Understanding EU Banned and Restricted Ingredients
The European Union maintains the world's most comprehensive regulatory framework for cosmetic ingredients. According to EU Regulation 1223/2009, substances used in cosmetic products are classified into several categories based on their safety profile, with the strictest controls applied to prohibited substances.
1,703+ Prohibited Substances
The regulatory framework divides cosmetic ingredients into distinct categories:
- Annex II — Prohibited substances (complete ban)
- Annex III — Restricted substances (allowed with conditions)
- Annex IV — Permitted colorants (positive list)
- Annex V — Permitted preservatives (positive list)
- Annex VI — Permitted UV filters (positive list)
What is Annex II? The Prohibited Substances List
According to ECHA's cosmetics database, Annex II contains substances that are completely banned from use in cosmetic products. As explained by industry analysis, this list has grown significantly over the years:
| Year | Number of Entries | Key Additions |
|---|---|---|
| 2009 (Original) | ~1,328 | Initial list from Cosmetics Directive |
| 2019 | ~1,400 | CMR substance updates |
| 2022 | ~1,530 | Omnibus III-V updates |
| 2024 | ~1,650 | Omnibus VI additions |
| 2025 | 1,703+ | Omnibus VII (Sept 2025) |
| 2026 | 1,750+* | Omnibus VIII (projected) |
* *Projected based on announced additions
Source: EU Regulation 1223/2009 amendments
Why Substances Are Prohibited
Substances are added to Annex II for several reasons:
Reasons for Annex II Prohibition
- CMR Category 1A or 1B classification (Carcinogenic, Mutagenic, Reprotoxic)
- SCCS opinion determining unsafe for cosmetic use at any concentration
- Endocrine disrupting properties confirmed by scientific evaluation
- Acute toxicity concerns with no safe use threshold
- Sensitization potential too high to manage through restrictions
- Environmental concerns requiring complete phase-out
Automatic Prohibition of CMR Substances
What is Annex III? Restricted Substances
Unlike Annex II, Annex III contains substances that may be used in cosmetics but only under specific conditions. As detailed by industry guidance, these restrictions may include:
| Restriction Type | Example | Practical Implication |
|---|---|---|
| Maximum concentration | Salicylic acid ≤2% in rinse-off | Formula must not exceed limit |
| Product type limitation | Only in rinse-off products | Cannot use in leave-on products |
| Body area restriction | Not for use on face | Labeling must warn consumers |
| Warning label required | "Contains [substance]" | Label compliance mandatory |
| Professional use only | Restricted to salon use | Not for retail sale |
| Purity requirements | Maximum impurity levels | Supplier certificates needed |
Source: EU Regulation 1223/2009, Annex III
Key Restricted Ingredients
| Substance | Restriction | Common Products |
|---|---|---|
| Hydrogen peroxide | ≤12% in hair products, ≤4% in skin | Hair bleach, tooth whitening |
| Salicylic acid | ≤3% rinse-off hair, ≤2% other products, ≤0.5% body lotion/eye/lips | Acne treatments, exfoliants |
| Retinol (Vitamin A) | ≤0.3% face, ≤0.05% body (Nov 2025 placement; May 2027 withdrawal) | Anti-aging creams |
| Alpha hydroxy acids | ≤10% with pH ≥3.5 | Chemical peels, serums |
| Hydroquinone | Prohibited except 0.02% in nail systems | Formerly in skin lighteners |
| Thioglycolic acid | Variable by use: 5% depilatory, 8-11% hair waving | Depilatory creams, perms |
Source: EU Regulation 1223/2009, Annex III
Salicylic Acid Limits (Omnibus III - Regulation EU 2021/850)
Thioglycolic Acid Limits by Product Category
How Substances Get Banned: The Process
The path from permitted ingredient to prohibition follows a structured process. According to regulatory analysis:
Substance Prohibition Process
Safety Concern Identified
New scientific data, adverse events, or updated hazard classification triggers review. This may come from ECHA, Member State authorities, or SCCS own-initiative.
SCCS Evaluation Requested
The European Commission mandates the Scientific Committee on Consumer Safety (SCCS) to evaluate the substance's safety for cosmetic use.
SCCS Opinion Published
After 12-24 months of evaluation, SCCS publishes an opinion with conclusions on safety and any recommended restrictions or prohibition.
Commission Drafts Amendment
Based on SCCS opinion, the Commission prepares an amendment to the Cosmetics Regulation (typically through Omnibus Regulation).
