Nickel Allergic Contact Dermatitis
Statement of position
of the member companies of the Nickel Institute
[For nickel industry activity in support of this position, click
here]
The Nickel Institute believes nickel allergy is a preventable condition and that appropriate regulation or, in the absence of regulation, voluntary industry initiatives, can provide a high level of protection against nickel allergy sensitization and nickel-induced allergic contact dermatitis.
To this end, and for articles intended for direct and prolonged contact with the skin, the Nickel Institute:
- supports the view that there are two critical factors to be taken into account when assessing and managing the risks associated with nickel allergy contact dermatitis: (a) the ability of and rate at which a material surface releases nickel when exposed to sweat and (b) the nature of the contact with the skin, in particular its duration and intimacy;
- supports the view that both factors have to be present in order for there to be a risk of sensitization or initiation of an allergic reaction in a previously sensitized individual; and
- believes that the “sweat test” for the determination of nickel release rate (EN1811) is relevant to skin contact exposures.1
For articles used to pierce the skin and/or for placement in the wound after piercing for the period of healing, the Nickel Institute:
- supports the view that the critical factor is the ability of and rate at which the surface of an article releases nickel in relevant environments.
- supports the view that it is prudent to have nickel release level for such items lower than for articles intended for direct and prolonged contact with the skin.2
In order for measures protective of the public to be best achieved, the Nickel Institute:
- believes that the marketplace should be regulated and to that end the Nickel Institute will actively support and promote appropriate regulatory initiatives;
- believes that in the absence of appropriate regulation, voluntary industry initiatives can significantly reduce the incidence of sensitization and initiation of an allergic reaction in a previously sensitized individual; and
- is actively supporting efforts to improve the “sweat test” (EN1811:1999) in accuracy, reliability, speed, and cost effectiveness.
1 The
EN1811:1999 test protocol is currently utilized as it is the most appropriate method, despite some
limitations. It has been determined by the European Union (EC/94/27) that a release rate of 0.5 micrograms
per square centimetre per week or less (using the EN1811:1999 test protocol) provides an appropriate level of
public protection. This cut-off is thought to be sufficiently conservative as the vast majority of previously
sensitized individuals would be protected. Articles that release 0.5 micrograms or less per square centimetre
per week are therefore suitable for use in direct and prolonged contact with the skin.
2 The
EN1811:1999 test protocol is currently utilized as it is the most appropriate method, despite some
limitations. It has been determined by the European Union (2004/96/EC) that for "studs" or "posts" placed in
wounds after piercing, a release rate of 0.2 micrograms per square centimetre per week or less provides
an appropriate level of public protection. This cut-off is thought to be sufficiently conservative as the
vast majority of previously sensitized individuals would be protected.
03 December, 2007
