No Objection Letter for Recycled Plastics #80
March 26, 2003
David R. Joy
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Dear Mr. Joy:
This letter is in response to your inquiry of March 10, 2003, requesting on behalf of your clients, Futura Polymers, a division of Futura Polyesters Limited, an opinion letter from the FDA confirming that monomers produced by Futura's polyethylene terephthalate (PET) tertiary recycling process are suitable for use in the manufacture of food contact articles. Futura's process utilizes glycolysis towards the depolymerization of post-consumer PET, including material obtained from curbside collection programs, into oligomers such as bis(hydroxylethyl) terephthalate (BHET) and its homologues. This BHET is then repolymerized with phthalate monomers into post-consumer recycled PET (PCR-PET) resin.
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 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 utilizing these techniques. Your submitted description of Futura'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 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 the above submission will produce PCR-PET that is acceptable for the intended 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.