No Objection Letter for Recycled Plastics #72
December 21, 2001
Ralph A. Simmons
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001
Dear Mr. Simmons:
This responds to your request of November 27, 2001, submitted on behalf of Teijin Limited, for an opinion letter from FDA confirming the suitability of a method for the tertiary recycling of pre-and post-consumer polyethylene terephthalate (PET) into food-contact articles. As discussed below, Teijin’s process involves depolymerization of PET into its constituent monomers, namely ethylene glycol (EG) and dimethyl terephthalate (DMT), which are then used to make new PET food containers.
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 in general 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, and that surrogate test data are no longer considered necessary by FDA for the evaluation of tertiary recycling processes. You have therefore provided a description of Teijin’s process to demonstrate its similarity to those tertiary recycling processes for which FDA has issued opinion letters.
As described in your submission, Teijin’s process includes glycolysis of cleaned PET flake in EG to depolymerize the PET and reacting the resultant oligomers with methanol to obtain DMT and EG. You state that the process may optionally include the additional step of hydrolysis of the DMT into terephthalic acid. The monomers are then repolymerized to form new PET. Based on the conclusions in our memorandum of July 16, 2001, we are of the opinion that the tertiary recycling process as described in your submission will produce recycled PET that is acceptable for use in contact with food, provided the resulting PET complies with applicable food additive regulations.
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.
Garfield N. Biddle, Ph.D.