The new UPF standard (ISO 23675 and 23698 standards) redefines formulation and marketing in the cosmetics industry.
If your laboratory continues to rely exclusively on in vivo tests, you could be losing months of competitive advantage and increasing your R+D costs under the new ISO standards.
SEE DIRECTLY THE TOPIC YOU’RE MOST INTERESTED IN
00:00 The risk of falling behind: Pruebas In Vivo vs. Efficiency 2024
00:52 ISO 23675 e ISO 23698: El aliado estratégico en I+D
01:24 ISO 23675 and ISO 23698: The strategic ally in R+D
01:52 Double Plate vs. Double Plate Method Hybrid Spectroscopy
02:46 Recast Alert: SCCS Scrutiny on UV Filters
03:28 Safety limits: The case of Homosalato in Europe vs. USA.
03:58 Plan B: Iron oxides and “Nano-Angst” solution
04:17 The regulatory landscape of the FDA and TGA
05:27 Why are sticks not suitable for octopuses?
06:18 How to avoid variations in the laboratory
06:40 Weight of Evidence: How to put together the regulatory dossier for success
07:32 Professional debate on technical implementation
The cosmetics industry is undergoing a fundamental regulatory and methodological transformation driven by the International Standards Organization (ISO). It’s crucial for professionals to understand the distinction. While the Ultraviolet Protection Factor (FPU or UPF) is the metric used to classify protection in textiles, the most significant innovation in this topic sector centers on the Solar Protection Factor (FPS or SPF).
This revolution in efficiency, marked by the publication of two new ISO standards in December 2024, affects the entire life cycle of the product. From the conceptualization of the formulation there is regulatory compliance in the market.
The revolution in R+D: ethical, fast and reliable tests
The development of sunscreens has historically depended on the in vivo method (ISO 24444:2019), known as the “golden standard”. However, this method has been questioned due to its inherent requirement to expose human volunteers to UV radiation to measure erythema (burn), which raises significant ethical concerns. ISO’s response has been the adoption of alternative methods that are more accurate, consistent and ethical:
ISO 23675:2024 — In Vitro Double Plate Method (DPM)
This standard introduces a completely in vitro approach that eliminates the need for human volunteers to measure SPF.
- Strategic Advantages: The DPM, developed by experts from Cosmetics Europe, offers reliable, repeatable and reproducible results. This consistency and speed translates into an acceleration of the product development process and a reduction in costs associated with efficiency tests.
- Formulation Restrictions: The DPM is designed for emulsions and single-phase alcoholic formulations. It is not applicable to determine the FPS of products in powdered or compressed octopus, sticks, nor to evaluate water resistance.
ISO 23698:2024 — Hybrid Diffuse Reflectance Spectroscopy (HDRS)
This hybrid method offers a non-invasive optical evaluation on the human skin.
- Advanced Metrics: HDRS allows you to characterize the SPF, the UVA Protection Factor (FPUVA) and the Critical Wavelength (LDC) without requiring a physiological response (erythema).
- Operation: Combines in vitro measurements (PMMA plates) with in vivo skin analysis using diffuse reflectance spectroscopy (DRS) to obtain a complete spectrum (UVB+UVA).
The early adoption of these standards (ISO 23675 and ISO 23698) by laboratories is considered fundamental for competitiveness.
The creation of the formula: More All of the SPF
The new SPF standards are integrated into a much broader R&D panorama, where the formulation must balance efficacy, ingredient safety, sensoriality and environmental impact:
Ultra-Wide Spectrum Protection
The demand for protection is greater than that of UVB and UVA rays. Now, the formulation must consider the contribution of Visible Light (VL) and Infrared Radiation (IR) to pigmentation, photoaging and color skin concerns. Advances in photoprotection seek to cover the UVA-HEVL spectrum.
Filter Security and “Nano-Angst”
Legislation requires rigorous characterization of active agents in its application vehicle.
- Endocrine Disruptors: Common filters such as benzophenone-3, octocrylene and homosalate are under scrutiny by the EU’s Scientific Consumer Safety Committee (SCCS) due to their percutaneous absorption potential and endocrine disrupting properties. Manufacturers must be prepared to present additional safety data.
- Particulate Filters: If particulate additives (ZnO, TiO2) are essential to achieve broad-spectrum protection, their use in nanoparticles has generated public concern (Nano-Angst) because these particles can penetrate the skin. Implementing iron oxides to create tinted sunscreens is a solution to mitigate the visible whitening effect that these inorganic ingredients produce.
Sustainability and sensoriality
The selection of ingredients is increasingly guided by environmental criteria. The development of tools such as EcoSun Pass (ESP) helps formulators evaluate the general environmental impact of UV filters, combining the ecotoxicological danger with concentration and effectiveness (FPS and FPUVA).
Regarding the consumer experience, the sensorial and olfactory properties are a key factor that drives purchase and regular use. Manufacturers must invest in the development of sensory modifiers and their expert incorporation, which is why they still have internal industry know-how.
Marketing and regulatory compliance (Claims)
The marketing of cosmetic sun protection products must navigate complex regulations, especially in Europe, where the status of the product as a cosmetic restricts health declarations.
Prohibition of Medical Claims (EU): In the European Union, sunscreens are classified as cosmetics. Therefore, it is not permitted to make reference to a medical condition or to make statements about the prevention of skin cancer. The cosmetic industry must focus on promoting the maintenance of “good skin condition”.
Prueba and Weight of Evidence Requirements: Given that the reliability of FPS measurement in vivo has been questioned by the large interlaboratory variance, the new ISO 23675 and 23698 standards allow us to build a robust data dossier (Weight of Evidence) that supports the final labeled protection.
Global Convergence: there are preferred methods
The European Union has stated that preference should be given to in vitro methods that deliver results equivalent to in vivo tests. This ethical stance has catalyzed the adoption of ISO 23675 and 23698. This trend is global.
The FDA (EE. UU.) is evaluating the possible adoption of ISO 23675 and 23698 to improve scientific precision and incorporate ethical considerations, which would simplify the approval of new filters in EE. UU..
LaTGA (Australia) has also recognized the publication of new ISO standards.
The current panorama suggests a significant risk for companies that delay investment in in vitro infrastructure (DPM and HDRS). The future of solar protection involves faster, more ethical methodologies and with greater certainty that the product’s performance will remain in line with consumer expectations.
Don’t settle for reading the news.
Access the intelligence that allows you to create it.
Join the Private Circle and become part of B2B Market Intelligence.
No te conformes con leer estos informes.
Accede a la inteligencia Mercado Exclusiva
Únete al Círculo Privado para que seas parte de la Inteligencia de Mercado B2B