General information about additives, colorants, and others

ingredients regulated by the FDA

The substances referred to as "additives" are those that, when added
intentionally to a food product, they become, directly or
indirectly, in part the whole of the food product or modify the
organoleptic characteristics of it. If the additive is added with a purpose
specific, it is then called "direct additive" (see 21CFR170.3)
while indirect additives are those that become part
of the food product through packaging or storage (see
21CFR174 to 178.

The "dyes" are all those substances or pigments that modify the
color of a food when added to it (see 21CFR70.3). There are
two types of dyes. Water-soluble dyes (used in
drinks, dairy products, etc.) are referred to as "dykes" while the
insoluble in water, called "lakes", are used in candies,
confectionery, pastries, etc.

The agencies that regulate this type of substances (FDA and USDA) have
prepared a list of authorized substances in such a way that all
Substances not included in this list are understood to be prohibited. From this
way, any new substance that is intended to be used in the manufacture of
a food must be previously authorized by those mentioned
departments.

FDA Regulation

Regarding products regulated by the FDA, additives and colorants

that are intended to be used in manufacturing, processing, packaging,
the transport or storage of a food product must be
previously authorized by the FDA, in the event that such substances do not
are included in the aforementioned list.

Request for authorization of a additive or colorant

Any person can request a specific additive or colorant

is authorized in the composition of the product to be exported to the United States.
This request must be directed to the Office of Premarket Approval.
Prior Approval for Marketing), in triplicate and translated into English
(ver 21CFR71.1 and 21CFR171.1).

It is the applicant's responsibility to provide information that demonstrates that the additive
in question (or any substance that can come into contact with the
same, see 21CFR170.20) is completely harmless to human health.
Specifically, the FDA requires the submission of the following information:

. Name of the food additive.

. Name and address of the applicant
 . The food product intended for the additive.
. Name and address of the manufacturers of said product
food.
. Amount to be used of the additive

Likewise, the FDA requires a series of scientific analyses on the

composition and properties of the additive or coloring agent (see 21CFR71.1 and
21CFR171.1). The FDA may request samples of the additive for testing.
supplementary analysis. In this regard, the FDA uses the system
called Adverse Reaction Monitoring System
of Adverse Reactions) to control the safety of additives in a way
continued.
1.2.) Exemptions (see 21CFR71.18)

Certain additives and colorants do not require obtaining authorization.

previously mentioned above as they are allowed by the FDA and
recognized as safe substances (GRAS, Generally Recognized As Safe,
see 21CFR182, 184 and 186). These substances are considered safe based on
to the history of its usage and the scientific evidence obtained. Not
however, these substances may lose this status if the FDA finds
conclusive scientific evidence to the contrary. In this regard,
indicates that the FDA publishes the list of GRAS substances monthly.

The FDA, after having authorized the new additives or colorings,

list the different food products for which you are
substances can be used as well as the amount of them to be employed
(these conditions are outlined in the 'Good Manufacturing Practices') thus
as its identification on the labeling. The FDA can also declare
these substances are considered GRAS.

FSIS

Regarding the products regulated by the FSIS (see section 1), the
additives and colorants that are intended to be used in them as well
must be authorized in advance (see 9CFR318.7). These substances
must have previously been approved by the FDA or have obtained
from the same the condition of FAT.

Request for authorization

After the authorization by the FDA, the substance in question must be

also authorized by the FSIS upon request of the interested party which
will decide on this approval as well as on the terms of use
of the aforementioned substance.

Authorized substances

The FDA's authorization for the substance in question is not binding.

for the FSIS which may, by virtue of the examination it conducts, prohibit the use
of said substance in meat products even when it is authorized
by the FDA.

The FSIS has a list of authorized substances as well as the

classification, mode of use and products for which these
substances are authorized. This list, for poultry products, can be
obtain in 9CFR318.147, and, for the rest of the products in 9CFR424.

It is emphasized that the irradiation technique for meat products is

considered by the FSIS as an additive and, as such, subject to the
corresponding regulation (see 9CFR318.7 for pork meat and
9CFR381.135, 147 and 149 for poultry meat.

