ADVERSE-EFFECTS OF COSMETICS AND TOILETRIES REPORTED TO THE SWEDISH-MEDICAL-PRODUCTS-AGENCY 1989-1994

In Sweden, a cosmetic control system was introduced in 1989 at the Med ical Products Agency (MPA). It consists of a register of importers, ma nufacturers and their products, and a voluntary adverse reaction repor ting system identical to that concerning drugs. Between 1989 and 1994, MPA evaluated 191 reports concerning adverse effects of 253 cosmetics and toiletries. 90% of the reports concerned women and the top-rankin g product category was moisturizers, followed by hair care products an d nail products. The majority of the adverse effects reported involved only the skin, and 90% were eczematous reactions. 70% of the eczemas were classified as contact allergic, as patch tests were positive to t he product as is, and in 1/2 of these products, 1 or more relevant all ergens could be identified when tests were made with individual cosmet ic ingredients. The most common offending ingredients were fragrances, toluenesulfonamide-formaldehyde resin and preservatives. The number o f reports is small in relation to the expected number of cosmetic adve rse effects, which can be explained by under-reporting. Efforts are be ing made to persuade Swedish physicians to report more often.