Contact Allergy to Preservatives—Is the European Commission a Commendable Risk Manager?

Schwensen, Jakob F.; Thyssen, Jacob P.

doi:10.3390/cosmetics3030029

Cited by 6 publications

(2 citation statements)

References 42 publications

(79 reference statements)

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“…The process of communicating the evidence of an emerging epidemic from the scientific community to the EC has not functioned optimally to protect the consumers from MI, delayed partly by neglect of the EC and opposing evidence by Cosmetics Europe 14,23 . It has previously been suggested that preservatives be adopted in Annex V on a time‐limited entry, thus requiring reevaluation after a certain time period 24 . It is not unreasonable to suggest that this would have limited the magnitude of the epidemic of contact allergy to MI.…”

Section: Discussionmentioning

confidence: 99%

The epidemic of contact allergy to methylisothiazolinone—An analysis of Danish consecutive patients patch tested between 2005 and 2019

et al. 2020

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Background In 2005, methylisothiazolinone (MI) was allowed as a stand‐alone preservative in cosmetics. This resulted in an epidemic of allergic contact dermatitis to MI, mainly affecting women exposed to leave‐on cosmetics. Consequently, a regulation of Annex V in the European Union in 2017 banned the use of MI in leave‐on cosmetics and reduced the allowed concentration in rinse‐off products. Objective To analyze the temporal trends in contact allergy to MI in Danish patients in relation to key events including European regulations over time. Methods A retrospective study of consecutive patients patch tested with methylisothiazolinone from 2005 to 2019. Demographics and clinical characteristics in terms of MOAHLFA (male, occupational, atopic dermatitis, hand dermatitis, leg dermatitis, facial dermatitis and age >40 years), sources of exposure, and clinical relevance were analyzed in relation to key historical events. Results Three hundred eighty of 12 494 patients (3.0%, 95CI: 2.7–3.4%) tested from 2005 to 2019 were sensitized to MI. An increasing trend in the prevalence of MI contact allergy from 2005 to 2019 (P < .01) was observed, although a decline in the absolute number of patch‐test positive patients was seen from 2013 and onward. A reduction in leave‐on cosmetics as a source of exposure was observed following the legislative ban in 2017, from 24.8% from in 2010 to 2013 to 6.2% in 2017 to 2019 (P < .01). Conclusion The epidemic of MI contact allergy is declining in absolute terms, although the prevalence in the patch‐tested population has not returned to its pre‐epidemic levels. The legislative regulation of MI in 2017 has been effective in terms of leave‐on cosmetics as a source of exposure in MI allergic patients. The process of post‐marketing risk assessment of contact allergens in the European Union needs improvement.

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Section: Discussionmentioning

confidence: 99%

The epidemic of contact allergy to methylisothiazolinone—An analysis of Danish consecutive patients patch tested between 2005 and 2019

et al. 2020

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“…Such products may consist of various hazardous ingredients that may cause skin and respiratory irritation. For example, exposure to preservatives, which used as antimicrobial ingredients, may lead to skin sensitization and allergic contact dermatitis (Schwensen and Thyssen, 2016). Meanwhile, inhalation of household disinfectants may cause serious lung injuries and even lead to fatality (Park et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

A Novel Methodology for Health Hazard and Risk Assessment of Dermal and Inhalation Exposure

et al. 2021

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Household products such as dishwasher products and multipurpose cleaners may contain specific chemical ingredients to meet the consumer needs. However, some of the ingredients may result in skin and respiratory irritation. Thus, a systematic methodology to estimate the extent of hazard and risk for consumers’ exposure to the products is needed. In this work, an index-based methodology is presented to estimate the severity of the hazards and risks of the ingredients at during the early stage of product design. Higher score was assigned to the higher potential of hazard and risk, and vice versa. The hazard potential was determined based on hazard classification by the Global Harmonised System (GHS). Risk assessment was performed by considering the Margin of Exposure (MOE) and Risk Characterization Ratio (RCR). To demonstrate the proposed methodology, the dermal and inhalation hazards as well as risks from ingredients used in formulation of liquid detergent were evaluated.

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Isothiazolinones

Schwensen¹,

Johansen²

2018

Kanerva’s Occupational Dermatology

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Contact Allergy to Preservatives—Is the European Commission a Commendable Risk Manager?

Cited by 6 publications

References 42 publications

The epidemic of contact allergy to methylisothiazolinone—An analysis of Danish consecutive patients patch tested between 2005 and 2019

The epidemic of contact allergy to methylisothiazolinone—An analysis of Danish consecutive patients patch tested between 2005 and 2019

A Novel Methodology for Health Hazard and Risk Assessment of Dermal and Inhalation Exposure

Isothiazolinones

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