Background Information for Lip Balm Project
An emulsion (IPA: /ɪˈmʌlʃən/[1]) is a mixture of two or more immiscible (unblendable) liquids.
Emulsions are part of a more general class of two-phase systems of matter called colloids.
Although the terms colloid and emulsion are sometimes used interchangeably, emulsion tends to
imply that both the dispersed and the continuous phase are liquid. In an emulsion, one liquid (the
dispersed phase) is dispersed in the other (the continuous phase).
Examples of emulsions include vinaigrettes, the photo-sensitive side of photographic film, milk
and cutting fluid for metal working.
Appearance and Properties
Emulsions are made up of a dispersed and a continuous phase; the boundary between these
phases is called the interface. Emulsions tend to have a cloudy appearance, because the many
phase interfaces scatter light that passes through the emulsion. Emulsions are unstable and thus
do not form spontaneously. The basic color of emulsions is white. If the emulsion is dilute, the
Tyndall effect will scatter the light and distort the color to blue; if it is concentrated, the color
will be distorted towards yellow. This phenomenon is easily observable on comparing skimmed
milk (with no or little fat) to cream (high concentration of milk fat). Microemulsions and
nanoemulsions tend to appear clear due to the small size of the disperse phase.
Energy input through shaking, stirring, homogenizing, or spray processes are needed to initially
form an emulsion. Over time, emulsions tend to revert to the stable state of the phases
comprising the emulsion; an example of this is seen in the separation of the oil and vinegar
components of Vinaigrette, an unstable emulsion that will quickly separate unless shaken
continuously.
Whether an emulsion turns into a water-in-oil emulsion or an oil-in-water emulsion depends on
the volume fraction of both phases and on the type of emulsifier. Generally, the Bancroft rule
applies: emulsifiers and emulsifying particles tend to promote dispersion of the phase in which
they do not dissolve very well; for example, proteins dissolve better in water than in oil and so
tend to form oil-in-water emulsions (that is they promote the dispersion of oil droplets
throughout a continuous phase of water).
Instability
There are three types of emulsion instability: flocculation, creaming, and coalescence.
Flocculation describes the process by which the dispersed phase come out of suspension in
flakes. Coalescence is another form of instability, which describes when small droplets combine
to form progressively larger ones. Emulsions can also undergo creaming, the migration of one of
the substances to the top (or the bottom, depending on the relative densities of the two phases) of
the emulsion under the influence of buoyancy or centripetal force when a centrifuge is used.
Surface active substances (surfactants) can increase the kinetic stability of emulsions greatly so
that, once formed, the emulsion does not change significantly over years of storage.
“Emulsion stability refers to the ability of an emulsion to resist change in its properties over
time.” D.J. McClements. [2]
Emulsifier
An emulsifier a substance (also called an emulgent) which stabilizes an emulsion by increasing
their kinetic stability. One class of emulsifiers are known as surface active substances, or
surfactants. Examples of food emulsifiers are egg yolk (where the main emulsifying chemical is
lecithin), honey, and mustard, where a variety of chemicals in the mucilage surrounding the seed
hull act as emulsifiers; proteins and low-molecular weight emulsifiers are common as well. Soy
lecithin is another emulsifier and thickener. In some cases, particles can stabilize emulsions as
well through a mechanism called Pickering stabilization. Both mayonnaise and Hollandaise
sauce are oil-in-water emulsions that are stabilized with egg yolk lecithin or other types of food
additives such as Sodium stearoyl lactylate.
Detergents are another class of surfactant, and will physically interact with both oil and water,
thus stabilizing the interface between oil or water droplets in suspension. This principle is
exploited in soap to remove grease for the purpose of cleaning. A wide variety of emulsifiers are
used in pharmacy to prepare emulsions such as creams and lotions. Common examples include
emulsifying wax, cetearyl alcohol, polysorbate 20, and ceteareth 20.[9] Sometimes the inner
phase itself can act as an emulsifier, and the result is nanoemulsion - the inner state disperses
into nano-size droplets within the outer phase. A well-known example of this phenomenon, the
ouzo effect, happens when water is poured in a strong alcoholic anise-based beverage, such as
ouzo, pastis, arak or raki. The anisolic compounds, which are soluble in ethanol, now form nanosized droplets and emulgate within the water. The colour of such diluted drink is opaque and
milky.
In medicine
20 ml ampule of 1% propofol emulsion suitable for intravenous
injection. The manufacturers emulsify the lipid soluble propofol in
a mixture of water, soy oil and egg lecithin.
In pharmaceutics, hairstyling, personal hygiene and cosmetics,
emulsions are frequently used. These are usually oil and water
emulsions, but which is dispersed and which is continuous depends
on the pharmaceutical formulation. These emulsions may be called
creams, ointments, liniments (balms), pastes, films or liquids,
depending mostly on their oil and water proportions and their route
of administration.[10][11] The first 4 are topical dosage forms, and
may be used on the surface of the skin, transdermally, ophthalmically, rectally or vaginally. A
very liquidy emulsion may also be used orally, or it may be injected using various routes
(typically intravenously or intramuscularly).[10] Popular medicated emulsions include calamine
lotion, cod liver oil, Polysporin, cortisol cream, Canesten and Fleet.
Microemulsions are used to deliver vaccines and kill microbes.[12] Typically, the emulsions used
in these techniques are nanoemulsions of soybean oil, with particles that are 400-600 nm in
diameter.[13] The process is not chemical, as with other types of antimicrobial treatments, but
physical. The smaller the droplet, the greater the surface tension and thus the greater the force to
merge with other lipids. The oil is emulsified using a high shear mixer with detergents to
stabilize the emulsion, so when they encounter the lipids in the membrane or envelope of
bacteria or viruses, they force the lipids to merge with themselves. On a mass scale, this
effectively disintegrates the membrane and kills the pathogen. This soybean oil emulsion does
not harm normal human cells nor the cells of most other higher organisms. The exceptions are
sperm cells and blood cells, which are vulnerable to nanoemulsions due to their membrane
structures. For this reason, these nanoemulsions are not currently used intravenously. The most
effective application of this type of nanoemulsion is for the disinfection of surfaces. Some types
of nanoemulsions have been shown to effectively destroy HIV-1 and various tuberculosis
pathogens, for example, on non-porous surfaces.
