Is E122 Banned in the US?

As of early 2025, several synthetic food dyes, including E122, are facing heightened scrutiny or outright bans across the globe. This has led many consumers to question the status of specific additives, such as the red dye E122, in the American food supply. The critical takeaway is that E122 is indeed banned for use in food products within the United States.

Quick Summary

This guide covers the legal status of the red food dye E122, known as azorubine or carmoisine, in the US. It details the Food and Drug Administration's (FDA) regulations prohibiting this additive and explains how to spot similar food dyes on ingredient lists. The information provided helps consumers understand the differences between US and international food regulations.

Key Points

• E122 is Banned in the US: The FDA prohibits the use of E122, also known as azorubine or carmoisine, in food products within the United States.

• Associated Health Concerns: The ban stems from historical links to allergic reactions, especially in those with aspirin sensitivity, and concerns regarding hyperactivity in children.

• Look for E-Numbers on Imports: When purchasing imported goods, check for 'E122' or 'azorubine' on the label, as it may be permitted in other regions like the EU.

• US Uses FD&C Alternatives: Manufacturers in the US use different, FDA-approved red dyes, such as FD&C Red 40 (Allura Red AC), which is regulated differently.

• Regulations Differ Globally: E122 is an example of how food additive laws vary internationally; it's banned in the US and Norway but permitted with a warning label in the EU.

• Natural Red Alternatives Exist: Due to consumer demand, many companies are shifting to natural coloring agents like beetroot red (E162) and cochineal (E120).

Why Is E122 Banned in the US?

E122, known by the common name azorubine or carmoisine, is a synthetic red azo dye that has been a long-standing point of contention in international food safety standards. While it is permitted with labeling requirements in the European Union, the United States Food and Drug Administration (FDA) has delisted and prohibited its use in food products for decades. The primary driver for its ban relates to historical and ongoing concerns about potential health effects.

The regulatory landscape in the US is guided by the Federal Food, Drug, and Cosmetic Act, which mandates that food additives are deemed safe before they can be used in commerce. E122's status as a coal tar derivative, combined with studies linking it to potential side effects, led the FDA to prevent its approval. Concerns have historically focused on allergic reactions and hyperactivity, which the European Union addresses with a warning label. In contrast, the US opts for outright prohibition when a food additive is not deemed safe for consumption.

The Health Concerns Behind the Ban

The decision to ban E122 in the US, along with other countries like Japan and Norway, is rooted in several documented health concerns, though the evidence can be debated.

• Hyperactivity in Children: A 2007 study, known as the 'Southampton Six,' linked a mixture of several artificial colors, including carmoisine (E122), with an increase in hyperactivity in some children. This study spurred changes in labeling requirements within the EU, but contributed to a more cautious approach in the US.
• Allergic Reactions: As an azo dye, E122 has been associated with triggering allergic reactions, particularly in individuals with a sensitivity to salicylates, such as aspirin. The reactions can manifest as asthma-like symptoms or skin conditions like hives.
• Coal Tar Origin: The dye's derivation from coal tar has also been a historical point of concern, even though modern synthetic production methods are used.

It is important to note that global regulatory bodies approach this information differently. While the EU requires a warning label on products containing E122, the FDA's stance is that the potential risks outweigh any benefits of its use in food.

How to Identify E122 on Product Labels

Since E122 is not permitted in the US, you will not find it explicitly listed on products manufactured for the American market. However, a key point of confusion for consumers traveling or purchasing imported goods is the different naming conventions. Outside the US, especially in the EU, it will be labeled by its E-number or chemical name.

• E-Number: E122
• Chemical Name: Azorubine or Carmoisine

When reading a label from a country where E122 is legal, you should look for one of these names. In the US, food manufacturers must use FDA-approved color additives, which have different names, such as FD&C colors. A comparable red color might be derived from Allura Red AC (FD&C Red 40), which is approved in the US but restricted in some other countries.

The Difference Between US and International Food Regulations

Food additive regulation varies significantly from one country to another. The US FDA operates under a pre-market approval system, requiring extensive safety data before an additive can be introduced. The European Union follows a similar approach but, in some cases, allows for a risk-based labeling approach rather than an outright ban, as seen with E122.

