The Spanish Agency of Medicines and Medical Devices (AEMPS) has reported the cessation of commercialization, market withdrawal, and recovery of two batches of dental whiteners marketed by Success Courier S.L. The measure affects the whitening strips 7D White Teeth Whitening Strips, batch T125218, and the product Teeth Whitening Pen, batch T125186, both intended for home use.
The decision responds to the detection of ingredients in concentrations exceeding the limits established for oral products by Regulation (EC) 1223/2009 on cosmetic products. Specifically, analyses carried out on the whitening strips identified a 6-methylcoumarin concentration of 0.05%, compared to the maximum permitted of 0.003%. In addition, the hydrogen peroxide content exceeded 0.9%, when the established limit is 0.1% of hydrogen peroxide present or released.
For its part, the analysis of the Teeth Whitening Pen revealed a hydrogen peroxide concentration of 8.1%, also above the maximum permitted of 0.1%.
The AEMPS became aware of these incidents through two alerts notified via the European Safety Gate system. After identifying the non-compliances, it has communicated the adopted measures to the health authorities of the autonomous communities to facilitate their dissemination.
Recommendations for consumers and distributors
The agency recommends that individuals who have any of the affected batches not use the products and return them to the establishment where they purchased them or contact the responsible company to manage their return. Likewise, it asks points of sale to review their stock, withdraw from commercialization the units corresponding to the affected batches, and contact Success Courier S.L.
This action once again highlights the importance of market controls and compliance with the safety and composition requirements established by European regulations for cosmetic products, also in categories such as oral care.