EU – New Nickel Release Standard Published – EN 1811:2023

Vol. 1347 | 24 Apr 2023

On 22 February 2023, CEN (European Committee for Standardization) published a new version of the reference test method for nickel release, EN 1811:2023, which superseded the previous version EN 1811:2011+A1:2015.

The new standard is scheduled to be implemented at the national level of CEN members at the latest by August 2023, by publication of an identical national standard or by endorsement. The standard is expected to be harmonized under Entry 27 of Annex XVII of EU REACH Regulation (EC) No 1907/2006 when it is accepted by the European Commission and will be published on the Commission website only and no publication in the Official Journal of the European Union is foreseen anymore. Furthermore, updated references and titles of standards relevant for entry 27 can be found in both the restrictions webpage and the harmonized standards webpage of DG GROW.

The test method applies to determine the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body, and articles intended to come into direct and prolonged contact with the skin (except spectacle frames and sunglasses).  EN 1811:2023 addresses more details about obtaining homogenous sub-part by disassembling, cutting or masking for testing and each sub-part is required to comply with the requirement, and requires to apply both methods (EN 1811 with and without EN 12472) when the presence of nickel in outer coating is uncertain.

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

1. Changed the result unit for nickel release to be “µg·cm^-2·week^-1”, which is equivalent to the unit “µg/cm²/week” used in the REACH Regulation;
2. Added permission for ready-to-use solutions (sodium hydroxide solution and hydrochloric acid solution) (Clauses 5.5 and 5.6);
3. Added notes for the application of wax or lacquer for masking: Samples are dipped into molten wax when using wax; 2 to 3 coats of lacquer might be required when using lacquer (Clause 5.9);
4. Added a note for rinsing sample with test solution (Clause 8.2);
5. Added permission for the clarification of filtering release solution, which could be done with syringe filter to avoid damage to the analytical spectrometer or the blocking of instrument’s capillary (Clause 8.2);
6. Clarified that the nickel release result of each sample has to be compliant with the migration limit when more than one sample of the same article is tested (Clause 9.2.2.1);
7. Update the result interpretation for articles with a migration limit of 0.5 µg·cm^-2·week^-1: the result is compliant when it is ≤ 0.88 µg·cm^-2·week^-1, instead of <0.88 µg·cm^-2·week^-1 in the previous version (Clause 9.2.2.2);
8. Updated the test report requirements, sample area used for calculation and volume test solution could be reported per request (Clause 10);
9. Deleted the requirements for quality control material (reference discs);
10. Clarified that both test methods should be applied (EN 1811 without and with EN 12472) when uncertainty exists about the presence of nickel in the outer coating (Annex B.3);
11. Summarized the preparation of samples in table form and added examples. Each individual sub-part shall comply with the requirement of nickel released when it is in direct and prolonged contact with skin. Homogenous sub-part could be obtained by disassembling, cutting or masking (Annex B);
12. Added the flowchart for sample preparation and test procedure for complete watches (Annex B.4.2.6).

If you have further questions, please contact Dr. Kathy Leung (Kathy.Leung@intertek.com) or Dr. Ben Cheng (Ben.PS.Cheng@intertek.com)