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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #170

November 13, 2013

Frank Welle, Ph.D.
Fraunhofer Institut für Verfahrenstechnik
und Verpackung IVV
Giggenhauser Straße 35
85354 Freising
GERMANY
 

Re: Prenotification Consultation PNC 1304

Dear Dr. Welle:

This letter is in response to your electronic submission, received on June 21, 2013 (PNC 1304), requesting on behalf of Protec Polymer Processing GmbH (Protec) (Bensheim, Germany), a no objection letter confirming the capability of the proposed 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 for contact with all food types under cold-filled and hot-filled conditions, i.e., Conditions of Use C through G, 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 Protec's secondary recycling process to remove potential contaminants from PCR-PET. Based on our review of these data, we have determined that Protec'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 the proposed 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 for contact with all food types under cold-filled and hot-filled conditions, i.e., Conditions of Use C through G, 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.

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