Cosmetics
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics
include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye
and facial makeup, permanent waves, colored contact lenses, hair colors, hair sprays [3] and gels,
deodorants, baby products, bath oils, bubble baths, bath salts, butters and many other types of
products. A subset of cosmetics is called "make-up," which refers primarily to colored products
intended to alter the user’s appearance. Many manufacturers distinguish between decorative
cosmetics and care cosmetics.
The manufacture of cosmetics is currently dominated by a small number of multinational
corporations that originated in the early 20th century, but the distribution and sale of cosmetics is
spread among a wide range of different businesses. The U.S. Food and Drug Administration
(FDA) which regulates cosmetics in the United States[1] defines cosmetics as: "intended to be
applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the
appearance without affecting the body's structure or functions." This broad definition includes, as
well, any material intended for use as a component of a cosmetic product. The FDA specifically
excludes soap from this category.[2]
Lipstick is a cosmetic product containing pigments, oils, waxes, and emollients that applies
color and texture to the lips. There are many varieties of lipstick. As with most other types of
makeup, lipstick is typically, but not exclusively, worn by women. It is usually not worn until
adolescence or adulthood.[citation needed]
History
Lipstick used to make a symbolic kiss.
Women in the ancient Indus Valley Civilization applied lipstick to
their lips for face decoration.[1] Ancient Egyptians extracted
purplish-red dye from fucus-algin, 0.01% iodine, and some
bromine mannite, which resulted in serious illness. Cleopatra had
her lipstick made from crushed carmine beetles, which gave a deep
red pigment, and ants for a base. Lipsticks with shimmering effects
were initially made using a substance found in fish scales called pearlescence.[2].
During the Islamic Golden Age the notable Arab Andalusian cosmetologist Abu al-Qasim alZahrawi (Abulcasis) invented solid lipsticks, which were perfumed stocks rolled and pressed in
special molds, and he described them in his Al-Tasrif.[3] In Medieval Europe, lipstick was banned
by the church and was thought to be used as an 'incarnation of satan',[4] cosmetics being
'reserved' for prostitutes. Lipstick started to gain popularity in England the 16th century, during
the reign of Queen Elizabeth I, who made piercing red lips and bright white faces a fashion
statement. By that time, lipstick was made from a blend of beeswax and red stains from plants.
During the Second World War, lipstick gained popularity as a result of its use in the movie
industry, and it became commonplace for women to apply makeup, or "put their face on."[citation
needed]
Another form of lip color, a wax-free semi-permanent liquid formula, was invented in the 1990s
by the Lip-Ink International company. Other companies have imitated the idea, putting out their
own versions of long-lasting "lip stain" or "liquid lip colour."
in many cultures make their lips even redder with lipstick.[5]
Lead traces
A study by US consumer group Campaign For Safe Cosmetics, in October 2007 found 60
percent of lipsticks tested contained traceable amounts of lead.[6] The levels of lead varied from
0.03 to 0.65 parts per million. One third of the lipsticks containing lead exceeded the 0.1ppm
limit set by the U.S. Food and Drug Administration for lead in candy.[7]
Lip gloss
Lip gloss being applied with a retractable lip brush
Lip gloss is a cosmetic product used primarily to give lips a mildly glossy lustre and sometimes
subtle color. It is distributed as a liquid or a soft solid (not to be confused with lip balm, which
generally has medicinal purposes). It can be completely clear, translucent, or various shades of
opacity, including frosted, glittered, and metallic looks.
The first commercially available lip gloss was Max Factor's X-Rated, launched in 1932. The
original formula was sold up until 2003, when Procter and Gamble retired the product.
Lip gloss in a tube and wand applicator format
Like lipstick, lip gloss comes in a variety of forms and may be
applied in different ways. It can be contained in a small
cylindrical bottle and applied with a rounded or sloped
applicator wand (known as a doefoot applicator), be applied
with a built in lip brush, or a small tube designed for application
with the fingertip. Solid glosses come in boxes and tubes,
sometimes blurring the distinction between lip gloss and lip
balm.
New types of 'plumping' lip gloss contain ingredients which make the lips appear softer and
plumper. These are a cheap, easy, and harmless alternatives to collagen, Restylane, Juvederm,
and/or fat injections, but are often not as effective. The effects are temporary and short-lasting.
Lip gloss is usually used as a cosmetic, however, some offer moisturizing benefits or protection
from the elements and other natural causes. Lip gloss containing sunscreen was first advertised
by actress Lillian Gish.[citation needed]. Bonne Bell introduced the first flavored lip gloss, Lip
Smackers, in 1973. BORBA cosmecuticals and Tarte cosmetics were the first to introduce
nutraceutical lip gloss to the market in 2005 providing antioxidents benefits to nourish lips as a
nutritional supplement. Natural makeup companies have made progress in creating lip gloss with
mainly natural ingredients except for preservatives.
Lip gloss is often used when a person wants to have some color on her lips, but does not want an
intense, solid lip color effect (i.e. a more "made-up" look), as lipstick would create. Lip gloss is
also often used as a sort of introduction to makeup. It's often used by preteen and young teenage
girls who want to wear some makeup, but who think (and/or whose mothers think) that they're a
bit too young to wear a more intense lipstick color.
Overall presentation is a chief part of the marketing and selling of lip gloss. Different packaging
is designed for different age groups. A packaging with bright colors and illustrations would be
suited for younger customers, whereas medical lip gloss is presented in a simple manner and
would be more popular with those of teenagers and adults.
Lip gloss is sometimes used with lipstick to create different effects. A clear, simple lip gloss (i.e.
one with no color, metallic effect or glitter) may be worn over a non-frosty (i.e. a "creme")
lipstick to make it shiny (e.g. '50's actress Marilyn Monroe used to do this). Some women also
mix clear lip gloss with any lipstick color to make colored lip glosses. In this case, a bit of
lipstick is applied to the lips with a lip brush, and the clear gloss is applied on top of the lipstick.
