The EU Nickel Directive revisited - future steps towards better protection against nickel allergy

Jacob P. Thyssen1, Wolfgang Uter2, John McFadden3, Torkil Menne1, Radoslaw Spiewak4, Martine Vigan5, Ana Gimenez-Arnau6, Carola Liden7

1Department of Dermato-Allergology, National Allergy Research Centre, Copenhagen University Hospital Gentofte, Hellerup, Denmark
2Department of Medical Informatics, Biometry and Epidemiology, Friedrich Alexander University, Erlangen-Nuurnberg, Erlangen, Germany
3Department of Cutaneous Allergy, St. John's Institute of Dermatology, London, UK
4Department of Experimental Dermatology and Cosmetology, Jagiellonian University Medical College, Krakow, Poland
5Dermato-Allergology, Department of Dermatology, Centre Hospitalier Universitaire Saint Jacques, Besancoon, France
6Department of Dermatology, Hospital del Mar, Universitat Autonoma, Barcelona, Spain
7Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden

Source: Thyssen JP, Uter W, Menne T, McFadden J, Menne T, Spiewak R, Vigan M, Gimenez-Arnau A, Liden C. The EU Nickel Directive revisited - future steps towards better protection against nickel allergy. Contact Dermatitis 2011; 64 (3): 121-125.


In July 2001, the EU Nickel Directive came into full force to protect European citizens against nickel allergy and dermatitis. Prior to this intervention, Northern European governments had already begun to regulate consumer nickel exposure. According to part 2 of the EU Nickel Directive and the Danish nickel regulation, consumer items intended to be in direct and prolonged contact with the skin were not allowed to release more than 0.5 µg nickel/cm2/week. It was considered unlikely that nickel allergy would disappear altogether as a proportion of individuals reacted below the level defined by the EU Nickel Directive. Despite this, the EU Nickel Directive part 2 was expected to work as an operational limit that would sufficiently protect European consumers against nickel allergy and dermatitis. This review presents the accumulation of epidemiological studies that evaluated the possible effect of this major public health intervention. Also, it evaluates recent exposure assessment studies that have been performed using the dimethyl glyoxime test. It is concluded that the EU Nickel Directive has started to change the epidemiology of nickel allergy in Europe but it should be revisited to better protect consumers and workers since nickel allergy and dermatitis remain very frequent.

Key words: allergy prevention; EU Nickel Directive; nickel allergy; nickel dermatitis; nickel exposure; public health.

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Document created: 25 February 2011, last updated: 1 September 2011.