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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #162

December 10, 2012

Catherine R. Nielsen
Keller and Heckman LLP
1001 G Street, N.W.
Ste. 500 West
Washington, DC 20001

Re: Prenotification Consultation (PNC) 1232

Dear Ms. Nielsen:

This is in response to your submission, received on November 7, 2012 (PNC 1232), on behalf of Selenis Canada, Inc. (Selenis), requesting an agency's non-objection letter (NOL) to confirm the capability of the tertiary recycling process (so-called "glycolysis") in cleaning post-industrial (PI) and post-consumer recycled polyethylene terephthalate (PCR-PET) for use in the manufacture of food-contact articles with all food types under the conditions of use for which the PET is permitted.

Based on the description of the glycolysis you submitted for our review, we have determined that your process is similar to the glycolysis we have previously reviewed and found to be effective in cleaning and producing recycled PET of a purity suitable for food contact. Therefore, we conclude that your glycolysis as described in this submission would be effective in cleaning and producing the recycled PET of a purity suitable for food contact, provided that the resultant recycled PET complies with all existing authorizations. The resultant recycled PET may be used in contact with all food types under the Conditions of Use as governed by the most restrictive component, either PET or adjuvant, if any.

The resultant recycled PET 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 material should not impart odor or taste to food rendering it unfit for human consumption.

If you have any 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