A cosmetovigilance survey in Europe.

Despite the widespread use of cosmetic products the rate of adverse reactions (ARs) is relatively low probably because they are underestimated. This could be due to self-diagnosis and self-medication that is common in the presence of mild reactions that are frequently related to the skin. The lack of information concerning the type, number and severity of adverse reactions to cosmetics (ACRs) could be, at least in part, responsible for the absence of a reporting culture and favourable reporting environment. The aim of this study was to collect, among the countries belonging to the European Union and to the Common European Economic Space, information concerning post-marketing cosmetovigilance, particularly with respect to notification of ARs. To this aim a questionnaire was sent, by e-mail, to the competent authorities. Of the 28 countries to whom the questionnaire was sent, 10 responded by returning the filled questionnaire and 8 indicated a more appropriate address, of them only 4 replied. So, at the end of the survey, about 16 months after the first mail (June 2004), we could get information from 50% of the countries to whom the survey was addressed. The results of the research show that post-marketing vigilance system for cosmetics is different from country to country, with particular regard to notification of ARs. So in few countries there is a formal system to collect reports, in others the rules are not yet established and ACRs are collected by different authorities or there is no obligation to report ACRs or no need to collect them. Another difference concerns the procedure for reporting ACRs. In fact, among the 14 countries who have supplied information, only two collect ACRs through a reporting form. Moreover, it is interesting to note that the professional categories authorized to report, as well as state bodies who take charge of post-marketing vigilance of cosmetic products, vary from country to country. In fact, it is up to agencies for food safety, for environment or consumer protection or for public health. Besides, it must be underlined that in some countries private initiatives are undertaken, either in the presence or absence of a formal cosmetovigilance system. In conclusions, this survey shows that cosmetovigilance is differently handled in the European countries, although in some countries attempts are underway to set up a formal system. Moreover, the general impression is that an European cosmetovigilance system would be really appreciated by many countries. © 2007 Elsevier Ltd. All rights reserved.