No Objection Letter for Recycled Plastics #176
Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles
See also Recycled Plastics in Food Packaging
June 9, 2014
Jeffrey A. Keithline
Keller & Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: Prenotification Consultation (PNC) 1359
Dear Mr. Keithline,
This letter is in response to your submission, received on October 30, 2013 (PNC 1359), requesting on behalf Extremadura TorrePet, S.L. (TorrePet), a no objection letter from FDA confirming the capability of the TorrePet’s secondary recycling process (a so-called “Super Clean”) to produce post-consumer recycled polyethylene terephthalate (PCR-PET) material that is suitable for use at a level of up to 100% recycled content in the manufacture of PET articles (e.g., semi-rigid sheet for thermoforming trays and thin oriented films for bags and snack food wrappers) that contact all food types under hot-filled (e.g. Condition of Use C) and lower, as described in Table 2, which can be accessed from the Internet in the Ingredients, Packaging & Labeling section under the Food topic of www.fda.gov.
We have reviewed the proposed recycling process as well as the information you obtained from surrogate testing and migration modeling, which were submitted to demonstrate the capability of TorrePet’s secondary recycling process to remove potential contaminants from PCR-PET. Based on our review of these data, we have determined that TorrePet’s secondary recycling process, as described in the subject submission, would be effective in reducing potential contaminants from PCR-PET to levels that result in dietary concentrations not to exceed 0.5 ppb, FDA's threshold of regulatory concern. This determination covers the use of PCR-PET derived from the feedstock that consists of post-consumer food and non-food PET containers (excluding industrial/chemical containers), which complies with the existing applicable authorizations.
We have concluded that TorrePet’s secondary recycling process, as described in the subject submission, would produce PCR-PET material that is suitable for use at levels of up to 100% recycled content in the manufacture of PET articles that may contact all food types under Conditions of Use C and lower, as described in Table 2, which can be accessed from the Internet in the Ingredients, Packaging & Labeling section under the Food topic of www.fda.gov.
The resultant recycled material 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 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