No Objection Letter for Recycled Plastics #91
December 29, 2004
Mr. Robin Tuckerman
Business Development Manager
47 Dallas Drive
Broadmeadows, Victoria, 3047
Dear Mr. Tuckerman:
This letter is in response to your inquiry, dated September 20, 2004, and additional information, dated November 30, 2004, requesting on behalf of SIGNUM, FDA's opinion regarding the suitability of their secondary recycling process to produce post-consumer recycled (PCR) polyethylene terephthalate (PET) suitable for use as the nonfood-contact inner layer of multilayered packaging in which the outer layers will be virgin PET at least 1.0 mil thick. The finished trilayered packaging would be used in contact with all food types at room temperature (120 oF) or below. This request has been entered into our files as CTS 89722.
As pointed out in your letter, this secondary recycling process was the subject of a previous no-objection letter (NOL), dated June 26, 2002, which was the result of CTS 80180. CTS 80180 consisted of data submitted by you on April 17, 2002 and further e-mails dated May 28, 2002 which outlined the source separation and washing procedure of SIGNUM's PET flake supplier as well as SIGNUM's secondary recycling process. The June 26, 2002, NOL covered SIGNUM's use of | | | | | | | | | | | | | |. obtained from a secondary supplier which provided a feedstock solely from previously used food containers. In CTS 89722 SIGNUM has changed their feedstock supplier which provides them with PCR-PET | | | | | | | | | | |. instead of | | | | | | | | | | | | | | | | |. and has asked FDA to re-review their recycling procedure incorporating their new | | | | | | |. supplier's process in the review.
We have previously concluded that a 1 mil thick virgin PET food-contact layer is a suitable functional barrier for a PCR PET core layer when used in food-contact applications at room temperature or below without restrictions on food types or storage times, if the post-consumer PET is from food containers and has undergone physical processing. We have no reason, at this time, to change this opinion. Therefore, we have concluded that the intended use of your PCR PET, as the inner nonfood-contact layer of laminated food packaging destined for use at room temperature or below without restrictions as to food type or storage times, is acceptable providing that the PCR PET is collected, sorted and processed in the manner described in your submission of April 20, 2004, and May 28, 2002, and the recycled PET is separated from food by a layer of virgin PET that complies with 21 CFR 177.1630 and is at least 1.0 mil thick.
Please note that our conclusion applies only to PCR-PET obtained from food container feedstock only, processed by the method described in CTS 89722, and would not apply to non-food contact PET containers obtained from curbside recycling programs. If SIGNUM's 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.
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