The Cosmetic Products ((Safety) Amendment) Regulations 2012 (implementing Directive
2011/84 EU which amends Directive 76/768/EEC) came into force on 31 October 2012.
- Toothwhitening products containing or releasing between 0.1% and 6% hydrogen peroxide cannot be used on
any person under 18 years of age except where such use is intended wholly for the purpose
of treating or preventing disease.
- Toothwhitening products containing or releasing less than 0.1% of hydrogen peroxide, including
mouth rinse, tooth paste and tooth whitening or bleaching products are safe and
will continue to be freely available on the market.
- Tooth whitening products containing or releasing between 0.1% - 6%
of hydrogen peroxide should be used as follows:
- an appropriate clinical examination is to be carried out in order to ensure that
there are not risk factors or any other oral pathology concerns;
- exposure to these products should be limited to ensure that the products are only
used as intended in terms of frequency and duration of application;
- the products should not be directly available to the consumer, only through a dentist,
dental hygienist or dental therapist.
Tooth whitening products containing or releasing between 0.1% to 6% hydrogen peroxide
can ONLY be sold to dental practitioners.
For each cycle of use, the first use can ONLY be carried out by dental practitioners
or under their direct supervision if an equivalent level of safety is ensured.
After the first cycle of use, the product may be provided by the dental practitioner
to the consumer to complete the first cycle of use.
- Concentrations exceeding 6% of hydrogen peroxide present or released in oral products,
including tooth whitening or bleaching products, remain prohibited UNLESS wholly
for the purpose of the treatment or prevention of disease.
- It is a criminal offence to act in breach of the Regulations.
- GDC registrants need indemnity for any treatment which they provide.
- The GDC does not bring criminal prosecutions of bring criminal prosecutions of breaches
of the regulations as this role is undertaken by Trading Standards. However, the
GDC is concerned with the fitness to practise of its members. It takes the view
that if a practitioner has committed a criminal offence, that must be relevant to
any assessment of that practitioner’s fitness to practise irrespective of whether
there has been a prosecution. Therefore, if we receive information or a complaint
that a registrant is using a product for cosmetic purposes in excess of the 6%,
they may face fitness to practise proceedings and can expect to have the matter
referred to the relevant Trading Standards department.