Food

Environmental Decision Memo for Food Contact Notification No. 000815

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: April 21, 2008

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

Subject: FCN No. 815 - Luphen® D for use as an adhesive for films, paper, and paperboard for packaging and holding all types of foods for single and repeat uses

Notifier: BASF SE
Product Safety and Regulatory Affairs
Ludwigshafen, Germany

To: Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam

The food contact substance for this FCN is β-alanine, N-(2-aminoethyl)-, monosodium salt, polymer with 1,4-butanediol, 1,6-diisocyanatohexane, 1,3-diisocyanatomethylbenzene and hexanedioic acid for use as an adhesive for films, paper, and paperboard for packaging and holding all types of foods in single and repeat-use applications.

Attached is the Finding of No Significant Impact (FONSI) for Food Contact Notification (FCN) 815. After this notification becomes effective, this FONSI and the notifier's environmental assessment (EA), dated March 5, 2008, may be made available to the public and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

Layla I. Batarseh, Ph.D.

Attachment
Finding of No Significant Impact for FCN 815


Finding of No Significant Impact

A food contact notification (FCN No. 815), submitted by BASF SE, to provide for the safe use of β-alanine, N-(2-aminoethyl)-, monosodium salt, polymer with 1,4-butanediol, 1,6-diisocyanatohexane, 1,3-diisocyanatomethylbenzene and hexanedioic acid for use as an adhesive for films, paper and paperboard for packaging and holding all types of foods in single and repeat-use applications.

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 dated March 5, 2008.

Prepared and Approved by:__________________________________________Date: April 21, 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


*The FDA web links cited in this article are now out of date.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

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