November 29, 2017
Frank Welle, Ph.D.
Fraunhofer-Institute for Process Engineering and Packaging (IVV)
Giggenhauser Straße 35
Re: Prenotification Consultation PNC 2075
Dear Dr. Welle:
This letter is in response to your electronic submission (PNC 2075), received on August 30, 2017, requesting on behalf of Battenfeld-Cincinnati Germany GmbH (Battenfeld), a letter of no objection, confirming the capability of Battnfeld's secondary recycling process in producing post-consumer recycled polyethylene terephthalate (PCR-PET) material that is suitable for food-contact. The PCR-PET material is intended for use at levels of up to 100% recycled content in manufacturing PET sheets for use in production of thermoformed PET containers that may contact all food types under Conditions of Use C-G, as described in Tables 1 and 2, which can be accessed from the Internet in the Ingredients, Packaging & Labeling section under the Food topic at 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 the proposed recycling process in removing potential contaminants from PCR-PET. Based on our review of these data, we have determined that the proposed recycling process, as described in the subject submission, is effective in reducing potential contaminants from PCR-PET material to levels that do not migrate to food at a dietary concentration exceeding 0.5 ppb, FDA's threshold of regulatory concern. Therefore, we concluded that the PCR-PET may be used as intended, above. This determination covers the use of PCR-PET derived from the feedstock that consists of food and non-food PET containers, which comply with 21 CFR § 177.1630 (polyethylene phthalate polymers) and other applicable authorizations. The feedstock excludes industrial/chemical containers. If the proposed recycling process is modified, new data may need to be re-revaluated.
The PCR-PET material should comply with all other 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