No Objection Letter for Recycled Plastics #103
December 6, 2006
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 510
Dear Drs. Franz and Welle:
This is in response to your submission received on 28 June 2006, requesting on behalf of Waste and Resource Action Program (WRAP) an opinion letter from the FDA confirming the capability of WRAP'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 WRAP'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 WRAP's recycling process to remove potential contaminants from PET. Based on our review of these data, we have concluded that WRAP's recycling process, as described in the 28 June 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. Therefore, we have concluded that WRAP'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.
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