Choosing suitable and safe Sunscreen / Sunblock Creams.

We need sun, but too much may cause sunburns,

accelerates aging, and causes skin cancer.

The best way to prevent from sun burn is cover-up and looking for shade!

Taking care of our skin from excessive sun exposure,

Follow the application instruction dose of the products precisely, don’t reduce it !

The best way to prevent from sun burn is cover up and looking for shade, especially during peak sunlight hours, between 10 a.m until 4 p.m. But as a matter of fact, there is no arguing about the fact that sunscreen creams / sunblock creams prevent painful sunburns, and they reduce the visible sign of aging, the best protection is achieved by application 15–30 minutes before exposure, followed by reapplication 15–30 minutes after the sun exposure begins.

Ultraviolet rays:

Infrared rays: wavelength: >780 nm.

Sunlight rays: wavelength: 400 – 780 nm.

Ultraviolet rays: wavelength: 100 – 400 nm.

X-rays: wavelength: <>

Ultraviolet rays (UV) exposure can be very harmful, or harmless, depending on

1. the type of UV,
2. the type of exposure,
3. the duration of exposure, and
4. the individual differences in response to UV.

The UV region of the electromagnetic spectrum encompasses a range from 400 nm (nanometers) through 100 nm, and is further sub-divided into four smaller regions:

1. UV-A (315 to 400 nm): Long wave UV, also known as "black light ", the major type of UV in sunlight, responsible for skin tanning, generally not harmful, used in medicine to treat certain skin disorders.
2. UV-B (280 to 315 nm): Medium-wave UV, a small, but dangerous part of sunlight. Most solar UV-B is absorbed by the diminishing atmospheric ozone layer. Prolonged exposure is responsible for some type of skin cancer, skin aging, and cataracts (clouding of the lens of the eye).
3. UV-C (200 to 280 nm): Also known as "shortwave" UV, includes germicidal (253.7nm wavelength) UV used for air disinfection. Unintentional overexposure causes transient redness and eye irritation, but does NOT cause skin cancer or cataracts.
4. Vacuum UV (100 to 200 nm)

Ultraviolet-B rays (UVB rays) causes sunburn and skin cancer, ultraviolet-A rays are more plentiful than UVB rays, also less carcinogenic, nevertheless, good sunscreen cream products should protect skin against both types of ultraviolet rays (UVA-UVB rays), since both can contribute to skin cancer and photo-aging, usually sunscreen cream products that protect both ultraviolet rays are labeled broad-spectrum.

It should be noted that

relating to the application of sunscreen creams, we have to follow the application instructions precisely, don’t reduce its dose!

What is Sun protection factor (SPF)?

The SPF of a sunscreen is a laboratory measure of the effectiveness the protection of sunscreen against UV-B, the ultraviolet radiation that causes sunburn, the SPF indicates the time a person with sunscreen applied can be exposed to sunlight before getting sunburn compare to the time a person without sunscreen, someone who would burn after 12 minutes in the sun would expect to burn after 120 minutes when protected by / uses a sunscreen with SPF 10.

Type of Sunscreen / Sunblock Cream

[1]. Mineral Sunblock creams (Mineral blocks):

TiO₂ & ZnO

Unlike Chemical sunscreen creams which prevent sun burn by absorbing the sun’s rays, the mineral sunscreen cream will block the sun rays. Mineral based sunscreen creams form protective physical barrier on the skin that deflects both Ultraviolet-A (UVA) and Ultraviolet-B (UVB) rays.

The most commonly used minerals for sunscreen (Sunblock) cream are Titanium dioxide (TiO₂) and Zinc oxide (ZnO). The different of the mineral based sunscreen and the chemical based sunscreen is the usage of the mineral based sunscreen will left a thin opaque white mark layer on the skin. In order to make Titanium dioxide and Zinc oxide sunscreen transparent, the manufacturers using smaller particles of the mineral ingredients, by micronization process to reduce the particle size, which is called nanoparticles (nanometer particles), nanoparticles are mineral particles that have been fragmented to size below 100 nanometers, the micronization process itself is called nanotechnology, nanoparticle mineral sunscreen cream when applied to the skin are less visible. It should be noted that, the term micronized (makes micron particles) does not always contains nanoparticles, the size of 1 micron (μm) particles equal with one millionth of a meter, while 1000 nanometer (nm) particles equal with 1 micron particles, so 1 nanometer particle equal with one billionth of a meter (m).

