Understanding EU Cosmetic Ingredient Restrictions
The European Union maintains the world's most comprehensive restrictions on cosmetic ingredients. According to EU Regulation 1223/2009, cosmetic products must not contain any prohibited substances and must comply with restrictions on regulated ingredients. These requirements are enforced through the regulation's Annexes II through VI.
EU Has the Strictest Standards
The Annex system creates a comprehensive framework:
- Annex II — Prohibited substances (cannot be used under any circumstances)
- Annex III — Restricted substances (can be used under specific conditions)
- Annex IV — Permitted colorants (only listed colorants allowed)
- Annex V — Permitted preservatives (only listed preservatives allowed)
- Annex VI — Permitted UV filters (only listed UV filters allowed)
How many cosmetic ingredients are banned in Europe?
More than 1,700 cosmetic ingredients are banned in the European Union. Annex II of EU Regulation 1223/2009 lists over 1,700 prohibited substances, and the list grows every year as newly classified CMR substances are added through Omnibus regulations — compared with only 11 substances banned at the US federal level.
Annex II: Prohibited Substances
Annex II lists substances that are completely banned from cosmetic products. As of January 2026, this annex contains over 1,700 entries and continues to grow with each Omnibus update.
| Category | Examples | Reason for Prohibition |
|---|---|---|
| CMR Substances | Formaldehyde (as preservative), Lead acetate | Carcinogenic, mutagenic, or reprotoxic |
| Antibiotics | Chloramphenicol, Tetracycline | Risk of antimicrobial resistance |
| Hormones | Estradiol, Progesterone | Endocrine-disrupting effects |
| Heavy Metals | Mercury, Lead compounds | Systemic toxicity |
| Dyes & Pigments | Coal tar colors (many) | Carcinogenic potential |
| Allergens | Balsam of Peru (crude) | High sensitization risk |
Source: EU Regulation 1223/2009, Annex II
Recent Annex II Additions
Recent Omnibus regulations have added numerous substances to Annex II:
Notable Recent Prohibitions
- Butylphenyl Methylpropional (Lilial) — prohibited from March 1, 2022 via Omnibus IV (EU 2021/1902)
- 30 CMR substances — prohibited from December 1, 2023 via Omnibus VI (EU 2023/1490)
- 22 CMR substances — prohibited from September 1, 2025 via Omnibus VII (EU 2025/877)
- Certain phthalates classified as CMR
- PFAS compounds (per- and polyfluoroalkyl substances)
- Additional azo dyes with carcinogenic potential
Zinc Pyrithione: Banned in EU Cosmetics Since March 2022
- INCI name: Zinc Pyrithione
- CAS number: 13463-41-7
- Status: Prohibited — Annex II
- Regulation: Commission Regulation (EU) 2021/1902 (Omnibus IV)
- Applies from: 1 March 2022
- Classification: Repr. 1B — toxic for reproduction
- Former use: Anti-dandruff agent and preservative
Zinc pyrithione was prohibited in all EU cosmetic products from 1 March 2022. Commission Regulation (EU) 2021/1902, published 3 November 2021, added it to Annex II following its classification as toxic for reproduction, category 1B, under the CLP Regulation.
Before the ban it was one of the most widely used anti-dandruff ingredients in Europe. It was permitted under Annex V as a preservative at up to 1.0% in rinse-off hair products and 0.5% in other rinse-off products, and under Annex III at up to 0.1% in leave-on hair products when not used as a preservative. Both entries were deleted when the Annex II prohibition took effect.
Butylphenyl Methylpropional (Lilial): Banned in EU Cosmetics Since March 2022
- INCI name: Butylphenyl Methylpropional
- Also known as: Lilial, Lysmeral, p-BMHCA
- CAS number: 80-54-6
- Status: Prohibited — Annex II
- Regulation: Commission Regulation (EU) 2021/1902 (Omnibus IV)
- Applies from: 1 March 2022
- Classification: Repr. 1B — toxic for reproduction
- Former use: Fragrance ingredient
Butylphenyl methylpropional, commonly known as Lilial, was prohibited in all EU cosmetic products from 1 March 2022 by the same regulation that banned zinc pyrithione.
Before the ban it was a listed fragrance allergen under Annex III, requiring declaration on the ingredient list whenever its concentration exceeded 0.001% in leave-on products or 0.01% in rinse-off products. Its Annex III entry was deleted when the Annex II prohibition took effect. It remains a recognised contact allergen.
