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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 000937

 

Date:December 14, 2009
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 937 - Copolymers of dimethyl terephthalate or terephthalic acid with ethylene glycol and 1,4-cyclohexanedimethanol as single- or repeat-use food-contact articles or components of such articles.
Notifier:Eastman Chemical Company
P. O. Box 511
Kingsport, TN 37662
 
To:Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: William H Lamont, Acting Supervisor, ERT
 

The food contact substance (FCS) comprises copolymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 15 to 85 mole percent of ethylene glycol and 85 to 15 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer), and optionally not more than 0.5 percent (by weight of the finished resin) trimellitic anhydride as a branching agent. The FCS is further identified as follows: ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers, manufactured from dimethyl terephthalate (DMT), ethylene glycol (EG), and 1,4-cyclohexanedimethanol (CHDM) or ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers, manufactured from terephthalic acid (TPA), EG, and CHDM.

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 repeat-use article and a permanent or semi-permanent food-contact surface. We have reviewed the claim of categorical exclusion and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section—21 CFR 25.32(j)—under which categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

Also, the notifier submitted an environmental assessment for the proposed use of the FCS for single-use applications. We have reviewed the environmental assessment, and we have prepared the attached Finding of No Significant Impact (FONSI) for FCN 937. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated September 18, 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.

 

Hoshing W Chang, Ph.D.

 

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 937), submitted by Eastman Chemical Company, to provide for the safe use of copolymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 15 to 85 mole percent of ethylene glycol and 85 to 15 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer), and optionally not more than 0.5 percent (by weight of the finished resin) trimellitic anhydride as a branching agent. as single- and repeat use articles or components of such articles intended to contact food.

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 September 18, 2009, and other information known to the agency.

 

Prepared by __________________________________________Date: December 14, 2009
Hoshing W Chang, Ph.D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: December 14, 2009
William H Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration