Legislation is an important tool in primary and secondary prevention of contact dermatitis. There are similarities and differences between the European and North American legislations. A brief description will be given of the European system and some examples of how exposure to major contact allergens has been limited.

Classification of dangerous substances and preparations
The EU Directives on classification, packaging and labelling of dangerous substances (Directive 67/548/EEC and amendments) and preparations (Directive 88/379/EEC and amendments; from July 2002 substituted by Directive 1999/45/EC) covers chemicals intended for both consumer and workplace use. Today, approximately 500 substances are classified as skin sensiter. Classified substances are listed in Annex I of Directive 67/548/EEC. The general concentration limit for classification of preparations/products as skin sensitiser is 1% (corresponding to “percentage cut-off”). Specific and lower limits are increasingly used, and specific concentration limits have been set for more than 30 substances. The lowest being 15 ppm for the preservative MCI/MI. Preparations have to be labelled with the name of the sensitiser and a risk phrase (R 43 “May cause sensitisation by skin contact”). The new Dangerous Preparations Directive (1999/45/EC) requires also that the packaging of products containing 0.1% or more of a skin sensitiser must bear the inscription ”Contains ‘the name of sensitiser’. Many produce an allergic reaction.”

In the EU, consumer products are subject to the same classification and labelling procedure as for workplace preparations. Safety Data Sheets have to be provided for professional users.

Nickel
The EU Nickel Directive (Directive 94/27/EEC) entered into full force in July 2001. Nickel is limited (1) in posts used during epithelization after piercing (nickel content below 0.05%); (2) in objects intended for direct and prolonged contact with the skin, such as jewellery, watches, buttons, zippers etc. (nickel release below 0.5 microgram/cm2/week); and (3) coated items under (2) must fulfil the criteria after ”two years of normal use”. The Nickel Directive is based on three reference test methods, CEN standards, for control of compliance with the requirements of the directive. There are strong indications that nickel allergy is decreasing in Denmark, where nickel has been limited for more than 10 years. The market in Sweden had, already before the entry into force, started to adapt to the requirements.

Cosmetics
The EU Cosmetics Directive (Directive 76/768/EEC, and amendments) covers cosmetics and hygiene products and ingredients. The Directive requires full ingredient identification by INCI names, with the exception that perfumes are not fully identified. Negative, restrictive, and positive lists control cosmetic ingredients. Several skin sensitisers are restricted and some are prohibited by the directive.

Chrome(VI) in cement
National regulation in Nordic countries limits chrome(VI) in cement (below 2 mg/kg, by the addition of iron sulfate). A similar approach has been proposed also on the European level. Cement, containing more than 2 mg/kg chrome(VI), requires labelling in Europe from July 2002 (1999/45/EC, first amendment) with the phrase "Contains chromium(VI). May produce an allergic reaction".

Standardisation
European standardisation (CEN) may support European and national legislation aiming at the prevention of contact dermatitis, such as the Nickel Directive. A standardisation project (CEN BT/WG 132 ”Methods for analysis of allergens”) is currently trying to identify also other areas where the development of standardised analytical methods for specific allergens could support existing or planned European legislation.

Active participation of experts on contact dermatitis, including dermatologists, chemists, hygienists and toxicologists is essential for the development of clinically relevant regulations. Scientific studies should be performed to evaluate the effects of legislation aiming at prevention of contact dermatitis.