Second report on undesirable effects published

02/ September

Today the CED published the second report on undesirable effects caused by tooth whitening products. This report covers the period from 1 November 2013 to 31 October 2014 and was prepared under an agreement signed between the CED and the European Commission on 31 March 2010 in the framework of the future regulation on the use of tooth whitening products (Directive 2011/84/EU later repealed by Regulation 1223/2009).

The agreement was signed to support the ongoing availability of tooth whitening products (TWPs) on EU market, to ensure that these products are not directly available to the consumer and that, for each cycle of use, the first use is limited to dental practitioners (dentists) or under their direct supervision if an equivalent level of safety is ensured.

The report was prepared based on the replies received from dentists who have themselves observed undesirable effects caused by TWPs or from dentists whose patients have reported to them the undesirable effects, with concentrations of hydrogen peroxide between 0.1% and 6% and of carbamide peroxide between 0.3% and 16.62%.

The questionnaire was anonymous and only the summary results are reported.

The CED continues to collect information about undesirable effects of TWPs. Dentists are encouraged to reply to the third survey through their national associations; more information is available here.

The first report is available here.

IMPORTANT NOTE: Tooth whitening or bleaching products are currently regulated by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. This Regulation repealed Council Directive 2011/84/EU of 20 September 2011 amending Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress. The latest consolidated version of Regulation (EC) No 1223/2009 is available here.

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