Monitoring levels of preservative sensitivity in Europe

Abstract

A 10-year multicentre analysis of the frequency of sensitivity to common preservatives collected in 16 centres in 11 countries has shown stable but persisting high levels of sensitivity to formaldehyde and 5-chloro-2-methyl-4-isothiazolin-3-one + 2-methyl-4-isothiazolin-3-one (MCI/MI). It has also revealed a significant increase in the level of reactivity to methyldibromoglutaronitrile (MDBGN) from 0.7% in 1991 to 3.5% in 2000. The current high level of sensitivity to MDBGN requires an urgent safety re-evaluation and risk assessment update along with consideration of immediate lowering of use concentrations, especially in leave-on products.

Periorbital Allergic Contact Dermatitis - The Most Common Allergens in the Czech Republic

“…Sensitization potential of parabens is relatively low, when considering long-term application. During 1999-2000 in 11 European countries, the frequency of sensitization was 0.5% [22], during [2004][2005] in Great Britain among 6,958 patients; sensitization was 0.8% [23]. Among our patients with periorbital dermatitis, sensitization was 0.6%, however with no clinical relevance (none of the patients had used any ophtalmic product containing parabens).…”

Kathon CG y Dermatología Laboral: Actualización

“…La MCI y la MI, al igual que otros conservantes del grupo formaldehído o mercuriales, pueden tener alto poder de sensibilización, como se ha demostrado por estudios experimentales y por la practica clínica, presentando la MCI mayor poder sensibilizante que la MI 12 . Actualmente constituye una de las causas más frecuente de alergia de contacto por preservativos [14][15][16] . Asimismo, además de la MCI y MI existen otras isotiazolinas disponibles para la producción de productos industriales, en particular, la benzisotiazolinona, que se utiliza con frecuencia en la pintura, pudiendo ser responsable de reacciones cruzadas con MCI/MI 17 .…”

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

“…While the overall prevalence of preservative contact allergy remains frequent in many EU member states, two Danish studies have shown that the overall prevalence and burden of preservative contact allergy is increasing every time a new preservative is marketed [6][7][8][9]. This has clearly been exemplified by the introduction of MI into the European cosmetic market in 2005 where MI was given a positive opinion by the SCCS and entered onto Annex V as a preservative allowed for use in cosmetic products.…”

“…Notwithstanding recent epidemics of contact allergy to single (troublesome) preservatives, the overall prevalence of contact allergy is maintained at alarmingly high levels above 10% in consecutive patch-tested dermatitis patients [6][7][8][9]. The former comprehensive observational study by Wilkinson et al showed that in 80,000 European patients from 11 European centers, stable and high levels of contact allergy to the "old and prior epidemic" preservatives (formaldehyde, formaldehyde releasers and MCI/MI) were observed [9].…”

“…Daily skin contact with preserved cosmetic products may, however, also cause preservative contact allergy and allergic contact dermatitis; in particular, one of the currently allowed preservatives for use in cosmetic products in the EU has shown to be of concern, i.e., methylisothiazolinone (MI) [1,2]. Over recent decades several recurring epidemics of preservative contact allergy have unfortunately been observed in Europe: formaldehyde contact allergy in the 1960s, methylchloroisothiazolinone in combination with methylisothiazolinone (MCI/MI) contact allergy in the 1980s, methyldibromo glutaronitrile contact allergy in the late 1990s/early 2000s, and recently the unprecedented increase in cases of MI contact allergy in the early 2010s [3][4][5][6][7][8][9].…”