Skip to Menu Skip to Search Contact Us Global Websites & Languages Skip to Content

SAFEGUARDS | Hardgoods NO. 198/15

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standard will be given the status of a national standard by May 2016 and any conflicting national standards will be withdrawn by November 2018.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 coating or 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

  • Sodium chloride
  • Lactic acid
  • Urea
  • Sodium hydroxide solution
  • Sodium chloride
  • Lactic acid
  • Urea
  • Ammonium solution

Principle

Test parts with organic coating

  • Coating test is based on Electrochemical Impedance Spectroscopy (EIS).
  • Non-compliant test parts may be subject to the 2-step migration test

Test parts without organic coating or not requiring EN 12472

  • A 2-step migration test using artificial sweat solution into a test paper (incubation at defined conditions for 1 week) and subsequent quantitative analytical detection of nickel released into the test paper

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

  • National standard status by May 2016
  • Conflicting national standards to be withdrawn by November 2018

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

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

© SGS Group Management SA – 2015– All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.