Adverse effects of cosmetics and toiletries reported to the Swedish Medical Products Agency 1989–1994

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Abstract
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 he explained, by under‐reporting. Efforts are being made to persuade Swedish physicians to report more often.