Nickel Tests in REACH Annex XVII Undergo Update

The EU has recently updated the list of standards for demonstrating compliance with nickel release under ANNEX XVII of REACH.

European Committee for Standardization Publishes Changes

In September 2015 the Comité Europeén de Normalisation (CEN, European Committee for Standardization) published EN 1811:2011+A1:2015 as a test standard for nickel release [1]. This standard has a number of important changes, including

- Eliminating measured migration values in the ‘inconclusive’ category
- Translating the measured migration values in the ‘inconclusive’ category under EN 1811:2011 A/C:2012 to a ‘pass’ or ‘compliant’  

According to EN 1811:2011+A1:2015, conflicting national standards are to be withdrawn by January 2016 at the very latest.

CEN Standards Harmonized

On 15 January 2016, Commission Communication 2016/C 014/04 [2] was published in the Official Journal of the EU (OJEU) harmonizing the list of standards for demonstrating presumption of conformity with nickel release under entry 27 of ANNEX XVII of REACH [3]. This revised list contains the following three harmonized standards:

- 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 16128:2011 ‘Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin’

EN 16128:2011 [4] is technically unchanged as compared to EN 1811:1998+A1:2008 and has been harmonized for demonstrating presumption of conformity with nickel release since May 2012. The substantially revised standard, EN 16128:2015 [5], is anticipated to become a harmonized standard for presumption of conformity with nickel release by November 2018.

These harmonized standards are European standards developed by a recognized European Standards Organization following a request from the European Commission. Manufacturers, other economic operators, or conformity assessment bodies can use these harmonized standards to demonstrate that affected products comply with nickel release under Annex XVII of REACH.

Commission Communication 2016/C 014/04 does not indicate when the standards take effect, but they can be considered as taking effect immediately, that is, 15 January 2016.

Highlights of the result interpretation for EN 1811:2011+A1:2015 and the superseded standard, EN 1811:2011 A/C:2012 are summarized in Table 1.

References:

[1] Safeguards. CEN Publishes Amendment to EN 1811 ‘Nickel Release’. September 2015

[2] Official Journal of the European Union. Commission Communication in the framework of the implementation of the Regulation (EC) No 1907 / 2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)

[3] European Chemicals Agency. Substances Restricted under REACH. February 2016.

[4] Safeguards. EU Harmonises Testing Method for Nickel Release Under REACH. May 2012.

[5] Safeguards. CEN Publishes New Method for Nickel Release for Spectacle Frames and Sunglasses. November 2015.

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