Source: fda.gov.com

02-26-2009 11:40

Color additives give the red tint to your fruit punch and the green hue to your mint-flavored toothpaste. They are dyes, pigments, or other substances that can impart color when added or applied to a food, drug, cosmetic, or the human body. They can be found in a range of consumer products—from cough syrup and eyeliner to contact lenses and cereal.

So how safe are they? "Color additives are very safe when used properly," says Linda Katz, M.D., M.P.H., Director of the Office of Cosmetics and Colors in FDA's Center for Food Safety and Applied Nutrition (CFSAN). "There is no such thing as absolute safety of any substance. In the case of a new color additive, FDA determines if there is 'a reasonable certainty of no harm' under the color additive's proposed conditions of use." Here are more facts you should know about color additive safety.

FDA regulates color additives used in the United States. This includes those used in food (and dietary supplements), drugs, cosmetics, and medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency and must be used only in compliance with the approved uses, specifications, and restrictions. In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Color additives that FDA has found to cause cancer in animals or humans may not be used in FDA-regulated products marketed in the United States.

Two main categories make up FDA's list of permitted color additives. In addition to undergoing approval, some color additives are known as "certifiable." Certifiable color additives are man-made, derived primarily from petroleum and coal sources. The manufacturer submits a sample from the batch for which it is requesting certification, and FDA tests the sample to determine whether it meets the color additive's requirements for composition and purity. If it does, FDA "certifies" the batch and issues a certification lot number. Only then can that batch be used legally in FDA-regulated products.