CEN has published EN 12472:2020 for the simulation of accelerated wear and corrosion for nickel release from coated items that come into direct and prolonged contact with the skin. Conflicting national standards are to be withdrawn by March 2021.
In September 2020, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published EN 12472:2020 ‘Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items’. This method is to be used prior to the detection of nickel release from coated articles that come into direct and prolonged contact with the skin.
This new standard contains, inter alia, several important changes to EN 12472:2005+A1:2009. It:
- Clarifies the scope of the standard – it does not apply to articles with a nickel-containing outer coating and those which are inserted into pierced ears and other parts of the human body
- Requires granules to be composed of coconut outer shells that are ground and sieved to give a mixture of particles with dimensions of 0.8 – 1.3 mm
- Strengthens the purity of DL-lactic acid to be greater than 88% for the preparation of corrosive medium
- References the latest version of the following standards for nickel release:
- 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’
- States that CR 12471 can be used as a method for obtaining indicative information on the extend of nickel release or the presence of nickel
According to EN 12472:2020, this standard will be given the status of a national standard by March 2021 and conflicting national standards are to be withdrawn by this date. This standard is expected to be harmonized under Regulation (EC) 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)’ upon official acceptance by the European Commission (EC) and by publication in the Official Journal of the European Union (OJEU).
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 www.sgs.com/reach.
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