2. 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)).
3. Terminologies: colorants
Coloring Agent: A generic term for any color imparting
substance. Classified as:
• Colorants: substances that are soluble in the medium (water
or oil) which is to be colored.
• Pigments: substances that are insoluble in the medium to be
colored. Coloring effect is achieved by uniform distribution of
pigments in the end product.
• Color lakes: pseudopigments produced by precipitation of
water soluble colorants with a water insoluble salt (e.g.
aluminium hydroxide), insoluble in water and can be
processed like pigments.
• Dyes: it is a coloured substance that has an affinity to the
substrate to which it is being applied and generally applied in
an aqueous solution.
4. Terminologies
• Water dispersible pigments: substances which provides a
stable dispersion in water with the addition of a dispersing
agent and then processed like a colorant but forms a cloudy
dispersion.
• Color additives: a dye pigment or other substance,
synthesized, isolated or derived from a vegetable, animal or
mineral source , that either alone or through reaction with
another substance imparts color when added or applied to
food, drug or cosmetics or human body or any part thereof.
5. Terminologies: Certified colors
• Certified color additives: synthetic organic dyes, described in
an approved color additive petition . Each manufactured lot of
a certified dye must be analyzed and certified by concerned
drug authorities.
• Non-certified color additives: color additives that are not
classified as ‘certified color’ or ‘color lakes’.
• Homologous colors: A series of colorants with similar
chemical structure , differ only in their chain lengths and
number of substitute groups.
6. Terminologies: color quality
• Hue: Red/yellow/blue quality of a sample compared to
standard.
• Chroma: Vividness of a color. Ex: Olive Green and sea
green.
• Opacity: Degree of impenetrability by light.
• Hiding power: Opacity, usually measured by comparing
the color of a colored dispersion over black and white
checkered paper.
“Low opacity/Hiding Power” – more black is visible
throughout the drawn sample.
7. Terminologies: color quality
• Under tone: color seen in a thin layer of a
pigment incorporated into a vehicle and drawn
down on a white paper.
• Mass tone: color of a thick layer of a colored
sample incorporated into a vehicle.
• Draw down: A sampling technique used to judge
undertone and mass tone sample, prepared by
spreading a quantity of colorant onto a white or
half white /half black backing with a single stroke
of a blade.
8. Terminologies: color quality
• Tinctorial strength: A dye’s potential coloring power.
• Flashing: The visible effect when individual colors in a
color blend dissolves separately as a blend is added to
the solvent.
• Bleed: the leaching of an impurity or minor constituent
from a colored article or solid dye.
• Morest paper: small sheet of a treated paper, half
white and half black.
9. Color Regulation
• INDIA (The drugs and cosmetics act, 1940 and
Rules 1945).
• USA (US code of Federal Regulations . CFR,
Title-21 Para 70-82).
• EUROPEAN UNION (Cosmetic directive of the
European Union).
10. Color Regulation: India
• Prohibit manufacture of cosmetics with coal tar colors other
than those prescribed in schedule Q.
• The coal tar color used in the manufacture of cosmetics shall
not contain:
1. 2 ppm of arsenic calculated as arsenic trioxide.
2. 20 ppm of lead calculated as lead.
3. 100 ppm of heavy metals other than lead , calculated as the
total of the respective metals.
• No use of coal tar dye or coal tar dye base for cosmetics to
used around the eyes or on the eyebrows.
• Natural Food colors: NMT 0.2 gm/Kg (Ex: Saffron, caramel,
curcumin, chlorophyll etc)- Prevention of Food adultarent act
, 1954 and Rules 1958.
11. Color Regulation: India
• No use of coal tar dye or coal tar dye base for cosmetics to
used around the eyes or on the eyebrows.
• Prevention of Food adultaretion act , 1954 and Rules 1958.
• Natural Food colors: NMT 0.2 gm/Kg
• (Ex: Saffron, caramel, curcumin, chlorophyll etc).
12. Color Regulation in USA
• CFR-21 list covers list of coloring agents permitted in the
united states for coloring cosmetics.
• CFR-21 also covers:
1. Application restriction particularly for eye use area.
2. Requirements for FDA test certification to use the coloring
agents.
13. Color Regulation in USA
The USFDA (Food and Drug Administration) Requires that the
most artificial coloring agents (Industrially synthesized and are
not found in nature) be certified by the FDA as a guarrantee
of their safety and purity as either D&C (Drugs and Cosmetics)
Colors or FD&C colors (Food, drug and cosmetics) colors.
Other naturally derived agents may be used without
certification.
14. Color Regulation in EU
• The Cosmetic Directive of the European Union (EU) identifies four
cosmetic application areas.
