Food

No Objection Letter for Recycled Plastics #118

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

See also Recycled Plastics in Food Packaging


November 21, 2008

Jeffrey A. Keithline
Keller and Heckman LLP
1001 G Street, NW
Suite 500 West
Washington, DC 20001

Re: Prenotification Consultation (PNC) 712

Dear Mr. Keithline:

This is in response to your submission (PNC 712), received on July 23, 2008 and amended on September 19, 2008 (following PNC 682 received on April 2, 2008), requesting on behalf of ECO2 Plastics an FDA opinion letter confirming the capability of ECO2 Plastics’ secondary recycling process to produce post-consumer recycled polyethylene terephthalate (RPET) suitable for use at levels up to 100% recycled content in the manufacture of articles to contact all food types, under Conditions of Use A (i.e., ready-prepared foods to be reheated in container at time of use) through H (i.e., frozen and refrigerated storage; ready-prepared foods intended to be reheated in container at time of use) and J (i.e., cooking at temperatures exceeding 121°C such as baking and browning) as described in Table 2, which can be accessed from the Internet in the Food Ingredients and Packaging section under the Food topic of www.fda.gov.

We have reviewed ECO2’s recycling process as well as the information obtained from surrogate testing, and migration modeling, which were submitted to demonstrate the capability of the ECO2’s secondary recycling process to remove potential contaminants from RPET. Based on our review of the data submitted we have determined that ECO2’s secondary recycling process, as described in the April 2, 2008 and July 23, 2008 submissions, would be effective in reducing potential contaminants in RPET to the levels that result in a dietary concentration (DC) below 0.5 ppb, FDA's threshold of regulatory concern. This determination covers the use of RPET derived from the feedstock that consists of food and non-food PET containers (excluding industrial PET containers), provided that the RPET complies with the existing applicable authorizations.

We have concluded that ECO2’s secondary recycling process, as described in the subject submissions, would produce RPET that is of a purity suitable for use up to 100% recycled content in the manufacture of articles in contact with all food types, under Conditions of Use A (i.e., ready-prepared foods to be reheated in container at time of use) through H (i.e., frozen and refrigerated storage; ready-prepared foods intended to be reheated in container at time of use) and J (i.e., cooking at temperatures exceeding 121°C such as baking and browning) as described in Table 2, which can be accessed from the Internet in the Food Ingredients and Packaging section under the Food topic of www.fda.gov.

We wish to point out that our review of the proposed recycling process toward a favorable opinion letter does not relieve use of the resultant RPET material from compliance with any other provision of the Federal Food, Drug, and Cosmetic Act or with 21 CFR § 174.5 General provisions applicable to indirect food additives. For example, in accordance with section 402(a)(3) of the Act, use of the recycled PET should not impart odor or taste to food rendering it unfit for human consumption.  | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |. If ECO2’s recycling process is modified, new data may be needed to be evaluated.

If you have any further questions concerning this matter, please do not hesitate to contact us.

Sincerely,

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