
Azo dyes in pharmaceuticals and food products
Often in the composition of medicines and food products you can find a group of excipients such as azo dyes. Azo dye content is mandatory for secondary packaging labeling of oral medicinal products, and their absolute safety is still controversial. What are the dangers of using azo dyes?
The group of azo dyes typically used in the pharmaceutical and food industries includes:
- sunset yellow (E110);
- azorubine (carmoisine, E122);
- crimson (ponceau 4R, cochineal red A, E124);
- brilliant black BN (black shiny BN, black PN, E151).
The structural formula of these compounds includes an unsaturated group N = N and aromatic rings, for which toxic, mutagenic and carcinogenic effects have been observed.
According to some studies, the sunset yellow azo dye exhibits genotoxic properties in experimental models with effects on learning and memory, and has an immunomodulatory effect.
To azo dyes (tartrazine, indigo carmine, ponceau, carmoisine, solar yellow) in children with bronchial asthma and atopic dermatitis, IgE antibodies were found in the blood, correlating with the sensitization of granulocytes, as well as IgA, IgE, IgG antibodies in the saliva.
Due to possible risks for children, labeling of, for example, food products containing azo dyes should contain the following warning statement: “contains dye(s) which may have a negative effect on the activity and attention of children”. Moreover, the maximum dose of this category of dyes in food products ranges from 50 mg/kg to 500 mg/kg, depending on the product.
As for medicinal products, according to the requirements of the General Pharmacopoeial Article “Choice of dosage forms for children” of the State Pharmacopoeia of the Russian Federation, 15th edition, the use of azo dyes in dosage forms for oral administration intended for children is prohibited: “Use in the composition of medicinal products for children, in the form of dosage forms for oral administration dyes such as tartrazine (E102), sunset yellow (E110), azorubine or carmoisine (E122), erythrosine (E127), which can cause allergic and other adverse reactions is prohibited.”
References:
- S. Aliakhnovich, D.K. Novikov “Dyes in food and drugs are potential immunomodulators”, Medical Immunology (Russia)/ Meditsinskaya Immunologiya, 2019, Vol. 21, no. 2, pp. 313-322. doi: 10.15789/1563-0625-2019-2-313-322;
- Technical regulations of the customs union 029/2012;
- https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-4/1-4-1-lekarstvennye-formy/vybor-lekarstvennykh-form-dlya-detey/