CARAMEL - The Dermatology Review




Caramel is a natural coloring agent used to provide a brown color in cosmetics and personal care products.


Caramel colors refer to a family of distinct red to dark-brown liquids or powders that are used as color additives. They are created through a process called caramelization. Caramelization involves slowly heating food grade carbohydrates (sugars) to around 170 °C (338 °F) in the presence of small amounts of food grade acids, alkalis, or salts. This process removes the water from the sugar. As the sugar melts, the molecules break down and re-form into compounds with a characteristic dark brown color. Of note, the term “caramel” is often used to describe confections and flavors made from caramelized sugar, whereas the term “caramel color” only describes the color additive.

The most commonly-used carbohydrate source to produce caramel color is high dextrose (glucose) corn syrup (HDCS). However, invert sugar and cane sugar (sucrose) are also used. High dextrose (glucose) corn syrup is the preferred carbohydrate since the resulting caramel color is more stable over time and less viscous.

Caramel has been used in the production of cosmetics and personal care products as a natural colorant for many years. The interest in caramel as a colorant continues to grow as the demand for natural personal care products increases. Caramel colorant is used to add a natural brown color to hair shampoos, tanning products, makeup, and many other skin and hair care products.

In addition to use in cosmetics, caramel color has been used in foods and beverages for over 150 years. The first commercially available caramel colors were manufactured in the United States in 1863. Caramel color is used to impart color in numerous foods and beverages, including colas, soy sauce, seasonings, breads, pet foods, cereals, etc. In fact, caramel color is the world’s most widely used food colorant.


Caramel functions as a natural coloring agent in cosmetics and personal care products. However, all caramels are not the same. They are divided into four classes, which we will explain below.

Class I, or plain caramel colors, are the most minimally processed of the four classes. The carbohydrate raw material is simply heated, and no ammonium or sulfite compounds are allowed in Class I production. The resulting caramel color carries a neutral to slightly negative ionic charge.

Class II, or caustic sulfite caramel colors, involves heating the carbohydrate raw material in the presence of sulfite compounds. The resulting caramel color carries a negative ionic charge.

Class III, or ammonia caramel colors, involves heating the carbohydrate raw material in the presence of ammonia compounds. The resulting low-sulfite caramel color carries a positive ionic charge.

Class IV, or sulfite ammonia caramel colors, involves heating the carbohydrate raw material in the presence of both sulfite and ammonium compounds. The resulting caramel color carries a negative ionic charge. These are the most widely produced caramel colors.


The United States Food and Drug Administration (FDA) includes caramel colors on its list of substances considered GRAS (Generally Recognized as Safe) according to 21 CFR 182.1235. Unlike FD&C dyes, caramel color does not require certification.

Caramel is determined to be safe for use in coloring cosmetics and personal care products, including products applied to the lips and area of the eye. The Cosmetic Ingredient Review (CIR) Expert Panel has deferred evaluation of this ingredient because the safety has been assessed by FDA.

Some people may be concerned with 4-MeI (4-Methylimidazole), which forms during the production of Class III and Class IV caramel colors. In the late 1960s, 4-Mel was found to elicit neurotoxicity at high doses in animals. However, more current data has revealed there is no evidence that 4-Mel causes cancer or poses any other health risks to humans. 4-Mel forms naturally during the heating, roasting or cooking process of many foods. Furthermore, the concern regarding 4-Mel was more applicable to food and beverage products containing caramel color rather than cosmetics.

References: Food Chem Toxicol. 2018, 111, 578-596, Wikipedia, “Caramel”, Sethness, “Caramel Color FAQs”.


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