How many ingredients are banned in EU cosmetics?

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.

What is the difference between Annex II and Annex III?

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.

How do I check if an ingredient is banned in the EU?

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.

What happens if I sell a product with a banned ingredient?

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.

Is there a grace period when an ingredient gets banned?

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.

Are natural ingredients exempt from the banned list?

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.

How often is the banned ingredients list updated?

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.

Banned Cosmetic Ingredients EU: Complete List & Guide

Q: Why was Lilial banned?

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.

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

As of 2025, the EU's Annex II (prohibited substances list) contains over 1,703 substances that cannot be used in any cosmetic product sold in the EU market. This number continues to grow as new safety data emerges and CMR classifications are updated.

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:

Evolution of Annex II Prohibited Substances
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

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

Under Article 15 of EU Regulation 1223/2009, substances classified as CMR Category 1A or 1B under CLP Regulation are automatically prohibited in cosmetics. This is why monitoring ECHA's CLP notifications is essential — a new classification can trigger immediate prohibition.

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:

Key Restricted Ingredients

Notable Annex III Restricted Substances
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

Salicylic Acid Limits (Omnibus III - Regulation EU 2021/850)

Full breakdown: - Rinse-off hair products: 3.0% - Other products (general): 2.0% - Body lotion, eye makeup, lipstick: 0.5%

Thioglycolic Acid Limits by Product Category

Expanded breakdown: - Hair waving/straightening: 8% (general) or 11% (professional) at pH 7-9.5 - Depilatories: 5% at pH 7-12.7 - Hair rinse-off products: 2% at pH up to 9.5 - Professional eyelash waving: 11%

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)

Recently Prohibited CMR Substances
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

Lilial: A Case Study

Lilial (INCI: Butylphenyl methylpropional) was one of the most widely used fragrance ingredients before its prohibition. Its classification as Repr. 1B in 2020 led to automatic prohibition, affecting thousands of products including iconic perfumes. Brands had limited transition time, highlighting the importance of monitoring CMR classifications.

Formaldehyde and Formaldehyde Releasers

Formaldehyde-Related Substances Status
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%

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

Homosalate is RESTRICTED, not prohibited. Per Regulation (EU) 2022/2195, it remains permitted in face products only at max 7.34%. It is NOT in Annex II.

Galaxolide Clarification

Galaxolide is under CMR classification review — a ban is anticipated but NOT finalized. Monitor ECHA for official classification decision.

Omnibus VII — Key Prohibited Substances (Annex II)
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

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

As noted by industry experts, CosIng may lag behind the latest amendments. For very recent changes (within 1-3 months of publication), also check EUR-Lex for the latest Omnibus Regulations directly.

Compliance Deadlines and Transition Periods

Understanding the difference between "placing on the market" and "making available on the market" is crucial:

Market Terms Defined
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

Typical Transition Periods
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

No Sell-Through for Prohibitions

Unlike some regulatory frameworks, EU Annex II prohibitions typically do not allow sell-through of existing stock. Products containing prohibited substances must be removed from the market by the deadline — retailers and distributors share this responsibility.

Summary: Key Banned Ingredient Categories

Banned Ingredient Categories Overview
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

Key Takeaways

Annex II contains 1,703+ prohibited substances as of 2025, growing with each Omnibus Regulation

CMR Category 1A/1B substances are automatically prohibited under Article 15

Annex III allows substances with restrictions (concentration limits, product types, warnings)

Use CosIng database to verify ingredient status, but check recent Omnibus acts for latest changes

No sell-through period for Annex II prohibitions — products must be off-market by deadline

Omnibus VII (Sept 2025) adds 21 substances including multiple colorants and hair dye intermediates to prohibited list

Note: Homosalate is RESTRICTED (not banned) — permitted in face products at 7.34% max

Monitor ECHA CLP notifications for new CMR classifications affecting cosmetic ingredients

Both manufacturers and distributors are responsible for removing non-compliant products