Académique Documents
Professionnel Documents
Culture Documents
Instituto de Investigacin de
Recursos Biolgicos
Alexander von Humboldt
Coordinacin general
Jos Antonio Gmez
Jos Andrs Daz M.
Compilacin y anlisis
Wilmer Marn
Director general:
Fernando Gast Harders
www.humboldt.org.co
Cra. 7 No 35 20
Tel.: 6086900-01-02-03
Bogot, Colombia.
TABLA DE CONTENIDO
RESUMEN
INTRODUCCIN
METODOLOGA
1. GENERALIDADES A CERCA DE LOS EDULCORANTES
1.1. Clasificacin de los Edulcorantes
1.1.1. Edulcorantes Nutritivos
1.1.2. Edulcorantes de Menor Valor Calrico
1.1.3. Edulcorantes No Nutritivos
2. STEVIA REBAUDIANA BERTONI
2.1. Cronologa de la Stevia
2.2. Caractersticas Qumicas
2.2.1. Capacidad Edulcorante
2.2.2. Estabilidad
2.2.3. Composicin
2.3. Algunas Consideraciones Medicas
2.3.1. A cerca de sus Propiedades
2.3.2. A cerca de la Toxicidad
2.4. Usos y Presentaciones
2.5. Produccin
2.6. Mercado
2.6.1. Demanda
2.6.2. Oferta
2.6.3. Precios y Canales de distribucin
2.6.4. Legislacin internacional
Esquema General de la Stevia
CONCLUSIONES y RECOMENDACIONES
BIBLIOGRAFA
ANEXO BIBLIOGRFICO
RESUMEN
Este documento explora la situacin actual del edulcorante Stevia
Rebaudiana Bertoni sealando algunos aspectos relacionados con sus
propiedades medicinales, la controversia respecto a los riesgos que implica
su consumo para la salud humana. La posicin frente a otros endulzantes
algunos de tipo natural como la sacarosa o la miel y otros sintticos con
grandes cuestionamientos a cerca de su toxicidad como el aspartame o el
ciclamato,
Adems se indican algunas
caractersticas del mercado desde la
produccin, la situacin de oferta y demanda, as como la legislacin
internacional referente a la distribucin y comercializacin.
INTRODUCCIN
Los actuales patrones de consumo han llevado al desarrollo de productos
que se adapten a nuevos requerimientos, en el caso de los bienes
relacionados con la alimentacin las condiciones se refieren a caractersticas
de salud, esttica y por supuesto el disfrute de los alimentos. El mercado de
edulcorantes, no escapa a la tendencia y en los ltimos aos se ha dado un
boom en torno a productos , ms dulces y con menos caloras; sin embargo,
muchos de ellos a pesar de su gran acogida en los mercados de
suplementos dietticos, son punto de una fuerte controversia sobre los
efectos que su consumo pueda traer a la salud humana ya sea por su uso
intenso o frecuente.
Entre algunos de los productos bajo dicho
cuestionamiento se encuentran el Ciclamato, el Aspartame y la Stevia, ms
especficamente los compuestos que se extraen de ella como son el
Steviosido y los Rebaudisidos, esto hace que su futuro como uno de los
productos con mayor potencial de comercializacin internacional se
encuentre sujeto a los dictmenes cientficos que sopesan la legislacin en
los pases que figuran como mercados potenciales.
El asunto se mueve en ltimas entre la creciente demanda de productos
naturales alternativos de la cual hace parte la Stevia, la millonaria industria
de productos competidores de este edulcorante y el riesgo latente de los
efectos colaterales que tanto unos como otros tengan sobre la salud
humana.
El objeto de este documento, es expresar de manera general la situacin de
la Stevia en cuanto a su desarrollo, ventajas y debilidades como un producto
de caractersticas naturales y aparente potencial comercial.
METODOLOGA
El presente documento, se elabor en su mayora con base en fuentes
secundarias que se sealan en la bibliografa y algunas en el anexo. El
compendio de informacin sobre el cual se desarroll el documento estuvo
5
1.
alta intensidad. Tanto los edulcorantes con un menor valor calrico, como
los edulcorantes no nutritivos resultan sustitutos de los azcares1.
1.1 Clasificacin de los Edulcorantes2
1.1.1 Edulcorantes Nutritivos
Azcar (Sacarosa)
La sacarosa es el compuesto edulcorante conocido comnmente como
azcar, el cual se extrae de la caa de azcar, de remolacha azucarera, del
sorgo azucarero y del arce de Canad. El complejo azucarero incluye una
serie de productos definidos segn sus caractersticas fisicoqumicas y su
grado de procesamiento3
Azcar blanco refinado.
