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Toxicity of tartrazine
Scientific review report
4. Use in other products
Many processed foods contain the dye, including dairy products, juices, pickles, candies and cake mixes, as well as cosmetics and toiletries. It is also found in many drug products that were approved prior to ADEC's 1983 recommendation. The amounts range between 0.001 to 2.5 mg.
Tartrazine is included in the Food Standards Code; Schedule 4 of Standard 1.3.1 Food Additives. Schedule 4 allows tartrazine in certain foods and beverages up to maximum 0.29 mg/g and 0.07 mg/mL, respectively. It also states that certain beverages (such as carbonated, mineralised and soda waters specified in Schedule 1) are exempted from this quantity restriction.
The acceptable daily intake (ADI) is the amount of a substance that can be taken every day for an entire lifetime without any adverse effect. Tartrazine has an ADI of up to 7.5 mg/kg bodyweight, which was established by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in1964. Recent reviews have concluded that a revision of the ADI based on the available data is not warranted. A dietary exposure assessment predicted that tartrazine consumption for children aged between 2 and 16 years in Australia, even at the highest daily consumption, would be between 0.21 and 0.38 mg/kg bodyweight (which corresponds to between 3 and 5% of the ADI). Elhkim et al. (2007) recently conducted a toxicological assessment and their bibliographical review of animal studies confirmed the initial hazard assessment conducted by JECFA (1964) and the ADI of 7.5 mg/kg bw. They calculated that in France the estimated maximum theoretical intake of tartrazine in children is 37.2% of the ADI at the 97.5th percentile.