No Objection Letter for Recycled Plastics #115
February 14, 2008
Frank Welle, Ph.D.
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 668
Dear Dr. Welle:
This is in response to your inquiry of February 7, 2008 (PNC 668), requesting on behalf of 4PET Recycling B.V. an opinion letter from FDA on their secondary recycling process, which was purchased from Rethmann whose secondary recycling process (called ‘Super Clean’) is the subject of a letter of “non-objection” (NOL).
We previously reviewed the information obtained from the surrogate testing and migration modeling and concluded in our letter to Rethmann dated October 10, 2006 that their process, which was described in their submissions dated 22 December 2005 and 26 July 2006, was effective in reducing potential contaminants from post-consumer recycled polyethylene terephthalate (PCR PET) to levels that would result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. We concluded that Rethmann’s recycling process would produce PCR 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.
You indicated in your email of February 7, 2008 that the 4PET Recycling BV’s recycling process will be identical to the Rethmann’s secondary recycling process. Hence, a surrogate testing is not needed to be performed for evaluating the 4PET Recycling B.V.’s recycling process. We concluded that the PCR PET derived from 4PET Recycling B.V.’s recycling process would be suitable for the uses described above.
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