title: Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health.
abstract: BACKGROUND
  In view of the current and unprecedented increase in contact allergy to methylisothiazolinone (MI), we characterized and evaluated two recent epidemics of contact allergy to preservatives used in cosmetic products to address failures in risk assessment and risk management.
  
  
  OBJECTIVE
  To evaluate temporal trends of preservative contact allergy.
  
  
  METHODS
  The study population included consecutive patch tested eczema patients seen at a university hospital between 1985 and 2013. A total of 23 138 patients were investigated for a contact allergy.
  
  
  RESULTS
  The overall prevalence of contact allergy to at least one preservative increased significantly over the study period, from 6.7% in 1985 to 11.8% in 2013 (p < 0.001). Importantly, the preservatives methyldibromo glutaronitrile and MI rapidly resulted in high sensitization prevalence rates, which reached epidemic proportions. Although the proportion of patients with current clinical disease attributable to methyldibromo glutaronitrile contact allergy decreased significantly following the ban on its use in cosmetic products (p < 0.001), the sudden and high proportion of current sensitization to MI requires immediate attention (p < 0.001).
  
  
  CONCLUSIONS
  The introduction of new preservatives in Europe with inadequate pre-market risk assessment has rapidly increased the overall burden of cutaneous disease caused by preservatives. We suggest that the cosmetic industry has a responsibility to react faster and replace troublesome preservatives when a preservative contact allergy epidemic is recognized, but the European Commission has the ultimate responsibility for failures in risk management after new, major sensitizing preservatives are introduced onto the market.
authors.affiliation: Department of Dermato-Allergology, National Allergy Research Centre, Copenhagen University Hospital Gentofte, 2900, Hellerup, Denmark.
authors.forename: Jakob F
authors.initials: JF
authors.lastname: Schwensen
authors.affiliation: St John's Institute of Dermatology, St Thomas' Hospital, London, SE1 7EH, UK.
authors.forename: Ian R
authors.initials: IR
authors.lastname: White
authors.affiliation: Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, 2900, Hellerup, Denmark.
authors.forename: Jacob P
authors.initials: JP
authors.lastname: Thyssen
authors.affiliation: Department of Dermato-Allergology, National Allergy Research Centre, Copenhagen University Hospital Gentofte, 2900, Hellerup, Denmark.
authors.forename: Torkil
authors.initials: T
authors.lastname: Menné
authors.affiliation: Department of Dermato-Allergology, National Allergy Research Centre, Copenhagen University Hospital Gentofte, 2900, Hellerup, Denmark.
authors.forename: Jeanne D
authors.initials: JD
authors.lastname: Johansen
mesh_terms: D003358:Cosmetics / Q000009:adverse effects*; D017449:Dermatitis, Allergic Contact / Q000453:epidemiology* / Q000209:etiology; D058872:Epidemics; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D009570:Nitriles / Q000009:adverse effects; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects*; D015995:Prevalence; D012189:Retrospective Studies; D018570:Risk Assessment / Q000592:standards*; D012308:Risk Management / Q000592:standards*; D013844:Thiazoles / Q000009:adverse effects
chemical_list: D003358:Cosmetics; D009570:Nitriles; D011310:Preservatives, Pharmaceutical; D013844:Thiazoles; C011506:2-methyl-4-isothiazolin-3-one; C039411:1,2-dibromo-2,4-dicyanobutane
keywords: allergic contact dermatitis; epidemic; methyldibromo glutaronitrile; methylisothiazolinone; preservatives; risk management