• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 001274

 

Date: April 2, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review
(HFS-255)
 
Subject: FCN 1274 – Co-poly alpha olefin (C18-C30) for use as an additive to improve mechanical properties of molded polypropylene articles, at a level not to exceed 10% by wt. of the finished single-use food contact articles, in contact with food types I, II, VI-A, and VI-B under Condition of Use E.
Notifier: Idemitsu Kosan Co., Ltd
 
To: Helen HC C Lee, Ph.D., 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 FCN 1274. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 19, 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.
 
 
Mariellen Pfeil
 
 
 
 
 
 
 
Attachment:   Finding of No Significant Impact


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1274), submitted by Idemitsu Kosan Co., Ltd, to provide for the safe use of co-poly alpha olefin (C18-C30) for use as an additive to improve mechanical properties of molded polypropylene articles, at a level not to exceed 10% by wt. of the finished single use food contact articles, in contact with food types I, II, VI-A, and VI-B under Condition of Use E.
 
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 February 19, 2013, as summarized below.
The Food Contact Substance (FCS) is used to improve the tensile strength of molded polypropylene (PP) articles. No significant introductions of the FCS to the environment are expected as a result of manufacturing. The FCS is expected to be fully incorporated into the polypropylene. Significant migration of the chemical during use is not expected. Finished food contact articles containing the FCS are expected to be disposed of at the same rate and disposal pattern of other non-FCS containing polypropylene food contact articles.
Introduction of the FCS into the environment is expected to occur primarily via disposal into landfills, combustion and recycling. Data compiled by EPA for Municipal Solid Waste (MSW) generation in 2010 show that of the total 250 million tons of MSW generated yearly, plastic containers and packaging constituted approximately 13 million tons, of which PP was roughly 2 million tons. Therefore, PP for all uses, including non-food contact uses, contributes only 0.8% to total MSW. This number reflects all PP uses, only a portion of which represent food contact applications.   No significant increase in the use of polypropylene is anticipated as a result of this action as the FCS would be expected to compete with and replace the same chemical produced by other manufacturers. 
When properly disposed of into MSW incineration facilities and landfills operating in compliance with EPA regulations in 40 CFR Parts 60 and 258, respectively, significant releases of the FCS to the environment would not be expected. 
EPA calculated that approximately 2%, 40,000 tons, of PP waste generated is expected to be recycled. The proposed use of the FCS is not expected to significantly impact the recyclability of PP.
 
 
Prepared by        __________________________________________Date: April 2, 2013
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by        __________________________________________Date: April 2, 2013
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