipic acid, hexamethylene diisocyanate and not more than 1 percent of the polyhydric alcohol, for use as a polyester film or coating intended for single use in contact with all food types under Conditions of Use C through G.
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 October 17, 2007.
Prepared by__________________________________________Date: January 4, 2008
Kiros Hailemariam, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by__________________________________________Date: January 4, 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