Finally, a lipstick is sometimes used to give more definition to lips that are made up with lip
gloss. In this case, the lip gloss is applied, and a lipstick of a similar (but slightly darker) shade is
applied (with a lip brush) to line the lips, as a lip pencil would. In this case, it is considered more
attractive if the line is thin and soft, and the shape of the lips is changed slightly, or not changed
at all.
Criticism and controversy
Woman using cosmetics
Further information: Campaign for Safe Cosmetics, California Safe
Cosmetics Act of 2005, and Testing cosmetics on animals
During the 20th century, the popularity of cosmetics increased
rapidly.[citation needed] Especially in the United States, cosmetics are used by
girls at an increasingly young age[citation needed]. Many companies[who?] have
catered to this expanding market by introducing more flavored lipsticks
and glosses, cosmetics packaged in glittery, sparkly packaging and
marketing and advertising using young models.[citation needed] The social consequences of younger
and younger beautification has had much attention in the media over the last few years.
Criticism of cosmetics has come from a variety of sources including feminists, animal rights
activists, authors and public interest groups. There is a growing awareness and preference for
cosmetics that are without any supposedly toxic ingredients, especially those derived from
petroleum, sodium lauryl sulfate (SLS), and parabens.[6]
Numerous published reports have raised concern over the safety of a few surfactants. SLS causes
a number of skin issues including dermatitis.[7][8][9][10][11]
Parabens can cause skin irritation and contact dermatitis in individuals with paraben allergies, a
small percentage of the general population.[12] Animal experiments have shown that parabens
have a weak estrogenic activity, acting as xenoestrogens.[13]
Prolonged use of makeup has also been linked to thinning eyelashes.[14]
Synthetic fragrances are widely used in consumer products. Studies concluded from patch testing
show synthetic fragrances are made of many ingredients which cause allergic reactions.[15]
Cosmetics companies have been criticised for making pseudoscientific claims about their
products which are misleading or not backed by science. [16] [17]
Lip stain is a cosmetic product that contains either water or a gel base. To help the product stay
on the lips, many stains may contain alcohol. These lip coloring products are available in a
variety of formulas, colors, and application types. The idea behind lip stains is to temporarily
saturate the lips with color with a dye, rather than applying a colored wax to the lips to color
them. A lip stain is usually designed to be waterproof so that the color will be long lasting, and
once the stain dries, it should not smear, stain, wear unevenly, or transfer to the teeth. A lip stain
may come in a bottle with an applicator which is used to brush the stain onto the lips, and it can
also come in a small jar, with users applying the stain with a finger or a cosmetic brush.
Organic and natural ingredients
With many new products released into the market every season, it is hard to keep track of the
safety of every product. Some products carry carcinogenic contaminant 1,4- dioxane. Many
cosmetic companies are coming out with "All natural" and "Organic" products. All natural
products contain mineral and plant ingredients and organic products are made with organic
agricultural products. Products who claim they are organic are not, unless they are certified
"USDA Organic."[19][20]
Cosmetic careers
A professional make-up artist servicing a client
An account executive is responsible for visiting all department and
specialty store counter sales and doors. They explain new products
and "gifts with purchase" (free items given out upon purchase of a
certain cosmetics item that costs more than a set amount).
A Beauty Advisor provides product advice based on the client's skin care and makeup
requirements. Beauty Adviors can become certified throgh the Anti-Aging Beauty Institute.
A cosmetician is a professional who provides facial and body treatments for clients. The term
cosmetologist is sometimes used interchangeably with this term, but most commonly refers to a
certified professional. A freelance makeup artist provides clients with beauty advice and
cosmetics assistance—usually paid by the cosmetic company by the hour.
Professionals in cosmetics marketing careers manage research focus groups, promote the desired
brand image, and provide other marketing services (sales forecasting, allocation to different
retailers, etc.).
Those involved in cosmetics product development design, create and refine cosmetics products.
Some positions that fall under this category include chemists, chemical engineers, quality
assurance and packaging people.
Surfactants are wetting agents that lower the surface tension of a liquid, allowing easier
spreading, and lower the interfacial tension between two liquids.
Properties
A micelle—the lipophilic tails of the surfactant molecules remain
on the inside of the micelle due to unfavourable interactions. The
polar "heads" of the micelle, due to favourable interactions with
water, form a hydrophilic outer layer that in effect protects the
hydrophobic core of the micelle. The compounds that make up a
micelle are typically amphiphilic in nature, meaning that not only
are micelles soluble in protic solvents such as water but also in
aprotic solvents as a reverse micelle
Surfactants reduce the surface tension of water by adsorbing at the liquid-gas interface. They
also reduce the interfacial tension between oil and water by adsorbing at the liquid-liquid
interface. Many surfactants can also assemble in the bulk solution into aggregates. Examples of
such aggregates are vesicles and micelles. The concentration at which surfactants begin to form
micelles is known as the critical micelle concentration or CMC. When micelles form in water,
their tails form a core that can encapsulate an oil droplet, and their (ionic/polar) heads form an
outer shell that maintains favorable contact with water. When surfactants assemble in oil, the
aggregate is referred to as a reverse micelle. In a reverse micelle, the heads are in the core and
the tails maintain favorable contact with oil. Surfactants are also often classified into four
primary groups; anionic, cationic, non-ionic, and zwitterionic (dual charge).
Thermodynamics of the surfactant systems are of great importance, theoretically and practically.
This is because surfactant systems represent systems between ordered and disordered states of
matter. Surfactant solutions may contain an ordered phase (micelles) and a disordered phase (free
surfactant molecules and/or ions in the solution).
Ordinary washing up (dishwashing) detergent, for example, will promote water penetration in
soil, but the effect would only last a few days (many standard laundry detergent powders contain
levels of chemicals such as sodium and boron, which can be damaging to plants and should not
be applied to soils). Commercial soil wetting agents will continue to work for a considerable
period, but they will eventually be degraded by soil micro-organisms. Some can, however,
interfere with the life-cycles of some aquatic organisms, so care should be taken to prevent runoff of these products into streams, and excess product should not be washed down.
