What Are Omnibus Regulations?
Omnibus regulations are amending regulations that update multiple Annexes of EU Regulation 1223/2009 in a single legislative package. According to European Commission guidance, these regulations are the primary mechanism for keeping EU cosmetic ingredient restrictions current with the latest scientific evidence and safety assessments.
Why 'Omnibus'?
The most significant recent updates are:
- Omnibus IV — Regulation (EU) 2021/1902 (Lilial ban, effective March 1, 2022)
- Omnibus VI — Regulation (EU) 2023/1490 (30 CMR substances, effective December 1, 2023)
- Omnibus VII — Regulation (EU) 2025/877 (22 CMR substances, effective September 1, 2025)
- Omnibus VIII — Regulation (EU) 2026/78 (CMR alignment with the 22nd ATP to CLP, in force since May 1, 2026)
Note: Regulation (EU) 2023/1545 (fragrance allergen labeling) is a separate amendment, NOT part of Omnibus VI.
These updates have major implications for cosmetic formulations, requiring reformulation of products containing newly restricted or prohibited ingredients.
Omnibus IV: The Lilial Ban
Omnibus IV (Regulation EU 2021/1902), published November 3, 2021, is notable for prohibiting Butylphenyl Methylpropional (Lilial), effective March 1, 2022:
Lilial Ban Has Been Active Since 2022
Omnibus VI: Key Changes
Omnibus VI (Regulation EU 2023/1490), published July 20, 2023 and effective December 1, 2023, added 30 CMR substances to the prohibited list (Annex II):
| Category | Change | Effective Date |
|---|---|---|
| CMR Category 1A/1B Substances | 30 substances prohibited (Annex II) | December 1, 2023 |
| Note | Lilial was NOT part of Omnibus VI | Lilial was banned in Omnibus IV (March 2022) |
Source: EU Regulation 2023/1490
Separate Regulations (NOT Omnibus)
Salicylic Acid Restrictions (Omnibus III)
Note: Salicylic acid restrictions come from Omnibus III (Regulation EU 2021/850), effective October 1, 2021 — NOT from 2023 regulations:
| Product Type | Maximum Concentration | Additional Requirements |
|---|---|---|
| Rinse-off hair products | 3.0% | Standard use |
| Other rinse-off products | 2.0% | Standard use |
| Leave-on products | 2.0% | With exceptions below |
| Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant | 0.5% | Specific product limit |
| Products for children under 3 | Not permitted | Warning required if 0.5-2% |
| Oral products | Not permitted | Prohibited use |
* These limits apply when salicylic acid is NOT used as a preservative
* Different rules apply when used as preservative (Annex V)
Source: EU Regulation 2021/850
Omnibus VII: September 2025 Changes
Omnibus VII (Regulation EU 2025/877), published May 12, 2025, is effective September 1, 2025:
| Category | Changes | Effective Date |
|---|---|---|
| CMR Substances | 22 substances prohibited (Annex II) | September 1, 2025 |
| TPO (Trimethylbenzoyl Diphenylphosphine Oxide) | Moved from Annex III (restricted) to Annex II (prohibited) | September 1, 2025 |
| Dimethyltolylamine | Prohibited (CMR classification) | September 1, 2025 |
| New Preservative Added | Ammonium Silver Zinc Aluminum Silicate added to Annex V | September 1, 2025 |
Source: Commission Regulation (EU) 2025/877
CMR Bans Have NO Transition Period
Regulation (EU) 2024/996: April 2024 Amendments
This significant April 2024 amendment (NOT part of the Omnibus CMR pathway) affects multiple ingredient categories:
| Substance | Change | Placement Deadline | Available Deadline |
|---|---|---|---|
| 4-Methylbenzylidene Camphor (4-MBC) | Prohibited (Annex II) | May 1, 2025 | May 1, 2026 |
| Vitamin A (Retinol) | New restrictions (Annex III) | Feb 1, 2025 | Nov 1, 2025 |
| Retinyl Acetate | New restrictions (Annex III) | Feb 1, 2025 | Nov 1, 2025 |
| Retinyl Palmitate | New restrictions (Annex III) | Feb 1, 2025 | Nov 1, 2025 |
| Alpha-Arbutin & Arbutin | Max 7% in face creams (Annex III) | Feb 1, 2025 | Nov 1, 2025 |
| Kojic Acid | New restrictions (Annex III) | Feb 1, 2025 | Nov 1, 2025 |
Source: Commission Regulation (EU) 2024/996
Omnibus VIII: May 2026 Changes
Omnibus VIII (Regulation EU 2026/78), published January 13, 2026, has applied since 1 May 2026. It aligns the cosmetic annexes with the CMR classifications introduced by Regulation (EU) 2024/2564 (the 22nd ATP to CLP), adding substances including perboric acid, silver (nano and massive) and acetone oxime to Annex II. Unlike Regulation 2023/1545 on fragrance allergens, it grants no transitional sell-through period: from 1 May 2026 non-compliant product could neither be placed on nor made available on the EU market, whatever its production date or whether it was already on retail shelves.
Omnibus VIII Key Changes
- New CMR substance prohibitions following latest CLP updates
- Additional substances added to Annex II
- Non-compliant stock had to be removed by 1 May 2026 — no sell-through period was granted
- Monitor Official Journal for complete substance list
How Omnibus Updates Work
Omnibus Amendment Process
SCCS Safety Assessment
The Scientific Committee on Consumer Safety (SCCS) evaluates ingredient safety and issues opinions recommending restrictions or prohibitions.
