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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000732

Date:June 12, 2007
From:Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 732 - Polyalkyl (C12-C17) methacrylate polymer or copolymer with alkyl (C18-C22) methacrylate monomers as a processing aid in the production of petroleum wax.
Notifier:RohMax USA, LP
723 Electronic Drive
Horsham, PA 19044
To:Division of Food Contact Notifications (HFS-275)
Attention: Helen Hc C. Lee, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT


 

Attached is the Finding of No Significant Impact (FONSI) for FCN 732. The food contact substance is poly(alkyl methacrylates) made from one or more C12 - C17 alkyl methacrylates (where the alkyl groups may be branched or linear and may be even- or odd-numbered in chain length), polymerized alone or in combination with one or more of the C18 - C22 alkyl methacrylate monomers permitted as reactants for poly(alkylmethacrylate) under 21 CFR 172.886(c)(2). After this notification becomes effective, this FONSI and the notifier's EA, dated May 31, 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

Attachments:
Finding of No Significant Impact


 

Finding of No Significant Impact

A food contact notification (FCN No. 732), submitted by RohMax U.S.A., LP to provide for the safe use of poly(alkyl methacrylates) made from one or more C12 - C17 alkyl methacrylates (where the alkyl groups may be branched or linear and may be even- or odd-numbered in chain length), polymerized alone or in combination with one or more of the C18 - C22 alkyl methacrylate monomers permitted as reactants for poly(alkylmethacrylate) under 21 CFR 172.886(c)(2) as a processing aid in the manufacture of petroleum wax that may be used as a direct food ingredient and as a food-contact substance.

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 May 31, 2007.

The food contact substance identified in the EA is poly(alkyl methacrylates) made from one or more C12-C18 alkyl methacrylates (wherein the alkyl groups may be branched or linear and may be even or odd numbered in chain length), polymerized alone or in combination with alkyl methacrylate monomers permitted as reactants for poly(alkylmethacrylate) under 21 CFR 172.886(c)(2). The identity should refer correctly to C12-C17. The slight difference in identity neither affects the EA nor the environmental finding of no significant impact for the food contact substance.

Prepared by __________________________________________Date: June 12, 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: June 12, 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.