No Objection Letter for Recycled Plastics #0043
May 2, 1996
Mr. George G. Misko
Keller and Heckman
1001 G Street, NW
Suite 500 West
Washington, DC 20001
Dear Mr. Misko:
This is in response to your letter of May 1, 1995, on behalf of Wellman, Inc., concerning the suitability for use in food-contact applications of polyethylene terephthalate (PET) that has been produced with post-consumer recycled material using Wellman’s XXX XXXXX process. Specifically, you requested that the recycled PET be permitted for use in articles intended to contact aqueous 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. Your letter states that the post-consumer material will consist exclusively of soda and juice bottles and other food-contact containers collected through a bottle deposit system, XXXXX XXXXXXXXX XXXXXXXX XXXXXX XXXX XXXXXXX XXXXXX XXXX XXXXXX.
The information you have provided described, in detail, the Wellman physical, or “secondary” recycling procedure (sorting, grinding, washing, melting and reforming followed by XXXXXXXX) 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 spectrophotometric data demonstrating that surrogate contaminants (representing volatile non-polar, volatile polar, and non-volatile non-polar compounds) intentionally added to post-consumer PET material would be reduced to levels that will result in a dietary concentration of less than 0.5 parts per billion (ppb), under the conditions of use stated in your submission. In addition, you have provided extraction data demonstrating that surrogate contaminants representing non-volatile polar and heavy metal compounds do not migrate in quantities exceeding concern levels of our threshold of regulation for aqueous and dry foods under the Condition of Use C (hot filled or pasteurized above 150°F) or less severe conditions, and for fatty foods under Condition of Use D (hot filled or pasteurized below 150°F) or less severe conditions.
Based on our review of this information, we conclude that the levels of dietary exposure to possible contaminants in the recycled PET resulting from the proposed recycling process would be below the threshold of regulation (0.5 ppb dietary exposure). Therefore, we also conclude that Wellman’s recycling process, described in your May 1, 1995 submission, will produce recycled PET that is suitably pure and therefore acceptable for use in contact with aqueous, dry, and acidic foods under Condition of Use C or less severe conditions, and fatty and alcoholic foods under Condition of use D or less severe conditions, provided that the recycled PET complies with 21 CFR 177.1630 and other applicable regulations.
Our conclusion applies only to PET treated as described in your submission of May 1, 1995. 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 Wellman’s intended use of their recycled post-consumer 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 regarding this letter, please do not hesitate to contact us.
Sandra L. Varner
Indirect Additives Branch
Division of Petition Control
Center for Food Safety
and Applied Nutrition