Sunscreen products occupy a distinctive position within EU cosmetic law. They are legally classified as cosmetic products under Regulation (EC) No 1223/2009 (1), yet their functional purpose is to protect against ultraviolet radiation, a carcinogenic environmental exposure recognised by the International Agency for Research on Cancer and the World Health Organization (4, 5). This dual identity – cosmetic in legal taxonomy, preventive in health relevance – has always required careful regulatory calibration.

Commission Recommendation 2006/647/EC (2) marked a significant step toward harmonisation by structuring SPF categories, discouraging misleading claims and introducing balanced UVA protection requirements. It improved consumer comparability and internal market coherence at a time when labelling practices were fragmented.

Nearly two decades later, however, the regulatory landscape has evolved. SPF claims now appear across a wide range of cosmetic formulations. Scientific understanding of cumulative UV damage has deepened. Consumer expectations regarding protection levels have intensified. In this context, the continued reliance on a non‑binding instrument to structure core efficacy standards warrants reassessment.

The 2006 Recommendation (2) was conceived in an environment characterised by divergent national practices and inconsistent communication of protection levels. Its principal achievement was to create a common language for SPF values and to introduce the principle of balanced UVA protection.

Since then, the Cosmetic Products Regulation has strengthened the legal framework for safety assessment, documentation and Responsible Person accountability (1). Regulation (EU) No 655/2013 has reinforced the evidentiary requirements for cosmetic claims (3). International scientific authorities have consolidated evidence linking cumulative UV exposure to skin cancer and photoaging (4, 5).

At the same time, the market has become more complex. SPF claims are now routinely incorporated into daily skincare products, decorative cosmetics and hybrid formulations. Consumers interpret SPF numerically, often without differentiating between product categories.

In this transformed context, the limitations of a non‑binding Recommendation become more visible. Recommendations depend on voluntary alignment and consistent national enforcement. Where interpretative divergence persists, legal certainty and consumer trust may be weakened.

The challenge today is therefore not scientific obsolescence, but structural adequacy. A framework that shapes essential efficacy standards may require binding force to ensure uniform application across the internal market.

The proliferation of SPF in multifunctional cosmetics has raised questions about differentiation between “primary” sunscreen products and cosmetics with ancillary UV protection. However, from a consumer protection perspective, differentiation in function should not result in differentiation in performance standards.

The Cosmetic Products Regulation requires safety under normal or reasonably foreseeable conditions of use (1). Foreseeability, however, is shaped by consumer perception. A numerical SPF value conveys a concrete level of protection, regardless of the product’s primary purpose.

Laboratory testing conditions may not fully reflect real‑world application thickness or frequency (4). Under‑application is well documented and can reduce effective protection. Yet this behavioural reality does not justify fragmenting the meaning of SPF across categories.

Any product bearing an SPF value should meet equivalent testing requirements and deliver the declared level of protection, irrespective of whether it is marketed as a dedicated sunscreen or as a daily cosmetic. The coherence of the SPF claim itself must remain intact. Introducing differentiated performance expectations based on product type risks undermining claim reliability and consumer trust.

What may legitimately differ is the contextual communication accompanying the claim, not the protection threshold. The numerical SPF value must remain scientifically and legally consistent across the Union.

SPF is scientifically defined as the ratio between minimal erythemal dose on protected and unprotected skin (2). Yet in consumer perception, SPF often functions as a simplified indicator of overall protection.

This perception gap has behavioural consequences. Higher SPF values may create a false sense of security, while undervaluation of UVA protection may neglect long‑term cumulative damage (4). Balanced UVA requirements introduced in 2006 represented a critical advancement (2).

However, as scientific emphasis on UVA‑induced photoaging and carcinogenesis continues to grow (4), the normative importance of balanced protection increases correspondingly. Where protection metrics directly influence behavioural exposure decisions, regulatory clarity becomes a matter of public health significance.

Annex VI of Regulation (EC) No 1223/2009 establishes a positive list of authorised UV filters (6), demonstrating that the EU legislator has not hesitated to impose binding harmonisation where safety considerations demand it. Protection metrics, which shape consumer reliance, merit comparable legal solidity.

SPF values are not merely technical descriptors. They operate as behavioural signals. Their regulatory treatment must reflect that normative weight.

The Cosmetic Products Regulation already provides a comprehensive framework for durability, safety assessment and documentation (1). Sunscreen products are subject to the same obligations regarding minimum shelf life and stability evaluation as other cosmetics.

However, the health‑relevant nature of UV protection differentiates sunscreen efficacy standards from ordinary cosmetic attributes. Core parameters governing SPF categorisation and balanced protection continue to rest on Commission Recommendation 2006/647/EC (2), an instrument without binding force.

In practice, market operators treat many of its provisions as normative benchmarks. Testing protocols and categorisation schemes are widely applied as if legally mandatory. This functional elevation of a Recommendation to quasi‑normative status raises a question of legal coherence.

Where compliance is effectively expected across the internal market, the absence of formal binding status may generate avoidable legal uncertainty. Divergent national interpretations remain possible, and enforcement intensity may vary.

Transforming essential sunscreen efficacy requirements into a directly applicable legislative instrument would enhance legal certainty, ensure uniform enforcement and reinforce consumer trust. Given the established public health relevance of UV protection (4, 5), binding harmonisation appears proportionate and justified.

Commission Recommendations, adopted under Article 292 TFEU, serve important coordination functions. Their flexibility allows regulatory guidance without immediate legislative amendment.

However, when a Recommendation structures core efficacy standards and shapes cross‑border market behaviour, its institutional limitations become evident. Soft law can produce hard effects, but without corresponding legal guarantees of uniformity.

In the field of sunscreen regulation, SPF categorisation and balanced UVA requirements are not peripheral technicalities. They form the backbone of consumer reliance and market comparability. Where such standards effectively operate as binding expectations, their continued location within non‑binding guidance may undermine transparency and democratic accountability.

The question is no longer whether soft law can influence behaviour – it clearly can. The more pressing issue is whether reliance on informal harmonisation remains appropriate once standards acquire structural significance for both public health protection and internal market functioning.

In this light, the transition from recommendation to binding legislation should not be viewed as regulatory expansion, but as regulatory clarification.

EU sunscreen regulation has evolved beyond its initial harmonisation phase. Scientific evidence, consumer reliance and market integration have elevated SPF standards to a level of normative centrality that exceeds the traditional function of soft law. Uniform performance standards for any product bearing an SPF claim are essential to preserve consumer trust and claim coherence. Differentiation in marketing context must not translate into fragmentation of protection thresholds.

The 2006 Recommendation played a decisive harmonising role. Yet its practical impact now suggests that sunscreen efficacy parameters have outgrown their non‑binding foundation. Moreover, ongoing regulatory discussions indicate a growing expectation that protection benchmarks should not only be formalised but also recalibrated in light of evolving scientific knowledge and exposure patterns, including the strengthening of balanced UVA protection requirements.

The logical next step in the maturation of EU sunscreen governance is therefore not further informal convergence, but legislative consolidation. Binding harmonisation would not merely codify existing practice; it would provide the appropriate legal framework to adapt protection standards to contemporary public health needs. In this sense, the future of EU sunscreen regulation lies not in incremental adjustment, but in structural clarification and calibrated reinforcement.