Azcar blanco de primera calidad y segunda calidad.
Azcar comn tipo A. y tipo B.
Azcar rubio, moreno terciado o negro (no refinado).
Azcar blanco finamente pulverizado con o sin
antiaglutinantes.
adicin
de
Arechederra, Teresa Mingo; Informe Especial -Sistemas Edulcorantes, tentando los sentidos- ;
nfasis Alimentacin Latinoamrica ; Edicin nmero 6 de diciembre 2002-enero 2003.
2
Ibid.
3
Cdigo Alimentario Argentino, Captulo X.
Anexo 1 Directiva 95/31/CE de la Comisin de las Comunidades Europeas; con actualizacin .M3
Directiva 2001/52/CE de la Comisin de 3 de julio de 2001 L 190 18 12.7.2001; por la que se
establecen criterios especficos de pureza de los edulcorantes que pueden emplearse en los productos
alimenticios.
6
Ibid.
10
11
Sacarina y Sales de Na, K y Ca Sacarina Sodica, Potasica, Calcica-; Anexo 1 Directiva 95/31/CE
de la Comisin de las Comunidades Europeas
12
11
Ciclamato
Los Ciclamatos14 se empezaron a utilizar a fines del 60 para uso industrial, a
partir de 1970, ante la sospecha de que poda actuar como cancergeno, se
prohibi su uso como aditivo alimentario en muchos pases, entre ellos
Estados Unidos, Japn e Inglaterra. Es unas 50 veces ms dulce que la
sacarosa, aunque tiene un cierto regusto desagradable, por lo que se mezcla
con la sacarina.
El ciclamato no tiene el status GRAS como aditivo alimentario sin riesgos; en
torno a este se han publicado trabajos indicando que, en animales de
experimentacin, dosis altas de esta sustancia actan como cancergeno y
teratgeno. Aunque no existen estudios concluyentes, su uso como
suplemento diettico esta condicionado al estricto etiquetado de los
productos lo contienen.
Neotame
Neotame es tanto un edulcorante no calrico como un mejorador de sabor.
Es estructuralmente similar al aspartame, pero 30 a 60 veces ms dulce. El
neotame es estable a travs de un amplio rango de aplicaciones. Es similar
en estabilidad al aspartame, pero posee mayor estabilidad que ste en
productos horneados y lcteos. La FDA ya aprob el uso del neotame en
bebidas y alimentos en general dentro de Estados Unidos.
Sucralosa
La sucralosa es 600 veces ms dulce que la sacarosa, es estable al calor y
no se absorbe o metaboliza. Segn la FDA no posee riesgos carcinognicos,
reproductivos, ni neurolgicos en los seres humanos razn por la cual se
aprob en abril de 1998 como aditivo para alimentos. En 1990, el JECFA
increment la ADI de 3.5 mg/kg de peso corporal, a 15 mg/kg de peso
corporal.
Alitamo
El Alitamo es 2.000 veces ms dulce que la sacarosa. La dulzura del alitamo
se describe como similar a la sacarosa, sin notas metlicas ni after-taste
amargo. Es un polvo cristalino e inodoro. Esta aprobado para su uso en
alimentos y bebidas en Australia, Nueva Zelanda, Mxico y China. El alitamo
14
12
13
De la Stevia se tiene conocimiento desde el siglo XVI, pero solo hasta finales
del siglo XIX el Dr. Moiss Santiago Bertoni la dio a conocer en Europa.
Antes de tener conocimiento en Europa, la planta era conocida y utilizada
comnmente por los indios guaranes bajo el nombre de ka-he, lo que en
esa lengua significa hierba dulce.
Esta planta posee excelentes
propiedades edulcorantes y
al parecer medicinales, aunque an no
concluyen los estudios a cerca de las posibles contraindicaciones por su uso.
La Stevia natural, sin refinar, contiene ms de 100 elementos y aceites
voltiles identificados. Comnmente se le utiliza para endulzar alimentos y
bebidas, al igual que la planta llamada lengua de buey o ms popularmente
lenguaza (Anchusa azurea), nctar que tambin es ms dulce que el azcar
y sobre el cual no se conocen estudios.
En la actualidad se utiliza de varias formas, como una simple infusin, en
forma lquida o en forma de cristales solubles, y cada una de estas tendr
diferentes propiedades o aplicaciones.
El rpido desarrollo de la industria de edulcorantes y la bsqueda de
alternativas menos riesgosas que los edulcorantes sintticos tradicionales ha
hecho que su cultivo prospere en pases como Brasil, China, Japn, Corea,
Tailandia, Israel entre otros y su consumo vaya desde la hoja seca hasta
cristales de steviosido pasando por extractos, lociones cosmticas y como
aditivo en diversidad de alimentos.
