Food
Environmental Decision Memo for Food Contact Notification No. 000963
| Date: | February 23, 2010 |
| From: | Biologist, Environmental Review Team (ERT) Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 963 - Polylactide polymers as components of food-contact articles. |
| Notifier: | Zhejiang Hisun Biomaterials Co. Ltd. No. 46 Waisha Road, Taizhou City Zhejiang Province, People's Republic of China, 318000 |
| To: | Division of Food Contact Notifications (HFS-275) Attention: Vanee Komolprasert, Ph.D., P.E. Through: William H Lamont, Acting Supervisor, ERT |
The food-contact substance is also known as (3R,6R)-3,6-dimethyl-1,4-dioxane-2,5-dione, polymer with rel-(3R,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione and (3S,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione.
Attached is the Finding of No Significant Impact (FONSI) for FCN 963. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 22, 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.
Attachment:
Finding of No Significant Impact
Finding of No Significant Impact
A food contact notification (FCN No. 963), submitted by Zhejiang Hisun Biomaterials Co. Ltd., to provide for the safe use of polylactide polymers as components of food-contact articles.
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 October 22, 2009, in the notification submitted by the notifier, and other information known to the agency.
Prepared by __________________________________________Date: February 23, 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: February 23, 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







