Ultimo aggiornamento 16 June 2026
During the summer months, market attention increasingly focuses on sunscreen products, but for companies marketing them in Europe, regulatory compliance cannot be a seasonal matter. Sun protection products are classified as cosmetics under Regulation (EC) No. 1223/2009, but they have certain technical and documentation-related specificities that require special attention from manufacturers, marketing authorization holders, and regulatory consultants.
From correctly defining the sun protection factor (SPF) to verifying claims, from preparing the Product Information File (PIF) to submitting notifications via the CPNP portal, every step must be approached with scientific rigor and a thorough understanding of the regulatory framework. In this article, we analyze the key requirements for ensuring the compliance of sunscreen products in the European market, with a focus on the most common challenges and the best practices to adopt.
At the European level, cosmetic products are regulated by the Regulation (EC) No. 1223/2009, which establishes safety, labeling, and market surveillance requirements for all products intended for application to the external surfaces of the human body for cosmetic purposes.
Within this vast sector, sunscreen products represent a distinct category, both because of the role they play in protecting skin health from damage caused by UV rays and because of the technical and regulatory implications related to their effectiveness. Despite their significant functional effect, sunscreens are not classified as medical devices or as medicines, but fully fall under the definition of cosmetics, provided they are intended to protect the skin from UV rays without therapeutic purposes.
This regulatory framework requires compliance with all provisions of the Cosmetics Regulation, including the preparation of the Product Information File (PIF), safety assessment, notification to the CPNP, and the correct use of claims, particularly those relating to sun protection factor (SPF) and water resistance.
In the following sections, we will analyze the key regulatory implications related to the marketing of sunscreen products, providing technical guidance for companies and industry professionals involved in compliance, formulation, labeling, and technical documentation.
The European Commission takes the efficacy and safety of sunscreen products very seriously, which is why, as early as 2006, it issued a recommendation setting out a series of guidelines on the efficacy of sunscreen products that every European sunscreen manufacturer must take into account when developing a sunscreen product.
Under this recommendation,“sunscreen product”means any preparation (such as creams, oils, gels, or sprays) intended to be applied to human skin for the sole or primary purpose of protecting it from UV rays by absorbing, scattering, or reflecting radiation.
For a sunscreen product to be considered effective in the European Union, it must protect against both UVB and UVA rays.
- “UVB radiation,” solar radiation in the 290–320 nm wavelength range.
- “UVA radiation,” solar radiation in the 320–400 nm spectrum.
Mandatory labeling and warnings for sunscreen products
Under Regulation (EC) No. 1223/2009, the claims used in the labeling and promotion of sunscreen products are also subject to specific rules. In particular, to ensure transparent and non-misleading communication to consumers, the European Commission has provided detailed guidance on the information that must (or must not) appear on the label and in the informational material for sunscreen products.
As can easily be seen in stores, European sunscreen products generally include specific information such as the sun protection factor (SPF), UVB/UVA protection, the term “broad spectrum,” and references to preventing sunburn.
However, to ensure regulatory compliance, the European Commission requires that the statements not imply:
total UV protection, with labels such as “sunblock,” “sunblocker,” or “total protection”;
that the product does not need to be reapplied, with claims such as “all-day protection.”
No sunscreen product can guarantee 100% protection from the sun. For this reason, sunscreen products must include mandatory warnings, such as:
- “Don’t stay in the sun too long, even when using sunscreen.”
- “Keep infants and young children out of direct sunlight.”
- “Excessive sun exposure is a serious health risk.”
In addition, to ensure proper use by consumers, it is strongly recommended that instructions for use be provided. Among these, it is essential to specify:
- “Apply sunscreen before going out in the sun.”
- “Reapply frequently to maintain protection, especially after sweating, swimming, or drying off.”
- “Warning: Reducing this amount will significantly reduce the level of protection.”
The clarity and consistency of the information on the label are key factors not only for consumer safety but also for the cosmetic product’s compliance during the Product Information File (PIF) evaluation process and when submitting notifications to the CPNP portal.
Sunscreen effectiveness: minimum technical requirements
To be legally marketed in Europe as a sunscreen product, a product must demonstrate a minimum level of efficacy as set forth in European Commission Recommendation 2006/647/EC. Although the Recommendation does not have the force of law, it serves as the reference standard for safety assessors, marketing authorization holders, and regulatory authorities. There are three essential technical parameters:
| Appearance | Minimum requirement | Regulatory rationale |
| UVB protection | SPF ≥ 6 | A lower value does not guarantee the necessary level of protection against sunburn, so the product cannot be classified as “sunscreen.” |
| UVA protection | PF-UVA ≥ 1/3 of the stated SPF | Ensures a balanced ratio of protection against rays of different wavelengths, limiting the risk of long-term photo-induced damage. |
| Critical wavelength | ≥ 370 nm | Requires a sufficiently broad protective spectrum, an essential condition for using the “broad spectrum” claim. |
Practical note: Values must be determined using harmonized test methods (ISO 24444 for SPF, ISO 24443 for PF-UVA), with complete reports included in the PIF and available for any post-market inspections.