The so-called nanoparticles are of most concern, it is unclear whether or not they are being absorbed through the skin, nano-particles have a greater potential to penetrate the skin dermis into the bloodstream, the consequences of which are unknown.

If we do not convince, the safety way we can take is avoiding mineral sunscreen products containing nanoparticles, caution also should be made to avoid applying nanoparticles sunscreen cream to cuts, wounds and abrasions (damage areas of the skin)!!!

Maximum concentration used:

1. Titanium dioxide (TiO₂): 25 % and no limit in Japan,
   
2. Zinc oxide (ZnO): 25 % in USA, 20 % in Australia, 25 % in EU particle size >100 nm, no limit in Japan.

[2]. Chemical Sunscreen creams (Chemical blocks):

The Chemical Sunscreen creams allow the sun’s rays to penetrate the skin, and the active ingredients the synthetic chemical compounds absorb the radiation of ultraviolet rays (UVA & UVB), prevent it from burning or damaging the skin.

Avobenzone / Butyl-Methoxydibenzoylmethane

Avobenzone is oil soluble, is one of the most common UVA-protective active ingredients used in Sunscreen cream, it absorbs the full spectrum of UVA rays, absorbs ultraviolet light over a wider range of wavelengths than many other organic chemical sunscreen agents used in many commercial preparations marketed as broad spectrum sunscreens creams, it has an absorption maximum of 357 nm, frankly speaking, the protection activity of Avobenzone is unclear, if it is not stabilized with photostabilizer, Avobenzone has a tendency to break down under sunlight, causes not effective anymore, Maximum concentration used: 3 % in USA, 5 % in European Union Countries (EC), 10 % in Japan.

Benzophenon (Diphenylmethanon)

Benzophenon may cause irritation and rashes in many users, and moreover, Benzophenon appears to mimic the hormone estrogen in the body, that means Benzophenon behaves like estrogen hormone, this chemical sunscreen may disrupt user’s endocrine system, as Benzophenon more readily to be absorbed by the skin compares to other sunscreen ingredients, the use of Benzophenon in sunscreen cream products is particularly concerning.

Maximum concentration used:

Ecamsule / Terephthalylidene Dicamphor Sulfonic Acid.

Similar to Avobenzone Ecamsule is a UVA-protective sunscreen active ingredient, filter out UVA rays to prevent UV-related signs of aging, it is known for its excellent photostability, Ecamsule was approved by the FDA in 2006, Maximum contration used: 10 %

Padimate-O / Octyldimethyl-PABA

Padimate-O is derivative of PABA / para-aminobenzoic-acid ( PABA is also a standard ingredient in sunscreen product for years, but recently most of the manufacturers remove it from sunscreen cream formula, because PABA stains clothing and causes allergies in many users).

Padimate-O used in sunscreen cream formulations because it can effectively protect the skin from untraviolet-B rays (UVB_rays), which are known to cause sunburn and skin cancer, Padimate-O preventing direct DNA damage by UVB rays.

Maximum concentration used: 8 % in USA, Australia, and EC (maybe delisted), 10 % in Japan.

Other FDA approved UV-filter chemical sunscreen ingredients:

• p-Aminobenzoic acid (PABA)
• Cinoxate (2-Ethoxyethyl p-methoxycinnamate).
• Dioxybenzone (Benzophenone-8).
• Homosalate (Homomethyl salicylate), The salicylic acid portion of the molecule absorbs ultraviolet rays, protecting the skin from sunburn, sun damage. Maximum concentration used: 15 % in USA and Australia, 10 % in EC and Japan, 15 % in USA and Australia.
• Methyl anthranilate (Methyl-aminobenzoate).
• Octocrylene (3-diphenyl acrylic acid).
• Octyl-methoxycinnamate / 2-ethylhexyl-paramethoxycinnamate, Its primary use is in sunscreens and other cosmetics to absorb UV-B rays from the sun, protecting the skin from damage, Maximum concentration used: 7.5 % in USA, 10 % in EU and Australia, 20 % in Japan.
• Octyl salicylate (2-Ethylhexyl salicylate).
• Oxybenzone (Benzophenone-3).
• Phenylbenzimidazole sulfonic acid.
• Sulisobenzone (2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid).
• Trolamine salicylate (Triethanolamine salicylate).

