FDA announces voluntary phase-out of certain PFAS in food packaging
The announcement follows an FDA post-market scientific review and analysis of data from rodent studies finding biopersistence of 6:2 FTOH, which is found in some food-contact packaging.
The US Food and Drug Administration (FDA) has announced the voluntary phase-out of a certain type of short-chain per- and poly-fluoroalkyl substances (PFAS) that contain 6:2 fluorotelomer alcohol (6:2 FTOH), which may be found in certain food contact substances used as grease-proofing agents on paper and paperboard food packaging.
While the announcement follows the findings of biopersistence of 6:2 FTOH in rodents, the data is said to point to the potential that 6:2 FTOH may also persist in humans following dietary exposure.
FDA noted that further scientific studies are needed to better understand the potential human health risks from dietary exposure resulting from authorised food contact substances for short-chain PFAS that contain 6:2 FTOH. Therefore, this phased market removal aims to balance uncertainty about the potential for public health risks while minimising potential market disruptions during the COVID-19 public health emergency.
Three manufacturers have agreed to a three-year phase-out of their sales of compounds that contain 6:2 FTOH for use as food contact substances in the US marketplace, beginning in 2021. After the three-year period, it is anticipated that it may take up to 18 months to exhaust existing stocks of products containing these food contact substances from the market. A fourth manufacturer informed the FDA in 2019 that they had already stopped sales of their food contact substances that may contain 6:2 FTOH for use in the US market.
Manufacturers of these short-chain grease-proofing agents obtained authorisation for the use of these substances in food contact paper packaging applications through the FDA’s Food Contact Notification (FCN) process. This pre-market scientific review set out to ensure food contact materials that contain or are made of food contact substances are safe for their intended use, based on the scientific data that is available at the time of submission.
There are 15 Food Contact Notifications held by the four manufacturers that contain 6:2 FTOH. These compounds are replacements for the long-chain PFAS that are no longer in use in food contact applications through voluntary agreements with manufacturers in 2011 and through FDA regulatory action. At the time, the FCNs for short-chain PFAS became effective, the available scientific data showed they were a safe alternative to the long-chain PFAS and did not indicate any potential for biopersistence.
The commitments made by the manufacturers that hold FCNs that contain 6:2 FTOH is noted on FDA’s Inventory of Effective Food Contact Substance (FCS) Notifications. This inventory is the main mechanism by which the FDA informs both the public and industry of substances authorised through the FCN programme. The FDA has stated that it will monitor the progress of the phase-out of the FCNs using annual updates provided by the three manufacturers. Additionally, the packaging manufacturers have agreed to supply FDA samples of each of the authorised food contact substances in case future analysis is needed.