Since 31 October 2012, the European regulation on cosmetics is tougher concerning all tooth whitening products that contain hydrogen peroxide. Currently, two types of products coexist on the market: some with a status of medical device, others with the status of cosmetic product. On 9 July 2013, the French ANSM took a decision of sanitary police, to wipe out from the market products that are unduly EC labelled as medical devices, when they are in the legal frame of cosmetics.
Since the overall of the European regulation on the tooth whitening products, implemented on 31 October 2012, the ANSM reminds us, tooth whitening products containing or releasing hydrogen peroxide are classified as cosmetic products.
Now, these products qualify as cosmetic products, considering, on the one hand, their application site (the outer surface of teeth) and, on the other hand, their main function (these products are designed to modify the teeth aspect).
Furthermore, this new regulation has put these products in a tougher frame, especially when allowing only dental surgeons to carry out the first use of the products in which the hydrogen peroxide concentration is between 0.1% and 6%, and for adults use only.
Currently, on the market, tooth whitening products with a status of medical device, and others with a status of cosmetics coexist.
The ANSM points out the fact that the tooth whitening claim is not per se a medical aim, even if a dark spot or some tooth colouring is due to an illness. In fact, such a product is used only for aesthetic purposes.
Considering these elements, the ANSM took a decision of sanitary police on 9 July 2013 to make compliant all the products present …
