Food

No Objection Letter for Recycled Plastics #154

Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles

See also Recycled Plastics in Food Packaging


September 23, 2011

Frank Welle
Fraunhofer Institut
Verfahrenstechnik und Verpackung
Giggenhauser Str. 35
D-85354 Freising
GERMANY

Re: Prenotification Consultation (PNC) 1070

Dear Mr. Welle:

This letter is in response to your electronic submission, received on June 6, 2011 (PNC 1070), requesting on behalf of Diamat Maschinenbau GmbH (Diamat) (Dinkelsbühi, Germany) a no objection letter confirming the capability of the proposed secondary recycling process (a so-called "super clean" process) to produce post-consumer recycled polyethylene terephthalate (PCR-PET) sheets that are suitable for use at levels of up 100% recycled content in the manufacture of PET containers for contact with all food types under Conditions of Use C 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 proposed recycling process as well as the information obtained from surrogate testing and migration modeling which were submitted to demonstrate the capability of the proposed secondary recycling process in removing potential contaminants from PCR-PET. Based on our review of these data, we have determined that proposed secondary recycling process, as described in the subject submission, would be effective in reducing potential contaminants from PCR-PET to levels that result in dietary concentrations not to exceed 0.5 ppb, FDA's threshold of regulatory concern. This determination covers the use of PCR-PET derived from the feedstock that consists of post-consumer food and non-food PET containers (excluding chemical PET containers), and the PCR-PET complies with the existing applicable authorizations.

We have concluded that the proposed secondary recycling process, as described in the subject submission, would produce PCR-PET sheets that are suitable for use at levels of up 100% recycled content in the manufacture of articles for contact with all food types under Conditions of Use C 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-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 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

Page Last Updated: 07/03/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.