Annex III: Restricted Substances
Annex III lists substances that may be used in cosmetics but only under specific conditions. These restrictions may include:
- Maximum concentration limits
- Specific product categories allowed/prohibited
- Mandatory warning phrases
- Purity requirements
| Ingredient | Restriction | Warning Required |
|---|---|---|
| Hydrogen Peroxide (hair dye) | Max 12% H₂O₂ equivalent | Professional use only warning if >12% |
| Salicylic Acid | Max 2% (rinse-off), 0.5% (leave-on) | Not for children under 3 years |
| Triclosan | Max 0.3% (toothpaste, soap) | Prohibited in leave-on products |
| Aluminum Compounds | SCCS: 6.25% (non-spray) / 10.6% (spray) as Al | Antiperspirants/deodorants |
| Retinol | Max 0.3% RE (face), 0.05% RE (body) | Contains vitamin A warning |
| Fluoride Compounds | Max 0.15% F (toothpaste) | Contains fluoride |
* Always check CosIng for current restrictions as limits are regularly updated
* Some restrictions have different limits for professional vs. consumer use
Source: EU Regulation 1223/2009, Annex III
Hair Dye Restrictions
Hair dyes face particularly detailed restrictions in Annex III. Per SCCS guidance:
| Category | Restriction Type | Typical Limits |
|---|---|---|
| Oxidative Dyes | Concentration limits + mandatory warnings | 0.5-6% depending on substance |
| Non-Oxidative Dyes | Often restricted to professional use | Product-type specific |
| Bleaching Agents | H₂O₂ equivalent limits | Max 12% H₂O₂ |
| Ammonia | Concentration limits | Max 6% |
Source: EU Regulation 1223/2009, Annex III
Annex IV: Permitted Colorants
Annex IV operates on a positive list principle — only colorants specifically listed can be used in cosmetics. Currently, 153 colorants are permitted.
Positive List = Restrictive
| Field of Application | Permitted Use | Examples |
|---|---|---|
| 1 (All) | All cosmetic products | CI 77891 (Titanium Dioxide) |
| 2 (All except eye) | Products not in contact with eyes | CI 15850 (D&C Red No. 7) |
| 3 (Rinse-off only) | Rinse-off products only | CI 42090 (Blue 1) |
| 4 (Mucous-compatible) | Products contacting mucous membranes | CI 77491 (Iron Oxides) |
Source: EU Regulation 1223/2009, Annex IV
Color Index (CI) Numbers
All permitted colorants are identified by their Color Index (CI) number. The CosIng database provides full details on each permitted colorant including:
- Permitted concentration limits
- Product category restrictions
- Required purity specifications
- Any mandatory warnings
Annex V: Permitted Preservatives
Annex V lists the only preservatives permitted in EU cosmetics. Currently, 59 preservatives are authorized, each with specific concentration limits.
| Preservative | INCI Name | Max Concentration | Restrictions |
|---|---|---|---|
| Phenoxyethanol | Phenoxyethanol | 1.0% | None |
| Parabens (combined) | Methylparaben, etc. | 0.4% single, 0.8% mix | Not in products for under 3 years (nappy area) |
| Benzisothiazolinone | BIT | 0.01% | Rinse-off only |
| Sodium Benzoate | Sodium Benzoate | 2.5% (acid) | As benzoic acid equivalent |
| Potassium Sorbate | Potassium Sorbate | 0.6% (acid) | As sorbic acid equivalent |
| Chlorphenesin | Chlorphenesin | 0.3% | None |
Source: EU Regulation 1223/2009, Annex V
Methylisothiazolinone (MIT) Banned in Leave-On
Annex VI: Permitted UV Filters
Annex VI lists permitted UV filters for sunscreen and UV protection products. Currently, 29 UV filters are authorized.
