National foreword

This British Standard is the UK implementation of EN 16128:2025. It supersedes BS EN 16128:2015, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/172/3, Spectacles.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2025.

This European Standard was approved by CEN on 8 September 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN 16128:2025) has been prepared by Technical Committee CEN/TC 170 “Ophthalmic optics”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2026, and conflicting national standards shall be withdrawn at the latest by April 2026.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 16128:2015.

EN 16128:2025 includes the following significant technical changes with respect to EN 16128:2015:

Clause 4 has been modified to give a better scientific explanation of why a sample that fails the coating test might pass the migration test. It also states that the coating test is not a screening test since a pass allows a product to be labelled as compliant with REACH. A revised flowchart (Figure 1) reinforces this. The warning about taking particular attention over handling samples to avoid additional damage has been reinforced;
Clause 5 emphasizes 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;
Clause 6 notes that the lenses are needed in the frame to protect the groove during the simulated wear and corrosion procedure. Although it applies to EN 12472, new Annex A provides illustrations of mounts that can be used to hold sample frames in the tumbling barrel;
Clauses 7 and 8 refer to the new normative Annex B for advice on where to test sides. Both recommend that the test or dummy lenses are kept in the frame for the tests;
More detailed advice on where to mask frames before the coating test has been provided in Clause 7. The new quality control samples are mentioned in the new Annex D. Photographic records of the samples are now required in the test report;
Clause 8 now permits the use of a hermetically-sealed cabinet and laboratory oven to be used for the migration process as well as a climate chamber. The concentration of the control solution has been doubled and the volume halved, to avoid overloading the piece of test paper, which is suggested to be 10 % larger. Again, photographic records of the samples are now required in the test report;
Annexes B, C and D have photographic figures to illustrate sample preparation since they give better clarity than drawings. The examples pictured provide no manufacturer markings and are in no way intended to promote a particular manufacturer or style;
Annex E has been revised to recommend folding of the sealing film over the test or dummy lenses rather than wrapping around the rim.

This document has been prepared under a standardization request addressed to CEN by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States.

Any feedback and questions on this document should be directed to the users’ national standards body. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Introduction

This document has been prepared under Mandate M/448 issued by the European Commission in the framework of Regulation (EC) No 1907/2006, REACH, in particular Commission Regulation (EC) No 552/2009 of 22 June 2009 amending regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and restriction of Chemicals (REACH) as regards Annex XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES.

The aim of the mandate was the development of a new method of analysis to detect the release of nickel from spectacle frames and sunglasses.

The availability of the new reference method for the determination of the release of nickel will provide the reliable framework to enforce the limit value for nickel release set forth by the European Regulation of 0,5 μg·cm⁻²·week⁻¹ (expressed as 0,5 µg/cm²/week in the Regulation). It will ensure a uniform application and control of the European legislation in all member states.

Harmonizing the test method for nickel release in all member states is vital with a view to protecting effectively the health of the end consumer, that is, the spectacle wearer. Nickel allergy is still the most frequent contact allergy in Europe and a significant health issue.

1 Scope

This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.

The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm⁻²·week⁻¹ set forth by European Regulation.

The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.

This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.

NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.

2 Normative references

3 Terms and definitions

4 Principle

5 Selection of test samples

6 Simulation of wear and corrosion

6.1 Preparation of test samples

6.2 Procedure

7 Coating test

7.1 General

7.2 Apparatus and consumables

7.3 Preparation of test samples for the coating test

7.4 Preparation of saline solution

7.5 Procedure

7.6 Calculation of results

7.7 Test report

8 Release of nickel and its quantitative analytical detection (migration test)

8.1 General

8.2 Apparatus and consumables

8.3 Preparation of test samples for the migration test

8.4 Procedure

8.5 Calculation of migration test results

8.6 Interpretation of migration test results

8.7 Test report

Bibliography

BS EN 16128:2025

Ophthalmic optics. Reference method for the testing of spectacle frames and sunglasses for nickel release

Current

Published:

31 Oct 2025