Friday June 21, 2024, 2:52 PM
The Spanish Medicines and Health Products Agency (AEMPS), part of the Ministry of Health, has issued a warning regarding several sunscreens sold in supermarkets.
As published by AEMPS in a statement, the agency became aware of alleged non-compliance with the labeling of seven sunscreen products through an investigation conducted by the Organization of Consumers and Users (OCU).
AEMPS has requested from the companies involved for tests to support the claims of SPF and FP-UVA, carried out according to official methods and in accordance with the European Commission recommendation of 22 September 2006 on the efficacy claims of the sunscreen products.
Following the review, AEMPS found discrepancies between the results of the SPF and FP-UVA tests conducted by the OCU and the test results provided by the companies themselves. As the authority in the field of cosmetic market control, AEMPS has requested that companies take appropriate measures to cease marketing and, in any case, withdraw the product from sale.
It should be noted that in recent years a certain variability has been observed in the application of the technical standard UNE EN ISO 24444, which hinders the ability to accurately measure the SPF of sunscreens. This has been pointed out by the AEMPS in several official forums at European and international level, opening the debate on the need to strengthen the method to reduce its variability. In addition, the agency is also promoting a revision of the information provided on labeling to indicate the sun protection factor.
Three of the companies against which AEMPS has taken action have now provided additional research to demonstrate that their products meet the SPF and/or PF-UVA claimed on the labelling.
Based on these new results, the AEMPS has taken the following actions regarding these products:
VICHY Capital Soleil Cream Onctueuse Protectrice SPF 50+:
The company Cosmetique Active International has provided additional studies carried out on this product with a different batch than that tested by the OCU:
Lot tested by the OCU: 54X200
Lot tested by the company: 54XN02
The reason why this company did not perform the additional testing on the same batch tested by the OCU was because it did not have the necessary amount of product to perform these tests.
After a detailed analysis of all available information, AEMPS has decided to modify the previously established measures. As a result, it has been concluded that the product VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+ can continue to be sold, with the exception of lot 54X200, for which the stop marketing measure remains in place as the company has not provided any additional data. on this plot.
The AEMPS, as reported in its previous information note, has ordered the cessation of marketing of the product and the withdrawal of lot 54X200 from the market.
BIOTHERM Waterlover Facial Sunscreen SPF 50+
The company Prestige & Collections International has provided new studies carried out on the product, on a batch also different from the batch tested by the OCU:
OCU tested lot: 40X300
Lot tested by the company: 40WD00
The reason why this company did not perform the additional testing on the same batch tested by the OCU was because it did not have the necessary amount of product to perform these tests.
After a detailed analysis of all available information, AEMPS has decided to adjust the previously established measures. As a result, it has been concluded that the product BIOTHERM Waterlover Face Sunscreen SPF 50+ can continue to be marketed, with the exception of lot 40X300, for which the measure of discontinuation of marketing is maintained, as the company has not provided any additional data in this regard. lot.
The AEMPS, as reported in its previous information note, has ordered the cessation of marketing of the product and the withdrawal of lot 40X300 from the market.
ISDIN Fusion Water Magic SPF 50
In this case, the alleged non-compliance concerned FP-UVA. The OCU has provided additional tests carried out on lot 30541F of the product using the official methods, namely one test according to UNE-EN ISO 24444, and one according to UNE-EN ISO 24443. Specifically a test according to UNE-EN ISO 24444 standard, and another according to the UNE-EN ISO 24443 standard. According to the results of the latter test, the FP-UVA value obtained would be lower than the value stated on the label.
ISDIN also provided new studies conducted on batch 30541F. In this case, three tests according to the UNE-EN-ISO 24443 standard, the results of which support the FP-UVA claims of the labeling.
After a detailed analysis of all available information, AEMPS remains of the opinion that no action is required regarding ISDIN Fusion Water Magic SPF 50.
AEMPS, as reported in its previous information note, has not taken any action regarding this product, as the company submitted two tests, both carried out with the official method, while the OCU used for the calculation of the FP-UVA data that was obtained by an unofficial method currently under evaluation, so the FP-UVA value obtained was not considered decisive for the decision to be made.
Creams involved and measures taken
RITUALS Invisible Sun Protection Face Cream SPF 50+ RITUALS COSMETICS0832913: Stop marketing the product and withdraw lot 0832913 from the market.
NIVEA SUN Sensitive facial protection SPF 50BEIERSDORF AG32032276: Stop marketing lot 32032276
LANCASTER Sun Sensitive Oil-Free Milky Liquid SPF 50 COTY SAS3157: Discontinuation of marketing of lot 3157.
PIZ BUIN Hydro Infusion Sun Gel Cream Face SPF 50 JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE (JJSBF)1362V A: Stop marketing of lot 1362V A
VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+COSMETIQUE ACTIVE INTERNATIONAL54X200: Discontinuation of marketing lot 54X200
BIOTHERMWaterlover Facial Sunscreen SPF 50+PRESTIGE & COLLECTIONS INTERNATIONAL40X300: Stop marketing batch 40X300
ISDINFusion Water Magic SPF 50Isdin SA.30541F: No action taken.
Regarding the product RITUALS Invisible Sun Protection Face Cream SPF 50+, AEMPS has been informed by the company that it is conducting additional testing on the product. Once the results of these tests are available, AEMPS will evaluate the information and update this information note if necessary. AEMPS did not receive any additional studies for the other products.
However, it is important to note that so far no sunburn incidents related to these products have been reported to the ‘Spanish Cosmetovigilance System’, which monitors and collects information on adverse reactions or incidents related to cosmetic products.
AEMPS continues to research sunscreen products and will promptly report any changes.