Allowed colorants in EU cosmetics: Annex IV of Regulation 1223/2009 explained

• Annex IV of Regulation (EC) 1223/2009 is a positive list: only the colorants it authorises may be used to colour a cosmetic product — as of June 2026, our database tracks 154 entries.
• The logic is the same as Annex V and VI, and the inverse of Annex II: a colorant not on Annex IV is not allowed, even if it appears nowhere in Annex II.
• The most common points of confusion are the hair-colourant carve-out (hair dyes are governed by Annex III, not Annex IV), the CI numbering system, the salts-and-lakes rule, and the dedicated conditions for nano colorants.

1. What is Annex IV of Regulation 1223/2009?

Regulation (EC) 1223/2009 organises cosmetic ingredient rules into a set of Annexes, each with a distinct logic. Annex II prohibits. Annex III restricts with conditions. Annex IV authorises.

Its official title is "LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS" — colorants that are allowed. Like Annex V (preservatives) and Annex VI (UV-filters), Annex IV is a positive list: only what appears on it may function as a colorant in a cosmetic product marketed in the EU.

This shared positive-list logic is the starting point for applying the Regulation correctly. For the full map of how the Annexes relate to each other, the guide What is the CosIng database and how to use it and the overview of the Annexes explained cover the complete architecture.

2. What does Art. 14(1)(c) say?

Art. 14(1)(c) is the legal basis of Annex IV. It states that cosmetic products shall not contain:

"colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex."

The prohibition is dual, exactly as it is for preservatives and UV-filters: it covers colorants not listed (first limb) and colorants listed but used outside their conditions (second limb). Being in Annex IV is not unconditional permission; it is permission conditional on meeting every column of the entry — colour, product type, body part, maximum concentration and any warning.

The same article carries one critical exception: "point (c)(i) does not apply to hair colouring products." That carve-out is explained in section 9.

3. The legal definition of colorant: Art. 2(1)(m)

Art. 2(1)(m) of the Regulation defines what counts as a colorant:

"'colorants' means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants."

Two consequences follow. First, the qualifier "exclusively or mainly" means the function matters: a substance with a primary function other than colouring may fall under a different Annex even if it has some colouring effect — the same dual-function logic that governs restricted substances in Annex III. Second, precursors of oxidative hair colorants are deemed colorants by definition, which connects directly to how hair dyes are handled (section 9).

4. The positive-list principle: what is not listed is not allowed

This is the conceptual core of Annex IV — and a frequent source of compliance failures.

In Annex II the logic is prohibitive: the list names what cannot be used. In Annex IV the logic is exclusively permissive: only the colorants it lists are authorised. Any substance used to colour a cosmetic that is not on the list is excluded — not because it has been evaluated and rejected, but because it has not been authorised. The absence from the list is the prohibition.

Practical consequence: a novel pigment not yet evaluated by the SCCS and not entered in Annex IV cannot be used to colour a cosmetic product in the EU, regardless of how it is used elsewhere in the world. The Product Information File (PIF) must justify every colorant against its Annex IV entry and conditions.

5. How colorants are identified: the Colour Index (CI) number

A single colorant can carry many trade and INCI names, so Annex IV identifies each one primarily by its Colour Index (CI) number — a five-digit code from the international Colour Index classification. Each entry also lists the chemical name, the CAS number and the EC number.

The Annex IV table is organised in these columns:

The CI number is the most reliable identifier when verifying a formulation, because it removes the ambiguity of commercial naming.

6. The salts-and-lakes rule and purity criteria

Two rules in the Annex IV preamble are easy to overlook and important to apply correctly.

Salts and lakes. The preamble states:

"Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also be included."

So an authorisation extends to the colorant's salts and lakes without each variant being listed individually. A lake is an insoluble pigment formed by fixing a soluble dye onto a metal substrate — and it is covered by the parent colorant's entry.

Purity criteria. Many Annex IV colorants — especially those also used as food colours — carry the condition "purity criteria as set out in Commission Directive 95/45/EC", referenced by their E-number (for example, titanium dioxide as E 171). Meeting the colour itself is not enough: the material must also meet the stated purity profile.

7. Verified colorant examples: reference table

The following entries illustrate how Annex IV works in practice, with CI numbers, colour and the principal condition as verified against the regulatory text:

Inorganic pigments such as titanium dioxide, iron oxides and mica are authorised across product types (subject to purity), which is why they are the workhorses of colour cosmetics. Several organic azo dyes, by contrast, carry application restrictions — and that is where most colorant non-compliance occurs.

