No Objection Letter for Recycled Plastics #174
Return to inventory: Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles
See also Recycled Plastics in Food Packaging
December 20, 2013
Intertek Health, Environmental & Regulatory Services
1060 Holland Drive, suite G
Boca Raton, FL 33487
Re: Prenotification Consultation (PNC) 1344
Dear Mr. Mady:
This letter is in response to your submission (PNC 1344) on September 17, 2013 in reference to PNC 1303, requesting on behalf of Americas Styrenics (Am Sty) (Gales Ferry, TX) an opinion letter from FDA confirming the capability of Am Sty’s secondary recycling process to produce recycled polystyrene (PS) that is suitable for use at levels of up to 25% recycled content in the manufacture of articles in contact with all food types under the Conditions of Use C through H, as described in Tables 1 and 2, which can be accessed from the Internet in the Ingredients, Packaging & Labeling section under the Food topic of www.fda.gov.
The proposed Am sty’s recycling process involves incorporating PCR-PS with virgin PS during the polymerization of PS, and produces a homogeneous finished PS product. The incoming source material is strictly controlled and derived from cloth hangers, trays, supplied from retailers, excluding any curbside source material. The source is identified as post-consumer recycled polystyrene (PCR-PS), compliant with 21 CFR 177.1640 (polystyrene and rubber-modified polystyrene). The adjuvants present in PS and added to the process 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 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 the proposed recycling process, as described in the subject submissions, may produce recycled PS material that may be suitable for use at levels of up to 25% recycled content in the manufacture of articles for contact with all food types under the Conditions of Use C through H, provided that the finished PCR-PS complies with 21 CFR 177.1640 and additives added to the reaction step or present in the finished PCR-PS, must be already authorized, and used within the limits described in the applicable authorizations. Specifically, the additive mentioned in your submission as <1.3 ppm would be acceptable, only if it means not to exceed 0.2 ppm, the level per a TOR exemption. 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