Is the additive Erythrosine (E-127) dangerous?

Fact checked – 8 min read

The US Food & Drug Administration (FDA) has announced a ban on a food additive Red dye number 3, otherwise known as Erythrosine (additive E-127) in the EU and UK. The additive which is made from petroleum and had been found to cause cancer in rats (1), was removed in response to a 2022 petition from the Centre for Science in the Public Interest and other advocacy groups applies to all foods, dietary supplements and oral medications, but the ban will not go into effect until early 2027 for food, and early 2028 for medications. Read on to learn which foods and medications may contain this additive and what other adverse effects could occur in humans.

What Is Red Dye No. 3, Where Is It Found, and Is It Banned?
Red Dye No. 3, also known as Erythrosine (E127), is a synthetic food colorant derived from petroleum-based compounds. It belongs to the xanthene dye class and is widely used to impart a bright, cherry-red colour to foods, cosmetics, and medications. However, its safety has been a topic of debate due to health concerns raised by studies linking it to carcinogenicity and hyperactivity in children (1,2).

Where Is Red Dye No. 3 Found?
In the US, Red Dye No. 3 is commonly used in:
– Candies: Found in products like gummy bears, lollipops, and jellybeans (1).
– Baked Goods: Used in frostings, cake decorations, and some pastries (1).
– Snacks: Often added to processed fruits like maraschino cherries (3).
– Beverages: Found in syrups and some flavoured drinks (4).
– Medications & Cosmetics: Used in pill coatings (medications listed below), toothpaste, and certain cosmetics (5).

In the UK, foods that may contain this additive include fruit cocktails, cocktails, glacé cherries, and certain candied fruits. The prevalence of E127 in these products stems from its vibrant appearance and stability, which enhances the visual appeal of consumer goods (3). In the UK, Erythrosine may also be used in some medications to provide a red or pink hue, such as: paracetamol, a pain reliever, generic over-the-counter cold & flu remedies (check labels), Fluoxetine, an antidepressant, Gabapentin, an anticonvulsant and Andomeprazole which treats heartburn

DISCLAIMER – you should not stop any of these medications as a result of any information provided on this blog post. Please consult your prescribing healthcare practitioner if you have any concerns for more information and guidance.

Where is Red Dye Number 3 banned in?
United States:
Red Dye No. 3 was up till now not banned in food products in the U.S. but was banned for use in cosmetics and topical drugs in 1990 due to findings of carcinogenicity in animal studies (5). Despite these restrictions, it remained widely used in foods and oral medications, as regulatory agencies have deemed it safe at current exposure levels (5,6). However, as of today, the FDA has announced a ban on all foods, dietary supplements and oral medications, but the ban will not go into effect until early 2027 for food and early 2028 for drugs (8).

European Union (EU)
The EU allows the use of Red Dye No. 3 under the label E127, but its applications are heavily restricted. It is primarily permitted in candied fruits, cocktail cherries, candied cherries preserved cherries, and specific decorative items. Additionally, EU regulations require a warning label indicating its potential to affect activity and attention in children (7). A 2011 report commissioned by the European Food Safety Authority (EFSA), established an Adverse Daily Inake (ADI) of 0-0.1 mg/kg bw per day. The report went on to suggest that the current levels of use intake estimates for adults on average was 0.0031 mg/kg bw/day and 0.01 mg/kg bw/day at the 95^th percentile, and were consequently below the ADI of 0.1 mg/kg bw/day, concluding that there would be no safety concerns at current levels of exposure including other sources of exposure.

United Kingdom / Gibraltar
In the United Kingdom, the Food Standards Agency (FSA) permits the use of E127, in certain food products under strict regulations. Its use is primarily limited to specific preserved cherries, such as fruit cocktails, cocktails, glacé cherries, and certain candied fruits. The FSA mandates that any food containing E127 must include a warning label indicating its potential effects on activity and attention in children. This aligns with broader European Union regulations, which also impose stringent controls on the use of Erythrosine in food products. Consumers in the UK who wish to avoid Red Dye No. 3 can check product ingredient lists for E127 or ‘Erythrosine’ and opt for alternatives that use natural colorants. It is likely that the same restriction (and allowed foods) may be the same in Gibraltar as in the UK.

Other countries
Countries such as Japan, Australia and Canada have also banned and considerably restricted their use.

What are the evidenced health concerns
The safety of Red Dye No. 3 has been questioned due to its potential health risks:

Carcinogenicity: Animal studies have shown an association between high doses of Red Dye No. 3 and thyroid tumors, raising concerns about its long-term safety (6).

Hyperactivity in Children: Red Dye No. 3 has been implicated in hyperactivity and attention deficits in children, particularly as part of broader concerns about artificial food dyes (2,7).

In summary, Red dye number 3 is a suspect additive which when consumed in large quantities could pose a problem to human health and underlines the rationale to reduce or eliminating consuming any processed foods anyway, particularly as there could be many other additives which may eventually be shown to be potentially hazardous for health and currently recognised as safe. Consumers who wish to minimise their exposure this this additive can check food labels for E127 or ‘Red Dye No. 3’ and opt for products using natural colorants such as beet juice or paprika extract (3).

Please reference or mention this blog post before using any of the content for your own use – PS: i’ve worked hard to research all this!