Food Additives Regulated by the FDA:

Generally Recognized as Safe (GRAS)

"GRAS" is an acronym for the phrase generally recognized as safe.

According to articles 201 (s) and 409 of the Federal Food Law,
Medicines and Cosmetics (the Law), any substance that is added
Intentionally to food is a food additive, which is subject
for review and approval before the FDA, unless the substance
it is generally recognized, among qualified experts, as if it had been
adequately shown to be safe under the conditions of its use
anticipated, or the use of the substance otherwise excluded from the
definition of food additive.

According to articles 201 (s) and 409 of the Law and the regulations of
application of the FDA in 21 CFR 170.3 and 21 CFR 170.30, the use of a
Food substance can be FATTY either through the procedures
scientists or, for a substance that is used in food before
1958, through experience based on common use in food.

Under 21 CFR 170.30 (b), the general recognition of safety to

through scientific procedures requires the same amount and
quality of the scientific evidence required to obtain the
approval of the substance as a food additive and generally
It is based on published studies, which can be corroborated by
unpublished studies and other data and information.

Under 21 CFR 170.30 (c) and 170.3 (f), the general recognition of
security through experience based on common use in the
food requires an important history of consumption for use
food-related by a significant number of consumers.
The Food and Drug Administration
The FDA of the United States has a list of food additives
generally recognized as insurance. Many of them have not been
subjected to no test, but the scientific community considers them
insurance. These substances are on the list of generally recognized
like GRAS (Generally Recognized as Safe), which contains about
700 products. Examples of some products from this list are the
guar gum, sugar, salt, and vinegar. The list is continuously evaluated.

The Congress defines the safe character of a product as: 'the certainty
reasonable that no damage will occur from the use of a
additive. It is possible that some substances that are considered harmful for
people and animals are admitted only at a level of one hundredth
part of the amount that is considered dangerous. This safety margin
it is a protection for the consumer, by limiting the consumption of a
hazardous substance. For example, some people are allergic to the
Sulfites and their reactions can be very mild or very severe. For your own
protection, people with allergies or intolerances to certain types of food
you should always check the list of ingredients that is found in the
product label.

The list of additives has changed tremendously since the time when
that the government began to monitor its security. It is still important to gather
information about the safety of food additives and it
invites the general public to report to the FDA about any reaction
adverse related to food or food additives.

Substances that are generally recognized as safe

A. It is impossible to list all the substances that are generally

recognized as safe for the intended use. However, as a way
In illustration, the Commissioner refers to such common ingredients.
like salt, pepper, vinegar, baking powder, and glutamate
monosodium as safe for its intended use. This part includes
other substances that, used for the indicated purposes, according to
with good manufacturing practices, they are considered by the
Commissioned as generally recognized as safe for
such uses.

B. For the purposes of this section, good manufacturing practices are

define to include the following restrictions:

The amount of a substance that is added to food does not

exceeds the reasonably necessary amount to obtain the
 physical, nutritional technique, or other type of effect on foods,
y
The amount of a substance that transforms into a
component of foods as a result of their use
in the manufacturing, processing, or packaging of food, and
that does not aim to achieve any physical or technical effect
others in the same food, is reduced to the measure of what
reasonably possible.
The substance is of appropriate food quality and is
prepared and handled like a food ingredient.
the Commissioner's request will offer an opinion, based on the
specifications and intended use, regarding whether or not a
determined degree or quantity of the substance of purity
suitable for use in food and are generally considered
insurance for the intended use, by qualified experts for
evaluate its security.

C. The inclusion of substances in the list of nutrients that does not constitute
a failure on the part of the Department that the substance is useful as
a dietary supplement for humans.

D. Substances that are generally recognized as safe for

its use in the sense of Article 409 of the Law is listed in this
part. When the state of a substance has been reevaluated, it will be
removed from this part, and will be published as a new regulation in
the corresponding part, for example, "he stated as FAT" in the
part 184 or 186 of this chapter, 'food additive regulation' in
the sections 170 to 180 of this chapter, "Provisional Regulations of
food additives "in part 180 of this chapter, or" prohibited the
use in food "in section 189 of this chapter.

