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The problem
The nickel legislation addresses a serious problem. The regulation of Nickel was prompted by concern over the growing number of people becoming sensitized to it. It is estimated that in Europe between at least 10% of females and 1% of males are sensitized to Nickel and will suffer problems for the rest of their life as a result.
Sensitization occurs when materials that contain nickel are placed in direct and prolonged contact with the skin. Nickel and Nickel salts can be dissolved by sweat and then penetrate the skin, interacting with the immune system to induce nickel allergy which then remains with the sufferer for life. One of the prime causes of sensitization is believed to be body and ear piercing and this is what the original regulations sought to control. By stipulating a low nickel content, less than 0.05%, for post assemblies to be worn during the period of healing after piercing the regulations significantly reduced the risk of sensitization.
However the content test (BS: EN 1810) has always raised questions. The period of healing varies widely between individuals and if a wound is accidentally reopened the person could be vulnerable many years after the initial piercing. The content test has prohibited the use of many stainless steel alloys, which typically have between 8% and 12% nickel content but some of which have been shown to release little or no nickel. These materials are used throughout the world on a daily basis for medical devices, such as wound staples, and yet since 2000 their use for initial body and ear piercing has been prohibited.
The amendments to the legislation have now removed this anomaly and opened up new options for the manufacturers of post assemblies.
New amendments
The new requirement is that post assemblies must now comply, not to the content test but with a Nickel release test. This will be conducted in the same way as the existing release test used for all other items that come into direct and prolonged contact with the skin, i.e. using BS EN 1811. However, the permissible release rate for post assemblies will be lower, at 0.2micrograms per square centimetre per week, as opposed to 0.5 micrograms per square centimetre per week for other items.
The differentiation between items intended for use during the period of healing and outside it has clearly been removed and there is no doubt that as of 1st September all post assemblies must be tested using the release test. The amendments to the Directive have also removed the requirement that post assemblies be homogenous. The result of these changes is that manufacturers can now consider new options for post assemblies, including some stainless steels and the option of plating them.
Implications
This amendment is clearly stated in the European Directive and is beyond doubt. However, further implications are not yet so clear cut. A consultation document has been circulated to over 80 interested bodies by the DTI. This includes the draft UK legislation and draft guidelines for their implementation. Until the period of consultation has finished, details could still change, but the following implications are detailed in the draft documents currently available.
* After 1st September the Nickel content test (BS: EN 1810) will not have any legal standing. However it could still be useful as part of a due diligence programme, to augment the recognised release tests. If there is not any nickel present, then none can be released
* It will not be illegal to supply any product or post assembly which was permitted under the previous regulations and which was placed on the market before the new regulations come into force. Nor any item which was first placed on the market in a Member state before 20th January 2000 (i.e. second-hand goods). However, note that all new articles containing post assemblies that come onto the market after 1st September 2005 will have to meet the new requirement.
Future Developments
As part of the changes to the Nickel Directive the European Union has requested the scientific establishment to review the testing procedures involved.
The wear corrosion method is already under scrutiny and current proposals will make the process less rigorous, but more labour intensive. The suggestion is that each item may have to be individually mounted into the barrel prior to testing, a new less rigorous medium used for barrelling and barrelling machines reprogrammed to revolve more slowly. These amendments will inevitably have an impact on the cost of testing, make nickel testing more complex and more labour intensive.
Clarification of changes to the regulations will continue to filter through to the trade. Any major new developments will be posted here.
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