No Objection Letter for Recycled Plastics #67
June 7, 2001
Roland Franz, Ph.D.
Fraunhofer-Institut für Verfahrenstechnik und Verpackung
Giggenhauser Strasse 35
Dear Dr. Franz:
This responds to your inquiry of February 9, 2001, requesting on behalf of your client, EREMA GmbH, our opinion on the capability of a secondary recycling process for producing post-consumer recycled (PCR) polyethylene terephthalate (PET) to be used in the manufacturing of food-contact articles when non-food containers are included in the feedstock at levels up to 20%. As pointed out in your letter, FDA previously issued a letter of no objection dated November 17, 2000, for this same recycling process to produce recycled PET for use in contact with all types of food at room temperature and below, provided the feedstock consists of PET food containers only (e.g., soft drink and mineral water bottles).
We have reevaluated the analytical data that you previously submitted on August 3, 1999, and August 28, 2000, to demonstrate the capability of EREMA's recycling process to remove potential contaminants from PCR-PET, and have assumed the worst case that 100% of the feedstock will consist of non-food containers. In the absence of future market data and to account for the possibility that the amount of non-food containers in the feedstock could be greater than 20%, we have evaluated your recycling process assuming the worst case that 100% of the post-consumer feedstock consists of non-food containers. Based on this reevaluation, we have determined that the levels of exposure to possible contaminants resulting from the proposed use of PCR-PET that was subjected to the process described in the above submissions would be below FDA's threshold of concern when non-food containers are included in the feedstock. Therefore, we conclude that this recycling process will produce PCR-PET that is acceptable for use in contact with all types of food at room temperature and below when the feedstock consists of food and/or non-food containers, provided the PCR-PET complies with 21 CFR 177.1630. Please note that our conclusion applies only to post-consumer 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 submissions. If EREMA's recycling process is modified, new data would need to be evaluated.
Although we have concluded that the recycling process described in the above submissions will produce PCR-PET that is acceptable for the intended use, 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 concerning this matter, please do not hesitate to contact us.
Sandra L. Varner