The United States Food and Drug Administration (FDA) announced an important decision on January 29, 2025 to ban the use of the Red No. 3 colorant known as erythrocin (E127). According to the new regulation, food and drug products containing erythrosine must be removed from the market by January 18, 2028 and manufacturers must update their formulations.
What is Erythrocin (Red No. 3)?
Erythrocin is a synthetic colorant widely used in the food and pharmaceutical industries. It is found in many products such asconfectionery, bakery products, beverages, jams, ice creams and some medicines. This colorant, which is used in the food industry to give red-pink hues, has been the subject of controversy for many years.
The FDA’s decision was taken because of the possible risks of erythrocin on human health. Some scientific studies on animals have shown that erythrocin may have carcinogenic effects and may have adverse effects on thyroid function.
Scope of the New Regulation
The ban announced by the FDA covers all food and pharmaceutical products, both manufactured in the US and imported. Manufacturers and suppliers must turn to alternative colorants by this date. This is an important reform process, especially for companies operating in the food sector.
Under the new regulation:
- From January 18, 2028, products containing erythrosine will no longer be sold in the US market.
- Imported products will also have to be free of erythrocin.
- Manufacturers must update their formulas to the alternative colorants identified by the FDA.
The FDA is giving manufacturers ample time for this transition, while also encouraging consumers to be more aware of colorant content.
Alternative Colorants and Industry Impacts
Following the ban on erythrocin in the food and pharmaceutical industry, manufacturers will turn to natural colorants. Among the alternatives recognized as safe by the FDA:
- Beet juice concentrate
- Carrot extract
- Liquid fruit extracts
- Carotenoids (such as beta-carotene) are available.
In particular, the transition to natural colorants will require manufacturers to reconsider their labeling and formulation processes. These changes may also be an important development in terms of consumer preferences. Today, there is a growing demand for products that are free from additives and have more natural ingredients.
An Important Change for Exporters
For food and pharmaceutical exporters to the US, the erythrocin ban requires them to review existing product formulations and comply with FDA regulations. Exporting companies:
- Replacing product ingredients with FDA-designated alternatives,
- Bringing product labels in line with the new regulation,
- Food safety certificatesneedto be updated.
This will entail additional costs for exporters and the need to speed up regulatory processes. At the same time, however, it is also anticipated that the transition to the use of natural colorants may have a positive impact on consumer demand.
The FDA’s erythrocin ban is considered as a development that will lead to significant changes in the food and pharmaceutical industry. As of January 18, 2028, products containing erythrosine will be banned from entering the US market, it is critical that manufacturers start updating their formulations and labeling processes now.
