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 Medical Products Agency (MPA). It consists of a register of importers, manufacturers and their products, and a voluntary adverse reaction reporting 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-ranking product category was moisturizers, followed by hair care products and 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 the product as is, and in 1/2 of these products, 1 or more relevant allergens could be identified when tests were made with individual cosmetic ingredients. The most common offending ingredients were fragrances, toluenesulfonamide-formaldehyde resin and preservatives. The number of reports is small in relation to the expected number of cosmetic adverse effects, which can be explained by under-reporting. Efforts are being made to persuade Swedish physicians to report more often.