Why 2025-2026 Are Critical Years for EU Cosmetics
The European Union is implementing a wave of regulatory changes that will fundamentally reshape the cosmetics industry. According to European Commission guidance, the period from 2025-2026 represents one of the most significant regulatory transitions since the original Cosmetics Regulation took effect in 2013.
Multiple Deadlines Approaching
These changes affect virtually every aspect of cosmetic formulation and compliance:
- Ingredient restrictions — New CMR substance bans and concentration limits
- Labeling requirements — Expanded fragrance allergen disclosure
- Safety assessments — Updated CPSR requirements for restricted ingredients
- INCI nomenclature — Comprehensive glossary update requiring label changes
Omnibus VII (Regulation 2025/877) — CMR Bans
Commission Regulation (EU) 2025/877, commonly called Omnibus VII, introduces significant new restrictions on CMR (Carcinogenic, Mutagenic, Reprotoxic) substances in cosmetics.
Two dates matter, and they are not the same. Omnibus VII was adopted on 12 May 2025, published in the Official Journal on 13 May 2025, and entered into force twenty days later, on 2 June 2025. Its prohibitions apply from 1 September 2025. Entry into force is when the regulation becomes law; application is when the bans bite. Nothing was prohibited in June 2025.
There is no transition period, and no distinction between placing a product on the market and making it available on the market — from 1 September 2025 the prohibitions apply to all affected products, including stock already in the supply chain.
Key Substances Banned Under Omnibus VII
| Substance | CAS Number | Common Use | Compliance Date |
|---|---|---|---|
| 2-Chloroacetamide | 79-07-2 | Preservative | 1 September 2025 |
| Triclocarban | 101-20-2 | Antimicrobial | 1 September 2025 |
| Climbazole | 38083-17-9 | Anti-dandruff | 1 September 2025 |
| PFAS compounds (various) | Multiple | Water/oil repellent | 2025-2026 |
| Additional coal tar dyes | Multiple | Colorants | 1 September 2025 |
* Omnibus VII entered into force 2 June 2025 and applies from 1 September 2025
* No transition period applies — affected products cannot be placed on or made available on the EU market from the application date
Source: Commission Regulation (EU) 2025/877
Zinc pyrithione is not part of Omnibus VII. It was prohibited earlier, by Omnibus IV (Regulation (EU) 2021/1902), effective 1 March 2022 — when did the zinc pyrithione ban take effect?
CMR Classification Updates
Under Article 15 of Regulation 1223/2009, substances classified as CMR under CLP Regulation are automatically prohibited in cosmetics. Omnibus VII codifies recent CLP classifications into the Cosmetics Regulation annexes.
| CMR Category | Cosmetic Use | Exceptions |
|---|---|---|
| Category 1A (Known CMR) | Prohibited | None |
| Category 1B (Presumed CMR) | Prohibited | None |
| Category 2 (Suspected CMR) | Prohibited | SCCS opinion may allow if safe at specific concentrations |
Source: Regulation 1223/2009 Article 15
Vitamin A & Arbutin Restrictions (Regulation 2024/996)
Commission Regulation (EU) 2024/996 introduces strict concentration limits on retinol, retinyl esters, and alpha-arbutin, effective from 2025.
New Vitamin A Limits
| Ingredient | Product Type | Maximum Concentration |
|---|---|---|
| Retinol | Face products | 0.3% |
| Retinol | Body products | 0.05% |
| Retinyl Palmitate | Face products | 0.55% (as retinol equivalent) |
| Retinyl Acetate | Face products | 0.4% (as retinol equivalent) |
| All Vitamin A forms | Lip products | 0.05% |
| All Vitamin A forms | Sunscreen (face) | 0.05% |
Source: Commission Regulation (EU) 2024/996
Vitamin A Compliance Timeline
Two-Phase Compliance Deadlines
| Milestone | Date | Requirement |
|---|---|---|
| Placement deadline | November 1, 2025 | New products must comply with concentration limits |
| Making available deadline | May 1, 2027 | All non-compliant products must be withdrawn from shelves |
Source: Commission Regulation (EU) 2024/996
Mandatory Warning Statement
Alpha-Arbutin Restrictions
Alpha-arbutin, a popular skin brightening agent, is now restricted to maximum 2% concentration in face products. Products must also include warnings about sun exposure.
Cyclic Siloxane Restrictions (D4/D5/D6)
Building on earlier restrictions, the EU has further tightened limits on cyclic siloxanes due to environmental persistence concerns.
| Siloxane | INCI Name | Maximum (Rinse-off) | Maximum (Leave-on) |
|---|---|---|---|
| D4 | Cyclotetrasiloxane | 0.1% | 0.1% |
| D5 | Cyclopentasiloxane | 0.1% | 0.1% |
| D6 | Cyclohexasiloxane | 0.1% | 0.1% |
* Limits apply to each siloxane individually, not combined
* Many formulations historically used 5-20% D5 in hair products
Source: EU Cosmetic Regulations
Major Reformulation Required
INCI Glossary Update (Decision 2025/1175)
Implementing Decision (EU) 2025/1175 introduces a comprehensive update to the INCI (International Nomenclature of Cosmetic Ingredients) glossary, requiring label updates across thousands of products.
