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

IF 4.8 1区医学 Q2 ALLERGY Contact Dermatitis Pub Date : 2025-02-07 DOI:10.1111/cod.14754

Mathias Krogh Pedersen, Jakob Ferløv Baselius Schwensen, Jose Hernán Alfonso, Steen Mollerup, Gianluca Selvestrel, Christina Rudén, Martin F Wilks, Jeanne Duus Johansen

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引用次数: 0

Abstract

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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来源期刊

Contact Dermatitis 医学-过敏

CiteScore

4.60

自引率

30.90%

发文量

227

审稿时长

4-8 weeks

期刊介绍： Contact Dermatitis is designed primarily as a journal for clinicians who are interested in various aspects of environmental dermatitis. This includes both allergic and irritant (toxic) types of contact dermatitis, occupational (industrial) dermatitis and consumers" dermatitis from such products as cosmetics and toiletries. The journal aims at promoting and maintaining communication among dermatologists, industrial physicians, allergists and clinical immunologists, as well as chemists and research workers involved in industry and the production of consumer goods. Papers are invited on clinical observations, diagnosis and methods of investigation of patients, therapeutic measures, organisation and legislation relating to the control of occupational and consumers".