What should the good Aromatherapy be ?

" The greatest joy for Aromatherapy lover is developing our own unique blends "
" A good blend of Aromatherapy essential oil is a well-balanced combination of Top, Middle, and Bottom notes "

What is Aromatherapy?

Aromatherapy is the therapeutic use of Essential Oils to heal and revitalize the body and mind, a complete psychosomatic system of healing, a holistic approached to health and well-being by means of AROMA.

Who is the pioneer of Aromatherapy?
A French Chemist Rene-Maurice Gattefosse, in 1930. He burned his hand and put in a jar of pure Lavender Essential Oil, and…… the pain was gone almost instantly, his burn healed with no blisters, scars or infections.

What are today’s Aromatherapy concepts ?

Aromatherapy is the science and art of using the pure volatile, non-oily essences of plants in healing, the precious Essential Oils heal and enliven body, mind and spirit by enchanting our senses, medicinal use of Essential Oils brings healing on 3 planes:

1. Physical: Essential Oils to be some of the strongest antimicrobial agents, ridding the body of toxins and fighting infection.
2. Mental: Essential Oils effect mood and have a historical reputation for increasing libido.
3. Spiritual: Essential Oils are used in ritual and ceremony to open and heighten spiritual awareness.

The use of Aromatherapy in business:

In Japan engineers are incorporating aroma systems into new buildings:

• The scent of Lavender & Rosemary is pumped into the customer waiting room to calm down the waiting customers.
• The Lemon & Eucalyptus fragrances are use by the bank teller counter to keep the staff always alert.

How do Aromatherapy Oils work?

• On the Physical body, locally & systematically, via absorbed through the skin into the lymphatic and blood circulation.
• On the Mind & Emotions, via the sense of smell and the Limbic System.
• On the Etheric Energy System of the body, via the energy vibration of the individual oils themselves.

The power of fragrance is used to influence and alter our emotional moods. Their aroma assists in balancing, stimulating, relaxing, invigorating and rejuvenating the body.

Human Brain-Limbic system-Olfactory

Limbic System in human brain consist of:

1. Hypothalamus regulating: hunger, thirst, response to pain, level of pleasure, and sexual satisfaction
2. Hippocampus regulating: short term memory, long term memory.
3. Amygdala regulating: anger, aggressive behavior.

In the Limbic system there is an organ called Olfactory which receives fragrance stimulation / odorant particles, and send the impulse through the olfactory nerves directly to the brain, through the olfactory organ in the nose human beings have the ability to distinguish many thousands of different odors, and the memories of these odors are stored deep in human’s sub-conscious minds. When men / women inhale air molecules which are carrying the odorants particles or odoriferous molecules of an Essential Oil, these molecules adhere to the Olfactory nerve endings in the back of the nose oil, producing stimulation in the nose direct to the brain, this is very rapid and direct pathway to the part of the brain which direct, controls, interprets and responds to sensory input.

Olfactory epithelium area, covered by mucus: 5 cm² in human (5% of the Nasal Cavity), but 25 Cm² in cat / dog, it contains odorant receptor cells 10 million in human, which are regularly replaced in about 4 – 8 weeks, each receptor cell possess a terminal enlargement that projects above the epithelial surface, from which extend about 8 – 20 Olfactory Cilia. We can smell between 4,000 to10,000 different odors.

Brain waves

Smelling Lavender fragrance Oil will increases α-waves in the back of the head, which are associated with relaxation.

Smelling Jasmine fragrance Oil increases β-waves in the front of the head, which are associated with a more alert state.

