About
What it is and where it shows up.
Tartrazine is a synthetic lemon-yellow azo dye derived from coal tar, used as a food colourant to impart bright yellow hues in beverages, confectionery, cereals, and pharmaceuticals. It is one of the most widely used synthetic food colours globally and is water-soluble.
Safety summary
The regulatory and scientific consensus.
EFSA (2009) and JECFA (2016) confirmed tartrazine is not carcinogenic or genotoxic under normal conditions of use, with an ADI of 7.5 mg/kg bw/day (EFSA) and 10 mg/kg bw/day (JECFA 2016). Sensitive populations — including children, asthmatics, and individuals with aspirin intolerance — face elevated risk of allergic reactions (urticaria, hives) and potential behavioural effects such as hyperactivity. Some European member states have taken additional regulatory measures to restrict its use due to concerns about childhood hyperactivity.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | Approved under Regulation (EC) No 1333/2008 but subject to mandatory warning label per Regulation (EU) No 238/2010: 'may have an adverse effect on activity and attention in children'. EFSA re-evaluation (2009) confirmed ADI of 7.5 mg/kg bw/day; some individual EU Member States have imposed additional national restrictions.source |
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | FSANZ colour surveys (2008, 2012) concluded estimated dietary exposure to tartrazine was less than 5% of the ADI for all consumers, including high consumers. JECFA (2016) also concluded dietary exposure does not present a health concern.source |
| JECFA (JECFA (FAO/WHO)) | Approved | JECFA first evaluated tartrazine in 1966 and established an ADI of 7.5 mg/kg bw/day. In 2016 (82nd JECFA report), the ADI was revised upward to 0–10 mg/kg bw/day based on a NOAEL of 984 mg/kg bw/day from a chronic rat study and an uncertainty factor of 100. Confirmed not carcinogenic, genotoxic, or a reproductive/developmental toxicant.source |
| FDA (Food and Drug Administration) (United States) | Approved | Approved as FD&C Yellow No. 5 under 21 CFR 74.705; subject to mandatory FDA batch certification before use. Must be declared by name on all food and cosmetic labels; on drug/medicine labels must additionally be identified by its uncertified name 'tartrazine'. No formal ADI established by FDA. |
Who should approach with care
Whose guidance would steer them away.
Children — A randomised double-blind study (McCann et al., 2007) linked a mixture including tartrazine to increased hyperactivity and impaired attention in 3-year-old and 8–9-year-old children, prompting the EU mandatory warning label 'may have an adverse effect on activity and attention in children'.
Other — Asthmatics and individuals with aspirin/NSAID intolerance are at elevated risk of cross-reactive allergic responses (urticaria, asthma attacks, angioedema) as tartrazine induces the most allergic and intolerance reactions among all azo dyes.
Migraine — Tartrazine has been associated with migraine episodes in susceptible individuals; it is listed among dietary triggers that may provoke headache attacks.
Thyroid Disease — Some studies suggest a potentially elevated risk of thyroid disturbance associated with tartrazine exposure, though evidence remains preliminary and primarily from animal or epidemiological data.
Ibd — Preclinical studies report tartrazine can induce oxidative stress and inflammatory responses in gut tissues, which may exacerbate underlying inflammatory bowel conditions.
Research citations
The sources behind this verdict.
- 1PubMed. Toxicological Effects of Tartrazine Exposure: A Review of In Vitro and Animal Studies with Human Health Implications. pmc.ncbi.nlm.nih.gov
- 2FDA. How Safe are Color Additives? — FD&C Yellow No. 5 (Tartrazine). fda.gov
- 3PubMed. Safety of tartrazine in the food industry and potential protective factors, 2024. pubmed.ncbi.nlm.nih.gov
- 4other. Food Colour Additives: A Synoptical Overview on Their Chemical Properties, Applications in Food Products, and Health Side Effects, 2022. pmc.ncbi.nlm.nih.gov
- 5PubMed. Lack of genotoxicity in vivo for food color additive Tartrazine, 2017. pubmed.ncbi.nlm.nih.gov
- 6EFSA. Re-evaluation of Tartrazine (E 102) as a food additive, 2009. efsa.europa.eu
Independently researched6 citations