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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #75

January 28, 2003

George Misko
Keller and Heckman LLP
1001 G. Street, N.W.
Suite 500 West
Washington, DC 20001
 

Dear Mr. Misko:

This responds to your inquiry of December 5, 2001, requesting an opinion on the suitability, for use in food-contact applications, of polyethylene terephthlate (PET) that has been produced by Wellman Incorporated's recycling process which includes their  | | | | | | | | | | | | | | | | | | | || | | . . Wellman recycling process will use  | | | | | | | | | | | | | | | | | | | || | | . . Specifically, the post consumer recycled PET (PCR-PET) will be manufactured from post consumer material collected from either curbside collection or bottle deposit recycling programs, which will subsequently be processed using  | | | | | | | | | | | | | | | | | | | || | | . . As pointed out in your letter, FDA previously issued a letter of no objection dated May 2, 1996 for this same recycling process to produce PCR PET for use in contact with aqueous, dry and acidic food under Condition of Use C (hot filled or pasteurized above 150o F) or less severe conditions and fatty and alcoholic food under Condition of Use D (hot filled or pasteurized below 150o F) or less severe conditions, provided the recycled PET complies with 21 CFR 177.1630 and the feedstock consists exclusively of food-contact containers collected through a bottle deposit system.

We have completed our review and have concluded that the dietary concentrations of possible contaminants in the PCR PET resulting from Wellman Incorporated's recycling process would be at or below the threshold of regulation (i.e., at or below 0.5 ppb). Therefore, we have concluded that Wellman's recycling process, as described in your submission of December 5, 2001, will produce PCR-PET of a suitable purity for the intended use. Therefore, we have concluded that the intended use of your PCR PET in contact with aqueous, dry and acidic food under Condition of Use C (hot filled or pasteurized above 150o F) or less severe conditions, and fatty and alcoholic food under Condition of Use D (hot filled or pasteurized below 150o F) or less severe conditions, is acceptable provided that the PCR-PET is collected from either a curbside collection system or a bottle deposit collection system and is sorted and processed in the manner described in your submission of December 5, 2001, and complies with 21 CFR 177.1630 and other applicable regulations.

Although we have concluded that the intended use of PCR-PET that has been collected, sorted and processed in the manner described in your submission is acceptable, you should be aware that we are currently developing a formal policy on the use of post-consumer recycled plastics in contact with food. Thus, the decisions set forth in this letter may need to be modified due to future deliberations on this matter.

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

 

Sincerely yours,

Julius Smith
Consumer Safety Officer,
Division of Food Contact Substance Notification Review, HFS-275
Center for Food Safety and Applied Nutrition