El Ka He (en guaran, hierba dulce), se denomina cientficamente Stevia
Rebaudiana, perteneciendo a la familia de las Compuestas. La planta es
herbcea y perenne, con hojas simples, inflorescencia capitular y frutos
denominados botnicamente aquenios.
No obstante, la produccin y comercializacin se dificulta debido a los
cuestionamiento sobre su inocuidad, los cuales condicionan la legislacin en
distintos pases. Adems presenta grandes retos inherentes a la planta
como es su proceso de fecundacin cruzada (algama); caracterstica muy
importante al momento de la multiplicacin comercial ya que -en la zona de
origen- existen otras 200 especies de Stevia, que pueden fecundar a la
Stevia Rebaudiana, variando, en forma impredecible, las caractersticas de la
descendencia, respecto al contenido del componente edulcorante.
2.1. Cronologa de la Stevia
14
15
Taiariol. Daro Rubn. El Steviosido y Los Dems Edulcorantes. Basado en Marcavillaca M.C.; Divo
de Sesar M. Stevia rebaudiana Bertoni. Informe agronmico. 1993.
15
16
16
Gutirrez Alicia Ester. Edulcorantes extrados de la Stevia. Coordinacin Jugos, Miel, Productos
Azucarados y Derivados CEIAL - INTI
ibid.
17
Steviadulri web page basado en Duke, James A. Handbook of phytochemical constituents of GRAS
herbs and other economic plants. Boca Raton, FL. CRC Press. 1992.
18
19
Usos y Presentaciones
22
Geuns, J.M.C. (1998) Stevia rebaudiana Bertoni plants and dried leaves as Novel Food. Final version
21.9.1998 with addendum.
23
SCF (1999) Opinion on Stevioside as a Sweetener, adopted on 17/6/1999,
http://europa.eu.int/comm/dg24/health/sc/scf/index_en.html.
Evaluation of Certain Food Additives. WHO Food Additives Series 42:119-143, Geneva,1999.
20
21
24
22
Ibid.
Columbus Mike;
The Cultivation
of en
Stevia, "Nature'
s Sweetener"- Ontario Ministry of Agriculture and
Fotografia:
Dulcestevia,
Esquejes
Food-OMAF-;
Canada,
AgostoSogamoso.
2003.
cmara
hmeda,
27
Ibid.
Colombia.
2002
26
23
Producto
Semillas (Cepas Seleccionadas)
Plantas (Plantines de Cultivo)
Hojas
Extractos
Steviosido en Polvo
Steviosido Refinado
Extracto con Chocolate
Cantidad
1000 g
unidad
100 g
100 ml
1000 g
1000 g
220 g
Precio (Dlares)
400
2
3-5
12 - 15
70 - 140
100 - 310
90 - 140
Aditivo para
alimentos
Tizanas
Extractos (liquido)
Suplemento
diettico
Cristales de steviosido
28
Segn la FDA un suplemento diettico es entendido como toda sustancia que contiene algn
ingrediente diettico como una vitamina, un mineral, alguna hierba o elemento botnico, un aminocido
u otra sustancia diettica para el consumo humano como concentrados, metabolitos, extractos.
Ingerido en pldoras, cpsulas, tabletas, o en forma liquida, que no representa un alimento
convencional o ingrediente o aditivo convencional de los mismos. [Section 201 (ff)(2)(B) of the Act].
25
30
26
27
40
28
En Argentina la Stevia, se
encuentra en el Cdigo
Alimentario Argentino (Cp.
X), en Brasil tambin se
encuentra
aprobada
su
produccin,
distribucin
y
comercializacin.
En
Colombia
se
encuentra
aprobado por el INVIMA su
procesamiento
y
comercializacin.
Fotografa: Dulcestevia, cultivo Tamesis,
Antioquia(Colombia).2002.
Cuadro4:
diettico.
Aprobado Como
Denegado Como
Aditivo
en Suplemento Aditivo
Alimentos
Diettico
Alimentos
Estados Unidos
Unin Europea
Japn
Hong Kong
Canad
Australia
Paraguay
Brasil
Colombia
Singapur
Argentina
29
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No Nutritivos
;/
Edulcorantes
Esquema de la Stevia:
33
Taumatina
Stevia
Aspartame
Sacarina
Acesulfame-K
Ciclamato
Sucralosa
Neotame
Alitamo
CONCLUSIONES Y RECOMENDACIONES
34
BIBLIOGRAFA
Agregadura Agrcola de Chile en Japn; Informe sobre aditivos alimentarios.
