No Objection Letter for Recycled Plastics #85
December 30, 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 June 26, 2003, requesting on behalf of your client, ERMA 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 sheet and trays (i.e., relativley amorphous forms of PET) for contact with all types of food under Conditions of Use C through G when up to 100% of the feedstock includes containers previously used for food and/or non-food containers (NOT including industrial PET containers). Your request has been entered into our tracking system as CTS 85019.
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). 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. Futhermore, in a letter of no objection dated February 10, 2003, FDA extended this opinion to the production of hot-fill food-contact articles.
In CTS 85019, you present comparison testing performed via the "PET inertness test" in order to determine the relative increases expected in the migration of chemical contaminants from sheet and trays over that observed from bottles. Although different time/temperature and food simulants were used in the inertness test then that recommended in our migration testing protocol, we will accept the results since the purpose of the test in this instance is to determine the relative difference in migration between articles and the fact that both bottle, sheet, and tray material were subject to identical tesing conditions. Using the migration factors determined from this inertness test in conjunction with the surrogate spiking data on highly crystalline PET bottles presented in your previous submission of December 14, 2001 (CTS 79164), we have evaluated the capability of ERMA GmBH's recycling process to remove contaminants from PCR-PET for use in manufacturing sheets and trays for food-contact use.
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 the manufacturing of sheet and trays (i.e., relativley amorphous forms of PET) 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 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 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.
Consumer Safety Officer,
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition