Food

No Objection Letter for Recycled Plastics #90

Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles

See also Recycled Plastics in Food Packaging


September 9, 2004

Dr. Edward Kosior
Research and Development Manager
Visy Industries
13 Reo Cresent
Campbellfield, Victoria, 3061

AUSTRALIA

Re: Prenotification Consultation (PNC) 266

This letter is in response to your inquiry, dated October 22, 2003, requesting on behalf of Visy Industries, FDA's opinion regarding the suitability of their  | | | | | | | | | | | | | | | | | | | | | | | | | |.  extrusion process to produce post-consumer recycled (PCR) polyethylene terephthalate (PET) suitable for food-contact use with the inclusion of non-food PET containers in the feedstock. This PCR-PET would then be used to manufacture food-contact articles for use with all food types under conditions of use E through G as defined in Table 2 in 21 CFR 176.170(c) - room temperature and below - as well as for use with dry (no surface fat or oil), aqueous, acidic, and low-alcohol content foods under conditions of use C through G. In addition to your inquiry of October 22, FDA also requested additional information for its review, and this information (dated June 25, 2004) was received and incorporated into the submission. This request has been entered into our files as PNC 266.

As pointed out in your letter, this secondary recycling process was the subject of a previous no-objection letter (NOL), dated June 1, 2001, which was the result of CTS 69475. CTS 69475 consisted of data submitted by you on February 18, 2000 and February 8, 2001. The June 1, 2001 NOL covered the use of 2 different manufacturing processes, one involving the  | | | | | | | | | | | |.  decontamination of PET flake followed by  | | | | | | | | | | | |.  extrusion and the other a  | | | | | | | | | | | |.  extrusion process with  | | | | | | | | | | | | | | | |. . That NOL covered PCR-PET produced by Visy Industries for contact with dry (no surface fat or oil), aqueous, acidic, and low-alcohol content foods at room temperature or below (conditions of use E through G) when non-food PET containers are included in the feedstock.

We have evaluated the surrogate contaminant and migration data provided in PNC 266 as well as the relevant data from CTS 69475. Please note that, although information contained in CTS 69475 was used in the current evaluation, PNC 266 only contained information and analytical data for the  | | | | | | | | | | | |.  extrusion process and therefore the current NOL covers only the  | | | | | | | | | | | |.  process. In conjunction with this information, migration modeling was performed in order to evaluate the potential dietary concentration of contaminants from use conditions above room temperature.

Based upon our review of the submitted data and subsequent modeling, we have concluded that Visy Industries' recycling process as presented in PNC 266 (washing followed by  | | | | | | | | | | | | | | | | | | | | | | | |.  extrusion) is capable of reducing the contaminant level in recycled PET below FDA's threshold of regulatory concern. This conclusion covers the use of PCR-PET with all food types under Conditions of Use E through G as described in Table 2 in 21 CFR 176.170(c) as well as for use with dry (no surface fat or oil), aqueous, acidic, and low-alcohol content foods under conditions of use C through G. This includes feedstock consisting of food and/or non-food containers, provided the PCR-PET complies with 21 CFR 177.1630 and any other applicable regulations. Please note that our conclusion applies only to PCR-PET containers obtained from deposit and curbside recycling programs (i.e., feedstock would not include industrial PET containers such as 55 gallon drums that had previously held chemicals) and processed by the method described in PNC 266. If Visy Industries' 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,

Paul Honigfort, Ph.D.
Consumer Safety Officer,
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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