No Objection Letter for Recycled Plastics #119
March 24, 2009
Frank Welle, Ph.D.
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
Re: Prenotification Consultation (PNC) 772
Dear Dr. Welle:
This letter is in response to your electronic submission (PNC 772), received on January 23, 2009, requesting on behalf of Luigi Bandera S.p.A. (Bandera) an opinion letter from FDA confirming the capability of Bandera’s secondary recycling process to produce post-consumer recycled polyethylene terephthalate (PCR PET) sheets that are suitable for use at levels up to 100% recycled content in the manufacture of articles to contact all food types under cold-fill and hot-fill conditions, i.e., under Conditions of Use C through G, as described in Tables 1 and 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov.
We have reviewed Bandera’s recycling process as well as the information obtained from surrogate testing and migration modeling which were submitted to demonstrate the capability of the Bandera’s secondary recycling process to remove potential contaminants from PCR PET. Based on our review of these data, we have determined that Bandera’s secondary recycling process, as described in the January 23, 2009 submission, would be effective in reducing potential contaminants from the feedstock, consisting of food and non-food PET containers, to levels that result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. This determination covers the use of PCR PET derived from the feedstock that consists of food and non-food PET containers (excluding industrial PET containers), provided that the PCR PET complies with the existing applicable authorizations.
We have concluded that Bandera’s secondary recycling process, as described in the subject submission, would produce PCR PET sheets that are suitable for use at levels up to 100% recycled content in the manufacture of articles to contact all food types under cold-fill and hot-fill conditions, i.e., under Conditions of Use C through G, as described in Tables 1 and 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov. If Bandera’s recycling process is modified, new data may need to be evaluated.
Our review of the proposed recycling process toward a favorable opinion letter does not relieve use of the resultant PCR PET material from compliance with any other provision of the Federal Food, Drug, and Cosmetic Act or with 21 CFR § 174.5 General provisions applicable to indirect food additives. For example, in accordance with section 402(a)(3) of the Act, use of the recycled PET 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.
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