Shiba, Minato-ku, Tokio, Japn, Junio de 2002
Alternative Medicine Foundation; Stevia Rebaudiana Bertoni, HerbMed web
page.
Alvarez,M., Bazzone,R.B., Godey,G.L., Cury,R., Botion,L.MI.
Brasilero de Stevia Rebaudiana Bertoni, Campinas, Brazil,1981.
Seminario
35
36
37
(d) Aspartame.
(e) Acesulfame Potassium.
(f) Cyclamic Acid.
(g) Sodium Cyclamate.
(h) Calcium Cyclamate.
(i) Thaumatin.
(j) Sucralose.
Legislative Council Secretariat FS04/01-02
Research and Library Services Division page 3
3.2 European Union
Rationale: Please refer to paragraph 2.1.
Relevant
Legislation:
According to the European Parliament and Council Directive 94/35/EC on
sweeteners for use in foodstuffs OJ No 237, Stevioside is not included in the
list of sweeteners which can be sold to consumers or used in the
manufacturing of foodstuff.
3.3 United States of America (US)
Rationale: ! According to the Food and Drug Administration (FDA), "the
available toxicological information on it [Stevioside] is inadequate to
demonstrate its safety as a food additive or to affirm its status as Generally
Recognized As Safe Substance (GRAS)."
! However, such restriction is not applicable to dietary supplements.
According to FDA, "in the absence of labeling specifying that stevia is being
or will be used for a technical effect, use of stevia as a dietary ingredient in a
dietary supplement is not subject to the food additive provisions of the Food,
Drug, and Cosmetic Act."
Relevant
Legislation:
Food, Drug, and Cosmetic Act.
3.4 Singapore
Rationale: According to the Ministry of the Environment, "the use of stevia in
food products will be approved in Singapore until its safety has been fully
established and recognized by international bodies, such as JECFA."
Relevant
Legislation:
Sale of Food Act (Cap 283), Pt III: Sale of Food.
3.5 Other jurisdictions which do not approve the use of Stevioside as a
sweetener include Canada and Australia, among others.
39
40
Whilst this Act makes no specific reference to Stevia or any other vegetable
or plant extracts, it makes it an offence to sell or possess for sale food which
is injurious to health.
This applies not only to retail sale but throughout the food chain. It would
therefore be an offence to use extracts of Stevia or Stevia plants and leaves
as food or food ingredients (or to offer them for sale) if it were to render the
product injurious to health.
Any food products which were not used for human consumption to a
significant degree within the European Community before 15 May 1997 are
considered to be novel foods and are therefore subject to approval under EC
Directive 258/97 on Novel Foods and Novel Food Ingredients.
An opinion of the SCF on Stevia plants and leaves has meant that approval
under this Regulation has not been granted at the present time.
Any new application to market Stevia or stevioside as a food or food
ingredient would have to include safety studies that sufficiently addressed any
concerns about the potential toxicological effects caused by them.
Any food additive used or intended to be used to impart a sweet taste to food
is subject to the provisions of the Sweeteners in Food Regulations 1995.
These regulations set out a list of permitted sweeteners. Again, following an
opinion issued by the SCF neither Stevia (Stevia rebaudiana Bertoni), Stevia
extracts or stevioside are permitted.
45
Fax.
+81-3-3769-4156
e-mail:
ESTADOS UNIDOS
FDA
Overview of Dietary Supplements
What is a dietary supplement?
Congress defined the term "dietary supplement" in the Dietary Supplement
Health and Education Act (DSHEA) of 1994. A dietary supplement is a
product taken by mouth that contains a "dietary ingredient" intended to
supplement the diet. The "dietary ingredients" in these products may include:
vitamins, minerals, herbs or other botanicals, amino acids, and substances
such as enzymes, organ tissues, glandulars, and metabolites. Dietary
supplements can also be extracts or concentrates, and may be found in many
forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They
can also be in other forms, such as a bar, but if they are, information on their
label must not represent the product as a conventional food or a sole item of
a meal or diet. Whatever their form may be, DSHEA places dietary
supplements in a special category under the general umbrella of "foods," not
drugs, and requires that every supplement be labeled a dietary supplement.
What is a "new dietary ingredient" in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined
both of the terms "dietary ingredient" and "new dietary ingredient" as
components of dietary supplements. In order for an ingredient of a dietary
supplement to be a "dietary ingredient," it must be one or any combination of
the following substances:
a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the diet by increasing the
total dietary intake (e.g., enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
46
A "new dietary ingredient" is one that meets the above definition for a "dietary
ingredient" and was not sold in the U.S. in a dietary supplement before
October 15, 1994.
What is FDA'
s role in regulating dietary supplements versus the
manufacturer'
s responsibility for marketing them?
