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of Environmental Impact Decisions for Food Contact Substance Notifications or
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See also Environmental Decisions.
Date: September 2, 2009
From: Acting Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 918 - Tricyclodecanedimethanol as a monomer in production of (1) polyester coatings and (2) polyester resinous components of adhesives.
Notifier: Evonik Degussa GmbH
Marl 45772, Germany
To: Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E.
The food contact substance (FCS) comprises a mixture of isomers. The FCS was notified for uses as a monomeric component in the production of polyester resins for (1) coil coatings and (2) adhesives and pressure sensitive adhesives that are compliant with 21 CFR 175.105 and 175.125, respectively. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(i) for the proposed use of the FCS as a component of a coating. Also, the notifier submitted a claim of categorical exclusion under 21 CFR 25.32(j) for the proposed use of the FCS as a component of a food contact article intended for repeated use.
We have reviewed the claims of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use of the FCS intended for single and repeated use. The claims of categorical exclusion cite the sections—21 CFR 25.32(i) and (j)—under which categorical exclusion is warranted, state compliance with the categorical exclusion criteria, and state that no extraordinary circumstances exist that require the submission of an environmental assessment.
The notifier submitted an environmental assessment (EA) for the proposed use of the FCS as a component of adhesives. In this instance for such a notified use, the need to submit an EA was appropriate.
Attached is the Finding of No Significant Impact (FONSI) for FCN 918 pertaining to the use of the FCS as an adhesive in articles or as a component of articles that contact food. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated June 29, 2009, may be made available to the public. We shall post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.
Please let us know if there is any change in the identity or use of the food-contact substance.
William H Lamont
Finding of No Significant Impact
Finding of No Significant Impact
A food contact notification (FCN No. 918), submitted by Evonik Degussa GmbH, to provide for the safe use of tricyclodecanedimethanol (1) as a monomer, alone or in combination with the polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii)(c), in the production of polyester resins for coil coatings used in the manufacture of articles or components of articles for contact with food and (2) as a monomer in the production of polyester resins used as components of adhesives and pressure sensitive adhesives that are compliant with 21 CFR 175.105 and 175.125, respectively, for food contact 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 (EA), dated June 29, 2009, and other information known to the agency.
Prepared by __________________________________________Date: September 2, 2009
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration