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The EU Updates the Harmonized standards under entry 27 (nickel) of Annex XVII to REACH regulation Release Time:2023-12-29

On December 20, 2023, the European Union issued the Notices C/2023/1604 in its Official

Journal (OJ) , updated the list of harmonised standards for entry 27 (nickel) of annex XVII to REACH regulation. The updated harmonized standard is mainly EN 1811:2023, the previous version EN 1811:2011 + A1:2015 was withdrawn.

The new list of the harmonized standards is as follows:


Supersede Standard

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

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

EN 16128:2015

Ophthalmic optics–Reference method for the testing of spectacle frames and sunglasses for nickel release

EN 16128:2011




Clause 3

Terms and definitions updated, terms surface finish and disassemble were added.

Clause 5.5

Permission of ready to use solutions of sodium hydroxide pellets in reagents added.

Clause 5.6

Permission of ready to use solutions of hydrochloric acid in reagents added.

Clause 8.2

Added the following content:

) Due to the structure of the article, rinsing with a small volume of test solution can be necessary inorder to collect all the release solution;

2) To avoid damage to the analytical spectrometer or blocking of the instrument's capillary, a syringe filter of appropriate membrane size should be used to remove particulates from the release solution prior to analysis.

Clause 9.1

Unit for nickel release changed toμg·cm -2·week -1.

 (expressed asμg/cm 2 /week in the Regulation)


Added the following content:

When more than one sample of the same article is tested, the nickel release of each sample has to be compliant with its migration limit in order for the article to be permitted to be placed on the market.


Migration limit of 0.5μg·cm -2·week -1:

The conformity determination limit for nickel release results was revised from < 0.88µg·cm-2·week-1 to ≤0.88µg·cm-2·week-1.

Clause 10

Added the following content:

If requested, the following information shall be included in the test report:

1) sample area used for the calculation expressed in square centimetres and information on the areas that have been excluded;

2) the volume of test solution used;

3) the limit of quantification.

Annex B

Requirements for Quality control material deleted.

Annex B.3

Added the following content:

When uncertainty exists about the presence of nickel in the outer coating, both test methods should be applied (EN 1811 without and with EN 12472).

Annex B.4

Added the procedures for homogeneous and inhomogeneous articles.

Annex B.4.2.6

Flowchart for sample preparation and testing procedure for complete watches added.



The Of icial Journal of the European Union:


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