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					Botanicals As Food Supplements

Dr. Ernst Schneider

The use of plants with physiological properties seem to be a very old behaviour in human
evolution. Chimpanzees, our closest relatives in the tribus Primatae from time to time use
unusual plant material containing active phytochemicals. The functional food wave first
emerged in the very liberal market of the United States where herbs and botanicals are used
as so called “nutraceuticals”, summing up all typical medicinal plant products known in
Europe. In a discussion paper of the Commission of the European Community from 1991
concerning “diet integrators” herbal extracts, herbal beverages, essential oils and
supplements from other ethnics are mentioned as “health promoting” products
(Commission of the European Community, 1991). Herbs and botanicals are very popular in
European countries, especially in Germany, France, Italy, Scandinavia and the UK. These
countries have a long tradition in using herbs to stay healthy according to the historical
theory of antique dietetics. But it is very useful also to have a closer look on the traditions of
other cultures. They have their own experience and history using native plants to stay
healthy. Therefore it is not only necessary to keep our own products on the market, but also
to allow introducing new plants from foreign origin and to define a fair legal status for herbs
and botanicals as food supplements. Of course safety reasons have to be observed, the
quality of the raw material and the products must be assured and the technological
procedures should be according to GMP. A harmonized information campaign on all levels
from authorities to companies will teach consumers the correct use of the products. Than
the informed customer can be sure to get a safe product for his intension to live healthy.
European authorities are on the way to fill this gap, but implementation requires a sure
sense of proportionality of the authorities and adoption of appropriate guidance still need
further discussion.

Lists of botanicals suitable for food supplements

The actual legal situation in the EC concerning herbs and botanicals as food supplements is
still confusing. There was a long lasting discussion about lists of plants suitable for food
supplements.

In the Directive 2002/46/EC of the European parliament and of the council of 10 June 2002
on the approximation of the laws of the Member States relating to food supplements it was
stated that specific rules concerning nutrients, other than vitamins and minerals, or other
substances with a nutritional or physiological effect used as ingredients of food supplements
should be laid down at a later stage, provided that adequate and appropriate scientific data
about them become available. According to Article 4 (8) not later than 12 July 2007, the
Commission shall submit to the European Parliament and the Council a report with positive
lists of such nutrients.

A platform for the discussion on these lists for plant ingredients in food supplements is the
working group on botanicals of the Scientific Committee of EFSA. But official information is
scarce and news on lists concerning plants suitable for food supplements are handled like a
secret.


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A discussion paper on “Botanicals widely used as food supplements” was released by this
working group of EFSA in June 2004. Because the emphasis of this paper was more on safety
reasons and side effects the official opinion seems to tend more to so called negative lists
enumerating plants excluded for food use. It may be speculated about the future decision of
the European Commission but in Regulation (EC) 1925/2006 on the addition of certain other
substances than vitamins and minerals to food the concept of a negative list is
predetermined. Although food supplements are excluded in this regulation, in Annex III
substances whose use in food is prohibited, restricted or under community scrutiny will be
summarised. A good example how to organise a negative list is also available at the British
MHRA. This list was compiled for herbal ingredients which are prohibited or restricted in
medicines.

Over the last years there was a vivid national discussion about lists of plants and even official
publications in several member states of the EU. In Belgium a comprehensive list of suitable
plants but also a list of forbidden because harmful plants was officially established. Also in
Austria a commission tried to publish a list with herbs suitable for food supplements with
only a few entries. In France a positive list of plants, excluding plants with medicinal claim
and -of course- harmful or toxic plants was elaborated but is still unpublished. Recently
there was an discussion about some inventory lists published by the German Herbal Infusion
Association with plants currently employed by the herbal infusion trade as food plants (WKF
2000) and by a working group of the German food authorities classifying the borderline
between herbal medicine and food (Gründig 2002). Another comment on the list comparing
the legal status of these plants in different European countries and evaluating the risk of the
ingredients was published (Schneider 2002).

Borderline between food supplement and herbal medicine

All herbs and botanicals with medicinal claims have to be registered as herbal medicinal
products according to drug law of the European countries. In contrary all other botanicals
with active ingredients should potentially be seen as functional food.

In German food law there are guidelines concerning herbal teas for food use („Leitsätze für
teeähnliche Erzeugnisse“) without any medical claims. It is interesting that plants
enumerated in this list are also used as medicinal plants according to drug law with definite
medicinal claims. Most of the plants were also evaluated by the German Commission E
(Blumenthal 1998). These example may enlighten the problems to define an exact borderline
between herbal medicinal products and food supplements with physiological effects.
In the 1970th there were about 900 medicinal plants in use as ingredients in herbal medicinal
products in the German market. Today only the approx. 180 plants included in the
Commission E monographs are accepted as medicinal plants. This deployment over the last
decades resulted in a reduction of the consumer choice. Newly a registration of traditional
medicinal plant products according to EC regulation is possible if the traditional use of a
plant over the last 30 years can be proofed. But there are a lot of other plants historically
used for their physiological properties that cannot be summarised under herbal medicine.
For example in Germany about 1.500 indigenous wild growing plants are known to be useful
as medicinal and aromatic plants and also a compendium on medicinal plants in folk
tradition of Britain and Ireland is available (Allen 2004). There is a broad field to be tilled by
new product development.

