No Objection Letter for Recycled Plastics #87
June 4, 2004
Roland Franz, Ph.D
Fraunhofer-Institut für Verfahrenstechnik und Verpackung
Giggenhauser Strasse 35
Dear Dr. Franz:
This letter is in response to your inquiry of July 3, 2003 requesting on behalf of your client, Se.Ri.Plast. s.r.l., Italy, FDA's opinion regarding the capability of their secondary recycling process for producing post-consumer recycled (PCR) polyethylene terephthalate (PET) flake to be used in the manufacture of agricultural trays when up to 100% of the feedstock includes containers previously used for food and/or non-food containers (NOT including industrial PET containers). Such PCR-PET agricultural trays are to be used at room temperature or below for short periods of time in contact with shell eggs and fresh fruit and vegetables that would be peeled or washed before consumption.
We have reviewed the analytical data presented in your letter on previous batches of post-consumer PET that has gone through the subject recycling process as well as diffusion calculations modeling the migration of potential contaminants into a fatty-food simulant based upon the molecular weight of the migrant. In most instances FDA would consider analysis of actual previous recycle batches as inadequate to establish the ability of a recycling process to produce recycled material of suitable purity for food contact use due to the potential for fluctuation in the feedstock composition. However, due to the concentration and molecular weight range of the analyzed migrants as well as the minimal food-contact involved in the intended application we are willing to accept such an analysis for this submission.
Based upon the information provided in your submission (CTS 85068), we have concluded that the levels of dietary exposure to possible contaminants resulting from the proposed use of PCR-PET that was subjected to this process would be below FDA's threshold of regulatory concern of 0.5 ppb. Therefore, we conclude that the recycling process described in your submission will produce PCR-PET that is acceptable for use in contact with shell eggs and fresh fruit and vegetables that would be peeled or washed before consumption at use temperatures not to exceed 120 °F when the feedstock consists of food and/or non-food containers, provided the PCR-PET complies with 21 CFR 177.1630 and any other applicable regulations. Please note that our conclusion applies only to PCR-PET containers obtained from deposit and curbside recycling programs (i.e., feedstock would not include industrial PET containers such as 55 gallon drums that had previously held chemicals) and processed by the method described in the above submission. If Se.Ri.Plast. s.r.l.'s recycling process is modified, new data would need to be evaluated.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Paul Honigfort, Ph.D.
Consumer Safety Officer,
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition