No Objection Letter for Recycled Plastics #78
February 21, 2003
Catherine R. Nielsen
Keller and Heckman LLP
1001 G. Street, N.W.
Suite 500 West
Washington, DC 20001
Dear Ms. Nielsen:
This letter is in response to your inquiry of February 5, 2003, requesting on behalf of your clients, Mitsubishi Heavy Industries Limited and Mitsubishi Chemical Corporation (collectively, "Mitsubishi"), an opinion letter from the FDA confirming that monomers produced by Mitsubishi's polyethylene terephthalate (PET) tertiary recycling process are suitable for use in the manufacture of food contact articles. Mitsubishi's process utilizes methanolysis towards the depolymerization of post-consumer PET, including material obtained from curbside collection programs, into dimethyl terephthalate (DMT) and ethylene glycol (EG), and | | | | | | | | | | | | | | | | | | | |. terephthalic acid (TPA). Recycled PET resin is then made from the reclaimed TPA and EG.
Your letter refers to FDA's memorandum of July 16, 2001, which summarizes our analysis of the surrogate testing data in our files for tertiary recycling processes for polyesters, including both methanolysis of PET or polyethylene naphthalate (PEN) to starting monomers, and glycolysis of PET to oligomers. Based on this analysis, we concluded that tertiary recycling of PET or PEN by methanolysis or glycolysis results in the production of monomers or oligomers that are readily purified to produce a finished polymer that is suitable for food-contact use. For this reason surrogate test data are no longer considered necessary by FDA for the evaluation of tertiary recycling processes. Your submitted description of Mitsubishi's process demonstrates its similarity to those tertiary recycling processes for which FDA has previously issued opinion letters. Therefore, we are of the opinion that the tertiary recycling process described in your submission will produce post-consumer recycled PET (PCR-PET) that is acceptable for use in contact with food, provided the resulting PCR-PET complies with applicable food additive regulations.
Although we have concluded that the recycling process described in your submission will produce PCR-PET that is acceptable for food-contact use, you should be aware that we are currently developing a formal policy on the use of post-consumer recycled plastics in contact with food. Thus, the decisions set forth in this letter may need to be modified due to future deliberations on this matter.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Paul Honigfort, Ph.D.