Types of Brain Waves

1. Alpha waves – regular and rhythmic, low-amplitude, slow, synchronous waves indicating an “idling” brain, Mid wave frequency: 8 - 13 Hz, subjective feeling states: awake but not actively processing information; relaxed; not agitated; not drowsy; tranquil & calm, associated tasks & behaviors: relaxing, watching television, light reading, eyes closed.
2. Beta waves – rhythmic, more irregular waves occurring during the awake and mentally alert state, High wave frequency: 12 - 35 Hz, the normal dominant rhythm, subjective feeling states: alert, concentrating, attentive, focused, anxious, associated tasks & behaviors: listening and thinking during analytical problem solving, judgment, decision making, processing information, REM sleep!
3. Delta waves – high-amplitude waves seen in deep sleep and when reticular activating system is damped, Slowest frequency waves: 1 – 3 Hz, subjective feeling states: deep, dreamless sleep, non-REM sleep, unconscious, associated tasks & behaviors: not moving, not attentive, sleeping.
4. Theta waves – more irregular than alpha waves; common in children but abnormal in adults, Slow wave frequency: 4 – 8 Hz, subjective feeling states: dreamlike, drowsy, distracted, unfocused, associated tasks & behaviors, state between wakefulness and sleep; during sleep, meditation, internal focus, and prayer; sub-consciousness.

The Benefits of Aromatherapy:

• Medicinal benefits: bruises, sprains, burns, wounds, scars, nervousness, stress, motion sickness, fatigue, respiratory illnesses, muscular aches, fungus, inflammation, digestive disorders
• Skincare benefits: dermatitis, stretch marks, eczema, acne, psoriasis, mature skin, varicose veins, dry skins, cellulite, wrinkles, fungus, bacteria.
• Emotional benefits: depression, frustration, grief, hysteria, anxiety, insomnia, lack of concentration, irritability, fear, poor memory, hopelessness, moodiness, panic attacks, nervous tension, sadness, worry.

Aromatherapy treatment techniques:

Skin absorption: massage blends: essential oil blended with carrier oil

Bath therapy: essential oil added directly to water (body, foot, and hand)

Inhalation: steam, handkerchief

Diffuser :

Clay candle or electric pottery

Cold / hot compresses.

Others: salves, mouthwashes, creams, gels

Aromatherapy Composition:

• Essential oil: liquid that is distilled from leaves, stems, flowers, bark, roots, and other plant elements
• Carrier oil : base or vegetable oils (e.g. sweet almond oil) used to dilute essential oils prior to applying to skin

To get the maximum benefit from Essential Oils, it should be made from natural, pure raw materials, synthetically made Essential Oils do not work !

Essential Oils that could be used in Aromatherapy:

Oil of Bergamot (Citrus bergamia), Oil of Cajuput (Melaleuca leucadendron), Oil of Chamomile (Chamomilla recutita), Oil of Eucalyptus (Eucalyptus globules), Oil of Geranium (Pelargonium odoratissimum), Oil of Jasmine (Jasminum officinale), Oil of Lavender (Lavadula officinalis), Oil of Lemon (Citrus limonum), Oil of Marjoram (Origanum marjorana), Oil of Orange (Citrus aurantium var sinensis), Oil of Patchouli (Pogostemon patchouli), Oil of Peppermint (Mentha piperita), Oil of Rose (Rosa gallica), Oil of Rosemary (Rosmarinus officinalis), Oil of Tea Tree (Melaleuca alternifolia), Oil of Ylang Ylang (Cananga odorata)

Essential Oils that should not be used at all in Aromatherapy:

Oil of Anise (Pimpinella anisum), Yellow Camphor (Cinnamomum camphora), Oil of Cassia (Cinnamomum cassia), Oil of Fennel (Foeniculum vulgare), Oil of Pine (Pinus pumilio), Oil of Sassafras (Sassafras albidum), Wintergreen Oil (Gaultheria procumbens), Mustard Oil (Brassica nigra).

Contra-indications

• Pregnant women, avoid: Basil, Cedarwood, Clary Sage, Coriander, Hyssop, Jasmine, Juniper, Marjoram, Oregano, Myrrh, Sage, Peppermint, Rosemary, Thyme.
• Hypoglycemia, avoid: Geranium
• High Blood Pressure, avoid: Pine, Rosemary, Sage, Thyme
• Photosensitivity, avoid: Bergamot, Lime, Mandarin, Lemon, Tangerine, Orange, Caraway, Cassia, Grapefruit, Patchouli, Petitgrain.
• Carcinogenic: Sassafras, Calamus, Yellow Camphor,

Essential Oil Grade:

1. Pure, Natural, Organic Essential Oils, can be used as Aromatherapy Oils
2. Natural Identical Essential Oils, Non-aromatherapy Oils. (due to highly complex components ± 300 chemicals, Essential Oil cannot be replicated in the Laboratory.
3. Synthetic Essential Oils, Non-aromatherapy Oils.

