The solar products belong to the category of cosmetics and for their regulation we refer to the EC 1223/2009 of the European Parliament and to the Recommendation EC 2006/647 on the efficacy and claims of sunscreen products. Based on these rules is the need to validate the photoprotection separately in the range of UVA and UVB, with in vitro and in vivo methods, with preference for the latter. For the UVA range (320 nm - 400 nm) in vivo tests have been replaced completely by those in vitro, in view of the good correlation found, harmonized and standardized in the ISO 24443: 2012. For the UVB range (290 nm - 320 nm) the use of the method in vivo is still a need, standardized by Standard ISO 24444: 2010, due to problems related to lack of correlation between the in vitro and in vivo data. The Sun Protection Factor is still largely used and sometimes “abused”, as the unique indicator for the efficacy of a solar product and more recently also for antiage and make-up. However a number of studies appeared in the last decade largely demonstrate that, beside its numeric value, several other properties and factors must be considered in giving useful indication to the customers in the selection of the right product.
The in vitro sun protection factor (SPF) is not descriptive of the real performance of solar products
MANFREDINI, Stefano;NUCIBELLA, Laura;ZIOSI, Paola;DISSETTE, Valeria;MAGRI, ILENIA;VERTUANI, Silvia
2015
Abstract
The solar products belong to the category of cosmetics and for their regulation we refer to the EC 1223/2009 of the European Parliament and to the Recommendation EC 2006/647 on the efficacy and claims of sunscreen products. Based on these rules is the need to validate the photoprotection separately in the range of UVA and UVB, with in vitro and in vivo methods, with preference for the latter. For the UVA range (320 nm - 400 nm) in vivo tests have been replaced completely by those in vitro, in view of the good correlation found, harmonized and standardized in the ISO 24443: 2012. For the UVB range (290 nm - 320 nm) the use of the method in vivo is still a need, standardized by Standard ISO 24444: 2010, due to problems related to lack of correlation between the in vitro and in vivo data. The Sun Protection Factor is still largely used and sometimes “abused”, as the unique indicator for the efficacy of a solar product and more recently also for antiage and make-up. However a number of studies appeared in the last decade largely demonstrate that, beside its numeric value, several other properties and factors must be considered in giving useful indication to the customers in the selection of the right product.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.