These three criteria—SPF, the PF-UVA/SPF ratio, and the critical wavelength—constitute the documentation that the safety assessor must review before signing the Cosmetic Product Safety Report and that the company must include in the CPNP notification. Compliance with these criteria not only ensures the conformity of the sunscreen product but also protects consumers by providing verified and scientifically sound information.
Efficacy testing of sunscreen products
To accurately measure the level of protection provided by European sunscreens, it is essential to conduct various tests on the product using specific and valid methods. The recommendation specifies that these methods must be standardized and reproducible and must also take photodegradation into account.
In vitro methods are often preferred. Only a few validated methods are recognized for conducting these tests to determine the SPF of sunscreen, UVA protection, and the critical wavelength.
- Sun Protection Factor (SPF) testing: must be performed in accordance with the international method for testing the sun protection factor (UNI-EN-ISO 24444:2022, in vivo) or any in vitro method.
- UVA protection testing: This information must be obtained using the persistent pigment darkening method as modified by the French health agency Agence française de sécurité sanitaire des produits de santé (Afssaps) (UNI-EN-ISO 24443:2022) or any in vitro method.
- Critical wavelength test: This test must be performed using the critical wavelength test method (as specified in the aforementioned UNI-EN-ISO 24443:2022 standard).
The results of these tests will allow for various claims to be made about the product. It is important that these claims be clear, unambiguous, and meaningful, and that they be based on standardized and reproducible criteria. For example, claims regarding protection against UVB and UVA rays may only be made if the product meets minimum efficacy standards. Depending on these results, the product should be classified into one of the following protection categories: “low,” “medium,” “high,” or “very high.”
The table below outlines the protection category based on the SPF results obtained from the tests. This table also specifies the SPF levels that may be labeled on the product based on these results.
| Labeled category | Labeled sun protection factor | Measured sun protection factor | Recommended minimum UVA protection factor | Recommended minimum critical wavelength |
| Low protection | 6
10 |
6–9.9
10–14.9 |
1/3 of the sun protection factor indicated on the label | 370 nm |
| Medium protection | 15
20 25 |
15–19.9
20–24.9 25–29.9 |
||
|
-level protection |
30–
–50 |
30–49.9
50–59.9 |
||
| Very high protection | 50+ | ≥ 60 |
Claims and Innovations in Sun Protection Measurement
As with any other cosmetic product, voluntary claims on sunscreen products must also comply with the common principles established by Regulation (EU) No. 655/2013, which requires that every claim be supported by adequate evidence. If the product meets the minimum efficacy requirements (SPF ≥ 6, UVA protection ≥ ⅓ SPF, critical wavelength ≥ 370 nm), it may include statements such as:
- “Broad-spectrum”
- “UVA Protection”
To ensure clarity for consumers, Cosmetics Europe has developed a standardized UVA logo, which has now been adopted by numerous brands. This symbol, displayed on the label next to the SPF value, visually indicates that the product has been tested according to harmonized methods, which ensure balanced protection against UVB and UVA rays, in line with European recommendations.
Selection of filters and the importance of efficacy testing
When formulating sunscreen products, the choice of UV filter system is crucial to ensuring a compliant and effective product. In this regard, it is essential to remember that only the UV filters listed in Annex VI of Regulation (EC) No. 1223/2009 may be used in cosmetics marketed in the European Union. The annex lists the authorized filters, specifying their maximum concentrations, restrictions on use, and any warnings to be included on the label.
The selected combination of chemical and physical filters must ensure adequate coverage of the UV spectrum, formulation stability, and skin compatibility. All of these aspects must be documented in the Product Information File (PIF) and evaluated in the cosmetic product safety report.
New methods for measuring SPF: ISO 23675 and ISO 23698
To support the scientific determination of the sun protection factor (SPF), two new ISO standards have recently been introduced to complement (and, in part, replace) the traditional ISO 24444:2020 method:
- ISO 23675:2024
This is the first entirely in vitro method for determining SPF. It eliminates the need for human volunteers, making the measurement more ethical and reproducible. It is applicable to emulsion products or single-phase alcohol-based solutions, but does not measure water resistance. - ISO 23698:2024 – Hybrid Diffuse Reflectance Spectroscopy (HDRS)
Combines in vitro and in vivo testing to determine SPF, UVA protection, and critical wavelength in an integrated manner, without requiring a biological response. It is based on the measurement of the absolute spectral absorbance of the product applied to the skin and is suitable for all skin formulations, excluding powders. It represents a major breakthrough for the rapid and accurate validation of sunscreen performance.
The introduction of these new methods enhances the scientific reliability of the information on the label and simplifies the technical evaluation during the preparation of the PIF and the supporting documentation for the CPNP notification.
Conclusions: Quality, Compliance, and Responsibility in Sun Protection
Ensuring the compliance of sunscreen products involves more than just meeting a set of technical and regulatory requirements. It means contributing to the protection of consumer health by offering safe, effective, and properly labeled products. From selecting authorized UV filters to the correct use of claims, from preparing the PIF to CPNP notification, every step requires up-to-date expertise and attention to detail.
If you are a company and need assistance with the evaluation, development, or market launch of a sunscreen product, we can provide you with tailored technical and regulatory consulting to ensure that all documents and processes are fully compliant with the Cosmetics Regulation.
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