Aromatherapy Essential Oils scents:

Floral, woody, fruity, greeny, herbaceous, earthy, citrusy, sweety, grassy, oriental, spicy, fishy, powdery, minty, musky, fresh

Aromatherapy Essential Oil Notes

• Top note (15 – 25 %), the initial impression of a scent, most volatile, fastest acting oils, stimulating & uplifting (
• Middle note (30 – 40 %), heart or main body of an aromatherapy Essential Oils, balancing & most therapeutic, generally forms the greatest proportion of the blind.
• Bottom note (40 – 55 %), hold & boost the strength of Top & Middle notes, bring depth & solidness, fixative, least volatile, slowest to evaporate, longest acting, relaxing & sedating.

Top – Middle – Bottom notes Aromatherapy Essential Oil

Top note Middle note Bottom note

Grapefruit Chamomile Cedarwood

Lemon Cassia Patchouli

Lime Cinnamon Rose

Orange Clove Sandalwood

Peppermint Fennel (sweet) Vanilla

Spearmint Geranium Spikenard

Tangerine Lavender Jasmine

Mandarin Tea Tree Vetiver

Eucalyptus Rosemary

Marjoram Neroli

Pine Ylang Ylang

Bergamot Nutmeg

Choosing the good Aromatherapy Oils:

Good Aromatherapy Essential Oils

SHOULD BE :

1. Organic, pure Natural Essential Oils
2. Natural identical Essential Oils.
3. No synthetic chemicals, pesticides or fertilizers.
4. No GMOs (Genetically Modified Organisms).
5. Food Grade (Perfumery grade has nothing to do with aromatherapy !).
6. Non oily, non greasy, do not leave a permanent mark on paper.
7. Therapeutic Grade (processed by distillation under low temperature and under low pressure).
8. No rancidity, not contaminated.

How safe are the color Additives used ?

Color Additives

Color additives are dyes, pigments, or other substances that can impart color when added or applied to a food, drug, cosmetic, or the human body.
FDA classifies color additives as those requiring certification and those not requiring certification (exempt from certification).

((1)). Color additives require certification / Certified Colors / Certfiable Colors :
Synthetic Colors: These do not occur in nature and are produced by chemical synthesis. These colors, especially in the U.S., must be tested for purity and certified, batch by batch, prior to sale to manufacturers. FDA analyses every batch because every batch is a little different from the one before it, the complex organic chemical reaction occurring during manufacturing can throw off a sample’s composition a little different each time. FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. The manufacturer submits a sample from the batch for which it is requesting certification, and FDA tests the sample to determine whether it meets the color additive's requirements for composition and purity. If it does, FDA "certifies" the batch and issues a certification lot number, and uses FDA color name. Only then can that batch be used legally in FDA-regulated products.
Examples :
Non certified...........Certified as
Tartrazine................FD & C Yellow 5..FDA assigned Lot No.…….
Allura Red AC..........FD & C Red 40....FDA assigned Lot No……….
Indigotine................FD & C Blue No.2.FDA assigned Lot No…….

The Federal Food, Drug & Cosmetic (FD&C) Act of 1938 made food color additive certification mandatory and transferred the authority for its testing from USDA to FDA. To avoid confusing color additives used in food with those manufactured for other uses, three categories of certifiable color additives were created :
1 Food, Drug and Cosmetic (FD&C)
- Color additives with application in foods, drugs or cosmetics;
2 Drug and Cosmetic (D&C)
- Color additives with applications in drugs or cosmetics;
3 External Drug and Cosmetic (External D&C)
- Color additives with applications in externally applied drugs (e.g. ointments) and in externally applied cosmetics.

Certified color additives have special names consisting of a prefix, such as FD&C, D&C, or Ext. D&C, a color; and a number. Sometimes a color additive is identified by a shortened form of its name, consisting of just the color and number, such as Yellow 6.
In 1960, the Color Additive Amendments to the FD&C Act placed color additives on a "provisional" list and required further testing using up-to-date procedures. One section of the amendment known as the Delaney Clause, prohibits adding to any food substance that has been shown to cause cancer in animals or man regardless of the dose. Under the amendments, color additives exempt from certification also are required to meet rigorous safety standards prior to being permitted for use in foods.
According to the Nutrition Labeling and Education Act of 1990, a certifiable color additive used in food must be listed in the ingredient statement by its common or usual name. All label printed after July 1, 1991 must comply with this requirement.