US vs. EU Food Additive Regulation

Aspect	United States (FDA)	European Union (EFSA)
E122 Status	Banned	Permitted with a warning label
Regulatory Philosophy	Pre-market approval, requiring robust safety data.	Pre-market approval, may permit with usage restrictions or warnings based on risk assessment.
Labeling	Must list specific color additive names, like FD&C Red 40.	Uses E-numbers (e.g., E122) and may require warnings for certain dyes.
Hyperactivity Concerns	Leads to outright bans for additives linked to effects like hyperactivity.	Acknowledges the Southampton study with a mandatory warning on labels: "may have an adverse effect on activity and attention in children".
Comparable Dyes	Uses FDA-approved alternatives like FD&C Red 40, which is also a controversial azo dye.	Employs a broader list of approved additives, some of which are banned in the US.

Natural Alternatives to E122

With the shift towards clean-label products, many manufacturers are moving away from artificial food dyes like E122 and using natural colorants instead. These natural alternatives provide vibrant red hues without the regulatory complications or health concerns associated with synthetic dyes.

• Beetroot Red (E162): A natural red color extracted from beets, widely used in products like yogurts and ice cream.
• Cochineal (E120): A crimson dye derived from insects, used for its rich red hue in both the US and EU.
• Paprika Oleoresin (E160c): Provides a reddish-orange color from the paprika plant and is approved in both the US and EU.

Conclusion: Navigating Banned Additives

In summary, E122 is banned in the US by the FDA, making its presence in any American food product illegal. This ban is a result of differing regulatory philosophies and concerns over potential health impacts, such as allergic reactions and links to hyperactivity, which prompted a similar ban in countries like Norway and Sweden. American consumers can rest assured they will not find E122 in legally produced domestic goods. For those purchasing imports, it is essential to check labels for the E-number (E122) or chemical name (azorubine/carmoisine) to avoid this particular additive. The availability of natural, safe alternatives means a vibrant red color can be achieved without the use of controversial synthetic ingredients.

References

• proE.info. “E122 – Azorubine, Carmoisine.” proe.info, 2024. https://proe.info/en/additives/e122
• International Association of Color Manufacturers. “Safety of Synthetic (Certified) Colors.” iacmcolor.org, 2024. https://iacmcolor.org/safety-of-synthetic-certified-colors/
• Dr. Watson - der Food Detektiv. “E122 Azorubine - Additives - Food - Risks/Facts/Backgrounds.” food-detektiv.de, 2024. https://food-detektiv.de/en/additives/?enummer=Azorubine
• Food and Drug Administration (.gov). “Color Additives in Foods.” fda.gov, 2023. https://www.fda.gov/food/color-additives-information-consumers/color-additives-foods
• The Vegan Catalog. “E122 - Azorubin, Carmoisine.” thevegcat.com, 2024. https://thevegcat.com/en-us/blogposts/food-additives/e122-azorubin-carmoisine
• Wikipedia. “E number.” wikipedia.org, 2024. https://en.wikipedia.org/wiki/E_number

Note: This article and the provided information are intended for informational purposes only and do not constitute medical or legal advice. Always consult with a qualified professional for specific health concerns or legal guidance.

Frequently Asked Questions

Is E122 legal for use in all countries?

No, the legal status of E122 varies significantly across the world. While it is banned in countries such as the United States, Japan, and Norway, it is permitted for use in the European Union, with a mandatory warning label.

What is another name for E122?

E122 is also commonly known as azorubine or carmoisine. These names might appear on product labels in countries where the dye is permitted, but in the US, manufacturers must use FDA-approved alternatives.

Why is E122 banned in the US but allowed in the EU?

The difference in regulation is due to different risk assessments and regulatory philosophies. While the EU mandates a warning label based on links to hyperactivity in children, the US FDA has not approved it for use based on its own safety evaluations and has banned it entirely.

What happens if a product containing E122 is imported into the US?

Products containing E122 that are imported and sold for consumption in the US would be in violation of FDA regulations and could be seized or refused entry at the border. Consumers should check labels carefully when purchasing goods from other countries.

Can I use products containing E122 if I live in the US?

Products containing E122 are prohibited for sale as a food additive in the US. However, enforcement focuses on commercial sale rather than personal import, though it is still not advised due to its banned status.

Is E122 the same as FD&C Red No. 40?

No, E122 (azorubine) and FD&C Red No. 40 (Allura Red AC) are different synthetic azo dyes, though both are red. Red 40 is approved by the FDA for use in the US, but E122 is not.

Where can I find natural alternatives to E122?

Natural food colorings like beetroot red (E162), cochineal (E120), and paprika oleoresin (E160c) are approved for use in both the US and EU and are used by manufacturers seeking clean-label options.