No Objection Letter for Recycled Plastics #113
October 22, 2007
Re: Prenotification Consultation (PNC) 623
Dear Mr. Jokela:
This is in response to your electronic submission of June 25, 2007 (logged in as PNC 623), requesting a “non-objection” letter from FDA regarding the capability of Preformia Oy’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 E through G, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.
We have reviewed Preformia’s proposed secondary recycling process, which is a combination of a typical conventional secondary recycling and Starlinger’s | | | | | | | | | | (a so-called “Super Clean”). With regard to the Super Clean process, we concluded that it would be equivalent to that described in PNC 244 (the subject of non-objection letter no. 86), which has demonstrated its capability to remove the concentrations of the surrogate contaminants from PCR PET to allow finished recycled containers to be used in contact with all types of foods under Conditions of Use E through G, as described in Table 2 on our website when the post-consumer feedstock consists of food or non-food PET containers. Thus, the proposed recycling process described in the June 25, 2007 submission would reduce the concentrations of each of these surrogates to levels that would result in a dietary concentration at or below 0.5 ppb, the level that FDA would equate to negligible risk for a contaminant migrating from food packaging. Therefore, we have concluded that Preformia’s secondary recycling process, as described in the June 25, 2007 submission, would produce PCR PET that is of a purity suitable for use in the manufacture of food-contact articles under 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 the PCR PET complies with 21 CFR 177.1630, and the feedstock consists of 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