No Objection Letter for Recycled Plastics #94
July 20, 2005
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Dear Mr. Misko:
This letter is in response to your inquiry of February 18, 2004, and additional information of January 12, 2005 requesting on behalf of your client, Sidel Inc., our opinion regarding the capability of their amorphous hydrogenated carbon coating to act as a functional barrier for contaminants that could potentially migrate from post-consumer recycled (PCR) polyethylene terephthalate (PET) in food-contact applications. The subject coating is currently the subject of Food Contact Notification (FCN) 00062 for use as an oxygen barrier coating on PET bottles. This coating would be applied at a minimum thickness of 0.065 microns to the internal surface of PET comprised of up to 50 % recycled content and is intended to contact all types of food under Conditions of Use C through G as defined in 21 CFR 176.170, Table 2. This request has been entered into our files as CTS 87480.
We have evaluated the surrogate contaminant and comparison migration data provided in CTS 87480. Based upon our review of this data we have concluded that Sidel Incorporated's amorphous hydrogenated carbon coating, as presented in FCN 62 and within the limitations of CTS 87480, is capable of acting as a functional barrier to reduce the migration of potential contaminants from resin consisting of up to 50 % post-consumer PET below FDA's threshold of regulatory concern. This conclusion covers the use of this coating as a functional barrier in contact with all food types under Conditions of Use C through G as described in Table 2 in 21 CFR 176.170 when applied at a minimum thickness of 0.065 microns. Please note that our conclusion applies only to PCR-PET feedstock which consists of food and/or non-food containers obtained from deposit and curbside recycling programs (i.e., this feedstock would not include industrial PET containers such as 55 gallon drums that had previously held chemicals).
Sidel Incorporated should inform the Agency of any modification in the FCS limitations/ specifications given in FCN 62 or of any alteration in the manufacturing process that would result in a change in the impurities or impurity level in the FCS. Such changes may require the submission of a new notification and new data may need to be evaluated to assess its ability to perform as a functional barrier.
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