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U.S. Department of Health and Human Services

Food

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No Objection Letter for Recycled Plastics #123

July 27, 2009

 

 

Ed N. Novak
M&G Polymers USA, LLC
Polymers Technology Center
6951 Ridge Road
P.O. Box 590
Sharon Center, OH 44274

 

Re: Prenotification Consultation (PNC) 790

Dear Mr. Novak:

This letter is in response to your submissions, received on May 11, 2009, April 8, 2009 (PNC 790) and January 26, 2009 (PNC 773), requesting on behalf of M&G Polymers USA (M&G) an opinion letter from FDA confirming the capability of M&G’s secondary recycling process (referred to as “XXX” XXXXXXXX) to produce PET resin containing up to 15 wt-% of post-consumer recycled polyethylene terephthalate (PCR-PET) that is suitable for use in the manufacture of containers in contact with food under cold-fill and hot-fill conditions, i.e., under Conditions of Use C through G, as described in Table 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov.

We have reviewed M&G’s recycling process as well as the information obtained from surrogate testing and migration modeling which were submitted to demonstrate the capability of the M&G’s secondary recycling process to remove potential contaminants from PCR-PET. Based on our review of these data, we have determined that M&G’s secondary recycling process, as described in the subject submissions, 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 food and non-food PET containers (excluding industrial PET containers), and the resulting PCR-PET complies with the existing applicable authorizations. 

We have concluded that M&G’s secondary recycling process (referred to as “XXX” XXXXXXXX), as described in the subject submission, would produce PET resin containing up to 15 wt-% of post-consumer recycled polyethylene terephthalate (PCR-PET) that is suitable for use in the manufacture of containers in contact with food under cold-fill and hot-fill conditions, i.e., under Conditions of Use C through G, as described in Table 2, which can be accessed from the Internet in the Ingredients and Packaging section under the Food topic of www.fda.gov. If M&G’s 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 , HFS-275
Office of Food Additive Safety
Center for Food Safety
    and Applied Nutrition