Tartrazine is an artificial azo dye commonly used in human food and pharmaceutical products. Since the last assessment carried out by the JECFA in 1964, many new studies have been conducted, some of which have incriminated tartrazine in food intolerance reactions. The aims of this work are to update the hazard characterization and to revaluate the safety of tartrazine. Our bibliographical review of animal studies confirms the initial hazard assessment conducted by the JECFA, and accordingly the ADI established at 7.5mg/kg bw. From our data, in France, the estimated maximum theoretical intake of tartrazine in children is 37.2% of the ADI at the 97.5th percentile. It may therefore be concluded that from a toxicological point of view, tartrazine does not represent a risk for the consumer. It appears more difficult to show a clear relationship between ingestion of tartrazine and the development of intolerance reactions in patients. These reactions primarily occur in patients who also suffer from recurrent urticaria or asthma. The link between tartrazine consumption and these reactions is often overestimated, and the pathogenic mechanisms remain poorly understood. The prevalence of tartrazine intolerance is estimated to be less than 0.12% in the general population. Generally, the population at risk is aware of the importance of food labelling, with the view of avoiding consumption of tartrazine. However, it has to be mentioned that products such as ice creams, desserts, cakes and fine bakery are often sold loose without any labelling.

Food allergies and asthma are increasing worldwide. It is estimated that approximately 8% of children aged <3 years have food allergies. Foods can induce a variety of IgE-mediated, cutaneous, gastrointestinal, and respiratory reactions. The most common foods responsible for allergic reactions in children are egg, milk, peanut, soy, fish, shellfish, and tree nuts. Asthma alone as a manifestation of a food allergy is rare and atypical. Less than 5% of patients experience wheezing without cutaneous or gastrointestinal symptoms during a food challenge. In addition to acute respiratory symptoms, a food allergy may also induce airway hyper-responsiveness beyond the initial reaction. This process can occur in patients who do not demonstrate a decrease in lung function during the reaction. Inhalation of aerosolized food particles can cause respiratory symptoms in selected food-allergic individuals, particularly with fish and shellfish during cooking and aerosolization. However, this has not been demonstrated with the smelling of, or casual contact with, peanut butter. Rarely, food additives such as sulfating agents can cause respiratory reactions. This reaction occurs primarily in patients with underlying asthma, particularly in patients with more severe asthma. In contrast, there is no convincing evidence that tartrazine or monosodium glutamate can induce asthma responses. Although food-induced asthma is rare, it is common for patients and clinicians to perceive that food can trigger asthma. Avoidance of specific foods or additives has not been shown to improve asthma, even in patients who may perceive that a particular food worsens their asthma.However, patients with underlying asthma are more likely to experience a fatal or near-fatal food reaction. Food reactions tend to be more severe or life threatening when they involve the respiratory tract. The presence of a food allergy is a risk factor for the future development of asthma, particularly for children with sensitization to egg protein.The diagnosis of a food allergy includes skin or in vitro testing as an initial study when the history suggests food allergy. While negative testing generally rules out a food allergy, positive testing should be followed by a food-challenge procedure for a definitive diagnosis. The CAP-RAST FEIA (CAP-radioallergosorbent test [RAST] fluoroenzyme immunoasssay system [FEIA]) is an improved in vitro measure that in some cases may decrease the need for food challenges. However, similar to skin testing and the RAST, there is good sensitivity but poor specificity, such that specific challenges are often warranted.

BACKGROUND: Tartrazine is the best known and one of the most commonly used food additives. Food colorants are also used in many medications as well as foods. There has been conflicting evidence as to whether tartrazine causes exacerbations of asthma with some studies finding a positive association especially in individuals with cross-sensitivity to aspirin. OBJECTIVES: To assess the overall effect of tartrazine (exclusion or challenge) in the management of asthma. SEARCH STRATEGY: A search was carried out using the Cochrane Airways Group specialised register. Bibliographies of each RCT was searched for additional papers. Authors of identified RCTs were contacted for further information for their trials and details of other studies. SELECTION CRITERIA: RCTs of oral administration of tartrazine (as a challenge) versus placebo or dietary avoidance of tartrazine versus normal diet were considered. Studies which focused upon allergic asthma, were also included. Studies of tartrazine exclusion for other allergic conditions such as hay fever, allergic rhinitis and eczema were only considered if the results for subjects with asthma were separately identified. Trials could be in either adults or children with asthma or allergic asthma (e.g. sensitivity to aspirin or food items known to contain tartrazine). DATA COLLECTION AND ANALYSIS: Study quality was assessed and data abstracted by two reviewers independently. Outcomes were analysed using RevMan 4.1.1. MAIN RESULTS: Ninety abstracts were found, of which 18 were potentially relevant. Six met the inclusion criteria, but only three presented results in a format that permitted analysis and none could be combined in a meta-analysis. In none of the studies did tartrazine challenge or avoidance in diet significantly alter asthma outcomes. REVIEWER'S CONCLUSIONS: Due to the paucity of available evidence, it is not possible to provide firm conclusions as to the effects of tartrazine on asthma control. However, the six RCTs that could be included in this review all arrived at the same conclusion. Routine tartrazine exclusion may not benefit most patients, except those very few individuals with proven sensitivity.