No Objection Letter for Recycled Plastics #0049
June 6, 1997
Mr. John B. Dubeck
Keller and Heckman
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Dear Mr. Dubeck:
This is in response to your submission dated August 21, 1996, concerning the regulatory compliance of recycled post-consumer polyethylene terephthalate (PET), produced by the Eastman Chemical Company (Eastman) alcoholysis process, for further use to manufacture articles intended to contact food. In your submission, “alcoholysis” actually means “glycolysis” in that PET is being depolymerized to its oligomers in the presence of ethylene glycol, purified, and subsequently repolymerized to reform PET resin. The glycolysis reprocessing method employed is classified by the Environmental Protection Agency as tertiary recycling.
We have reviewed the data that you have provided on the Eastman depolymerization/repolymerization process to produce recycled PET resins from post-consumer PET. In particular, you have provided gas chromatographic data demonstrating that surrogate contaminants representing volatile non-polar, volatile polar, non-volatile non-polar, and non-volatile polar compounds intentionally added to PET material would be reduced to levels equivalent to a dietary concentration of less than 0.5 parts per billion (ppb), our threshold of regulation level.
Based upon our review of these data, we believe that Eastman’s glycolysis depolymerization/repolymerization process is extremely efficient at reducing the dietary concentration of potential contaminants to below 0.5 ppb and that PET produced by this process will be of suitable purity for use in the production of PET articles intended for contact with food, in accordance with 21 CFR 174.5. Therefore, we conclude that the food-contact use of PET produced by Eastman’s glycolysis process would be acceptable, provided that the resulting polymer and its use are in compliance with 21 CFR 177.1315 or 177.1630.
Our conclusion applies only to recycled PET produced as described in the stated submissions. The commercial process should be equivalent to that process. If the commercial process is not equivalent, new data will need to be evaluated.
Although we have concluded that your intended use of recycled post-consumer PET does not require an amendment to the 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 related to this letter, please do not hesitate to contact us.
Eugene C. Coleman
Division of Petition Control, HFS-215
Center for Food Safety
and Applied Nutrition