The Truth About Caramel Colour

Caramel color does not cause cancer - get the facts about caramel color safety
Caramel color results from the process of caramelization, or the carefully controlled heating of carbohydrates (nutritive sweeteners). 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.

What is Caramel Color?

Caramel colour is naturally derived. 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.

Learn more about caramel color in the following video interview with food industry expert Margaret Lawson, Chief Science Officer, DDW “The Color House”:

4-MeI is ubiquitous in foods in the food supply and is a common trace element commonly created in the natural heat processing of many foods — including roasted coffee, chocolate, baked goods and class 3 and 4 caramel colors. However, it was still listed on Prop 65, despite all this use. Caramel class III and IV have been tested for rodent toxicity and have been found not carcinogenic.

Read EUTECA’s article about Caramel Colours and 4-MEI:The Facts.

Furthermore, on March 8, 2011, EFSA released its report that assessed the safety of caramel colors. 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 colors “are neither genotoxic nor carcinogenic and there is no evidence of any adverse health effects on human reproduction or the developing child.

In addition, DDW also offers multiple low 4-MeI versions of class III and IV caramel colors in both liquid and powder form. Although conventional Class I caramels do not contain 4-methylimidazole, Class I caramels are not traditionally stable at low pH. DDW 520 is an acid-proof class one caramel color.

What is 4-MeI?

Margaret Lawson, Chief Science Officer at DDW and a leading expert in the food & beverage industry, explains the naturally formed 4-Methylimidazole (4-MeI, sometimes incorrectly referred to as “4-MI” by CSPI) appearing in many foods:

Video – “What is 4-MeI”

Video – “Caramel Colors are safe”

Is Caramel Color Safe?

Caramel colour has undergone complete food safety testing more than 20 times in the past 35 years, and caramel colour meets rigorous food safety standards
around the world. According to the European Food Safety Authority (EFSA):

“Based on all available data, the Panel concluded that these caramel colours are neither genotoxic, nor carcinogenic.”
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.”
Caramel colouring has been tested extensively in the 1970s and 1980s and was found to be safe. Caramel colour does not cause cancer and has Generally Recognized as Safe (GRAS) status with the American Food and Drug Administration (FDA).

Industry expert Margaret Lawson, Chief Science Officer, DDW, has this to say about caramel colouring in food and beverage products:

“Caramel colors are extremely safe. There’s never been any evidence to show that caramel color causes cancer.” Citing studies including the Ontario Research Foundation’s study on Caramel Toxicity (1979 – 1981) and Bio Research Laboratories Bioassey of Caramels Consumed By Rats (1978), Lawson points out that caramel colouring for food and beverage products has gone through “extensive toxicological testing” and the colours “were proven to be extremely safe to consume.”
Historically, caramel colour has been produced for years and can be found in soft drinks, pet foods, alcoholic beverages, sauces, and more.

“There’s never been any issue with caramel colors,” Lawson adds.


There has never been a study that showed any health risk from caramel colour. See the facts

The American Beverage Association states that:

“Caramel color is not a threat to human health. … Studies show that and the FDA has agreed by classifying caramel color 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 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 stakes remain very high for agriculture, foods and supplements, since our products will be under increasing regulatory and legal pressure from Prop 65.”

40 years of caramel safety studies have all indicated that caramel is of no health threat to humans. DDW, for example, has participated in millions of dollars of safety studies over the past forty years, all of which have concluded that caramel colour is safe and harmless. Ted Nixon, President and CEO of DDW, says, “There has never been a study showing any health risk from caramel coloring.”

Video – “Ted Nixon on Caramel Safety”


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

Caramel is Safe, Science Shows

from Soft Drinks International, April 2012:

“In response to a release issued by the US Center for Science in the Public Interest regarding the safety of 4-MeI, which forms in foods such as caramel used by the beverage industry, the American Beverage Association stated 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.”

The European Food Safety Authority (EFSA) reaffirmed the safety of caramel colouring back in March 2011 following a comprehensive review of the scientific literature. It stated that the presence of 4-MeI in caramel colouring is not a health concern.

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 these numbers would be for an entire lifetime!

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 Color is Not a Health Risk

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