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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000501

Date: May 25, 2005

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 501 - A polymer composed of one or more of the following: 1-decene, 1-dodecene hydrogenated, and 1-octene intended for use in pressure-sensitive adhesives.

Notifier: ExxonMobile Chemical Co.
P.O. Box 3140
Edison, NJ 08818-3140

To: Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

The notifier had submitted a claim of categorical exclusion under 21 CFR 25.32(i) on the basis that they considered an adhesive to be a coating. We disagree with this argument. The FDA has no history of viewing adhesives as coatings. While no definition of a coating exists in 21 CFR, they are traditionally considered to be layers on either the inner or outer most layers of food packaging, while adhesives are frequently used as inner layers with different functional properties. The notifier did not have any information that would demonstrate the percent-by-weight of the FCS in the sticker and, therefore, the requested use does not qualify for the cited claim of categorical exclusion. However, the notifier had also submitted an environmental assessment, dated March 4, 2005, which we reviewed and used as the basis for the attached Finding of No Significant Impact (FONSI) for FCN 501.

After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated March 4, 2005, may be made available to the public and we will post 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.

Annette M. McCarthy, Ph.D.



*The FDA web links cited in this article are now out of date.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.