Written by: Dr. Huqiu Zhang, Senior Scientist at Sevee & Maher Engineers, Inc.
Global Food Contact Regulation Updates - Q3 2020
It feels like Covid 19 pandemic has been slowing everything down since earlier this year, but nothing seems impacting the urge to phase out the use of per- and polyfluoroalkyl substances (PFASs) in paper food packaging and food containers. On July 31, 2020, the US FDA announced that four manufacturers of the effective Food Contact Notifications (FCNs), related to short-chain PFASs that contain 6:2 fluorotelomer alcohol (6:2 FTOH), have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the United States in the next three years . This marks the most recent major action from government agencies in this area.
By way of background information, PFASs are used for grease-proofing in paper and paperboard for food packaging. For example, PFASs are used as additives in some paper based fast-food wrappers, restaurant containers, to-go boxes, and pizza boxes, etc. PFASs are persistent chemicals in the environment, also known as “forever chemicals”. Some relatively long chain of PFASs, e.g. eight carbon chain perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), are persistent pullulans and detected in human and wildlife. They are the two most studied PFAS chemicals. Scientific evidences show that PFOA and PFOS can cause reproductive and developmental, liver and kidney, and immunological effects in laboratory animals. Both chemicals have caused tumours in lab animals.
In 2006, the EU Commission published Directive 2006/122/ECOF, restricted market and use of PFOS for new products in the non-food area. This Directive also stated that on-going risk assessment activities for PFOA should be kept under review. In 2009, PFOS was added to REACH Annex XVII, the restricted substance list, through Regulation (EC) No 552/2009 amending REACH Regulation (EC) No 1907/2006. In 2017, PFOA was added to REACH Annex XVII through Regulation (EU) 2017/1000.
As food contact paper is not regulated at European Union level, industries rely on German BfR XXXVI for the Positive Listing of additives used in food contact paper materials and products. In 2003, BfR removed PFOS and related substances from the Positive List of BfR XXXVI, Paper and Board for Food Contact. In 2016, BfR removed PFOA and related substances from BfR XXXVI.
In early 2016, the US FDA removed three long chain PFASs, as oil and water repellents for use in food contact paper, from 21 CFR 176.170 through Federal Register 81 FR 5. Later the same year, FDA removed two more PFOS additives from 21CFR 176.170 through Federal Register 81 FR 83672.
Although no direct toxicity studies show all PFASs have the same adverse effects as PFOS and PFOA, evidences suggest PFASs may cause serious health conditions . EU Commission has initiated plans to tackle PFASs under chemicals management strategy, REACH Regulation.
The most regulatory activities in the US on restrictions and banning the uses of PFASs in paper food packaging are within the states. Among them, Washington state is leading the effort to conduct Alternative Assessment for materials that provide the same technical functionalities, i.e. grease resistance and leak proof, and can replace PFASs. Due to the technical challenge, there is no direct drop-in replacement of PFAS chemicals at wet end chemistry in manufacturing. Most of the potential replacement identified are related to coating or lamination of plastic films, such as PE, PET, PLA, PVOH, etc.
As the states regulatory developments progressing, we expect to see more activities in these industries.
To learn more about Dr. Huqiu Zhang you may visit her contributor page here.