On the 20th July 2001 it become illegal to sell to a consumer any product that is made or imported into the European Union after 20th January 2000 and intended to come into direct and prolonged contact with the skin which releases from the parts of these products coming into contact with the skin more than a set limit of Nickel ions. Also banned from these dates those parts of jewellery that are inserted into the human body, or come in contact with the wound, during the time the wound caused by the piercing is healing. In 2004 this directive was amended because a targeted risk assessment concluded that a migration limit for piercing post assemblies would be more appropriate than a content limit. This change came into effect on the 1 September 2005. This legislation was introduced because statistically at least 10% of the female population and 1% of the male population suffer from an allergic reaction to Nickel, so the European Union decided to control its use in an attempt over the long term to reduce the numbers of people who suffer from this reaction. The directive was passed on the 30th June 1994 and the tests required for implemention were published in the Official Journal of the EC on the 20th July 1999. In order to validate that goods for sale comply with the Directive CEN was asked to produce three reference tests. These have been produced by the CEN TC284 committee and can be purchased from your national standards association. Because the Spectacles Industry was unhappy with the destructiveness of the Wear Test the Italian Spectacles Industry has devised its own Wear Test. Because these tests are costly, distructive, take up to ten days to complete and require an analytical laboratory CEN also has devised a scanning field test. While it mimics the reference test method for Release of Nickel it can not replace it. Due to the controversy surrounding the implementation of this directive - especially the lack of definitions concerning key terms - it is likely that the directive will be reviewed at the end of 2001. In the UK the negotiations will be handled by the DTI. Industry input to this process is primarily through the Nickel Working Group.

Page address http://www.teg.co.uk/nickel/index.html Last Updated 8th March 2010

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