Joint statement from the Danish Medicines Agency, the National Board of Health and the Danish Environmental Protection Agency about tooth whitening and tooth whitening products.
Tooth whitening products for cosmetic purposes are subject to the rules about cosmetic products (executive order no. 422 of 4 May 2006).
Tooth whitening products contain the strong bleaching agent hydrogen peroxide. Hydrogen peroxide and other mixtures that may release hydrogen peroxide must only be in or be released from oral care products in a dose of maximum 0.1 %. According to the EU Scientific Committee on Consumer Products (SCCP), this dose is not high enough to whiten teeth.
In the EU in December 2005, a suggested amendment of the cosmetics directive was adopted. Hence, it will probably become permitted to sell tooth whitening products with up to 6 % hydrogen peroxide for use after recommendation from a dentist. The European Commission has not yet processed the suggestion completely, so it is unknown when it will enter into force.
This means that products marketed and sold for tooth whitening and which contain more than 0.1 % hydrogen peroxide are illegal cosmetic products.
Mixtures with hydrogen peroxide are chemical products. Chemical products containing more than what the cosmetics legislation allows must not be marketed for tooth whitening. Chemical products must comply with the rules about classification and labelling of chemical substances and products.
Dentists may use chemical substances and products according to the same rules as for all other kinds of work: It must take place with due care and be based on an individual assessment of advantages, disadvantages and patient safety risks before start of treatment.
It is a presupposition that informed consent is obtained prior to any kind of treatment.
On the Danish market, it is illegal to market tooth whitening products with a CE mark as medical devices. Under the Danish legislation on medical devices, tooth whitening products are not considered to be medical devices.
The National Board of Health: Dentist Mette Halberstadt, tel.: +45 7222 7659 or Head of Department Mette Dons, tel.: +45 7222 7800.
The Danish Medicines Agency: Press Officer Christian Howard-Jessen, tel.: +45 4488 9566.
The Danish Environmental Protection Agency: Head of Department Lea Frimann Hansen, tel.: +45 3266 0546 or mobile: +45 2565 0242.
The Danish Medicines Agency, 29 August 2006, update 26 Octobre 2010