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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #0010

March 10, 1992

 

Mr. Alex Malaspina
Senior Vice President
The Coca-Cola Company
P.O. Drawer 1734
Atlanta, Georgia 30301

 

Dear Mr. Malaspina:

This responds to our meeting with Dr. Bayer and Ms. Martin on February 4, and your submission of February 7, 1992, concerning the use of by-product ethylene glycol in the manufacture of polyethylene terephthalate (PET) resin intended for food-contact use. You stated that the ethylene glycol is reclaimed by the XXXXX XXXX as a by-product from their manufacturing process for virgin PET, and that the virgin PET, catalysts, and adjuvants are currently regulated by FDA for food-contact use. You further stated that XXXX by-product ethylene glycol is purified by the XX XX XXXXX XX XXXXXX XXXXX using a XXXXX XXXXX procedure.

We have reviewed the data that you have provided demonstrating that the purity of XXXXX XXXXX ethylene glycol for use in the manufacturing of PET bottle resin. Specifically, you have provided the analytical data, including gas chromatographic data, demonstrating that XXXXX XXXXX ethylene glycol is of a suitable purity for use in the manufacture of PET resins intended to contact food. Your data indicate that there is virtually no difference between PET resins manufactured with a mixture of XX percent virgin ethylene glycol and XX percent XXXXX by-product ethylene glycol, as compared with PET resins manufactured with 100 percent virgin ethylene glycol. Furthermore, you have noted that PET manufactured with a mixture of XX percent virgin ethylene glycol and XX percent XXXXXXX by-product ethylene glycol meets the specifications in § 177.1630 (f) of Title 21 Code of Federal Regulations (21 CFR 177.1630(f)).

Based on our review of these data, we believe that ethylene glycol reclaimed as a by-product from XXXX manufacturing process for PET and re-purified by the XXXXXX process, is of a suitable purity for reuse in the production of PET resin intended for food-contact use, in accordance with 21 CFR 174.5. In addition, because ethylene glycol reclaimed by is a by-product from the manufacture of PET resin regulated for food-contact use and the resin is in fact a pre-consumer material, post-consumer contamination and abuse are not issues. Further, the purity data supplied in your submission indicate that the very low levels of contamination detected result from materials currently regulated in § 177.1630. Therefore, we do not object to the use of XXXXX by-product ethylene glycol that has been purified by the XXXXX process as a component in the manufacturing of PET packaging for food contact, provided that its use in making such articles is in compliance with 21 CFR 177.1630.

We emphasize that the data you submitted, and the opinion set forth in this letter, address only the use of ethylene glycol obtained as a by-product from the XX manufacturing process for PET intended for food-contact use which has been purified by XXXXXXXXXXXXXXXXXXXXXXXXXX procedure. Thus, this opinion does not authorize or approve the reuse of ethylene glycol obtained as a by-product from and purified by other processes.

We trust this letter responds fully to your request on this matter. If you have any further questions, please do not hesitate to contact our Indirect Additives Branch at 202-254-9541.

 

Sincerely yours,

 

Alan M. Rulis, Ph. D.
Director
Division of Food and Color Additives
Center for Food Safety
and Applied Nutrition