• They are:
1. Application Area 1: Coloring agents used in all cosmetics.
2. Application Area 2: Coloring agents used in all cosmetics
except those applied to the eyes, such as
eye make up and eye make up remover.
3. Application Area 3: coloring agents usable in cosmetics not
intended to come into contact with
mucous membrane.
4. Application Area 4: Coloring agents usable in cosmetics that come
in contact with the skin, only briefly.
15. Color Regulation in EU
• Selection of coloring agent is also limited by type of cosmetic
products.
1. Water soluble colorants: Creams, soaps and toothpastes,
bath preparations (shampoo,
shower bath and foam baths).
2. Pigments dispersed in bulk mass : Toothpastes, Face make-up,
powder, lipsticks, soaps etc.
3. Oil-soluble Colors: Oils and soaps.
4. Color Lakes: Lipsticks and Eye make-up.
16. Color Quality Control
• QC test for appropriate color matching test for accepting or
rejecting colorants lots from suppliers, by evaluating finished
products and suggesting methods for shade correction.
• Color quality test is not just knowledge of appropriate color
matching tests but also evaluation of products as well.
17. Guidelines For Color Quality Assessment
• Use common descriptive terminology throughout the company.
• All departments R&D, production, QA-QC and marketing should
decide together the common descriptive terminology.
• Use of a standardized evaluation sheet.
• Controlled evaluations, controlled lighting and color cabinet.
• Minimize color fading, keep standard pigments dry and prepare
fresh standard samples to avoid fading of standards due to storage.
• Use current standards.
• Label with expiration data.
• In R&D formulate with newest pigment standards and destroy old
lots.
• Deep understanding of compounding process to understand
difference in color, intensity, hue value and chroma.
18. Causes of Color Variation
• Poor lot-to-lot color match in colorants.
• Incorrect color compounding.
• Pigment level below the formulation level.
• Incorrect pigment level.
• Oily and waxy liquid due to too little pigments in the
batch.
• Soft lipsticks and spongy pressed powders results
due to pigment levels higher than designed
percentage.
• Liquid make up may ball upon application to skin.
19. Evaluation of Colored Cosmetics
A. Evaluating Oil-Soluble Pigments.
B. Evaluation of Dry Products.
C. Evaluating Water Soluble Colourants.
D. Evaluating Colors in Emulsion Based Make-up
Products.
20. Evaluating Oil-Soluble Pigments
• Blend oil soluble Pigments in Oil (Castor
Oil).
• Grind in Hoover-Muller Grinder by
setting number of rotations and
pressure between the glass plates.
• Draw down the grind on morest paper,
half white half black.
• Use Fineness-of-Grind gauge to check
uniformity.
• Compare production grind to standard
grind.
21. Evaluating Oil-Soluble Pigments: Products
• Lipsticks:
Evaluation of lipstick sample between two glass slides for pigment
dispersion.
Chatillion instrument: The breakage gauge for stick hardness test,
after storage at 250C for 24-28 hrs.
Melt point/ Slip Point Test (No sweat, crumble or cake or pigment
bloom on storage at elevated temperatures).
• Eyeliner Pencil:
Checking of hardness of lead and pigment dispersion as lipsticks.
Drop Test: Pencil lead break strength.
Cut wooden pencil wit razor to check unidispersed pigment
particles.
Maintain and monitor pencils ate elevated temperatures (37-500C)
for shrinking, melting, oil-separation and pigment bleeding.
23. Evaluation of Dry Products
• Check for undispersed pigment.
• Glazing (hard shiny cake surface): poor oil distribution or an
improper balance of ingredients.
• Check for Pressing Quality:
Method 1: indention depth of a pencil eraser at the edges of
the cake compared to a standard.
Method 2: Drop 10 cakes from 10 inches height, 3 number of
drops befor breakage/chipping around the edges, compare
with a standard.
Test for glazing, moisture, pay-off, texture, ease of
application and wear by applying with an applicator.
24. Evaluating Water Soluble Colourants
• Mix with water and compare with a freshly prepared
standard.
• In a Nessler Cylinder.
• Color/intensity is compared by taking a drop or so in filter
paper.
• Analyze in uv-vissible spectroscopy.
• Visual color evaluation is most accurate one.
25. Evaluating Colors in Emulsion Based Make-up
Products
• Morest paper, porcelin plate or in white paper to check
color and pigment dispersion for streaks.
• Check for excessive air by pressing sample between two
glass slides.
• Check for emulsion stability (24h). Improper emulsion
gives an off-shed product.
• Appearance is tested by applying on forearm and
compare with standard using four-site pattern or on the
palm.
• Check for correct solvent level of mascara or eyeliner
before correcting shades.
