No Objection Letter for Recycled Plastics #0037
October 12, 1995
Mr. Ralph A. Simmons
Keller and Heckman
1001 G Street, NW
Suite 500 West
Washington, DC 20001
Re: Food Additive Master File No. 569
Dear Mr. Simmons:
This is in response to your letter of August 23, 1994, and clarification of September 28, 1995, concerning the regulatory status of recycled post-consumer and post-industrial polyethylene terephthalate (PET) produced by the Hoechst Celanese’s glycolysis process for further use to manufacture articles intended to contact food. In your letter “glycolysis” means that PET has been depolymerized to its oligomers in the presence of ethylene glycol, purified, and subsequently repolymerized to reform PET resin. You have also defined post-industrial PET as “off-quality” material generated during Hoeschst’s manufacture of food packaging grade resins. 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 Hoechst depolymerization/repolymerization process to produce PET resins from recycled post-consumer and post-industrial PET. In particular, you have provided gas chromatographic and high-performance 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 recycled post-consumer and post-industrial PET feed material would be reduced to levels equivalent to a dietary concentration of less than 0.5 parts per billion (ppb), a level below our threshold of regulation.
Based upon our review of these data, we believe that the Hoechst Celanese’s glycolysis depolymerization/repolymerization process is extremely efficient at reducing potential contaminants to levels below our threshold of regulation (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 the Hoechst Celanese’s glycolysis process would not require an amendment to the food additive regulations, provided its use in making such articles is in compliance with 21 CFR 177.1315 or 177.1630.
Although we have concluded that your intended use of recycled post-consumer and post-industrial 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.
Corbin I. Miles, Ph.D.
Indirect Additives Branch
Division of Petition Control
Center for Food Safety
and Applied Nutrition