Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Premarket Approval⁺
August 23, 2000

No Objection Letter for Recycled Plastics #63

August 23, 2000

John B. Dubeck
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001

Dear Mr. Dubeck:

This responds to your inquiry of June 1, 2000, requesting on behalf of your client, Eastman Chemical Company, confirmation regarding the suitability of a method for the recycling of polyethylene terephthalate (PET) into food-contact articles. The proposed new process for recycling PET combines glycolysis and methanolysis. Although your submission does not specifically mention the source of the feedstock, we assume that it will be PET containers previously used for food and non-food applications obtained from deposit and curbside recycling programs (i.e., would not include industrial PET containers such as 55 gallon drums that had previously held chemicals).

We have reviewed the information submitted to demonstrate that the subject recycling process has similar capability to remove potential contaminants from post-consumer recycled PET (PCR-PET) as the glycolysis and methanolysis processes that have been previously reviewed. Based on our review of this information, we conclude that the levels of exposure to possible contaminants resulting from the proposed use of PCR-PET that resulted from the tertiary recycling process described in your submission would be below FDA's threshold of regulatory concern. Therefore, we conclude that the recycling process described in the above submission will produce PCR-PET that is acceptable for use in contact with food, provided the PCR-PET complies with 21 CFR 177.1630 or 21 CFR 177.1315. Our conclusion applies only to post-consumer PET containers obtained from deposit and curbside recycling programs and processed as described in the above submission. If your recycling process is modified, new data would need to be evaluated.

Although we have concluded that the intended use of PCR-PET that has been processed in the manner described in your submission is acceptable, 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.

⁺ The Office of Premarket Approval became the Office of Food Additive Safety on June 18, 2001.
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