Ponceau 4R
A synthetic red azo dye used to give food and drink a bright strawberry-red colour. One of the Southampton Six colours linked to hyperactivity in children.
Regular intake in children is linked to increased hyperactivity and attention problems. EFSA found in 2009 that children's estimated exposure can exceed the safe daily limit even at typical use levels. A mouse study identified kidney damage at higher doses, which drove a large reduction in the acceptable daily intake.
What is it?
Ponceau 4R is a synthetic azo dye, also labelled as Cochineal Red A, Food Red 7, or Acid Red 18. It is made from petroleum-derived aromatic hydrocarbons. Despite the name 'Cochineal Red A', it contains no animal ingredients and is fully synthetic. It produces a stable strawberry-red colour resistant to heat and light.
What does it do?
It colours food and drink red by absorbing light in the blue-green range. The dye is water-soluble and disperses evenly through liquids and soft foods. It is stable under acidic conditions but can fade in the presence of ascorbic acid (vitamin C). Its chemical structure is an azo group linking two aromatic ring systems, which allows it to absorb visible light strongly.
Where you will see it
Jelly, dessert toppings, fruit-flavoured sweets and candies, soft drinks, seafood dressings, tinned strawberries and fruit pie fillings, packet cake mixes, trifles, cheesecakes, and some processed meat products such as salami and Spanish cured sausages. On the label it appears as 'E124', 'Ponceau 4R', or 'Cochineal Red A'. Products containing it must also carry the warning 'may have an adverse effect on activity and attention in children'.
What the science says
Hyperactivity in children
A 2007 randomised controlled trial by McCann et al., commissioned by the UK Food Standards Agency and published in The Lancet, tested mixtures of six artificial food colours (including E124) plus sodium benzoate on 153 three-year-olds and 144 eight-to-nine-year-olds. Children given the colour mixtures showed significantly higher rates of hyperactive behaviour compared with those on placebo. EFSA reviewed the study and concluded it provided limited evidence of a small effect on activity and attention in some children, but judged the findings alone were not enough to revise the acceptable daily intakes at that time. The UK FSA subsequently asked manufacturers to voluntarily remove the six colours. EU law from 2010 requires the mandatory warning label on all products containing any of the six.
A randomised double-blind placebo-controlled trial found that consumption of a mixture of six artificial food colours including E124 plus sodium benzoate was associated with increased hyperactivity in both 3-year-old and 8-9-year-old children from the general population.
EFSA's AFC Panel concluded that the Southampton study provided limited evidence that the mixtures had a small effect on activity and attention in some children, but the findings alone could not be used as a basis for altering the acceptable daily intake.
Kidney effects and the ADI reduction
In 2009 EFSA's ANS Panel re-evaluated the toxicology of E124 and cut the acceptable daily intake from 4 mg/kg body weight per day to 0.7 mg/kg body weight per day. The key study driving the change was a long-term mouse experiment (Mason et al., 1974) that found increased rates of glomerulonephrosis (a form of kidney inflammation) at dietary levels of 0.25% and above. The lowest no-observed-adverse-effect level was 70 mg/kg body weight per day; applying the standard safety factor of 100 gave the new limit of 0.7 mg/kg. Carcinogenicity studies in rats and mice were negative. A 2015 EFSA refined exposure assessment found that children aged 1-10 at mean and high intake levels, and adults at the 97.5th percentile, can exceed even the reduced ADI when manufacturers use maximum permitted levels.
A long-term mouse study found increased glomerulonephrosis (kidney inflammation) at dietary levels of 0.25% and 1.25%, with a no-observed-adverse-effect level of 70 mg/kg body weight per day. EFSA applied a safety factor of 100 and derived a new ADI of 0.7 mg/kg body weight per day, reducing the previous limit of 4 mg/kg by almost six-fold.
A refined exposure assessment found that high-consuming children aged 1-10 and high-consuming adults can exceed the ADI of 0.7 mg/kg body weight per day when foods are produced at maximum permitted levels, representing a potential concern for those population groups.
Long-term toxicity and carcinogenicity studies in rats and mice found no evidence of carcinogenicity. Ponceau 4R was negative in standard in vitro genotoxicity tests.
Conflicting genotoxicity findings
In vitro tests and carcinogenicity studies have been negative, and EFSA's conclusion is that carcinogenic risk is absent. However, an in vivo mouse cytogenetic study found that a dose of 4 mg of Ponceau 4R, which the authors noted was near the then-current acceptable daily intake, induced a significant number of chromosome aberrations in bone marrow cells, and the researchers concluded the dye should be delisted. EFSA's 2009 re-evaluation acknowledged conflicting genotoxicity data but judged the weight of evidence did not indicate a carcinogenic or genotoxic risk at regulated exposure levels.
