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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #160

June 5, 2012
 
 
Roland Franz, Ph.D.
Frank Welle. Ph.D.
Fraunhofer Institut
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
D-85354 Freising
GERMANY
 
Re: Prenotification Consultation (PNC) 1132
Dear Drs. Franz and Welle:  
 

This letter is in response to your submission, received on December 22, 2011 (PNC 1132), requesting on behalf of Starlinger & Co. GmbH (Starlinger) (Wien, Austria), a no objection letter confirming the capability of the proposed secondary recycling process (a so-called “Super Clean”) to produce postconsumer recycled high-density polyethylene (PCR-HDPE) that is suitable for use at levels of up to 50% recycled content in the manufacture of HDPE containers for contact with fresh milk or juices, meat trays, and similar products under Conditions of Use E through G, 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 the information you provided in the submission, including surrogate testing, which were submitted to demonstrate the capability of Starlinger’s secondary recycling process to remove potential contaminants from PCR-HDPE. Based on our review of these data, we have determined that Starlinger’s secondary recycling process, as described in the subject submission, will unlikely introduce any contaminants into food at levels that would result in a dietary concentration to exceed 0.5 ppb, the level that FDA would equate to negligible risk for a contaminant migrating from food packaging. This determination was based on use of up to 50% recycled content in the manufacture of HDPE containers for contact with fresh milk or juices, meat trays, and similar products, under Conditions of Use E through G, 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, provided the PCR HDPE comes from milk containers only.

We have concluded that the proposed secondary recycling process, as described in the subject submission, would produce PCR-HDPE material that is suitable for use at levels of up to 50% recycled content in the manufacture of articles for contact with fresh milk or juices, meat trays, and similar products under Conditions of Use E through G, 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. If the proposed recycling process is modified, new data may need to be evaluated. The resultant PCR-HDPE 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 PCRHDPE 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