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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #168

May 29, 2013
 
Catherine Nielsen
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001
Re: Prenotification Consultation (PNC) 1281
 
Dear Ms. Nielsen:
 
This letter is in response to your submission, received on May 2, 2013 (PNC 1281), requesting on behalf of DAK Americas LLC (DAK) an agency’s letter of no objection confirming the capability of the proposed tertiary recycling process (a so-called “glycolysis”) to produce post-industrial, and post-consumer recycled polyethylene terephthalate (PCR-PET) material that is suitable for use at levels of up to 100% recycled content in the manufacture of PET containers for contact with all food types under all Conditions of Use as prescribed in all applicable authorizations.
 
You provided for our review the description of the proposed recycling process that involves depolymerization of PCR-PET into oligomers (glycolysis), followed by repolymerization and purification of the oligomers, extrusion, and pelletization. Based on the information you provided, we determined that the proposed DAK process is tertiary recycling process, as described in our guidance.  Since our guidance indicates that tertiary recycling process is effective in cleaning PCR-PET for food contact, we no longer recommend the surrogate testing data be submitted for our review. Therefore, we have concluded that the subject tertiary recycling process as described in the submission may produce PCR-PET material that is suitable for use at levels of up to 100% recycled content in the manufacture of articles for contact with all food types under all Conditions of Use as prescribed in all applicable authorizations, provided that the PCR-PET complies with all applicable authorizations.  If the proposed recycling process is modified, new data may need to be evaluated.
 
The resultant PCR-PET 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 PCR-PET 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