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 (FDC)- Color additives
  with application in foods, drugs or cosmetics
  Drug and
• Cosmetic (DC) - Color additives with
  applications in drugs or cosmetics and External
  Drug and Cosmetic
• (External DC) - 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