UK: Review of permitted levels of Benzophenone-3 for Cosmetic Products

The United Kingdom (UK) has notified the World Trade Organization (WTO) of its intention to amend Regulation (EC) No 1223/2009 , as applied to Great Britain, to limit the concentration of benzophenone-3 (BP-3) in various cosmetic products. The proposal—notified by notification G/TBT/N/GBR/102 of 8 May 2025—is based on the recent opinion of the Scientific Advisory Group on Chemical Safety (SAG-CS), which concluded that the substance is safe within specific thresholds.

This article summarizes the comparative regulatory framework (UK-EU), sets out the toxicological rationale, and assesses the technical and commercial implications of the measure.

Table of contents

• 1. Introduction

• 2. Comparative regulatory framework

• 3. Scientific basis

• 4. Schedule and comment procedure

• 5. Implications for industry and commerce

• 6. Conclusions

UK Proposal to Restrict Benzophenone-3 in Cosmetic Products: Regulatory Alignment, Toxicological Evidence and Market Outlook (2025)

1. Introduction

Benzophenone-3 (also known as oxybenzone; CAS 131-57-7) is a broad-spectrum UV filter used to protect skin and stabilize cosmetic formulations. However, its potential endocrine activity and findings of phototoxicity have prompted successive regulatory reviews to ensure a high level of public health protection.

2. Comparative regulatory framework

2.1 European Union

Since the adoption of Regulation (EU) 2022/1176, the EU has limited BP-3 to 6% in facial products and 0.5% when used as a stabilizer; in 2022, it also introduced a limit of 2.2% for body applications, following opinion SCCS/1625/21.

2.2 United Kingdom

Following Brexit, the UK maintains Regulation (EC) 1223/2009 as "retained EU" legislation and amends it through Statutory Instruments (SI). Notification G/TBT/N/GBR/102 announces the "Draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025" , which introduces the same thresholds recommended by the SAG-CS:

Product category	Proposed BP-3 boundary
Facial creams, hand creams, and lip products	6% w/w
Extensive body application (lotions, sprays)	2.2% w/w
Use as a UV stabilizer	0.5% w/w

Adoption is expected on July 21, 2025 , entry into force on January 21, 2026 , and a transitional period until July 21, 2026, to exhaust previously marketed stocks.

3. Scientific basis

SAG-CS/Opinion 14 (October 2024) evaluated in vitro, in vivo, and in silico data on the toxicokinetics, endocrine-disrupting potential, and phototoxicity of BP-3. The panel concluded:

• Dermal safety : margins of exposure (MoE) ≥ 100 for concentrations of 6% (facial use) and 2.2% (body use).

• Aggregate exposure : The simultaneous contribution as a filter and as a stabilizer (0.5%) remains below the derived Acceptable Exposure Level (AED).

• Recommendation : Adopt differentiated limits by application area to minimize the daily systemic dose (SED) and prevent photoallergenic events.

  
  

4. Schedule and comment procedure

The UK has opened a 60-calendar-day period— until 7 July 2025 —for receiving technical comments through the UK TBT Enquiry Point ( tbtenquiriesuk@businessandtrade.gov.uk ). The measure will subsequently be incorporated into domestic law through a separate SI detailing the affected HS codes and the penalties for non-compliance.

5. Implications for industry and commerce

1. Alignment with the EU : Convergence of limit values reduces technical barriers for products exported to/from the EU, simplifying safety dossiers and bilingual labeling.

2. Reformulation : Manufacturers still using concentrations > 6% must adjust matrices and validate photochemical stability by January 21, 2026.

3. Inventory management : Distributors have an additional six months (until July 21, 2026) to clear stock, requiring sell-through strategies and document traceability.

4. International trade : By notifying the amendment via the WTO-TBT, the UK is fulfilling its transparency obligations and providing third countries with the opportunity to justify equivalences or raise specific concerns.

   
   

6. Conclusions

The British proposal consolidates the global regulatory trend toward stricter levels of BP-3, based on recent toxicological evidence and the need to harmonize post-Brexit standards with the European acquis. Successful implementation will depend on the cosmetics industry's ability to reformulate in a timely manner and on continued monitoring of new scientific evidence on emerging UV filters.

Official references

1. WTO – TBT Committee : Notification G/TBT/N/GBR/102 (8 May 2025). WTO Center

2. SAG-CS : Final Opinion on Benzophenone-3 in Cosmetic Products (Oct 24, 2024). UK Government

3. Commission Regulation (EU) 2022/1176 amending Annex VI to Regulation (EC) 1223/2009 (28 June 2022). EUR-Lex

   
   

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