No Objection Letter for Recycled Plastics #70
September 20, 2001
William A. Olson, Ph.D.
Center for Regulatory Services
5200 Wolf Run Shoals Road
Woodbridge, VA 22192
Dear Dr. Olson:
This responds to your letter of August 22, 2001, requesting on behalf of your client, AIES Company, Ltd., our opinion on the suitability of a method for the tertiary recycling of post-consumer polyethylene terephthalate (PET) into food-contact articles. The AIES process uses glycolysis in which the PET is dissolved in ethylene glycol (EG) to form oligomers such as bis(hydroxyethyl) terephthalate (BHET) and its homologues, which are then purified by crystallization and distillation. The oligomers are then repolymerized with the addition of EG and terephthalic acid to form PET. Your submission includes surrogate contaminant testing data to demonstrate that the AIES process produces finished polymer of suitable purity for food-contact use.
We recently reviewed 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. The processes we have reviewed yielded products that consistently met our 0.5 ppb dietary concentration limit for surrogate contaminants, even assuming 100% migration of the residual surrogates to food. We have now 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 testing of new tertiary recycling processes for PET or PEN is no longer necessary. Therefore, without reviewing the surrogate testing data included with your submission, we are of the opinion that the tertiary recycling process involving glycolysis, which is 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.
Garfield N. Biddle, Ph.D.