Spices and other condiments and flavorings

natural
The spices and other condiments and natural flavorings that are
generally recognized as safe for the intended use, in the sense
from article 409 of the Law, are the following:

Botanical name of the

Common name
plant source
Alfalfa herb and seeds Alfalfa

Allspice Pimenta officinalis Lindl.

Ambrette Seed Hibiscus Abelmoschus L.
Angelica L. archangelica
Angelica
other spp. of Angelica.
Angelica root To do.

Angelica Seeds To do.

Angostura (Cusparia bark) Galipea officinalis Hancock.

Anise Anise (Pimpinella anisum L.)

Star anise Illicium verum Hook. f.

Melissa (lemon balm) Melissa officinalis L.

Basil, the shrub Ocimum L. minimum

Sweet basil Basil

Bay Laurus nobilis L.

Marigold Calendula officinalis L.

Chamomile, English or
Noble chamomile
Romanian
Chamomile (manzanilla), German
Matricaria chamomilla L.
the Hungarian

Capers Capparis spinosa L.

Capsicum frutescens L. and
Pepper
Capsicum annuum L.
Cumin Caraway
Caraway, black (cumin)
Nigella sativa L.
black
Elettaria cardamomum
Cardamom (cardamom)
Maton.
Cinnamon cassia
Cassia, Chinese
Flower.
Cinnamomum burmanni
Cassia, Padang or Batavia
Flower.
Cinnamomum loureirii
Cassia, Saigon
None.
Capsicum frutescens L. and
Cayenne pepper
Capsicum annuum L.
celery seed Celery
Anthriscus cerefolium (L.)
Perifollo
Hoffm.
Chives Allium schoenoprasum L.
Ceylon cinnamon
Ceylon cinnamon
Needs.
Cinnamon cassia
Chinese cinnamon
Flower.
Cinnamomum loureirii
Cinnamon, Saigon
Needs.
Clary (salvia) Salvia sclarea L.

Clover Trifoliumspp.

Cilantro Coriandrum sativum L.

Cumin (cumin) Cuminum cyminum L.

The cumin, the black (black of
Nigella sativa L.
caraway
Elder flowers American elderberry

Fennel, the common Foeniculum vulgare Mill.

Sweet fennel (Finocchio, fennel) Fennel
from Florence var. duice (DC.) Alex.
Fenugreek
Fenugreek
L.
Galanga (galangal) Alpinia officinarum Hance.

Geranium Pelargonium spp.

Ginger Ginger

Grains of paradise Amomum melegueta Rosc.

Hoarhound Marrubium vulgare L.

Armoracia lapathifolia
Horseradish
Gilib.
Hyssop Hyssopus officinalis L.

Lavender Lavandula officinalis Chaix.

Linden flowers Tilia spp.

Fun Myristica fragrans Houtt.

Marigold, pot Calendula officinalis L.

Marjoram, pot Majorana onites (L.) Benth.

Majorana hortensis
Marjoram, sweet
Mendicant.
Mustard, black or brown Black mustard

Mustard, brown Brassica juncea (L.) Coss.

Mustard, white or yellow Brassica hirta Moench.

nutmeg Myristica fragrans Houtt.

Oregano (oregano, oregano
Mexican, Mexican sage, Lippia spp.
oregano
Paprika Capsicum annuum L.
Curly parsley
Parsley
(Mill.) Mansf.
Black pepper Black pepper
Capsicum frutescens L. and
Cayenne pepper
Capsicum annuum L.
Red pepper Make.

White pepper Black pepper

Mint Peppermint L.

Poppy seed Opium poppy

Marigold pot Marigold (Calendula officinalis L.)

Marjoram pot Majorana onites (L.) Benth.

Rosemary Rosemary

Saffron Crocus sativus L.

Wise Sage
The wise man, the Greek Salvia triloba L.
Saturea hortensis L.
Tasty, summer
Satureja
Satureja montana L.
Tasty winter,
Satureja.
Sesame Sesame indium L.

Peppermint Mentha spicata L.