Applications and sources
Surfactants play an important role in many practical applications and products, including:
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Detergents
Fabric softener
Emulsifiers and Emulsions
Paints
Adhesives
Inks
Anti-fogging
Soil remediation
Dispersants
Wetting
Ski wax, snowboard wax
Deinking of recycled paper, both in flotation, washing and enzymatic processes
Foaming agents
Defoamers
Laxatives
Agrochemical formulations
o Herbicides some
o Insecticides
Quantum dot coating
Biocides (sanitizers)
Shampoo
Hair conditioners (after shampoo)
Spermicide (nonoxynol-9)
Firefighting
Pipeline, Liquid drag reducing agent
Alkali Surfactant Polymers (used to mobilize oil in oil wells)
Ferrofluids
Leak Detectors
Pulmonary surfactants are also naturally secreted by type II cells of the lung alveoli in mammals.
Health and environmental controversy
Some surfactants are known to be toxic to animals, ecosystems and humans, and can increase the
diffusion of other environmental contaminants.[2][3][4] Despite this, they are routinely deposited in
numerous ways on land and into water systems, whether as part of an intended process or as
industrial and household waste. Some surfactants have proposed or voluntary restrictions on their
use. For example, PFOS is a persistent organic pollutant as judged by the Stockholm
Convention. Additionally, PFOA has been subject to a voluntary agreement by the U.S.
Environmental Protection Agency and eight chemical companies to reduce and eliminate
emissions of the chemical and its precursors.[5]
Micelle
Cross section view of the structures that can be formed by
phospholipids in aqueous solutions
Scheme of a micelle formed by phospholipids in an aqueous solution.
A micelle (pronounced /maɪˈsɛl/ ("my sell") or /maɪˈsiːl/ ("my seal"), plural micelles, micella, or
micellae) is an aggregate of surfactant molecules dispersed in a liquid colloid. A typical micelle
in aqueous solution forms an aggregate with the hydrophilic "head" regions in contact with
surrounding solvent, sequestering the hydrophobic single tail regions in the micelle centre. This
phase is caused by the insufficient packing issues of single tailed lipids in a bilayer. The
difficulty filling all the volume of the interior of a bilayer, while accommodating the area per
head group forced on the molecule by the hydration of the lipid head group leads to the
formation of the micelle. This type of micelle is known as a normal phase micelle (oil-in-water
micelle). Inverse micelles have the headgroups at the centre with the tails extending out (waterin-oil micelle). Micelles are approximately spherical in shape. Other phases, including shapes
such as ellipsoids, cylinders, and bilayers are also possible. The shape and size of a micelle is a
function of the molecular geometry of its surfactant molecules and solution conditions such as
surfactant concentration, temperature, pH, and ionic strength. The process of forming micellae is
known as micellization and forms part of the phase behavior of many lipids according to their
polymorphism.
History
The ability of a soapy solution to act as a detergent has been recognised for centuries. However,
it was only at the beginning of the twentieth century that the constitution of such solutions was
scientifically studied. Pioneering work in this area was carried out by James William McBain at
the University of Bristol. As early as 1913 he postulated the existence of “colloidal ions” to
explain the good electrolytic conductivity of sodium palmitate solutions.* These highly mobile,
spontaneously formed clusters came to be called micelles, a term borrowed from biology and
popularized by G.S. Hartley in his classic book “Paraffin Chain Salts, A Study in Micelle
Formation”.*
Uses
When surfactants are present above the CMC (Critical micelle concentration), they can act as
emulsifiers that will allow a compound that is normally insoluble (in the solvent being used) to
dissolve. This occurs because the insoluble species can be incorporated into the micelle core,
which is itself solubilized in the bulk solvent by virtue of the head groups' favorable interactions
with solvent species. The most common example of this phenomenon is detergents, which clean
poorly soluble lipophilic material (such as oils and waxes) that cannot be removed by water
alone. Detergents also clean by lowering the surface tension of water, making it easier to remove
material from a surface. The emulsifying property of surfactants is also the basis for emulsion
polymerization.
Micelle formation is essential for the absorption of fat-soluble vitamins and complicated lipids
within the human body. Bile salts formed in the liver and secreted by the gall bladder allow
micelles of fatty acids to form. This allows the absorption of complicated lipids (e.g., lecithin)
and lipid soluble vitamins (A, D, E and K) within the micelle by the small intestine.
Federal Food, Drug, and Cosmetic Act
Acronym / colloquial name
FFDCA, "FD&C Act"
FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug
Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of
this law was Royal S. Copeland, a three-term U.S. Senator from New York.[1] In 1968, the
Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the
FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C
regulations the recommendations from a National Academy of Sciences investigation of
effectiveness of previously marketed drugs.[2] The act has been amended many times, most
recently to add requirements about bioterrorism preparations.
The introduction of this act was influenced by the death of more than 100 patients due to a
sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a
liquid form.[3] See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act
of 1906.
Contents
The FD&C Act has nine chapters:[4]
Food coloring
The FD&C is perhaps best known by the consumer because of its use in the naming of food
coloring additives, such as "FD&C Yellow No. 6." The Act made the certification of some food
color additives mandatory. Some food colorings are generally recognized as safe (GRAS) by the
FDA and do not require certification.[8]
The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods
in the United States, plus numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs
or cosmetics. Color additives derived from natural sources, such as vegetables, minerals or
animals, and man-made counterparts of natural derivatives, are exempt from certification. Both
artificial and natural color additives are subject to rigorous standards of safety before their
approval for use in foods.
Certifiable colors
Name
Common name
Color
Comment
FD&C Blue No. 1 Brilliant Blue FCF bright blue
FD&C Blue No. 2
Indigotine
FD&C Green No. 3 Fast Green FCF
royal blue
sea green
FD&C Red No. 3
Erythrosine
cherry red
FD&C Red No. 40
Allura Red AC
orange-red
FD&C Yellow No. 5
Tartrazine
lemon yellow
FD&C Yellow No. 6 Sunset Yellow FCF
orange
Orange B
Restricted to specific uses
Citrus Red No.2
Restricted to specific uses
There are also "D&C" colors that are only approved for use in pharmaceuticals and cosmetics.
