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FDA reviews red food colour additive, Red No.3

Amid considerations to tighten regulations around artificial ingredients, the US Food and Drug Administration (FDA) is exploring a potential ban on particular type of red food dye.

Following a formal request, the US Food and Drug Administration (FDA) is actively reviewing the petition for Red No. 3, approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Red No. 3 is a red food colour additive made from petroleum that produces a bright cherry-red colour.

Food additive legislation differs across the world

Legislation on the permitted use of additives in food and drinks differs depending on the country. Authorities undertake safety and quality assessments to determine the use of specific additives entering the food supply, including colour. However, due to varying assessment approaches, cultural attitudes, and regulatory priorities, authorities often come to different conclusions.

Food colouring broadly falls into two categories: artificial and natural.

Natural colouring refers to pigments from naturally derived sources, such as plants, animals and minerals. Whereas artificial colouring – manufactured colours added to foodstuff during production – falls under food additives as they alter the natural state of the product’s colouration.

Food additive laws

In the US, the FD&C Act sets out a framework for governing food additives and those approved by the FDA.

In the European Union (EU), several regulations govern the requirements, specifications, and authorisation procedures surrounding the use of food additives.

In Japan, Act No. 233 of 24 December 1947, the Japan Food Sanitation Act/Japan Food Sanitation Law (JFSL), governs food safety and quality, with the Ministry of Health and Welfare Notification No. 370 (1959) setting out specifications and standards for foods and food additives.

Singapore has regulatory requirements for food additives, with the Singapore Food Agency performing food safety assessments before additives can be sold in the Asian market.

Food additive re-evaluations and reviews

Regardless of whether an ingredient, like food additives, has been approved, agencies like the FDA can and do review ingredients post-approval and market entry to ascertain their ongoing presence in the food supply chain.

In the EU, the European Food Safety Authority (EFSA) is currently re-evaluating all food additives authorised for use in the EU before 20 January 2009. Specified under Regulation (EU) No 257/2010, as of 4 November 2024, EFSA had reviewed more than 70% of the 315 food additives applicable.

The Food Safety and Standards Authority of India has continued to propose amendments to the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2021.

Now, in the US, the FDA is examining the specific issue of artificial food colouration, pertaining to one specific red food dye, FD&C Red No. 3.

FDA is re-analysing Red No.3 food colouring

“The FDA is actively reviewing a petition filed for FD&C Red No. 3, which proposed that the FDA repeal the colour additive regulations for the use of FD&C Red No. 3 in foods and ingested drugs,” a spokesperson for the FDA told Ingredients Network.

Whether Red No.3 food colouring is permitted for future use in foods closely revolves around the Delaney Clause, which entered into the US FD&C Act as part of the Food Additives Amendment 1958. The Delaney Clause requires the FDA to ban food additives that, through testing, have been found to cause or induce cancer in humans or animals.

However, under the FDA’s FD&C Act, colour additives are not included in the definition of food additives. The FDA states that “other legal pre-market approval requirements apply”. Under the Act, through (Chapter VII, section 721), colour additives including FD&C Red No. 3 are subject to FDA approval before they can be used in food that comes into contact with the bodies of people or animals for a significant period. Currently, the CFR – Code of Federal Regulations Title 21 (fda.gov) is the relevant colour additive regulation for FD&C Red No 3.

Yet, in the US different legislative rules exist for using Red No. 3 in cosmetics and topical drugs compared to food, prompting calls for its ban in food production.

Under the Delaney Clause, the FDA denied a petition to authorise the use of the colour additive in cosmetics and topical drug applications due to the presence of data showing its connection with animal carcinogenicity. In 1990, when this decision was made, the use of this dye, Red No. 3, was authorised for use in foods and ingested drugs.

“The way that Red No. 3 causes cancer in animals, specifically rats, does not occur in humans, so these animal results have limited relevance to humans,” the FDA said. “Because these studies did not raise safety concerns, the FDA did not take action to revoke the authorisation of Red No. 3 in food,” the spokesperson added.

Under FDA rules, most colour additives, including Red No. 3, require the Administration to undertake a pre-market review and approval of the food colourant. With Red No.3 in particular, the FDA only permits the colour additive from certified batches. FDA chemists must, therefore, have analysed a batch sample of Red No. 3 dye and confirmed it meets the composition and purity requirements set out by law.

“The FDA hopes to make a regulatory determination on FD&C Red No. 3 soon,” the FDA spokesperson added. The Administration has also stated that FDA scientists will continue to review publicly available information about the safety and toxicology of colour additives to ascertain whether their use continues to be safe under the FD&C Act.