In October 1994, the Dietary Supplement Health and Education Act (DSHEA)
was signed into law by President Clinton. Before this time, dietary
supplements were subject to the same regulatory requirements as were other
foods. This new law, which amended the Federal Food, Drug, and Cosmetic
Act, created a new regulatory framework for the safety and labeling of dietary
supplements.
Under DSHEA, a firm is responsible for determining that the dietary
supplements it manufactures or distributes are safe and that any
representations or claims made about them are substantiated by adequate
evidence to show that they are not false or misleading. This means that
dietary supplements do not need approval from FDA before they are
marketed. Except in the case of a new dietary ingredient, where pre-market
review for safety data and other information is required by law, a firm does not
have to provide FDA with the evidence it relies on to substantiate safety or
effectiveness before or after it markets its products.
Also, manufacturers do not need to register themselves nor their dietary
supplement products with FDA before producing or selling them. Currently,
there are no FDA regulations that are specific to dietary supplements that
establish a minimum standard of practice for manufacturing dietary
supplements. However, FDA intends to issue regulations on good
manufacturing practices that will focus on practices that ensure the identity,
purity, quality, strength and composition of dietary supplements. At present,
the manufacturer is responsible for establishing its own manufacturing
practice guidelines to ensure that the dietary supplements it produces are
safe and contain the ingredients listed on the label.
When must a manufacturer or distributor notify FDA about a dietary
supplement it intends to market in the U.S.?
The Dietary Supplement Health and Education Act (DSHEA) requires that a
manufacturer or distributor notify FDA if it intends to market a dietary
supplement in the U.S. that contains a "new dietary ingredient." The
manufacturer (and distributor) must demonstrate to FDA why the ingredient is
reasonably expected to be safe for use in a dietary supplement, unless it has
been recognized as a food substance and is present in the food supply.
47
What is FDA'
s oversight responsibility for dietary supplements?
Because dietary supplements are under the "umbrella" of foods, FDA'
s
Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the
agency'
s oversight of these products. FDA'
s efforts to monitor the
marketplace for potential illegal products (that is, products that may be unsafe
or make false or misleading claims) include obtaining information from
inspections of dietary supplement manufacturers and distributors, the
Internet, consumer and trade complaints, occaisional laboratory analyses of
selected products, and adverse events associated with the use of
supplements that are reported to the agency.
Does FDA routinely analyze the content of dietary supplements?
In that FDA has limited resources to analyze the composition of food
products, including dietary supplements, it focuses these resources first on
public health emergencies and products that may have caused injury or
illness. Enforcement priorities then go to products thought to be unsafe or
fraudulent or in violation of the law. The remaining funds are used for routine
monitoring of products pulled from store shelves or collected during
inspections of manufacturing firms. The agency does not analyze dietary
supplements before they are sold to consumers. The manufacturer is
responsible for ensuring that the "Supplement Facts" label and ingredient list
are accurate, that the dietary ingredients are safe, and that the content
matches the amount declared on the label. FDA does not have resources to
analyze dietary supplements sent to the agency by consumers who want to
know their content. Instead, consumers may contact the manufacturer or a
commercial laboratory for an analysis of the content.
Is it legal to market a dietary supplement product as a treatment or cure for a
specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in
labeling* as a treatment, prevention or cure for a specific disease or condition
would be considered an unapproved--and thus illegal--drug. To maintain the
product'
s status as a dietary supplement, the label and labeling must be
consistent with the provisions in the Dietary Supplement Health and
Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by
a manufacturer to promote and market a specific product.
Who validates claims and what kinds of claims can be made on dietary
supplement labels?
FDA receives many consumer inquiries about the validity of claims for dietary
supplements, including product labels, advertisements, media, and printed
50
materials. The responsibility for ensuring the validity of these claims rests with
the manufacturer, FDA, and, in the case of advertising, with the Federal
Trade Commission.
By law, manufacturers may make three types of claims for their dietary
supplement products: health claims, structure/function claims, and nutrient
content claims. Some of these claims describe: the link between a food
substance and disease or a health-related condition; the intended benefits of
using the product; or the amount of a nutrient or dietary substance in a
product. Different requirements generally apply to each type of claim, and are
described
in
more
detail
at
the
following
site:
(http://www.cfsan.fda.gov/~dms/hclaims.html).
Why do some supplements have wording (a disclaimer) that says: "This
statement has not been evaluated by the FDA. This product is not intended to
diagnose, treat, cure, or prevent any disease"?
This statement or "disclaimer" is required by law (DSHEA) when a
manufacturer makes a structure/function claim on a dietary supplement label.