Key INCI Changes
INCI Glossary 2025 Major Updates
- New INCI names for approximately 200 ingredients
- Standardized naming conventions for plant extracts
- Updated nomenclature for fermented ingredients
- New entries for biotechnology-derived ingredients
- Clarified naming for nanomaterial forms
- Harmonized naming with international standards
Label Compliance Timeline
Products must display the updated INCI names on labels. A transition period allows existing labeled stock to be sold, but new production must use updated names by October 2025.
Fragrance Allergen Requirements (In Force Since July 2026)
Regulation 2023/1545 significantly expands fragrance allergen labeling requirements, with key deadlines in 2026 and 2028.
| Requirement | Deadline | Impact |
|---|---|---|
| Label newly added allergens | July 31, 2026 | Products containing new allergens above thresholds must list them |
| All products must comply | July 31, 2028 | Products already on market must update labels |
Source: Commission Regulation (EU) 2023/1545
Expanded Allergen List
The regulation expands the list of declarable fragrance allergens from 26 to over 80 substances. This includes:
- 56 new individual allergens requiring labeling
- Natural extracts containing allergens (e.g., essential oils)
- Pre-haptens and pro-haptens that convert to allergens
Compliance Timeline Summary
| Date | Regulation | Requirement |
|---|---|---|
| September 2025 | 2025/877 | Omnibus VII CMR bans apply (in force since 2 June 2025) |
| September 2025 | 2025/877 | Climbazole prohibition |
| October 2025 | 2025/1175 | INCI glossary updates required on new labels |
| November 2025 | 2024/996 | Vitamin A — placement deadline (new products must comply) |
| July 2026 | 2023/1545 | Expanded allergen declaration required for products placed on the market |
| May 2027 | 2024/996 | Vitamin A — complete market withdrawal deadline |
| July 2028 | 2023/1545 | All products must comply with allergen labeling |
Source: European Commission Regulations
Impact on Formulations
These regulatory changes require systematic review of cosmetic portfolios:
| Product Category | Primary Impact | Reformulation Priority |
|---|---|---|
| Anti-aging skincare | Vitamin A limits | High — most affected category |
| Hair care (silicones) | D4/D5/D6 limits | High — major ingredient change |
| Fragranced products | Allergen labeling | Medium — label updates needed |
| Skin brighteners | Arbutin limits | Medium — concentration adjustments |
| Preservative systems | CMR bans | Variable — depends on current system |
Reformulation Strategies
Managing Multi-Regulatory Compliance
Audit Current Portfolio
Map all products against upcoming restrictions to identify affected formulations.
Prioritize by Deadline
Create timeline-based action plans starting with nearest deadlines.
Evaluate Alternatives
Source and test alternative ingredients before reformulation commitment.
Update Safety Assessments
Ensure CPSRs reflect new formulations and any new ingredient safety data.
Coordinate Label Changes
Batch label updates where possible to minimize print runs and costs.
Key Takeaways
Frequently Asked Questions
The changes have staggered effective dates throughout 2025-2027. Omnibus VII CMR bans apply from 1 September 2025 (the regulation entered into force on 2 June 2025, but nothing was prohibited on that date), INCI updates by October 2025, Vitamin A placement deadline November 2025, fragrance allergen labeling July 2026, and Vitamin A market withdrawal by May 2027. Omnibus VII itself has no transition period; other changes may.
Most regulations include transition periods allowing existing compliant stock to be sold. However, new production must comply from the effective date. The specific transition period varies by regulation — check each regulation's text for exact timelines. Products non-compliant after transition periods must be withdrawn from the market.
Yes, but within new concentration limits. Face products may contain maximum 0.3% retinol, body products 0.05%. Retinyl esters are allowed at equivalent concentrations. Products must carry the mandatory warning: 'Contains vitamin A. Consider your daily intake before use.' New products must comply by November 1, 2025; existing non-compliant products must be withdrawn by May 1, 2027.
Common alternatives include pyroctone olamine (Octopirox), salicylic acid, climbazole (until September 2025), ketoconazole (limited use), and natural alternatives like tea tree oil. Each has different efficacy profiles and regulatory status. Safety assessments must be updated for new formulations.
Yes. Any reformulation requires CPSR update. Additionally, CPSRs for products containing newly restricted ingredients should document compliance with new concentration limits, even if the formulation itself doesn't change. The safety assessor must verify continued safety under new regulatory requirements.
Regulation 2023/1545 lists all declarable allergens with concentration thresholds (0.001% for leave-on, 0.01% for rinse-off). Your fragrance supplier should provide allergen declarations for their compositions. Natural ingredients like essential oils must be assessed for their allergen content.
No. Unlike some other regulatory regimes, EU Cosmetics Regulation applies equally to all businesses regardless of size. Small businesses must comply with all ingredient restrictions, labeling requirements, and safety assessment obligations. The only flexibility is in transition period timing.
Penalties are set by individual Member States and can include product withdrawal orders, fines, and potential prosecution. Market surveillance authorities actively check compliance. Non-compliant products may be reported through the EU RAPEX system, resulting in EU-wide enforcement action.