The Spanish Agency for Medicines and Health Products orders the cessation of sales and the withdrawal of two batches of home dental whiteners for exceeding legal limits of hydrogen peroxide and 6-methylcoumarin.
The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the cessation of sales and the withdrawal from the market of two batches of home dental whiteners. The measure, as published by lavozmadrid.es, affects batches T125218 of 7D White Teeth Whitening Strips and T125186 of Teeth Whitening Pen, both marketed by the company Success Courier S.L.
Analyses detected 6-methylcoumarin at a concentration of 0.05% in the product 7D White Teeth Whitening Strips, when the permitted limit is 0.003%. In the same product, hydrogen peroxide exceeded 0.9% compared to the legal maximum of 0.1%.
In the case of the Teeth Whitening Pen, the concentration of hydrogen peroxide reached 8.1%, well above the authorized 0.1%.
These concentrations violate Regulation (EC) No. 1223/2009 on cosmetic products. AEMPS became aware of the problem through alerts notified in the European Safety Gate system and has communicated the measures to the health authorities of the autonomous communities.
The responsible company, Success Courier S.L., is located at calle Río Tormes nº1, planta 1 derecha, oficina 3, in Fuenlabrada (Madrid).
AEMPS recommends that users who have units from the affected batches do not use them and return them to the point of purchase or to the responsible company.
Retailers must remove these products from sale and contact the company. AEMPS has communicated the measures to the regional health authorities.
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