The Truth About Caramel Colour

Caramel colour does not cause cancer - get the facts about caramel colour safety

What is Caramel Colour?

Caramel colour is a naturally derived colourant that results from the process of caramelization, or the carefully controlled heating of carbohydrates. These sugars are cooked to produce a brown colour that is used in a wide variety of soft drinks, baked goods, pet foods, alcoholic beverages, sauces and other food and beverage products that have a brown hue.The use of caramel colouring in food products is nothing new; in fact, caramel colour has been used for centuries. Caramel colour in food and beverage products is not a health risk.

Want to learn more about caramel colour? Watch this video interview with food industry expert Margaret Lawson, Chief Science Officer at DDW, The Colour House.

What is 4-MeI?

4-methylimidazole, or 4-MeI has been a hot topic in recent news, mostly due to its listing on California’s Prop 65. But what is it? 4-MeI is a common trace compound created during the natural heat processing of many foods through the Maillard Reaction. It is ubiquitous in foods – including roasted coffee, chocolate, grilled and roasted meats, baked goods and class III and IV caramel colours.

Caramel Colour is Safe, Science Shows

“Caramel colours are extremely safe. There’s never been any evidence to show that caramel colour causes cancer…There’s never been any issue with caramel colours”
Margaret Lawson, Chief Science Officer, DDW

Caramel colour has been tested extensively, especially in the 1970s and 1980s, undergoing complete food safety testing more than 20 times in the past 40 years, and all caramel safety studies have indicated that caramel colour is of no health threat to humans. DDW has participated in millions of dollars of safety studies, all of which have concluded that caramel colour is safe and harmless. It meets rigorous food safety standards around the world. Caramel colour does not cause cancer and has Generally Recognized as Safe (GRAS) status with the US Food and Drug Administration (FDA).

The Southern California Institute of Food Technologists
In 2012, the Southern California Institute of Food Technologists Section (SCiftS) released the following statement in preparation for the Southern California Food Industry Conference. This includes a presentation by Jim Coughlin, Ph.D., world-renowned Sane Science Food Consultant with over 35 years of experience in food and nutritional toxicology, diet and health, risk communication and scientific regulatory affairs. In his presentation — entitled Prop 65: Foods and Dietary Supplements Under Siege! — Coughlin will be discussing scientific and regulatory issues in the food and beverage industry under California’s Proposition 65. More information is available here. Coughlin had the following to say about Prop 65:

“Foods and supplements have become major targets of regulatory enforcement and litigation activities in the past several years.

Unfortunately, [California’s Proposition 65] and its regulations focus only on the presence of trace levels of individual, listed chemicals in products, but not on the safety or benefits of the whole food or supplement product, nor about real harm to California consumers.”

The European Food Safety Authority
On March 8, 2011, the European Food Safety Authority (EFSA) released its report that assessed the safety of caramel colours. Based on all available data, including the NTP report that formed the basis of the 4-MeI Prop 65 listing, the EFSA panel concluded that caramel colours “are neither genotoxic nor carcinogenic and there is no evidence of any adverse health effects on human reproduction or the developing child.

The EFSA affirmed the safety of caramel colouring following a comprehensive review of the scientific literature. It stated that the presence of 4-MeI in caramel colouring is not a health concern.

The US Food & Drug Administration
Leading regulatory authorities around the world also judge caramel colouring as safe for use in food and beverages. In November 2011, Health Canada said that 4-MeI, including that found in certain caramel colours, does “not represent a risk” to consumers, and the US Food and Drug Administration (FDA) has approved caramel as a colour additive and lists it as a “generally recognized as safe” food ingredient.

Commenting on the CSPI study linking caramel to cancer in rodents, an FDA spokesperson noted that “a consumer would have to drink more than 1,000 cans a day to reach the doses administered in the study,” and the consumer would have to consumer this number of sodas for an entire lifetime!

a consumer would have to drink more than 1,000 cans a day to reach the doses administered in the study

Caramel Colour in Soft Drinks

On 26th June, 2012, the British Soft Drink Association issued a statement saying “the 4-MI [4-MeI] levels found in food and drink products pose no health or safety risks. Outside the State of California, no regulatory agency around the world considers the exposure of the public to 4-MI [4-MeI] as present in caramels as an issue. … The presence of 4-MI [4-MeI] in caramel colouring is not a health concern.”

The American Beverage Association states that “caramel colour is not a threat to human health. … Studies show that and the FDA has agreed by classifying caramel colour as Generally Recognized as Safe. [That’s] the affirmed position of the federal government’s health agencies as well as regulatory agencies around the world.”

In April 2012, Soft Drinks International and the American Beverage Association said in response to a release issued by the US Center for Science in the Public Interest (CSPI) regarding the safety of 4-MeI, which forms in foods such as caramel used by the beverage industry, that “this is nothing more than CSPI scare tactics, and their claims are outrageous. The science simply does not show that 4-MeI in foods or beverages is a threat to human health. In fact, findings of regulatory agencies worldwide, including the US Food and Drug Administration, European Food Safety Authority and Health Canada, consider caramel colouring safe for use in foods and beverages. CSPI fraudulently claims to be operating in the interest of the public’s health when it is clear its only motivation is to scare the American people.”

DDW Chairman & CEO, Ted Nixon, on Caramel Colour


My hope is that people truly get the idea that caramel colour is and always has been a safe ingredient.”
Ted Nixon, Chairman and CEO, DDW

To learn more about the safety of caramel colour and 4-MeI, watch these videos:

DDW Chief Science Officer, Margaret Lawson Explains 4-MeI

Global Food Science & Regulatory Manager, Jennifer Guild, Discusses the Safety of Caramel Colour”

Scientific Information & Resources

See the following resources for more information about caramel colouring in food and beverage products.

Studies on Caramel Colour Safety:
EFSA Reviews Safety of Caramel Colours

FDA Department of Health and Human Services

Ontario Research Foundation’s study on Caramel Toxicity (1979 – 1981)

Bio Research Laboratories Bioassey of Caramels Consumed By Rats (1978)

Official Statements

A Letter to Our Customers about California Proposition 65

DDW’s Official Statement

Caramel Colour is Not a Health Risk

US FDA Q&A on Caramel Colouring and 4-MeI