Member State Vote
The Standing Committee on Cosmetic Products votes on the proposed amendment. Simple majority required.
Publication and Transition
Amendment published in Official Journal with compliance deadlines. Typically 6-12 months for market adjustment.
Major Banned Ingredient Categories
CMR Substances (Carcinogenic, Mutagenic, Reprotoxic)
| Substance | CAS Number | CMR Classification | Ban Date |
|---|---|---|---|
| Lilial (Butylphenyl methylpropional) | 80-54-6 | Repr. 1B | March 2022 |
| Zinc pyrithione | 13463-41-7 | Repr. 1B | March 2022 |
| 2-Chloroethanol | 107-07-3 | Carc. 1B, Repr. 1B | Sept 2025 |
| Chloroacetamide | 79-07-2 | Repr. 1B | Sept 2025 |
| TPO (Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide) | 75980-60-8 | Repr. 1B | May 2026 |
Source: Omnibus VII & VIII
Lilial: A Case Study
Formaldehyde and Formaldehyde Releasers
| Substance | Status | Notes |
|---|---|---|
| Formaldehyde (free) | Annex II - Prohibited | Cannot be added as ingredient |
| DMDM Hydantoin | Annex V - Restricted | Max 0.6% as preservative |
| Imidazolidinyl urea | Annex V - Restricted | Max 0.6% as preservative |
| Diazolidinyl urea | Annex V - Restricted | Max 0.5% as preservative |
| Bronopol | Annex V - Restricted | Max 0.1% |
| Quaternium-15 | Annex V - Restricted | Max 0.2% |
* Products containing formaldehyde releasers must be labeled 'contains formaldehyde' if free formaldehyde exceeds 0.05%
Source: EU Regulation 1223/2009, Annexes II & III
Nanomaterials: Special Considerations
Nanomaterials have specific notification requirements under Article 16 of EU Regulation 1223/2009:
Nanomaterial Requirements
- Must be notified to Commission 6 months before placing on market
- Labeled with [nano] after INCI name on product
- SCCS evaluation may be requested for new nanomaterials
- Prohibited if insoluble or biopersistent with toxicity concerns
- Some nanomaterials listed in Annex IV-VI with nano-specific limits
- Carbon black, nano-titanium dioxide, and nano-zinc oxide have specific restrictions
Recent Additions: Omnibus VII and VIII
Omnibus VII (Effective September 1, 2025)
According to CIRS analysis and Coslaw, Omnibus VII adds 21 substances to Annex II:
Homosalate Clarification
Galaxolide Clarification
| Substance | Use | Reason for Ban |
|---|---|---|
| Basic Red 51 | Hair colorant | CMR classification |
| Disperse Violet 23 | Colorant | CMR classification |
| Acid Green 25 | Colorant | CMR classification |
| Solvent Violet 13 | Colorant | CMR classification |
| 2,4-Diaminodiphenylamine | Hair dye intermediate | CMR classification |
| Chloroacetamide | Preservative | CMR classification (Repr. 1B) |
| 2-Chloroethanol | Solvent/Intermediate | CMR classification (Carc. 1B) |
* 21 total substances added to Annex II — table shows representative examples
Source: Commission Regulation (EU) 2025/877
Omnibus VIII (Effective 2026)
As reported by Cosmetics Care, Omnibus VIII continues the trend with additional prohibitions effective throughout 2026.
How to Check if an Ingredient is Banned
The CosIng database is the official tool for checking ingredient status. According to regulatory guidance:
Using CosIng to Check Ingredient Status
Access CosIng
Navigate to the official CosIng search tool at ec.europa.eu/growth/tools-databases/cosing/
Search by Name or CAS
Enter the INCI name, chemical name, or CAS number in the search field. CosIng recognizes multiple naming conventions.
Review Regulatory Status
Check which Annex the substance appears in. Annex II = prohibited, Annex III = restricted, Annex IV-VI = permitted with conditions.
Check Restriction Details
For Annex III-VI substances, review the specific conditions: concentration limits, product types, required warnings.
Verify Current Status
CosIng is updated regularly. Check the 'last updated' date and cross-reference with recent Omnibus Regulations for very recent changes.
