A tablet, gummy or capsule contents rarely need colour to work, but brands add it anyway — to match a flavour, to look consistent batch to batch, or simply because a plain grey-brown tablet looks unfinished on a shelf. The colourant is a small line on the formula and a large one on the compliance file.
This guide covers the two families of colourant, how Japan classifies and permits them, where the EU and the US currently disagree with Japan and with each other, and what to fix before a factory can quote.
💬 Choosing a colourant for a Japan-made product? We check it against the current Japanese additive list before it goes into a specification. See Japan-made supplement OEM.
Natural and synthetic colourants
Natural colourants come from a plant, insect or fermentation source and are listed by origin; synthetic colourants are manufactured dyes listed by name and number.
| Type | What it is | Strengths | Watch-outs |
|---|---|---|---|
| Natural colourant (e.g. grape-skin anthocyanin, cacao pigment, gardenia yellow, caramel colour, carotenoid) | Extracted or processed from a natural source, usually declared by a class name such as “carotenoid” or “anthocyanin” | Fits a “natural” or “clean label” positioning; wide acceptance across markets | Colour can vary batch to batch; may shift with pH or light; sourcing and extraction method affect the “natural” claim |
| Synthetic colourant (a tar colour / lake pigment) | A manufactured dye, each with its own name and identifying number | Strong, consistent colour at very low use levels; stable under heat and light | Subject to country-specific permitted lists that do not match each other; some carry mandatory warning labels in some markets |
In Japan, synthetic food colourants are drawn from a defined list of tar colours (合成着色料／タール色素) that the Ministry of Health, Labour and Welfare has designated as food additives — currently 12 individual colours, each identified by a colour name and number (for example Red No. 2, Red No. 3, Red No. 40, Red No. 102, Red No. 104, Red No. 105, Red No. 106, Yellow No. 4, Yellow No. 5, Blue No. 1, Blue No. 2 and Green No. 3). Natural colourants used in Japan are mostly on the “existing food additives” list (既存添加物名簿) maintained by the health ministry — long-used natural substances such as grape-skin colour, cacao colour, gardenia yellow, caramel colour and carotenoid colours, which can usually be declared by a simplified class name on the Japanese label.
How Japan, the EU and the US differ
The same colourant can be permitted in one market, permitted with a warning label in another, and withdrawn in a third — brands exporting from Japan need to check all three.
Titanium dioxide (white, used to opacify capsule shells and coat tablets) is a clear example. It is an approved food additive in Japan, first designated in 1983 and reconfirmed as safe by Japan’s food safety authorities after reviewing the same 2021 EFSA data the EU relied on. The European Commission reached the opposite conclusion: Commission Regulation (EU) 2022/63 withdrew the authorisation of titanium dioxide (E171) as a food additive across the EU, with a transition period ending on 7 August 2022 — food placed on the EU market after that date cannot contain it as an additive. The UK, Canada, Australia and New Zealand reviewed the same EFSA opinion and did not follow the EU’s ban.
Synthetic colours carry a different kind of gap: a warning label, not a ban. Under EU Regulation (EC) No 1333/2008, Article 24 and Annex V, food and drink containing any of six synthetic colours — Sunset Yellow (E110), Quinoline Yellow (E104), Carmoisine (E122), Allura Red (E129), Tartrazine (E102) and Ponceau 4R (E124) — must carry the wording “may have an adverse effect on activity and attention in children” next to the colour’s name on the ingredient list. This requirement, in force since 20 July 2010, followed a UK-funded study (the “Southampton study”) on a possible link between these colours and hyperactivity in children. All six colours remain permitted in the EU; only the warning is mandatory. Japan has no equivalent warning-label requirement for these colours, several of which (including Tartrazine, listed in Japan as Yellow No. 4) are separately permitted as designated food additives there.
The US runs its own list under the FD&C colour-additive system. FD&C Red No. 3 (erythrosine) — one of Japan’s 12 permitted tar colours, listed as Red No. 3 — was withdrawn by the FDA for food and ingested drugs by an order issued 15 January 2025, under the Delaney Clause, which bars authorisation of an additive shown to cause cancer in animal or human studies; manufacturers have until 15 January 2027 to reformulate food. A colour permitted in Japan can therefore already be non-compliant for a US-bound product, on a timeline that keeps moving.
