SG 181/25
The European Committee for Standardization (Comité Européen de Normalisation, CEN) has published the latest version of the nickel release standard for spectacle frames and sunglasses – EN 16128:2025.
In October 2025, CEN issued EN 16128:2025 ‘Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release’. This updated standard specifies the reference method for testing nickel release from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection. It applies to metal spectacle frame components and metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. It also applies to relevant metal parts of ready-to wear near-vision spectacles, sunglasses and spectacle frames for eye and face protection.
Additionally, the method described in the standard supports the demonstration of compliance with the nickel release limit value of 0.5 µg/cm²/week in Entry 27 to Annex XVII of Regulation (EC) No 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals’ (Entry 27 to Annex XVII of REACH).
Key changes in EN 16128:2025 include:
- Modifying Clause 4 ‘Principle’, including an updated flowchart (Figure 1), with clearer scientific explanation on why a sample that fails the coating test may pass the migration test. It indicates that the coating test is not a screening test, as a pass allows labeling as REACH-compliant
- Emphasizing that if a sample fails the coating test, all parts of the sample must undergo migration testing (Clause 5)
- Adding notes to Clause 6 that lenses are required in the frame to protect the groove during the simulated wear and corrosion procedure in EN 12472
- Referring to Clauses 7 and 8 in Annex B for guidance on where to test sides (both recommend that the test for dummy lenses is kept in the frame for the tests)
- Providing additional details in Clause 7 on where to mask frames before the coating test. The new quality control samples are detailed in Annex D
- Mandating photographic records of samples in test reports
- Permitting the use of a hermetically sealed cabinet and laboratory oven as an alternative to climate chamber for the migration process
- Revising the preparation of control solutions in Clause 8, including concentrations of artificial sweat solutions and the size of test papers
- Inclusion of photographic figures in color into the following Annexes for clarity:
- Annex B ‘Measuring device and identifying where to test’
- Annex C ‘Cutting and masking of test samples (Coating test)’
- Annex D ‘Quality control material for the coating test’
- Updating Annex E ‘Selection of test areas and application of the test paper (Migration test)’ (formerly Annex B)
It is important to note that the release of nickel from all post assemblies which are inserted into the pierced parts of the human body and articles (except spectacle frames, ready-to wear near-vision spectacles, sunglasses and spectacle frames) intended to come into direct and prolonged contact with the skin is specified in EN 1811 (SafeGuardS 2/24).
According to EN 16128:2025, this standard will gain national standard status by April 2026, with conflicting national standards being withdrawn by this date at the latest. It is expected to be harmonized under REACH upon official acceptance by the European Commission and publication in the Official Journal of the European Union (EU).
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