((2)). Color additives exempt from certification :
These are obtained largely from plant, animal, or mineral sources. They are not subject to batch certification requirements, but they are still artificial color additives and must comply with regulatory requirements. Both types of color additives are subject to rigorous safety standards.
•-Natural colors,
--the term "natural colors" does not legally exist and is not recognized by FDA.
--It was left up to each manufacturer to define "natural” for itself.
• Nature Identical Colors:
--These colors are also manufactured by chemical synthesis, but do not require FDA certification, and are considered chemically and functionally indistinguishable from the same colorant found in nature, for example : Beta-Carotene synthesized from Acetone.

Colors Exempt from Certification
Annatto extract, B-Apo-8'-carotenal*, Beta-carotene, Beet powder, Canthaxanthin, Caramel color, Carrot oil, Cochineal extract (carmine); Cottonseed flour, toasted partially defatted, cooked; Ferrous gluconate *, Fruit juice, Grape color extract*,
Grape skin extract* (enocianina), Paprika, Paprika oleoresin, Riboflavin, Saffron, Titanium dioxide*, Turmeric, Turmeric oleoresin, Vegetable juice
* These food color additives are restricted to specific uses.

So how safe are they ?
There is no such thing as absolute safety of any substance. Color additives are very safe when used properly. Food Drug Administration (FDA) regulates color additives used in the United States. This includes those used in food (and dietary supplements), drugs, cosmetics, and medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency and must be used only in compliance with the approved uses, specifications, and restrictions. Information on intended uses for a batch of color additive is used to assure that a batch of certified color additive will be used in accordance with the requirements of its listing regulation.

In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Color additives that FDA has found to cause cancer in animals or humans may not be used in FDA-regulated products marketed in the United States.
Approval of a color additive for one intended use does not mean approval for other uses. For example, no color additives have been approved for injection into the skin even though tattoo parlors often claim that the pigments in their inks are "FDA-approved." Likewise, no color additives are approved for permanent makeup (a form of tattooing). And henna is approved for use on the hair, but not the skin. FDA assures that only safe color additives will be used in foods, drugs, cosmetics, and medical devices sold in the United States.

FDA lists color additives that have been shown to be safe for their intended uses in title 21 of the Code of Federal Regulations (CFR). FDA requires batch certification for all color additives listed in 21 CFR part 74 and for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification.

Examples :
Color additive,FDA approved
FD&C Blue No.1
(.)Human Foods:Foods generally./1969,Added Mn spec./1993,
(.)Drugs:Ingested drugs generally./1969, Externally applied drugs/1982,Eye area use (include lake)/1994
(.)Cosmetics: Cosmetics generally./1982, Allows MnO2 in manufacture/1993

DC Green No.5
(.)Drugs:Drug generally/1982,Eye area use (includes lake)/1994
(.)Cosmetics:Cosmetic generally/1982, Eye area use/1994.

If the color additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used and how it should be identified on food labels. Color additives proposed for use in meat and poultry products also must receive specific authorization by USDA.

Reactions to color additives are rare. It is possible, but rare, to have an allergic-type reaction to a color additive. For example, FD&C Yellow No. 5 may cause itching and hives in some people. This color additive is widely found in beverages, desserts, processed vegetables, drugs, makeup, and other products. FDA requires all products containing FD&C Yellow No. 5 to identify it on their labels so that consumers who are sensitive to the dye can avoid it. On medicine labels, this certified color additive is also identified by its uncertified name, "tartrazine". FDA certified more than 2 million pounds of Tartrazine (FD & C Yellow No.5) yearly.

FDA can take action against companies if there are violations. In the absence of a voluntary action such as a product recall, FDA can issue warning letters, detentions, and import alerts for products that are found to be unsafe or to contain color additives that are prohibited, misused, or not properly identified as ingredients. FDA can also seize such products. Color additive violations are a common reason for detaining imported cosmetic products that are offered for entry into the United States. Color additives in foods and cosmetics marketed abroad are not subject to the same safeguards as those marketed in the United States.

