Navigating sunscreen regulation in the EU: Standards, testing, and industry implications

Sunscreen is a key product in protecting human skin from the harmful effects of ultraviolet (UV) radiation, including sunburn, premature aging, and skin cancer. In the European Union (EU), these products are regulated as cosmetics with a market value of USD 2.53 billion in 2024, which is expected to grow by 7.3% annually through 2030[1], reflecting both increasing consumer awareness and rising demand for effective and reliable sun protection.

Over the past decades, scientific advances, public health guidance, and regulatory revision have continuously shaped the requirements for UV-filters, their concentrations, and labelling practices. This article provides an overview of the current EU regulatory framework for sunscreens, recent developments affecting UV-filters, standardisation of testing methods, and practical considerations for formulators and claims strategies.

Sunscreens and the role of UV filters
Before delving into regulatory aspects, it is important to understand what sunscreens are and how UV-filters function.  Sunscreens are products applied to the skin that helps to protect it from the sun’s harmful ultraviolet (UV) radiation by absorbing, reflecting, or scattering both UVA and UVB, thus reducing the risk of sunburn and associated skin damage[2].

Skin protection is achieved through the use of UV-filters, which can be either organic (carbon-based) or inorganic (mineral-based) substances incorporated into the sunscreen formulation whose function is to exclusively or mainly intended to reduce the amount of certain UV radiation reaching under the skin. Examples of the two types of UV-filters include:

• Inorganic filters: only zinc oxide and titanium dioxide.
• Organic filters: made from petrochemicals, examples include Homosalate or Avobenzone – although it is also possible to find benzophenone-3 and octocrylene

In terms of their mode of action, both organic and inorganic UV filters primarily protect the skin by absorbing UV radiation. Only about 10%[3] of the protective effect comes from reflection or scattering, which for inorganic filters can contribute to a visible “screen effect”.

EU regulatory framework for sunscreen products
In the EU, sunscreens meet the definition under Art.(2)(1)(a) of Regulation (EC) No 1223/2009 (Cosmetic Products Regulation or CPR) in protecting an external part of the human body, and are regulated as cosmetic products rather than medicinal products. The CPR regulation establishes the general safety, labelling and market requirements applicable to all cosmetic products placed on the EU market.

As for any cosmetic product, claims related to sunscreens must fulfil both Art.20 of the CPR as well as meet the six common criteria outlined in Regulation (EC) No. 655/2013, to avoid misleading consumers. In practice, this means that beyond providing skin protection, any claims related to efficacy should be communicated in a clear, simple,  and meaningful manner, based on standardised and reproducible criteria.

In addition, labels and claims should provide sufficient information to help consumers choose the appropriate product and apply it correctly. This includes indicating the SPF value, determined according to standardised norms, and avoiding misleading statements, such as claims suggesting “total protection.”

Under the CPR, sunscreen products must undergo a safety assessment before being placed on the market and must comply with the ingredient restrictions laid down in the Regulation’s annexes. In particular, only those UV-filters positively listed in Annex VI of the CPR are authorised for use. This annex defines not only the substances that may be used, but also establishes their maximum permitted concentrations in ready for use preparations and conditions of use that may apply.

Beyond the core legislative framework, in 2006 the European Commission published a legally non-binding recommendation on the efficacy of sunscreen products and related claims (Commission Recommendation 2006/647/EC). Although the recommendation does not impose legal obligations, it encourages compliance with a harmonised approach, and has played an important role in shaping industry practices across the EU. This is not unexpected given this type of instrument can help promote consistency between industry practices and EU authorities without requiring formal legislation.

As such, the Recommendation establishes common principles regarding product efficacy, specifies claims that should not be made, outlines precautions including correct application instructions, defines minimum efficacy standards to ensure high levels of public health protection, and provides guidance on how protection claims should be presented to consumers.

Together, these instruments form the basis of the EU approach to sunscreen regulation, combining legally binding safety and ingredient rules with harmonised guidance on product efficacy and communication, ensuring a high level of consumer protection and market transparency.

Recent regulatory developments affecting UV-filters
In recent years, the EU Cosmetics Regulation has undergone updates that have introduced significant changes to the permitted UV-filters and their conditions of use. These changes reflect evolving scientific assessments and regulatory priorities, and they have direct implications for product formulation and market compliance.

Updates to Annex VI and ingredient-specific restrictions
The European Commission periodically amends Annex VI to reflect new safety data. In 2025, two major regulatory changes were adopted that directly impact sunscreen formulation in the EU:

1. Homosalate (HMS): Under Commission Regulation (EU) 2022/2195, the permitted use of HMS — a widely used chemical UVB filter — was revised. The regulation now restricts HMS to facial products only (excluding propellant sprays) at a maximum concentration of 7.34 %, and products not compliant with these requirements had to be withdrawn from the market by 1^st July 
2. 4-Methylbenzylidene Camphor (4-MBC): This UV filter was removed from Annex VI and added to Annex II (prohibited substances) by Commission Regulation (EU) 2024/996. Since 1^st May 2025, products containing 4‑MBC have not been allowed to be placed on the EU market.
3. Benzophenone: This substance was delisted from Annex VI and moved to the prohibited list of substances (Annex II), as part of the Omnibus VI act on CMRs in Regulation (EU) 2023/1490

These changes follow safety assessments by the EU Scientific Committee on Consumer Safety (SCCS), which identified potential endocrine‑related concerns for certain substances and concluded that existing data do not support their continued use at previous concentration levels.

