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  1. Packaging & Food Contact Substances (FCS)

No Objection Letter for Recycled Plastics 208

Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles

See also Recycled Plastics in Food Packaging


March 22, 2018

Frank Welle, Ph.D.
Fraunhofer-Institute for Process Engineering and Packaging (IVV)
Giggenhauser Straße 35
85354 Freising
Germany

Re: Prenotification Consultation PNC 2098

Dear Dr. Welle:

This letter is in response to your electronic submission (PNC 2098), received on October 5, 2017 and amended on January 12, 2018, requesting on behalf of Total Research and Technology Feluy (Total), a letter of no objection, confirming the capability of Total’s secondary recycling process (a so-called as “super clean” process) in cleaning and producing post-consumer recycled high-density polyethylene (PCR-HDPE) material that is suitable for food-contact. The PCR-HDPE material is intended for use at levels of up to 60% recycled content in manufacturing HDPE bottles for fresh milk and juices, meat trays and similar products at room and refrigeration temperatures, i.e., under Conditions of Use E-F, 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.

We have reviewed the proposed recycling process as well as the information you obtained from surrogate testing and other supporting information, which were submitted to demonstrate the capability of the proposed recycling process in removing potential contaminants from PCR-HDPE. 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-HDPE 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-HDPE produced from the proposed recycling process may be used under the intended use conditions, as described above. This determination covers the use of PCR-HDPE derived from the feedstock that consists of food-grade HDPE containers (e.g. those that hold milk), which comply with 21 CFR§ 177.1520 and other applicable authorizations. If the proposed recycling process is modified, new data may need to be re-revaluated.

The PCR-HDPE material should 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.

Sincerely,

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