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Legislation and Current Practices Concerning Risk Assessment of Skin Sensitizers in the European Union: A Comparative
Mathias Krogh Pedersen1,2, Jakob Ferløv Baselius Schwensen1, Jose Hernán Alfonso3,4
1The National Allergy Research Centre (Videncenter for Allergi), Department of Allergy, Dermatology and Venerology, Copenhagen University Hospital Herlev-Gentofte, Gentofte Hospital, Hellerup, Denmark.
Background:
Despite legislation aimed to protect the population against skin sensitization in the European Union (EU), over one quarter of the general population is sensitised to at least one chemical.
Objectives:
To provide an overview and comparison of European legislation concerning skin sensitization. In addition, we gathered the opinions of experts and stakeholders regarding improvements in the legislation and risk assessment process in the EU, to provide suggestions for improvement.
Methods:
Legislation was identified and compared. Four questionnaires were created towards industry, competent authorities and regulators, researchers/clinicians, and non-governmental organisations. The questions concerned the legislation, the risk assessment process, data collection and potential improvements.
Results:
Seven areas of legislation were analysed. The legislation was found to be unharmonised, for example, differing modes of restriction and accepted tests for skin sensitization. Approximately 40% of the questionnaire respondents found that the EU legislation and tools were not sufficiently protective. To improve the legislation 83% suggested harmonisation and 68% suggested better data sharing. Other areas were: improved exposure data (78%), better understanding of the skin sensitization mechanism (67%) and non-animal tests (66%).
Conclusions:
Stakeholders had varying confidence towards the protection of European citizens against skin sensitization. Multiple areas for improvement regarding the legislations and the risk assessment process were identified.
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