A pigment that is approved in one market is not approved in another, and the difference is not a matter of paperwork. A shade developed against a supplier's standard colour card can be fully compliant in the United States, non-compliant in the European Union and registerable in China only after a material substitution — from one formula and one set of raw materials. Brands that plan a single shade range for several markets without checking the listings find this out at the registration stage, which is the most expensive moment to learn it.
This article covers why the three major systems diverge, how each one is structured and what it actually controls, why the product type is part of the permission rather than a separate question, how nanomaterials and particles small enough to be inhaled are handled differently in each market, what impurity limits mean for the raw material specification, and how to build one shade range that can be registered in more than one market without reformulating from scratch.
Why a pigment approved in one market is not approved in another
The three systems grew from different legal traditions and they answer different questions. The European system asks whether a colourant appears on a positive list for the specific product type, and it is administered centrally. The United States system grew from a drug-style model in which certain synthetic organic colours are certified batch by batch, and it restricts a relatively small number of colourants rather than maintaining a complete list. The Chinese system maintains its own permitted list within a technical standard and administers it through the registration and filing process for the finished product.
Each one therefore produces a different answer to the same question. A colourant can be absent from the European list and therefore prohibited there while being permitted in the United States, because the United States does not require a listing to permit a use in every case. A colourant can be present in the Chinese list at a newer revision while the European entry still carries a restriction on mucous membrane contact. A colourant can be permitted in both and still be prohibited for lip products in one of them.
The practical consequence for a brand is that the regulatory work belongs in the shading brief rather than after it. Choosing the colourant palette before the shade is mixed costs nothing; discovering at registration that one of the four pigments in a shade cannot be used costs a formula revision, a stability repeat and a new sample round.
How the three systems are structured
The European Union operates a positive list under Regulation (EC) No 1223/2009. Every colourant permitted in cosmetics appears in the annex that governs colourants, and each entry is keyed to its CI number with columns that restrict the product types where it may be used and the conditions that apply. A colourant that is not on the list is not permitted, whatever its history of use elsewhere.
The United States regulates colour additives under the Federal Food, Drug and Cosmetic Act and the associated regulations. Synthetic organic colours require batch certification and each certified batch carries a lot number that has to be traceable through the supply chain. Mineral and plant-derived colourants are exempt from certification, which does not mean unregulated: they still carry permitted-use listings and purity specifications. The United States does not maintain a complete positive list of the kind used in Europe, and only a limited number of colourants are explicitly prohibited or restricted.
China maintains a permitted list within its technical standard for cosmetics, and administers it through the registration or filing route for the finished product. New colourants that are not on the list follow a new-ingredient pathway rather than an amendment to the list, which makes the entry of a novel colourant a different kind of project from the European route. The list itself is revised periodically and the revision in force at the time of filing is the one that applies.
What the European list actually controls
The first control is the listing itself. The colourant has to appear in the annex, identified by its CI number, and the formulation has to use a grade that meets the purity criteria attached to that entry. A colourant supplied under a trade name that does not correspond to a listed CI number cannot be used, however the supplier describes it.
The second control is the product type column. Many entries are unrestricted for all cosmetic products, and a significant number are restricted — some are not permitted in products applied to mucous membranes, which means they cannot be used in lip products, and some are restricted for the eye area. A shade intended for both eyeshadow and lipstick therefore has a narrower palette than a shade intended for eyeshadow alone, and that constraint is read from the annex rather than from experience.
The third control is the labelling requirement. The annex entry determines how the colourant must be named on the ingredient list, and for some entries there are additional conditions relating to the purity or the particle form. The label is checked against the annex, so a brand that reformulates for a new market has to reformulate the label at the same time.
What the United States system controls, and why batch certification matters
Certification is the part of the American system that most often surprises a new buyer. A synthetic organic colour or a lake made from one requires a batch that has been certified, and the certification lot number is part of what the manufacturer must be able to show. A shipment of a lakes blend without a traceable certification number is a compliance problem regardless of how the material performs.
The permitted-use listing is the second control. Several of the classic reds and oranges are permitted for external application and prohibited in the eye area, and some are restricted from lip products altogether. These restrictions are specific to the American system and do not map onto the European or Chinese lists, so a shade that is unrestricted in Europe can be restricted in the United States for the same product type.
