3. "any substance the intended use of
which results or may reasonably
be expected to result -- directly or
indirectly -- in its becoming a
component or otherwise affecting
the characteristics of any food." -
FDA
any dye, pigment or substance
which when added or applied
to a food, is capable (alone or
through reactions with other
substances) of imparting color
FOOD ADDITIVE COLOR ADDITIVE
5. HISTORY
Around 1200 BC (Bronze age), Cleopatra and others added saffron in butter as first
colorant to put a rich yellow color.
Around 1500 BC, candy makers in Egyptian cities added natural extracts and wine to
improve the products appearance.
In 1856, William Henry Perkin discovered the first artificial organic dye, called
“mauve” by oxidizing aniline while trying to form an anti-malaria drug (quinine)
By 1900, many foods and drugs in U.S. were artificially colored with many blatantly
poisonous materials such as lead, arsenic, and mercury to hide inferior or defective
foods.
In 1906, Congress passed the Food and Drugs Act, which prohibited the use of
poisonous or deleterious colors in food industries
In1962 The first EU directive, focusing on the use of colorants in foods was published.
36 colors (20 natural and 16 artificial) were considered safe for human consumption
6.
7.
8.
9.
10. 80 synthetic dyes for
coloring foods – US in 1990
no regulation for safety
11.
12.
13. •Produce toxic metabolites after azo bond reduction
since amino group gets exposed
•Hydrophilic parent dye can become hydrophobic
after reduction/desulfonation
•Increased permeability due to breakdown of dye
into low molecular weight amines
•Carcinogenic/mutagenic metabolites get produced
14.
15. This value indicates the amount of food additive that can be consumed daily
throughout life without posing an appreciable risk to consumer health
16. Unlike other food additives, dyes are not permitted
to be used unless the U.S. Food and Drug
Administration (FDA) has tested and certified that
each batch meets the legal specifications.
One benefit of the certification process is that it
provides information about the amounts of dyes sent
into commerce each year for use in foods, drugs, and
cosmetics (see Table 1).
17. Safety of FD&C Colors
Color Risk Assessment
Substantial safety datasets
for many colors
FDA review led to listing as
allowed colors
WHO/FAO review establish
Acceptable Daily Intakes
(ADIs)
Additional data collected
Genotoxicity
Allergenicity
other studies
18. In order to evaluate potential toxicity of food additives, clinical studies are
done in order to determine the NOAEL (No-Observed-Adverse-Effect Level)
19. CONTROVERSIES ON SYNTHETIC FOOD DYES
•Some FDA-approved food
colorings pose certain risks to
health.
•Research has linked Erythrosine
to thyroid cancer in rats.
•The cochineal insect extract rarely
causes severe allergic reactions.
20. Red #3 – used in cherries,
sausages casings (hotdogs), and
candies, banned in Europe due
to altering child’s behavior, and
thyroid function due to high
iodine
Red 3 was recognized in 1990
by the FDA as a thyroid
carcinogen in animals and is
banned
ADI for Red 3 is 2.5 mg/kg
bw/day or 75 mg/day for a 30-
kg child (FDAe)
21. Citrus Red #2 – is permitted
only for coloring the skins of
oranges not used for processing
is toxic to rodents at modest
levels and caused tumors of the
urinary bladder and possibly
other organs
the dye poses minimal human
risk, because it is only used at
minuscule levels and only on
orange peels
22. Brilliant blue #1 – is not
readily absorbed by our
bodies, and some reports
showed changes in
mitochondrial respiration,
and also concern of the
blue lollipop with direct
absorption of the dye to
the lingual mucosa
may cause hypersensitivity
reactions
23. In 1937, dimethyl
amino azobenzene
or butter yellow
was found to
induce malignant
tumors in rats. The
carcinogenicity of
butter yellow was
later confirmed.
24.
25. Because of those
toxicological considerations,
including carcinogenicity,
hypersensitivity reactions, and
behavioral effects, food dyes
cannot be considered safe
The British government
advised companies to stop
using most food dyes by the
end of 2009, and the European
Union is requiring a warning
notice on most dye-containing
foods after July 20, 2010.
The issue of food dyes and
behavior has been discussed in
a separate CSPI report and
petition calling on the FDA to
ban most dyes.
26. GENOTOXICITY
A chemical’s ability to cause mutations
or damage chromosomes in bacterial or
eukaryotic cells (ones with a nucleus) is
an indication that the chemical might
cause cancer in humans.