Commission Proposal
Based on SCCS opinions and other evidence, the European Commission drafts proposed amendments to the Annexes.
Standing Committee Review
The Standing Committee on Cosmetic Products reviews and votes on proposed amendments.
Publication in Official Journal
Approved amendments are published in the Official Journal of the European Union.
Transition Period
Most amendments include transition periods allowing industry time to reformulate and sell existing stock.
Compliance Deadline
After the transition period, products must fully comply with new restrictions.
Understanding Transition Periods
Omnibus regulations typically include different transition dates:
| Date Type | What It Means | Example |
|---|---|---|
| Entry into Force | Regulation becomes legally binding | 20 days after publication |
| Application Date (New Products) | New products must comply | Often 6-12 months |
| Making Available Deadline | Existing stock can no longer be sold | Often 12-24 months |
Two-Phase Compliance
Impact Assessment for Formulators
When an Omnibus update is published, take these steps:
Omnibus Impact Assessment
Review the Full Regulation Text
Read the complete regulation in the Official Journal. Summaries may miss important details.
Identify Affected Products
Cross-reference your product portfolio against the amended Annexes.
Note Transition Deadlines
Document all relevant compliance dates for affected products.
Assess Reformulation Needs
Determine which products need reformulation and prioritize by sales volume and deadline.
Contact Suppliers
Work with ingredient suppliers on compliant alternatives.
Update CPSRs and CPNP
Ensure all documentation reflects reformulated products.
SCCS Opinions: Early Warning System
SCCS opinions often precede Omnibus amendments. Monitoring SCCS publications provides early warning of potential restrictions:
| Stage | Typical Duration | Action |
|---|---|---|
| SCCS Opinion Published | Starting point | Review immediately |
| Commission Proposal | 6-18 months later | Begin reformulation planning |
| Standing Committee Vote | 3-6 months later | Finalize alternatives |
| Official Journal Publication | 1-3 months later | Compliance clock starts |
| Compliance Deadline | 6-24 months later | Full compliance required |
Proactive Approach
Corrected Omnibus Timeline
| Regulation | Published | Effective | Key Changes |
|---|---|---|---|
| Omnibus III (EU 2021/850) | 2021 | Oct 1, 2021 | Salicylic acid restrictions |
| Omnibus IV (EU 2021/1902) | Nov 3, 2021 | Mar 1, 2022 | Lilial ban, Zinc Pyrithione, 23 CMR substances |
| Omnibus V (EU 2022/...) | Sep 2022 | Dec 2022 | Additional CMR bans |
| Omnibus VI (EU 2023/1490) | Jul 20, 2023 | Dec 1, 2023 | 30 CMR substances prohibited |
| Reg. (EU) 2024/996 | Apr 3, 2024 | Apr 24, 2024 | 4-MBC ban, Vitamin A/Arbutin restrictions |
| Omnibus VII (EU 2025/877) | May 12, 2025 | Sep 1, 2025 | 22 CMR substances prohibited |
| Omnibus VIII (EU 2026/78) | Jan 13, 2026 | May 1, 2026 | New CMR restrictions |
Source: EU Official Journal
Staying Compliant: Monitoring Resources
Regulatory Monitoring Resources
- Official Journal of the European Union (primary source)
- European Commission Cosmetics website
- SCCS opinions and meeting minutes
- CosIng database (reflects current Annex status)
- Cosmetics Europe regulatory updates
- National competent authority notifications
- Industry trade publications and newsletters
Key Takeaways
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Get Compliance HelpFrequently Asked Questions
An Omnibus regulation is an amending regulation that updates multiple Annexes of EU Regulation 1223/2009 simultaneously. These regulations add new prohibited substances (Annex II), modify restrictions (Annex III), and update permitted lists (Annexes IV-VI). They are numbered sequentially (Omnibus VI, VII, VIII, etc.).
The Lilial (Butylphenyl Methylpropional) prohibition took effect on March 1, 2022, per Omnibus IV (Regulation EU 2021/1902). Products containing Lilial have been prohibited from the EU market since this date — over three years ago. Note: Lilial was NOT banned by Omnibus VI as sometimes incorrectly stated.
Review the full regulation text in the Official Journal, cross-reference against your formulations, and check the CosIng database for current ingredient status. Pay particular attention to fragrances (which may contain restricted substances) and preservative systems.
Transition periods allow industry time to comply with new restrictions. Typically there are two dates: one for placing products on the market (after which new non-compliant products cannot be manufactured) and a later date for making available (after which existing stock cannot be sold).
Major Omnibus regulations are typically published every 1-2 years, but smaller amendments may occur more frequently. The Annexes are also automatically updated when substances are classified as CMR under CLP Regulation. Monitor the Official Journal and CosIng database regularly.
SCCS opinions are published on the European Commission's SCCS website. Opinions provide scientific assessment of ingredient safety and often precede Omnibus restrictions. Monitoring SCCS publications provides early warning of potential regulatory changes.
It depends on the specific transition period structure. Many Omnibus amendments have a 'making available' deadline that is later than the manufacturing deadline, allowing existing compliant stock to be sold. Check the specific regulation text for each substance.
Non-compliant products can be removed from the market by competent authorities, recalled, and the Responsible Person can face fines and legal action. Retailers are also increasingly verifying compliance before stocking products.