8. The restriction patterns of Annex IV

Rather than numbered "fields of application" like Annex III, Annex IV expresses its restrictions as descriptive conditions in the product type / body parts column. Four patterns recur:

1. Allowed in all cosmetic products. Most inorganic pigments (titanium dioxide, iron oxides, mica, ultramarines) carry no use restriction beyond purity. They may colour any product type.

2. Rinse-off products only. Some organic colorants are authorised only in products that are washed off after use — shampoos, cleansers, shower gels. CI 12120 and CI 15620 are examples. Using them in a leave-on product is a direct infringement.

3. Not in eye products / not on mucous membranes. Certain colorants are excluded from sensitive applications. CI 10316 may not be used in eye products; CI 11680 and CI 26100 may not be used on mucous membranes (lips, oral and intimate areas).

4. Maximum concentration. A few entries cap the concentration in the ready-for-use product. Where a cap is stated, it must be respected in addition to every other condition.

A colorant can be perfectly legal in one product and illegal in another at the same concentration — the determining factor is the product type and body part, not the dose alone.

9. Why hair dyes are not in Annex IV

This is the most common misconception about cosmetic colour regulation.

Although Art. 2(1)(m) deems oxidative hair-colorant precursors to be colorants, Art. 14(1)(c) explicitly states that the colorant restriction "does not apply to hair colouring products". As a result, substances used to dye the hair are not authorised through Annex IV. Oxidative hair-dye substances are instead governed as restricted substances in Annex III, each with its own conditions, concentrations and warnings.

The Regulation foresees a future Commission decision that could extend the scope of Annex IV to hair colouring products, but that extension is not yet in force. Until it is, the correct place to verify a hair-dye substance is Annex III — not Annex IV.

10. Nano colorants: Carbon Black and Titanium Dioxide

When a colorant is used in nanomaterial form, it is assessed separately and listed with its own conditions. Two cases matter most in practice:

• Carbon Black (nano) has its own Annex IV entry, distinct from conventional carbon black: capped at 10%, with a primary particle size of ≥ 20 nm, and prohibited in applications that may lead to exposure of the lungs by inhalation (a restriction aimed at loose powders and sprays).
• Titanium dioxide sits at the intersection of two Annexes: it is an Annex IV colorant (CI 77891) and an Annex VI UV-filter. Its nano form carries dedicated conditions in the UV-filter regime.

Nano forms are not interchangeable with their conventional counterparts. The dedicated rules — the [nano] INCI suffix, the separate listing and the inhalation restrictions — are explained in the guide on nanomaterials in EU cosmetics.

11. How to verify the current state of Annex IV

Two resources in our database resolve this with up-to-date regulatory data:

CosIng database — /en/cosing-database: covers all authorised colorants, with CI numbers, colour, permitted product types, maximum concentrations and purity conditions, updated on every CosIng release.

Search tool: query by CI number, INCI name or CAS to see whether a substance appears in Annex IV and under what conditions — and whether it is also listed in another Annex, as titanium dioxide is.

The other Annexes that complete the regulatory picture: Annex II (prohibited ingredients), Annex III (restricted substances), Annex V (preservatives) and Annex VI (UV-filters).

12. Frequently asked questions

What is Annex IV of Regulation 1223/2009? The positive list of colorants allowed in cosmetic products. Only listed colorants may be used, only under their stated conditions. A colorant not on the list is not allowed.

How does EU law define a colorant? Art. 2(1)(m): substances exclusively or mainly intended to colour the product or the body by absorption or reflection of visible light. Precursors of oxidative hair colorants are deemed colorants.

Why are hair dyes not in Annex IV? Art. 14(1)(c) states the colorant restriction does not apply to hair colouring products. Hair-dye substances are governed by Annex III instead.

What is a Colour Index (CI) number? A five-digit international code identifying each colorant (e.g. CI 77891 for titanium dioxide) — the most reliable identifier because one colorant can have many names.

Does Annex IV cover salts and lakes? Yes. A colorant authorisation extends to its salts and lakes without each variant being listed separately.

Are nano colorants treated differently? Yes. Carbon Black (nano) is a separate entry capped at 10% with no inhalation exposure; titanium dioxide is both a colorant and a UV-filter with dedicated nano rules.