No Objection Letter for Recycled Plastics #167
May 28, 2013
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001
Re: Prenotification Consultation (PNC) 1251
Dear Ms. Nielsen:
This letter is in response to your electronic submission, received on January 14, 2013 (PNC 1251), requesting on behalf of AlphaPet Inc. (AlphaPet) an agency’s letter of no objection confirming the capability of the proposed secondary recycling process (a so-called "super clean" process) to produce post-industrial, and post-consumer recycled polyethylene terephthalate (PCR-PET) material that is suitable for use at levels of up to 100% recycled content in the manufacture of PET containers for contact with all food types under all Conditions of Use as prescribed in the applicable authorizations.
The proposed recycling process is the same as that of Uhde Inventa-Fischer (UIF) via a sublicensing agreement with UIF. We have previously reviewed the UIF process (under PNC 553) and issued a letter of no objection dated June 25, 2007, allowing use of PCR-PET at levels up to 50% recycled content in the manufacture of containers for contact with all food types under Conditions of Use C through G
, when the feedstock consists of post-consumer food and/or non-food containers (excluding chemical PET containers), and the PCR-PET complies with all applicable authorizations.
We have reviewed the information you referenced in PNC 553 and migration modeling, which were submitted to demonstrate that the capability of the process in removing potential contaminants from PCR-PET. Based on our review of these data, we have determined that AlphaPet process, as described in the subject submission, would be effective in reducing potential contaminants from PCR-PET materials to levels that result in dietary concentrations not to exceed 0.5 ppb, FDA's threshold of regulatory concern. We have concluded that the subject secondary recycling process would produce PCR-PET material that is suitable for use at levels of up to 100% recycled content in the manufacture of articles for contact with all food types under all Conditions of Use
as prescribed in the applicable authorizations, when the feedstock consists of post-industrial and post-consumer food and/or non-food containers (excluding chemical PET containers), and the PCR-PET complies with all applicable authorizations. If the proposed recycling process is modified, new data may need to be evaluated.
The resultant PCR-PET must comply with all applicable authorizations including 21 CFR § 174.5 General provisions applicable to indirect food additives. For example, in accordance with section 402(a)(3) of the Federal Food, Drug and Cosmetic Act, use of the recycled PCR-PET material should not impart odor or taste to food rendering it unfit for human consumption.
If you have any 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