Mineral and plant-derived colourants are exempt from batch certification, but they carry their own listing and purity expectations. Iron oxides, titanium dioxide, mica, ultramarines and carmine all sit in this group, and the exemption from certification is a difference in administrative route rather than a difference in the level of control.
What the Chinese list controls
China works from its own permitted list, and the listed colourants under its current standard are a similar number to the European list but not the same set. A colourant that appears on both lists may still carry a different restriction in China than in Europe, and a colourant that appears on only one of them cannot be substituted without checking the other.
Naming follows the standard Chinese name of the colourant rather than the INCI name used in Europe, so the ingredient list has to be translated and mapped rather than copied. Getting that mapping wrong is a common cause of a filing being returned, and the mapping is done from the list rather than from the supplier's documentation, because suppliers describe their materials in the terminology of their main market.
Impurity limits are set within the same technical standard and they differ from the European values. Lead, arsenic, mercury and cadmium limits apply to the finished colourant, and the testing that demonstrates compliance is part of the raw material file rather than something the finished product manufacturer can generate afterwards. That means the documentation has to be requested from the pigment supplier at the specification stage.
New colourants that are not on the list follow the new-ingredient route, with its own documentation. For a brand, the practical implication is that a novel effect pigment available in Europe may simply not be usable in China until that route has been completed, and the timeline for doing so belongs in the launch plan rather than in the registration phase.
Product type is part of the permission
The single most common error in cross-market planning is regarding a colourant as either allowed or not allowed. Every one of the three systems restricts by product type as well as by substance, and the categories do not match between them. Lip products and eye-area products are the two categories that carry the most restrictions, because they involve mucous membrane contact and the eye respectively.
Ferric ferrocyanide is a useful example of a colourant that is widely used in one product type and restricted in another, and it is not lip-approved in a number of markets despite being perfectly usable elsewhere. Chrome oxide greens are permitted in Europe with a restriction on mucous membrane contact, and restricted separately in several other markets. Certified reds that are common in blush and lipstick in Europe are restricted from the eye area in the United States.
A brand planning a full colour range across several markets therefore has to plan per product type rather than per formula. A palette that shares a base across eyeshadow, blush and lip will not be able to share the colourant blend across all three, and the divergence has to be identified before the shades are mixed rather than discovered at the labelling stage.
Nanomaterials and the inhalation question
A pigment that is permitted in its ordinary form is not automatically permitted in its nano form. The European system regards a nanomaterial as a distinct entry with its own assessment, and where it is permitted the label has to identify the ingredient as nano. A supplier selling a nano-grade titanium dioxide for its optical properties is selling a material with a different regulatory status from the standard grade.
Powder products carry a further consideration that applies to the ordinary form as well. A fine powder that can be inhaled while the product is being applied is handled differently from the same material in a cream, and the European classification of respirable titanium dioxide powder has made formulators rethink loose powders with a high titanium dioxide content. The practical responses are to move the titanium dioxide into a coated or a larger-particle grade, to reduce the level, or to shift the format towards a pressed or a cream product where the dust exposure is lower.
The same logic applies to effect pigments in loose form. Borosilicate-based glitter and fine mica powders in a loose format create an inhalation exposure that the same pigments in a cream or a pressed pan do not, and the safety assessment has to reflect the format rather than the ingredient list alone.
Impurity limits and the documentation trail
Heavy metal limits exist in every market and the numbers do not match between them. A pigment lot that passes the limit in one market can exceed the limit in another, and because the limits apply to the colourant rather than to the finished product, the compliance evidence is generated by the pigment supplier at the point of manufacture.
That means the documentation has to be specified in the purchase specification rather than requested after the fact. A pigment specification for a cross-market product usually names the CI number, the permitted product types, the particle size distribution, any surface treatment, and the heavy metal and polycyclic aromatic hydrocarbon limits the lot must meet, along with the certificate of analysis that reports them.
Batch traceability is the second half of the trail. In the American system the certification lot number follows the material from the certified batch through the lake or the blend to the finished product, and a manufacturer that cannot connect a finished unit to a certification number cannot demonstrate compliance. Keeping the lot documentation with the batch record rather than with the commercial file is the practical discipline, because the commercial file moves and the batch record stays.
