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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #104

December 26, 2006

Roland Franz
Frank Welle
Fraunhofer Institut
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
D-85354 Freising
Germany
 

Re: Prenotification Consultation (PNC) 531

Dear Drs. Franz and Welle:

This is  | | | | | | | | | | | | | | |, in response to your submissions, received on 12 April 2006 (PNC 495) and 26 July 2006 (PNC 531), requesting on behalf of U.O.P. Sinco s.r.l. (UOPS) an opinion letter from the FDA confirming the capability of UOPS's secondary recycling process (called 'Super Clean') to produce suitable polyethylene terephthalate (PET) for use in the manufacture of articles in contact with food under conditions of use C through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.

We have reviewed UOPS's recycling process as well as the information obtained from surrogate testing and migration modeling that were submitted to demonstrate the capability of the UOPS's recycling process to remove potential contaminants from PET. Based on our review of these data, we have concluded that UOPS's recycling process, as described in the 12 April 2006 submission, would be effective in reducing potential contaminants from the feedstock consisting of food and non-food PET containers to levels that would result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. This conclusion was based on the Super-Clean process that involves a solid state polycondensation (SSP) step carried out  | | | | | | | | | | | | | | | | | | | | | |. Therefore, we have concluded that UOPS's recycling process would produce recycled PET that is of a purity suitable for use in the manufacture of articles in contact with food under conditions of use C through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.

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