What are the EU regulatory requirements for SPF products and UV filters?
SPF products in the European Union are regulated as cosmetics and must comply with strict requirements on safety, efficacy, labelling, and claims under Regulation (EC) No. 1223/2009. In addition to UV protection performance, increasing regulatory attention is being placed on the environmental impact of UV filters and the substantiation of sustainability and “reef-safe” claims. Read more to understand the European regulations for sunscreen products.
Although summer may seem far off, if you’re planning to launch a sunscreen products campaign in Europe during that season, it’s important to begin familiarising yourself with the European sunscreens regulations. Understanding these rules is crucial as they will significantly influence the formulation of your product, especially if you are targeting the European sunscreen market.
Sunscreen product classification in Europe
Unlike other regions, sunscreen products are classified as cosmetic products in the European Union, therefore European sunscreen products must comply with EU Cosmetics Regulation 1223/2009.
The European Commission takes the efficacy and safety of sunscreen products very seriously, which is why it has published a document with a series of recommendations on the efficacy of sunscreen products that every European sunscreen manufacturer must take into account during the development of a sunscreen product.
According to this Recommendation, a ‘sunscreen product’ means any preparation (such as creams, oils, gels, sprays) intended to be placed in contact with the human skin with a view exclusively or mainly to protect it from UV radiation by absorbing, scattering or reflecting radiation.
For a sunscreen product to be considered effective in the European Union, it must protect against UVB and UVA radiation.
- ‘UVB radiation’ means sun radiation in the spectrum 290-320 nm.
- ‘UVA radiation’ means sun radiation in the spectrum 320-400 nm.
Claims and warnings required by European regulations for sunscreen products
European sunscreen products, as you may have seen at points of sale, usually have specific claims, such as the sun protection factor (SPF), UVB and/or UVA protection, broad spectrum and sunburn prevention claims. However, the European Commission requests that claims don’t imply the following:
- 100 % protection from UV radiation (such as ‘sunblock’, ‘sunblocker’ or ‘total protection’)
- No need to re-apply the product under any circumstances (such as ‘all-day prevention’).
No sunscreen can provide 100% protection from the sun, which is why European sunscreen products are required to have warnings such as the following:
- ‘Do not stay too long in the sun, even while using a sunscreen product’.
- ‘Keep babies and young children out of direct sunlight’.
- ‘Over-exposure to the sun is a serious health threat’.
It is also recommended to include instructions for use on the sunscreen product labelling to ensure consumers use it correctly and the claims on the label can be verified. Providing information on the correct amount of product to apply is crucial for effectiveness. Additionally, it is important to include warnings about the consequences of reducing the recommended amount of product used.
- ‘Apply the sunscreen product before exposure’.
- ‘Re-apply frequently to maintain protection, especially after perspiring, swimming or towelling’
- ‘Warning: reducing this quantity will lower the level of protection significantly’.
Sunscreen efficacy
As we mentioned before, European sunscreen products must protect from UVB and UVA radiation.
The European Commission, through the Recommendation, has established a minimum efficacy that sunscreen products marketed in the European Union must have. For this, it has given details on three key aspects directly related to efficacy: UVB protection, UVA protection and Critical Wavelength.
- UVB protection: A European sunscreen product must have a sun protection factor (SPF) of at least 6. A product with an SPF below 6 cannot be classified as a sunscreen product.
- UVA protection: The UVA protection factor must be 1/3 of the sun protection factor.
- Critical Wavelength: The minimum critical wavelength of a sunscreen product must be 370 nm.
Efficacy testing of sunscreen products
To accurately measure the protection level of European sunscreens, it is essential to conduct various tests on the product using specific, valid methods. The Recommendation specifies that these methods should be standardised and reproducible, and must also consider photo-degradation.
Preference is often given to in-vitro methods. Only certain validated methods are recognized for conducting these tests to determine the sunscreen’s SPF, UVA protection, and critical wavelength.
- Sun Protection Factor (SPF) test: It must be carried out according to the International Sun Protection Factor Test Method (ISO-EN-UNE 24444, in vivo) or any in vitro method.
- UVA Protection test: 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 (ISO-EN-UNE 24443) or any in vitro method.
- Critical Wavelength test: It must be carried out using the Critical Wavelength Testing Method (ISO-EN-UNE 24443).
The results from these tests will allow for various claims to be made about the product. It’s important that these claims are clear, unambiguous, and meaningful, and they must be based on standardised, reproducible criteria. For instance, claims about protection against UVB and UVA rays can only be made if the product achieves the minimum efficacy standards. Depending on these results, the product should then be classified into one of the following protection categories: ‘low’, ‘medium’, ‘high’, or ‘very high’.