Food additives
The FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no
harm will result from the intended use of an additive. If the FDA finds an additive to be safe the
agency issues a regulation specifying the conditions under which the additive may be safely
used.
Definition of food additive
The definition of "food additive" is "any substance, the intended use of which results directly or
indirectly, in its becoming a component or otherwise affecting the characteristics of food".
However, excluded from the definition of "food additive" are substances that are generally
recognized, among experts qualified by scientific training and experience to evaluate their safety,
as having been adequately shown through scientific procedures (or, in the case of a substance
used in food before January 1, 1958, through either scientific procedures or through experience
based on common use in food) to be safe under the conditions of their intended use. This is the
so called generally recognized as safe (GRAS) exemption.[9]
Cosmetics
This Act defines cosmetics as products for "cleansing, beautifying, promoting attractiveness, or
altering the appearance." In this sense the FDA can classify cosmetics without actually
regulating them. This allows a manufacturer the ability to use ingredients or raw materials and
market the final product without government approval.
Significant amendments to FDCA and other laws related to
FDCA
Descriptions of these can be found at the FDCA's web site.[15]
Amendments:
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Infant Formula Act of 1980, Public Law (PL) 96-359 (Oct. 26, 1980)
Orphan Drug Act, PL 97-414 (Jan. 4, 1983)
Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-417 (Sept. 24, 1984)
Prescription Drug Marketing Act of 1987, PL 100-293 (Aug. 18, 1988)
Generic Animal Drug and Patent Term Restoration Act of 1988, PL 100-670 (Nov. 16, 1988)
Nutrition Labeling and Education Act of 1990, PL 101-535 (Nov. 8, 1990)
Safe Medical Devices Act of 1990, PL 101-629 (Nov. 28, 1990)
Medical Device Amendments of 1992, PL 102-300 (June 16, 1992)
Prescription Drug User Fee Act (PDUFA) of 1992, PL 102-571 (Oct. 29, 1992)
Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, PL 103-396 (Oct. 22, 1994)
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Dietary Supplement Health and Education Act of 1994, PL 103-417 (Oct. 25, 1994)
Food Quality Protection Act of 1996, PL 104-170 (Aug. 3, 1996)
Animal Drug Availability Act of 1996, PL 104-250 (Oct. 9, 1996)
Food and Drug Administration Modernization Act (FDAMA) of 1997, PL 105-115 (Nov. 21, 1997)
Best Pharmaceuticals for Children Act, PL 107-109 (Jan. 4, 2002)
Medical Device User Fee and Modernization Act (MDUFMA) of 2002, PL 107-250 (Oct. 26, 2002)
Animal Drug User Fee Act of 2003, PL 108-130 (Feb. 20, 2003)
Pediatric Research Equity Act of 2003, PL 108-155 (Dec. 3, 2003)
Minor Use and Minor Species Animal Health Act of 2004
Food Allergen Labeling and Consumer Protection Act of 2004, PL 108-282 (Aug. 2, 2004)
Drug Efficacy Amendment ("Kefauver Harris Amendment") of 1962
Other laws:[16]
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Federal Food and Drugs Act of 1906 (repealed; for historical reference)
Federal Meat Inspection Act (March 4, 1907)
Federal Trade Commission Act (Sept. 26, 1914)
Filled Milk Act (March 4, 1923)
Import Milk Act (Feb. 15, 1927)
Public Health Service Act (July 1, 1944)
Trademark Act of 1946 (July 5, 1946)
Reorganization Plan 1 of 1953 (March 12, 1953)
Poultry Products Inspection Act (Aug. 28, 1957)
Fair Packaging and Labeling Act (Nov. 3, 1966)
The National Environmental Policy Act of 1969 (Jan. 1, 1970)
Controlled Substances Act (Oct. 27, 1970)
Controlled Substances Import and Export Act (Oct. 27, 1970)
Egg Products Inspection Act (Dec. 29, 1970)
Lead-Based Paint Poisoning Prevention Act (Jan. 13, 1971)
Federal Advisory Committee Act (Oct. 6, 1972)
Government in the Sunshine Act (Sept. 13, 1976)
Government Patent Policy Act of 1980 (Dec. 12, 1980)
Federal Anti-Tampering Act (Oct. 13, 1983)
Sanitary Food Transportation Act (Nov. 3, 1990)
Mammography Quality Standards Act (MQSA) (Oct. 27, 1992)
Bioterrorism Act of 2002 (June 12, 2002)
Project BioShield Act of 2004 (July 21, 2004)
Food and Drug Administration Amendments Act of 2007
Castor oil and its derivatives are found in many cosmetics as it is "non-comedogenic" (does not
exacerbate or contribute to acne).[1]
Castor oil adds a shiny quality to cosmetic products
In many countries colors in cosmetics are listed as numbers from the Colour Index International.
The scheme covers colours used in food, personal care products, cosmetics, household products
and fabric dyeing. So, for example you will not normally see tartrazine listed in lipstick
ingredients, but it may be there listed as C.I. 19140. Erythrosine will be listed as C.I. 45430, and
so on. In US and Canada colors are listed as FD & C colors. tartrazine (E012) is FD & C Yellow
5 and erythrosine (E127) is FD & C Red 3.
Visual effects
Strong red colours for eye products have been produced using the dye carmine, made from
carminic acid extracted form the crushed bodies of the cochineal insect.[citation needed] Carmine was
once the only bright red color permitted by the FDA for use around the eye.[citation needed]
Titanium dioxide
Pearlescence, also sometimes spelled as "pearl essence", is a shine
or gloss effect commonly used in a wide variety of cosmetic
products. The most usual source of pearlescence is the natural mineral mica covered by a thin
layer of titanium dioxide. This coating causes goniochromism – the colour appears through
interference effects with the naturally translucent mica, and varying the thickness of the titanium
dioxide changes the colour.[3] Alternatives exist, including the suspension of tiny flakes of a
suitable material within the product, often a wax such as glycol distearate. A shimmery substance
found on fish scales, most usually obtained from herring and one of many by-products of
commercial fish processing, can also be used for pearlescent effects, primarily in nail polish, but
is now rarely used due to its high cost, bismuth oxychloride flakes being used as a substitute
instead. [2]
Lipstick
Lips with various shades of lipstick applied.
