The creation of the blue dye, as described in the patent, involves a multi-step process that includes diazotization and coupling reactions. The process begins with the preparation of 2-Amino-5-nitrophenol, which is dissolved in water under alkaline conditions using liquid caustic soda to adjust the pH to 12.5-13. This solution is then cooled to 0-5°C, and hydrochloric acid and sodium nitrite are added to perform the first diazotization reaction in an ice-water bath, resulting in the formation of the first diazonium product. This diazonium product is then coupled with another aromatic compound, such as 1-naphthol-5-sulfonic acid, to form the first coupling product.
The first coupling product undergoes two complexing reactions. In the first complexing step, the coupling product is mixed with basic chromium sulfate, Whitfield's ointment, and sodium formiate under acidic conditions and heated to 140-145°C to obtain the first complexing product. This product is then mixed with a second coupling product and subjected to a second complexing reaction at a higher pH (10.0-10.5) and temperature (85-90°C). After the reaction is complete, the pH is adjusted to 7.5-8.0, and the mixture is cooled and treated with refined salt to precipitate the final blue dye, which is then filtered and obtained as the final product[1].
The safety profile for human consumption of Blue 2 (Indigo Carmine) in food and beverages is marked by several concerns and uncertainties. While regulatory agencies such as the FDA, EFSA, and JECFA have approved Blue 2 for use in limited amounts, there are potential health risks associated with its consumption. These include allergic reactions, gastrointestinal issues, and in rare cases, anaphylaxis. Long-term health risks may involve neurobehavioral problems in children, such as worsening symptoms of attention-deficit/hyperactivity disorder (ADHD), and there are also concerns about potential carcinogenic effects, as animal studies have linked Blue 2 to brain tumors in rats, although human studies are lacking[1][2][3].
Regarding potential contamination risks, the use of Blue 2 in food and beverages does not directly involve heavy metals or pesticide contamination, as it is a synthetic dye. However, the broader context of food safety can be impacted by these factors. Foods that may contain Blue 2 could potentially be contaminated with heavy metals or pesticide residues if the ingredients used in their production are not properly monitored. For instance, heavy metals like lead, mercury, and arsenic can contaminate food through various sources, including soil and water pollution, and pesticide residues can accumulate in crops if not managed according to safety guidelines. Additionally, pathogen risks can be present in any food product if proper handling, storage, and processing protocols are not followed. Therefore, while Blue 2 itself is not a source of these contaminants, the overall safety of the food products it is used in can be compromised by these factors[4].
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