No Objection Letter for Recycled Plastics #101
October 10, 2006
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 532
Dear Drs. Franz and Welle:
This is in response to your submissions, received on 22 December 2005 (PNC 462) and 26 July 2006 (PNC 532), requesting on behalf of Rethmann Plano BV an opinion letter from the FDA confirming the capability of Rethmann'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 Rethmann's recycling process as well as the information obtained from surrogate testing and migration modeling that were submitted to demonstrate the capability of the Rethmann's recycling process to remove potential contaminants from PET. Based on our review of these data, we have concluded that Rethmann's recycling process, as described in the 22 December 2005 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 Rethmann'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