SAFEGUARDS | Hardgoods NO. 010/17

SafeGuardS girl in sunglasses

The EU has recently updated the list of harmonized standards for nickel falling under entry 27 to Annex XVII of REACH. The newest entry for EN 16128:2015 takes effect immediately.

On January 13, 2017, Commission Communication 2017/C 011/02 [1] was published in the Official Journal of the European Union (EU) harmonizing the list of methods for demonstrating presumption of conformity with nickel falling under entry 27 to Annex XVII of REACH.

This Communication contains three methods:

  • 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 12472:2005+A1:2009 ‘Method for the simulation of 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’. The scope of this standard applies to spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection

It is interesting to note that EN 16128:2015 has now been harmonized for presumption of conformity. The 2015 version [2] contains a number of changes to the 2011 version. The Communication does not indicate an effective date, however, this can be considered as immediate; January 13, 2017.

Both EN 1811:2011+A1:2015 [3] and EN 12472:2005+A1:2009 are already in force for demonstrating presumption of conformity with nickel.

The effective date for the three methods is summarized in Table 1. 

Method for nickel under entry 27 of Annex XVII of REACH
Standard EN 1811:2011+A1:2015 EN 12472:2005+A1:2009 EN 16128:2015                             
Effective date for demonstrating presumption of conformity In force In force January 13, 2017

SGS will follow up and inform interested parties as developments on REACH regulation occur. Our expertise combined with consultancy services and experience in consumer product supply chains provides a central point of contact for global solutions. If you would like to learn more about how SGS can support your REACH compliance activities please visit

For enquiries, please contact:

Hingwo Tsang
Global Hardlines Information and Innovation Manager
t: +852 2774 7420

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