Dental News - New study reports issues of non-compliance with tooth whitening products

Dental Tribune International

Wed. 8. May 2019

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STRASBOURG, France: In a recent market surveillance study, the European Network of Official Cosmetics Control Laboratories (OCCLs) has assessed cosmetic products for tooth whitening in order to check their compliance with European or national regulations and to gather information on their active ingredients. The findings suggested that a large number of cosmetic products were non-compliant with European Union or national regulations for cosmetic products and should be more closely monitored by national competent authorities and OCCLs.

The study was coordinated by the European Directorate for the Quality of Medicines and HealthCare. In total, 261 samples were analysed by 13 OCCLs between 2013 and 2017. Almost half of the samples collected were bleaching toothpastes. Whitening gels represented 23 per cent of the samples, whereas the remaining 30 per cent were tray-based tooth whiteners, whitening strips, paint-on whiteners, mouthwashes and general cosmetics products.

The findings showed that the majority of the products, 68 per cent, were manufactured in European countries. Several products were not registered in the Cosmetic Products Notification Portal and the labels of some products wrongly reported CE marking, a symbol that indicates conformity with health, safety, and environmental protection standards for products manufactured in or sold within the European Economic Area. The overall compliance of tooth whitening products tested in the study was 71 per cent. The non-compliance issues concerned the high hydrogen peroxide content, the presence of a CMR substance, sodium perborate, and labelling issues. CMR substances are those that have been proved carcinogenic, mutagenic or toxic for reproduction. No issues of non-compliance related to microbiological contamination were found, while mouthwashes and whitening rinses tested in the study were found compliant with all safety regulations.

The cosmetic category that showed the largest percentage of non-compliance was paint-on, or brush-on, whiteners (78 per cent), followed by tray-based tooth whiteners (59 per cent), whitening strips (53 per cent) and whitening gels (45 per cent). Toothpaste was the most compliant product in this category (3 per cent).

According to the researchers, none of the products were recalled after the study. However, for some products, the results obtained led to voluntary withdrawal from the market, demands for corrective measures, or sales bans. Finally, the study suggested that national competent authorities and OCCLs should continue to work closely to prevent the incorrect labelling of cosmetic products as medical devices.

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