On October 22, 2025, the European Committee for Standardization (CEN) issued EN 16128:2025 "Ophthalmic Optics – Reference Method for Nickel Release from Optical Glasses and Sunglasses Frames," replacing the previous version EN 16128:2015.
Standard EN 16128:2025 will be designated as a mandatory standard for EU member states no later than the end of April 2026, and conflicting national standards will be replaced simultaneously by that date. It is expected to be approved by the European Commission and, upon publication in the Official Journal of the European Union, will become the harmonized standard for nickel release (applicable to metal components of optical and sunglass products) under Article 27 of Annex XVII (List of Substances Subject to Restrictions) of the EU REACH Regulation. The new 2025 version of the EN 16128 method features a more rigorous process, explicitly stating that coating testing is not a screening test and emphasizing that if a sample fails the coating test, all components of the sample must undergo migration testing. The operational guidelines are clearer, specifying that lenses must be installed in frames background On December 20, 2023, the European Commission released the official bulletin C/2023/1604, updating the versions of the three coordinated testing standards under nickel release control in Article 27 of Annex XVII of the REACH Regulation.