No Objection Letter for Recycled Plastics #100
June 15, 2006
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 460
Dear Drs. Franz and Welle:
This is in response to your submissions on December 12, 2004 (PNC 355) and December 21, 2005 (PNC 460), requesting on behalf of SIPA SpA Plastic Packaging Systems an opinion letter from the FDA confirming the capability of SIPA's secondary recycling process (called 'Super Clean') to produce suitable polyethylene terephthalate (PET) for use in manufacturing PET containers to contact all types of food under conditions of use C through G as described in Tables 1 and 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.
We have reviewed SIPA's recycling process as well as the information obtained from surrogate testing, migration studies and migration modeling that were submitted to demonstrate the capability of the SIPA's recycling process to remove potential contaminants from PET. Based on our review of these data, we have concluded that SIPA's recycling process, as described in the 12 December 2004 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. Therefore, we have concluded that SIPA's recycling process will produce recycled PET that is of a purity suitable for use in the manufacture of articles in contact with all types of food under conditions of use C through G as described in Tables 1 and 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.
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