Star anise Illicium verum Hook. f.

Tarragon Artemisia dracunculus L.

Thyme Thyme

Thyme, wild or reptiles Thyme (Timo serpyllum L.)

Turmeric Turmeric
Vanilla planifolia Andr.
Vanilla Tahitian vanilla JW
Moore.
Cedoaria Curcuma zedoaria Rosc.

Essential oils, oleoresins (without solvents), and

natural extracts (including distillates)
Essential oils, oleoresins (without solvents), and extracts
natural (including distilled), which are generally
recognized as safe for the intended use, in the sense of
Article 409 of the Law is as follows:

Botanical name of the fountain

Common name
from the plant
Alfalfa Alfalfa

Allspice Pimenta officinalis Lindl.

Bitter almond Prunus amygdalus Batsch, Prunus
(acid free armeniaca L., Prunus persica Batsch
Prussian) o (L.).
Ambrette (seed) Hibiscus moschatus Moench.

Angelica root Angelica archangelica L.

Angelica Seeds to Do.

Angelica mother To do.

Angostura (bark
Galipea officinalis Hancock.
cusparia
Anise Pimpinella anisum L.
Ferula assa-foetida L. and species
Asafoetida
fines. of Ferula.
Melissa (lemon balm) Melissa officinalis L.

Balm of Peru Myroxylon pereirae Klotzsch.

Basil Basil (Ocimum basilicum L.)

Bay leaves Bay laurel

Bay (myrcia oil) Pimenta racemosa (Mill.) JW Moore.

Bergamot Bergamot orange (Citrus aurantium L. subsp. bergamia)

bergamot orange Wright et Arn.

Bitter almonds Prunus amygdalus Batsch, Prunus
acid-free armenian apricot, peach
Prussian o (L.).
Rosewood Aniba rosaeodora Ducke.

Cocoa Theobroma cacao L.

Manzanilla
(chamomile) Flowers, the Matricaria chamomilla L.
Hungarian
Chamomile
(chamomile) flowers, Noble chamomile L.
Roman or English
Cananga Cananga odorata Hook. f. and Thoms.
Capsicum frutescens L. and Capsicum
Pepper
annuum L.
Caraway Caraway
Cardamom the
Elettaria cardamomum Maton.
seeds (cardamom)
Carob Carob tree L.

Carrot Carrot

Cinnamon bark Croton eluteria Benn.

Cassia bark,
Cinnamomum cassia Blume.
Chinese
Cassia bark,
Cinnamomum burmanni Blume.
Padang or Batavia
Cassia bark,
Cinnamomum loureirii Nees.
Saigon
Celery seed Celery
Cherry, bark
Prunus serotina Ehrh.
wild
Perifollo Anthriscus cerefolium (L.) Hoffm.

Chicory Chicory
Cinnamon bark of
Cinnamomum zeylanicum Nees.
Ceylon
Cinnamon bark,
Cinnamomum cassia Blume.
Chinese
Cinnamon bark,
Cinnamomum loureirii Nees.
Saigon
Cinnamon leaf of
Cinnamomum zeylanicum Nees.
Ceylon
Cinnamon leaf, Chinese Cinnamomum cassia Blume.
Cinnamon leaf,
Cinnamomum loureirii Nees.
Saigon
Lemon balm Cymbopogon Nardus Rendle.

Citrus peels Citrus species

Clary (salvia) Clary sage

Clover Trifolium spp.

Coca Erythroxylum coca Lam. and others
(decocainized) species of Erythroxylum.
Cafe Coffea spp.
Cola acuminata Schott and Endl., Y
The cola nut
other species. of Tail.
Cilantro Coriander

cumin Cumin
Orange liqueur
(orange, peel) Bitter Orange
bitter)
Cusparia bark Galipea officinalis Hancock.
Taraxacum officinale Weber and T.
Dandelion
laevigatum DC.
Dandelion root To do.
Dog grass
(quackgrass, Agropyron repens (L.) Beauv.
Wheat
Elderflower Sambucus canadensis L. and S. nigra I.
Estragol (esdragol,
Artemisia dracunculus L.
dragon, tarragon
Tarragon (tarragon) To do.

