No Objection Letter for Recycled Plastics #105
December 26, 2006
Carolyn A. Case
Merlin Plastics Alberta Inc
8927 Whittingham Dr.
Waxhaw, NC 28173-6582
Re: Prenotification Consultation (PNC) 562
Dear Ms. Case:
This is in response to your submission, received on 13 December 2006 (PNC 562), requesting on behalf of Merlin Plastics Alberta Inc. an opinion letter from the FDA regarding the use of post-consumer, recycled polyethylene terephthalate (PCR-PET) flake in the manufacture of single layer trays (i.e. clamshells) for use in direct contact with raw fruits and vegetables and shell eggs (which would be peeled or washed before consumption) for short periods of time at room temperature or below (i.e. conditions of use E through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html).
We have reviewed the proposed recycling process, including the information provided on a close loop collection (deposit system) used to obtain a feedstock that will consist of only post-consumer, food and beverage containers, and a typical physical recycling process with a hot-caustic wash and surface drying, as well as a subsequent thermoforming operated at | | | | | | | | | | | | | | | to produce PCR-PET trays for the proposed use. Based on our review of the information provided in the 13 December 2006 submission, we determined that the levels of dietary exposure to possible contaminants (mainly food residues) resulting from the proposed use of PCR-PET would be below 0.5 ppb, FDA's threshold of regulatory concern. Therefore, we conclude that the recycling process described in the 13 December 2006 submission would produce PCR-PET that is acceptable for use in direct contact with shell eggs, and fresh fruits and vegetables (which would be peeled or washed before consumption) for short periods of time at room temperature or below (i.e. conditions of use E through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html). Please note that our conclusion only applies to the PCR-PET obtained from a tight close loop collection of a feedstock consisting of only food and beverage PET containers (e.g. feedstock would not include non-food PET containers and industrial PET containers). If Merlin Plastics Alberta Inc.'s recycling process is modified, new data would need to be re-revaluated.
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