Lipstick is known to have been used around 5000 years ago in
ancient Babylon, when semi-precious jewels were crushed and
applied to the lips and occasionally around the eyes. Ancient
Egyptians extracted purplish-red dye from fucus-algin, 0.01%
iodine, and some bromine mannite, which resulted in serious illness. Cleopatra had her lipstick
made from crushed carmine beetles, which gave a deep red pigment, and ants for a base.[5]
The red color of modern lipstick can come from synthetically derived pure iron oxide (one of the
components of rust), however most leading brands use the more economical synthetic colors. In
the United States, every batch of synthetic dye and pigment must have a sample sent to the US
FDA for testing and certification that the batch is pure and its contaminants are below the levels
specified by law (Federal Food, Drug and Cosmetic Act CHAPTER VII—GENERAL
AUTHORITY SUBCHAPTER B--COLORS LISTING AND CERTIFICATION OF COLOR
ADDITIVES FOR FOODS, DRUGS, AND COSMETICS [1]). Synthetic colours are listed in
the ingredients as a code (eg: F &D red no 6) and may contain up to 10 parts per million of lead /
3 parts per million of arsenic. (Code of Federal Regulations, Title 21, Volume 1 -FOOD AND
DRUGS, CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, PART 74--LISTING OF COLOR ADDITIVES
SUBJECT TO CERTIFICATION) There is some controversy over the presence of these trace
ingredients, especially since makeup worn on the lips is not just absorbed through the skin, but
also swallowed with drinking and eating. Since lowering these levels would make the production
and sale of practically all lipstick illegal, and since the FDA has determined that the existing
levels are safe, the cosmetic industry continues to produce and sell lipstick. (Color Additives:
FDA's Regulatory Process and Historical Perspectives)[2]
Typically, the pigment is crushed very finely (7 to 10 micrometres) while being mixed with
castor oil and is then mixed with a wax base to form a finished lipstick.
Lipsticks may be sheer or dense, matte or shiney. In their thinnest and most fluid consistency
they are given their own category, lipgloss.
Vegetable oils
Although most plants contain some oil, only the oil from certain major oil
crops [1] complemented by a few dozen minor oil crops[2] is widely used and
traded. These oils are one of several types of plant oils.
Vegetable oils can be classified in several ways, for example:
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By source: most, but not all vegetable oils are extracted from the
fruits or seeds of plants, and the oils may be classified by grouping
oils from similar plants, such as "nut oils".
By use: oils from plants are used in cooking, for fuel, for cosmetics, for medical purposes, and
for other industrial purposes.
The vegetable oils are grouped below in common classes of use.
Edible oils
Major oils
Sunflowers are the source of Sunflower oil.
These oils account for a significant fraction of worldwide edible oil production. All are also used
as fuel oils.
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Coconut oil, a cooking oil, high in saturated fat, particularly used in baking and cosmetics.[3]
Corn oil, a common cooking oil with little odor or taste.[4]
Cottonseed oil, used in manufacturing potato chips and other snack foods. Very low in trans
fats.[5]
Olive oil, used in cooking, cosmetics, soaps, and as a fuel for traditional oil lamps.[6]
Palm oil, the most widely produced tropical oil. Popular in West African and Brazilian cuisine.[7]
Also used to make biofuel.[8]
Peanut oil (Ground nut oil), a clear oil used for dressing salads and, due to its high smoke point,
especially used for frying.[9]
Rapeseed oil, including Canola oil, one of the most widely used cooking oils.[10]
Safflower oil, produced for export for over 50 years, first for use in paint industry, now mostly as
a cooking oil.[11]
Sesame oil, cold pressed as light cooking oil, hot pressed for a darker and stronger flavor.[12]
Soybean oil, produced as a byproduct of processing soy meal.[13]
Sunflower oil, a common cooking oil, also used to make biodiesel.[14]
Nut oils
Hazelnuts from the Common Hazel, used to make Hazelnut oil.
Nut oils are generally used in cooking, for their flavor. They are
also quite costly, because of the difficulty of extracting the oil.
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Almond oil, used as an edible oil, but primarily in the manufacture of pharmaceutical drugs.[15]
Cashew oil, somewhat comparable to olive oil. May have value for fighting dental cavities.[16]
Hazelnut oil, mainly used for its flavor. Also used in skin care, because of its slight astringent
nature.[17][18]
Macadamia oil, strongly flavored, contains no trans fat, and a good balance of omega-3 and
omega-6 fatty acids.[19]
Mongongo nut oil (or manketti oil), from the seeds of the Schinziophyton rautanenii, a tree
which grows in South Africa. High in vitamin E. Also used in skin care.[20]
Pecan oil, valued as a food oil, but requiring fresh pecans for good quality oil.[21]
Pine nut oil usually added to foods as a flavoring agent.
Pistachio oil, strongly flavored oil, particularly for use in salads.[22]
Walnut oil, used for its flavor, also used by Renaissance painters in oil paints.[23][24]
Edible oils
Carob seed pods, used to make carob pod oil.
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Amaranth oil, high in squalene and unsaturated fatty acids, used in food and cosmetic
industries.[34]
Apricot oil, similar to, but much cheaper than almond oil, which it resembles. Only obtained
from certain cultivars.[35]
Apple seed oil, used in cosmetics and shampoos.[36] Also used as an edible oil.[37]
Argan oil, a food oil from Morocco that has also attracted recent attention in Europe.[38]
Artichoke oil, extracted from the seeds of the Cynara cardunculus. Similar in use and
composition to safflower and sunflower oil.[39]
Avocado oil, a nutty-flavored culinary oil, also used as a base for infusions.[40] Also used in
cosmetics.[41] Unusually high smoke point of 510°F.[42]
Babassu oil, similar to, and used as a substitute for, coconut oil.[43]
Ben oil, extracted from the seeds of the Moringa oleifera. High in behenic acid. Extremely stable
edible oil. Also suitable for biofuel.[44]
Borneo tallow nut oil, extracted from the fruit of species of genus Shorea. Used as a substitute
for cocoa butter, and to make soap, candles, cosmetics and medicines.[45]
Cape Chestnut oil, otherwise known as Yangu oil, is a popular oil in African skin care.