Sweet fennel Fennel

Fenugreek Fenugreek

Galanga (galangal) Alpinia officinarum Hance.

Geranium Pelargonium spp.

Geranium, from the Indies
Cymbopogon martini Stapf.
Eastern
Geranium, rose Pelargonium graveolens L'Her.

Ginger Ginger

Pomelo Citrus paradisi Macf.

Guava Psidium spp.

Hickory bark Carya spp.

Hoarhound (Marrubium vulgare L.)

Hops Humulus lupulus L.

Horsemint Monarda punctata L.

Hyssop Hyssopus officinalis L.

Everlasting Helichrysum augustifolium DC.

Jasminum officinale L. and others
Jasmine
species of Jasminum.
Juniper (berries) Common Juniper
Cola acuminata Schott and Endl., Y
Kola nut
other species. of Tail.
Laurel berries Laurel

Bay leaves Laurus spp.

Lavender Lavandula officinalis Chaix.

Lavender peak, Lavandula latifolia Vill.

The hybrids between Lavandula
Lavandin officinalis Chaix and Lavandula latifolin
Village.
Lemon Citrus limon (L.) Burm. f.
Lemon balm
(see balm)
Cymbopogon citratus DC.
Lemongrass
Cymbopogon lexuosus Stapf.
Of lemon peel Citrus limon (L.) Burm. f.

Cal Citrus aurantifolia Swingle.

Linden flowers Tilia spp.

Carob Carob tree L,

Little Wolf Humulus lupulus L.

pleasure Nutmeg

Mandarin Citrus reticulata Blanco.

Marjoram, sweet Majorana hortensis Moench.

Yerba mate Ilex paraguariensis St. Hil.

Melissa (see balm)

Menthol Mint species.

Menthol acetate Make.

Molasses (extract) Sugar cane L.

Mustard Brassica spp.

Naringina Citrus paradisi Macf.

Neroli, BIGARADE Bitter Orange

Nutmeg Myristica fragrans Houtt.

Onion Onion
Orange, flowers
Bitter orange
bitter,
Orange, peel
To do.
bitter
Leaf orange Citrus sinensis (L.) Osbeck.

Orange, sweet Do.

Orange, flowers
Do.
sweets,
Orange peel
To do.
sweets,
Oregano Origanum spp.

Palmarosa Cymbopogon martini Stapf.

Paprika Capsicum annuum L.

Parsley Parsley

Black pepper Black pepper

White pepper To do.

Mint Peppermint

Balm of Peru Myroxylon pereirae Klotzsch.

Petitgrain Bitter orange

Lemon petitgrain Citrus limon (L.) Burm. f.

Mandarin petitgrain
Citrus reticulata Blanco.
the tangerine
Pepper Pimenta officinalis Lindl.

Pepper leaf Pimenta officinalis Lindl.

Pipsissewa leaves Chimaphila umbellata Nutt.

Granada Pomegranate
Xanthoxylum (or Zanthoxylum)
Ash bark
Americanum Molino. or Xanthoxylum
thorny
clava-herculis L.
Rosa alba L., Rosa centifolia L., Rosa
Absolute rose Damask rose, Gallica rose
and VARs. of these spp.
Rose (rose oil,
Make.
essence of roses
Rose buds To do.

Rose flowers To do.

Rose of the fruit (the
Do.
hips)
Geranium rose Pelargonium graveolens L'Her.

Rose petals Rose species

Romero Rosemary

Saffron Crocus sativus L.

Wise Sage

The wise man, the Greek Salvia triloba L.

Sage, Spanish Salvia lavandulaefolia Vahl.

Saint John's Bread Carob tree

Tasty, summer Savory

Tasty winter, Satureia montana L.

Peruvian pepper tree Schinus molle L.

Endrina berries
Blackthorn
blackthorn berries
Mint Spearmint

Lavender peak Lavandula latifolia Vill.

Tamarind Tamarindus indica L.

Mandarin Citrus reticulata Blanco.

Tarragon Artemisia dracunculus L.

