ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
ESTABLISHING
STANDARDS
ON COLORS FROM
NATURAL SOURCES*
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
1
Background
1
Food and beverage colors are used in a
wide range of different products. Numerous
Certified colors, subject to the
studies have concluded that color is at FDA certification process
least as important as flavor in determining
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consumer preference for a given food
product.
Colors exempt from certifications,
often referred to as ‘natural’ colors
Color additives are defined by the Food
and Drug Administration (FDA) as any dye,
pigment, or substance that can impart color In recent years, consumer interest and
to a food, drug, cosmetic or to the human demand for “natural” colors has led to
body. Under the present regulations, color growing use of exempt plant extracts and
additives fall into two categories: other materials as food colorants.
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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adulterated with colorants, such as chalk in milk.
Natural Sources In 1396, the first decree prohibiting the use of
colorants in milk was issued in Paris (Burrows
Current regulations for colorants from “natural 2009). Until the middle of the 19th century, all
sources” lack a consistent definition as well as colorants used in foods, drugs and cosmetics
publicly available quality control and product were from animals, vegetables and minerals - all
safety specifications. There is also a lack of natural sources. In 1856, Sir William Henry Perkin
agreement regarding appropriate methods for discovered the first synthetic organic dyestuff, and
“
testing the purity of these colorants. A survey artificial colors took off (Burrows 2009).
66%
conducted by Sensient Colors in 2015 reported
that 34% of American consumers surveyed were
either very or extremely concerned about synthetic
or artificial food colorings and 66% were at least
somewhat concerned. This represents a significant
and growing market share that has been
undervalued and underserved.
To address the pressing need for consistent
standards for generation and application of colors of American consumers
were at least somewhat
from natural sources, a panel of experts in plant
biology, food chemistry, food toxicology, food
product development and manufacturing, as well
as food quality and regulatory affairs was created.
The focus of this expert panel was to discuss and concerned about
synthetic or artificial
deliberate quality attributes and potential safety
”
hazards affecting food colorants from natural
sources. This effort was sponsored by Sensient
Technologies in collaboration with the U.S.
Pharmacopeial Convention. food colorings
Historical Perspective In 1886, the U.S. Congress passed the first bill
allowing colorants in butter and in 1896 Congress
on Color Regulations recognized colorants in cheese (U.S. Congress,
1896). The rise of the use of colorants was
Colorants have a long history, dating back to prompted by changes in food technology—more
ancient Egypt, where they were used to color processed foods, use of preservatives, refrigeration
food and cosmetics. Foods have also long been and canning, all of which altered the natural
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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appearance of foods. Consumers then began or polished with intent to deceive or to make the
demanding that something be done to restore the article appear of better quality than it really is.”
natural color of foods. Dr. Bernhard Hesse, who was hired as an outside
consultant by the Division in 1906, conducted
Dr. Harvey Wiley took over the Division of extensive studies on hundreds of colorants to
Chemistry (the early Food and Drug Administration) determine which ones could be safely added
in 1883, with a major goal of protecting the purity to food. He proposed a list of 7 colorants and
of the nation’s food supply. States were passing established a procedure for the certification of
their own laws, which prompted a demand from these and future colorants. Up until then, quality
industry for consistent standards. In 1899, the had been poor and some firms took up the
National Confectioners’ Association issued a challenge to make purer colorants. One of these
circular that enumerated 21 coal-tar colorants companies was H. Kohnstamm & Co. On April 1,
found in foods that they considered harmful and 1908, the first batch of colorants produced by the
unfit for human consumption. company was certified. Then the Food, Drug and
Cosmetic Act was passed in 1938—giving teeth to
In the 1906 Pure Food and Drug Act, a food was the 1906 Act (Burrows 2009).
declared adulterated “if it be colored, powdered
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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As this white paper will illustrate, there are similar In 1960, the FDA passed the Color Additive
areas of concern with colorants from synthetic Amendment, which also included the “Delaney
and natural sources and, as demand for natural Clause.” The amendment defined the term “color
colorants increases, better standards will be additive” and required that only color additives listed
needed to ensure they are safe for consumption. as “suitable and safe for a given use could be used
in foods, drugs, cosmetics and medical devices.”
The amendment outlined the procedural regulations
Current Regulatory Situation for the petition process for a color to be listed.
Also included through the Delaney Clause, was a
The FDA oversees color additives in foods, drugs,
prohibition of listing a color if it was shown to be a
cosmetics and medical devices. All color additives
carcinogen.
that are required to be listed by the FDA fall
into two categories: Those subject to the FDA’s
Certification-exempt color additives must comply with
certification process, and those that are exempt.
identity and purity specifications and use limitations
Those that are exempt are generally those derived
described in their listing regulations (in Section 401 of
from plant or mineral sources.
the Act), establishing some basic standards for these
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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“ With
substances. In Title 21 of the CFR, parts 70 to 82, the
FDA issued certain regulations for color additives.
