Berne B, Boström A, Grahnén A F, Tammela M
Medical Products Agency, Uppsala, Sweden.
Contact Dermatitis. 1996 May;34(5):359-62. doi: 10.1111/j.1600-0536.1996.tb02223.x.
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.
1989年，瑞典医疗产品管理局（MPA）引入了一个化妆品控制系统。该系统包括进口商、制造商及其产品的登记册，以及一个与药品不良反应报告系统相同的自愿报告系统。1989年至1994年间，MPA评估了191份关于253种化妆品和洗漱用品不良反应的报告。90%的报告涉及女性，排名第一的产品类别是保湿霜，其次是护发产品和美甲产品。报告的不良反应大多仅涉及皮肤，90%为湿疹反应。70%的湿疹被归类为接触性过敏，因为斑贴试验对产品本身呈阳性，并且在这些产品的一半中，当用单个化妆品成分进行测试时，可以识别出一种或多种相关过敏原。最常见的致病成分是香料、甲苯磺酰胺 - 甲醛树脂和防腐剂。与预期的化妆品不良反应数量相比，报告数量较少，这可能是由于报告不足所致。目前正在努力说服瑞典医生更频繁地报告。
