The Spanish Agency for Medicines and Health Products (Aemps), dependent on the Ministry of Health, has requested the cessation of marketing of the sun creams Invisible Sun Protection Face Cream SPF 50 from Rituals, Capital Soleil Crème Onctueuse Protectrice SPF 50 from Vichy and Waterlover Face Sunscreen SPF 50 from Biotherm, “in the interest of protecting the health of consumers”, by not presenting data that demonstrates that the composition of these products is equal or equivalent to the marketed formula.
This is just one of the actions announced by the agency after the complaint from the Organization of Consumers and Users (OCU) which, through a study, has observed non-compliance in the labeling of these products, as well as in protection lot 32032276. Nivea Sun Sensitive SPF 50 facial; batch 3157 of Lancaster’s Sun Sensitive Oil-Free Milky Fluid SPF 50; and lot 1362V A of Piz Buin’s Hydro Infusion Sun Gel Cream Face SPF 50, whose recalls have also been requested.
Of the seven sunscreens analyzed by the OCU, only Fusion Water Magic SPF 50 from Isdin has not been withdrawn from the market, as it has provided several tests, the results of which support the claim of the label and contradict an alleged non-compliance with the FP-UVA.
According to the Aemps, as the competent authority in controlling the market for cosmetic products, it has requested and analyzed the necessary documentation from the companies marketing these products and, after carrying out an investigation, it has taken measures to cease marketing and withdraw the product. market appropriate to each case.
The agency asked the companies involved to provide the tests that support the SPF and FP-UVA claims, carried out in accordance with official methods and in accordance with the Recommendation of the European Commission, of September 22, 2006, regarding the effectiveness of sun protection products and statements about them. These companies facilitated the tests carried out using official methods.
“All the results submitted support the claims indicated on the labels. In some cases, even the tests carried out by the companies had been carried out in the same laboratory that carried out the OCU tests.” However, “after evaluating all the information provided”, the Aemps has observed discrepancies between the results of the tests to determine the SPF carried out by the OCU and the results of the tests provided by the companies involved.
In the case of the three products that must cease marketing, the Health agency states that these products claim on their labeling a “very high” sun protection category, in accordance with the recommendations of the European Commission (EC). . However, according to the results of the tests provided by the OCU, the category obtained for these products is “high.”
These companies have not presented, to date, data that demonstrates that the composition of the product used to carry out their tests is equal or equivalent to the marketed formula. Because the test results for these products are divergent and the manufacturers have not provided data to demonstrate that the formula used in their tests is the same, the Aemps has requested these companies to withdraw the tested batches from the market. , as well as the cessation of marketing of the products.
In the case of Nivea, Lancaster and Piz Buin, it explains that these products claim a high sun protection category on their labeling, in accordance with the EC recommendation. According to the results provided by the OCU for these products, the category obtained remains high. However, the numerical SPF values obtained do not agree with those listed on the labeling.
These companies have provided data that guarantees that the formulas tested agree with those marketed. Due to the non-concordance detected and the fact that sun protection continues to be high, the Aemps has requested that companies stop marketing only the units of the tested batches of the products.
Initially, the company has provided two tests, one carried out with the official in vivo method (UNE EN ISO 24442), and another with the official in vitro method (UNE EN ISO 24443). In both cases the result obtained supports the claim of the label.
To calculate the FP-UVA according to the UNE EN ISO 24443 method, the in vivo SPF data of the product is required, obtained through the official UNE EN ISO 24444 method. The OCU has not carried out this last test, using it to calculate the FP-UVA is a data obtained by an unofficial method currently being evaluated, so the FP-UVA value obtained by the OCU is not considered decisive for decision making.
Consequently, the agency has not taken action against this product. Furthermore, it states that, additionally, Isdin has presented more tests carried out with the official method, which support the claims related to the SPF.