cochineal extract
cochineal extract

Cochineal Extract

Common names: CarmineNatural Red 4C.I. 75470Carmine LakeE120 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on May 6, 2025
Medically reviewed by Dr. William Lin, MD
Cochineal extract, also known as carmine or E120, is a natural red dye derived from the dried bodies of female Dactylopius coccus insects. It is widely used in the food industry to color products such as candies, yogurts, beverages, and baked goods due to its vivid and stable red hue. The pigment is composed primarily of carminic acid, which is water-soluble and heat-stable, making it suitable for a variety of food processing conditions.[1]
Despite being a natural alternative to synthetic dyes, cochineal extract has raised concerns among consumers due to its insect origin and potential allergenicity. Some individuals may experience hypersensitivity reactions, including anaphylaxis, particularly those with preexisting allergies to insect-derived compounds.[2] Regulatory authorities require its clear labeling in food products, and its use remains approved under strict guidelines in many countries.[3]

Safety Overview

Regulatory Bodies

FDA (US)
The U.S. Food and Drug Administration (FDA) classifies cochineal extract and carmine as color additives exempt from certification, permitting their use in foods and cosmetics, including products applied around the eyes. However, due to potential allergic reactions, the FDA mandates that products containing these additives must declare them by their specific names on labels.[4]
Health Canada
Health Canada acknowledges that certain natural color additives, such as cochineal extract and carmine, have been linked to allergic responses. Consequently, they have proposed improved labeling requirements to ensure these additives are clearly identified by their common names on food labels, aiming to inform consumers who may be sensitive to them.[5]
EFSA (Europe)
The EFSA has re-evaluated cochineal extract, carminic acid, and carmines (E 120) as food additives and established an Acceptable Daily Intake (ADI) of 5 mg/kg body weight per day. While generally considered safe, EFSA has noted that these additives can cause allergic reactions in some individuals, leading to recommendations for appropriate labeling to inform consumers.[3]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has assessed cochineal extract and carmine; they have not set an ADI for it. They recognize that, although rare, allergic reactions can occur, emphasizing the importance of monitoring and managing potential hypersensitivity among consumers.​[6]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
Cochineal extract is not classified as GRAS (Generally Recognized As Safe) by the U.S. Food and Drug Administration. Instead, it is regulated as a color additive that is exempt from certification, meaning its use is permitted under specific conditions but it must be explicitly declared on product labels due to its potential to cause allergic reactions in sensitive individuals.[4] This classification ensures regulatory oversight while allowing its use in foods, drugs, and cosmetics when properly labeled.

EWG Rating

Environmental Working Group
  • EWG Rating: Cochineal extract, also known as carmine or CI 75470, is rated by The Environmental Working Group (EWG) with a hazard score of 1–3, indicating low to moderate concern depending on usage context.[7]
  • Level of Caution: The EWG flags cochineal extract for potential allergic reactions, including rare but severe responses such as anaphylaxis, especially in sensitive individuals.[7]
  • Possible Health Risks: Although considered safe for the general population, carmine and cochineal extract have been linked to hypersensitivity reactions, which may range from mild irritation to life-threatening events.[7]
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More about Cochineal Extract

  • Beverages: Fruit juices, flavored waters, liqueurs
  • Dairy Products: Strawberry yogurt, ice cream, flavored milk
  • Confectionery and Baked Goods: Gummies, frosted cupcakes, jelly candies

Historical Use
Cochineal extract has been used as a natural red dye since the 15th century by indigenous peoples of Central and South America and became a widely traded commodity in Europe during the colonial era.[8]
Current Exposure
Today, consumers are exposed to cochineal extract in various products such as yogurts, juices, candies, and cosmetics, especially those labeled as using natural colorants.[3]

Allergic Reactions
Cochineal extract has been associated with immediate hypersensitivity reactions, including urticaria and anaphylaxis, particularly in individuals sensitized through prior dietary or cosmetic exposure.[2]
Occupational Asthma
Workers exposed to airborne carmine powder in industrial settings have reported occupational asthma, highlighting the need for respiratory protection in processing environments.[9]
Respiratory Hypersensitivity
IgE-mediated responses such as rhinitis and bronchial asthma have been documented in sensitized individuals exposed to cochineal extract.[10]
Non-Carcinogenicity
Long-term toxicological evaluations, including EFSA reviews, have found no evidence of carcinogenicity associated with cochineal extract.[3]