Tea Thea sinensis L.

Thymus vulgaris L. and Thymus zygis var.
Thyme
gracilis Boiss.
The thyme, the white Make.
Thyme, wild or
Thyme-leaved sandwort
reptiles
Wheat (see herb
dog
Nardo Polianthes tuberosa L.

Turmeric Turmeric
Vanilla planifolia Andr. ovainilla
Vanilla
tahitensis JW Moore.
Purple flowers Viola odorata L.

Violet leaves To do.

Violet leaves
To do.
absolute
Cherry bark
Prunus serotina Ehrh.
wild
Ylang-ylang Cananga odorata Hook. f. and Thoms.

Fungus bark Curcuma zedoaria Rosc.

Natural extracts (without solvents) that are used along with spices, seasonings and
flavorings

Natural extracts (without solvents) that are used together with the
spices, condiments, and flavorings that are generally
recognized as safe for the intended use, in the sense of the
Article 409 of the Law is as follows:

Botanical name of the fountain

Common name
from the plant
Apricot pit
Apricot
peach oil
Peach kernel (oil
Prunus persica Sieb. et Zucc.
Persian
Peanut stearin Arachis hypogaea L.

Fifteen seeds Cydonia oblonga Miller.

Some other spices, condiments, essential oils,

oleoresins and natural extracts

Certain other spices, condiments, essential oils, oleoresins

and natural extracts that are generally recognized as
insurance for the intended use, in the sense of article 409 of the Law,
they are the following:

Common name Derivation

Ambergris Physeter macrocephalus L.

Beaver Castor fiber L. and C. canadensis Kuhl.

Civet (zibeth, African civet, Viverra civetta Schreber
zibet, zibetum and Viverra zibetha Schreber.
Cognac oil,
Ethyl Enanthate, the so-called.
white and green
Musk The musk deer, Moschus
Tonquin moschiferus L.

Synthetic flavoring substances and additives

The synthetic flavoring and auxiliary substances that are
generally recognized as safe for the intended use, in the
The meaning of article 409 of the Law is as follows:

. Acetaldehyde (ethanal).
. Acetoin (acetyl methylcarbinol).
. Anetole (parapropenyl anisole).
. Benzaldehyde (benzoic aldehyde).
. N-butyric (butanoic acid).
. d - o L-carvone (carvone).
. Cinnamaldehyde (cinnamic aldehyde).
. Citral (2,6-dimethyloctadien-2, 6 - aldehyde -8, geranial, neral).
. Decanal (N-decylaldehyde, capraldehyde, capric aldehyde,
caprinaldehyde, C-10 aldehyde.
. Ethyl acetate.
. Ethyl butyrate.
. 3-methyl-3-phenyl glucidic ethyl ester of the acid (ethyl-methyl-phenyl-
glycidate, called strawberry aldehyde, C-16 aldehyde.
. Etilvanillin.
. Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1-ol).
. Geranyl acetate (geraniol acetate).
. Limonene (d, l-, and DL-).
. Linalool (linalool, 3,7-dimethyl-1,6-octadien-3-ol).
. Linalyl acetate (bergamot).
. Methyl anthranilate (methyl-2-aminobenzoate).
. Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).
. Vanillin.

Substances that migrate from cotton fabrics

cotton used in food packaging
dry
The substances that migrate to food from tissues of
cotton and cotton used in the packaging of dry foods that
are generally recognized as safe for their intended use, in
The meaning of article 409 of the Law is as follows:

. Beef tallow.
. Carboxymethyl cellulose.
. Refined coconut oil.
. Corn starch.
. Gelatin.
. Pork lard.
. Lard.
. Oleic acid.
. Peanut oil.
. Potato starch.
. Sodium acetate.
. Sodium chloride.
. Sodium silicate.
. Sodium tripolyphosphate.
. Hydrogenated soybean oil.
. Talc.
. Hydrogenated Sebo.
. Fat scales.
. Tapioca starch.
. Tetrasodium pyrophosphate.
. Wheat starch.
. Zinc chloride.

