How many ingredients are banned in EU cosmetics?

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.

What is the difference between Annex II and Annex III?

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.).

Can I use a preservative not listed in Annex V?

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.

How do I know if my colorant is allowed?

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).

What happens when a new CMR substance is identified?

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.

How often are the Annexes updated?

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.

Are natural ingredients automatically safe?

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.'

What is CosIng and how do I use it?

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.

EU Banned Cosmetic Ingredients: Complete Annex II & Restrictions Guide

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 EU prohibits over 1,700 substances in cosmetics — compared to 11 categories/substances prohibited at the US federal level. This significant difference means formulations compliant in other markets often require reformulation for EU sale.

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)

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.

Categories of Annex II Prohibited Substances
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

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

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

Hair Dye Restrictions

Hair dyes face particularly detailed restrictions in Annex III. Per SCCS guidance:

Hair Dye Ingredient Categories
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%

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

Any colorant NOT listed in Annex IV is prohibited. This is the opposite of Annex II — unlisted substances are banned rather than allowed.

Annex IV Colorant Categories
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)

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.

Common Permitted Preservatives (Annex V)
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

Methylisothiazolinone (MIT) Banned in Leave-On

As of February 2017, MIT is prohibited in leave-on cosmetic products. It remains permitted only in rinse-off products at max 0.0015% concentration.

Annex VI: Permitted UV Filters

Annex VI lists permitted UV filters for sunscreen and UV protection products. Currently, 29 UV filters are authorized.

Common Permitted UV Filters (Annex VI)
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

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 Categories and Cosmetic Use
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

CMR Updates Are Automatic

When a substance is classified as CMR under CLP Regulation, it automatically becomes prohibited in cosmetics without requiring an Omnibus amendment. Formulators must monitor CLP updates.

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:

Omnibus Regulations Timeline
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

Separate Allergen Regulation

Regulation (EU) 2023/1545 (entered into force August 16, 2023) addresses fragrance allergen labeling only — expanding declarable allergens from 26 to 80+ substances. This is NOT part of the Omnibus CMR pathway. Compliance deadlines: July 31, 2026 (new products) and July 31, 2028 (existing products).

CMR Bans Have No Transition Period

CMR substance bans under Omnibus regulations are effective immediately with NO transition period: - Omnibus IV (Lilial): Banned March 1, 2022 - Omnibus VI (30 CMR substances): Prohibited December 1, 2023 - Omnibus VII (22 CMR substances): Prohibited September 1, 2025 Non-CMR restrictions (like 4-MBC, Vitamin A) may include transition periods — check specific regulation text.

Impact on Formulation

Understanding Annex restrictions is essential for cosmetic formulation:

Formulation Considerations by Product Type
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

The EU prohibits over 1,700 substances via Annex II — the world's strictest cosmetic ingredient list

Annexes IV, V, VI operate as positive lists — only listed colorants, preservatives, and UV filters are permitted

CMR substances (carcinogenic, mutagenic, reprotoxic) are automatically prohibited under Article 15

Omnibus regulations regularly update the Annexes — check CosIng database for current status

Transition periods apply but new products must comply immediately with updated restrictions

Formulations compliant in US or other markets often require reformulation for EU sale

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