No Objection Letter for Recycled Plastics #158
February 22, 2012
Dr. Naeem Mady
540 White Plains Road
Tarrytown, NY 10591
Re: Prenotification Consultation (PNC) 1115
Dear Dr. Mady:
This letter is in response to your submission, received on October 18, 2011 (PNC 1115), 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 disposable articles intended for use with alcoholic beverages at room temperature.
We have previously reviewed the same recycling process and issued a no objection letter dated May 11, 2010, which allowed the use of the recycled PS, derived from the clothes hangers collected from qualified retail stores in the U.S., as thermoformed or injection molded articles for contact with non-alcoholic foods under Conditions of Use B through H, provided that recycled PS complies with the existing applicable authorizations.
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 disposable articles intended for use with alcoholic beverages at room temperature, provided that recycled PS complies with the existing applicable authorizations. 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 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