While one or two positive genotoxicity
studies might not ring alarm bells, a
chemical like Yellow 5, which showed
positive findings in 6 out of 11
genotoxicity studies deserves special
attention and study—perhaps new and
larger chronic feeding studies (50%)
27.
28. AMARANTH (FD&C Red No. 2)
• 1-(4-sulfo-1-paphthylazo)-9-naphthol-3,6-disulfonic
acid, trisodium salt
• it is a reddish-brown powder with a water
solubility of 12 g/100 ml at 30C
• prohibited by the FDA in 1976 but
not in European Union
• induced malignant tumors in rats
• juice, ice creams, cherries, cake, wine
29. • In toxicity studies, amaranth (0.5 ml of a 0.1% solution)
was injected under the skin of rats twice a week for 365
days, in which no tumor growth was observed
• When 0.2% of amaranth in feed (average 0.1 g/kg/day)
was fed to rats for 417 days, no induction of tumors was
observed.
• However, one case of intestinal cancer was observed when
feeding was continued for an additional 830 days.
• The FAO/WHO special committee determined its ADI as 0 to
1.5 mg/kg
30. It was determined that
amaranth is metabolized into
amine derivatives in vivo.
Amaranth is reduced by
aqueous D-fructose and D-
glucose at elevated temperatures
to form a mixture of hydrazo
and amine species, which may
have toxicological significance.
31. TARTRAZINE (FD&C Yellow No. 4)
• 5-hydroxy-1-p-sulfophenyl-4-(p-
sulfophenylazo)-pyrazol-3-
carboxylic acid, trisodium salt
• it is a yellow powder and has
been used as food coloring
additive since 1916
• candies, ice creams, cakes,
noodles, wine, cheese, butter
• The ADI for Yellow 5 is 5
mg/kg/day (FDAg), which
equates to 150 mg/day for a
30-kg child.
32. METABOLISM AND METABOLIC EFFECTS
Sulfanilic acid is a metabolite that results from
the reduction of Yellow 5 at the N=N azo link
Ryan et al. confirmed that Yellow 5 is primarily
metabolized in the guts of rats after an oral
dose, where the gut microflora perform the
majority of the compound’s degradation
Apart from the metabolism of the dye, a 50-mg
dose of Tartrazine led to increased or accelerated
urinary excretion of zinc in hyperactive children
33. In the United States, tartrazine can be used in foods only
as a coloring agent (FDA Regulations 8.275, 8.501).
It is also permitted in Great Britain for use as a food-
coloring agent.
Six out of 11 mutagenicity studies indicated potential
problems like mild to severe hypersensitivity reactions,
but Yellow 5 did not appear to be carcinogenic in rats.
On another front, Tartrazine (the only dye to be tested on its
own, instead of in mixtures) has caused hyperactivity in
children (Rowe 1988; Rowe and Rowe 1994).
34. Although many synthetic coloring
agents are toxic if used in large
enough amounts, and many are
suspected carcinogens as well, natural
coloring agents are not always safe.
Caramel, which gives a light brown
color, contains carcinogenic
benzo[a]pyrene in small amounts, used
in softdrinks/soda drink;
37. • In the 1970’s artificial food dyes
began being linked to hyperactivity in
children.
• Dr. Feingold, pediatric allergist from
California, created a diet free
of artificial colors, artificial flavors
that was meant to reduce
hyperactivity
• There are 10 banned artificial dyes
that were once used in the food supply
• “To date, no conclusive evidence has
been found to show that food coloring
causes ADHD” - WebMD
54. 54
803 New York City Public Schools
National California Achievement Test Scores
2001-2002
Before
diet change
2004-2005
After
diet change
50% = national average
59. Food additives play a vital
role in today’s bountiful and
nutritious food supply, they
allow our growing population
to enjoy a variety of safe,
wholesome and tasty foods
year round, and they make
possible an array of
convenience foods without the
inconvenience of daily
shopping.
INTRODUCTION
60. • Colorant plays a significant role
in enhancing the artistic appeals
of foods that are aesthetically
pleasing more likely to be
consumed and to contribute to a
varied diet (Hallagan et al., 1995).
• Food colors are materials of natural origin have
been used to provide color in foods for thousands
of years. Ash from fires mineral compounds and
plants were probably among the first materials
used (Gaunt et al., 1972).
• By the early 1995, natural and synthetic color
additives were used extensively to color foods,
drugs and cosmetics (Hallagan et al., 1995).
• Color is an important characteristic and selection
criterion for food choice, recent studies have high
lighted this importance and have shown how
selection may change among certain, populations,
and over time (Clydesdale, 1993).
