No Objection Letter for Recycled Plastics 204
Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles
See also Recycled Plastics in Food Packaging
September 6, 2017
Mitzi Ng Clark
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: Prenotification Consultation PNC 2050
Dear Ms. Clark:
This letter is in response to your submission (PNC 2050), received on July 12, 2017, requesting on behalf of CORESA Compañía Recicladora S.A. (CORESA), an Agency's a letter of no objection regarding the capability of CORESA's secondary recycling process in producing post-consumer recycled polyethylene terephthalate (PCR-PET) that is suitable for food-contact. The PCR-PET material is intended for use at levels of up to 100% recycled content in the fabrication of articles (e.g., single layer trays, containers, and clamshells) that contact raw fruits, vegetables, and shell eggs under the Conditions of Use E through G, as described in Table 2, which can be accessed from the Internet in the Ingredients, Packaging & Labeling section under the Food topic at www.fda.gov.
The CORESA's process is a typical secondary recycling process, which we have reviewed multiple times. We have reviewed the proposed recycling process as well as supporting information submitted to demonstrating the capability of the proposed recycling process in removing potential contaminants from PCR-PET. Based on our review of the information provided, we have determined that because of strict source control, there is little likelihood of unacceptable contaminant levels in your PCR-PET material. Therefore, we conclude that the proposed recycling process as described in the subject submission would produce PCR-PET material that may be used at levels of up to 100% recycled content in the manufacture of articles (e.g., single layer trays, containers, and clamshells) that contact raw fruits, vegetables, and shell eggs (which would be peeled or washed before consumption) for short periods of time at room temperature or below (i.e., Conditions of Use E through G). This determination applies to PCR-PET material that is obtained from strict source control of a feedstock, derived from PET beverage bottles, excluding industrial/chemical containers. If the CORESA recycling process is modified, new data may need to be re-evaluated.
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 further 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