Cocoa butter, from the cacao plant. Used in the manufacture of chocolate, as well as in some
cosmetics.
Carob pod oil (Algaroba oil), from carob, used medicinally.[46]
Cocklebur oil, from species of genus Xanthium, with similar properties to poppyseed oil, similar
in taste and smell to sunflower oil.[47][48]
Cohune oil, from the Attalea cohune (cohune palm), similar to coconut oil in makeup and
usage[49]
Coriander seeds are the source of an edible pressed oil, Coriander seed
oil.
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Coriander seed oil, from coriander seeds, used medicinally. Also
used as a flavoring agent in pharmaceutical and food industries.[50]
Dika oil, from Irvingia gabonensis seeds, native to West Africa. Used to make margarine, soap
and pharmaceuticals, where is it being examined as a tablet lubricant. Largely underdeveloped.
[51][52]
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False flax oil made of the seeds of Camelina sativa, available in Russia as ryjhikovoye maslo
(рыжиковое масло). Considered promising as a food or fuel oil.[53]
Flax seed oil (called linseed oil when used as a drying oil). High in omega 3 and lignans, which
can be used medicinally. Easily turns rancid.[54]
Grape seed oil, suitable for cooking at high temperatures. Also used as a salad oil, and in
cosmetics.[55]
Hemp oil, a high quality food oil.[56]
Kapok seed oil, used as an edible oil, and in soap production.[57]
Kenaf Seed oil a fibre plant similar to Hemp.
Lallemantia oil, from the seeds of Lallemantia iberica, discovered at archaeological sites in
northern Greece.[58]
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Marula oil, extracted from the kernel of Sclerocarya birrea. Used in the food and cosmetic
industry, it has strong antioxidant and moisturising properties.[59]
Meadowfoam seed oil, highly stable oil, with over 98% long-chain fatty acids. Competes with
rapeseed oil for industrial applications. [60]
Mustard oil (pressed), used in India as a cooking oil. Also used as a massage oil.[61]
Nutmeg butter, extracted by expression from the fruit of cogeners of genus Myristica. Nutmeg
butter has a large amount of trimyristin. Nutmeg oil, by contrast, is an essential oil, extracted by
steam distillation.[62]
Okra seed oil (Hibiscus seed oil), from the seed of the Hibiscus esculentus. Composed
predominantly of oleic and linoleic acids.[63] The greenish yellow edible oil has a pleasant taste
and odor.[64]
Papaya seed oil.
Perilla seed oil, high in omega-3 fatty acids. Used as an edible oil, for medicinal purposes, in skin
care products and as a drying oil.[65]
Pequi oil, extracted from the seeds of Caryocar brasiliense. Used in Brazil as a highly prized
cooking oil.[66]
Pine nut oil. An expensive food oil, from pine nuts, used in salads and as a condiment. [67]
Poppy seeds, used to make poppyseed oil
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Poppyseed oil, used for cooking,[68] moisturizing skin,[69] in
paints and varnishes,[70] and in soaps.
 Prune kernel oil, marketed as a gourmet cooking oil.[71]
Quinoa oil, similar in composition and use to corn oil.[72]
Ramtil oil, pressed from the seeds of the one of several species of genus Guizotia abyssinica
(Niger pea) in India and Ethiopia. Used for both cooking and lighting.[73]
Rice bran oil, suitable for high temperature cooking. Widely used in Asia.[74]
Royle oil, pressed from the seeds of Prinsepia utilis, a wild, edible oil shrub that grows in the
higher Himalayas. Used medicinally in Nepal.[75]
Sacha Inchi oil, from the Peruvian Amazon. High in omega-3 and omega-6 fatty acids.[76]
Tea seed oil (Camellia oil), widely used in southern China as a cooking oil. Also used in making
soaps, hair oils and a variety of other products.[77]
Thistle oil, pressed from the seeds of Silybum marianum. Relatively unstable. Also used for skin
care products.[78]
Tigernut oil (or nut-sedge oil) is pressed from the tuber of Cyperus esculentus. It has properties
similar to soybean, sunflower and rapeseed oils.[79] It is used in cooking and making soap[80] and
has potential as a biodiesel fuel.[79]
Tomato seed oil. High in unsaturated fats and lysine. Potentially useful as a protein
supplement.[81]
Wheat germ oil, used as a dietary supplement, and for its "grainy" flavor. Also used medicinally.
Highly unstable.[82]
Other oils
A number of pressed vegetable oils are either not edible, or not used as an edible oil.
Castor beans are the source of castor oil
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 Amur cork tree fruit oil, pressed from the fruit of the
Phellodendron amurense, used medicinally and as an insecticide.[118]
Balanos oil, pressed from the seeds of Balanites aegyptiaca, was used in ancient Egypt as the
base for perfumes.[44]
Bladderpod oil, pressed from the seeds of Lesquerella fendleri, native to North America. Rich in
lesquerolic acid, which is chemically similar to the ricinoleic acid found in castor oil. Many
industrial uses. Possible substitute for castor oil as it requires much less moisture than castor
beans.[119]
Brucea javanica oil, extracted from the seeds of the Brucea javanica. Used medicinally.[120]
Burdock oil (Bur oil) extracted from the root of the burdock. Used medicinally in scalp
treatment.[121]
Candlenut oil (Kukui nut oil), produced in Hawai'i, used primarily for skin care products.[122]
Carrot seed oil (pressed), from carrot seeds, used in skin care products.[123][124]
Castor oil, with many industrial and medicinal uses. Castor beans are also a source of the toxin
ricin.[125]
Chaulmoogra oil, from the seeds of Taraktogenos kurzii, used for many centuries, internally and
externally, to treat leprosy.[126] Also used to treat secondary syphilis, rheumatism, scrofula, and
in phthisis.[127]
Crambe oil, extracted from the seeds of the Crambe abyssinica, is used as an industrial lubricant,
a corrosion inhibitor, and as an ingredient in the manufacture of synthetic rubber.[128]
Cuphea oil, from a number of species of genre Cuphea. Of interest as sources of medium chain
triglycerides.[129]
Illipe butter, from the nuts of the Shorea stenoptera. Similar to cocoa butter, but with a higher
melting point. Used in cosmetics.[130]
Jojoba oil, used in cosmetics as an alternative to whale oil spermaceti.[131]
Lemon oil, similar in fragrance to the fruit. One of a small number of cold pressed essential oils.
