The year 2025 marks a decisive turning point for the solar care industry with the approval by ISO, the International Organization for Standardization, of two new SPF testing methods. These approaches, more ethical and less invasive, allow for an equally reliable evaluation of the UV protection offered by sunscreens. Read on for more information about these new standards.
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- Sun Protection: Two New SPF Testing Methods Approved by ISO.
Sun Protection: Two New SPF Testing Methods Approved by ISO.
- Development of Sunscreen Protection: Why Do We Need New SPF Testing Methods?
- A closer look at the new SPF testing methods approved by the ISO
- Sources
Development of Sunscreen Protection: Why Do We Need New SPF Testing Methods?
Photoprotection is a major public health issue. Indeed, let's remember that prolonged and/or repeated exposure to the sun's UV rays is responsible for immediate skin damage, such as sunburns, but also for long-term consequences, such as premature skin aging and an increased risk of skin cancers, particularly melanomas. To prevent these dangers, the use of sun protection is essential. Their action is based on the presence of chemical or mineral filters in their formulas, which absorb and reflect UV rays, thus protecting the skin. Their effectiveness is evaluated by the sun protection factor (SPF), characterizing the ability of a sunscreen to block erythemogenic UV rays. There are currently four levels of SPF.
Sun Protection Factor (SPF) | Level of Protection |
---|---|
From 6 to 10 | Low Protection |
From 15 to 25 | Average Protection |
From 30 to 50 | High Protection |
50+ | Very high protection |
For several decades, the in vivo test ISO 24444:2019 has been considered the benchmark for measuring the SPF of a sunscreen product. It involves applying the sunscreen to the skin of volunteers, then exposing them to an artificial UV source to observe the onset of erythema. The SPF is then calculated by comparing the UV dose required to cause a sunburn with and without protection. This method therefore relies on a direct approach, where the skin's reaction to UV rays is used to quantify the effectiveness of a sunscreen. Although the ISO 24444:2019 test has proven its worth, it presents several ethical, scientific, and practical problems, which justify the development of alternative methods.
Indeed, the main drawback of the in vivo ISO 24444:2019 method is its impact on the participants and the necessity for them to develop a sunburn. However, even in the short term, the damage caused by UV rays is real. As has been done for other cosmetic evaluations, there is therefore a real need to minimize human testing as much as possible. Moreover, the ISO 24444:2019 standard suffers from a high inter-individual variability as the reaction to UV rays depends on many factors, such as the phototype and the effectiveness of the participant's skin barrier. Finally, the cost of this test is not insignificant for manufacturers, which can be a deterrent for innovation.
For several years, the European Union has been encouraging the development of alternative methods to in vivo tests, particularly with Recommendation 2006/647/EC. The goal is to develop in vitro or ex vivo tests that can provide results as reliable as the ISO 24444:2019 method, without requiring human exposure to UV.
Note : There are also the ISO 24442:2011 and ISO 24443:2021 standards that allow for the determination of the UVA protection index, respectively in vivo and in vitro. However, they do not allow for the evaluation of the protection provided by a sunscreen against erythemal UV, that is, the SPF.
A closer look at the new SPF testing methods approved by the ISO.
In response to the limitations of in vivo tests, the cosmetics industry has been working for several years on alternatives capable of assessing SPF without resorting to exposing human volunteers to UV rays. The challenge for these methods is to be more ethical, but also to provide statistically correlated results with the values obtained with the ISO 24444:2019 method. Among the various approaches studied, two methods were validated by the International Organization for Standardization in December 2024 and could become the first reference methods in addition to in vivo tests. These are the ISO 23675 standards (SPF in vitro "double plate" test) and ISO 23698 (HDRS sun protection test).
The method in vitro "double plate" (ISO 23675).
Among the alternatives currently being validated, the in vitro method known as the "double plate" is based on the use of two superimposed quartz plates, between which the sunscreen product to be tested is applied. This protocol aims to simulate the diffusion and absorption of the product on the skin, while ensuring rigorous standardization. In practice, the sunscreen product is first applied evenly on a quartz plate, then subjected to a drying phase. This step replicates the stabilization time of a sunscreen after application on the skin, a key factor influencing the effectiveness of the UV filter. A second plate is then placed on top, forming a multilayer system that mimics the distribution of sunscreen filters within the stratum corneum, the outermost layer of the epidermis.
The evaluation of the sun protection factor relies on measuring the transmission of UV rays through this system, using a calibrated light source and specific optical sensors. By comparing the amount of light absorbed by the preparation with that of a control sample, it is possible to determine the sun protection factor. The main challenge of this approach lies in its ability to accurately replicate the interactions between sunscreens and human skin. Indeed, the lipid and protein structure of the epidermis influences the distribution of filters, a parameter that is difficult to replicate on an inert substrate such as quartz.
Despite this complexity, the results obtained so far with the ISO 23675 method show a good correlation with the values measured in in vivo tests and allows for the elimination of the need for human volunteers. However, the use of this technique is limited to the determination of a static sun protection factor, and is not applicable to the characterization of a sunscreen's water resistance properties.
More information about the standard ISO 23675 can be found on the website of the International Organization for Standardization.
The hybrid diffuse reflectance spectroscopy (HDRS - ISO 23698).
Hybrid Diffuse Reflectance Spectroscopy (HDRS) is based on the analysis of interactions between light and sunscreens applied on a standardized surface. Unlike the so-called "double plate" method, which evaluates UV transmission through a multilayer system, HDRS relies on a double spectroscopic analysis. Firstly, an in vitro measurement is carried out on a standardized surface to assess the transmission and reflection of light through the tested formulation across the entire UV spectrum. Then, a second analysis is conducted directly on human skin, focusing specifically on the transmission of UVA. This hybrid approach allows for the generation of a combined spectrum, incorporating both UVB and UVA protection performances.
The major advantage of this technique lies in its ability to provide a comprehensive evaluation of sun protection, without requiring prolonged exposure to UV rays. It thus allows for the determination of the SPF, but also the UVA protection factor (UVA-PF) and the critical wavelength, which characterizes the extent of protection across the entire UV spectrum. Thanks to the combination of in vitro and in vivo non-invasive measurements, the results obtained show a close correlation with the ISO 24444:2019 method. This technique is also presented as an alternative to the ISO 24442:2011 and ISO 24443 standards.
More information about the standard ISO 23698 can be found on the website of the International Organization for Standardization.
The "double plate" and HDRS methods are now integrated into ISO standards and mark a key step in the evolution of sun protection tests. While they will not immediately replace in vivo tests, they will help to limit their use and offer reliable and more ethical alternatives for SPF evaluation.
Sources
Regulation (EC) No 1223/2009 of the European Parliament and the Council.
LIM H. & al. Photoprotection of the Future: Challenges and Opportunities. Journal of the European Academy of Dermatology and Venereology (2020).
PASSERON T. & al. Photoprotection of the skin against pigmentation induced by visible light: Current testing methods and suggested harmonization. Journal of Investigative Dermatology (2021).
BANSAL V. & al. Sunscreen testing: A critical perspective and future roadmap. TrAC Trends in Analytical Chemistry (2022).
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