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CFSAN/Office of Food Additive Safety
May 25, 2005
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.
Attachment
A food contact notification (FCN No. 501), submitted by ExxonMobil Chemical Company, to provide for the safe use of a polymer composed of one or more of the following: 1-decene, 1-dodecene hydrogenated, and 1-octene, for use as an additive at levels up to 25% in pressure-sensitive adhesives that comply with 21 CFR 175.125.
The Environmental Review Group 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 4, 2005.
Prepared by ______________________________ Date: May 25, 2005
Annette M. McCarthy, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by ______________________________ Date: May 25, 2005
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
