Teeth Whitening Products To Be Regulated by The European Commission

Published:August 20th, 2010

The official position of the European Commission is that teeth whitening products are cosmetics. As such, they they have put together guidelines regarding the concentration of hydrogen peroxide in the finished product in order to ensure consumer safety.

According to the EU commission, teeth whitening products should adhere to a maximum of 3.6% hydrogen peroxide (equivalent to around 10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should ideally be administered under supervision of a dentist (“take home”) and come with suitable health warnings to make sure consumers follow instructions to avoid side effects.

The decision was based on the claim that such products are aesthetic only and do not match the definition of a medical device. They have to be regulated as cosmetics, and the proposal to allow higher concentration of peroxide was rejected.

But the major issue is that although Carabide Peroxide teeth whitening is safe up to levels of 22% and above ( and is used by dentists throughout the world at these levels), the issue is whether consumers follow guidelines in order to remain safe.

The biggest issues consumers should be warned against include:

  • Applying too much product (which could lead to burns to gums)
  • Not using a tight enough mouth tray (which could lead to burns to gums)
  • Using too high levels of hydrogen or carabide peroxide
  • Using teeth whitening whilst pregnant
  • Using non FDA approved teeth whitening kits (or cheap knockoffs)

Its interesting to note that this concerns the EU only, and could be subject to change. In the US and around the world there have been no objections, and the leading teeth whitening kits have received FDA approval and have been proven to be safe.

Products containing a higher concentration should only be sold to dental practitioners. As cosmetic products, teeth whitening kits can undergo a safety assessment report, including a toxicological report and have to labelled accordingly.

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