No Objection Letter for Recycled Plastics #111
August 27, 2007
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 588
Dear Dr. Welle:
This letter is in response to your submission (PNC 588), received on 13 March 2007, requesting on behalf of SIG Corpoplast GmbH & Co. KG, an opinion letter regarding the capability of | | | | | | | | (silicon oxide) coating to act as an effective barrier to chemical contaminants that may potentially migrate from post-consumer recycled PET (PCR-PET) to food. The subject coating is the subject of food contact notification (FCN) 329 for use as a gas barrier coating on PET containers. The coating would be applied at a thickness of 100 nanometers to the internal surface of PET containers intended to contact aqueous, acidic, and low alcoholic beverages (< 8% alcohol content) under cold-fill conditions, i.e., Conditions of Use E through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.
We have reviewed the information obtained from the surrogate testing and migration studies, which were submitted to demonstrate that the silicon oxide coating can reduce migration of potential contaminants from PCR-PET to food. Based on our review of these data, we have determined that SIG’s silicon dioxide coating, as described in FCN 329 and the 13 March 2007 submission, would reduce the migration of potential contaminants from PCR-PET, derived from the feedstock containing of food and nonfood containers, to levels that would result in dietary concentrations not to exceed 0.5 ppb, FDA's threshold of regulatory concern. Therefore, we have concluded that SIG’s silicon oxide coating at a thickness of 100 nanometers, as described in the 13 March 2007 submission, would act as effective barrier to chemical contaminants that may potentially migrate from PCR-PET to aqueous, acidic and low alcoholic beverages (< 8% alcohol content) under cold-fill conditions, i.e., Conditions of Use E through G as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html, provided that PCR-PET complies with 21 CFR 177.1630, and is derived from the feedstock containing food and non-food PET containers, excluding industrial PET containers.
If you have any further questions concerning this matter, please do not hesitate to contact us.
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