How Do Changes Affect You?
The last revision of the European Nickel Directive was meant to address the concerns raised from the 2004 version. More stable artificial sweat solutions are used, which are likely more aggressive. The requirements are outlined in the table to the right. This law went into effect April 2013. The results include an uncertainty factor where it is considered “non-conclusive.” This still puts the burden on the manufacturer to prove it is compliant.
The acceptable nickel release rates are much lower than in earlier standards.
History of the European Directive
Based on the pioneering work on allergy to nickel in 1991 by Dr. Carola Linden, a Swedish dermatologist, the first European Nickel Directive became a law and came into force June 1994 in all the European Community Countries.
The supporting test method on nickel release became a Standard (EN 1811), which outlines the requirements of the Directive and pass the nickel release test conducted on jewelry products.
The test measures the leaching rate of nickel when the jewelry article is immersed in an artificial sweat solution. The 1994 European Directive established two basic nickel requirements for jewelry alloys:
It practically excludes the use of nickel in the alloys that come in intimate contact with parts of human body by restricting the nickel content to be less than 0.05% by weight. Earring posts, ear wire assemblies, and other body piercing jewelry articles fall under this restriction.
For jewelry articles that come into direct and prolonged contact with the skin, the test result should show the nickel release rate to be less than 0.5 microgram per square centimeter per week (0.5 μg/week/cm2). There is no restriction on the nickel content in the alloy used to make the jewelry articles.
Previous Revision of European Directive
The practical exclusion of nickel and numerous discrepancies of testing instances brought about the first revision of the Directive in 2004, which dealt only with nickel release rates and removed the restriction on the nickel content.
In spite of these improvements, the nickel release limits imposed by revisions of the standard have proved to be insufficient to avoid reactions in sensitized subjects. In addition, tests revealed that the artificial sweat degraded over the course of a week’s testing which made the nickel release result to be suspect.
The Tools Tech Team experts are here for you. Give them a call at 800-877-7777 ext. 4300