EU Annex IV vs FDA Color Additives: What European Cosmetic Brands Must Know Before Exporting to the US

A European blush brand spent 18 months reformulating for the US market — not because of labelling, not because of preservatives, but because a single colorant in their hero product had no equivalent on the FDA’s approved list. The CI number was right there on EU Annex IV. The CPSR was airtight. The Responsible Person had signed off. But under 21 CFR Part 74, the dye simply didn’t exist as a US-approved colour additive.

This happens more often than it should.

When European cosmetic brands plan US market entry, the colour additive question is typically an afterthought. Teams focus — rightly — on MoCRA facility registration, product listing obligations, and allergen labelling. But colorants are where quiet non-compliance hides. And unlike a borderline label claim, a non-approved color additive in a US-marketed cosmetic is a per se adulteration under the Federal Food, Drug, and Cosmetic Act. There’s no “substantially compliant” middle ground. The product is either lawfully coloured or it isn’t.

How the EU System Works Under Regulation (EC) No 1223/2009

Annex IV of Regulation (EC) No 1223/2009 is the EU’s positive list for cosmetic colorants. If a substance isn’t on it, it can’t be used. The list currently covers more than 150 permitted colorants, each identified by its Colour Index (CI) number alongside four data columns: the permitted colorant name, application restrictions (e.g., “not in products applied near the eyes,” “rinse-off only,” “not for use on mucous membranes”), maximum concentrations where relevant, and purity criteria.

The CI number system — maintained jointly by the Society of Dyers and Colourists and the American Association of Textile Chemists and Colorists — is the universal language of EU cosmetics documentation. Your safety assessor cites CI numbers in the Cosmetic Product Safety Report. Your CPNP notification references them. Your finished product labels carry them. For EU-trained formulators, CI numbers are second nature.

What’s less intuitive is that the FDA doesn’t use CI numbers at all.

The FDA’s Three-List System — and Why It Trips Up European Brands

The FDA governs color additives in cosmetics through 3 separate regulatory lists under Title 21 of the Code of Federal Regulations:

21 CFR Part 73 covers color additives exempt from batch certification. These are predominantly mineral pigments and inorganic lakes: Ultramarine Blue (CI 77007), titanium dioxide (CI 77891), iron oxides (CI 77491, 77492, 77499), chromium hydroxide green (CI 77289), and similar substances. No FDA certification is needed lot-by-lot, but the colorant must still meet FDA purity specifications — and those specifications aren’t always identical to the purity criteria in EU Annex IV.

21 CFR Part 74 covers color additives subject to mandatory batch certification. These are the synthetic organic dyes — the FD&C and D&C colours that appear in everything from lipsticks to hair rinses. FD&C Blue No. 1 (CI 42090), FD&C Red No. 40 (CI 16035), D&C Red No. 7 (CI 15850:1), D&C Red No. 27 (CI 45410:1). For every production lot of a Part 74 colorant, the manufacturer must submit a sample to FDA’s Color Certification Program and receive a certification number before that batch can legally be used in US-marketed products. FDA charges a per-pound submission fee for this service, and the certificate is lot-specific. It cannot be transferred to a different production batch.

21 CFR Part 82 is a legacy category — provisionally listed color additives dating from the 1960s that are largely phased out of active use.

The batch certification requirement under Part 74 is the element most EU brands don’t see coming. In Europe, once a colorant meets the Annex IV purity criteria, you use it — your safety assessor verifies the supplier’s CoA, the CPSR reflects the CI number, and that’s the end of it. FDA’s mechanism is categorically different. Certification happens at FDA’s own laboratory, on a batch-by-batch basis, before the dye reaches your filling line. If your supplier hasn’t obtained FDA certification for that specific production lot, the colour additive is non-compliant — regardless of its purity, regardless of its EU compliance history, regardless of how many years it’s been on EU Annex IV.

This is not a technicality. FDA has issued import alerts and warning letters specifically targeting cosmetics containing uncertified synthetic dyes. The enforcement record is real.

Where the Lists Diverge — and the Reformulation Consequences

Here’s the uncomfortable truth: the EU Annex IV list and the FDA colour additive lists are not interchangeable. They overlap substantially in the mineral pigment range — iron oxides, ultramarines, titanium dioxide, manganese violet — but diverge meaningfully in synthetic dyes, particularly those used in lip colour, eye shadow, and professional hair colorant products.

