No Objection Letter for Recycled Plastics #0011
August 21, 1992
Mr. Eric F. Greenberg
Bullwinkel Partners, LTD.
19 South LaSalle Street
Chicago, Illinois 60603-1493
Re: Food Additive Master File 492
Dear Mr. Greenberg:
This responds to your submissions of June 13 and October 17, 1991, and your recent letter of July 24, 1992, regarding the use of post-consumer polyethylene terephthalate (PET) to manufacture fresh fruit and vegetable baskets and to manufacture tri-laminate clamshell food-contact containers consisting of a XXXXX thick inner and outer layer of food-contact virgin PET, complying with 21 CFR 177.1630, sandwiching a core layer of post-consumer PET. Your letter also states that the clamshell and basket containers are intended to contact food for only short periods of time and at ambient temperatures and below.
The information you have provided describes, in detail, your collection, washing, sorting, grinding, separation, cleaning, processing, and extrusion processing procedures for the use of recycled PET to manufacture baskets for packaging fresh fruits and vegetables. Based upon our review of this information, we find that there will be little likelihood that substances from recycled PET will migrate at significant levels from the baskets and remain on the fresh fruits and vegetables at the time of consumption. Therefore, your intended use of recycled PET to manufacture baskets for fresh fruits and vegetables will not require an amendment to the food additive regulations as long as use is limited to room temperature or below.
We have also reviewed the analytical data you provided to demonstrate that the XXXXX layer of virgin PET is an affective functional barrier for intentionally contaminated post-consumer PET resin used as the non-food contact layer of laminate structures. Based on our review of these data, we find that there is little likelihood that substances from the recycled PET will migrate to food at significant levels if the recycled PET is separated from food by at least a 1.0-mil thick layer of virgin PET that complies with 21 CFR 177.1630. Therefore, your intended use of recycled PET as the non-food-contact layer in laminated clamshell containers does not require amendment of the food additive regulations as long as it is separated from food by a layer of virgin PET at least 1.0 mil thick and the use of the containers is limited to short term storage (less than 2 weeks) of food at room temperature or below.
If you have any further questions related to this letter, please do not hesitate to contact us.
Alan M. Rulis, Ph.D.
Division of Food and Color Additives
Center for Food Safety
and Applied Nutrition