No Objection Letter for Recycled Plastics #0048
June 6, 1997
Mr. George G. Misko
Keller and Heckman
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Dear Mr. Misko:
This is in response to your submissions of August 8, 1996, and February 26, 1997, on behalf of Wellman, Inc., concerning polyethylene terephthalate (PET) sheet made from flakes containing recycled post-consumer material for use in the manufacture of food-contact articles. The recycled PET articles are intended to be used in contact with aqueous and dry foods under Condition of Use C (hot filled or pasteurized above 150°F) or less severe conditions, and fatty foods under Condition of Use D (hot filled or pasteurized below 150°F) or less severe conditions. You stated that the recycled post-consumer PET flakes will be formed from soda and juice bottles and other food-contact containers collected through a bottle deposit system, XXXXXX XXXXX XXXXXXXX XXXXXX XXXX XXXXX XX XXXX XXXXX XXXXX XXXXX.
The information you have provided describes, in detail, the Wellman’s physical recycling procedure (sorting, grinding, washing, single-drying, and single-extrusion) for converting post-consumer PET food containers into new PET food-contact articles. In addition, you have provided gas chromatographic, high-performance liquid chromatographic, and spectroscopic data demonstrating that surrogate contaminants (representing volatile non-polar, volatile polar, non-volatile non-polar, non-volatile polar, and heavy metal compounds) intentionally added to post-consumer PET feed material would be reduced to levels that will result in a dietary concentration of less than 0.5 parts per billion (ppb), the threshold of regulatory concerns, under the conditions of use stated in your submissions.
Based on our review of this information, we agree that the dietary concentrations of possible contaminants in the recycled PET resulting from the proposed recycling process would be below 0.5 ppb. Therefore, we conclude that Wellman’s recycling process described in your August 8, 1996, and February 26, 1997, submissions, will produce recycled PET that is suitably pure, and that is therefore acceptable for use in contact with aqueous and dry foods under Condition of Use C and less severe conditions, and fatty foods under Condition of Use D and less severe conditions, provided that the recycled PET complies with 21 CFR 177.1630 and other applicable regulations.
Our conclusion applies only to recycled PET produced as described in the stated submissions. The commercial process should be equivalent to that process. If the commercial process is not equivalent, new data may need to be evaluated.
Although we have concluded that your intended use of recycled PET is acceptable, 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 related to this letter, please do not hesitate to contact us.
Eugene C. Coleman
Division of Petition Control, HFS-215
Center for Food Safety
and Applied Nutrition