Carmoisine's History and Regulatory Status with the FDA
Carmoisine, a synthetic red azo dye, was once a permitted substance in the US but has been explicitly prohibited for decades. Initially evaluated and listed, the FDA made the decision to delist it in 1963, a move that is distinct from an outright "ban" but results in the same outcome: it cannot be legally used in American-made products. This places carmoisine, along with other unapproved color additives, on a list of substances prohibited from use in food, drugs, and cosmetics.
The Reasons for Delisting Carmoisine
The delisting of carmoisine stems from evolving regulatory standards and safety concerns surrounding synthetic dyes. The FDA's process for approving and re-evaluating color additives is rigorous, based on the principle of a "reasonable certainty of no harm". The decision to remove carmoisine from the list of approved additives was influenced by several factors, including broader health considerations related to azo dyes and new scientific evidence regarding their potential effects. The FDA does not approve any color additive that is found to induce cancer in humans or animals. While carmoisine itself has not been conclusively labeled as carcinogenic, studies on similar azo dyes and the potential for toxic metabolite formation raised sufficient concerns for regulatory action.
Global Regulatory Differences: US vs. Europe
The regulation of carmoisine highlights a significant divergence in food safety policy between the United States and other regions, most notably the European Union (EU). While the FDA delisted the dye, the EU allows its use as E122 under specific conditions. This difference can be confusing for consumers and manufacturers alike.
European Union's "Southampton Six" Warning
In Europe, carmoisine is part of a group of color additives known as the "Southampton Six". Following a 2007 study linking these additives to hyperactivity in children, the EU mandated that any food or drink containing one of these six colors must carry a warning label stating, "may have an adverse effect on activity and attention in children". This regulatory approach, which allows the use of the dye with a warning, contrasts with the FDA's more prohibitive stance.
Carmoisine Regulatory Comparison
| Aspect | United States (FDA) | European Union (EFSA) |
|---|---|---|
| Approval Status | Not Approved (delisted in 1963) | Approved as E122, but with conditions |
| Use in Foods | Prohibited in food, drugs, and cosmetics | Permitted in specific food types, like some desserts and drinks |
| Labeling | Not applicable; prohibited from use | Must carry a mandatory warning label about potential effects on children |
| Controlling Body | U.S. Food and Drug Administration (FDA) | European Food Safety Authority (EFSA) |
Potential Health Concerns and Azo Dyes
Carmoisine belongs to the family of azo dyes, which are known to break down into aromatic amines in the human body, particularly by gut bacteria. This process is central to the safety concerns surrounding these compounds, as some of these metabolites are known or suspected carcinogens. Health concerns specifically associated with carmoisine include:
- Allergic Reactions: In sensitive individuals, carmoisine can trigger allergic responses such as skin rashes, hives, itching, or even more severe reactions.
- Hyperactivity: Studies, like the one conducted in Southampton, have suggested a potential link between carmoisine and hyperactivity or behavioral issues in children, especially those with ADHD.
- Respiratory Issues: The dye has been documented to cause asthma symptoms, particularly in those with pre-existing respiratory sensitivities.
- Toxicity Reports: Some animal studies have investigated the potential for hepatotoxicity and renal failure at very high doses, though human exposure at legal limits in other countries is typically well below these levels.
Natural and Approved Alternatives to Carmoisine
For food manufacturers in the US and abroad seeking a natural alternative for a red colorant, several options are available. These alternatives are derived from natural sources and approved by the FDA for use in food products.
- Beetroot Red: Derived from beets, this natural colorant provides a vibrant red to maroon hue.
- Anthocyanins: Found in a variety of fruits and vegetables such as berries and red cabbage, anthocyanins can produce red to purple shades.
- Cochineal Extract/Carmine: This is a red pigment extracted from cochineal insects. While a natural extract, some vegetarians consider it non-vegan, though it is FDA-approved.
- Lycopene: Sourced from tomatoes, this carotenoid offers a red color and is also a powerful antioxidant.
Conclusion: Navigating Carmoisine's Regulatory Landscape
The question of whether carmoisine is banned in the US has a clear answer: it is not a permitted food, drug, or cosmetic additive, following its delisting by the FDA in 1963. This decision was based on evolving safety data, particularly concerns surrounding synthetic azo dyes and their metabolic byproducts. The contrast with European regulations, where the dye is permitted but with a cautionary label, underscores the different risk assessment approaches taken by global food safety authorities. For consumers and manufacturers in the US, the takeaway is simple: carmoisine (E122) is not found in legally produced US food products, and a range of natural alternatives are available to achieve similar coloring effects. For further information, consult the National Institutes of Health's research on azo dye toxicity via the provided link in the citations section below.
