EU – CEN Approves EN 16128:2015 Nickel Release Standard for Spectacle Frames and Sunglasses

Vol. 893 | February 05, 2016

On 19 September 2015, the European Committee for Standardization (CEN) approved EN 16128:2015 - Ophthalmic optics — Reference method for the testing of spectacle frames and sunglasses for nickel release.

According to EN 16128:2015, the EN 16128:2015 will be given the status of a national standard at the latest by May 2016, and conflicting national standards shall be withdrawn at the latest by November 2018. EN 16128:2011 is still being harmonized for compliance with the nickel release limit (< 0.5 µg/cm2/week) in entry 27 under Annex XVII of Registration, Evaluation, Authorization and restriction of Chemicals (REACH)

Following is a summary comparison between EN 16128:2015 and EN 16128:2011:

 

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

 

Principle

Test parts with organic coating

  • Coating test based on Electrochemical Impedance Spectroscopy (EIS) to ensure the organic coating can prevent the nickel release from the parts exceed the regulatory limit.
  • Impedance ≥ 3.0 x 105 Ω.cm² is deemed compliant
  • Or the non-compliant parts may be subject to the migration test below

Test parts without organic coating or test parts not requiring the simulation of wear and corrosion specified in EN 12472.

  • Migration test comprises two steps: release of nickel by artificial sweat solution into a test paper and the subsequent quantitative analytical detection of the nickel released into the paper
  • < 0.76 μg/cm²/week is deemed compliant

Test parts are placed in an artificial sweat solution for one week, and then the concentration of dissolved nickel in the solution is determined by appropriate analytical method.


The analytical result is adjusted with the 0.1 times correction factor and the adjusted test result should be lower than the regulatory limit to deem compliant.

Artificial sweat solution

Deionized water containing:

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

Deionized water containing:

  • Ammonium solution
  • Sodium chloride
  • Lactic acid
  • Urea
 

 

For additional information please contact:

John Wong
john.wong@intertek.com 
852 2173 8637

 

 

 

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