No Objection Letter for Recycled Plastics #124
August 20, 2009
George G. Misko
Keller and Heckman LLP
1001 G Street, NW
Suite 500 West
Washington, DC 20001
Re: Prenotification Consultation (PNC) 792
Dear Mr. Misko:
This letter is in response to your submission of April 14, 2009 (PNC 792), requesting on behalf of Plastic Technologies, Inc. (PTI) an opinion letter from the FDA regarding the capability of Phoenix’s recycled polyethylene terephthalate (RPET) cleaning process (referred to as XXXXX XXXXX XXXXXXX XXXXX) in producing RPET that is of a purity suitable for use at levels up to 100% recycled content in the manufacture of containers for contact with all food types under Conditions of Use A through H and J, as described in Table 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov.
We have reviewed the information on the thermal process used in the PTI’s cleaning process to decontaminate the RPET. The process parameters would be determined by using a computer model (XXXXX) that is developed based on diffusion and other processes. The thermal process will be variable and depends on the process parameters, including the PET particle size and geometry, and the temperature and time required to ensure the suitable purity of the RPET for use in the manufacture of food contact articles. We reviewed the information obtained from surrogate testing and migration modeling, which were submitted to validate the capability of the computer model in determining the cleaning conditions. Based on our review of these data, we have determined that the XXXXXX XXXXXX XXXXXX as described in the submission, would be capable of determining the time and temperature conditions to decontaminate RPET (XXX XXXXXXXXXX) and limit the migration levels in food to a dietary concentration of ≤ 0.5 ppb, the level FDA would generally consider to be of negligible risk for a contaminant migrating from food packaging.
We have concluded that PTI’s secondary recycling process, as described in the subject submission, can produce RPET that is of a purity suitable for use at levels up to 100% recycled content in the manufacture of food contact articles in contact with all food types under conditions of use A-H and J, provided that the post-consumer feedstock consists of food or non-food PET containers, excluding industrial containers. If PTI’s recycling process is modified, new data may need to be evaluated.
The resultant RPET material must comply with all applicable authorizations including 21 CFR § 174.5 General provisions applicable to indirect food additives. For example, in accordance with section 402(a)(3) of the Federal Food, Drug and Cosmetic Act, use of the recycled PET should not impart odor or taste to food rendering it unfit for human consumption.
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