Caramel

What Is It?

Caramel is a colorantIngredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics. derived from heating edible sugar. In cosmetics and personal care products, Caramel is used in the formulation of a wide variety of product types.

Why Is It Used?

Caramel imparts a brown color to cosmetics and personal care products.

Scientific Facts

Caramel is obtained by the controlled heat treatment of food-grade carbohydrates (sugars). As the sugar melts, it breaks down to give a characteristic caramel color and flavor. Caramel is commonly used as a food coloring and to flavor various candies, confections and desserts.

Safety Information

The Food and Drug Administration (FDA) includes Caramel on its list of substances considered Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) as a multipurpose food substances. FDA also lists Caramel as a color additive exempt from 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 ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.

You can find out more about FDA regulation of colors at: http://www.cfsan.fda.gov/~dms/cos-col.html

FDA: Links to Code of Federal Regulations for Caramel

Caramel is listed in Annex IV, Part I (coloring agent allowed for use in cosmetic products) of the Cosmetics Directive of the European Union and may be used without restriction when purity requirements included in food regulations are fulfilled.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

The World Health Organization Food Additives Committee has evaluated the intake of Caramel colour II, which differs from Caramel colour I, or plain Caramel. Caramel 1 has not been evaluated.
http://www.inchem.org/documents/jecfa/jecmono/v46je13.htm#_46134000

You can learn more about the regulation and labeling of colors at:
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…

More Scientific Information

Caramel functions as a colorant in cosmetics and personal care products. To be used as a colorant in the United States, Caramel must comply with FDA manufacturing requirements. For example, only certain food-grade acids, alkalis, and salts may be used to assist carmelization, in amounts consistent with good manufacturing practice.

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/