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Botanicals with function

Food products with functional properties are not intended to diagnose, treat, cure or
prevent diseases. Consumer motives for use of food supplements are to live forever, be
happy, keep healthy, be dynamic … and clever !

All „ethno-botanicals“ like traditionally used herbal beverages, fruit juices and vegetables
with physiological active principles even from other cultural background should be accepted
as botanical food supplements. As a guideline to identify botanicals with bioactive
substances a recently published review may help (Watzl 1999). Discussion about functions
associated with botanicals should be kept alive and the wishes and imagination of the
customers must be elucidated by a suitable opinion poll.

As a framework how to elaborate proper documentation to substantiate certain claims the
European Commission has proposed a Regulation Nr.1924/2006 on the use of nutrition and
health claims for foods although suitable scientific and technical guidelines still are to
establish.

Safety

Of course safety reasons must be considered. The quality and safety check-list presented
here was a very useful tool for the author with introducing new botanicals to the European
market (Figure 1).

Main topic is that no acute and chronic side effects of the botanicals are allowed and no
active substances with harmful effects (mutagens, cancerogens, allergenic properties)
should be known for these plants. More sophisticated decision trees for safety reasons were
elaborated for an extensive guidance by ILSI (Schilter 2003). Also the ILSI Monograph on
threshold of toxicological concern (TTC) should be followed (Barlow 2005) and the use of the
plant as food or traditional medicine in any place of the world should be proofed. After this
paper work is done laboratory tests concerning taste, flavour and quality assurance are the
second step. Also the search for a good quality source we should have in view. Generally
keep in mind that the producer is hold responsible for his product.

Quality assurance

The quality and the origin of botanicals have to be described and all results documented for
each batch. The master for a specification for botanicals presented here will help to
elaborate quality assurance sheets for each plant material (Fig. 2). References like botanical
literature, floras and reviews on economic and medicinal plants will give information on
proper identification of the plants and often are accompanied by helpful illustrations. The
importance for this is documented by a confusion of plant material used in Traditional
Chinese Medicine for sliming products resulting in severe kidney failures. Because of similar
Chinese names plants containing aristolochia acid with high mutagenic risk were confused
with herbs only containing a mild diuretic principle. This could be prevented by careful
identification procedures worked out for the quality assurance sheets. Specifying the
contents of active ingredients will result in good homogeneity from batch to batch.

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The intentional addition of synthetic substances in the origin of the botanical must be
excluded especially when preparations were imported instead of crude plant material.
Recently cases were reported that medicinal substances were added to traditional plant
material from Asia and introduced to the US and European market. Therefore, during
product development it is necessary to collect a data base for all synthetic substances active
for the same application as the botanical. Then it will be possible to detect addition of these
substances during quality assurance.

Technological quality

Of course all herbs and botanicals must be produced according to the rules of food law or
GMP. The classical form for botanicals as food supplement is the herbal tea. Today usually
extracts or other concentrates were used in form of tablets, capsules, drops or granules. All
these formulations should be produced in fair quality according to the rules of good
manufacturing practice (GMP).

References:

Allen DE, Hatfield G. (2004) Medicinal plants in folk tradition – An ethnobotany of Britain and
Ireland. Cambridge, Timber Press.

Barlow S. (2005) Threshold of toxicological concern (TTC) – A tool for assessing substances of
unknown toxicity present at low levels in the diet. ILSI Europe Concise Monograph Series.
Brussels, ILSI Europe.

Blumenthal M. ed. 1998. The Complete German Commission E-Monographs – Therapeutic
guide to herbal medicines. Austin, American Botanic Council.

Commission of the European Community DG III (1991). Diet integrators – proposal for
discussion. III/3767/91. Brussels.

Gründig F, Hey H. (2002) Inventarliste Lebensmitteldrogen.           Deutsche Lebensmittel-
Rundschau 98(2):35-39.

Schilter B et al. (2003) Guidance for the safety assesssemnt of botanicals and botanical
preparations for use in food and food supplements. Food Chem Tox 41:1625-1649.

Schneider, E. 2002 . Bewertung einer Liste von Pflanzen, die sich zur Herstellung von Kräuter-
und Früchtetee, funktionellen Lebensmitteln, Nahrungsergänzungs-mitteln oder
„Nutraceuticals“ eignen. Deutsche Lebensmittel-Rundschau 98(4):125-148.

Watzl, B., Leitzmann, C. (1999). Bioaktive Substanzen in Lebensmitteln. Stuttgart:
Hippokrates.

WKF,   Wirtschaftsvereinigung     Kräuter- und     Früchtetee (2000). Inventarliste
Lebensmitteldrogen der Wirtschaftsvereinigung Kräuter- und Früchtetee (WKF). Deutsche
Lebensmittel-Rundschau, 96(5), 172-176.

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Figure captions:

Figure 1
Guidelines to check safety procedures and literature for new botanicals.




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Figure 2
Master to elaborate specifications and testing procedures for plants as starting material of
food supplements.



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