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Is annatto extract a carcinogen? Unpacking the safety of this natural food coloring

4 min read

An estimated 70% of natural food colors are derived from annatto, a pigment from the seeds of the achiote tree. This ubiquity, however, has led some to question the safety of this ingredient and ask: is annatto extract a carcinogen?

Quick Summary

Annatto extract is a widely used natural food colorant, and extensive scientific research has found no evidence that it is carcinogenic when consumed in normal food amounts. Regulatory bodies worldwide deem it safe for its approved uses.

Key Points

  • Not a Carcinogen: Extensive scientific research and major food safety authorities, including the FDA and EFSA, have found no evidence that annatto extract causes cancer when consumed in food amounts.

  • Regulatory Approved: Annatto is considered safe for use as a food coloring, with regulatory bodies establishing acceptable daily intake levels and finding no concern for genotoxicity.

  • Rich in Antioxidants: Annatto contains beneficial antioxidant compounds like bixin and norbixin, and some preliminary lab studies show these may have potential anticancer properties, but this does not affect its food safety profile.

  • Potential for Allergies: Although rare, some individuals are sensitive to annatto and may experience allergic reactions, including hives, swelling, and stomach upset.

  • Possible Drug Interactions: Annatto may interact with medications for diabetes by affecting blood sugar levels and could interfere with drugs metabolized by the liver.

  • Natural Alternative: As a natural alternative to synthetic dyes, annatto offers coloring benefits while being considered safe for consumption by the general population in its approved quantities.

In This Article

What Is Annatto and How Is It Used?

Annatto is a natural food coloring and flavoring derived from the reddish seeds of the achiote tree (Bixa orellana), native to tropical regions of the Americas. The vibrant yellow-to-orange color is due to its high concentration of carotenoid pigments, primarily bixin (oil-soluble) and norbixin (water-soluble). Annatto is a staple ingredient in many cuisines and is a common additive in a wide range of processed foods to provide or enhance color.

Common food products containing annatto include:

  • Cheddar, Colby, and other orange-colored cheeses
  • Butter and margarine
  • Processed snack foods
  • Breakfast cereals
  • Baked goods
  • Smoked fish
  • Sausages and other processed meats

The Carcinogenicity Question: What the Science Says

The potential for annatto extract to cause cancer has been thoroughly investigated through numerous studies and evaluated by regulatory agencies. The overwhelming consensus is that annatto is not carcinogenic in the amounts typically consumed in food.

Absence of Carcinogenic Effects

Several key studies have explicitly examined annatto's potential for causing cancer:

  • Medium-Term Bioassays in Rats: A 2004 study published in Food and Chemical Toxicology found no evidence that dietary annatto was genotoxic or carcinogenic in a medium-term bioassay on rat liver. The study, conducted at a dietary level of 1000 ppm (containing approximately 5% bixin), concluded that annatto showed no hepatocarcinogenic effect.
  • Genotoxicity Studies: Multiple genotoxicity and mutagenicity assays have been conducted on annatto and its main components, bixin and norbixin. The weight of evidence from these assays supports a conclusion that they are negative for mutagenic activity. One animal study noted an increased frequency of micronucleated cells at extremely high concentrations (10,670 ppm) when administered with a known mutagen, but stated annatto alone was not mutagenic.
  • Long-Term Animal Studies: Longer-term studies on experimental animals have also been conducted. For instance, a 1959 study on rats and mice, while lacking some specific details, reported no increase in tumor incidence in animals treated with high doses of annatto for extended periods. More recent, detailed studies further solidify the safety conclusion.

Potential Anti-Cancer Properties (In Vitro)

Ironically, some test-tube and animal studies have explored the anticancer properties of annatto's components, specifically bixin and norbixin. These lab-based findings suggest that annatto constituents may possess potential therapeutic qualities, such as suppressing the growth of certain cancer cells.

  • A study on prostate cancer cells showed that annatto tocotrienol could suppress cell growth.
  • Other research indicated that bixin could induce cytotoxicity in various solid tumor cell lines.

It is crucial to emphasize that these are preliminary findings from lab and animal studies and do not equate to annatto being a cancer cure or preventative agent in humans through regular dietary intake.

