Published Jan 16, 2025 | 5:49 PM ⚊ Updated Jan 16, 2025 | 5:49 PM
INS 127
The colour additive INS 127, widely used in strawberry-flavoured milkshakes, ice cream, candies, bubble gum, and waffles in India, has been banned in the USA by the Food and Drug Administration (FDA) after it was found to cause cancer in rats.
Whether it is a well-known brand or a newly introduced one, most brands in India continue to use INS 127, also known as Red No. 3 or Erythrosine.
“FDA finds that FD&C Red No. 3 can induce cancer in male rats through a rat-specific hormonal mechanism. Therefore, we are revoking the listings providing for these uses of this colour additive under section 721(b)(5)(B) of the FD&C Act as a matter of law, as described further below,” said the FDA in its order.
In India, under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, Erythrosine, also referred to as FD&C Red No. 3, is recognised as a synthetic food colour. According to the International Numbering System (INS) for Food Additives, it is listed as INS 127.
In India, the usage of INS 127 is permitted in the following products:
Erythrosine is primarily used to impart a bright red hue to various food items, including candies, baked goods, and beverages. It enhances the visual appeal of products such as cakes, cookies, frostings, and frozen desserts.
However, the use of Erythrosine has raised health concerns due to its potential carcinogenic properties. Studies have shown that it can cause cancer in laboratory rats, prompting scrutiny over its safety in food products.
While Erythrosine is still permitted for use in food products in India, the regulatory landscape is gradually evolving. The U.S. FDA recently announced a ban on Erythrosine in food and ingested drugs due to similar health concerns. This decision could potentially influence regulatory practices in other countries, including India.
The additive has been linked to behavioral issues in children. A 2021 report by the California Office of Environmental Health Hazard Assessment found that children who consumed Red Dye 3, along with other food dyes, were more likely to experience hyperactivity and difficulty focusing.
Growing consumer awareness about the potential risks associated with synthetic dyes like Erythrosine, has also led to a shift in the food industry. As a result, some manufacturers are actively reformulating their products to eliminate such additives.
U.S. regulators on Wednesday, 15 January, banned the dye called Red 3 from the nation’s food supply, nearly 35 years after it was prohibited in cosmetics due to its potential cancer risk.
The FDA stated, “We are revoking the authorisation for the use of FD&C Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The Delaney Clause, enacted in 1960 as part of the Colour Additives Amendment to the FD&C Act, prohibits FDA authorisation of a food additive or colour additive if it has been found to induce cancer in humans or animals.
According to the FDA, “Data presented in a 2022 colour additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 through a hormonal mechanism specific to male rats.” However, the agency noted that studies in other animals and humans did not show the same effect and there is no evidence suggesting FD&C Red No. 3 causes cancer in humans.
The FDA emphasised, “Colour additives, including FD&C Red No. 3, require pre-market review and approval. The law requires evidence that a colour additive is safe under its intended conditions of use before it may be added to foods.”
When manufacturers seek approval for a colour additive, they submit a petition with data and information. The FDA evaluates this data and considers factors such as the likely amount of consumption, intended use, manufacturing process, and the physical and chemical properties of the additive. The FDA stated, “If the data available demonstrates that the substance is safe under the proposed conditions of use, the agency issues a regulation authorising its use.”
However, “In cases where data demonstrates that a colour additive intended for ingestion can induce cancer in humans or animals based on appropriate tests, the Delaney Clause directs the FDA to find such uses unsafe,” the FDA clarified.
The FDA further explained its labelling regulations: “Certified colours must be declared in the statement of ingredients on food labels as ‘FD&C Red No. 3,’ or without the ‘FD&C’ prefix or the term ‘No.’ – for example, ‘FD&C Red 3’ or ‘Red 3.’”
Other countries allow the use of FD&C Red No. 3 under different names, such as erythrosine in Canada and Europe.
Past Regulatory Actions
FD&C Red No. 3 was first listed in 1907 under the Food and Drugs Act of 1906. It was later provisionally listed in 1960 for food, drug, and cosmetic use. In 1969, it was permanently listed for food and ingested drugs. However, in 1990, its provisional listing for cosmetics and externally applied drugs was terminated following rat studies linking the dye to thyroid cancer.
(Edited by Ananya Rao)
