No Objection Letter for Recycled Plastics #116
February 26, 2008
Frank Welle, Ph.D.
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 641
Dear Dr. Welle:
This is in response to your electronic submission (PNC 641), received on September 11, 2007 and amended on January 30, 2008, requesting on behalf of Starlinger & Co. GmbH (Starlinger) an opinion letter from FDA confirming the capability of Starlinger’s secondary recycling process (referred to as | | | | | | | | | |) (called “Super Clean”) to produce post-consumer recycled polyethylene terephthalate (PCR PET) that is of a purity suitable for use in the manufacture of articles in contact with all food types 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 Starlinger’s recycling process as well as the information obtained from surrogate testing and migration modeling, which were submitted to demonstrate the capability of the Starlinger’s secondary recycling process to remove potential contaminants from PCR PET. Based on our review of these data, we have determined that Starlinger’s secondary recycling process, as described in the September 11, 2007 submission, would be effective in reducing potential contaminants from the feedstock, consisting of food and non-food PET containers, to levels that result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. Therefore, we have concluded that Starlinger’s secondary recycling process, as described in the September 11, 2007 submission, can produce PCR PET that is of a purity suitable for use in the manufacture of articles in contact with all food types under Conditions of Use C through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html, provided that the PCR PET complies with 21 CFR 177.1630, and the feedstock consists of food and non-food PET containers, excluding industrial PET containers. If Starlinger’s recycling process is modified, new data may be needed to be evaluated.
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