Substances that migrate to food from products

of paper and cardboard

Substances that migrate to food from paper products and

cardboard used in food packaging that is generally
recognized as safe for the intended use, in the sense of the
Article 409 of the Law is as follows:

. Alum (double sulfate of aluminum and potassium of ammonium or of

sodium).
. Of aluminum hydroxide.
. Aluminum oleate.
. Aluminum palmitate.
. Casein.
. Cellulose acetate.
. Corn starch.
. Diatomaceous earth fill.
. Ethyl cellulose.
. Ethylvanillin.
 . Glycerin.
. Oleic acid.
. Potassium sorbate.
. Silicon dioxide.
. Sodium aluminate.
. Sodium chloride.
. Sodium hexametaphosphate.
. Sodium hydrosulfite.
. Sodium phosphoaluminate.
. Sodium silicate.
. Sodium sorbate.
. Sodium tripolyphosphate.
. Sorbitol.
. Isolated soy protein.
. Starch, modified acid.
. Starch, pre-gelatinized.
. Starch, unmodified.
. Talc.
. Vanillin.
. Zinc Hydrosulfite.
. Zinc sulfate.

Colorants Regulated by the FDA

A colorant (or color additive) is any dye, pigment, or substance
that can impart color when applied to a food, medicine,
cosmetic or to the human body. Dyes are used in food because
various reasons, one of which is to compensate for the loss of the
colors, caused by storage or chemical process and to correct
the natural color variations of some foods.

The permitted colors for use in food are classified

as certified and exempt from certification. The certified colorants are
artificial colors, manufactured synthetically, so each batch
it must be tested by the manufacturer and the FDA to ensure that
gather the rules and specifications of purity. The exempt dyes
certification, include pigments derived from natural sources such
such as vegetables, minerals, or animals. Most of the colors
exempt from certification must also comply with certain legal standards
of discernment of specifications and purity.

The colorants approved by the FDA for use in food are

found under the heading of "Color Additives Approved for Use in Humans"
Food within the Summary of Color Additives Listed for Use in the United
States in Food, Drugs, Cosmetics, and Medical Devices
they indicate on the website of the source of information.

Every new dye must be approved by the FDA before being used.
food products that are marketed in the U.S. Once approved, the FDA
Establish in which foods they can be used, the maximum quantities.
allowed and how they should be identified on the product labeling.

Main Colorants approved by the FDA

Blue No. 1 or Brilliant Blue

  Derived from coal tar, which is used as

colorant in beverages, gelatin desserts, ice cream, ice or,
drink powders, confectionery, bakery products,
cereals and puddings. Can cause allergic reactions.
  Produces malignant tumors at the injection site in rats.
  It is on the permanent list of color additives in the
FDA.
  Toxicity evaluated as grade 1A.
  Suspected carcinogenic potential.

Green No. 3

Used in mint-flavored jelly, frozen desserts, dessert of

gelatin, confectionery, bakery products, and cereals.
Produces malignant tumors at the injection site in rats.
The World Health Organization classifies it as 1A of
toxicity, which indicates that it is completely accepted.

Orange B

Coal tar dye. Used for sausages

Frankfurt and sauces.
The additive was limited to no more than 150 ppm by weight.
of the finished food.
In 1978, the FDA said that its use could result in a
exposure of consumers to beta-naphthylamine, a
known carcinogen. However, it has been listed
permanently in the DFA.

Red 40 or Red Allura

Dye that quickly replaced the banned Red No. 2.

The newest and latest general-purpose red dye
used in American food, cosmetics, and medications.
Although Red 40 was identified as a dye of
permanent safety grade by the FDA, after 1971,
 Due to laboratory tests carried out, the dye has been
prohibited since 1973 for being a potential carcinogen.

Yellow No. 6

Used in carbonated drinks, gelatin desserts, powders

for beverages, sweets, and confectionery products that do not
contain oils or fats, bakery products, cereals,
puddings and tablets.
It may cause allergic reactions.
Toxicity grade 1A according to the WHO.

