Food

No Objection Letter for Recycled Plastics #96

Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles

See also Recycled Plastics in Food Packaging


May 25, 2005

Joan Sylvain Baughan
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001

Dear Ms. Baughan:

This is in response to your inquiry of December 9, 2004, requesting on behalf of Eastman Chemical Company an opinion letter from the FDA confirming that Eastman's modified glycolysis process can produce recycled polyethylene terephthalate (PET) of suitable purity for use in the manufacture of food contact articles.

We have reviewed Eastman's modified glycolysis recycling process as compared to their previous glycolysis recycling process submitted in 1996 (Letter No. 49).  | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | || | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | || | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . We believe that the modified glycolysis process described in your letter of December 9, 2004, is as effective as the previous glycolysis process.

In FDA's memorandum of July 16, 2001 that 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, we have 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 Eastman'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 of a purity suitable for use in contact with food, provided the resulting PCR-PET complies with all applicable food additive regulations.

If you have any further questions concerning this matter, please do not hesitate to contact us.

Sincerely,

Vanee Komolprasert, Ph.D., P.E.
Consumer Safety Officer
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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