Caramel color is a naturally derived colorant that results from the process of caramelization, or the carefully controlled heating of carbohydrates. These sugars are cooked to produce a brown color 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 coloring in food products is nothing new; in fact, caramel color has been used for centuries. Caramel color in food and beverage products is not a health risk.
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 colors.
40 years of caramel safety studies have all indicated that caramel color is of no health threat to humans. DDW has participated in millions of dollars of safety studies over the past forty years, all of which have concluded that caramel color 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.”
Caramel color has been tested extensively, especially in the 1970s and 1980s, undergoing complete food safety testing more than 20 times in the past 35 years, and meets rigorous food safety standards around the world. Caramel color 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 stakes remain very high for agriculture, foods and supplements, since our products will be under increasing regulatory and legal pressure from Prop 65.”
The European Food Safety Authority
On March 8, 2011, the European Food Safety Authority (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.
The EFSA affirmed the safety of caramel coloring following a comprehensive review of the scientific literature. It stated that the presence of 4-MeI in caramel coloring is not a health concern.
The US Food & Drug Administration
Leading regulatory authorities around the world also judge caramel coloring as safe for use in food and beverages. In November 2011, Health Canada said that 4-MeI, including that found in certain caramel colors, does “not represent a risk” to consumers, and the US Food and Drug Administration (FDA) has approved caramel as a color 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
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 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 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 coloring 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.”
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
To learn more about the safety of caramel color and 4-MeI, watch these videos:
See the following resources for more information about caramel colouring in food and beverage products.
Read EUTECA’s article about Caramel Colours and 4-MEI:The Facts.
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)
US FDA Q&A on Caramel Coloring and 4-MeI