💬 Exporting the same formula to more than one market? We flag a colourant that is compliant in Japan but restricted where you plan to sell before it reaches the specification. Tell us your markets.
How to choose a colourant
Start from the destination markets, not from the shade you want, because the markets set which colours are even available to choose from.
- List every market the finished product will be sold in first. A colourant that only needs to clear Japan has far more options than one that must also clear the EU or a market that has adopted the EU list.
- Prefer a natural colourant when the product will be positioned as “clean label” or when export markets are undecided. It avoids the synthetic-colour warning-label question entirely, at the cost of batch-to-batch shade variation.
- Check the colourant’s stability against the product’s own conditions — pH (for drinks and gummies), heat (for anything baked or retorted), and light exposure over the shelf life — before committing to a shade.
- Confirm the source and processing method of any natural colourant, since two suppliers’ “carotenoid colour” can differ in extraction solvent and concentration, which affects both the shade and any “natural” claim made on pack.
What to put in the specification
A workable specification names the colourant by its Japanese-permitted identity, not just the shade.
| Item | Why it matters |
|---|---|
| Colourant name and, for a synthetic colour, its designated Japanese colour number | Confirms it is on Japan’s permitted list, not just “a red dye” |
| Source and extraction/production method, for a natural colourant | Needed to check the “existing food additive” listing and any natural claim |
| Target shade and the pH/heat/light conditions it must survive | Lets the factory match a colourant that holds up in your dosage form |
| Every export market for the finished product | Determines whether a warning label or an alternative colourant is needed |
| Amount used per serving | Needed for the specification and for any market with a use-level limit |
Before you ask for a quotation
- Every export market for the finished product, listed up front
- Preferred shade, and whether a natural or synthetic colourant is acceptable
- The dosage form the colourant goes into (tablet, capsule shell, gummy, drink)
- Any “natural”, “clean label” or allergen-related claim planned for the pack
- First order and annual volume
💬 Ready to specify a colourant for a Japan-made product? Send us your markets and target shade and we check it against the current lists before quoting.
Frequently asked questions
1. Is titanium dioxide allowed in a Japan-made supplement?
Yes. It is an approved food additive in Japan, reconfirmed as safe by Japan’s food safety authorities. It has not been permitted as a food additive in the EU since 7 August 2022, so a product also sold in the EU needs a different opacifying approach.
2. Do EU warning labels apply to a supplement made in Japan?
If the product is sold in the EU and contains any of the six colours named in Regulation (EC) No 1333/2008 Annex V, the EU-market pack needs the “may have an adverse effect on activity and attention in children” wording next to the colour. This is a labelling requirement, not a ban, and does not apply to a Japan-only pack.
3. Why does Japan allow a colour the US just withdrew?
Japan, the EU and the US each run their own additive review and their own permitted list, and they do not always reach the same conclusion on the same data or the same timeline. FD&C Red No. 3 remained on Japan’s tar-colour list after the FDA withdrew it for US food use in 2025.
4. Are natural colourants automatically compliant everywhere?
No. A natural colourant still needs to be on the relevant market’s permitted list, and its declared name, source and use level still need to be confirmed for each destination.
5. What should I send a factory to get an accurate colourant recommendation?
The export markets, target shade, dosage form and any “natural” or allergen-related claim you plan to make — see “Before you ask for a quotation” above.
Sources: Commission Regulation (EU) 2022/63 amending Annex II to Regulation (EC) No 1333/2008 as regards the use of titanium dioxide (E171), eur-lex.europa.eu; Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, Article 24 and Annex V, eur-lex.europa.eu / legislation.gov.uk; Food Safety Authority of Ireland, “Titanium Dioxide is No Longer Authorised as a Food Additive in the EU from 7 August 2022”, fsai.ie; Consumer Affairs Agency (Japan), food additive council materials on titanium dioxide, caa.go.jp; Ministry of Health, Labour and Welfare (Japan), list of designated food additives (tar colours) and list of existing food additives (既存添加物名簿), mhlw.go.jp; US Food and Drug Administration, “FD&C Red No. 3”, order revoking authorisation issued 15 January 2025, fda.gov. Checked on 25 September 2026.