Food

Environmental Decision Memo for Food Contact Notification No. 000903

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: 7/7/2009

From: Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)

Subject: FCN No. 903 – Polyamide copolymer as a component of multilayer films.

Notifier: UBE America, Inc.
261 Madison Avenue, 28th Floor
New York, NY 10016

To: Division of Food Contact Notifications (HFS-275)
Attention: K. Williams Randolph, CSO
Through: William H. Lamont, Ph.D., Acting Supervisor, ERT

Attached is the Finding of No Significant Impact (FONSI) for FCN 903, the subject food contact substance of which is; hexanedioic acid, polymer with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one and 1,6-hexanediamine, for use as a component of multi-layer laminate food-contact articles used in contact with all types of food. After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated April, 2009, may be made available to the public, and we will post them on the internet where they can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.

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

Ron C. Hardman

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 903), submitted by UBE America, Inc., to provide for the safe use of Hexanedioic acid, polymer with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one and 1,6-hexanediamine, that will function as a component of multi-layer laminate food-contact articles used in contact with all types of food.

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 April, 2009, submitted by the notifier and other information known to the agency.

Prepared by __________________________________________Date: July 7, 2009
Ron C. Hardman, Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: July 7, 2009
William H. Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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