Is Sunset Yellow Safe to Consume? Understanding the E110 Food Additive

January 1, 2026 •

3 min read

Sunset Yellow (E110), a synthetic azo dye, has been approved for use in food and beverages by regulatory bodies like the EU and FDA. However, the orange-yellow colorant has faced scrutiny over potential health concerns, particularly links to hyperactivity in children and allergic reactions in sensitive individuals.

Quick Summary

Sunset Yellow is an approved food additive used globally, but concerns exist regarding its link to hyperactivity in children and potential allergic reactions in sensitive people. Official bodies consider it safe within regulated consumption limits.

Key Points

Generally Safe: Regulatory bodies like EFSA and FDA consider Sunset Yellow safe to consume within the Acceptable Daily Intake (ADI).
Hyperactivity Link: The EU mandates a warning label linking Sunset Yellow to potential hyperactivity in children, based on the 'Southampton Study'.
Allergic Reactions: Some sensitive individuals may experience allergic reactions, such as hives or asthma symptoms.
ADI Limits: The established ADI is 4 mg/kg body weight per day in the EU, and 3.75 mg/kg in the US.
Read Labels: Consumers are advised to check food labels for E110 or FD&C Yellow No. 6 to monitor intake or avoid the additive if concerned.
Natural Alternatives: Plant-based alternatives like paprika extract or beta-carotene offer a natural option for coloring food.

What is Sunset Yellow?

Sunset Yellow FCF is a synthetic orange-yellow azo dye used in many processed foods and drinks. It's also known as Orange Yellow S, CI Food Yellow 3, or FD&C Yellow No. 6. Derived from petroleum, it's chosen by manufacturers for its bright color and stability in various food environments. This additive is found in a wide array of products, including sweets, snacks, sauces, and desserts. Its use is regulated globally by food safety authorities, each with their own standards and labeling rules. The safety of these regulated amounts for all consumers, especially sensitive groups, is a point of ongoing discussion.

The Debate on Safety and Health Concerns

Despite regulatory approval, Sunset Yellow's safety remains debated. Key concerns involve potential links to behavioral changes, allergic reactions, and broader issues associated with synthetic colorants.

The Southampton Study and Hyperactivity

A significant concern arose from the 2007 'Southampton Study,' which suggested a possible link between a mix of food colors, including Sunset Yellow, and increased hyperactivity in children. This study led to the requirement for a warning label on certain products in the EU. Reviews by EFSA and the FDA, however, found insufficient evidence to prove a link to hyperactivity in the general population. Despite these differing conclusions, EU warning labels persist.

Allergic Reactions and Sensitivities

A small number of people may experience allergic reactions or hypersensitivity to Sunset Yellow. Symptoms can include skin issues like hives or eczema, or respiratory problems similar to asthma. While infrequent, these reactions are a documented concern, particularly for individuals with pre-existing conditions.

The Azo Dye Link and Toxicology

As an azo dye, Sunset Yellow has also been examined for potential toxicity. Some animal studies, often using high doses, have indicated possible issues such as oxidative stress and harm to organs like the kidney and liver. Recent research has also suggested potential damage to the small intestine's mucous membrane. Nevertheless, regulatory bodies like EFSA and JECFA have determined that within the Acceptable Daily Intake (ADI), Sunset Yellow does not pose a carcinogenic or genotoxic risk.

Regulatory Status and Acceptable Daily Intake (ADI)

Regulatory bodies establish an ADI to ensure safe consumption levels of food additives.

European Union (E110): EFSA's ADI is 4 mg per kilogram of body weight per day. A hyperactivity warning label is mandatory on relevant products.
United States (FD&C Yellow No. 6): The FDA permits its use in food, drugs, and cosmetics with an ADI of 3.75 mg/kg body weight. A hyperactivity warning label is not required.
WHO/FAO: International guidelines recommend an ADI of 0-4 mg/kg body weight.

Regulatory authorities generally agree that consuming Sunset Yellow below the ADI is safe for most people. However, this doesn't negate the potential sensitivity of a small number of individuals.

Synthetic vs. Natural Colorants: A Comparison

Comparing synthetic and natural colorants helps in making informed food choices.


Feature	Synthetic (Sunset Yellow)	Natural (e.g., Paprika, Beta-carotene)
Source	Petroleum derivatives	Plant-based extracts
Potential Concerns	Hyperactivity link (EU label), rare allergic reactions	Generally considered safe
Regulatory Status	Regulated with ADI limits	Generally recognized as safe (GRAS)
Labeling	Explicitly named (FD&C Yellow No. 6 or E110), plus EU warning	Often labeled as 'natural color'
Color Stability	Highly stable	May be less stable

Conclusion: Making an Informed Choice

Determining if Sunset Yellow is safe involves considering various factors. For most people, consuming it within the ADI is considered safe by global regulatory bodies. However, concerns regarding hyperactivity links and documented allergic reactions highlight that risks exist for some individuals. Consumers who are concerned, particularly parents of sensitive children, should check labels for E110 or FD&C Yellow No. 6 and might consider products with natural colorants instead. {Link: EFSA website https://www.efsa.europa.eu/en/press/news/140715}

Frequently Asked Questions

FD&C Yellow No. 6 is the name used in the United States for the food additive also known as Sunset Yellow or E110. It is a synthetic orange-yellow colorant approved for use in food, drugs, and cosmetics.

While it was previously banned in certain European countries like Norway and Austria, these bans were lifted after the countries aligned with EU regulations. Currently, Sunset Yellow is widely permitted in many countries, including the EU and US, though with specific restrictions and labeling requirements.

There is a long-standing debate on this issue. A 2007 study suggested a possible link between certain food colors (including Sunset Yellow) and increased hyperactivity. In response, the EU requires a warning label. However, reviews by authorities like EFSA and the FDA have stated that the available evidence is not strong enough to substantiate a definitive link for the general population.

People with known sensitivities or allergies to azo dyes should avoid Sunset Yellow. Parents who are concerned about potential behavioral effects in their children may also choose to limit or avoid products containing this additive.

The Acceptable Daily Intake (ADI) is 4 mg per kilogram of body weight per day in the EU, and 3.75 mg/kg in the US. Consumer exposure estimates are generally well below these limits.

Yes, natural alternatives are available for coloring foods. These include paprika extract, beta-carotene (from carrots), and annatto extract. Many food manufacturers use these options to provide coloring without using synthetic dyes.

In the United States, look for 'FD&C Yellow No. 6' on the ingredient list. In Europe, it will be listed as 'E110'. The presence of a warning label on EU products indicates its inclusion.