AEMPS Reports 130% Increase in Unwanted Effects Notifications - Cosmetovigilance 2023

The Spanish Agency for Medicines and Medical Devices (AEMPS) reported a 130% increase in notifications of unwanted effects of cosmetics in 2023. The agency received and investigated 120 notifications, with over 70% not being serious. The most common unwanted effects were non-specific dermatitis, cosmetic acne or folliculitis, allergic dermatitis, and irritant dermatitis. The most recurrent serious adverse reaction was allergic dermatitis. In 84 per cent of the 31 severe cases, the severity criterion was temporary or permanent functional disability. The Spanish Cosmetovigilance System (SECV) received 40 notifications, but most could not be investigated due to insufficient information. The AEMPS determined that in 86 products, there was no risk to the general population, but in all cases, the related unwanted effects were due to particular reactions related to each consumer's idiosyncrasies. The increase in notifications allows for better study of unwanted effects, their nature, and frequency, and to take necessary measures to prevent their occurrence, reduce their incidence, and protect public health. The AEMPS encourages continuous communication with notifiers and encourages participation from citizens, industry, health professionals, and hairdressers and beauticians in the Spanish Cosmetovigilance System.