Environmental Decision Memo for Food Contact Notification No. 001355

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: January 9, 2014

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN 1355: 1-Butene, polymer with 1-propene (CAS No. 29160-13-2) as a component of articles that are intended for use in food contact applications.

Notifier: Mitsui Chemicals, Inc.

To: Vanee Komolprasert, Ph.D., P.E., Division of Food Contact Notifications (HFS-275)

Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____

Attached is the Finding of No Significant Impact (FONSI) for the above referenced notification. After this becomes effective, copies of this FONSI and the notifier's environmental assessment, dated October 21, 2013, 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.

Talia A. Lindheimer

Finding of No Significant Impact

File: FCN 1355


A food-contact notification (FCN No. 1355), submitted by Mitsui Chemicals, Inc., to provide for the safe use of 1-butene, polymer with 1-propene (CAS No. 29160-13-2) as a component of articles that are intended for use in food contact applications.

The Office of Food Additive Safety 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 October 21, 2013, as summarized below.

This notification has been submitted to support the use of the FCS as an elastomer in both single and repeat-use food-contact articles. Examples of articles that may contain the FCS include sealing gaskets, packing, plugs, and similar uses.  The FCS is expected to used be in place of similar polymers that are currently on the market, and therefore is not expected to result in a net increase in the use of energy and resources. The differences between the FCS and these similar polymers are minor manufacturing differences. No significant environmental introductions are expected as a result of these differences such that the authorization of the FCS is not expected to result in any significant new introductions of chemicals or products into the environment.

Disposal of the food-contact materials, which contain the FCS, will be by conventional trash disposal and primarily by incineration or sanitary landfills. This is because the articles which contain the FCS are not intended to be recovered for recycling. It is reasonably expected that there will not be leaching to the environment from disposal into landfills in light of the retention of the FCS by the food contact article and the Environmental Protection Agency’s (EPA) regulations which govern municipal solid waste landfills, i.e. 40 CFR Part 258. 

When FCS-containing articles are disposed of via incineration, it will be expected to produce carbon dioxide and water. Market volume information[1] provided in a confidential attachment to the EA supports that the combustion of the FCS in municipal waste combustors is not expected to threaten a violation of applicable emissions laws and regulations (40 CFR Part 60).  Based on the information provided in the EA, we have concluded that no toxic combustion products are expected as a result of the use and incineration of the FCS.

No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of the use and post-consumer disposal of the food-contact articles manufactured with the FCS.

Prepared by     _________________________________________Date: January 9, 2014
Talia A. Lindheimer
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by   __________________________________________Date: January 9, 2014
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


[1]The market volume is protected from disclosure under 18 U.S.C. 1905 and 21 U.S.C. 331(j).

Page Last Updated: 12/31/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English