Legislation and Current Practices Concerning Risk Assessment of Skin Sensitizers in the European Union. A Comparative and Survey Study

Background: Despite legislation aimed to protect the population against skin sensitization in the European Union (EU), overone 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 gath-ered 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 authoritiesand regulators, researchers/clinicians, and non-governmental organisations. The questions concerned the legislation, the riskassessment process, data collection and potential improvements.Results: Seven areas of legislation were analysed. The legislation was found to be unharmonised, for example, differing modesof restriction and accepted tests for skin sensitization. Approximately 40% of the questionnaire respondents found that the EUlegislation and tools were not sufficiently protective. To improve the legislation 83% suggested harmonisation and 68% suggestedbetter 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.