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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #98

January 13, 2006

Ralph A. Simmons
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001
 

Re: Prenotification Consultation (PNC) 414

Dear Mr. Simmons:

This responds to your inquiry of August 9, 2004 (referred as PNC 414 in our files, formerly CTS 89203), requesting on behalf of Plastic Technologies, Inc. (PTI) an opinion letter from the FDA regarding the capability of Phoenix's proprietary recycled polyethylene terephthalate (RPET) cleaning process  | | | | | | | | | | | | |for use in the manufacture of containers to contact all types of food under Conditions of Use B through H as listed in Tables 1 and 2, respectively, of 21 CFR§176.170 (c).

We reviewed the information on the proposed cleaning process, in which the RPET is subjected to  | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |   to remove contaminants. The process parameters would be determined by using a computer model  | | | | | | | | || | || | || | || | || | || | || | |. The cleaning process will be variable and depends on the process parameters,    | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | required to ensure the suitable purity of the RPET for manufacture of food contact articles. We determined that the computer model would be applicable for calculating   | | | | | | | | | | | | | required to remove contaminants from the RPET   | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |  , to the levels that would limit the migration of contaminants into food to 10 ppb or less, which equates to a 0.5 ppb dietary concentration which corresponds to FDA's threshold of regulatory concern. This conclusion was based on the use of 50% RPET in the manufacture of the finished food contact article. Therefore, we have concluded that the proposed cleaning process under the specified conditions above would produce RPET for subsequent use in the manufacture of RPET containers of suitable purity to contact all types of food under Conditions of Use B through H as listed in Tables 1 and 2, respectively, of 21 CFR§176.170 (c).

 

If you have any further questions concerning this matter, please do not hesitate to contact us.

 Sincerely,

Vanee Komolprasert, Ph.D., P.E.
Consumer Safety Officer
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
     and Applied Nutrition