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EU Update REACH Appendix XVII Harmonized Standard for Nickel Release Test Methods

Time：

2023-12-29

EU updated REACH Regulation (EC) No. 1907/2006 Appendix XVII, item 27, latest coordinated standard list for nickel release testing methods.

On December 20, 2023, the European Commission updated the latest coordinated standard list of testing methods for nickel release in Appendix XVII, item 27 of EU REACH Regulation (EC) No. 1907/2006. Starting today, the changes to the testing standards used to demonstrate compliance with the nickel release requirements of Appendix XVII, item 27 of the REACH regulation are as follows:

The latest testing method coordinates the standard number and name	Standard number of replaced testing methods
EN 1811:2023 Reference test method for release of 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 1811:2011+A1:2015
EN 12472:2020 Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items	EN 12472:2005+A1:2009
EN 16128:2015 Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release	EN 16128:2011

This coordinated standard update has updated EN 1811:2011+A1:2015 to EN 1811:2023. Compared to the old version, the 2023 version includes the following main updates:

1. Change the unit of nickel release to“ μ G · cm-2 · week-1 (micrograms per square centimeter per week) (equivalent to the unit originally used in REACH regulations)“ μ G/cm2/week;

2. Allow the use of ready to use solutions of sodium hydroxide and hydrochloric acid (clauses 5.5 and 5.6);

3. Added precautions regarding the use of masking wax or paint: when using wax, immerse the sample in molten wax; When using paint, it may be necessary to use 2 to 3 layers of paint (clause 5.9);

4. Added instructions for rinsing samples with test solution (clause 8.2);

5. It is allowed to use filtration to make the released liquid clear: injection filters can be used to avoid damaging the analytical instrument or blocking the capillary of the instrument (Article 8.2);

6. Clarify that when multiple samples of the same item are tested, the nickel release of each sample must meet the migration limit (Article 9.2.2.1);

7. For a migration limit of 0.5 μ For items with g · cm-2 · week-1, the limit value for determining the conformity of nickel release results is set from<0.88 μ G · cm-2 · week-1, revised to ≤ 0.88 μ G · cm-2 · week-1 (clause 9.2.2.2);

8. The testing report requirements have been updated, and according to the requirements of the testing applicant, the testing report can include the sample testing area and the volume of the testing solution used (Article 10);

9. The requirement for quality control materials (reference test pieces) has been removed;

10. When the presence of nickel in the outer coating is uncertain, two testing methods should be used (i.e. EN 1811 combined with wear and corrosion simulation method EN 12472, and not combined with EN 12472) (Appendix B.3);

11. Summarized the preparation status of the samples in the form of a table and added examples. Each individual sub component must meet the limit requirements for nickel release in direct and long-term contact with the skin. Uniform sub components can be obtained through disassembly, cutting, or masking (Appendix B);

12. Added a complete sample preparation and testing procedure flowchart for the watch (Appendix B.4.2.6).