Review of clinical studies for claim validations of European oral hygiene cosmetics – Part 1


1. Chimar Group S.r.l., Crema, Italy
2. Eurofins Cosmetics & Personal Care Italy S.r.l., Roma, Italy


The efficacy tests in the field of cosmetics used in oral care are evolving more and more with the arrival of new technological resources. In order to correctly support the claims of effectiveness, it becomes essential to understand which tests are currently available and which are the most reliable. In this review, the most widespread claims in the cosmetic market are taken into account and the mainly used tests to validate them, are reported. Research has shown that existing tests exploit specific endpoints. Consequently, it seems that a gold standard does not exist, and that the choice of efficacy tests strongly depends on the type of claim, equipment and experience of the experts involved.

The oral cavity, or mouth, is the first part of the digestive canal and has three major and essential functions: digestion, communication and breathing. Given its functions, importance is paid in protecting its health, good condition and controlling the growth of pathogenic microorganisms directly responsible of the formation of plaque, tartar, caries and halitosis.


In Europe, the products used to maintain in good hygiene or to improve the aspect of oral cavity mainly fall under the definition of cosmetic products defined by the EU Regulation 1223/2009 (1). These in fact are used exclusively or mainly to clean, perfume, changing the appearance, protecting or keeping in good condition the oral cavity.


The claims associated to oral care products are mainly referred to have the following actions: anti-plaque, anti-bacterial, anti-halitosis, anti-tartar, whitening and anti-hypersensitivity. 
As established by the Annex of the EU Regulation 655/2013 “for the justification of claims used in relation to cosmetic products”, claims, whether explicit or implicit, shall be supported by ade ...