EU REACH – Commission Updates EN 1811:2023 as Harmonised Method

Vol 1389 | 15 Jan 2024

In Feb 2023, the CEN (European Committee for Standardization) released new version of the reference test method for nickel release, known as EN 1811:2023, which superseded the previous version EN 1811:2011+A1:2015 (Refer to Insight Vol. 1347).

On 20 Dec 2023, the EU Commission 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.

European Standardisation Organisation	Reference and title of the Standard	Reference of Superseded Standard
CEN	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 1811:2011+A1: 2015
CEN	EN 12472:2020 Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items	EN 12472:2005+A1:2009
CEN	EN 16128:2015 Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release	EN 16128:2011

Access the update via the following link https://eur-lex.europa.eu/eli/C/2023/1604/oj

If you have further questions, please contact Dr. Kathy Leung (Kathy.Leung@intertek.com) or Dr. Ben Cheng (Ben.PS.Cheng@intertek.com)