In general, these claims describe the role of a nutrient or dietary ingredient
intended to affect the structure or function of the body. The manufacturer is
responsible for ensuring the accuracy and truthfulness of these claims; they
are not approved by FDA. For this reason, the law says that if a dietary
supplement label includes such a claim, it must state in a "disclaimer" that
FDA has not evaluated this claim. The disclaimer must also state that this
product is not intended to "diagnose, treat, cure or prevent any disease,"
because only a drug can legally make such a claim.
How are advertisements for dietary supplements regulated?
The Federal Trade Commission (FTC) regulates advertising, including
infomercials, for dietary supplements and most other products sold to
consumers. FDA works closely with FTC in this area, but FTC'
s work is
directed by different laws. For more information on FTC, go to:
http://www.ftc.gov/bcp/menu-health.htm. Advertising and promotional material
received in the mail are also regulated under different laws and are subject to
regulation by the U.S. Postal Inspection Service.
How do I, my health care provider, or any informed individual report a
problem or illness caused by a dietary supplement to FDA?
If you think you have suffered a serious harmful effect or illness from a
product FDA regulates, including dietary supplements, the first thing you
should do is contact or see your healthcare provider immediately. Then, you
and your health care provider are encouraged to report this problem to FDA.
51
53
The DSHEA provides for the use of various types of statements on the label
of dietary supplements, although claims may not be made about the use of a
dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific
disease (unless approved under the new drug provisions of the FD&C Act).
For example, a product may not carry the claim "cures cancer" or "treats
arthritis." Appropriate health claims authorized by FDA--such as the claim
linking folic acid and reduce risk of neural tube birth defects and the claim that
calcium may reduce the risk of osteoporosis--may be made in supplement
labeling if the product qualifies to bear the claim. Under DSHEA, firms can
make statements about classical nutrient deficiency diseases--as long as
these statements disclose the prevalence of the disease in the United States.
In addition, manufacturers may describe the supplement'
s effects on
"structure or function" of the body or the "well-being" achieved by consuming
the dietary ingredient. To use these claims, manufacturers must have
substantiation that the statements are truthful and not misleading and the
product label must bear the statement "This statement has not been
evaluated by the Food and Drug Administration. This product is not intended
to diagnose, treat, cure, or prevent any disease." Unlike health claims,
nutritional support statements need not be approved by FDA before
manufacturers market products bearing the statements, however, the agency
must be notified no later than 30 days after a product that bears the claim is
first marketed.
INGREDIENT AND NUTRITION INFORMATION LABELING
Like other foods, dietary supplement products must bear ingredient labeling.
This information must include the name and quantity of each dietary
ingredient or, for proprietary blends, the total quantity of all dietary ingredients
(excluding inert ingredients) in the blend. The label must also identify the
product as a "dietary supplement" (e.g., "Vitamin C Dietary Supplement").
Labeling of products containing herbal and botanical ingredients must state
the part of the plant from which the ingredient is derived. If a supplement is
covered by specifications in an official compendium and is represented as
conforming, it is misbranded if it does not conform to those specifications.
Official compendia include the U.S. Pharmacopeia, the Homeopathic
Pharmacopeia of the United States, or the National Formulary. If not covered
by a compendium, a dietary supplement must be the product identified on the
label and have the strength it is represented as having.
Labels also must provide nutrition labeling. This labeling must first list dietary
ingredients present in "significant amounts" for which FDA has established
daily consumption recommendations, followed by dietary ingredients with no
daily intake recommendations. Dietary ingredients that are not present in
significant amounts need not be listed. The nutrition labeling must include the
55
quantity per serving for each dietary ingredient (or proprietary blend) and may
include the source of a dietary ingredient (for example, "calcium from calcium
gluconate"). If an ingredient is listed in the nutrition labeling, it need not
appear in the statement of ingredients. Nutrition information must precede
ingredient statements on the product label.
NEW DIETARY INGREDIENTS
Supplements may contain new dietary ingredients--those not marketed in the
United States before October 15, 1994--only if those ingredients have been
present in the food supply as an article used for food in a form in which the
food has not been chemically altered or there is a history of use, or some
other evidence of safety exists that establishes that there is a reasonable
expectation of safety when the product is used according to recommended
conditions of use. Supplement manufacturers must notify FDA at least 75
days before marketing products containing new dietary ingredients, providing
the agency with the information on which the conclusion that a dietary
supplement containing the new dietary ingredient "will reasonably be
expected to be safe" was based. Any interested party, including a
manufacturer of a dietary supplement, may petition FDA to issue an order
prescribing the conditions of use under which a new dietary ingredient will
reasonably be expected to be safe.
