Major Ingredient Changes Coming in 2025-2026
The EU cosmetics regulatory landscape is undergoing significant changes with multiple Omnibus Regulations adding new substance bans and restrictions. According to Obelis analysis, these changes stem from ongoing REACH evaluations and SCCS opinions identifying safety concerns.
Action Required
Omnibus VII: Effective September 1, 2025
According to Coslaw analysis, Omnibus VII (Regulation 2024/996) introduces:
| Substance | CAS Number | Category | Reason for Ban |
|---|---|---|---|
| 2-Chloroethanol | 107-07-3 | Solvent/Intermediate | CMR classification (Carc. 1B, Repr. 1B) |
| 2,4-Diaminodiphenylamine | 136-17-4 | Hair dye intermediate | CMR classification |
| 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline | 3248-93-9 | Colorant/dye | CMR classification |
| Acid Green 25, CI 61570 | 4403-90-1 | Colorant | CMR classification |
| Basic Red 51 | 77061-58-6 | Hair colorant | CMR classification |
| Chloroacetamide | 79-07-2 | Preservative | CMR classification (Repr. 1B) |
| Disperse Violet 23 | 6408-72-6 | Colorant | CMR classification |
| Solvent Violet 13, CI 60725 | 81-48-1 | Colorant | CMR classification |
* 21 total substances added to Annex II under Omnibus VII (Regulation EU 2025/877)
* Table shows representative examples — consult official regulation for complete list
Source: Commission Regulation (EU) 2025/877
Galaxolide (Hexamethylindanopyran) — Pending Classification
Homosalate — RESTRICTION, Not Ban
Omnibus VIII: Effective Throughout 2026
Per Coslaw and BeLab Services, Omnibus VIII (Regulation 2024/2052) introduces additional restrictions:
Lilial Ban — Already in Effect Since 2022
| Substance | Deadline | Previous Status | New Status |
|---|---|---|---|
| Titanium dioxide (CI 77891) certain applications | Throughout 2026 | Annex IV allowed | Restrictions for spray products |
| Various CMR substances (36+ entries) | March 2026 | Previously unrestricted | Annex II prohibited |
| Certain azo dyes | 2026 | Allowed | New restrictions |
Source: Regulation (EU) 2024/2052
CMR Substance Updates
The European Commission continues adding CMR (Carcinogenic, Mutagenic, Reprotoxic) substances to Annex II as they're classified under CLP Regulation. According to Article 15 of Regulation 1223/2009:
CMR Classification Impact
- CMR Category 1A/1B substances are automatically prohibited in cosmetics
- CMR Category 2 substances may be prohibited following SCCS evaluation
- No transition period once listed in Annex II (prohibited)
- Responsible Person must monitor CLP changes affecting ingredients
- 6-month transition period applies to Annex III/V/VI restrictions
Timeline of 2025-2026 Compliance Deadlines
| Date | Regulation | Key Changes | Products Affected |
|---|---|---|---|
| March 1, 2022 (PAST) | Omnibus IV | Lilial fully banned | Perfumes, scented skincare — already prohibited |
| July 1, 2025 | 2022/2195 | Homosalate restrictions (face products only, 7.34% max) | Sunscreens — restriction, not ban |
| September 1, 2025 | Omnibus VII | 21 substances prohibited | Hair dyes, colorants, fragranced products |
| July 31, 2026 | 2023/1545 | New fragrance allergen labeling | All fragranced products (new products) |
| September 2026 | Omnibus VIII | Additional CMR bans (36+ entries) | Various categories |
| July 31, 2028 | 2023/1545 | Allergen labeling for existing products | All fragranced products |
Source: EU Omnibus Regulations
Impact by Product Category
Sunscreens and SPF Products
| UV Filter | Current Status | 2025 Status | Notes |
|---|---|---|---|
| Homosalate | Annex VI (previously 10%) | RESTRICTED to 7.34% face products only (July 2025) | Not banned — permitted in face products |
| Octocrylene | Under SCCS review | Awaiting opinion | Monitor closely |
| Benzophenone-3 | Annex VI (up to 6%) | Lower limits in discussion | Alternative: Tinosorb S, Uvinul A Plus |
| Butyl Methoxydibenzoylmethane (Avobenzone) | Annex VI (up to 5%) | Stable, no changes planned | N/A |
Source: SCCS Opinions and Omnibus Regulations
Sunscreen Reformulation
Hair Colorants
Multiple hair dye intermediates face prohibition under Omnibus VII and VIII:
| Ingredient | Deadline | Action Required |
|---|---|---|
| 2,4-Diaminodiphenylamine | Sept 2025 | Reformulate or discontinue |
| Basic Red 51 | Sept 2025 | Find alternative colorant |
