November 20, 2025

Sunscreen products play a critical role in protecting skin from ultraviolet (UV) radiation, which causes sunburn, photoaging, and skin cancer. However, ensuring that sunscreens are both safe and effective requires strict adherence to European Union (EU) cosmetic regulations.

In the EU market, sunscreen products are regulated as cosmetics, demanding rigorous safety assessments, approved UV filters, validated SPF testing, and compliant labeling.

At Maven Regulatory Solutions, we specialize in guiding global cosmetic manufacturers through the EU sunscreen compliance process—from toxicological evaluation and Product Information File (PIF) preparation to ISO-based SPF testing and Cosmetic Products Notification Portal (CPNP) registration.

Our mission is simple: ensure that your sunscreen products meet every EU regulatory requirement and are ready for safe, legal, and successful market placement.

Understanding the European Regulatory Framework for Sunscreens

Under Regulation (EC) No. 1223/2009 on Cosmetic Products, sunscreens are classified as cosmetic formulations rather than medicinal products. This classification mandates that all products undergo comprehensive safety evaluation prior to sale.

Every sunscreen marketed in the EU must include:

  • Cosmetic Product Safety Report (CPSR): A detailed safety assessment performed by a qualified safety assessor.
  • Product Information File (PIF): Comprehensive documentation including formulation data, toxicological profile, manufacturing compliance, and testing results.
  • CPNP Notification: Pre-market submission of product details to the Cosmetic Products Notification Portal, ensuring traceability and transparency.

The Responsible Person (RP), often a company or EU-based representative, bears the legal responsibility for ensuring the product’s safety, compliance, and labeling accuracy.

Approved UV Filters in the EU: Annex VI and SCCS Oversight

UV filters are the functional actives that shield skin from UVA and UVB radiation. Only UV filters listed in Annex VI of Regulation (EC) No. 1223/2009 are permitted for use in European sunscreen products.

Each authorized filter includes defined parameters such as maximum concentration limits, permitted formulations, and nanomaterial disclosure requirements.

The Scientific Committee on Consumer Safety (SCCS) regularly reviews the toxicological profiles and photostability of these filters, issuing updated opinions to ensure continued consumer protection.

Manufacturers must also verify compliance with nanomaterial-specific regulations, including labeling obligations under Article 19(1)(g), if applicable.

New 2025 EU Updates on UV Filters and Restrictions

The European Commission periodically amends Annex VI to reflect new safety data. As of 2025, two major updates are critical for sunscreen manufacturers:

1. Homovalvate – Regulation (EU) No. 2022/2195

  • Effective January 1, 2025: Restricted to face products only (excluding sprays/aerosols).
  • Maximum concentration: 7.34%.
  • Deadline: Non-compliant products must be withdrawn by July 1, 2025.

2. 4-MBC (4-Methylbenzylidene Camphor) – Regulation (EU) No. 2024/996

  • Effective May 1, 2025: Banned in all formulations.
  • May 1, 2026: All non-compliant products must be removed from the market.

These updates require immediate reformulation, documentation updates, and PIF revisions to maintain compliance.

Sunscreen Labeling & Marketing Compliance Under EU Law

Labeling transparency is essential under Article 19 of Regulation (EC) No. 1223/2009, which defines mandatory labeling and consumer information requirements.

Key Labeling Requirements:

  • SPF Classification: Products must indicate their level of protection — Low (6–10), Medium (15–25), High (30–50), or Very High (50+).
  • Mandatory Warnings: e.g., “Keep babies and young children out of direct sunlight.”
  • Usage Instructions: “Apply generously before exposure” and “Reapply frequently.”
  • Prohibited Terms: Claims like sunblock, 100% protection, or total protection are forbidden.

Commission Recommendation 2006/647/EC provides guidance on sun protection efficacy labeling and consumer information, ensuring users understand how to achieve optimal protection.

Note: The European Commission is currently reviewing these recommendations for revision in 2026, expected to further standardize SPF and UVA labeling claims.

SPF, UVA & UVB Testing Standards (ISO Updates 2025)

Efficacy validation of sunscreens relies on scientifically robust testing protocols that demonstrate UV protection capabilities.

1. SPF (Sun Protection Factor) – UVB Protection

Traditionally tested in vivo under ISO 24444, SPF measures protection against UVB-induced erythema (sunburn).

Newly published ISO standards (2025) introduce validated in vitro alternatives:

  • ISO 23675 (2025): In vitro SPF determination using transmittance analysis.
  • ISO 23698 (2025): SPF measurement via diffuse reflectance spectroscopy.

2. UVA Protection

Assessed in vitro following ISO 24443, ensuring adequate UVA defense relative to UVB protection.

3. Additional Testing Parameters

  • Photostability Testing: Confirms active ingredients remain effective under UV exposure.
  • Water Resistance Testing: Demonstrates protective performance during swimming or perspiration.

At Maven Regulatory Solutions, our expert partners provide full support in SPF testing protocol selection, ISO method interpretation, and reporting compliance for the PIF.

Ensuring Market Compliance: Maven Regulatory Solutions as Your Partner

Navigating the EU sunscreen regulatory landscape demands precision, scientific knowledge, and continuous monitoring of updates from ECHA, SCCS, and the European Commission.

At Maven Regulatory Solutions, we offer end-to-end EU compliance support, including:

  • Cosmetic Product Safety Reports (CPSR)
  • Product Information File (PIF) preparation and review
  • CPNP notification and Responsible Person representation
  • Ingredient review and Annex VI verification
  • Labeling and claims substantiation
  • ISO SPF & UVA/UVB testing guidance
  • Continuous regulatory monitoring and post-market compliance

With Maven as your compliance partner, you gain not only regulatory assurance but also strategic market readiness, helping your brand maintain consumer trust and meet all EU cosmetic safety and labeling obligations.