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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #107

January 31, 2007

Dr. Frank Welle
Fraunhofer-Institut für Verfahrenstechnik und Verpackung
Abt. Produktsicherheit und Analytik
Giggenhauser Str. 35
D-85354 Freising
Germany

Re: Prenotification Consultation (PNC) 554

Dear Dr. Welle:

This letter is in response to your inquiry of November 3, 2006, requesting on behalf of your client, Plastlac Srl (Italy), FDA's opinion regarding the suitability of recycling Plastlac's coated polyethylene terephthalate (PET) bottles into new direct food contact applications by "super-clean" recycling processes. The acrylic polymeric coating applied to the non-food-contact layer of the PET bottles consists of a confidential formulation of  | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . This coating would be expected to enter the recycle system as part of the post-consumer PET recycle feedstock. As such, components of the coating could potentially become incorporated into the food-contact layer of post-consumer recycled (PCR) PET containers and subsequently migrate to food. This request has been logged into our tracking system as PNC 554.

In your letter, you presented analytical testing data from feedstock consisting of PET bottles coated with the subject coating and recycled via either conventional wash-and-grind recycling processes or several "super-clean" processes which involve high-temperature vacuum decontamination or solid-stating steps. Based upon this information as provided in your submission (PNC 554), we have concluded that the introduction of PET bottles coated with the Plastlac coating described above into the recycling stream will not affect the capability of a recycling process that consists of a "super-clean method" to produce PCR-PET products that are of a purity suitable for food-contact use. Please note that our conclusion applies only to the Plastlac coating and the "super-clean" method utilized in the test samples analyzed in this submission. If the formulation of this coating or if the "super-clean" method is significantly 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,

Julie N. Mayer, M.F.S.
Consumer Safety Officer
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
     and Applied Nutrition