Colorants

inCosmetics

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)).

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Chatillion instrument:

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.

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.

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.

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.

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.

CONTENTS: Color Cosmetics

• LIPSTICS• MASCARA• NAIL ENAMEL• FOUNDATION• COMPACT POWDER

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

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.

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

Conti…………………………..

REQUIRED QUALITIES1. Proper creamines and slip are needed with out greasiness.2. Easy application3. Uniformity4. Sufficient adhesion is required, non allergenic.

Conti………………………………

composition function %(w/w)

water vehicle Q.S

Hydro ethylcellulose

thickener 0. 50

triethanolamine Ph buffer/neutraliser

2.00

Butylenes glycol humectants 8.00

Iron oxides pigment 10.00

Glyceryl stearate

emulsifier 2.50

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.

Conti……….

REQUIRED QUALITIES Must have an important adhesion power. Shining film. Easy application , easy spread ability. Homogeneity Fast drying.

INGREDIENTSNitrocellulose – film forming agentSolvent , like toluenePigments – mineral or organic lakesPlasticizers – DEP , camphorResins – toluene sulphonamide formaldehyde ,polyester

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 foundation2. Cream foundation3. Powder foundation

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.

Conti…………..

INGRADIENTSVEHICLEPIGMENTSSILICONESPRESERVATIVES,FRAGRANCES.

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.

• 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.

References1. Harry R.G., Reiger M.M., Harry’s Cosmeticology, Chemical publishing company. Newyork2. Balsam M.S., Sagarin E., Cosmetics: Science and Technology. Wiley Interscience. Newyork3. Rao Y.M., Shayeda, Cosmeceuticals, Pharma Med Press. Hyderabad4. Paye M., Basel A.O., Maibach H.I., Handbook of Cosmetic Science & Technology, InformaHealthcare. Newyork5. Sharma P.P., Cosmetics Formulation, Manufacturing and Quality control, Vandana Publication

Pvt. Ltd. Delhi6. Poucher W.A., Butler H., Poucher’s Perfumes, Cosmetic & Soaps, Springer India Pvt. Ltd. NewDelhi.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 byGovt. of India.