post-bg-464
calendary July 5, 2024

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:
  1. 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;
  2. Technical regulations of the customs union 029/2012;
  3. https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-4/1-4-1-lekarstvennye-formy/vybor-lekarstvennykh-form-dlya-detey/

More related posts

new-img-1

Control

Fine for spa resort in Yessentuki

Roszdravnadzor has imposed a fine of 130 thousand rubles on a spa resort in Yessentuki for improper storage of medical products…

03.03.2016
READ ARTICLE
new-img-2

Roszdravnadzor

Roszdravnadzor – patients’ rights

In 2015, Roszdravnadzor restored the rights of more than 460 thousand citizens to effective, accessible, and safe medical…

03.03.2016
READ ARTICLE
new-img-3

Regulation

The certification scheme for medical products hasn’t changed recently

Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the…

03.04.2016
READ ARTICLE
new-img-4

Control

Fines – Rostov region

In one and a half months of 2016, the Local Agency of Roszdravnadzor in Rostov Region imposed fines of the total amount of…

03.10.2016
READ ARTICLE
new-img-5

Control

Unregistered medical products

Two citizens were fined for selling unregistered medicinal products on the Internet in the Republic of Bashkortostan.

03.10.2016
READ ARTICLE
new-img-6

Control

Unscheduled inspection by roszdravnadzor

Roszdravnadzor started an unscheduled inspection of the Federal State-Funded Institution of Sverdlovsk Region Kirovgrad Central…

03.14.2016
READ ARTICLE
new-img-7

Medical Devices

International medical device regulators forum (IMDRF)

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor,…

03.17.2016
READ ARTICLE
new-img-8

Pharmaceuticals

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF”

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF” in which pills the metal wire was found.

05.18.2016
READ ARTICLE
new-img-9

Roszdravnadzor

Medical equipment stands idle in the Pskov region

Roszdravnadzor (RZN) statement: the expensive medical equipment for the total amount of 342 million rubles stands idle in…

05.19.2016
READ ARTICLE
new-img-10

Control

Hospital control Jewish autonomous region

Roszdravnadzor has audited the activity of the Regional Budgetary Public Health Facility “Central district hospital of Lenin”…

05.20.2016
READ ARTICLE