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CEN Issues EN 1811:2023 for Nickel Release

SafeGuardSElectrical & Electronics, Hardgoods, Softlines, Toys and Juvenile ProductsApril 11, 2023

SG 44/23

CEN has published EN 1811:2023 for the release of nickel. Conflicting national standards are to be withdrawn by August 2023.

In February 2023, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published EN 1811:2023, the latest reference test method for the release of nickel from 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 in order to determine whether such articles are in compliance with entry No. 27 to Annex XVII of Regulation (EC) 1907/2006 (REACH).

It is important to note that spectacle frames and sunglasses are not within the scope of EN 1811:2023 as these are subject to the requirements of EN 16128 ‘Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release’

Highlights of major changes brought in by EN 1811:2023 are summarized in Table 1.

Section to EN 1811:2023Highlights of changes
3.1 ‘Homogeneous’
  • Revises definition for ‘homogeneous’: ‘of uniform composition throughout that cannot be separated into different materials’ (a coated material is not homogeneous)
3.3 ‘Surface finish’
  • Adds new definition for surface finish: ‘appearance and texture of a surface characterized by smoothness or roughness’ (in order of increasing smoothness, the surface finish can be typically described as cut finish, machined finish, brushed finish, matt finish, satin finish, mirror finish or polished finish)
3.5 ‘Disassemble’
  • Adds new definition for disassemble: ‘separate into its constituent parts without damaging these parts or their surface condition’
5.5.1 ‘Preparation of 1 mol/l sodium hydroxide solution’
  • Allows the use of ready-to-use solutions
5.9 ‘Wax or lacquer (e.g., suitable for electroplating) capable of protecting a surface from nickel release’
  • Adds new notes for improvements to adhesion of wax and to cover cracks and fissures
7.2.1 ‘Definition of sample area’
  • Clarifies definition with new language
8.2 ‘Release procedure’
  • Clarifies procedures for handling very small samples and filtration step to remove particulates from the release solution prior to analysis
8.3 ‘Blank tests’
  • Clarifies procedure for filtering of release solutions and blank solutions ‘General’
  • Clarifies that ‘when more than one sample of the same article is tested, the nickel release of each sample has to be compliant with its migration limit in order for the article to be permitted to be placed on the market’
10 ‘Test report’
  • Updates the minimum information required in test reports for each determination.
  • The following information is to be included in the test report if requested:
    • Sample area used for calculation (cm²) and the information on the areas that have been excluded
    • Volume of test solution used
    • Limit of quantification (LOQ)
Annex B (normative) ‘Requirements for quality control material’ in EN 1811:2011+A1:2015
  • Deleted
Annex B (informative) ‘Preparation of articles prior to nickel testing’
  • Updates preparation of articles prior to nickel testing, which includes:
    • Application of both test methods (EN 1811 with and without EN 12472) when uncertainty exists about the presence of nickel in the outer coating.
    • New Table B.1 ‘General procedure for post assemblies, homogeneous and inhomogeneous articles’ in relation to preparation, testing and calculation of results
    • Revised detailed information on the preparation, testing and calculation of results for jewelry and watches (B.4.2). This includes:
      • A new flow chart for sample preparation and testing procedure for complete watches (Figure B.9)
      • Detailed information for the calculation of articles/parts made from perforated or mesh materials or from twisted or woven wires (B.5.1.2)

Table 1

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.

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