Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Additive Safety
December 18, 2001

No Objection Letter for Recycled Plastics #71

Note: Material that is not releasable under the Electronic Freedom of Information Act (EFOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks.

December 18, 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 19, 2001, submitted on behalf of your client, NanYa Plastics Corporation, for an opinion letter from FDA confirming the suitability of a method for the tertiary recycling of post-consumer polyethylene terephthalate (PET) into food-contact articles. You state that PET recycled by NanYa’s process would be used at levels up to and including 100% in food-contact articles.

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 NaYa’s process to demonstrate its similarity to those tertiary recycling processes for which FDA has issued opinion letters.

NanYa’s process uses glycolysis in which cleaned PET flake is dissolved in ethylene glycol to form oligomers, which are then purified. The purified oligomers are combined with virgin esters and then repolymerized with the addition of heat to form PET. Following polymerization, the PET is pelletized and then solid-stated | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |.  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 and summarized above 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.

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.