CEN has published the new version of the nickel release method which is a quantitative method for detecting the presence of nickel in articles. This standard should be effective immediately.

In February 2023, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published EN 1811:2023 - a new version of reference method to determine the compliance with entry No. 27 to Annex XVII of Regulation (EC) 1907/2006 (REACH); this is specific to all post assemblies that are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin.

According to EN 1811:2023, this standard will be given the status of a national standard by August 2023 and conflicting national standards are to be withdrawn by this date at the latest.

This new version of method has several important updated points:

- Includes minor clarification about the definition of terms (i.e., sample area)

- Allows the usage of “ready-to-use” solution

- Withdraws the usage of reference disc as a quality control step

- Mentions about the procedure for filtering of test solution after a 7-day leaching step

- Includes examples illustrating surface area measurement including braided material

This standard does not apply to the nickel release testing of spectacle frames and sunglasses. These products are subject to the requirements of EN 16128:2015 - ‘Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release’.

Restrictions on manufacture, placing on the market and use of certain dangerous substances, mixtures and articles:

Links:

CEN: 

https://standards.cencenelec.eu/dyn/www/f?p=CEN:110:0::::FSP_PROJECT,FSP_ORG_ID:65837,413439&cs=11CE3B335EC0E7D1F395E7774F8D5B9AD

REACH:

https://echa.europa.eu/documents/10162/3bbe9024-52a6-8e63-5581-e686331eb459

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