Building a shade range that survives several markets
The efficient approach is to start from the intersection. The colourants that appear on all three lists with no product-type restriction for the intended use form the safe core palette, and a range built on that core can be registered without substitution. In practice that core includes the iron oxides, titanium dioxide, mica, carmine and a limited set of certified organic colours and lakes.
Shades that need a colourant outside the core are then planned as market-specific variations rather than as global formulas. A deep red that requires a certified red restricted from the lip in one market can be built on a different blend for that market, and the two versions share a base, a fragrance and a pack while differing in the colour blend. That keeps the development effort close to that of a single range.
The planning has to extend to the labelling, because the naming convention differs between markets and the label artwork is usually the longest lead item in a launch. Building the ingredient list from the regulatory mapping rather than from a translation of the home market's artwork is what prevents a reprint, and the shade planning logic is the same as in our guide to foundation shade range manufacturing.
Pigment regulation at a glance
The table below compares the three systems on the dimensions that affect a formulation decision. It is a structural comparison rather than a statement of current limits, because every one of these frameworks is revised and the version in force at the time of a filing is the one that applies.
| Dimension | European Union | United States | China |
|---|---|---|---|
| Legal basis | Cosmetics regulation with an annex for colourants | Food, drug and cosmetic act with colour additive regulations | Technical standard plus registration or filing |
| List type | Positive list keyed to CI numbers | No complete positive list; a limited set of restrictions | Own permitted list under the standard |
| Approximate entries | Around one hundred and fifty five | Two classes, certified and exempt | Around one hundred and fifty seven |
| Batch certification | Not required | Required for synthetic organic colours and lakes | Not required in that form |
| Product type control | Per entry, by product type column | Per colour, including eye and lip restrictions | Per entry, with its own restrictions |
| Labelling identifier | CI number and INCI naming | Certified colour name | Standard Chinese name |
| Nanomaterials | Separate assessment and nano labelling | Assessed within the existing pathway | Handled within the raw material framework |
| New colourant route | Amendment of the annex | Petition for a new listing | New ingredient registration or filing |
The table is a structural guide rather than a compliance statement. Each framework is revised periodically, the entry counts shift, and the restrictions are read from the current text for the intended product type rather than from a summary. Any specification should be confirmed against the text in force at the time of the filing.
What to put in the brief
- The markets of sale, listed at the brief stage, since the palette follows from them.
- The product type for each shade, because lip and eye carry the heaviest restrictions.
- The permitted product types for every colourant in the blend, checked against each market.
- The CI number and the regulatory listing for each pigment, recorded on the specification.
- The particle size distribution and any surface treatment, since both affect the listing and the process.
- The impurity limits the supplier must certify for the strictest destination market.
- The certification lot traceability where the American route applies.
- The naming and mapping convention for the label in each market, prepared from the list rather than translated.
Where our capability fits
We approach the regulatory palette as the first constraint in a colour project rather than as a check at the end, because changing a colourant after a shade is approved restarts the stability work and the sample sequence. The colourant blend is mapped against each destination market before the shade is mixed, the impurity and traceability documentation is written into the pigment specification, and the labelling convention is prepared from the list rather than from the home market artwork.
We work with brands on private label (your brand on a proven base), OEM/ODM contract manufacturing, and full custom formula development — whichever matches where your brand is today. Our lines include a long-lasting waterproof foundation, a vitamin C brightening face cream and a fragrance line, all of which are developed against the same palette-mapping and documentation disciplines that a colour range needs.
Tell us the markets you are selling into and the product types in your range, and we will map the colourant palette, the documentation and the labelling against your own brief. Start at our inquiry page, email capsulebiotech@163.com, or message the right team on WhatsApp: Capsule Series (capsules only) +86 158-7655-5319, Cosmetics Series (serum, hair care, body care, fragrance) +86 158-7655-5319.
General manufacturing information, not regulatory or legal advice. Permitted colourants, restrictions, limits and labelling differ by market and are revised periodically; confirm the current text for the intended product type before filing.