In these sections, the identity of each listed color
additive, its chemical specifications and identified
increasing demand
uses and restrictions are described. The use of an
unlisted color additive, or the use of a color additive
that doesn’t conform to the purity and identity
specifications of the listing regulation may cause a
product to be considered adulterated, according to for natural colorants
comes the requisite
the provisions of the FD&C Act, and the FDA may take
enforcement action against such products.
While the FD&C Act allows food ingredients to be
exempt from the definition of a “food additive” if need and expectation of
a reliable and consistent
they are GRAS (generally recognized as safe), such an
exemption does not apply to color additives.
supply of defined raw
”
There are examples of GRAS ingredients that are also
listed as color additives, such as ferrous lactate (21
materials.
CFR 184.1311 and 21 CFR 73.165). Therefore, even
if a substance is listed as a GRAS substance, it would
still require pre-market approval by the FDA as a color
additive.
All of these factors contribute to a supply of
inferior plant pigments, creating a climate in
Trends which some individuals may compensate with the
addition of adulterants. The field of medicinal and
With increasing demand for natural colorants comes aromatic plants is challenged by a similar concern.
the requisite need and expectation of a reliable and As a consequence, the WHO drafted a series of
consistent supply of defined raw materials. In the publications that serve as guidelines for the wild
future, global food and food ingredient shortages crafting/collection and cultivation of medicinal and
could occur due to many factors, ranging from aromatic plants (WHO 2003). Such guidelines are
environmental degradation, loss of agricultural now used around the world and help provide the
areas due to increasing urbanization, infrastructural framework for traceability from the origin of the
limitations in developing countries, competition for plant through the value chain into a final processed
food production and even political instability, to the product and can be used if/when needed for ethical
effects of climate change and population growth. sourcing and provide established guidelines for
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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How often do other the documentation of non-adulterated and non-
contamination of raw materials.
people ask your The Consequences to an Industry with a
opinion when making Lack of Controls
purchase decisions?
The natural food colors industry can look to the
experiences of the herbal products industry to avoid
similar fates. As noted, natural colors are enjoying
annual sales growth and increased consumer
demand. People are seeking food products with
natural colors over those that are artificially colored in
the belief that those foods are safer. One food safety
33% incident, coupled with media exposure of the lack
of standards and food safety testing, is all it takes
55% for natural colors to be abandoned by consumers.
The industry would experience a significant drop in
sales as a result. This statement is not made from
conjecture, but from direct experience with the history
49%
of herbal products.
Prior to the passage of the Dietary Supplement Health
35% and Education Act (DSHEA) of 1994, herbal products
(now called dietary supplements) enjoyed a good
reputation with, and enthusiasm from, consumers.
11% 6%
Prior to passage, Congress received the most
correspondence from consumers since the Vietnam
War (wanting the FDA to NOT restrict the sale of
Total Moms Millennial Moms herbal products). When DSHEA was passed, in fact,
the industry grew at an even faster rate, as the FDA
Frequently had clearly laid out the ‘rules’ or regulations to which
companies needed to adhere (and they were not
Occasionally strict), so that companies now had the confidence to
invest in product development and marketing. In the
Rarely 4.5 years after the passage of DSHEA, the industry
grew exponentially to an estimated US$12 billion.
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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However, the FDA was slow in developing the of these adulterants, even when from natural sources,
final key standards needed (the GMP regulations, may contain other allergenic and/or potentially toxic
namely) to lend credence to the industry, and this materials or lower cost plant materials not easily
became the material the critics used to ‘debunk’ discovered, especially if the colorant is screened only
“
the industry, especially as a controversy was for the concentration of a particular color compound.
building with the herbal supplement ephedra. Since
The origin
then, the industry has ridden the rising and falling
tides of consumer distrust.
Hazard Analysis
The origin of raw material sources is an area of
serious concern, largely due to the presence of heavy
of raw material sources
metals, which is more common in material originating
from some countries. Some safety issues are is an area of serious
indigenous to each raw material and it is unclear to
what degree blending and other practices contribute
to violations.
concern, largely due to
the presence of heavy
”
As raw material is the starting place for any natural
product, and is a source of adulteration, this is where
the standard-setting process should begin. Typical to
the trade of raw materials and natural products is the
metals.
development of ‘specification sheets,’ which would be
crosschecked with a ‘certificate of analysis.’
