Crossing the borders. Access to the different regulatory categories of the European skin care products


*Corresponding author
1. Eviderm Institute, Solna, Sweden
2. K.L.A.P.P. Utvecklingskonsult, Sollentuna, Sweden
3. Departments of Dermatology, University Hospitals Basel and Zürich, Switzerland


European legislation on products for curing or beautifying skin, hair and nails provides companies with a lot of freedom, which comes with the responsibility to protect users against unsafe products and misleading marketing.
Cosmetics and class I medical devices do not require any external pre-market review before being launched, since the burden of proof of their efficacy and safety is placed squarely on the responsible company. However, products presented for treatment or prevention of diseases and those that significantly change physiological function via pharmacological, immunological or metabolic action require external review prior to placement on the market.
The authorities are responsible for controlling the market and prohibiting the presentation of cosmetics for the treatment of diseases. For those not authorized as medicinal products, proof may be requested of the absence of e.g. pharmacological effects to remain on the market.


The skin is not only a barrier against desiccation and intrusion of harmful materials but also an organ of social communication. Touching the skin is essential to numerous aspects of parental and sexual behaviour, and the appearance and texture of the skin are also prominent factors in the skin´s communicatory role. A bumpy, rough, uneven and discoloured skin is linked to anxiety and depression. The value of healthy skin has also been shown repeatedly in studies of quality of life in patients with skin diseases. This value is also shown by the extensive use and high expenditures on skin care and beauty products.

In the European Union (EU), most topically applied products fall within one of the regulatory categories cosmetics (1, 2), medicinal products (3), medical devices (4) or biocidal products (5, 6) (Figure 1. Table 1). The primary aim of the regulatory categories is user protection, while at the same time exploiting health gains from innovations.

In order to ensure harmonisation across the European market, various guidance documents are published by the European Commission on the demarcation between cos ...