Enlightening innovations in the field of teeth whitening?

What does the law say about cosmetic bleaching?

Most dental practices offer bleaching treatments on site and at home, as the demand for radiantly white teeth is high. In Switzerland, tooth whitening and bleaching products are considered cosmetic products and are regulated in the Ordinance on Cosmetic Products (Art. 7 VKos).

Hydrogen peroxide is a tried-and-tested and common bleaching agent for bleaching products: depending on the concentration and frequency of use, the oxidative effect of the substance leads to visibly lighter teeth. Hydrogen peroxide is therefore an integral part of most bleaching products, whether they are whitening gels, strips or pens. Its use is regulated by law and is categorised into different concentration levels.

Bleaching products with a hydrogen peroxide concentration of less than 0.1% may be sold freely according to the law. This means that all kinds of whitening products from well-known brands are sold in shops and dental practices every day. However, if the hydrogen peroxide concentration in the bleaching product is between 0.1 and 6%, it may only be dispensed or sold by dentists and dental hygienists after the patient has been examined and advised. The first application must therefore be carried out in the dental practice by a specialist before the patient is allowed to take the bleaching product home for further use.

As an alternative to home bleaching kits, many dental practices also offer bleaching treatments that are carried out directly in the practice and deliver perfect results after one session. Bleaching products used for on-site treatment often have a high hydrogen peroxide concentration, i.e. over 6%. However, the law now stipulates a maximum limit of 6%. What does this mean for the use of high-percentage bleaching products in everyday practice?

Is high-percentage bleaching (still) allowed?

In a recommendation dated May 2023, the FSVO (Federal Food Safety and Veterinary Office), which is responsible for cosmetic products, points out that tooth whiteners with a peroxide content of over 6% are not safe for health and therefore may not be placed on the market and used as cosmetic products. This statement corresponds to the current legal regulation. In its recommendation, the FSVO also refers to a scientific opinion from the European Commission, which categorises the use of bleaching products with a peroxide concentration of over 6% as unsafe for consumers.

With the entry into force of the new MepV (Medical Devices Ordinance) in Mai 2022, Switzerland largely adapted its medical device legislation to the EU Medical Device Regulation (MDR). As part of these changes, the requirements for medical devices were tightened and certain products that were previously not considered medical devices were reclassified as such. However, it has not yet been explicitly clarified whether bleaching products with a peroxide content of over 6% are now considered medical devices in Switzerland, as they are no longer cosmetics due to their high peroxide content. This legal vacuum has even led to certain manufacturers announcing that they will cease production of bleaching products with a peroxide content of over 6% in future.

What applies now and in the future?

What now applies to bleaching treatments that are carried out with products that have a peroxide content of over 6%? This requires a brief look at the legislation: The predecessor of the European MDR, the MDD, qualified bleaching products with a peroxide content of over 6% as medical devices. The new and currently applicable MDR lays down stricter rules for medical devices, which means that bleaching products previously marketed under the old MDD regulation may no longer be marketed from May 2024. The EU currently refuses to qualify bleaching products with a peroxide content of over 6% as medical devices under the new law, as tooth bleaching does not have a primary medical purpose. This approach also has an impact on Switzerland, as the Swiss MepV has been largely harmonised with the regulations of the European MDR. It can therefore be assumed that Switzerland will follow this approach.

In practice, this means that bleaching treatments with products with a peroxide content of over 6% will probably not (or no longer) be permitted in the near future. However, transitional phases and deadlines must be observed, which may vary depending on the product. We therefore recommend checking the products used for bleaching treatments in advance to ensure that all legal requirements are met.