Which Colorants Annex IV Lets You Use in EU Cosmetics

Colorants are one of the few places in EU cosmetics regulation where the logic flips from restriction to permission. Most of Regulation EC 1223/2009's annexes tell you what's banned or capped. Annex IV does the opposite: it's a positive list, meaning if a colorant isn't on it, you can't use it in a cosmetic product sold in the EU, full stop. That's a meaningfully different compliance posture than checking an ingredient against a prohibited list.

Why colorants get their own annex

Colorants sit in a strange regulatory spot because the same molecule can show up in food, textiles, and cosmetics under completely different rules. The EU decided cosmetics needed a dedicated, closed list rather than relying on general chemical safety assessments alone, partly because colorants are often used at very low concentrations but have a long history of skin sensitization and photostability concerns.

Annex IV lists each permitted colorant by its Colour Index (CI) number, the field of application it's approved for (some are approved for all cosmetic products, others only for specific product types or excluded from certain applications like eye contact products), and any purity criteria or restrictions attached.

Reading a CI number

The CI number is a standardized identifier from the Colour Index International system, shared across industries, not unique to cosmetics. A colorant like CI 77891 (titanium dioxide, used widely as a white pigment and UV filter component) will show up in food coloring contexts, textile dye contexts, and cosmetic contexts under the same numeric identity, but each industry's regulation decides independently whether and how it can be used.

On an EU cosmetic label, colorants are declared by CI number in the ingredient list, which is one of the few places EU labeling departs from pure INCI naming. Fragrance ingredients get INCI names or "parfum," but colorants get CI numbers. If your ingredient list only has an INCI name for a colorant and no corresponding CI number sourced from your supplier, that's a gap to close before notification.

What purity criteria mean in practice

Annex IV doesn't just say "CI 77891 is permitted." Many entries carry specific purity criteria, limits on heavy metal content or other impurities that can arise from the manufacturing process of the pigment itself. This is a supplier documentation issue as much as a regulatory one. Your colorant supplier should be able to provide a certificate of analysis showing the pigment meets the purity criteria tied to its entry in Annex IV, and that documentation belongs in your Product Information File alongside your CPSR.

Common colorant categories in soap and skincare

Colorant type	Typical CI range	Common use	Note
Titanium dioxide	CI 77891	Whitening, UV filter component	Widely used, check nano-form labeling if applicable
Iron oxides	CI 77491, 77492, 77499	Natural-looking browns, reds, yellows	Common in mineral makeup and soap
Ultramarines	CI 77007	Blue and violet shades in soap	Popular in cold-process soap
Chromium oxide greens	CI 77288	Green shades	Check field-of-application restrictions
Synthetic organic dyes	Varies (CI 15xxx to 45xxx range)	Bath products, lip color	Field of application varies significantly by specific colorant

This table is illustrative of categories you'll encounter, not a substitute for checking the current Annex IV text against your specific colorant and its supplier documentation, since the list is amended periodically and field-of-application restrictions differ colorant by colorant.

Where cold-process soap makers get tripped up

Soap makers moving into cosmetic-claim territory (a soap marketed as moisturizing or exfoliating, which pulls it out of "true soap" treatment and into cosmetic regulation) often bring over colorant habits from a non-regulated hobby context. Micas and oxides sold for "soap making" or "candle making" on general craft marketplaces are not automatically documented to Annex IV purity standards. Before you notify a product through CPNP, confirm your colorant supplier can provide EU cosmetic-grade documentation, not just a general craft-safe assurance, which is a different and lower bar.

Practical steps before notification

1. List every colorant in your formula by CI number, not just by trade name or INCI name
2. Confirm each CI number appears in the current Annex IV for your product's field of application
3. Request purity documentation from your supplier tied specifically to cosmetic use
4. Keep that documentation in your PIF, since it supports your CPSR and may be requested during market surveillance

Cosmetic Comply's ingredient-mapping approach, matching a maker's ingredient list to INCI names and CAS numbers with concentrations carried through, is built around the same idea colorant compliance depends on: know exactly what you're using, in what amount, under what identifier the regulator actually recognizes. The EU module isn't live yet, Canada is the current focus, but the mapping discipline transfers directly once it is.