Dec. 7, 2023 — The Vision Council (TVC)’s government and regulatory affairs team has released a statement regarding recent updates to regulations on per- and polyfluoroalkyl substances (PFAS) reporting by the Environmental Protection Agency.
Known as “forever chemicals,” PFAS are thousands of synthetic chemicals that, for years, have been used in a wide variety of industrial and consumer products. They are used in the manufacturing of other chemicals that are then used in other products.
TVC shares that since TVC members manufacture or import finished articles and not bulk chemicals, this alert focuses mainly on the regulations regarding articles containing PFAS.
The PFAS reporting regulations are required under the Toxic Substances Control Act, so medical devices regulated by the U.S. Food and Drug Administration are exempt from the updated reporting requirements.
The reporting requirement is a one-time submission covering the period of Jan. 1, 2011, through Nov. 13, 2023. Therefore, manufacturers and importers of optical products that contain PFAS and are not regulated by the FDA as medical devices must report the required information for those products from 2011 onward.
TVC offers more information here.