Thursday, December 2

The Aemps once again recognizes the difficulty in measuring the level of photoprotection of solar products and will lead a review of the method in Europe

Aemps questioned the SPF of 14 photoprotection products.

The new rectification of the Spanish Agency of Medicines and Health Products (Aemps) regarding the products of photoprotection marketed in the Spanish market returns to question the efficacy and credibility of current measurement methods of the sun protection index (SPF).

This summer and after commissioning its own studies, Aemps questioned the SPF of 14 photoprotection products of different brands that are marketed in the Spanish market, which would have obtained in those studies commissioned by Aemps lower SPF values ​​than those indicated by the industry.

After some of the companies involved have contributed numerous reports and studies to Aemps, the agency has rectified its previous considerations in relation to a part of these products, it has endorsed the SPF claimed in some of these sunscreens and, with this, it has once again recognized and confirmed that there is a high degree of variability in the results SPF measurement that is currently the most widely followed method (the ISO 24444 method).

In its last official statement this Friday, the Aemps admits that “once again it is observed variability in methodological application of the technical standard ‘ISO 24444 Sun protection test methods. In vivo determination of SPF ‘, which affects high SPFs (50 and 50+). This variability hinders the desirable reproducibility to accurately measure the most relevant parameter of the effectiveness of sunscreens, which is the SPF. ” Not in vain the AEMPS has detected variabilities of more than 30 points in some of the products tested, which by applying the same method (the ISO 24444 method) can obtain SPF results higher than 60 in some laboratories and lower than 29.9 in others.

Faced with this situation, what repeats itself in time (In 2019 the AEMPS already had the opportunity to verify the existence of variability in the determination of the SPF as a result of the OCU campaign regarding certain photoprotectors on the market), the Aemps has once again announced that its objective is to lead before the groups of work of the European institutions and, at the international level, in the ISO / TC 217 Cosmetics Committee, responsible for the development of the ISO 24444 method, on the need to have a robust measurement method for the determination of SPF, which generates confidence to citizens, the solar products industry and decision-making authorities.

With all this, the position of the Aemps and its new rectification agrees and confirms the arguments of some companies in the sun protection sector, which in recent years have been denouncing the extreme variability existing in the ISO 24444 measurement method to determine the SPF in this type of products, and the need to adapt it.

For its part, the National Perfumery and Cosmetics Association (Stanpa) has also been advocating a change in measurement methods for some time, stating that sun protection test methods are very complex techniques with many variables.

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