Toxicological Studies
Animal studies reviewed by EFSA reported no significant genotoxic, carcinogenic, or reproductive toxicity effects from carmine or cochineal extract when administered at doses up to 500 mg/kg body weight/day.[1] The No Observed Adverse Effect Level (NOAEL) was identified at 250 mg/kg bw/day in a 90-day rat study.[3]
Long-Term Safety
Long-term studies have concluded that cochineal extract does not pose carcinogenic risks and is not associated with significant chronic toxicity at typical exposure levels.[3] However, rare hypersensitivity reactions remain a concern for sensitive individuals even at low doses.[2]

High-Risk Groups
Individuals with existing allergies or asthma, as well as those with heightened immune sensitivity, are considered high-risk groups for adverse reactions to cochineal extract.[2] Children and occupationally exposed workers, such as food or cosmetic handlers, may also face increased sensitization risk.[10]
Health Impacts
In vulnerable individuals, cochineal extract can trigger severe IgE-mediated allergic responses including urticaria, respiratory distress, or anaphylaxis even at low exposure levels.[2][10] These effects highlight the importance of allergen labeling and exposure monitoring in susceptible populations.

Recommended Intake
The European Food Safety Authority (EFSA) has established an Acceptable Daily Intake (ADI) for cochineal extract (E120) at 5 mg/kg body weight per day, based on toxicological studies identifying no adverse effects at this exposure level.[3]

General Safety Level
Cochineal extract is generally safe for the population and is permitted in many countries for use in food and cosmetics, but its allergenic potential has led to mandatory labeling requirements in jurisdictions like the EU and U.S.[3]
Sensitive Individuals
In rare cases, cochineal extract can cause IgE-mediated allergic reactions, including urticaria, asthma, and anaphylaxis, particularly in individuals with prior sensitization.[10]

FAQ

Is cochineal extract bad for you?

Cochineal extract is generally safe but may cause allergic reactions in some individuals.

What is cochineal extract?

Cochineal extract is a red dye made from crushed cochineal insects.

What foods have cochineal extract in them?

Cochineal extract is found in candies, yogurts, juices, and other red or pink-colored foods.

References

  1. Marmion, D.M., 1991. Handbook of U.S. Colorants for Foods, Drugs, and Cosmetics. 3rd edn. New York: John Wiley & Sons. ↩︎
  2. Takeo N., et al., 2011. 'Cochineal dye-induced immediate allergy: Review of Japanese cases and proposed new diagnostic chart', Allergology International, 67(4), p. 496-505. Available at: https://pubmed.ncbi.nlm.nih.gov/29705083/ ↩︎
  3. European Food Safety Authority, 2015. 'Scientific Opinion on the re-evaluation of cochineal, carminic acid, carmine (E 120) as a food additive', EFSA Journal, 13(11), p. 4311. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/4288 ↩︎
  4. U.S. Food and Drug Administration, n.d. Code of Federal Regulations Title 21 - Cochineal extract; carmine. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-A/section-73.100 ↩︎
  5. Health Canada, 2010. 'Proposal to Improve Food Colour Labelling Requirements', Government of Canada. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/public-involvement-partnerships/proposal-improve-food-colour-labelling-requirements-2010/document.html ↩︎
  6. World Health Organization, 2000. Cochineal extract. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/392 ↩︎
  7. Environmental Working Group, n.d. 'Cochineal, Carmine, and Carminic Acid', EWG's Food Scores. Available at: https://www.ewg.org/foodscores/ingredients/7733-CochinealCarmineandCarminicAcid/ ↩︎
  8. Greenfield, A.B., 2005. A Perfect Red: Empire, Espionage, and the Quest for the Color of Desire. New York: Harper Perennial. ↩︎
  9. Thermo Fisher Scientific, n.d. 'Allergen Encyclopedia: Cochineal Carmine (f340)', Phadia Allergen Encyclopedia. Available at: https://www.thermofisher.com/phadia/us/en/resources/allergen-encyclopedia/f340.html ↩︎
  10. Voltolini S., 2014. 'New risks from ancient food dyes: Cochineal red allergy', European Annals of Allergy and Clinical Immunology, 46(6), pp. 232-233. Available at: https://www.researchgate.net/publication/268281482 ↩︎

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