EDQM warns of problem tooth whiteners in Europe

A study of tooth whitening products sold in Europe has found that a high proportion didn’t meet cosmetic regulatory standards.

The testing by the European Directorate on the Quality of Medicines and Healthcare (EDQM) involved 261 samples collected between 2013 and 2017, mainly bleaching toothpastes and whitening gels but also including tray-based whiteners, whitening strips and paint-on whiteners.

While the overall level of compliance with regulations was 71 per cent – which meant that nearly a third of all products failed testing – the EDQM found that the situation was much worse in some product categories.

In particular, 78 per cent of paint-on whiteners and more than 50 per cent of tray-based tooth whiteners and whitening strips were non-compliant for various reasons, including higher than permitted levels of the bleaching agent hydrogen peroxide and the presence of substances that could be carcinogenic, mutagenic or toxic for reproduction (CMR), including sodium perborate.

The British Dental Association recommends that “due to serious concerns regarding the safety of sodium perborate” it should not be used in tooth whitening products.

It is also apparent this isn’t a problem simply of imported products as two-thirds of the sampled products were manufactured in European countries.

The percentage of non-compliant samples of toothpaste was very low compared to other cosmetics categories at 3 per cent, said the EDQM. Several products were found not to be registered in the Cosmetic Products Notification Portal (CPNP) and the labels of some products wrongly reported CE marking.

The findings indicate that the European Network of Official Cosmetics Control Laboratories (OCCLs) coordinated by the EDQM and national regulators should monitor these products much more closely than at present, says the agency.

While there’s no suggestion that the samples tested were fake, there have been incidents in European countries, including the UK, of counterfeit teeth whitening kits containing dangerous amounts of hydrogen peroxide.

A 2012 EU regulation says teeth whiteners must contain no more than 0.1 per cent hydrogen peroxide or chemicals which release the substance.