In February 2023, the European Committee for Standardization (CEN) introduced a revised edition of the reference test method for nickel release, referred to as EN 1811:2023. This updated version replaced the previous edition EN 1811:2011+A1:2015, as mentioned in Insight Vol. 1347.
On 20 December 2023, the European Union (EU) published the official Journal C/2023/1604, officially adopting the EN 1811:2023 as the harmonized standard for nickel release testing. This adoption applies to entry 27 of Annex XVII to REACH Regulation (EC) No.1907/2006.
With immediate effect, the following updated standards shall be used to demonstrate the product is compliance with entry 27 of Annex XVII to REACH regulation (EC) No.1907/2006.
Harmonised Standards for EU REACH Annex XVII Entry 27 Nickel Release |
EN 1811:2023 Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin. |
EN 12472:2020 Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items |
EN 16128:2015 Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release |