Annatto Safety: A Comparison with Other Dyes

Annatto is often viewed as a safer, natural alternative to synthetic food dyes. However, it is not without its own considerations, particularly regarding allergic reactions.

Feature Annatto (Natural) Common Synthetic Dyes (e.g., Tartrazine, Allura Red)
Source Seeds of the achiote tree (Bixa orellana). Synthetically produced from petroleum-based sources.
Carcinogenicity No carcinogenic effect found in extensive animal studies when used in food amounts. Some have historical concerns, but are generally deemed safe by regulatory bodies after testing. Early research sometimes flagged synthetic dyes as more reactive in allergy tests, but annatto may be more allergenic for some.
Key Concerns Rare allergic reactions (hives, swelling, IBS flare-ups), blood sugar interactions. Allergic reactions (annatto allergies may be more common than for some synthetics), hyperactivity concerns in children for some dyes.
Regulatory Status Exempt from FDA certification as a colorant; has acceptable daily intake (ADI) levels set by EFSA. Requires FDA certification for each batch. Strict regulations on purity and usage.

Key Regulatory Perspectives

  • U.S. Food and Drug Administration (FDA): The FDA considers annatto extract and annatto to be safe color additives that are exempt from certification for their intended uses.
  • European Food Safety Authority (EFSA): The EFSA has reviewed annatto extracts multiple times. Based on genotoxicity studies, they concluded that annatto does not raise a concern for genotoxicity and have established acceptable daily intake (ADI) levels for its color compounds, bixin and norbixin. In cases where exposure levels for norbixin for toddlers were shown to exceed the ADI, EFSA concluded the level of exposure was not a health concern due to uncertainties and likely overestimation.

Potential Side Effects and Interactions

While annatto is overwhelmingly safe for most people, some potential issues are worth noting:

  • Allergic Reactions: Although uncommon, allergic reactions to annatto appear to be more frequent than to some synthetic food dyes. Symptoms can include hives, swelling, and stomach pain.
  • IBS Flare-ups: In some rare cases, annatto has been linked to triggering symptoms of irritable bowel syndrome (IBS), such as abdominal pain, bloating, and diarrhea.
  • Drug Interactions: Annatto can potentially interact with certain medications, particularly antidiabetes drugs, by affecting blood sugar levels. It may also interfere with medications broken down by the liver.

Conclusion

Based on decades of toxicological research and extensive review by major international food safety authorities, the answer to the question "Is annatto extract a carcinogen?" is no. When consumed in the typical amounts found in foods, annatto is considered safe for the vast majority of the population. While preliminary lab studies have shown potential anticancer properties of annatto's components, these are not relevant to its safety as a food additive. Consumers should be aware of the rare possibility of allergic reactions or interactions with certain medications, but for most, annatto remains a safe, natural, and widely used food colorant.

For more information on the toxicology of annatto extracts, a comprehensive review can be found on the Inchem website.

Frequently Asked Questions

Annatto extract is a natural, reddish-orange food coloring derived from the seeds of the achiote tree (Bixa orellana). It contains carotenoid pigments, primarily bixin and norbixin.

No, extensive toxicological studies and review by major regulatory agencies have found no evidence that annatto extract is carcinogenic when consumed in food amounts.

Yes, the U.S. FDA considers annatto extract and annatto to be safe color additives that are exempt from certification.

Yes, while uncommon, some individuals can have an allergic reaction to annatto. Symptoms may include hives, swelling, or stomach issues. Allergic reactions to annatto may be more frequent than those to some synthetic food dyes.

Annatto contains antioxidant compounds, and some test-tube and animal studies have explored potential health benefits, including antioxidant and anti-inflammatory properties, and potential effects on cancer cells. However, more human research is needed to confirm these findings.

Individuals with known allergies to food additives should be cautious. Those with diabetes or who take certain medications metabolized by the liver should also monitor their health and consult a healthcare provider, as annatto can potentially affect blood sugar levels.

Regulatory bodies like EFSA have established an acceptable daily intake (ADI) for the active compounds (bixin and norbixin). The amount found in typical food consumption is generally below these limits.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.