26. Evaluation of Finished Product for Color
• For rebuilding or correction of color.
• Be familiar with the entire process.
• Understanding of limits of correction and product quality.
• A light shaded powder can be color corrected by milling again.
• Too light colored lipstick- color correct by letting the batch
cool and reheating with mixing for 30 mins.
• Over mixing and heating can produce too dark and
unacceptable shade.
• In w/o emulsions no color adjustment is possible after two
phases are combined.
• Aliquots are combined in laboratory scale batch after shade
correction and then the ratio is of color and emulsion volume
is calculated.
• Monochromatic color correction blenders.
27. Manufacturing Process For Color Cosmetics
• Lip make-up: Lip gloss, lipstick, lip liner.
• Nail make-up: Nail Polish, Nail Lacquer.
• Facial Make-up: emulsions and aqueous
dispersions, anhydrous preparations
(powders/rouges/powder compatcs).
• Eye Make-up: Mascara, Eye shadows, Eye
brow pencil, eyeliners.
29. LIPSTICS
COMPOSITION
WAXES –Methyl beeswax, carnauba wax, candellila wax, ozokerite
and other synthetic waxes.
OILS - Essentially castor oil.
PIGMENTS-Mineral or lacquers of organic pigments
mica or pearlized pigments.
PRESERVATIVES-Parabins.
FRAGRANCES
30. Continu……………..
Waxes-form the structure of the stick.
form a film on the lips.
OILS- used to wet the pigments and give slip to the
stick
silicones may be added for smother slip.
31. MASCARA
• Mascara used to enhance the eye lashes
• They were prepared with oil and lamp back.
• Two types of mascara are there
water based mascara –cream mascara o/w emulsion.
Water proof mascara-anhydrous mascara
33. Conti………………………………
composition function %(w/w)
water vehicle Q.S
Hydro
ethylcellulose
thickener 0. 50
triethanolamine Ph
buffer/neutrali
ser
2.00
Butylenes glycol humectants 8.00
Iron oxides pigment 10.00
Glyceryl
stearate
emulsifier 2.50
34. NAIL POLISH
Nail polishes are the preparations whose main function is
color and enhance aesthetics of both hands and feet ,giving
them more attractive aspect .nail polish basically consists of
pigments suspended in a volatile solvent to film former have
been added.
35. Conti……….
REQUIRED QUALITIES
Must have an important adhesion power.
Shining film.
Easy application , easy spread ability.
Homogeneity
Fast drying.
36. INGREDIENTS
Nitrocellulose – film forming agent
Solvent , like toluene
Pigments – mineral or organic lakes
Plasticizers – DEP , camphor
Resins – toluene sulphonamide formaldehyde ,polyester
37. FOUNDATION
It is the first cosmetic to be applied on the face while
doing make up to serve as the base .
mainly 3 types
1. Liquid foundation
2. Cream foundation
3. Powder foundation
38. Conti…………
1. Liquid foundation- it is best for natural look makeup
and most commonly used for daily purpose.it is available
both in oil based formula and water based formula.
2. Cream foundation-available as sticks and compacts
3. Powder foundation-combines action of both
foundation and powder in one.
40. POWDERS
• Loose powder is a mixture of talc , pigments and fragrance
• Powders have asbestos(other fibers) free talc
• Talc particle size is 20 microns for loose powder, below for
pressed powder is acceptable.
41. • Preservatives mainly parabens are used
• Pressed powders will contains binders(oil or fatty esters)
• Mica and other pearls used as colorants.
• Powders contain silicones to give softer touch
• Wet-dry powders contain silicones.
42. References
1. Harry R.G., Reiger M.M., Harry’s Cosmeticology, Chemical publishing company. Newyork
2. Balsam M.S., Sagarin E., Cosmetics: Science and Technology. Wiley Interscience. Newyork
3. Rao Y.M., Shayeda, Cosmeceuticals, Pharma Med Press. Hyderabad
4. Paye M., Basel A.O., Maibach H.I., Handbook of Cosmetic Science & Technology, Informa
Healthcare. Newyork
5. Sharma P.P., Cosmetics Formulation, Manufacturing and Quality control, Vandana Publication
Pvt. Ltd. Delhi
6. Poucher W.A., Butler H., Poucher’s Perfumes, Cosmetic & Soaps, Springer India Pvt. Ltd. New
Delhi.
7. Nanda S., Nanda A., Cosmetic Technology, Birla Publication, Delhi.
8. SCCS's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation,
7th Revision. European Commission.
9. Indian Pharmacopoeia 2014(7th edition), Ministry of Health and Family Welfare, Published by
Govt. of India.