CosIng Limitations
Compliance Deadlines and Transition Periods
Understanding the difference between "placing on the market" and "making available on the market" is crucial:
| Term | Definition | Practical Meaning |
|---|---|---|
| Placing on the market | First making available in the EU | Manufacturing or importing for first time |
| Making available | Any supply for distribution, consumption, or use | Wholesale, retail, including existing stock |
| Transition period (placing) | New products must comply | Cannot manufacture/import non-compliant products |
| Transition period (making available) | All products must comply | Existing stock must be removed from shelves |
Source: EU Regulation 1223/2009, Article 2
| Type of Change | Placing on Market | Making Available |
|---|---|---|
| Annex II prohibition | Immediate or 6 months | Same as placing (no sell-through) |
| Annex III new restriction | 6-12 months | Often 6 months after placing deadline |
| Annex VI UV filter limit change | 6-12 months | 6-12 months after placing deadline |
| New labeling requirement | 12-24 months | 12-24 months additional |
* Exact periods specified in each amending regulation
Source: EU Omnibus Regulations
No Sell-Through for Prohibitions
Summary: Key Banned Ingredient Categories
| Category | Examples | Count (Approx.) |
|---|---|---|
| CMR substances (1A/1B) | Lilial, Zinc pyrithione, TPO | 500+ |
| Heavy metals & compounds | Lead, mercury, arsenic compounds | 100+ |
| Antibiotics | Chloramphenicol, nitrofurans | 50+ |
| Hormones & steroids | Estradiol, testosterone, progesterone | 80+ |
| Prohibited colorants | Various azo dyes, CI numbers | 100+ |
| Solvents & intermediates | 2-Chloroethanol, chloroacetamide | 50+ |
| Drugs & pharmaceuticals | Prescription substances | 200+ |
| Pesticides | Various agricultural chemicals | 100+ |
| Other toxic substances | Miscellaneous hazardous chemicals | 500+ |
* Categories overlap; total entries exceed sum due to compounds appearing in multiple categories
Source: EU Regulation 1223/2009, Annex II
Key Takeaways
Frequently Asked Questions
As of 2025, Annex II of EU Regulation 1223/2009 lists over 1,703 prohibited substances. This number continues to grow with each Omnibus Regulation as new CMR classifications are made and SCCS opinions identify safety concerns. The list includes CMR substances, heavy metals, antibiotics, hormones, certain colorants, and various other hazardous chemicals deemed unsafe for cosmetic use at any concentration.
Annex II contains substances that are completely prohibited from use in cosmetics — they cannot be used at any concentration in any product type. Annex III contains restricted substances that may be used but only under specific conditions such as maximum concentration limits, product type restrictions (e.g., rinse-off only), body area limitations, or mandatory warning labels. The key difference is that Annex II = total ban, while Annex III = conditional use.
The official tool is the CosIng database (ec.europa.eu/growth/tools-databases/cosing/). Search by INCI name, chemical name, or CAS number to see the regulatory status. Annex II means prohibited, Annex III means restricted with conditions. For very recent changes, also check EUR-Lex for the latest Omnibus Regulations as CosIng updates may lag by 1-3 months after publication.
Selling cosmetics containing Annex II prohibited substances is illegal in the EU. Consequences include: immediate product recall and market withdrawal, fines that vary by Member State (can exceed €50,000), personal liability for the Responsible Person, potential criminal charges for serious violations, and reputational damage. Market surveillance authorities conduct testing and take enforcement action, and non-compliant products can also damage retailer relationships.
Unlike Annex III restrictions which typically have transition periods, Annex II prohibitions often have limited or no sell-through allowance. The deadline specified in the Omnibus Regulation applies to both 'placing on market' (manufacturing/importing) and 'making available' (retail sales). This means existing stock must be removed from shelves by the deadline — you cannot continue selling until inventory is depleted. Plan reformulation well in advance.
Lilial (Butylphenyl methylpropional, CAS 80-54-6) was banned after being classified as Repr. 1B (reproductive toxicant) under CLP Regulation. Under Article 15 of the Cosmetics Regulation, CMR Category 1A/1B substances are automatically prohibited. Lilial was widely used in perfumes and scented products, making its ban highly impactful. The prohibition took effect March 1, 2022, with products containing Lilial removed from EU market.
No. EU cosmetic regulations apply equally to all ingredients regardless of natural or synthetic origin. 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. For example, certain essential oils contain naturally occurring allergens or restricted substances that must be accounted for in formulation.
The prohibited substances list is updated through Omnibus Regulations, typically issued 1-2 times per year. Each Omnibus amendment adds new entries based on SCCS opinions and CLP classification updates. Additionally, CMR substances are automatically prohibited upon classification, which can occur throughout the year through ECHA's CLP notification process. Formulators should monitor both Omnibus publications and ECHA CLP updates regularly.