No Objection Letter for Recycled Plastics #76
February 10, 2003
Roland Franz, Ph.D.
Fraunhofer-Institut für Verfahrenstechnik und Verpackung
Giggenhauser Strasse 35
Dear Dr. Franz:
This letter is in reponse to your inquiry of December 14, 2001 requesting on behalf of your client, EREMA GmbH, our opinion regarding the capability of their secondary recycling process for producing post-consumer recycled (PCR) polyethlene terephthalate (PET) to be used in the manufacturing of hot-filled food-contact articles when up to 100% of the feedstock includes containers previously used for food and/or non-food containers (NOT including industrial PET containers).
As pointed out in your letter, the 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). The FDA also subsequently issued a letter of no objection dated June 7, 2001, for this same recycling process to produce recycled PET 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.
In conjunction with the analytical data and procedural test documentation that you previously submitted on August 3, 1999, August 28, 2000, and further summarized on February 9, 2001, we have evaluated the summarized results submitted in your letter of December 14, 2001 towards the capability of EREMA GmbH's recycling process to remove contaminants from PCR-PET for use in manufacturing hot-filled food-contact articles. Although analytical data was not submitted, based upon the tesing procedures used and previous related submission documentation, we accept the results provided. Based upon these results we have concluded that the levels of dietary exposure to possible contaminants resulting from the proposed use of PCR-PET that was subjected to the process described in your submission (CTS 66652) 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 all types of food for hot fill applications both above 150 °C and less severe conditions (Condition of Use C through G as described in Table 2 of 21CFR 176.170) when the feedstock consists of food and/or non-food containers, provided the PCR-PET complies with 21CFR 177.1630 and any other applicable regulations. Please note that our conclusion applies only to PC-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 GmbH's recycling process is modified, new data would need to be evaluated.
Although we have concluded that the recycling process described in the above submission 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.
Paul Honigfort, Ph.D.