An in vivo mouse cytogenetic study found that Ponceau 4R induced a significant number of chromosome aberrations at a minimum effective dose of 4 mg, near the then-current acceptable daily intake. The authors recommended it should be delisted as a food dye.
Photodegradation products of Ponceau 4R formed in beverages were identified and their mutagenic potential was assessed by the Ames bacterial reverse mutation assay.
Aspirin sensitivity and asthma
As an azo dye, Ponceau 4R may trigger intolerance reactions in people who are sensitive to salicylates (aspirin). It is also reported to act as a histamine liberator, which can worsen asthma symptoms in susceptible individuals. These reactions are not allergies in the strict immunological sense but rather intolerance responses that can be dose-related.
Ponceau 4R, as an azo dye, may elicit intolerance reactions in people sensitive to salicylates and can act as a histamine liberator, potentially intensifying asthma symptoms.
Where it stands with the regulators
Who should be careful
Children, particularly those prone to hyperactivity or attention difficulties. People sensitive to aspirin (salicylates) and those with asthma may also be more likely to react. Look for 'E124', 'Ponceau 4R', or 'Cochineal Red A' on the label. Products must also carry the specific warning 'may have an adverse effect on activity and attention in children'.
The honest read
E124 is one of the most regulated food colours in the UK. It carries a mandatory warning label, its acceptable daily intake was cut almost six-fold by EFSA in 2009 following kidney findings in animal studies, and a 2015 exposure assessment found that children eating foods at maximum permitted levels can exceed even the reduced limit. The hyperactivity evidence comes from a randomised controlled trial, the strongest study design, though EFSA noted the findings reflect an effect in some children rather than a universal response. Genotoxicity tests have been broadly negative in formal assessments, but a separate in vivo mouse study found chromosome damage near the old daily limit. The science on E124 is not unsettled in the sense of a new debate: regulators have progressively tightened controls on it, and many UK manufacturers reformulated away from it after 2008.
Related additives
Common questions
Is E124 banned in the UK?
No. E124 remains an approved food additive in England, Scotland, and Wales, listed on the UK FSA approved-additives register (last confirmed April 2025). However, it is not approved by the US FDA, and UK manufacturers must put a mandatory warning on any product containing it. Many UK supermarket own-brands reformulated away from it after the FSA's 2008 voluntary withdrawal request.
Why does packaging say 'may have an adverse effect on activity and attention in children'?
EU law (Regulation 1333/2008, Article 24), now retained in UK law, made this warning compulsory from July 2010 for any food or drink containing E124 and five other artificial colours. The requirement followed a 2007 University of Southampton randomised controlled trial that found mixtures of these colours plus sodium benzoate were associated with increased hyperactivity in children aged 3 and 8-9.
What foods contain E124?
Jelly, dessert toppings, fruit-flavoured sweets and candies, soft drinks, seafood dressings, tinned strawberries, fruit pie fillings, packet cake mixes, trifles, cheesecakes, and some processed meat products such as salami and cured sausages. The dye is less common in UK own-brand products now than before 2008, but branded and imported products may still contain it.
Is E124 vegan?
Yes. Despite being called 'Cochineal Red A', Ponceau 4R is fully synthetic and contains no animal-derived ingredients. It is not extracted from insects (that is E120 Carmine). E124 is suitable for vegans and vegetarians.
Sources
- EFSA ANS Panel, Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive, EFSA Journal 1328
- EFSA, Refined exposure assessment for Ponceau 4R (E 124), EFSA Journal 4073
- McCann et al., 'Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial', The Lancet
- EFSA evaluates Southampton study on food additives and child behaviour, EFSA news
- UK FSA approved-additives list, E124 Ponceau 4R, Cochineal Red A
- UK FSA food additives page
- Commission Regulation (EU) No 232/2012 amending Annex II to Regulation 1333/2008 (conditions of use for E124)
- In vivo cytogenetic studies on male mice exposed to Ponceau 4R and beta-carotene, PubMed 8330485
- Safety and efficacy of ponceau 4R for cats, dogs and ornamental fish, EFSA Journal (2018), PMC7009515
- Separation, identification and mutagenic assessment of the photodegradation products of Ponceau 4R (E124) in a beverage, Analytical Methods, RSC Publishing
- University of Southampton news: Major study indicates a link between hyperactivity in children and certain food additives (2007)
- Telford Council: Colours in food and drink warnings (mandatory label text)
- Ponceau 4R, Wikipedia
- Norwegian Food Safety Authority (Mattilsynet): Food additives, enzymes and flavourings - Norway follows EU Regulation 2008/1333 as an EEA member
- Canadian Food Inspection Agency: Food colours - specific food colours permitted in Canada
Aaron Keen is the founder of NutraSafe. He researches and writes every additive entry himself, from the primary sources. About the research →
This is a guide, not medical advice. If an additive affects you, speak to your GP or a dietitian.
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