No Objection Letter for Recycled Plastics #84
November 18, 2003
Ralph A. Simmons
Keller and Heckman, LLP.
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: Prenotification Consultation (PNC) 206
Dear Mr. Simmons
This letter is in response to your inquiry of May 14, 2003, requesting on behalf of your client, Plastic Technologies, Inc., our opinion regarding the capability of two secondary recycling processes used by Plastic Technologies, Inc. to produce post-consumer recycled (PCR) polyethylene terephthalate (PET) suitable for use in manufacturing food-contact articles for use with all types of food under conditions of use B through H when non-food PET containers are included in the feedstock. These two methods both involve | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |. of post-consumer PET. This request has been entered into our files as PNC 206 and is a follow up to your submission of March 11, 1997 with additional information provided on June 16, 1998 and February 26, 1999 (CTS 51519), and your submission of August 7, 2000 (CTS 71902).
As pointed out in your letter, the requested opinion would be an extension to two previously issued letters of no objection from the FDA. The first, dated August 10, 1999, was issued to Plastic Technologies, Inc. to produce PCR-PET for contact with dry (no surface fat or oil), aqueous, acidic, and low-alcoholic (= 15%) foods at room temperature and below when the PCR feedstock consists of food and nonfood-contact PET containers as a result of CTS 51519. The second, dated April 20, 2001, expanded the use of PCR-PET produced via these methods to include Conditions of Use B through H as described in Table 2 in 21 CFR 176.170, as a result of CTS 71902.
We have evaluated the original surrogate testing information in conjunction with the combined experimentally determined and modeled migration data submitted in your previous submissions with that provided in PNC 206. Based upon our review of these data, we have concluded that the two recycling processes put forth by Plastic Technologies, Inc. are capable of effectively removing contaminants from PET resin to levels safe for food contact use. This conclusion covers the use of PCR-PET with all food types under Conditions of Use B through H as described in Table 2 in CFR 176.170 when the feedstock consists 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 CTS 51519 and discussed in CTS 71902 and PNC 206. If Plastic Technologies, Inc.'s recycling process is modified, new data would need to be evaluated.
Although we have concluded that the recycling process described in the above submission will produce PCR-PET that is acceptable for the intended use, you should be aware that we are currently developing a formal policy on the use of post-consumer recycled plastics in contact with food. Thus, the decisions set forth in this letter may need to be modified due to future deliberations on this matter.
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