What is the Nickel Directive?
The nickel directive is a European Union directive regulating the use of nickel in jewellery and other consumer products designed to come into direct and prolonged skin contact. Nickel released is regulated under EC 1907/2006 REACH Annex XVII, Item 27.
EN 1811 is the internationally recognised test method for determining the rate of nickel release from jewellery, spectacle frames and other items. The test was devised to assess whether articles comply with the requirements of the EU Nickel Directive.
Following lengthy consideration by a European CEN Steering Group, BS EN 1811: 1988+A1:2008, the legal standard for testing articles for nickel compliance, has been revised. The new version BS EN 1811:2011, incorporated into REACH, is effective in the UK from 31st March 2013.
BS EN 1811:2011 is applicable to articles intended to come into prolonged and direct contact with the skin and all post assemblies inserted into body piercings, but does not apply to spectacle frames and sunglasses. Various changes to the method will make results more consistent and repeatable.
What are the limits for Nickel under the directive?
BS EN 1811:2011 will be used to verify the conformity of the products to the regulation. The limits set out in this test method are:
- Any post assemblies which are inserted into pierced ears and other pierced parts of the human body: 0.2 µg/cm2/week.
- Articles intended to come into direct and prolonged contact with the skin such as: necklaces, watch straps, bracelets etc: 0.5 µg/cm2/week.
Do I comply with the Nickel Directive?
In order to ensure that your products are compliant, they should be tested by a UKAS accredited laboratory. The new standard is not effective until March 2013; however EU Member States may choose to withdraw BS EN 1811:1998 and introduce the revised 2011 standard immediately. The combined use of the two standards may cause confusion for those trading in several EU countries and so compliance with the revised 2011 standard is the safest option.
Why do I need to comply with the directive?
The presence of nickel in certain products which are intended to come into direct and prolonged skin contact, such as jewellery, may cause sensitization of humans to nickel and may lead to allergic reactions. Compliance with the nickel directive will help to ensure protection to the consumer as well as maintaining your business reputation and brand image.