No Objection Letter for Recycled Plastics #135
May 11, 2010
Dr. Naeem Mady
Ciba Specialty Chemical Corporation
540 White Plains Road
PO Box 2005
Tarrytown, NY 10591
Re: Prenotification Consultation (PNC) 890
Dear Dr. Mady:
This letter is in response to your submission, received on February 17, 2010 (PNC 890) and amended on March 13, 2010, requesting on behalf of Nextlife Enterprises, LLC (NLE) an opinion letter from FDA confirming the capability of NLE’s secondary recycling process to produce recycled polystyrene (PS) that is suitable for use at levels up to 100% recycled content in the manufacture of thermoformed or injection molded articles intended to contact with non-alcoholic foods under Conditions of Use B through H, as described in Tables 1 and 2, which can be accessed from the Internet in the Food Ingredients and Packaging section under the Food topic of www.fda.gov.
The information you have provided describes the proposed recycling process, which involves the collection, sorting, washing, drying, and extruding procedures for post-consumer PS. The recycled PS would be produced from cloth hangers collected from qualified retail stores in the U.S. You stated that the cloth hangers are made of food grade PS complaint with 21 CFR 177.1640 (Polystyrene and rubber-modified polystyrene) and the adjuvants added to the PS are in compliance with 21 CFR 178.2010 (Antioxidants and/or stabilizers for polymers). You stated that the recycled PS will be blended with virgin, food grade PS or used "as is" to produce a finished food contact article. The finished article may be laminated with a barrier film on one or both surfaces. The food contact layer will be comprised of virgin, food-grade PS and may or may not contain the recycled PS. The recycled PS will not be used in food contact film applications.
We have reviewed the information you have provided, above, and found that because of strict source control, there is little likelihood of unacceptable contaminant levels in your recycled PS. Therefore, we have determined that NLE’s secondary recycling process, as described in the subject submission, would produce recycled PS material that would be suitable for use at levels up to 100% recycled content in the manufacture of articles for contact with non-alcoholic foods under Conditions of Use B through H, as described in Tables 1 and 2, which can be accessed from the Internet in the Food Ingredients and Packaging section under the Food topic of www.fda.gov. If NLE’s recycling process is modified, new data may need to be evaluated.
While the agency encourages the use of tight source control in the collection of products for recycling into food-contact articles, it remains the responsibility of the manufacturer to ensure that the final plastic article is free of possible chemical and microbiological contaminants. Furthermore, if any adjuvants are used in the blending of virgin and recycled resin to form the food-contact articles, those adjuvants and their levels must be appropriately regulated for the proposed use. The use of unregulated adjuvants or the use of regulated adjuvants at levels higher than are currently authorized would require further review by FDA.
Please note that the resultant recycled PS 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 PS material 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.
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