| UV Filter | Type | Max Concentration | Notes |
|---|---|---|---|
| Zinc Oxide | Physical | 25% | Nano form also permitted with conditions |
| Titanium Dioxide | Physical | 25% | Nano form conditions apply |
| Avobenzone | Chemical (UVA) | 5% | May degrade in sunlight |
| Octocrylene | Chemical (UVB) | 10% | Under SCCS review |
| Homosalate | Chemical (UVB) | 7.34% | Reduced from 10% (Omnibus) |
| Ethylhexyl Methoxycinnamate | Chemical (UVB) | 10% | Under SCCS review |
Source: EU Regulation 1223/2009, Annex VI
Nano Materials Requirements
UV filters used in nano form face additional requirements per Commission guidance:
Nano Material Requirements
- CPNP notification must indicate nano form usage
- Label must include '[nano]' after ingredient name
- Safety assessment must address nano-specific concerns
- Only specifically approved nano forms may be used
CMR Substances: The Strictest Prohibition
Article 15 of Regulation 1223/2009 establishes that substances classified as CMR (Carcinogenic, Mutagenic, or toxic to Reproduction) under CLP Regulation are prohibited in cosmetics:
| CMR Category | Classification | Cosmetic Use |
|---|---|---|
| Category 1A | Known CMR to humans | Prohibited |
| Category 1B | Presumed CMR to humans | Prohibited |
| Category 2 | Suspected CMR to humans | Prohibited unless SCCS opinion allows |
Source: EU Regulation 1223/2009, Article 15
CMR Updates Are Automatic
Using the CosIng Database
The CosIng database is the official EU database for cosmetic ingredients. It provides:
How to Check Ingredient Compliance in CosIng
Access CosIng
Navigate to the CosIng database on the European Commission website.
Search by INCI Name
Enter the INCI name or CAS number of your ingredient.
Review Annex Status
Check if the ingredient appears in Annexes II-VI and under what conditions.
Note Restrictions
Document any concentration limits, product-type restrictions, or required warnings.
Check Function Restrictions
Some functions (e.g., preservative, UV filter) are only permitted if listed in Annex V/VI.
Omnibus Regulation Updates
The Annexes are regularly amended through Omnibus regulations. Recent significant updates:
| Regulation | Published | Effective | Key Changes |
|---|---|---|---|
| Omnibus III (EU 2021/850) | 2021 | Oct 1, 2021 | Salicylic acid concentration restrictions |
| Omnibus IV (EU 2021/1902) | Nov 3, 2021 | Mar 1, 2022 | Lilial ban, Zinc Pyrithione, 23 CMR substances |
| Omnibus VI (EU 2023/1490) | Jul 20, 2023 | Dec 1, 2023 | 30 additional 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 | Additional CMR restrictions |
Source: European Commission Official Journal
Separate Allergen Regulation
CMR Bans Have No Transition Period
Impact on Formulation
Understanding Annex restrictions is essential for cosmetic formulation:
| Product Type | Key Restrictions | Common Reformulation Needs |
|---|---|---|
| Leave-On Skincare | MIT banned, paraben restrictions | Alternative preservation systems |
| Hair Care | Hair dye limits, silicone restrictions | Natural alternatives |
| Sunscreen | UV filter concentration limits | Combination systems for efficacy |
| Color Cosmetics | Colorant positive list only | Annex IV compliance verification |
| Baby Products | Enhanced restrictions (under 3 years) | Fragrance-free, minimal ingredients |
Key Takeaways
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Get Formulation ReviewFrequently Asked Questions
The EU bans over 1,700 substances in cosmetics through Annex II of Regulation 1223/2009. Additionally, colorants, preservatives, and UV filters are only permitted if specifically listed in Annexes IV, V, and VI respectively, effectively banning thousands more unlisted substances in these categories.
Annex II lists completely prohibited substances — they cannot be used under any circumstances. Annex III lists restricted substances that can be used but only under specific conditions (concentration limits, product types, warnings, etc.).
No. Annex V operates as a positive list, meaning only the 59 preservatives listed can be used for preservation purposes. Any unlisted substance used as a preservative would violate the regulation.
Check Annex IV of Regulation 1223/2009 or the CosIng database. Your colorant must be listed in Annex IV, and you must comply with any restrictions on concentration or product type (field of application).
Under Article 15, substances classified as CMR category 1A, 1B, or 2 under CLP Regulation are automatically prohibited in cosmetics. No Omnibus amendment is needed — the prohibition is immediate upon CLP classification.
The Annexes are typically updated several times per year through Omnibus regulations. Major updates (Omnibus VI, VII, VIII) contain numerous changes, while smaller amendments address individual substances. Always check CosIng for current status.
No. Many natural substances are prohibited or restricted in EU cosmetics. For example, certain essential oils contain allergens requiring labeling, and some natural extracts are prohibited due to toxicity. 'Natural' does not equal 'compliant.'
CosIng (Cosmetic Ingredients) is the official EU database containing all cosmetic ingredients and their regulatory status. You can search by INCI name or CAS number to find which Annexes apply, concentration limits, required warnings, and other restrictions.