No Objection Letter for Recycled Plastics #161
June 19, 2012
Dr. Naeem Mady
Intertek Expert Services
540 White Plains Road
PO Box 2005
Tarrytown, NY 10591
Re: Prenotification Consultation (PNC) 1133
Dear Dr. Mady:
This letter is in response to your submission, received on January 10, 2012 (PNC 1133), requesting on behalf of Total Petrochemicals USA (TP) a no objection letter from FDA confirming the capability of the proposed physical recycling process to produce recycled polystyrene (PS) material that is suitable for use in contact with food.
You described the proposed recycling process that mainly involves extrusion of feedstock derived from pre-consumer (post industrial) recycled PS polymer complying with 21 CFR 177.1640 (Polystyrene and rubber-modified polystyrene). You provided analytical data demonstrating that the recycled PS is comparable to virgin PS complying with CFR 177.1640. The sources of the recycled PS are controlled and collected from the same qualifies manufacturers in the U.S. You stated that the recycled PS will be blended with virgin, food grade PS 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.
We have reviewed the information you have provided and found that because of strict source control, there is little likelihood of unacceptable contaminant levels in your recycled PS. Based on our guidance, "Use of Recycled Plastics in Food Packaging: Chemistry Considerations", reprocessing of pre-consumer/post-industrial material is regarded as primary recycling. Therefore, the proposed recycling process as described in the submission is acceptable to produce recycled PS that is suitable for food contact under the Conditions of Use as defined in 21 CFR 177.1640 and other applicable authorizations.
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