No Objection Letter for Recycled Plastics #92
January 25, 2005
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: Prenotification Consultation (PNC) 281
Dear Mr. Misko:
This letter is in response to your inquiry, dated February 27, 2004, requesting on behalf of Mitsui Chemicals Inc., FDA's opinion regarding the suitability of their secondary recycling process to produce post-consumer recycled (PCR) polyethylene terephthalate (PET) suitable for food-contact use provided only post-consumer PET food containers are included in the feedstock. This PCR-PET would then be used to manufacture food-contact articles for use with aqueous, acidic, and low-alcohol content foods under conditions of use B through H as defined in Table 2 in 21 CFR 176.170(c). In addition to your inquiry of February 27, FDA also requested additional information for its review, and this information (dated October 21, 2004) was received and incorporated into the submission. This request has been entered into our files as PNC 281.
We have evaluated the surrogate contaminant and migration data provided in PNC 281. Based upon our review of the submitted experimental and modeled data, we have concluded that Mitsui Chemicals Incorporated's recycling process as presented in PNC 281 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 in contact with aqueous, acidic, and low-alcohol content foods under conditions of use B through H as defined in Table 2 in 21 CFR 176.170(c). This includes feedstock consisting exclusively of post-consumer PET food containers obtained from deposit and curbside recycling programs and processed by the method described in PNC 281, provided the PCR-PET complies with 21 CFR 177.1630 and any other applicable regulations. If Mitsui Chemicals Incorporated's recycling process is modified, new data would need to be evaluated.
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