Other permitted and prohibited colorants

Azoic Dyes

Synthetic dyes can be aggressive or dangerous for the

health, particularly those that are part of the azoic group. These
Dyes are part of a family of organic substances.
characterized by the presence of a peculiar group that contains nitrogen
joined to aromatic rings. All are obtained by chemical synthesis, not
none of them existing in nature (E-102, E-110, E-123, E-124, E-
154, E-155)

E-102 Yellow No. 5 Tartrazine

Its use is authorized in more than sixty countries, including the EU and
United States. It is a widely used dye, for example, in
bakery products, cookie manufacturing, meat derivatives, soups
prepared, frozen vegetable preserves and candies. For drinks
refreshing, to which it gives a color of 'Lemon'. Causes allergic reactions
in individuals sensitive to aspirin.

In 1966, the FDA proposed a maximum use of 300ppm for foods, but
later the additive was approved to be used without limitations. By the WHO
It has a toxicity level of 1A (completely plant-based).

E-104 Quinoline Yellow

It is used in refreshing drinks with an 'Orange' color, in beverages

alcoholic beverages, and in the preparation of pastry products, preserves
vegetables, meat derivatives, ice creams, etc. Although there is no data that
indicate potential harmful effects at the concentrations used in the
foods, is not authorized as a food additive in the United States,
Canada and Japan.

E-122 Azorubine or Carmoisine

This dye is used to achieve the color 'Raspberry' in

candies, ice creams, desserts, etc. Their use is not authorized in the Countries
Nordics, United States, and Japan.

E-123 Red No. 2 Amaranth

This colorant 'Red' has been used as a food additive since

early 20th century. It was determined that one of the products of the
decomposition of this dye by intestinal bacteria was able to
cross the placenta to some extent. On the other hand, it has also been
indicated that this dye is capable of producing alterations in the
chromosomes. Although the risks could not be reliably confirmed
from amaranth, the U.S. administration, by not considering it either
fully confident, it was banned in 1976. Its use is accepted in the CE,
but not in some countries like France and Italy.

The World Health Organization said that the dye has been proven to
causes cancer and that the available toxicological data was inadequate
to establish a maximum security limit. They recommended prohibiting it
use in food.

E-124 Cochineal Red A, Ponceau Red 4R

It is used to give a 'Strawberry' color to candies and products.

pastries, ice creams, etc. and also in caviar substitutes and derivatives
meats. It has not been used in the United States since 1976. Its use has been discussed.
possible carcinogenic effect in experiments conducted with hamsters.

E-127 Red No. 3 Erythrosine

It is the most popular coloring in dairy desserts with strawberry flavor.

used in flavored yogurts, in jams, especially in the one of
strawberry, in candies, meat derivatives, tuna or salmon pâtés, in
canned fruit cocktails, fruit salads, cherries, desserts of
gelatin, ice creams, confectionery, bakery products, cereals, and puddings. The
the main health risk of its use is its action on the thyroid,
due to its high iodine content. In 1981 it was reported that it could interfere
with the neurotransmitters of the brain. It is suspected to cause cancer.

E-151 Brilliant Black BN

It is used almost exclusively to color caviar substitutes, although

it is also authorized for other applications. Its use is not permitted in
the Nordic countries, Canada and Japan.

E-132 Blue No. 2 Indigotina, carmine indigo

This dye is used practically all over the world. It is absorbed very
little in the intestine. It is not mutagenic. It is used in beverages, candies,
confectionery, ice cream cereals, bakery products, and drink powders.
It is a navy blue powder that almost always contains chloride or sulfate of
sodium. It decomposes easily with light.

The World Health Organization gives a toxicity of grade B, in which

It is expressed that there is not enough information to accept its use. List
permanently in 1983 by the FDA.

E-142 Bright Acid Green BS, Green Lisamine

It is used in soft drinks, confectionery products, and chewing gum.

candies. From a technological point of view, this coloring would be useful
to color peas and other vegetables whose color is altered by the
destruction of chlorophyll in the blanching prior to freezing or during it
the canning. It is a dye whose use is not authorized in the countries
Nordics, Japan, United States, and Canada. One of the reasons
fundamental for the current limitation of its use is the lack of data
conclusive about its eventual toxicity.