Adulteration from Raw Materials
Botanical Authentication Many of the starting points for the development
of natural colors for foods include the use of raw
There are several models and practical approaches material from botanicals. The problem of adulteration
to botanical authentication that can be used for within the herbal industry prompted a study by
natural colorants. Without such authentication, there several industry organizations to take an in-depth
is an increased risk that the material from which the look at commercial plants and their common
natural colorant originates may be purposefully or adulterants. The natural colorant, saffron, has been
inadvertently sourced from plant materials other than particularly vulnerable to adulteration, because
what is disclosed on the label or combined with other it is expensive and difficult to obtain. Although
improperly labeled plants or synthetic materials. Some the adulteration of this favored spice has been a
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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Managing the Key Risk Factors for Natural Colors
Hazards Mitigation Strategy
Test all incoming raw materials for pathogens. Test all finished products
Microbiological
for pathogens and spoilage organisms
Heavy Metals Test for most common heavy metals (FDA, EU & Codex)
Pesticides Test for pesticides that are not allowed (FDA, EU & Codex)
Test for synthetic dyes or other additives that adulterate product.
Adulteration
Screening established for unknown adulterants
Map all supplier process and detail solvents used to ensure they meet
Unauthorized Solvents
all local regulations. Test for the presence of solvents.
Supplier Reliability All vendors should be “certified” by the manufacturer
Raw Material Traceability Need full traceability for all ingredients
problem for hundreds of years, it will continue until several countries, notably China. The key benefit
the industry accepts standards to easily check for to this initiative is to ensure safe colorants in the
the presence of the raw material on a routine basis. marketplace, to build consumer confidence, to
A recent import alert for saffron adulterated with convince more manufacturers and processors to use
unauthorized tartrazine food coloring is evidence natural colors by facilitating a strong, agreed-upon
of the problem. Other adulterants and risk factors approach in their use and definition and, perhaps
to colors from natural sources include microbial most importantly, to preempt a future, serious,
contamination, solvent residues, and pesticide adverse reporting incident resulting from purposeful
residues. A comprehensive testing protocol to identify or inadvertent adulteration and/or contamination.
these risk factors is required. The crops that provide the raw materials from which
natural colorants are produced come from similar
growing regions across the globe. It will take only
Benefits and Conclusion one major product safety incident involving natural
colors to change the entire landscape of the industry.
We are all aware of the food safety incidents Reaching an industry-wide agreement on the
that have occurred with products supplied out of proper collection and harvesting of plants for their
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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natural colors could easily follow the WHO-accepted
guidelines now in place for medicinal plants. The
WHO Guideline on GACP for Medicinal Plants (2003)
could be used as a template to ensure traceability,
beginning with the collection of the plant and ending
with what consumers put on their plates, which is
required of other foodstuffs.
The advantages of development and publishing the
proposed standards include:
Higher quality color sources available to
The Certasure™
processors, therefore raising the quality bar
across the industry
Program
Developing and harmonizing standards will Until either Food Industry trade groups
stimulate trade or the FDA itself defines a specific set of
standards for natural-sourced colorants,
Ensuring a practical system relative to
there is a risk of a similar outcome
botanical authentication
to the herbal supplement market. For
Ensuring consumer product safety this reason, Sensient has created a
comprehensive certification program for
Better definition of product quality
colors from plant sources that combines
Guidance for sourcing stringent quality testing, comprehensive
vendor certification, full raw material
Brand protection of all companies in the
traceability and best manufacturing
supply chain
practices to ensure that colors from
Availability and reference by all in the industry natural sources meet all safety and
authenticity requirements. Backed by
Stimulating industry “self-policing,” thus
preventing the FDA from establishing further Sensient, the global leader in food and
enforcement or restricting trade in natural beverage colors, Certasure™ provides
colors food manufacturers full brand protection.
ESTABLISHING STANDARDS ON COLORS FROM NATURAL SOURCES
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* Source: The Committee on Standards for Natural Colors, 2015
The Committee
Dr. James E. Simon – Lead Author Dr. M. Monica Giusti
Rutgers University Ohio State University
Distinguished Professor of Plant Biology Professor of Food Science and Technology
Dept. of Plant Biology & Pathology 110 Parker Food Science and Technology Bldg
Foran Hall/Cook Campus 2015 Fyffe Road
59 Dudley Road Columbus, OH 43210
New Brunswick, NJ 08901
Dr. Carla D. Mejia
Dr. Eric A. Decker United States Pharmacopeia /
University of Massachusetts Amherst Food Chemical Codex
Professor and Department Head of Food Science Senior Scientific Liaison
236 Chenoweth Laboratory 12601 Twinbrook Parkway
Amherst, MA 01003 Rockville, MD 20852
Dr. Mario G. Ferruzzi Dr. Stephen T. Talcott
Purdue University Texas A&M University
Professor of Food Science and Nutrition Professor of Food Chemistry and Nutrition
Dept. of Food Science and Nutrition Science 1500 Research Parkway A, 220F
745 Agriculture Mall Drive College Station, TX 77843
West Lafayette, IN 47906
