Food

Environmental Decision Memo for Food Contact Notification No. 000958

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: April 26, 2010

From: Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)

Subject: FCN No. 958 - Polyglycolic acid as a nonfood-contact layer of multi-layer polyethylene terephthalate or polylactic acid food-contact articles or as a component blended with polyethylene terephthalate.

Notifier: Kureha Corporation
3-3-2, Nihonbashi-Hamacho
Chuo-ku, Tokyo, Japan

To: Division of Food Contact Notifications (HFS-275)
Kelly Randolph, D.V.M., M.P.H.
Through: William H Lamont, Acting Supervisor, ERT

For uses as an internal nonfood-contact layer, we have reviewed the claims of categorical exclusions for the above referenced notification and have concluded that categorical exclusions are warranted. The claims of categorical exclusion cite the sections, 21 CFR 25.32 (i) and 21 CFR 25.32 (j), under which categorical exclusions are warranted, state compliance with the categorical exclusion criteria, and state that no extraordinary circumstances exist that require the submission of an environmental assessment.

For use in blends with polyethylene terephthalate, attached is the Finding of No Significant Impact (FONSI) for FCN 958. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated December 9, 2009, may be made available to the public. We will 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.

1 Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 958), submitted by Kureha Corporation, to provide for the safe use of polyglycolic acid as an internal nonfood-contact layer in polyethylene terephthalate (PET) or in polylactic acid food-contact articles or as a component in blends with PET.

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, including an environmental assessment, dated December 9, 2009, in the notification submitted by the notifier, and other information known to the agency.

Prepared by __________________________________________Date: April 26, 2010
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: April 26, 2010
William H Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


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