No Objection Letter for Recycled Plastics #79
March 17, 2003
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 April 8, 2002, requesting on behalf of your client, OHL Apparatebau & Verfahrenstechnik GmbH, Germany, our opinion regarding the capability of OHL's | | | | |. Process | | | | . for producing post-consumer recycled (PCR) polyethylene terephthalate (PET) pellets to be used in the manufacturing of food-contact articles at room temperature or below when up to 20% 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 April 13, 1999, 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), and provided that the PCR-PET complies with 21 CFR 177.1630.
In conjunction with the analytical data and procedural test documentation that you previously submitted on May 28, 1998, we have evaluated the summarized results submitted in your letter of April 8, 2002, towards the capability of OHL's | | | | . recycling process to remove contaminants from PCR-PET. In the absence of future market data and in order to account for the possibility that the amount of non-food containers in the feedstock could be greater then 20%, we have evaluated your recycling process assuming the worst case: that 100% of the post-consumer feedstock consists of non-food containers. Based upon this reevaluation, 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 59489) 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 at room temperature (120 °F) and below 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 OHL's | | | | . recycling process is modified, new data would need to be evaluated. 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 OHL'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.