| Various p-phenylenediamine derivatives | Ongoing | Verify current Annex III status |
| HC dyes (selected) | Various | Check individual entries |
Source: Omnibus VII & VIII
Fragranced Products
| Ingredient | INCI Name | Status | Impact |
|---|---|---|---|
| Lilial | Butylphenyl methylpropional | BANNED since March 2022 | Already prohibited — verify your fragrances are Lilial-free |
| Galaxolide | Hexamethylindanopyran | Under CMR review (pending) | Anticipate potential ban — monitor classification decision |
| 80+ allergens | Various | July 2026/2028 labeling | Expanded labeling required above threshold |
Source: EU Omnibus Regulations
How to Prepare for Ingredient Bans
Compliance Action Plan
Audit Current Formulations
Review all product formulas against the upcoming ban lists. Check raw material specifications — some ingredients may be present as impurities or fragrance components rather than declared ingredients.
Identify Affected Products
Create a list of products requiring reformulation and prioritize by sales volume, deadline proximity, and reformulation complexity.
Source Alternatives
Work with ingredient suppliers to identify compliant alternatives. Request regulatory documentation confirming new ingredients are permitted under EU regulations.
Reformulate and Test
Develop new formulations, conduct necessary stability and safety testing. Allow adequate lead time for full testing programs.
Update CPSR and Documentation
Revise safety assessments for reformulated products. Update CPNP notifications and labels accordingly.
Plan Stock Transition
Calculate sell-through dates for existing inventory. Products on EU shelves must comply by the deadline — plan production and distribution accordingly.
Monitoring Future Changes
Stay Informed: Resources to Monitor
- EUR-Lex for new Omnibus Regulations (search 'cosmetics regulation amendments')
- SCCS opinions on ingredient safety (health.ec.europa.eu)
- ECHA CLP notifications for new CMR classifications
- CosIng database updates (ec.europa.eu/growth/tools-databases/cosing)
- Industry associations: Cosmetics Europe, CTPA, national associations
- Regulatory consultancy newsletters and alerts
Key Takeaways
Frequently Asked Questions
No. Once a substance is added to Annex II (prohibited), products containing it cannot be placed on the market OR made available on the market after the deadline. This means existing retail stock must be removed. For Annex III/V/VI restrictions, there is typically a 6-month transition allowing sale of existing stock, but this does not apply to prohibitions.
Request a detailed composition statement from your fragrance supplier that lists all components at or above 0.0001% (for allergen tracking). Many banned ingredients like Lilial or Galaxolide are fragrance compounds that may not appear in your declared INCI list but are present in 'parfum.' Your supplier should provide regulatory compliance declarations.
Penalties vary by Member State but typically include: product seizure and withdrawal from market, fines (can exceed €50,000), reputational damage, and potential personal liability for the Responsible Person. Market surveillance authorities conduct testing and take enforcement action. Non-compliant products discovered in the supply chain can also affect retailer relationships.
No. The EU Cosmetics Regulation applies equally to all cosmetics regardless of natural, organic, or conventional positioning. If a banned substance occurs naturally in a botanical extract, the extract cannot be used if it causes the finished product to contain the prohibited substance above trace levels. Natural does not mean exempt from safety requirements.
Transition periods vary. For Annex II additions (prohibitions), there is often minimal transition time once the regulation is published. For Annex III/V/VI modifications (restrictions), a 6-month transition is typical. Omnibus regulations are usually published 12-18 months before major deadlines, but monitoring SCCS opinions gives earlier warning of likely changes.
Yes. If you reformulate to remove a banned ingredient, your CPSR must be updated to reflect the new composition. Even if you don't reformulate (because you already don't use the ingredient), your safety assessor should confirm compliance with current regulations. Annual CPSR reviews should verify all ingredients remain permitted.