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November 2020 Regulatory Update

CEN Published EN 12472:2020 ‘Method for the Simulation of Accelerated Wear and Corrosion for the Detection of Nickel Release from Coated Items’


The European Committee for Standardization (CEN) published EN 12472 ‘Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items’ (EN 12472:2020). This test method is related to the detection of nickel release from coated articles with direct and prolonged skin contact, and was published in September of this year.

In comparison with the previous version EN12472:2005+A1:2009, the 2020 version contains some major changes as follows:

  • 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 used in the REACH Regulation;
  • Update of normative references:
    • EN 1811 “Reference test method for release from 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 16128 “Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release”
  • Clarification of articles covered by the scope of this standard – the scope of this standard excludes articles with an outer coating containing nickel and those which are inserted into pierced ears and other parts of the human body;
  • Clarification of the concentration of the lactic acid stock solution – The purity of DL lactic acid for preparation of corrosive medium shall be more than 88%;
  • Requirement for granules has been changed – Outer shells of coconuts, ground and sieved to give a mixture of particles having dimensions between 0.8 mm and 1.3 mm;
  • Tests specified in CR 12471 can be performed to obtain indicative information on the extent of nickel release or the presence of nickel.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March of 2021, and conflicting national standards shall be withdrawn by March of 2021 at the latest.

This standard would be harmonized under Regulation (EC) No 1907/2006 (REACH) when it is accepted by the European Commission and announced in the Official Journal of the European Union (OJEU).

For More Information About This Story:
Contact: Andy Choi (Senior Manager)
Phone: (852) 3185 8045
Email: regulatoryupdates@qima.com

Andy Choi

Vivian Chan

David Zhao

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