Used medicinally, as an antiseptic, and in cosmetics.[132]
Mango oil, pressed from the stones of the mango fruit, is high in stearic acid, and can be used
for making soap.[133]
Mowrah butter, from the seeds of the Madhuca latifolia and Madhuca longifolia, both native to
India. Crude Mowrah butter is used as a fat for spinning wool, for making candles and soap. The
refined fat is used as an edible fat and vegetable ghee in India.[27]
Neem oil, used in cosmetics, for medicinal purposes, and as an insecticide.[134]
Ojon oil, extracted from the nut of the American palm (Elaeis oleifera). Used as a skin and hair
treatment. Oil extracted from both the nut and husk is also used as an edible oil in Central and
South America.[135]
Orange oil, like lemon oil, cold pressed rather than distilled. Consists of 90% d-Limonene. Used
as a fragrance, in cleaning products and in flavoring foods.[136]
The fruit of the sea-buckthorn
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Rose hip seed oil, used primarily in skin care products,
particularly for aging or damaged skin. Produced in Chile.[137]
Rubber seed oil, pressed from the seeds of the Rubber tree (Hevea brasiliensis), has received
attention as a potential use of what otherwise would be a waste product from making rubber. It
has been explored as a drying oil in Nigeria[138] as a diesel fuel in India[139] and as food for
livestock in Cambodia and Vietnam[140]
Sea buckthorn oil, derived from Hippophae rhamnoides, produced in northern China, used
primarily medicinally.[141]
Shea butter, used primarily in skin care products.[142]
Snowball seed oil (Viburnum oil), from Viburnum opulus seeds. High in tocopherol, carotenoides
and unsaturated fatty acids. Used medicinally.[143]
Tall oil, produced as a byproduct of wood pulp manufacture. A further byproduct called tall oil
fatty acid (TOFA) is a cheap source of oleic acid.[144]
Tamanu oil, originates in Tahiti, from the Calophyllum tacamahaca, used for skin care and
medicinally.[145]
Tonka bean oil (Cumaru oil), used for flavoring tobacco and snuff.[146]
Essential oil
Not to be confused with essential fatty acid.
An essential oil is a concentrated, hydrophobic liquid containing volatile aroma compounds
from plants. Essential oils are also known as volatile or ethereal oils, or simply as the "oil of"
the plant from which they were extracted, such as oil of clove. An oil is "essential" in the sense
that it carries a distinctive scent, or essence, of the plant. Essential oils do not as a group need to
have any specific chemical properties in common, beyond conveying characteristic fragrances.
They are used in perfumes, cosmetics, soap and other products, for flavoring food and drink, and
for scenting incense and household cleaning products.
Various essential oils have been used medicinally at different periods in history. Medical
application proposed by those who sell medicinal oils range from skin treatments to remedies for
cancer, and are often based on historical use of these oils for these purposes. Such claims are
now subject to regulation in most countries, and have grown more vague to stay within these
regulations.
Interest in essential oils has revived in recent decades with the popularity of aromatherapy, a
branch of alternative medicine which claims that the specific aromas carried by essential oils
have curative effects. Oils are volatilized or diluted in a carrier oil and used in massage, diffused
in the air by a nebulizer or by heating over a candle flame, or burned as incense.
Use in aromatherapy
Aromatherapy is a form of alternative medicine, in which healing effects are ascribed to the
aromatic compounds in essential oils and other plant extracts. Many common essential oils have
medicinal properties that have been applied in folk medicine since ancient times and are still
widely used today. For example, many essential oils have antiseptic properties.[2] Many are also
claimed to have an uplifting effect on the mind. The claims are supported in some studies[3][4]
and unconfirmed in others.[5]
Dilution
Essential oils are usually lipophilic (literally: "oil-loving") compounds that usually are not
miscible with water. Instead, they can be diluted in solvents like pure ethanol (alcohol),
polyethylene glycol, or oils.
Raw materials
Main article: List of essential oils
Essential oils are derived from various sections of plants. Some plants, like the bitter orange, are
sources of several types of essential oil.
Berries
Leaves
Flowers
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Allspice
Juniper
Seeds
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Almond
Anise
Celery
Cumin
Nutmeg oil
Bark
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Cassia
Cinnamon
Sassafras
Basil
Bay leaf
Cinnamon
Common sage
Eucalyptus
Lemon grass
Melaleuca
Oregano
Patchouli
Peppermint
Pine
Rosemary
Spearmint
Tea tree
Thyme
Wintergreen
Cannabis
Chamomile
Clary sage
Clove
Scented geranium
Hops
Hyssop
Jasmine
Lavender
Manuka
Marjoram
Orange
Rose
Ylang-ylang
Peel
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Bergamot
Wood
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Resin
Camphor
Cedar
Rosewood
Sandalwood
Agarwood
Rhizome
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Frankincense
Myrrh
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Grapefruit
Lemon
Lime
Orange
Tangerine
Root
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Valerian
Galangal
Ginger
Dangers
Because of their concentrated nature, essential oils generally should not be applied directly to the
skin in their undiluted or "neat" form. Some can cause severe irritation or provoke an allergic
reaction. Instead, essential oils should be blended with a vegetable-based "carrier" oil (a.k.a., a
base, or "fixed" oil) before being applied. Common carrier oils include olive, almond, hazelnut
and grapeseed. Only neutral oils should be used. A common ratio of essential oil disbursed in a
carrier oil is 0.5–3% (most under 10%), depending on its purpose. Some essential oils, including
many of the citrus peel oils, are photosensitizers, increasing the skin's vulnerability to sunlight.