No Objection Letter for Recycled Plastics #108
April 20, 2007
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 561
Dear Drs. Franz and Welle:
This is in response to your submissions received on 12 December 2006 (PNC 561) and 22 May 2006 (CTS 66104), 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(a so-called “Super Clean”) to produce suitable post consumer high density polyethylene (PCR HDPE) for use in manufacturing HDPE bottles, containing up to 50% recycled HDPE content, to hold fresh milk under refrigerated temperatures, i.e. Condition of Use F 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 statistical analyses of collected data that were submitted to demonstrate the capability of the WRAP’s recycling process to remove potential contaminants from PCR-HDPE. Based on our review of these data, we have concluded that WRAP’s recycling process, as described in the 22 May 2006 submission, will unlikely introduce any contaminants into food at levels that would result in a DC of > 0.5 ppb, the level that FDA would equate to negligible risk for a contaminant migrating from food packaging. This conclusion was based on use of up to 50% recycled content in the manufacture of HDPE bottles to hold fresh milk only, under Condition of Use F as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html, provided the PCR HDPE comes from milk bottles only.
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