GOOD MANUFACTURING PRACTICES (GMPs)
DSHEA grants FDA the authority to establish GMP regulations governing the
preparation, packing, and holding of dietary supplements under conditions
that ensure their safety. These regulations are to be modeled after current
good manufacturing practice regulations in effect for the rest of the food
industry. FDA intends to work with the supplement industry and other
interested persons to develop GMPs and, in doing so, will seek public
comment as to their scope.
COMMISSION ON DIETARY SUPPLEMENTS
The DSHEA requires the formation of a Commission to conduct a study and
make recommendations on the regulation of label claims and statements for
dietary supplements and procedures for the evaluation of the claims. The
members of the Commission will evaluate how best to provide truthful,
scientifically valid, and not misleading information to consumers so that they
can make informed and appropriate health care choices. The Commission will
be composed of seven members, appointed by the President, with experience
in dietary supplements and in the manufacture, regulation, distribution, and
use of supplements. Three members must be qualified by scientific training
56
NOTE
57
: Automatic Detention
PRODUCT CODE
: 45T[][]99
COUNTRY
: See attachment
MANUFACTURER/
SHIPPER
: See attachment
MANUFACTURER/
SHIPPER
I.D.#
: N/A
IMPORTERS
I.D. #
: N/A
CHARGE
RECOMMENDING
OFFICE
: DAL-DO (HFR-SW140);
CFSAN/Office of Special Nutritionals/Regulatory
Branch, (HFS-456);
CFSAN/Office of Field Programs/Import Programs Branch,
(HFS-637)
REASON FOR
58
ALERT
GUIDANCE
59
In FY'
95, there have been several shipments of pickled
radishes from Japan detained because of presence of
stevioside. Also, in recent years stevia has been
found in many seafood products from Japan. Districts
should consider sampling these products for the
presence of stevioside if its presence cannot be
determined from the label.
: No purging required.
KEYWORDS
60
PRODUCT:
Kuroda Shokuhin
Pickled Radish 9/18/95 25J[][]26
Co., Inc.
Kobe City, Hyogo, Japan
MID# JPKURSHO1511KOB
Miyazaki Nosan K.K
Shiiki Kijo
Miyazaki, Japan
FEI #1000329644
25J[]P26
25J[]P26
UNION EUROPEA
p:\food2\hojovi\scf\op_final\Rebaud.doc
EUROPEAN COMMISSION
DIRECTORATE-GENERAL XXIV
CONSUMER POLICY AND CONSUMER HEALTH PROTECTION
Directorate B - Scientific opinions on health matters
Unit B3 - Management of scientific committees II
SCIENTIFIC COMMITTEE ON FOOD CS/NF/STEV/3 Final
17 June 1999
Opinion on
Stevia Rebaudiana Bertoni plants and leaves
(adopted on 17/6/99)
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As the plant does not survive winter climate it is cultivated in Europe as a leaf
crop under greenhouse conditions. It is propagated by outgrowths of axially
buds and by cuttings and is harvested after 3-4 months growth by cutting. The
parts of the plant used are the aboveground portions of the living plant and
the dried and powdered leaves. The commercial dried leaf product may
include small amounts of flowers,
stems and seeds.
The leaves contain a complex mixture of natural sweet diterpene glycosides.
These are stevioside (4-13% dry weight), steviolbioside (trace), the
rebaudiosides A (2-4%), B (trace), C (1-2%), D (trace), E (trace) and
dulcoside A (0.4-0.7%). The dry weight composition is given as protein
~6.2%, lipids ~5.6%, total carbohydrates ~52.8%, stevioside~15% (1) and
about 42% water-soluble substances (5). The following nonsweet constituents
have been identified: labdane diterpene, triterpenes, sterols, flavonoids,
volatile oil constituents, pigments, gums and inorganic matter (5).
No information is given regarding the geographical location of the source
material, the composition of the commercial dried leaf products, the species
variety cultivated nor is a minimum lower limit for stevioside in the product
specified. The composition of the commercial plant product is not
standardised with regard to any of its components, especially stevioside, and
no analytical data have been supplied. No inherent toxic components are
described but again no analytical evidence for their absence has been
supplied. No microbiological specification has been supplied The plant is well
identified botanically and a sample of the living plant cultivated in Belgium has
been deposited with the Laboratory of Plant Physiology of KUL (Catholic
University of Leuven) at Heverlee as well as with the National Plant Collection
of Belgium. A sample of the dried plant and leaves of the Belgian cultivar has
also been deposited in the Laboratory of Systematics of KUL at Heverlee.
The dried and ground leaves can thus be identified microscopically.
No detailed information is available on material of non-Belgian origin.
