The European Committee for Standardisation (CEN) has published the nickel release standard EN 16128:2015 for spectacle frames and sunglasses. This substantially revised standard will be given the status of a national standard by May 2016 and any conflicting national standards will be withdrawn by November 2018.
In May 2012, we [1] informed you that the European Union (EU) harmonised the standard EN 16128:2011 for spectacle frames and sunglasses for demonstrating presumption of conformity with nickel release under entry 27 of ANNEX XVII of REACH [2]; Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals. This method is technically unchanged as compared to EN 1811:1998+A1:2008.
In September 2015, the Comité Europeén de Normalisation (CEN, European Committee for Standardisation) approved EN 16128:2015 ‘Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release’. This new standard was published in November 2015 and is now available on a commercial basis at the national standards organizations such as the British Standards Institution (BSI).[3]
The new standard EN 16128:2015 has been substantially revised and contains important changes, including:
Artificial sweat solution
- The use of sodium hydroxide solution in the formulation is now in line with EN 1811:2011+A1:2015 ‘Nickel release 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’.
Test parts with organic coating
- These test parts require a coating test using an electro-chemical cell based on Electrochemical Impedance Spectroscopy (EIS).
- A test part is deemed to be compliant if the impedance is ≥ 3.0 x 105 Ω.cm².
- A non-compliant test part may be subject to the 2-step migration test as for parts without an organic coating. It is preferable to use new samples for the migration test.
Test parts without organic coatingor not requiring EN 12472 [4] 'Simulation on wear and corrosion'
- A 2-step migration test to determine nickel release by artificial sweat solution into a test paper (incubation at defined conditions for 1 week) and subsequent analytical detection of the nickel released into the paper.
- A combination of test parts (e.g. front) is deemed to be compliant if the migration value is <0.76 μg/cm²/week. This is in consideration of a number of statistical factors, including the measurement uncertainty factor.
According to EN 16128:2015, this new standard will be given the status of a national standard by May 2016 at the latest and any conflicting national standards will be withdrawn by November 2018 at the latest.
Highlights of the new standard and a comparison with the existing method EN 16128:2011 are summarized in Table 1.
Table 1
Standard Method for Nickel Release | ||
|---|---|---|
EN 16128:2015 | EN 16128:2011 | |
Title | Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release | Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin |
Scope | Parts of metal spectacle frames, combination spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection that are intended to come into direct and prolonged contact with the skin of the wearer | Parts of spectacle frames and sunglasses intended to come into direct and prolonged contact with the skin |
Sweat solution |
|
|
Principle | Test parts with organic coating
Test parts without organic coating or not requiring EN 12472
| Parts to be tested are placed in an artificial sweat solution for 1 week follow by analytical detection |
Result assessment | EIS test Impedance≥ 3.0 x 105 Ω.cm² is deemed compliant Migration Test < 0.76 μg/cm²/week is deemed compliant | Test result x 0.1 (adjusted value) follow by comparison with regulatory requirements |
Requirement | Entry27 under ANNEX XVII of REACH ≤0.5 μg/cm²/week | |
Remark |
| In force (Harmonised since May 2012) |
Throughout our global network of laboratories, we are able to provide a range of services, including testing for nickel release for the EU and worldwide markets. Please do not hesitate to contact us for further information.
For enquiries, please contact:
Hing Wo Tsang
Global Toys and Juvenile Products
t: +852 2774 7420
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