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Teeth Whitening and Oral Health Products Containing Peroxide

For safety reasons, the concentration of hydrogen peroxide permitted in cosmetic products is controlled.

The content of hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, in oral health and tooth whitening products is restricted by European Cosmetics Regulation (EC) No. 1223/2009.

This can be summarised as follows:

Concentration of Hydrogen Peroxide (present or released)

Restriction

0.1% or below

The product can be sold as a cosmetic without specific restrictions.

Higher than 0.1% up to 6% 

The product can only be sold to dental practitioners (dentists). There are other legal restrictions in relation to these products, including that the product must also be applied under the supervision of a dental practitioner. 

 

Higher than 6%

The product is not compliant with the EU Cosmetic Regulations; it is prohibited from use and considered an illegal cosmetic product.  

Examples of other compounds or mixtures that release hydrogen peroxide in tooth whitening or bleaching products include carbamide peroxide, zinc peroxide, calcium peroxide, magnesium peroxide, sodium carbonate peroxide and urea peroxide. Please refer to entry 12 of Annex III of Regulation (EC) No. 1223/2009 for further information.

Reminder: all cosmetic products, including oral health and teeth whitening products, must include an EU or EEA name and address as the Responsible Person for the product. Products without an EU/EEA name and address should not be used or supplied, as they may not meet the EU safety requirements.

Note: sodium perborate and other perborate and perboric acids are prohibited from use in cosmetic products. Please refer to entries 1397, 1398, 1399 of Annex II of Regulation (EC) No. 1223/2009 for more detailed information.

All correspondence and queries in relation to teeth whitening products should be sent to cosmetics@hpra.ie.

Previous HPRA communications on tooth whitening products, issued under our former name of IMB, are available at the links below. 

Information for distributors
Information for retailers
Information for consumers