In-Market Control of Sun Care Products in Spain
Sun care products play an important role in our daily life, protecting us from the UV rays and their consequences. As a cosmetic product, sunscreens must be safe for humans and need to have the SPF factor they claim. In December 2019, the Spanish AEMPS started a campaign with the aim of guaranteeing that the claimed FPS of sunscreens available in the market are indeed correct and in accordance with testing results.

EUROPEAN UNION LEGAL FRAMEWORK AND SPF

According to the European Cosmetics Regulation (EC) No 1223/2009, a cosmetic product is defined as “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.

In the European Union, sunscreens are within the scope of cosmetic products and must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use (for more information, see our previous post).

Sun care products should contain protection against all dangerous UV (ultraviolet) radiation (UVB and UVA). UVB radiation (shorter) is the main responsible for the inflammation of the skin (‘sun burn’) and the resulting reddening of the skin (erythema). On the other hand, UVA radiation is the main contributor for the cancer risk, and it cannot be neglected.

SPF means “sun protection factor” and it refers only to protection against the radiation which causes erythema (mainly UVB radiation). It is calculated by the ratio of minimum erythemal dose on skin protected by a sunscreen product to the minimum erythemal dose on the same unprotected skin. UVA protection factor means the ratio of minimum UVA dose necessary to induce a persistent pigment darkening on the skin protected by a sunscreen product to the minimal UVA dose necessary to induce the minimal darkening effect on the same unprotected skin.

The efficacy of sunscreen products is an essential factor of its safety and an important public health-issue. The degree of protection should be measured using standardized, reproducible testing methods and take photo-degradation into account. ISO 24444:2019 (which updated ISO 24444:2010) sets global and harmonized guidelines for the in vivo determination of the sun protection factor (SPF) of sunscreen products.

Sun Protection Factor, UVA, critical wavelength and water resistance tests need to be performed in order to ensure such safety and protection of sunscreens.

SPANISH CAMPAIGN TO CONTROL SUNSCREENS AVAILABLE ON THE MARKET

In December 2019, the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) started a campaign that consists of an in-market control of sun protection products. The main goal of the campaign was to guarantee that the SPF that appeared on the label did not differ from that determined in the tests. As a result, AEMPS has requested the voluntary withdrawal of 14 sunscreens because their SPF does not match to that on the label.

The campaign focused on sunscreens with SPF 50 or SPF 50+ and a total of 19 products were analysed. The tested sunscreens with novel galenic forms, such as very light creams, mists and sprays, have different price ranges, companies and countries of origin (Spanish, European and non-European), with the objective of having a representative sample. AEMPS evaluation was based on the interpretation of results together with the documentation that is requested to the companies. It performed an in-depth analysis, comparing studies of determination of products’ SPF and the efficacy studies with the labelling claims.

Only 5 of the products had the SPF accordant with the degree indicated on their labels, while the other 14 have not achieved the level claimed on the package. In fact, 5 of these 14 did not exceed 29.9 SPF and the other 9 obtained a value lower than 60, when their label indicated a very high protection category (50+).

Although the sunscreens are within the range of efficacy of high protection category (values between 20-49.9) and there were no incidents of sunburn related to any of these products reported to the Spanish Cosmetovigilance System, the AMPS has urged the companies to voluntary withdraw the batches tested and to carry out additional trials and investigations on other batches to verify the safety of the products. The list of the 14 sunscreens has been made publicly available by the AEMPS.

It is common knowledge that a sunscreen must be safe, protecting us against both UVA and UVB rays. But don’t forget that it also must claim the truth (real SPF) so it can be in accordance with the law and properly inform consumers.

If you have any questions regarding sun care products, SPF and what type of tests you need to perform, do not hesitate to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Informe sobre el análisis del FPS de productos de protección solar. Campña de control de mercado 2020. Agencia Española de Medicamentos y Productos Sanitarios. Ministerio de Sanidad. 26 de julio de 2021. Available at: https://www.actasanitaria.com/wp-content/uploads/2021/07/Informe_AEMPS-an%C3%A1lisis_FPS_de_productos_solares.pdf

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