No Objection Letter for Recycled Plastics #82
June 30, 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 June 18, 2002, requesting on behalf of your client, OHL Apparatebau & Verfahrenstechnik GmbH, Germany, our opinion regarding the capability of OHL's | | | | | | | | | | | | | | | | | | | | | | | | |. for producing post-consumer recycled (PCR) polyethylene terephthalate (PET) pellets to be used in the manufacturing of food-contact articles to be used under hot-fill conditions. This letter has been entered into our files as CTS 81240.
As pointed out in your letter, the requested opinion would be an extension to a previously issued letter of no objection from the FDA, 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 (120 °F) and below, provided the feedstock consists of PET food containers only. This no objection letter was a result of your opinion letter request, dated May 28, 1998 (CTS 59489). In addition, in response to your inquiry of April 8, 2002 (CTS 80283), FDA has subsequently published a no objection letter, dated March 13, 2003, for the same recycling process to 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 and any other applicable regulations.
In your original submission for | | | | |. (CTS 59489), you provided analytical data and results from diffusion modeling on surrogate contaminants intentionally added to PET to represent contaminated post-consumer feed material and the migration of any residual contaminants into food from the PCR-PET at room temperature. In your current submission you summarize the application of new diffusion coefficients to this information in order to calculate the potential migration of any residual contaminants into food from the PCR-PET under hot-fill use conditions.
Based upon our review of these data and corrected migration calculations, we have concluded that | | | | |. recycling process is capable of reducing the contaminant level in recycled PET below FDA's threshold of regulatory concern. This conclusion covers the use of PCR-PET with all food types under Conditions of Use C through G as described in Table 2 in 21 CFR 176.170 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 | | | | |. 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.
Consumer Safety Officer,
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition