No Objection Letter for Recycled Plastics #0042
May 1, 1996
Mr. Phillip Krasnostein,
Innovations in PET Pty Ltd
433-451 Somerville Road
West Footscray, Victoria 3012
Dear Mr. Krasnostein:
This responds to your submission of May 25, 1995, requesting FDA’s opinion on whether polyethylene terephthalate (PET) produces from post-consumer PET containers by your XXXXX process is suitable for manufacturing food packaging. Your submission indicates that your XXXXX process is a multi-step glycolysis procedure in which post-consumer PET is depolymerized in the presence of ethylene glycol, purified, and subsequently repolymerized in the presence of ethylene glycol 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 purification process to produce reformed PET from depolymerized PET containers. In particular, you have provided gas chromatographic and neutron activation analysis data demonstrating that surrogate contaminants (representing volatile non-polar, volatile polar, non-volatile non-polar, non-volatile polar, and heavy metal compounds) intentionally added to post-consumer PET feed material are adequately removed during your multi-step glycolysis process. In addition, you have provided data demonstrating that your reformed PET resin complies with the extraction limitation requirement of § 177.1630 of Title 21 Code of Federal Regulations (21 CFR 177.1630).
Based upon our review of these data, we believe that your multi-step glycolysis process will produce PET that is of suitable purity, and that is therefore acceptable, for use in the production of PET articles intended for food packaging, in accordance with 21 CFR 174.5, provided that the recycled PET complies with 21 CFR 177.1630 and other applicable regulations.
Our conclusion applies only to PET resins reformed as described in your May 25, 1995, submission. The commercial process should be equivalent to that process. If the commercial process is not equivalent, new data may need to be evaluated.
Although we have concluded that your intended use of recycled post-consumer PET 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 related to this letter, please do not hesitate to contact us.
Sandra L. Varner
Indirect Additives Branch, HFS-216
Division of Petition Control
Center for Food Safety
and Applied Nutrition