Vigilance in industry: cosmetics and household cleaning products. Balance sheet of case report from 2005 to 2007.
BACKGROUND
Unlike medicinal products, cosmetics are not subject to marketing authorization in France. Nevertheless, the Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS; French Agency for the Safety of Healthcare Products) has been working on the development of a cosmetovigilance system for several years, with the aim of establishing standard procedures for collecting adverse reactions to cosmetics from the manufacturers.


OBJECTIVE
To assess the incidence of skin reactions to cosmetics or household products. Unilever established its own 'vigilance' standard system in France in late 2003. This report describes the experience acquired from 2005 to 2007.


METHODS
Case reports were collected in compliance with a standard procedure. The cases were then analysed by the consultant dermatologist in accordance with a pharmacovigilance-based method (chronological criteria, clinical criteria, possible rechallenge test, patch tests).


RESULTS
During the period 2005 to 2007, a total of 102,689 consumers contacted the consumer department, including 842 (0.82%) who reported skin reactions. After analysis of the collected data, 0.144 skin reaction cases per million units sold were found to be attributable to cosmetic or household products.


CONCLUSIONS
The implementation of a structured vigilance system in the cosmetics and household products industry is an efficient tool for manufacturers, both for information purposes and for product improvement, as well as meeting the transparency requirements of health authorities and consumers.
Kornfeld-Lecanu
S
S
Unilever France, Rueil-Malmaison, France.
Zajaczkowski
F
F
Dubourg
S
S
Martin
L
L
Lefort
S
S
Siest
S
S
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D003257:Consumer Product Safety; D003358:Cosmetics / Q000009:adverse effects; D003877:Dermatitis, Contact / Q000453:epidemiology*; D005602:France / Q000453:epidemiology; D006795:Household Products / Q000009:adverse effects*; D006801:Humans; D010328:Patch Tests
D003358:Cosmetics