This new standard -- prepared by Technical Committee CEN/TC 347 "Methods for analysis of allergens" and published by CEN ("Comité Européen de Normalisation") in September 2020 -- specifies a method for the simulation of accelerated wear and corrosion, to be used prior to the detection of nickel release from coated articles that come into direct and prolonged contact with the skin. According to the Commission Regulation (EC) No 1907/2006 (REACH), 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 document.

This new standard supersedes the previous version: EN 12472:2005+A1:2009: "Method for the simulation of wear and corrosion for the detection of nickel release from coated items", and expected to be soon listed in the Official Journal of the European Union (OJEU) under the REACH.  This document Includes the revised text of EN 12472:2005+41:2009, as well as the changes proposed by CEN/TC 170 regarding spectacle frames and sunglasses.

Changes:

The major changes are:

— reference to Regulation (EC) No 1907/2006 (REACH) instead of Directive 94/27/EC

— use of the term ‘article’ instead of ‘items,’ in order to adopt the use of terms in the REACH Regulation

— update of normative references

— clarification of articles covered by the scope of this document

— clarification of concentration of the lactic acid stock solution

— requirements for granules have been changed

— A.3 regarding spectacle frames has been updated

— the document has been editorially updated

Effective Date:

This EN shall be given the status of a national standard of each country of the European Single Market, either by publication of an identical text or by endorsement (and with all conflicting national standards withdrawn), at the latest by March 2021.

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