Food

No Objection Letter for Recycled Plastics #121

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

See also Recycled Plastics in Food Packaging


May 19, 2009

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

Re: Prenotification Consultation (PNC) 778

Dear Dr. Welle:

This letter is in response to your electronic submissions, received on February 17, 2009 (PNC 778) and November 12, 2008 (PNC 750), requesting on behalf of Equipolymers GmbH (Equipolymers) an opinion letter from FDA confirming the capability of Equipolymers’ secondary recycling process (a so-called “super clean” process) to produce post-consumer recycled polyethylene terephthalate (PCR-PET) pellets that are suitable for use at levels up to 100% recycled content in the manufacture of PET containers in contact with all food types under cold-fill and hot-fill conditions, i.e., under Conditions of Use C through G, as described in Tables 1 and 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov.

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We have reviewed Equipolymers’ recycling process as well as the information obtained from surrogate testing and migration modeling which were submitted to demonstrate the capability of the Equipolymers’ secondary recycling process to remove potential contaminants from PCR PET. Based on our review of these data, we have determined that Equipolymers’secondary recycling process, as described in the subject submissions, would be effective in reducing potential contaminants from the feedstock, consisting of food and non-food PET containers, to levels that result in dietary concentrations below 0.5 ppb, FDA's threshold of regulatory concern. This determination covers the use of PCR PET derived from the feedstock that consists of food and non-food PET containers (excluding industrial PET containers), and the PCR PET complies with the existing applicable authorizations.

We have concluded that Equipolymers’secondary recycling process, as described in the subject submissions, would produce PCR PET pellets that are suitable for use at levels up to 100% recycled content in the manufacture of articles to contact all food types under cold-fill and hot-fill conditions, i.e., under Conditions of Use C through G, as described in Tables 1 and 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov. If Equipolymers’ 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 PET should not impart odor or taste to food rendering it unfit for human consumption.

If you have any further 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

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