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EU Updates References of Nickel Release Standards for Compliance with Entry 27 of Annex XVII to REACH Regulation

On 20 April 2021, the European Commission has published a document on the latest references of standards for nickel release testing under Entry 27 of Annex XVII to REACH Regulation (EC) No 1907/2006. The document shall replace the previous document (2017/C 011/02) published in the Official Journal of the European Union (OJEU) on 13 January 2017.

The reference of standard (harmonised standard) for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items, has been updated from EN 12472:2005+A1:2009 to EN 12472:2020.

Compared to its 2009 version, the standard EN 12472:2020 has following important updates:

  • The material for granules changed to be “100% outer shells of coconuts” (updated from “outer shells of coconuts, walnuts, peanuts and almonds, mixed in a ratio 1:1:1:1 by weight”);
  • The purity requirement for the DL-lactic acid for preparing corrosive medium changed to be “> 88%” (updated from “> 85%”);
  • Scope: articles with an outer coating containing nickel and those which are inserted into pierced ears and other parts of the human body are excluded from the scope of this standard.

With immediate effect, the list of nickel release test methods for demonstrating conformity with Entry 27 of Annex XVII to REACH shall become as follows:

Harmonised Standards for EU REACH Annex XVII Entry 27 Nickel Release
EN 1811:2011+A1:2015
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

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