Ongoing proposals and consultations
In addition to formal amendments already adopted, regulatory developments are still in progress. One notable example involves octocrylene, another common UV-filter recognised for broad UVB protection:

• ECHA Restriction Proposal on Octocrylene: In late 2025, the European Chemicals Agency (ECHA), which is responsible for the safe use of chemicals, issued a proposal based upon a dossier submitted by France to restrict the use of octocrylene under the EU REACH Regulation (EC 1907/2006) due to concerns over its potential effects on the environment and the availability of safer alternatives. The downstream impact of the proposed restriction for cosmetics would prohibit placing or using octocrylene at concentrations ≥ 001% w/w within 24 months after entry into force of the restriction. This proposal is open for public consultation until 24^th March 2026, with stakeholders including industry groups and scientific experts providing input on risk characterisation and available data. Interestingly the concerns did not relate to human health, which is the focus of the CPR.

Testing and Standardisation

Reliable and harmonised testing methods are essential to ensure the accuracy of sunscreen efficacy claims. Recital 16 of Recommendation 2006/647/EC highlights the need for European standards in testing approaches. In line with the Vienna agreement, which outlines cooperation between the European Committee for Standardisation (CEN) and the International Standardisation Organisation (ISO) to avoid redundancy, new norms have been developed at ISO level and subsequently transposed as CEN standards. Work by ISO and related standardisation bodies, including CEN, aims to ensure that testing methods remain aligned with evolving scientific knowledge, advances in formulation technologies, and regulatory expectations.

In particular, work carried out within the ISO Technical Committee 217 (ISO/TC 217) on Cosmetics, the Sun Protection Working Group (WG7) has focused on updating and refining methodologies to assess sun protection factor (SPF) and UVA protection. Until recently, the established  reference method for SPF was the in-vivo protocol (ISO 24444:2019), which measures SPF directly on the skin of human volunteers.

Until December 2024, the in-vivo method ISO 24444:2019 remained the “gold standard” for SPF testing. While long considered the reference method, it has been increasingly debated due to its time-consuming nature, variability between volunteers, and ethical concerns. Recommendation 2006/647/EC highlighted these ethical concerns and encouraged the development of in-vitro alternatives, that could complement or replace in-vivo testing in the future.

In response to this need, work was carried out within the ISO Technical Committee 2017 to update and refine SPF and UVA testing methodologies. Following its completion, CEN TC/392 (Technical Committee on Cosmetics) transposed ISO’s new international norm ISO 23675:2024 into a European norm. Commonly known as the “double-plate method”, this in-vitro approach represents a significant advancement in sunscreen testing. It is laboratory-based, does not require human volunteers and offers a faster, more cost-efficient alternative while showing a strong correlation with in-vivo results.

Another alternative, ISO 23698:2024, combines in-vivo and in-vitro testing in a non-invasive “hybrid” approach, providing additional flexibility for manufacturers. Although neither ISO 23675:2024 nor ISO 23698:2024 are mandatory in Europe, both are widely recognised and validated alternatives to the in-vivo standard. In fact, Cosmetics Europe, the European cosmetics trade association, has issued its own recommendation reflecting this point.

In practice, there are therefore three SPF testing approaches, but ISO 24444:2019 remains the gold standard, and in cases of differing results, its outcome prevails until alternative methods are fully validated, for example, through proficiency testing during the first five years after release.

Given its twenty-year application, discussions on revising the 2006 Recommendation remain on-going between the European Commission and external stakeholders.

What comes next for sunscreen formulations
Recent regulatory developments affecting UV-filters highlight the need for manufacturers to continuously monitor changes in the EU regulatory landscape and adapt their formulations accordingly. Restrictions on certain filters and the potential introduction of new limitations may require reformulation efforts, updates to safety documentation, and careful review of product portfolios. From a compliance perspective, companies must ensure that product information files (PIFs), safety assessments, and ingredient lists remain aligned with current regulatory requirements.

At the same time, these developments have implications for product claims and positioning. Sunscreen efficacy claims must remain consistent with regulatory expectations and supported by appropriate testing data, while communication to consumers should remain clear, accurate, and compliant with EU guidance. Looking ahead, the continued scientific evaluation of UV-filters and ongoing regulatory discussions suggest that the sunscreen regulatory framework will keep evolving. For industry stakeholders, maintaining regulatory vigilance, scientific monitoring, and proactive formulation strategies will be essential to ensure both compliance and innovation in the sun care market.

Article written by Dr Mark Smith, NATRUE Director General, and Paula Gómez de Tejada, NATRUE Global Communications and Public Relations Manager.
Originally published in Kosmetica magazine (in Italian)

References:

[1] https://www.grandviewresearch.com/horizon/outlook/sun-care-cosmetics-market/europe

[2] https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sunscreen?utm_source=chatgpt.com

[3] https://care360.basf.com/emea/en/industries/personal-care/core-competencies/all-about-sun/sun-protection/absorption-is-the-key-factor-in-uv-protection