2025-12-05 Reading format 中文
Targeted audience EU/EEA manufacturers, EU/EEA importers and their upstream providers, EU/EEA distributors
Products concerned Spectacle frames, ready-to-wear near-vision spectacles, sunglasses, spectacle frames used for eye and face protection
Key industries concerned with this insight Glasses
Application date 30 April 2026
Main content or requirements On 22 October 2025, the European Standard EN 16128:2025 on nickel release from spectacle frames and sunglasses is published. In the new standard, the test procedure is revised. The standard will be given the status of a national standard and the conflicting national standards will be withdrawn at the latest by April 2026
Reference Link 1
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On 22 October 2025, the European Committee for Standardization (CEN) published a new version of the European Standard EN 16128, EN 16128:2025 Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release, superseding the previous version EN 16128:2015.

The main technical changes are as follows:

  1. Modified Clause 4 and Figure 1 to give a better scientific explanation of why a sample that fails the coating test might pass the migration test. Stated that the coating test is not a screening test since a pass allows a product to be labelled as compliant with REACH. Reinforced the warning about taking particular attention over handling samples to avoid additional damage.
  2. Modified Clause 5 to emphasize that if a sample fails the coating test, then all parts of the sample have to be tested with the migration test, not just the part that failed.
  3. Modified Clause 6 to note that the lenses are needed in the frame to protect the groove during the simulated wear and corrosion procedure. Added new Annex A to provide illustrations of mounts that can be used to hold sample frames in the tumbling barrel.
  4. Modified Clauses 7 and 8 to refer to the new normative Annex B for advice on where to test sides, which recommend that the test or dummy lenses are kept in the frame for the tests.
  5. Provided in Clause 7 more detailed advice on where to mask frames before the coating test. Added new Annex D on the new quality control sample.
  6. Modified Clause 8 to permit the use of a hermetically-sealed cabinet and laboratory oven to be used for the migration process as well as a climate chamber. Doubled the concentration of the control solution and halved the volume to avoid overloading the piece of test paper, which is suggested to be 10% larger.
  7. Added in Annexes B, C and D photographic figures to illustrate sample preparation.
  8. Revised Annex E to recommend folding of the sealing film over the test or dummy lenses rather than wrapping around the rim.

The new standard EN 16128:2025 will be given the status of a national standard and the conflicting national standards will be withdrawn at the latest by April 2026. The standard is expected to become a harmonised standard under the EU REACH Regulation (EC) No 1907/2006 Annex XVII Entry 27 after it is accepted by the European Commission and is published in the Official Journal of the European Union (OJEU).

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