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.
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.
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.
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.
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.
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.
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.
References and notes
- European Parliament and Council. Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products. OJ L 342, 22.12.2009, p. 59–209. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223
- European Commission. Commission Recommendation 2006/647/EC of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto. OJ L 265, 26.9.2006, p. 39–43. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006H0647
- European Commission. Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products. OJ L 190, 11.7.2013, p. 31–34. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0655
- International Agency for Research on Cancer (IARC). Solar and Ultraviolet Radiation. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 100D. Lyon: IARC; 2012. Available from: https://www.who.int/publications/m/item/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-volume-100d
- World Health Organization (WHO). Ultraviolet radiation. Fact sheet, 21 June 2022. Available from: https://www.who.int/news-room/fact-sheets/detail/ultraviolet-radiation
- European Parliament and Council. Regulation (EC) No 1223/2009 on cosmetic products, Annex VI – List of UV filters allowed in cosmetic products. Consolidated version. Available from: https://eur-lex.europa.eu/eli/reg/2009/1223/oj
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