Obelis O.E.A.R.C.

Debate on Tooth Whitening Products is over

Tooth whitening products are in fact considered cosmetics - It is now an official position of the European Commission.

They must meet the provisions of Annex III, Part I, Item 12: Hydrogen peroxide, (d) Oral hygiene products: Maximum authorized concentration in the finished cosmetic product: 0.1% of H2O2, present or released.

The Commission has made proposals to increase the maximum levels permitted, subject to stringent labeling requirements and use, but there is still no consensus and it is therefore the present Directive which applies pending possible adjustments in the future.

Hence, higher levels than O.1 % are prohibited for tooth whitening sold in the EU for the moment.

The decision from the EU Commission not to consider these products as medical devices are based on the fact that the primary claim is aesthetic, dental curing is secondary or non-existent. As such, these products (with a claim solely of teeth whitening without curing) do not match the definition of a medical device and therefore are not medical devices but to be regulated as Cosmetics.

During the last meeting of the Standing Committee on Cosmetic Products (February 8th 2010), the Commission Services have presented a NEW PROPOSAL to allow higher concentrations of peroxide under strict conditions:

1. 0.1% -6% - To be only sold to dental practitioners/For each cycle of use, first use by dental practitioners/ Specific Labeling requirements, including no use on persons under 18.

2. More than 6% - To be only sold to dental practitioners/to be only used by dental practitioners/ Specific Labeling requirements, including no use on persons under 18.

If the proposal will be supported by the majority of the member states, an official vote will be requested followed by scrutiny procedure at the Parliament level and publication in the official journal of the EU commission – this is if the proposal shall be accepted as is and no revisions are required prior to the above procedure – there is no deadline for the above procedure to be completed.

As this is only a proposal and there is no current consensus on higher concentrations of H2O2 in Europe – the Cosmetic Directive applies – in which case, the restriction of 0.1% is what is currently approved in the European market.

Cosmetic products may NOT bare the CE marking; they need to comply with the applicable regulation populated in the European Cosmetic Directive 76/768/EEC and the NEW Cosmetic Regulation EC 1223/2009, such as:

- Appointing a European “Responsible Person” (aka Authorized Representative) – covering the European Union - 31 EEA (European Economic Area) countries.

- Undergoing a Safety Assessment report for your Cosmetics (Toxicological report) done by a European Safety Assessor.

- Notification (Registration) with the all 31 EEA countries Authorities.

- Notification (Registration) with the all 31 EEA countries Anti-Toxic Centers.

- Labeling compliance for all 31 EEA Countries.

- Overall compliance with National Laws in all 31 EEA countries