Market Surveillance Uncovers Failure of Dental Hygiene Products to Meet Legal Requirements

In particular, tooth whiteners are often deficient. A CMR substance, sodium perborate (German only), was found in one sample, and an excessive amount of hydrogen peroxide was found in another. Those are the findings the Official Cosmetics Control Laboratories (OCCLs) discovered in a market surveillance project in 2013-17. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has issued a press release on the findings.

During the project, a total of 261 samples were taken at 13 laboratories. Almost half of the samples examined were bleaching toothpastes. A little more than 20% were bleaching gels. The rest were tooth whiteners, mouthwashes, and other cosmetics. Three of four products were manufactured in Europe. The most defects were found in tooth whiteners: Paint-on (brush-on) whiteners (78%), tray-based tooth whiteners (59%), whitening strips (53%), and whitening gel (45%).

Many of the products were not registered through the Cosmetic Products Notification Portal (CPNP), the online notification system of the European Commission, and the labels of many products wrongfully carried the CE symbol.

The manufacturers removed some of the defective products from the market on their own initiative. National agencies issued sales prohibitions for the others.

In October of this year, the EU will add 12 substances of very high concern (SVHC), including sodium perborate to Annex XIV of the REACH Authorization List.

Ensure the legal security of your products as soon as possible. Contact us at cosmetic@kft.de.

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