Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health

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 - 2015/9/1

Y1 - 2015/9/1

N2 - Summary 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 - Summary 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

SN - 0105-1873

VL - 73

SP - 133

EP - 141

JO - Contact Dermatitis

JF - Contact Dermatitis

IS - 3

ER -