61. •Tartrazine known as E102 or FD&C
Yellow 5 or C.I. 19140 is a synthetic
lemon yellow azo dye used as a food
coloring.
•It is derived from coal tar.
•It is water soluble and principally
trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-
sulfonatophenylazo)-H-pyrazol-3-carboxylate.
• The ADI for tartrazine is 7.5
mg/kg/day (Walton et al., 1999).
TARTRAZINE
62. •Carmoisine and its different names
as Azorubine, Food Red 3, Azorubin
S, Brillant carmoisine O, Acid Red
14, or C.I. 14720 is a synthetic red
food dye from the azo dye group
•It usually comes as a disodium salt.
It is a red to maroon powder; it has
been used for the purposes where
the food is heat-treated after
fermentation.
•It has E number E122 carmoisine
CARMOISINE
63. •are a nitrous derivatives (azo class) they can be reduced in the organism to an
aromatic amine which is highly sensitizing.
•the main metabolite identified to date is sulfanylic acid (Maekawa et al., 1987; Chung
et al., 1992).
•Two doses of synthetic dyes (low or high doses) mostly attributable to
hepatocellular damage when the toxic effects of synthetic dyes that tartrazine
and carmoisine were among of them (ponceau, carmoisine, erythrosine, sunset
yellow, tartrazine, fast green, indigotine, brilliant blue and brilliant black) were
tested in rats by the biochemical and histopathological examinations.
•Dyes exert histopathological effects on the hepatic and renal tissues of the rats,
indicated by vacuolation, swelling, necrosis and pyknosis of their cells (Mekkawy
et al., 1998).
TARTRAZINE and CARMOISINE
64. to study the effects of tartrazine and
carmoisine as coloring agent widely
used in food products, drugs and
cosmetics on on some biochemical
parameters in serum of young male
albino rats (as a model of children)
associated with liver and kidney
functions, blood glucose and serum
lipids, also our study was extended to
evaluate the effect of these additives
on the biomarkers of the oxidative
stress in tissue homogenates
OBJECTIVE OF THE STUDY
65. • loss in drying and sodium
chloride/sulphate is less than 13%
• water insoluble matter less than
0.2% lead less than 0.01 ppm
Arsenic less than 1 ppm
• heavy metals less than 40 ppm
Tartrazine (87%)
and
Carmoisine
(87%)
•Kept under observation – 7
days
•In stainless steel cages
•Atmospheric temp is 27±5°C
32 young male
(Rattus Norvegicus)
albino rats (60-
80g)
Tartrazine, and carmoisine were in a
solid state so we prepared two
solutions of each substance (one low
and the other high) by dissolving the
solid in distilled water, low doses of
tartrazine and carmoisine were 15
and 8 mg/kg bw respectively while
high doses were were 500 and 100
mg/kg bw respectively
18/08/15
MATERIALS AND METHODS
Animals were fed on the standard
basal diet and provided with tap
water a composition of experimental
diets according to Kim et al. (2005)
as follows: (fat 5%, carbohydrates
65%, protein 20.3%, fiber 5%, salt
mixture 3.7%, vitamins mixture 1%).
66. Venous blood samples were collected from the orbital sinus of
control, and food dyes treated rats via glass capillaries at fasting state
Homogenates of liver tissues were prepared by dissolving 0.25 g of liver tissue in 5 ml of
NaOH 0.9% in test tube then homogenized by the homogenizer for 15 min then
centrifuged by centrifuge for 10 min at 3000 rpm then the supernatants were collected
for determination of biomarkers of oxidative stress.
The blood samples were collected in dry glass centrifuge tubes and
allowed to coagulate at room temperature and centrifuged at 3500
rpm for 15 min at room temperature for separation of serum.
MATERIALS AND METHODS
70. CONCLUSION
Tartrazine and Carmoisine affect
adversely and alter biochemical
markers in vital organs e.g. liver
and kidney not only at higher
does but also at low doses.
71. References
•www.feingold.org/Research/dye-studies.html
•FDA Public Health Advisory (2003): Reports of Blue Discoloration and
Death in Patients Receiving Enteral Feedings Tinted With The Dye, FD&C
Blue No. 1
•http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecific
Products/InMedicalDevices/ucm142395.htm
•Department of Health & Human Services, September 1, 2010: Interim
Toxicology Review Memorandum
•Maloney JP, Halbower AC, Fouty BF, et al. Systemic absorption of food dye
in patients with sepsis. N Engl J Med. 2000;343:1047–1048.
•Granville LA, Finch C., Blue colon at autopsy. Arch Pathol Lab Med. 2001
May;125(5):599.
