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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #110

June 25, 2007

Frank Welle
Fraunhofer Institut
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
D-85354 Freising
Germany

Re: Prenotification Consultation (PNC) 553

Dear Dr. Welle:

This is in response to your electronic submission, received on 12 November 2006 and amended on 5 April 2007, requesting on behalf of Uhde Inventa-Fischer GmbH & Co. KG (UIF) an opinion letter from the FDA confirming the capability of UIF’s secondary recycling process (called “Super Clean”) to produce post-consumer recycled polyethylene terephthalate (PCR PET) of suitable purity for use in the manufacture of articles in contact with food under conditions of use C through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.

We have reviewed UIF’s recycling process as well as the information obtained from surrogate testing and migration modeling, which were submitted to demonstrate the capability of the UIF’s recycling process to remove potential contaminants from PCR PET. Based on our review of these data, we have determined that UIF’s recycling process, as described in the 12 November 2006 submission, would be effective in reducing potential contaminants from the feedstock, consisting of food and non-food PET containers, to levels that would result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. Therefore, we have concluded that UIF’s recycling process, as described in the 12 November 2006 submission, would produce PCR PET that is of a purity suitable for use in the manufacture of food-contact articles under conditions of use C through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html, provided that the PCR PET complies with 21 CFR 177.1630, and the feedstock consists of food and non-food PET containers, excluding industrial PET containers. This conclusion was based on the submitted data that support use of up to 50% recycled content in the manufacture of PET food-contact articles. If UIF’s recycling process is modified, new data would need to be evaluated.

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