Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health
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Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health. / Schwensen, Jakob F; White, Ian R; Thyssen, Jacob P; Menné, Torkil; Johansen, Jeanne D.
In: Contact Dermatitis, Vol. 73, No. 3, 09.2015, p. 133-41.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health
AU - Schwensen, Jakob F
AU - White, Ian R
AU - Thyssen, Jacob P
AU - Menné, Torkil
AU - Johansen, Jeanne D
N1 - © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2015/9
Y1 - 2015/9
N2 - 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.
AB - 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.
KW - Cosmetics
KW - Dermatitis, Allergic Contact
KW - Epidemics
KW - Europe
KW - Female
KW - Humans
KW - Male
KW - Nitriles
KW - Preservatives, Pharmaceutical
KW - Prevalence
KW - Retrospective Studies
KW - Risk Assessment
KW - Risk Management
KW - Thiazoles
U2 - 10.1111/cod.12446
DO - 10.1111/cod.12446
M3 - Journal article
C2 - 26184096
VL - 73
SP - 133
EP - 141
JO - Contact Dermatitis
JF - Contact Dermatitis
SN - 0105-1873
IS - 3
ER -
ID: 162154429