E120 – Carmine | Allergy Risk, Side Effects & Where It’s Used

Quick analysis summary about E120 – Carmine food additive

Bottom line

E120, usually called carmine or carminic acid, is a natural red food colour made from cochineal insects. For most people, the general toxicology data look reassuring at normal food-use levels, but this additive also has a real allergy risk in sensitive individuals. That keeps it at ORANGE – SOME CONCERNS.

Why this grade

Long-term animal studies did not show a convincing cancer, reproductive, developmental, or genotoxicity signal at the tested doses. However, unlike many approved colours, carmine also has human case reports and challenge-based evidence showing true allergy, including hives, breathing symptoms, and rare anaphylaxis.

Who may want to limit or avoid it

People with a known allergy to carmine or cochineal should avoid it. Extra caution also makes sense for anyone with unexplained reactions after red foods or a wish to avoid insect-derived ingredients for personal, ethical, or religious reasons.

Common uses and where it appears

Carmine is used to create stable pink or red shades. It can appear in fruit yoghurts, confectionery, ice cream, bakery fillings, drinks, jams, sauces, and some processed meat or fish products.

Source or origin

This additive is animal-derived. The colour comes from carminic acid obtained from dried female cochineal insects, after which manufacturers may use cochineal extract or carmine lakes.

Intake note

EFSA kept the Acceptable Daily Intake (ADI) at a level corresponding to 2.5 mg carminic acid per kg body weight per day, equivalent to 5 mg carmine per kg body weight per day when the colour contains about 50% carminic acid. That is about 175 mg carminic acid or 350 mg carmine for a 70 kg adult, and about 50 mg carminic acid or 100 mg carmine for a 20 kg child. This limit is based on general toxicology, not allergy, so a sensitised person may still react at much lower intake.

Is it banned anywhere?

No clear major food-use ban was identified in the reviewed EU and US jurisdictions. E120 remains authorised in the EU for defined food categories and conditions of use, and in the US cochineal extract and carmine remain listed colour additives, but US labels must name them specifically.

Safety grading ORANGE – SOME CONCERNS

At normal food-use levels, E120 does not look like a typical carcinogenic or reproductive toxin. The orange grade reflects a different concern: clinically relevant immunoglobulin E (IgE)-mediated allergy has been documented often enough to matter, including urticaria, asthma-type reactions, and rare anaphylaxis after ingestion in sensitised people [1-4]. For most consumers the practical risk is probably low, but E120 is less reassuring than a truly green additive because the human allergy signal is real rather than theoretical.

Study basis or key toxicological reasoning

The toxicology package is broadly reassuring. In rats, a long-term study lasting up to 109 weeks found no carcinogenic effect at doses up to 500 mg/kg body weight/day, which was also the reported NOAEL (No Observed Adverse Effect Level) [5]. Separate three-generation and developmental rat studies did not show harm to fertility or embryo-fetal development at doses up to 500 mg/kg/day and 1,000 mg/kg/day, respectively [6,7]. A genotoxicity test battery on carminic acid was negative in both in vitro and in vivo systems [8]. The main caveat is that human reports and oral-challenge data support true allergy in a susceptible minority, likely linked to individual sensitisation and possibly residual cochineal-related proteins rather than ordinary dose-dependent toxicity [1-4].

Side effects

Hives, itching, or swelling: sensitised people may develop urticaria, facial swelling, or mouth and throat symptoms after ingestion.
Breathing symptoms: wheeze or asthma-type reactions have been reported in allergy settings and occupational exposure.
Rare anaphylaxis: severe systemic reactions are uncommon, but they are well documented for carmine.
Skin-related sensitisation: some people appear to become sensitised through cosmetics that contain carmine before reacting to food.
Higher intake: no special high-intake toxicity pattern stands out, but repeated exposure increases the chance of triggering symptoms in sensitised people.

Should You Avoid This Additive?

Most people do not need to avoid E120 routinely if they tolerate foods containing it without symptoms. Avoidance is more sensible for people with a known carmine or cochineal allergy, those who have had unexplained reactions after red-coloured foods or cosmetics, and anyone who wants to exclude insect-derived ingredients for ethical or religious reasons.

Common Uses

Fruit yoghurts and dairy desserts – to create pink or red shades that stay stable during storage.
Sweets and confectionery – to give candies, gummies, chewing gum, and coatings a bright red appearance.
Ice cream, icings, and bakery fillings – to improve colour in strawberry, raspberry, or cherry-style products.
Flavoured drinks and syrups – to provide a natural-origin red colour.
Jams, sauces, and dessert toppings – to intensify or standardise red colour.
Some processed meat or fish products – to support a red or rosy appearance where allowed.

Common names / Synonyms

Carmine
Carminic acid
Carmines
Cochineal extract
Cochineal
Natural Red 4
CI 75470
E120

What is it?

E120 is a red colour additive based on carminic acid, a pigment obtained from the cochineal insect Dactylopius coccus. After extraction and purification, manufacturers may use it as water-soluble cochineal extract or as carmine lake pigments. It is valued because it gives strong pink-to-red shades and is relatively stable in acidic foods and during storage.

In practice, carmine is chosen when manufacturers want a natural-source red with good performance in products such as yoghurt, confectionery, fruit preparations, and desserts. A small number of people can become genuinely allergic to it, which matters more here than classic cancer or reproductive-toxicity concerns. It also matters because it is insect-derived.

Where it’s allowed (EU vs US)

In the EU, E120 is an authorised food colour for defined categories and conditions of use. In the US, cochineal extract and carmine are permanently listed colour additives exempt from certification for foods generally, and labels must declare them by name. No clear major food-use ban was identified in the reviewed EU and US jurisdictions.

E120 – Carmine