No Objection Letter for Recycled Plastics #169
September 20, 2013
Martha E. Marrapese
Keller & Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: Prenotification Consultation (PNC) 1317
Dear Ms. Marrapese:
This letter is in response to your submission, received on July 18, 2013 (PNC 1317), requesting on behalf of KW Plastics (KW) a no objection letter from FDA confirming the capability of the proposed physical recycling process to produce post-consumer recycled polypropylene (PCR-PP) material (containing up to 30% post-consumer recycled low density polyethylene, PCR-LDPE) that is suitable for use at levels of up to 100% recycled content in the manufacture of reusable crates or pallets for holding relatively large quantities of fresh, unwrapped produce and shelled eggs under room temperature and below, i.e. Conditions of Use E-G, as described in Table 2, which can be accessed from the Internet in the Ingredients, Packaging & Labeling section under the Food topic of www.fda.gov.
You described the proposed physical recycling process that mainly involves a series of shredding, sink-float, washing, and drying of the mixed PP/LDPE feedstock. No additives are used during the KW's recycling process. KW employs strict source control over the feedstock to ensure that it consists only of food grade PP and LDPE that comply with 21 CFR 177.1520 (olefin polymers) and contain adjuvants complying with applicable authorizations
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 PP/LDPE blend. Therefore, the proposed recycling process as described in the submission is acceptable to produce recycled PP/LDPE blends that are suitable for use at levels of up to 100% recycled content in the manufacture of reusable crates or pallets for holding relatively large quantities of fresh, unwrapped produce and shelled eggs under room temperature and below (i.e. Conditions of Use E-G).
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 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 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