Why is quinoline yellow allowed in Europe but not in US food?

The difference is mostly historical, not a safety verdict. The EU authorises E104 in specified foods within limits, and since July 2010 has required any food containing it to state that it 'may have an adverse effect on activity and attention in children'. In the United States the same dye is listed as D&C Yellow No. 10 for drugs, cosmetics and medical devices only — it was never added to the US list of colour additives approved for food, so nothing was withdrawn or revoked.

Which foods contain quinoline yellow?

In markets where it is permitted it is used for yellow and greenish-yellow shades in boiled sweets, jellies, ice lollies, soft-drink concentrates, decorated bakery items, smoked fish, pickles and some sauces. It also appears in medicine coatings, capsules, mouthwashes and shampoos as D&C Yellow No. 10 or CI 47005. On labels look for quinoline yellow, E104, INS 104 or CI Food Yellow 13.

How much quinoline yellow is considered acceptable?

The two main expert bodies disagree by about six times. EFSA's 2009 re-evaluation lowered the EU acceptable daily intake from 10 to 0.5 mg per kg of body weight per day. The joint FAO/WHO expert committee JECFA set an acceptable daily intake of 0-3 mg per kg of body weight at its 82nd meeting in 2016. EFSA's follow-up exposure assessment in 2015 estimated that both average and high-level intakes in the EU sat below its own 0.5 mg/kg limit.

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Is quinoline yellow (E104) safe?

Q: Is quinoline yellow allowed in India?

No. India's food additive regulations list eight permitted synthetic food colours — tartrazine, sunset yellow FCF, ponceau 4R, carmoisine, erythrosine, indigo carmine, brilliant blue FCF and fast green FCF. Quinoline yellow is not among them, so it is not a permitted synthetic colour in Indian food. It can still turn up on imported sweets, medicines and supplements that were made for other markets.

Q: Does quinoline yellow cause hyperactivity in children?

It has not been shown to cause hyperactivity on its own. Quinoline yellow was one of six colours tested as part of mixtures in the 2007 UK Southampton study, which linked those mixtures to increased hyperactivity and inattention in some children. Because the study tested mixtures rather than single colours, it cannot show which ingredient did what. The EU responded with a mandatory warning label rather than a ban.

By LabelCop · Last updated 22 August 2026 · Sources: EFSA, FDA, FSSAI, WHO/JECFA

The short answer: three regulators, three different answers — and India's answer surprises most people.

EU: permitted within limits, but every food containing it must carry a child-behaviour warning
US: not permitted in food — approved only for drugs, cosmetics and medical devices
India: not on FSSAI's list of eight permitted synthetic food colours
WHO/JECFA vs EFSA: their daily limits differ by roughly six times
LabelCop: flags E104 on every label — strictest regulator wins

What is quinoline yellow?

A synthetic dye giving yellow to greenish-yellow shades — brighter and more stable than turmeric or annatto
One job in food: colour. It adds no flavour, nutrition or preservation
Label names: quinoline yellow, E104, INS 104, CI Food Yellow 13, CI 47005
In medicines and cosmetics the same dye is called D&C Yellow No. 10

Which products contain it?

Boiled sweets, jellies and ice lollies in markets where it is permitted
Soft-drink concentrates, squashes and flavoured syrups
Decorated bakery, icings and dessert mixes
Smoked fish, some pickles and sauces
Non-food uses everywhere: tablet coatings, capsule shells, mouthwash, shampoo and soap

In India: it should not appear as a food colour at all, because it is not on the permitted list. Where you may still meet it is on imported sweets and confectionery made for other markets, and in medicines and personal-care products, where different rules apply. Look for INS 104 or quinoline yellow on any imported pack

One of the "Southampton Six"

In 2007 a UK Food Standards Agency-funded study at the University of Southampton tested six synthetic colours plus the preservative sodium benzoate in children
The mixtures were linked to increased hyperactivity and inattention in some of the children in the trial
Quinoline yellow was one of the six, alongside tartrazine (E102), sunset yellow (E110), carmoisine (E122), ponceau 4R (E124) and allura red (E129)
What the EU did: not a ban — a mandatory warning on the label from July 2010
What the UK did: the FSA asked manufacturers to remove them voluntarily; most large UK brands did
Important limit on the evidence: the study tested mixtures, not quinoline yellow alone, so it cannot show which ingredient did what. Regulators have described the effects as modest and variable between children

