No Objection Letter for Recycled Plastics #112
September 12, 2007
136C Fuller Road
Albany, NY 12205-5698
Re: Prenotification Consultation (PNC) 638
Dear Mr. O'Clair:
This is in response to your inquiry dated August 6, 2007 (logged in as PNC 638), requesting confirmation of the suitability of UltrePET’s post-consumer recycled polyethylene terephthalate (PCR PET) extruded products for food-contact use, when the PCR PET is produced from flake under a sub-license following the Wellman's secondary recycling process that is the subject of a letter of “non-objection” (NOL).
We previously reviewed the information obtained from the surrogate testing and concluded in our letter to Wellman dated June 6, 1997 that their process, which included sorting, grinding, washing, single-drying, and single-extrusion (as described in their letters dated August 8, 1996 and February 26, 1997), was effective in reducing potential contaminants from PCR PET to levels that would result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. We concluded that the PCR PET sheet made from flake produced by the Wellman’s process would be suitable for use in the manufacture of containers for contact with aqueous and dry foods under Condition of Use C (hot filled or pasteurized above 150°F) and less severe conditions (i.e., Conditions of Use C through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html), and fatty foods under Condition of Use D (hot filled or pasteurized below 150°F) and less severe conditions (i.e. Conditions of Use D through G), provided that the PCR PET comes from the feedstock consisting of soda and juice bottles and other food containers collected through a bottle deposit system, and the PCR PET complies with 21 CFR 177.1630 and other applicable regulations.
You indicated in your letter of August 6, 2007 that the UltrePET’s recycling process will be operated equivalently to the Wellman's secondary recycling process, which includes source control of feedstock, sorting, grinding, washing, drying and other thermal treatments used to clean the PCR PET material. Hence, a surrogate testing is not needed to perform for evaluating the UltrePET’s recycling process. We also determined that the suitability of the PCR PET would not be affected by the shape and form of PCR PET (i.e. pellets, performs, or any other extruded forms) as long as the PCR PET is subjected to the same heat treatments as described in the Wellman’s recycling process. Therefore, we concluded that the PCR PET that is collected, sorted and processed in the manner described in your letter of August 6, 2007, 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