Evidence map›Paper›PMID 39917955›Full record

ArticleContact dermatitis2025

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

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

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Contact dermatitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Mathias Krogh PedersenThe National Allergy Research Centre (Videncenter for Allergi), Department of Allergy, Dermatology and Venerology, Copenhagen University Hospital Herlev-Gentofte, Gentofte Hospital, Hellerup, Denmark.ORCID https://orcid.org/0009-0006-7185-2042
Jakob Ferløv Baselius SchwensenThe National Allergy Research Centre (Videncenter for Allergi), Department of Allergy, Dermatology and Venerology, Copenhagen University Hospital Herlev-Gentofte, Gentofte Hospital, Hellerup, Denmark.ORCID https://orcid.org/0000-0003-0418-1622
Jose Hernán AlfonsoSection of Occupational Medicine and Epidemiology, National Institute of Occupational Health, Oslo, Norway.ORCID https://orcid.org/0000-0003-3504-2473
Steen MollerupSection of Occupational Toxicology, National Institute of Occupational Health, Oslo, Norway.ORCID https://orcid.org/0000-0002-3306-8998
Gianluca SelvestrelLaboratory of Environmental Chemistry and Toxicology, Environmental Health Department, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.ORCID https://orcid.org/0000-0003-0653-3302
Christina RudénDepartment of Environmental Science, Stockholm University, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-9193-1147
Martin F WilksSwiss Centre for Applied Human Toxicology & Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland.ORCID https://orcid.org/0000-0003-3984-5935
Jeanne Duus JohansenThe National Allergy Research Centre (Videncenter for Allergi), Department of Allergy, Dermatology and Venerology, Copenhagen University Hospital Herlev-Gentofte, Gentofte Hospital, Hellerup, Denmark.ORCID https://orcid.org/0000-0002-3537-8463

Funding

EU's Horizon Europe research and innovation program 101057014Unrestricted grant to The National Allergy Research center from the Danish Financial Act
6 · The paper itself

Abstract

backgroundDespite 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.

objectivesTo 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.

methodsLegislation 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.

resultsSeven 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%).

conclusionsStakeholders 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.

Indexed as

AllergensDermatitis, Allergic ContactEuropean UnionHumansRisk AssessmentSurveys and QuestionnairesAllergensallergic contact dermatitiscontact allergyregulatory statusrisk assessmentskin sensitization

Identifiers

PMID39917955
PMCPMC12055314

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.