Only 9 certified colors approved for use in food in the USA, they are :
(1) FD & C Blue No.1.……….(Brilliant Blue FCF)…………use for : Beverages, dairy products powders, jellies, confections, condiments, icings, syrups, extracts
(2) FD & C Blue No.2.……….(Indigo Carmine / Indigotine)..use for : Baked goods, cereals, snack foods, ice cream, confections, cherries
(3) FD & C Green No.3.……....(Fast Green FCF)…………..use for : Beverages, puddings, ice cream, sherbert, cherries, confections, baked goods, dairy products
(4) FD & C Red No.3.………..(Erythrosine)………………..use for : Cherries in fruit cocktail and in canned fruits for salads, confections, baked goods, dairy products, snack foods
(5) FD & C Red No.40.………(Allura Red AC)…………….use for : Gelatins, puddings, dairy products, confections, beverages, condiments
(6) FD & C Yellow No.5……..(Tartrazine)………………….use for : Custards, beverages, ice cream, confections, preserves, cereals
(7) FD & C Yellow No.6……..(Sunset Yellow FCF)………..use for : Cereals, baked goods, snack foods, ice cream, beverages, dessert powders, confections
(8) Orange B………………………………………………….use for : These food color additives are restricted to specific uses.
(9) Citrus Red No.2…………………………………………..use for : These food color additives are restricted to specific uses.

Issue on FD & C Red No.3
In 1990, FDA discontinued the provisional listing of all lake forms of FD&C Red No.3 and its dye form used in external drugs and cosmetics. The uses were
terminated because one study of the color additive in male rats showed an association with thyroid tumors. In announcing the decision, FDA that any human risk
posed by FD&C Red No.3 was extremely small and was based less on safety concerns than the legal mandate of the Delaney Clause. FD&C Red No.3 remains
permanently listed for use in food and ingested drugs, although FDA has announced its intent to propose rescinding those listings.
Decision about the safety of food color additives sometimes changed :
Since absolute safety of any substance can never be proven, decisions about the safety of color additives or other food ingredients are made on the best scientific
evidence available. Because scientific knowledge is constantly evolving, federal officials often review earlier decisions to assure that the safety assessment of a food
substance remains up-to-date. Any change made in previous clearances should be recognized as an assurance that the latest and best scientific knowledge is being
applied to enhance the safety of the food supply.

Do food color additives cause hyperactivity ?
Although this theory was popularized in the 1970's, well-controlled studies conducted since then have produced no evidence that food color additives cause
hyperactivity or learning disabilities in children. A Consensus Development Panel of the National Institutes of Health concluded in 1982 that there was no scientific evidence to support the claim that colorings or other food additives cause hyperactivity. The panel said that elimination diets should not be used universally to treat childhood hyperactivity, since there is no scientific evidence to predict which children may benefit.

Dyes and Lakes
Certifiable color additives are available for use in food as either "dyes" or "lakes."
Dyes dissolve in water and are manufactured as powders, granules, liquids or
other special purpose forms. They can be used in beverages, dry mixes, baked goods, confections, dairy products, pet foods and a variety of other products.
Lakes are the water insoluble form of the dye. Lakes are more stable than dyes and are ideal for coloring products containing fats and oils or items lacking sufficient
moisture to dissolve dyes. Typical uses include coated tablets, cake and donut mixes, hard candies and chewing gums.

Delaney clause
In 1960, amendments to the Food, Drug, and Cosmetic Act of 1938 added the so-called Delaney anti-cancer clause to FDA's legal mandate. Among other things,
the clause prohibits marketing any color additive the agency has found to cause cancer in animals or humans, regardless of amount.
FDA applied the Delaney clause in 1990 when it outlawed several uses of the strawberry-toned FD&C Red No. 3. The banned uses include cosmetics and
externally applied drugs, as well as uses of the color's non-water-soluble "lake." FDA previously had allowed these "provisional" uses while studies were in progress
to evaluate the color's safety. Research later showed large amounts of the color causes thyroid tumors in male rats.

References : U.S. Food and Drug Administration,
Center for Food Safety and Applied Nutrition.