Recently, the European Committee for Standardization (CEN) has released a new version of the reference test method for nickel release EN 1811:2023, replacing EN 1811:2011+A1:2015. This standard is expected to be approved by the European Commission, after being published in the Official Journal of the European Union (OJEU), as a harmonized standard for the EU’s REACH regulation, Appendix XVII, item 27 on nickel release testing. The relevant updates are as follows:

Products covered:

Metallic products for piercing the ears and other body parts or intended for direct and prolonged contact with the skin (excluding spectacle frames and sunglasses).

Compared to the previous version, EN 1811:2023 includes the following main changes:

1. The unit for nickel release has been changed to “”μg cm-2 week-1″” (micrograms per square centimeter per week) (equivalent to the unit “”μg/cm2/week”” used in REACH regulations);
2. Allows the use of pre-mixed solutions of sodium hydroxide and hydrochloric acid (Sections 5.5 and 5.6);
3. Supplements prevention measures when using wax or coating: when using wax, the sample is dipped in melted wax, and when using coating, 2 to 3 layers of coating may be necessary (Section 5.9);
4. Adds instructions for washing the sample with a test solution (Section 8.2);
5. Allows the use of filtration methods to clarify liquid samples: a syringe filter can be used to avoid damaging the analysis equipment or clogging the apparatus (Section 8.2);
6. Clearly states that when testing multiple samples of the same product, the amount of nickel released from each sample must meet the threshold limit value (Section 9.2.2.1);
7. For products with a threshold limit value of 0.5 μg cm-2 week-1, the limit for the determination of the conformity of nickel release results has been adjusted from <0.88 μg cm-2 week-1 to ≤0.88 μg cm-2 week-1 (Section 9.2.2.2);
8. The reporting requirements for testing have been updated, and the testing report may include the test sample area and volume of the test solution used, as requested by the test registrant (Section 10);
9. The requirements for quality control materials (reference test samples) have been deleted;
10. Clarifies that when there is uncertainty about the presence of nickel in the outer coating, two testing methods should be used (i.e., EN 1811 combined with the EN 12472 corrosion and erosion simulation method and not EN 12472) (Appendix B.3);
11. The sample preparation process is summarized in a table, and examples have been added. Each individual component must comply with the threshold limit values for nickel release when in direct and prolonged contact with the skin. Uniform components can be obtained by dismantling, cutting or covering (Appendix B);
12. A process flowchart for sample preparation and testing for complete watches has been added (Appendix B.4.2.6).

Release date: February 22, 2023

The new version of the standard is expected to be adopted as a national standard in CEN member countries by the end of August 2023 (equivalent to the application of European standards and the publication of national standards or recognition of those standards at the national level).

Note:

This test item is being developed in the laboratory at CTT Lab. We recognize the significant impact the expected standard will have, which will be approved by the European Commission. We recommend that customers monitor and update information regularly to stay informed of changes in standards and testing methods.