No Objection Letter for Recycled Plastics #0007
August 20, 1991
Mr. John Dubeck
Keller and Heckman
1150 17th. Street N.W.
Washington, DC 20036
Dear Mr. Dubeck:
This responds to your submissions of April 12, June 6, and June 14, 1991, on behalf of Eastman Chemical Company, concerning the use of post-consumer polyethylene terephthalate (PET) to produce regenerated ethylene glycol (EG) and dimethyl terephthalate (DMT) for further use as components in the manufacture of PET for food packaging. In this letter “regenerated” means that EG and DMT are chemically recovered from PET that has been depolymerized to its constituent monomers.
We have reviewed the data that you have provide on the Eastman isolation an purification process to produce regenerated EG and DMT from depolymerized PET bottles. In particular, you have provided analytical data including gas chromatographic data demonstrating that regenerated EG and DMT are of suitable purity and that marker contaminants purposefully added to the reaction mixture are removed during Eastman’s multi-step process. Based upon our review of these data, we believe that Eastman’s multi-step process is extremely efficient at reducing potential contaminants, and that EG and DMT produced by this process will be of suitable purity for use in the production of PET intended for use in contact with food, in accordance with 21 CFR 174.5. Therefore, we do not object to the use of EG and DMT regenerated by this process as components in the manufacture of PET packaging for food-contact, provided that its use in making such articles is in compliance with 21 CFR 177.1315 and 177.1630.
In addition, PET articles, because they are free of adjuvants, such as antioxidants that are typically present in other types of plastic food-contact articles, present a special case. Because of the absence of such adjuvants, their fate during the Eastman reprocessing of post-consumer PET bottles need not be considered. This would not be the case, however, with other plastics approved for food-contact use.
We emphasize that the data you submitted and reviewed, and the opinion set forth in this letter address only the use of regenerated EG and DMT from Eastman’s process. Thus, this opinion does not authorize or approve the reuse of PET or other food-contact polymers, to regenerate EG and DMT by other processes.
We further emphasize that we are issuing this letter addressing the Eastman process because, based on the data that you have submitted, we believe that the use of regenerated EG and DMT produced by this process from depolymerized post-consumer PET to manufacture PET food-contract articles is within the purview of existing regulations (21 CFR 174.5, 177.1315 and 177.1630).
We trust this letter fully responds to your request on this matter. If you have further questions, please do not hesitate to contact out Indirect Additives Branch at 202-472-5690.
Alan M. Rulis, Ph. D.
Division of Food and Color Additives
Center for Food Safety
and Applied Nutrition