No Objection Letter for Recycled Plastics #0039
March 12, 1996
Mr. George G. Misko
Keller and Heckman
1001 G Street, NW
Suite 500 West
Washington, DC 20001
Dear Mr. Misko:
This is in response to your letters of March 31, and April 20, 1995, concerning the suitability of recycled post-consumer polyethylene terephthalate (PET) produced by Wellman, Inc., glycolysis process for use to manufacture articles intended to contact food. Specifically, you requested that PET produced by Wellman’s glycolysis process be permitted for use in articles intended to contact aqueous foods under Condition of Use C (hot filled or pasteurized above 150°F) and less severe conditions, and fatty foods under Condition of Use D (hot filled or pasteurized below 150°F) and less severe conditions.
Your letter states that the post-consumer PET of interest will consist exclusively of soda and juice bottles and other food-contact containers collected through a bottle deposit system. The washing and processing procedures were described. In your letter “glycolysis” means that PET has been depolymerized to its oligomers in the presence of ethylene glycol, purified, and subsequently repolymerized in the presence of phthalate monomers to reform the PET resin. The glycolysis reprocessing method employed is classified by the Environmental Protection Agency as tertiary recycling. You further state that no additional adjuvants are used in the production of the recycled resin.
We have reviewed the data that you provided on Wellman’s depolymerization/repolymerization process to produce PET resins from post-consumer PET. In particular, you have provided gas chromatographic, high-performance liquid chromatographic, and spectroscopic 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 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 Wellman’s glycolysis depolymerization/repolymerization process will produce PET that is of suitable purity, and that is therefore acceptable, for use in the production of PET articles intended for contact with food, in accordance with 21 CFR 174.5, provided that the recycled PET complies with 21 CFR 177.1630 and other applicable regulations and that the subject PET contacts aqueous foods only under Condition of Use C and less severe conditions and fatty foods only under Condition of Use D and less severe conditions.
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
Center for Food Safety
and Applied Nutrition