Transcript The Regulation Of Colors

The Regulation of
Colors
Color Additives
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
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
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
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)).
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.
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
Regulation of Color
Additives
•
1938 Act created 3categories of
certifiable color additives
1. Food, Drug and Cosmetic (FD&C)- Color
additives with application in foods,
drugs or cosmetics; Drug and
2. Cosmetic (D&C) - Color additives with
applications in drugs or cosmetics; and
External Drug and Cosmetic
3. (External D&C) - Color additives with
applications in externally applied drugs
(e.g. ointments) and in externally
applied cosmetics.
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
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
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.
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
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)
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
Summary:
• Types of color additives
• Straight
• Lake
• Color additive petition
• Colors tested and certified
• Safety standard it reasonable
certainty of no harm