The Regulation of Colors

1. The Regulation of Colors Color Additives

2. History of Color Additives • Food once was colored only with natural dyes • Beets, peppers, grape skins, saffron, and even the brilliantly scarlet cochineal insects • By the 19th century, colors derived from minerals came into use with sometimes serious health problem

3. History of Color Additives • Lead chromate and copper sulfate began to be used to tint candy and pickles • Arsenic and other poisonous impurities were added when mixing new color additives • Dyes and pigments made from coal tar and petroleum derivatives

4. History of Colors Additives • FDA began assessing the safety of color additives with the passage of the Pure Food and Drugs Act of 1906 • 1960 that Congress amended the Food, Drug, and Cosmetic Act of 1938 to set up a pre-market approval system for color additives and to reevaluate the safety of color additives already in use

5. Definition • A color additive is a dye, pigment, or other substance, whether synthetic or derived from a vegetable, animal, mineral, or other source, which imparts a color when added or applied to a food, drug, cosmetic, or the human body (Sec. 201(t)).

6. Regulation of Color Additives • (21 CFR 73, 74 and 81) list the approved color additives and the conditions under which they may be safely used, including the amounts that may be used when limitations are necessary • Separate lists are provided for color additives for use in or on foods, drugs, medical devices, and cosmetics. Some colors may appear on more than one list.

7. Regulation of Color Additives • 1906 Act listed only seven man-made color additives permitted for use in foods • Established a voluntary certification program • 1938 made food color additive certification mandatory and transferred the authority for its testing from USDA to FDA

8. Regulation of Color Additives • 1938 Act created 3categories of certifiable color additives • Food, Drug and Cosmetic (FD&C)- Color additives with application in foods, drugs or cosmetics; Drug and • Cosmetic (D&C) - Color additives with applications in drugs or cosmetics; and External Drug and Cosmetic • (External D&C) - Color additives with applications in externally applied drugs (e.g. ointments) and in externally applied cosmetics.

9. Regulation of Color Additives • 1960 Color Additive Amendments • placed color additives on a "provisional" list and required further testing • Delaney Clause, prohibits adding to any food substance that has been shown to cause cancer in animals or man regardless of the dose

10. Types of Color Additives • Two types of color additives: • Straight colors • Water soluble dyes • manufactured as powders, granules, liquids or other special purpose forms • Lakes • Insoluble compounds used where color leaching undesirable • Coloring products containing fats and oils or items lacking sufficient moisture to dissolve dyes

11. Color Additive Approval • Testing and certification by the Food and Drug Administration of each batch of color is required before that batch can be used, unless the color additive is specifically exempted by regulation.

12. Color Additive Approval • Manufacturer must first petition FDA for its approval • Convincing evidence that the proposed color additive performs as it is intended • FDA must determine if there is a reasonable certainty of no harm from the color additive under its proposed conditions of use

13. Tatoos • Inks used in tattoos and permanent makeup subject to FDA regulation as cosmetics and color additives • FDA has not attempted to regulate the use of tattoo inks and the pigments • Does not control the actual practice of tattooing • Handled through local laws and by local jurisdictions (MDA)

14. Summary: • FDA color safety assessment began with PFDA • 1960 Color Additives Amendment set up premarket approval scheme for colors • Definition • List of approved color additives

15. Summary: • Types of color additives • Straight • Lake • Color additive petition • Colors tested and certified • Safety standard it reasonable certainty of no harm