Several azo dyes permitted under EU Annex IV have no approved FDA equivalent. Certain hair colorants listed in EU Annex IV — routinely used by European professional hair care brands — are simply not approved by FDA for cosmetic application in the United States. A hair colour range fully compliant under Regulation (EC) No 1223/2009 may require reformulation of 3, 5, or more shades before those products can legally enter US commerce. The precise number depends on the formulation portfolio, but it’s rarely zero.

Going the other direction creates its own complications. D&C Red No. 33 (CI 17200) is FDA-approved for externally applied cosmetics but carries different restriction language in EU Annex IV. D&C Orange No. 4 (CI 15510) has a more limited scope under FDA rules than its EU Annex IV entry might suggest. And some FDA-approved colours simply don’t appear on EU Annex IV at all, meaning a palette designed for the US market may need its own adaptation for EU sale.

The application area restrictions compound the complexity. EU Annex IV restriction language is granular and anatomically specific — “not for use in products applied near the eye area,” “not for use in products applied to lips.” FDA uses a different taxonomy: colors are designated for “use in cosmetics generally,” “for use in externally applied cosmetics only (not lip products and eye area),” or “for ingested drugs and cosmetics.” These category systems don’t map onto each other precisely. A colorant with a “not near eyes” EU restriction doesn’t automatically carry the same limitation under FDA rules — and vice versa. Each restriction must be verified independently for each jurisdiction.

What MoCRA Changed — and What It Didn’t Touch

Since the Modernization of Cosmetics Regulation Act came into effect in December 2022, European brands have been navigating a meaningfully changed US regulatory landscape. MoCRA gave FDA authorities it hadn’t previously held: mandatory recall power over cosmetic products, access to company safety records during inspections, new facility registration and biennial renewal requirements, and the mandate to develop Good Manufacturing Practice regulations for cosmetics under 21 CFR Part 700.

But MoCRA did not alter the color additive framework. The FD&C Act provisions governing color additives pre-date MoCRA by roughly 6 decades, and the 21 CFR Parts 73, 74, and 82 lists were unchanged. The petition process for adding a new color additive to FDA’s approved roster remains extraordinarily slow — a full petition involves toxicological data packages that take years to compile, FDA review timelines that routinely stretch beyond 3 years, and no guarantee of approval at the end. Industry almost never pursues it for cosmetic-use-only colorants. If your formulation depends on a substance not currently on the FDA lists, reformulation is effectively the only viable path.

What MoCRA did change is the consequence structure. With FDA now holding mandatory recall authority and actively investing in its cosmetics enforcement infrastructure, colorant adulteration findings carry more formal risk than they did 5 years ago. The probability of enforcement action following a non-compliant colorant finding has risen. That’s not alarmism — it’s a calibrated read of how FDA is deploying its new statutory tools.

A Practical Framework Before You Launch

The colorant audit should be an early-stage gate in US market entry planning, not a final-week check. A few principles that cut through most of the complexity:

Start with your mineral pigment inventory. If your palette is built primarily on iron oxides, ultramarines, titanium dioxide, and chromium pigments, your FDA alignment will be strong. These Part 73 exempts have broadly consistent purity standards across EU and US requirements.

Flag every synthetic dye in the first formulation review. Any CI number corresponding to an FD&C or D&C colour needs supplier-level, lot-specific batch certification verification. Ask your US-facing colorant supplier — not your EU supplier — for FDA batch certification documentation on each lot they’ll supply. Some European dye manufacturers do seek FDA certification for batches intended for the US market. Many don’t. Knowing which you’re working with before the formulation is locked prevents expensive surprises later.

Map application area restrictions independently for each jurisdiction. Don’t assume the EU Annex IV restriction column translates to FDA restriction language. Run the two assessments as separate exercises and reconcile them at the formulation level.

Document the full colorant audit. Under MoCRA’s safety substantiation requirements, the records supporting your product’s safety — including colorant compliance — must be available to FDA on request. A well-documented colorant mapping is both a compliance asset and evidence of good faith.

European brands with rigorous CPSR processes sometimes arrive at US market entry with confidence in their compliance posture. That confidence is warranted — EU cosmetics regulation is genuinely demanding and the CPSR standard is high. But the FDA color additive system was built on a separate legal foundation, runs on different mechanics, and requires its own compliance layer. Not an extension of EU compliance. A parallel system.

The brands that get this right before launch are the ones that treat the two regulatory frameworks as distinct challenges from day one — and allocate the formulation review time accordingly.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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