No Objection Letter for Recycled Plastics #173
November 21, 2013
Intertek Health, Environmental & Regulatory Services
1060 Holland Drive, suite G
Boca Raton, FL 33487
Re: Prenotification Consultation (PNC) 1347
Dear Mr. Mady:
This letter is in response to your submission, received on September 13, 2013 (PNC 1347), requesting on behalf of Wellmark an opinion letter from FDA confirming the capability of Wallmark's secondary recycling process to produce recycled polystyrene (PS) that is suitable for use at levels of up to 100% recycled content in the manufacture of articles in contact with all food types under the conditions of use as described in all applicable authorizations.
The information you submitted describes the proposed recycling process, which involves collection, granulating, sorting, washing, drying and color sorting. The recycled PS is produced from hangers, trays or fibers collected from nationwide retailers, excluding any curbside source material. You stated that the collected materials are made of food grade PS complaint with 21 CFR 177.1640 (polystyrenes and rubber-modified polystyrene) and the adjuvants present in PS are already authorized and in compliance. You also submitted analytical data to demonstrate that the recycled PS meets the specifications and limitations as described in 21 CFR 177.1640.
We have reviewed the information you have submitted, 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 Wellmark's secondary recycling process, as described in the subject submission, may produce recycled PS material that may be suitable for use at levels of up to 100% recycled content in the manufacture of articles for contact with all food types under the conditions of use as described in all applicable authorizations. If the subject 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 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