Below is a chart that outlines the protection category based on the SPF results obtained from testing. This chart also specifies the SPF levels that can be labelled on the product according to these results.
| Labelled category | Labelled 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 labelled sun protection factor | 370 nm |
| Medium protection | 15 20 25 | 15-19.9 20-24.9 25-29.9 | ||
| High protection | 30 50 | 30-49.9 50-59.9 | ||
| Very high protection | 50+ | ≥ 60 |
And remember, as with any other cosmetic product, any additional claims made on a European sunscreen product must be supported by evidence. If a sunscreen meets the minimum efficacy standards, it can feature claims such as “Broad Spectrum” or “UVA protection.”
Furthermore, Cosmetics Europe, the European trade association for the cosmetic and personal care industry, has introduced a standardised logo that is now used by many brands. By displaying this logo on their products, European sunscreen manufacturers can assure consumers that the sunscreen offers the necessary protection against both UVB and UVA rays and that this protection has been verified using standardised testing methods.
Therefore, when formulating and developing European sunscreen products, it’s crucial to carefully select a UV filter or a combination of UV filters. This ensures that the resulting product not only meets the minimum required efficacy but also becomes a top-choice product for individuals seeking effective sun protection.
Trends for environmental safety
Alongside the regulatory aspects, another crucial issue is emerging: the environmental sustainability of solar products.
The impact of UV filters
Some chemical filters, such as oxybenzone and octinoxate, have been linked to coral bleaching and damage to marine ecosystems. Some countries and states, including Hawaii, Palau, and Aruba, have already banned the use of these ingredients in sunscreens.
Alternatives and innovations
Companies are responding with several strategies:
- Mineral filters such as titanium dioxide and zinc oxide, increasingly used in micronized or coated forms to reduce the whitening effect.
- New photostable and biodegradable filters, in the process of approval at the European Commission.
- Reef-safe formulations communicated to the consumer through environmental claims.
Sustainable packaging
In addition to formulations, packaging is also undergoing a transformation:
- use of recycled or recyclable plastic;
- refillable packs;
- Eco-friendly labels with low-impact inks.
Communication challenges and green claims
A delicate point is communication. Environmental claims must comply with Regulation 655/2013 and, shortly, the European Directive 2024/825 against greenwashing, which will impose greater rigor in justifying claims such as reef-safe or eco-friendly.
To be credible, brands will need to back up these claims with:
- biodegradability studies;
- environmental toxicological data;
- certifications by independent bodies.
What is the future regulatory outlook for SPF products and UV filters?
SPF products now face a combined regulatory and sustainability challenge. On one hand, consumer health protection is ensured through strict European and UK requirements covering safety, efficacy, and labelling. On the other, growing environmental concerns are driving increased scrutiny of UV filters, formulations, and their wider ecological impact.
Transparency for consumers, continuous regulatory monitoring, and the adoption of responsible and innovative formulation strategies are becoming decisive factors in the future of the sun care market. Sun protection products are no longer assessed solely on their ability to protect against UV radiation; they must also demonstrate safety for both human health and the environment.
Are you concerned about current or upcoming regulatory changes affecting UV filters or sunscreen formulations? Keeping track of ingredient restrictions and compliance obligations can be complex. Contact us to ensure your SPF products remain compliant across all relevant target markets and regulatory frameworks.
What are the key regulatory and compliance takeaways for SPF products?
- SPF products are classified as cosmetics in the EU and must comply with Regulation (EC) No. 1223/2009, Commission Recommendation 2006/647/EC, and Cosmetics Europe guidelines
- Effective sun protection must cover both UVA and UVB rays, with minimum SPF, UVA ratio, and critical wavelength requirements
- Labelling must include clear usage instructions, mandatory warnings, and scientifically substantiated claims, in line with Regulation 655/2013
- SPF efficacy must be demonstrated using recognised ISO methods, including newer in vitro and hybrid testing standards
- Environmental concerns around certain UV filters are driving innovation in formulations, packaging, and sustainability strategies
- Environmental and “reef-safe” claims must be carefully substantiated to avoid misleading consumers and future greenwashing enforcement risks
Frequently asked questions about SPF product compliance in the EU
What labelling obligations apply to spf products in the European Union?
Labels must show SPF, protection category, directions for use, and mandatory warnings. Terms like “sunblock” or “100% protection” must not be used.
What testing is required to substantiate SPF and UVA protection claims?
SPF and UVA protection must be tested using standardised methods, including ISO 24444 and ISO 24443, or approved in vitro and hybrid tests.
Are environmental or reef-safe claims permitted on sunscreen labels?
Environmental claims must be truthful. Harmful UV filters like oxybenzone and octinoxate are being replaced with mineral or biodegradable alternatives.
How are protection categories defined for SPF products?
Protection categories (low, medium, high, very high) are based on the measured SPF value to help consumers choose according to skin phototype and exposure conditions.
