REACH: Harmonised Nickel release test methods officially published

The Official Journal of the EU has published a harmonised version of the test methods to determine the amount of Nickel migration from metal parts in direct and prolonged contact with the human skin. The standards EN 1811:2011, EN 12472:2005 and EN 16128:2011 will become the official reference methods to determine the compliance of products with entry 27 of the REACH regulation. The prior versions of the standards will still be applicable until 31 March 2013.

Background
In 2011 standards EN 1811:2011 and EN 16128:2011 were published to replace the standard EN 1811:1998 + A1:2008. EN 1811 is a test method to determine the release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles coming into direct and prolonged skin contact. Spectacle frames and sunglasses are now covered by standard EN 16128:2011 instead of EN 1811:2011. Nickel release is regulated under EC 1907/2006 REACH Annex XVII, Item 27 with the following limits:

The main difference between old and new standards is a change in the calculation of results. The old standard applies a factor of 0.1 to the actual test result to take into account measurement uncertainties. The new standards however have no such factor but instead define a certain level of uncertainty were no conclusion of compliance can be made. This results in a lowered actual limit as shown in the table below:

On 22 May 2012 the Official Journal of the European Union published harmonised versions of both Standards EN 1811:2011 and EN 16128:2011. Due to this, these standards take over from the superseded standard EN 1811:1998 + A1:2008 for demonstrating conformity with the restrictions given in entry 27 of Annex XVII of REACH after 31 March 2013.

Additional Information
Publication in the Official Journal of the European Union:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:142:0008:0008:EN:PDF

View more information regarding the new standards in this previously published Bulletin from August 2011.

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