Food

No Objection Letter for Recycled Plastics #164

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

See also Recycled Plastics in Food Packaging

March 25, 2013

Frank Welle
Fraunhofer Institut für
Verfahrenstechnik und Verpackung IVV
Giggenhauser Strße 35
85354 Freising
GERMANY

Re: Prenotification Consultation (PNC) 1243

Dear Mr. Welle:

This letter is in response to your electronic submission, received on December 18, 2012 (PNC 1243), requesting on behalf of Bühler Thermal Processes AG (formerly Bühler AG) 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-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 Conditions of Use B through H, 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 previously reviewed the same recycling process (under PNC 948) and issued a letter of no objection dated September 14, 2010, allowing use of PCR-PET material at levels up to 100% 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 the previous submission and literature information submitted to demonstrate the capability of Bühler’s secondary recycling process to remove potential contaminants from PCR-PET. Based on our review of these data, we have determined that Bühler’s secondary recycling 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 Conditions of Use B through H, 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, 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. If the proposed recycling process is modified, new data may need to be evaluated.

The resultant PCR-PET 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 PCR-PET 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