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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000766

Date:December 19, 2007
From:Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 766 - Polyester-urethane formulation used as an adhesive in laminated structures that are intended for use at retort temperatures.
Notifier:Nippon Polyurethane Industry Co., Ltd.
440 Akiba cho, Totsuka ku
Yokohama, Japan 245-0052
To:Division of Food Contact Notifications (HFS-275)
Attention: Julius Smith
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT


 

 

Attached is the Finding of No Significant Impact (FONSI) for FCN 766. The food contact substance is a two component adhesive formulated from the following:

(1) Polyester-urethanediol resins described in 21 CFR 177.1390(c)(2)(iv)(a). In addition, 2,2-bis(hydroxymethyl) butanoic acid may be used as an optional polyhydric alcohol, and 2,2-dimethyl-1,3-propanediol may be used as a polyhydric alcohol in structures that are intended to contact alcoholic foods containing up to 8 percent ethyl alcohol.

(2) Urethane cross-linking agent consisting of 1,3-butanediol reaction products with 1,6-diisocyanatohexane.

After this notification becomes effective, this FONSI and the notifier's EA, dated November 5, 2007, may be made available to the public in response to a FOIA 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.

William H. Lamont

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 766), submitted by Nippon Polyurethane Industry Co., Ltd., to provide for the safe use of compositions composing (1) a base material component of polyester-urethanediol resins described in 21 CFR 177.1390(c)(2)(iv)(a), which may be prepared with 2,2-bis(hydroxymethyl) butanoic acid, as an optional polyhydric alcohol, and with 2,2-dimethyl-1,3-propanediol, as an optional polyhydric alcohol in structures that are intended to contact alcoholic foods containing up to eight percent ethyl alcohol, and (2) a curing agent component of urethane cross linking agent consisting of 1,3-butanediol reaction products with 1,6-diisocyanatohexane as an adhesive in laminated structures that are intended for use at retort temperatures.

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 an environmental assessment (EA), dated November 5, 2007.

Prepared by __________________________________________Date: December 19, 2007
William H. Lamont, Chemist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: December 19, 2007
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


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.