What the regulators actually say

Regulator	Status	Reasoning
EFSA / European Union	Permitted within limits + mandatory warning	Authorised as E104 in specified foods. EFSA's 2009 re-evaluation lowered the acceptable daily intake from 10 to 0.5 mg/kg body weight per day, based on a rat study of effects on reproduction and development. Since July 2010, Annex V of Regulation (EC) No 1333/2008 has required foods containing it to state that it "may have an adverse effect on activity and attention in children".
FDA (United States)	Not permitted in food — never approved	The dye is listed in US law as D&C Yellow No. 10, approved for drugs, cosmetics and medical devices such as contact lenses. It was never added to the list of colour additives approved for food, so nothing was withdrawn or revoked — it simply never entered the US food-colour list.
FSSAI (India)	Not on the permitted-colours list	India's food additive regulations permit eight synthetic food colours: tartrazine, sunset yellow FCF, ponceau 4R, carmoisine, erythrosine, indigo carmine, brilliant blue FCF and fast green FCF. Quinoline yellow is not among them, so it is not a permitted synthetic colour in Indian food. Surveys have reported it turning up in samples as a non-permitted colour.
WHO / JECFA	ADI 0–3 mg/kg bw/day	The joint FAO/WHO expert committee set an acceptable daily intake of 0–3 mg/kg body weight at its 82nd meeting in 2016, based on a no-observed-adverse-effect level of 250 mg/kg bw/day for body-weight and organ-weight effects in two long-term rat studies, with a 100-fold safety factor.
UK / FSA	Permitted within limits + warning retained	The UK kept the EU-style child-behaviour warning after leaving the EU, and the FSA asked industry to phase the Southampton colours out voluntarily. Most major UK brands did, so it now appears mainly on imports and smaller brands.

Why do regulators disagree?

The EU–WHO split is a number, not a verdict. Neither body has declared E104 unsafe — they disagree on how much is too much
EFSA (2009): weighted rat reproductive and developmental findings more heavily and applied a large safety margin → 0.5 mg/kg/day
JECFA (2016): anchored on long-term rat studies of body and organ weight → 0–3 mg/kg/day, roughly six times higher
The US position is historical, not a safety finding. America's colour-additive system requires a petition and approval for each use; quinoline yellow was petitioned for drugs and cosmetics, not food
India's position is a closed list. FSSAI permits eight named synthetic colours and nothing else, so E104 falls outside by default rather than by a specific ruling against it
The EU chose disclosure over prohibition. A warning label let shoppers decide — and in practice most manufacturers reformulated rather than print it
An honest counterpoint: EFSA's 2015 refined exposure assessment estimated that average and high-level EU intakes were below its own 0.5 mg/kg limit for all population groups

Who should pay closest attention

Parents buying imported sweets — the child-behaviour warning is the whole reason the EU label exists
People with colour or salicylate sensitivities — reactions such as hives, rhinitis or asthma symptoms have been reported in sensitive individuals, often when several synthetic colours appear together
Anyone in India reading an imported pack — a colour that is normal on a foreign label may not be permitted in food here

How LabelCop scores it

E104 is a high-risk flag in LabelCop
Rule: strictest regulator wins — it is not permitted in US or Indian food and carries a mandatory child-behaviour warning in the EU, so we flag it everywhere
The product's score takes a penalty — and you see the flag, the reason and the sources. No black box
Because LabelCop reads the printed ingredients list, it catches "INS 104" on an imported pack that has no barcode in any local database

Frequently asked questions

Is quinoline yellow allowed in India?

No. FSSAI's regulations permit eight synthetic food colours and quinoline yellow is not one of them. You can still meet it on imported confectionery, and in medicines and cosmetics, where different rules apply.

Why is it allowed in Europe but not in US food?

Mostly history rather than a safety verdict. The EU authorises E104 within limits and requires a child-behaviour warning on the label. In the US the same dye is approved as D&C Yellow No. 10 for drugs, cosmetics and medical devices — it was never added to the food colour list, so nothing was revoked.

Does it cause hyperactivity?

It has not been shown to do so on its own. It was one of six colours tested in mixtures in the 2007 Southampton study, which linked those mixtures to increased hyperactivity and inattention in some children. Because mixtures were tested, the study cannot single out one colour. The EU's response was a warning label, not a ban.

Is it the same as the yellow in my shampoo or tablets?

Yes — as D&C Yellow No. 10 or CI 47005 it is widely used in medicines, mouthwash, shampoo and soap. Those uses are regulated separately from food.

Which label names should I look for?

Quinoline yellow, E104, INS 104, CI Food Yellow 13, CI 47005, or D&C Yellow No. 10. Some packs declare only "permitted synthetic food colour" without naming which one — that phrasing should not cover E104 in India, because it is not a permitted colour here.

Is E104 vegan?

It is a synthetic dye, not animal-derived. Carrier and coating ingredients used alongside it can vary, so check the full ingredients list if that matters to you.

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Sources

EFSA (2009): re-evaluation of Quinoline Yellow (E 104) as a food additive · EFSA (2015): refined exposure assessment for Quinoline Yellow (E 104) · EFSA (2009): updated safety advice on six food colours · Regulation (EC) No 1333/2008, Annex V — mandatory warning statement · 21 CFR 74.1710 — D&C Yellow No. 10 (drug uses) · FDA: summary of colour additives permitted in the United States · WHO/JECFA database: Quinoline Yellow (INS 104), ADI 0–3 mg/kg bw · FSSAI Appendix A — list of permitted food additives, including synthetic colours · FSSAI: compendium of food additive regulations

Related ingredients: Tartrazine (E102 / Yellow 5) — the yellow India does permit · Sunset yellow (E110) — same EU warning, permitted in India · Ponceau 4R (E124) — another Southampton colour never approved in US food · Red 3 / Erythrosine (E127)

This article explains regulatory status and published scientific assessments in plain English. It is not medical advice.