Technological information
The dried plant material is produced in Europe, Paraguay and Japan by
traditional processes for vegetable crops, i.e. drying in warm air at 70C for 3
hours to a moisture content of 5-8%. Under these conditions the stevioside is
not decomposed. The dried material can be stored in the dark in airtight
containers for up to 2 years (1).
Intakes
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The dried leaves are about 30-45 times as sweet as sucrose. The leaves
have not been widely consumed in Europe. Among those who do consume
them, about 90 mg dry powder are used per cup of tea or coffee. The dried
powder can be added to chocolate (1.2 g in 120 g, i.e. 1%) and to jam (9 g to
1 kg fruit). Fresh leaves can be used to sweeten vinegar (6-9 g fresh weight
to 1 L). Fresh leaves can be added to salads. The claimed intake per person
per day in Europe from these uses of the fresh and powdered leaves is 2.4 g
dry powder equivalent to 400 mg stevioside. The application suggests an
acceptable daily intake of 5g/day but this figure is not based on the results of
any toxicity studies (1). In Paraguay a mixture of milled dried leaves, flowers
and fine branchlets at a daily dose of up to 5 g in the form of a tea has been
used for some 45 years in diabetic patients to reduce the blood sugar level
with a maintenance dose of 1 g /day also as a tea. Small capsules containing
dried leaves have also been used to relieve physical and emotional fatigue.
No intake estimates have been submitted (5).
In Japan SRB was introduced as cultivar from Brazil and Paraguay about
1970. New varieties yielding 3-5% more of the sweet diterpeneglycosides are
grown in the warm regions. In 1992 some 70 SRB-extracts were marketed in
Japan for use in canned foods, pickles, sauces, baked goods, ice creams and
soft drinks. Some SRB extracts high in rebaudioside A in combination with
glycyrrhizin are available.
The average intake is estimated at 4 mg/kg b.w./day/person (5). Large
quantities of SRB leaves are cultivated in China, mostly for export, but local
use is limited to dried leaves packaged for use as tea. Intake estimates have
not been supplied (5). In Brazil the dried leaves, sterilised with ethylene oxide,
are used for the preparation of different flavoured teas (5). In the US only leaf
extracts are marketed as dietary supplements (not regulated under the Food
and Drug Regulations) but the same products are forbidden as sweeteners or
food additives (5).
Nutritional implications
The fresh leaves are used in very small amounts and are therefore most
unlikely to
replace other vegetable foods to any significant extent. The dry powder is
intended to replace some of the sucrose in drinks, jams and sweets to reduce
the caloric intake. It may be used by diabetics and overweight individuals. No
relevant studies have been submitted to show the physiological and
pharmacological effects of this substitution on diabetic or obese individuals.
No studies have been submitted showing the effect of the addition of the
powdered material on the bioavailability of macro and microconstituents of the
normal diet.
64
Toxicological evaluation
Almost all the toxicological data submitted concern essentially crude or
purified extracts or pure stevioside and have been summarised by the SCF
and JECFA (3,4). As the studies do not enable determination of the precise
specification and origin of the source material used for these extracts they are
irrelevant for the assessment of the safety of the leaves and powdered leaf
products. These studies are therefore not reviewed again in this opinion. The
only reported study using the plant material is a feeding study in rats using
10% dried SRB leaves of unknown specification in a high carbohydrate diet
investigating the effect on blood glucose level. No details of the study have
been submitted but the results were reported as showing a continued
significant decrease in liver glycogen after 2 weeks and a significant decrease
in blood glucose levels after 4 weeks (6).
No investigations on the allergenic potential of the leaves and the powdered
leaves
have been submitted.
Conclusion
The information submitted on the plant products was insufficient with regard
to specification and standardisation of the commercial product and contains
no safety studies. There are no satisfactory data to support the safe use of
these products as ingredients of food or as sucrose substitute for diabetics
and obese individuals.
The only toxicological data submitted are essentially concerned with the
stevioside component of the plant product. No appropriate data were
presented to enable the safety of the commercial plant product to be
evaluated.
References
1. Geuns, J.M.C. (1998) Stevia rebaudiana Bertoni plants and dried leaves as
Novel Food. Final version 21.9.1998 with addendum.
2. EU Commission (1997) Regulation 258/97 EC , O.J.No L 43, 14.2.1997,
p1-7.
3. SCF (1999) Opinion on Stevioside as a Sweetener, adopted on 17/6/1999,
http://europa.eu.int/comm/dg24/health/sc/scf/index_en.html.
4. Evaluation of Certain Food Additives. WHO Food Additives Series 42:119143, Geneva,1999.
5. Kinghorn,A.D. (1992) Food Ingredient Safety Review. Stevia rebaudiana
leaves. 16.3.1992, Unpublished report submitted to the European
Commission.
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