A few weeks ago we found the news bomb of the OCU complaint that the cream ISDIN Photoprotector Pediatrics Transparent Spray SPF 50+ and the Babaria Infantil Spray Protector SPF 50+ they did not offer the announced protection in the label, but rather much lower ones, and all this according to the own studies carried out.
As we informed at the time, after such a complaint, from ISDIN assured us that had been addressed to the competent authorities, that is, to the Spanish Medicines Agency-AEMP, which depends on the Ministry of Health, putting At their disposal the five studies they had carried out that demonstrated the safety and efficacy of the product.
Well, now it has been the AEMP that has ruled on this issue after examining the trials provided by all parties involved and, interestingly, everyone is right in a statement that Has published.
The Spanish Agency of Medicines and Health Products (AEMPS) has verified that all the studies presented, both by companies and by the Organization of Consumers and Users (OCU), on the products “ISDIN Photoprotector Pediatrics Transparent Spray SPF 50+ and Babaria Solar Child Spray Protector SPF 50+ ”are valid and have been carried out according to the reference methods. Studies by both companies confirm that the sun protection factor (SPF or SPF) corresponds to their labeling.
That is ISDIN and Babaria comply with the protection they put on their labeling, but what the OCU study is fully valid too. So, Who has the reason? As AEMPS continues to say, the methodology used by both parties, the OCU and the companies denounced, is different in their laboratories, which could explain the different results obtained, in addition to the existence of the new formats of the lots (transparent spray, mists, etc).
In fact, it seems that it is precisely to these new formats that the ISO standard has to be adjusted, with which these products are evaluated and that it is from 2010, as assured by the head of the Department of Sanitary Products of the Agency of the Drug, Carmen Ruiz-Villar, who concludes by saying that ISO is revising the standard to avoid this variability of methodology between laboratories.
The AEMPS after the valuation of all available information and taking into account that notifications of serious unwanted effects of the aforementioned products have not been received in the Spanish Cosmetovigilance System, considers that there is no evidence of risk to human health, provided that solar products are used according to the mode of use indicated on their labels.
This concludes the Agency depends on the Ministry of Health, ensuring that there are no health risks but, in any case, sowing the shadow of doubt.
In any case, how could it be otherwise, OCU He has already published his own statement in which he says…
AEMPS has released the resolution on sunscreens: recognizes that the OCU study is correct and follows current regulations, but it also gives the reason to the manufacturers of the products that OCU denounced, questioning the ISO standards of analysis, casting doubts about all the companies in the sector and sowing confusion and helplessness among consumers.
Thus, from the OCU ensure that the AEMPS does not contradict its study, in fact, they endorse it, but take the arguments put forward by the companies for good, in any case questioning ISO standards that regulate the tests of sun protection factors, tests that, as they indicate, come from the European Commission and have been supported by the industry.
Therefore, as a conspiracy, We understand that the explanations given by the AEMPS that do not provide any clarity are insufficient, in fact they sow more doubts about the issue and leave it entirely in the hands of the consumer, as if it were an act of faith, to trust one or the other.