The Spanish Agency of Medicines and Health Products (AEMPS) communicated this Wednesday the order to stop the marketing, withdraw from the market, and proceed with the recovery of lot 20250620 of the cosmetic "Smilekit Teeth Whitening pen", after it was verified that it contains a concentration of hydrogen peroxide higher than allowed in oral products intended for the general public.
As the body, which depends on the Ministry of Health, has specified, the analyses carried out by the French authorities on this item have determined a hydrogen peroxide concentration of 7.6 percent, despite the fact that the maximum authorized content of hydrogen peroxide present or released in products for the oral cavity is 0.1 percent.
Consequently, the agency has indicated that the product, introduced on the market by the French company France Effie Cosmeceuticals Technology and distributed through the Temu platform, violates the requirements established in Regulation (EC) no. 1223/2009 relating to cosmetic products.
The AEMPS became aware of this situation following an alert communicated through the European Safety Gate notification system and has transferred the instructions to cease sale, withdraw, and recover to the health authorities of the autonomous communities so that they may disseminate them.
The body recommends that those who have purchased this cosmetic, if they have any unit belonging to the affected lot, refrain from using it.