No Objection Letter for Recycled Plastics #97
October 26, 2005
Jerome H. Heckman
Keller and Heckman LLP
1001 G. Street, N.W.
Suite 500 West
Washington, DC 20001
Re: Prenotification Consultation (PNC) 366
Dear Mr. Heckman:
This responds to your inquiry of February 1, 2005 (referred as PNC 366 in our files), requesting on behalf of Toyo Seikan Kaisha Ltd. an opinion letter from the FDA regarding the use of post-consumer recycled polyethylene terephthalate (PCR-PET) in multi-laminate containers, of which the food contact layer has a minimum thickness of at least 2 mils as intended for use with all types of food listed in Table 1 of 21CFR§176.170 (c) under Conditions of Use C and below as listed in Table 2 of 21CFR§176.170 (c), provided that the PCR-PET complies with 21CFR§177.1630.
We have reviewed the calculations based on migration modeling for the use of a 2 mil virgin PET layer as a barrier to migration of four test surrogates from a recycled PET layer to food under Condition of Use C. We have determined that the migration levels would not exceed 10 ppb which would result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. Therefore, we have concluded that the laminate structure proposed with a 2 mil virgin PET layer would serve as a suitable barrier for use in contact with all types of food listed in Table 1 of 21CFR§176.170(c) under Conditions of Use C and below as listed in Table 2 of 21CFR§176.170(c), provided that the PCR-PET complies with 21CFR§177.1630.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Vanee Komolprasert, Ph.D., P.E.
Consumer Safety Officer
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition