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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5336_Библиотеки_им_академика_М_И_Перельмана
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436 Farsad Nadjafi and Hartwig Schulz
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zones worldwide), Iran is a rich source of
medicinal plants, some of which have been
used in traditional medicine for centuries.
The flora of Iran is very rich with almost
8000 species and, together with Turkey,
these countries have the highest plant diversity and percentage of endemic plants (more
than 2000 species) in the Middle East and
West Asia (Ghahreman and Attar, 1999). It
is estimated that nearly 13% of Iran’s plant
flora (850–1000 species) are used as herbs
in the traditional and ethno-medicine of the
country (Bagheri and Reghan, 1994). Culti
vation of herbs has a long history in Iran and
the cultivation of some of them, like saffron,
goes back to 3000 years ago (Koocheki,
2013). Cultivation of herbs in Iran is mostly
done by local smallholders. According to the
statistics of the Iranian Ministry of Agriculture, the cultivation area of medicinal plants
in 2015 was about 171,463 ha (Salehi Sardoei, 2022). Various herbs and spices are
cultivated in different parts of the country
such as coriander (Coriandrum sativum), tarragon (Artemisia dracunculus), fennel (Foe-
niculum vulgare), dill (Anethum graveolens),
cumin (Cuminum cyminum), black cumin (Ni-
gella sativa), damask rose (Rosa × damascena), saffron (Crocus sativus), blue mallow
(Malva sylvestris), savory (Satureja hortensis), anise (Pimpinella anisum), spearmint
(Mentha spicata), and henna (Lawsonia inermis). The farmers used their own selected
propagation materials and the vast geo
graphical distribution and different climatic
conditions resulted in a rich genetic diversity of land races with different growth and
quality characteristics. The cultivation and
postharvest methods in these agricultural
systems are based on traditional knowledge
and are very labor-intensive (Fig. 15.1).
Women have an important role in the collection and processing of herbs. The products
are mostly sold in local markets but rarely
used by the pharmaceutical and food industries, as they often do not meet the required
standards. The reason is that the farmers
use traditional processing methods like natural
drying that may cause hygiene problems.
In recent years, the development of
medicinal plant industries and export markets
has significantly increased the demand for
standardized herbal raw materials. These increased demands have led to the industrial
cultivation of some aromatic and medicinal
plant species such as cumin, peppermint,
lemon balm (Melissa officinalis), coriander,
damask rose, fennel, saffron, and tarragon,
as well as introduced some new herbs such
as Stevia rebaudiana and Aloe vera into the
country’s agricultural systems (Fig. 15.2). As
acreage expanded, so did the need for mechanization and improved varieties, especially
in terms of yield, resistances against
drought, pests, and diseases, salt tolerance
as well as quality.
Among the medicinal and spice plants,
saffron has the largest area with almost
100,000 ha (Salehi Sardoei, 2022). Although
the cultivation and harvesting of saffron
require a lot of labor, the farmers are very
interested in growing this plant species. The
reason is its low water requirement and high
economic income to be obtained from this
crop. In 2014, 135 t of saffron were exported
from Iran and it is estimated that the production volume in 2022 will reach more than 300 t
(Salehi Sardoei, 2022). Damask rose is another
plant that is extensively cultivated in Iran.
Together with Turkey and Bulgaria, Iran is
the largest producer of damask rose in the
world. This species had a cultivation area of
18,000 ha in 2016. More than 85% of the
cultivation area is located in Fars, Kerman,
Isfahan, and East Azerbaijan provinces (Salehi Sardoei, 2022). The livelihood of many
farmers in these regions is completely related
to the cultivation and processing of this plant.
Despite the large number of processing companies in the country, industrial production
is mainly focused on rose water, which is a
cheap product, while valuable products like
essential rose oil, rose concrete, and rose absolute are produced only in very low amounts.
This is mainly due to traditional concepts of
the industry and low investment in new distillation and extraction technologies in recent
years. Cumin is another spice plant cultivated
mostly in dryland agricultural systems of the
country. The area of this plant under cultivation
and production in Iran has significantly increased in recent years. In 2020, the cultivation
The Current Situation 437
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438 Farsad Nadjafi and Hartwig Schulz
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area was nearly 18,000 ha with more than
12,000 ha cultivated in Razavi Khorasan Province alone (Sefidkon, 2021). Coriander is
also produced in Iran mostly for seed production and the spice industry; the cultivation
area was nearly 7000 ha in 2021 and located
mainly in Hamadan Province. Ninety-five
percent of the production is exported to
countries such as Pakistan, Germany, and the
United Arab Emirates (Salehi Sardoei, 2022).
In Iran only 54 species are cultivated,
while most of the medicinal plants (>95%)
used in the country are collected from the
wild (Mashayekhan et al., 2016). It is estimated that 40% of rural families in Iran live
in poverty and rely on medicinal plant collection for their livelihood. Medicinal plants
can provide a significant source of income
for rural people in Iran especially through
the sale of wild collected material, which
contributes 10% to the total income of
poorer households in the northeastern part
of Iran (Mashayekhan et al., 2016). Some
wild collected medicinal plants of the country that are well known in the international
market are tragacanth (Astragalus gum-
mifer), galbanum gum (Ferula gummosa),
asafoetida (Ferula assa-foetida), and licorice
(Glycyrrhiza glabra). Due to increased
harvesting and unsustainable harvesting
methods, many medicinal plant species are
currently threatened in the country. The
plants are mostly exported and introduced
in the markets as raw and unprocessed materials. There exist some licorice extraction
companies with a production capacity of
18,350 t in 2021, of which 95% is exported
(Salehi Sardoei, 2022).
Research and education
With the development of the medicinal plant
industry, the need for scientific information
The Current Situation 439
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and expert personnel in this field had increased.
Research and education related to medicinal
plants and natural products in Iran are managed by the following three ministries: the
Ministry of Science, Research and Technology;
the Ministry of Health; and the Ministry of
Agriculture. The Ministry of Health is responsible for education at graduate level and research
related to traditional medicine and pharmacognosy. The Ministry of Science, Research
and Technology is responsible for establishing
scientific and technological bases in the field of
medicinal and aromatic plants in areas such as
agriculture, phytochemistry, biology and process engineering, etc. and for training experts
in these fields. This Ministry has also created a
National Network for Research and Technology of Medicinal Plants of Iran to improve the
collaboration between laboratories, promote
cooperation between industry and research institutes, and organize scientific and technical
conferences and workshops related to medicinal
plants (https://en.mpnet.ir/, accessed 19 April
2023).
Figure 15.3 shows an overview of the
situation of education and research in the
field of medicinal plants in 2014 and 2015.
The number of scientific papers, the number
of companies in science and technology parks,
the number of journals that published articles
on medicinal plants, and the research in universities increased from 2014 to 2015. Since
standards in the field of medicinal plants were
largely lacking in Iran, the responsible organizations developed appropriate standards in
cooperation with universities, research institutes, and industrial centers.
One of these standards, which was of
particular importance to the country, is the
national standard GAP (Good Agricultural
Practices of Medicinal and Aromatic Plants).
In addition, the number of companies associated to universities has been increased, reference laboratories have been installed, and
more entrepreneurial offerings for medicinal
plants have been developed (Fig. 15.4).
The revival of Traditional Iranian/Persian
Medicine (TIM/TPM) and its use in the country’s healthcare system was followed in recent
years in medical universities. Figure 15.5 shows
the situation of TIM/TPM and pharmacognosy
in the universities during 2014 and 2015.
Development of traditional medicine was not
only pursued in universities, but also specialized clinics were established to serve the public.
The number of these clinics that serve TIM/
TPM was seven in the year 2015 (unpublished
data of the National Council for Science and
Technology Development of Medicinal Plants
and Traditional Medicine).
PhD researches on the subject of MPs
Knowledge-based companies in science and
Academic journals (specialized & general)
publishing articles on MPs
Scientific articles on MPs (in ISI citation
Fig. 15.3. Education and research situation in the field of medicinal plants (MPs) in Iran in 2014 and 2015.
(Unpublished data of the National Council for Science and Technology Development of Medicinal Plants
and Traditional Medicine.)
technology parks
MP entrepreneurship centers
MP-related theses (×100)
databases) (×100)
2015 2014
0
10 20 30 40 50 60 70 80
Number
440 Farsad Nadjafi and Hartwig Schulz
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Standards on MPs
Entrepreneurship packages on MPs
Reference laboratories on MPs
University-based companies on MPs
0 20 40 60 80 100 120 140
Number
Fig. 15.4. Innovation and technology of medicinal plants (MPs) in Iran during 2014 and 2015. (Unpublished data of the National Council for Science and Technology Development of Medicinal Plants and
Traditional Medicine.)
Graduated in Pharmacogonosy
Graduated in ITM
PhD students in Pharmacogonosy
PhD students in ITM
Faculty members in Pharmacogonosy
Faculty members in ITM
2015 2014
2015 2014
Fig. 15.5. The situation of Traditional Iranian Medicine (TIM) and pharmacogonosy fields in the medical
universities in Iran during 2014 and 2015. (Unpublished data of the National Council for Science and
Technology Development of Medicinal Plants and Traditional Medicine.)
The trend toward herbal medicine, medicinal
plants as well as the use of traditional medicine medical services has led to the continous
growth of herbal products industries in the
country. In 2015, already 350 medicinal plant
companies existed in Iran and from them, 183
companies produced herbal waters, plant extracts, and essential oils. It should be said that
most of them are selling herbal waters due to
Industry
0 100 200 300 400 500
Number
the high national consumption and good markets in Arab countries (unpublished data of
the National Council for Science and Technology Development of Medicinal Plants and
Traditional Medicine). Figure 15.6 shows the
number of herbal products and licenses issued
to manufacture herbal medicines and other
plant-based products during 2014 and 2015.
To support the medicinal plant industries, the
government placed 56 herbal drugs under insurance coverage.
The Current Situation 441
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Number of plants used in herbal and traditional
Approved licenses for traditional medicine
Approved licenses for essential oils and extracts
Fig. 15.6. The situation of herbal products in Iran during 2014 and 2015. (Unpublished data of the
National Council for Science and Technology Development of Medicinal Plants and Traditional
Medicine.)
National policy-making processes aiming
to improve the market for medicinal plants
medicine products
products
Herbal drugs under insurance coverage
Approved veterinary drugs
2015 2014
Approved licenses for herbal products
0 200 400 600 800 1000 1200 1400 1600
Number
resulting in vomiting, diarrhea, coma, or other
toxic reactions. In this way, however, early
humans were able to develop a huge know-
Due to the large number of government
organizations involved in the issue of medicinal
plants, in order to improve coordination among
these organizations and ministries and to
define national strategies, the National Council for Science and Technology Development
of Medicinal Plants and Traditional Medicine was established at the Vice Presidency of
Science and Technology in Iran. This Council
has prepared the national document on
medicinal plants and traditional medicine,
which defines the country’s strategies in this
area. All ministries and governmental organizations are obligated to perform their duties
within the framework of these strategies.
ledge about edible materials and natural
medicines. Subsequently, humans invented
fire, learned how to make alcohol, developed
religions, achieved technological breakthroughs, and learned how to develop new
medicines. All the different forms of Traditional Medicine such as Traditional Chinese
Medicine (TCM), Ayurveda, Kampo, Tradi tional
Korean Medicine (TKM), Traditional Persian Medicine (TPM), and Unani use natural
products and have been practiced around
the world for hundreds or even thousands of
years, and they have developed into properly
regulated systems of medicine. In their various manifestations, they have certain shortcomings, but they are still a valuable part of
human knowledge (Fabricant and Farnsworth,
Adaptation of Traditional Persian
Medicine Products to European
Market Needs
2001; Alves and Rosa, 2007).
Persia was a center of academic knowledge in ancient times and became the first
world empire in history, stretching at those
times from Bulgaria to Pakistan and from
Using natural products as medicines must
have been an enormous challenge for early
humans and it is very likely that they often
ingested poisonous plants in search of food,
Egypt to the Caucasus. The experience and
knowledge of Greece, Egypt, Babylon, India,
and also China could thus enrich TPM and
develop it over the last 4000 years.
442 Farsad Nadjafi and Hartwig Schulz
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During the Middle Ages and the following centuries in Europe, mainly monks, experienced women, and later pharmacists
practiced the art of healing by means of naturally obtained extracts and preparations.
This Traditional European Medicine (TEM)
was enriched from the 15th century onward
by the discovery of America and India with
new plants and healing methods. Today,
multicomponent mixtures and their natural
substances are still in the focus of modern
pharmaceutical research. In this context,
scientists specialized in various disciplines
are working closely together to find new applications for plant constituents in complementary medicine or to rediscover traditional knowledge with the techniques and
methods available today on the basis of current studies (Bunse et al., 2022).
Thus, in the Western world, phytotherapy became the culmination point for the
emergence of today’s classical medicine.
Today, nearly a quarter of all modern medicines are derived from natural products,
which thus represent a resource for primary
care, but also have become very important
for innovation and discovery of new active
substances. As can be demonstrated by the
discovery of artemisinin to combat malaria,
the extensive knowledge of natural products
is very promising for the future, and it is
therefore expected that modern analytical
techniques will be a very important tool to
identify other pharmaceutically relevant active compounds in plants endemic to Iran
(Wu, 2009).
In order to reorganize and support the
worldwide application of Traditional Medicine
systems, the World Health Organization
(WHO) has published various policy papers
aiming to strengthen quality assurance,
safety, proper use, and efficacy, in particular
through the regulation of traditional medical
products. In this context, the importance of
training, skill development, services, and
reliable therapies is also clearly emphasized
(WHO, 2015). More than 100 million
Europeans are currently users of TCM, with
one-fifth using TCM regularly and preferring
healthcare including TCM. There are many
more TCM users in Africa, Asia, Australia,
and North America.
In modern times, it is often forgotten
that TEM and TPM have a common heritage
based on the four elements doctrine, the socalled “humoral medicine”. Various medicinal plants known in Europe, such as sage
(Salvia officinalis), fennel (Foeniculum vul-
gare), and lovage (Levisticum officinale), had
already been mentioned by Avicenna and are
later found in various herbal books on herbal
remedies of monastic medicine. In Europe,
Persian physicians were long regarded as
role models, and many elements of TPM
were incorporated into European healing
practice in the 13th century. Avicenna in
particular is considered the “father of mod
ern medicine” because he was the first who
introduced clinical trials to experimentally
test medicines for their individual effectiveness of natural healing substances. Important approaches to health prevention can
also be taken from various Islamic writings
such as the Taqwim al-Sihha (Tacuinum sani-
tatis) written by Ibn Butlan, in which individual food materials were assigned to the
four elements (warm, cold, moist, dry) and
in this way the different health effects of a
food were presented for the first time.
In recent years, medical systems such as
TCM and Ayurveda are attracting more and
more attention in the Western world, where
the demand for inner balance and a holistic
view of body and mind has increased significantly. In this context, numerous vitality
and wellness organizations have emerged
that have developed individual concepts from
these two traditional systems and adapted
them to the Western way of life. In addition to
the respective herbal therapies, one of the
main goals is a change of the nutritional
pattern based on Avicenna’s approach that a
balanced diet using valuable food components
has a significant impact on human health.
Today, it is widely recognized among health
care providers that access to a healthy diet,
optimally adapted to our living conditions,
significantly strengthens our immune system
and reduces the risk of diabetes and cardiovascular disease, including inflammation, elevated cholesterol, high blood pressure, and
poor sleep. The main emphasis of this “food as
medicine” concept is put on the consumption
of a variety of herbs and spices, legumes,
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nuts and seeds, fruits and vegetables, while
the concept of conventional medicine is
based primarily on technological medical advances to treat diseases with various synthetic drugs. However, the concept of “food
as medicine” does not always work equally
well for all people, which is why the individual case must be carefully examined. In many
cases, however, it is advisable to carry out
the change in diet with the help of dietary
supplements and in conjunction with appropriate conventional medical treatment.
The marketing of phytopharmaceuticals based on endemic species is difficult
because these plant species must first be
approved by the European authorities, and
this process is usually time-consuming and
costly. To enable inclusion in the European
Pharmacopoeia (Ph.Eur.), it may therefore
be advantageous to first cultivate the relevant species in Europe in order to increase
awareness in individual European countries.
Corresponding studies were conducted by
Bomme et al. (2006) on the introduction of
traditional Chinese medicinal plants to the
European market, for example to compare
possible quality differences of plants from
experimental cultivation in Germany and
corresponding imported plants from China.
Detailed botanical species identification
using DNA sequence and fingerprint analyses was performed in the cultivation of 16
selected Chinese medicinal plant species.
In addition, the harvesting technique and
various active ingredients were determined.
Through this controlled and documented
cultivation, the relevant data for inclusion in
the Ph.Eur. with regard to drug safety and
general quality requirements could be collected
(Bomme, 2001).
Before the introduction of Western
medicine in the 16th century, TCM was the
predominant form of medical care in China
(Dong, 2013). Like TPM, TCM is based on
thousands of years of medical practice and
experience, from which its efficacy and
effectiveness are derived. It is generally noteworthy that today traditional medical systems
and modern medicine are increasingly
converging, and it has become possible to
determine the pharmacology as well as the
mechanisms of action of numerous endemic
medicinal plants in TPM and TCM with the
help of modern technology. With the under
standing of life sciences, it was thus possible
to make the traditional medical systems
more understandable for modern medicine
(Tu et al., 2002; Zhang and Li, 2011; Zhang
et al., 2012; Dong, 2013; Haidan et al., 2016).
Quality assessment
Reliable quality control of medicinal plants,
which have been collected and used worldwide for the pharmaceutical industry, has
always been one of the main concerns of the
WHO. Therefore, internationally accepted
guidelines for assessing the quality of the individual plant raw materials were established that can be used in each country to set
up individual quality specifications of the
medicinal drugs. These guidelines were developed to promote the proper use and development of traditional medicine and, in
this context, to ensure an objective description of the quality of individual pharmaceutical products. According to the WHO (2000),
the following specific objectives represent
the most important guidelines:
-
• harmonization of recognized and most
important concepts applied in Traditional Medicine;
• elaboration of key issues in the develop-
ment of methods for research and
evaluation in Traditional Medicine;
• improving quality and importance of re-
search in the eld of Traditional Medicine; and
• provision of appropriate evaluation
methods to facilitate regulatory development and registration in Traditional
Medicine.
In order to ensure high quality, safety, and
efficacy of medicinal plants, most of which
come from wild collections, it is first important to reliably identify the respective plant
species. In this context, particular attention
should be paid to the current botanical
names (genus and species), but also synonyms and vernacular names, of the plant
parts used for the individual preparations,
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as well as detailed instructions for agricultural production and collection conditions
according to the good agricultural practice of
the respective country. For quality control,
different sources can be used, such as the individual WHO quality control methods
(WHO, 1998b) for medicinal drugs and the
WHO monographs of selected medicinal
plants (WHO, 1999).
When researching and evaluating herbal
medicinal products for which there is no
long history of use or that have not been
researched at all, the “WHO research guide
lines for the evaluation of safety and efficacy” should be regarded in detail. In the
case of well-documented traditional uses of
herbal medicinal products, the procedure
can be simplified and it is mostly sufficient
to follow a reduced number of procedures
for conducting research and evaluating
safety and efficacy according to the relevant
WHO guidelines (WHO, 1993, 1998a).
Whereas in the past the term “quality”
was described primarily as product quality
(efficacy, composition, taste, shelf life, etc.),
for some years we must also ensure that
suitability value, ecological quality, social
and sociocultural value, and nutritional convenience quality are guaranteed.
Furthermore, particularly in the food
sector including food supplements, there
has been an enormous increase in labels
with regard to aspects of fair trade, regionality, organic cultivation, and sustainability.
The individual quality of medicinal and
aromatic plants offered on the market, as
well as extracts and distillates isolated from
them, is usually specified by different parameters, using different physical, chemical, microbial, and sensory test methods (described
by the International Organization for Standardization (ISO) and various national/international pharmacopoeia). For the respective
products (e.g., teas, drugs, spices, essential
oils, and solvent extracts) usually also company-internal specifications exist. In addition to the classical sum parameters such as
density, refractive index, optical rotation as
well as various titrimetrically determined
key parameters, nowadays mainly chromatographic methods such as gas chromatography (GC) and high-performance liquid
chromatography (HPLC) are used for qualitative and quantitative analyses. In addition,
vibrational spectroscopic methods are increasingly applied especially for rapid and
mostly nondestructive characterization of
plants and the extracts obtained from them.
In most cases, it is possible to determine the
botanical origin of the plant material (species, chemotype) under investigation and to
detect reliably possible adulterations and impurities.
Contaminants
The European Union has created a very complex set of regulations for medicinal products, including in particular various regulations, guidance documents of the European
Medicines Agency (EMA), monographs,
pharmacopoeias, and other specific regulations of the national health authorities. All
these legal provisions also apply to herbal
medicinal products, which must therefore
meet the same quality, safety, and efficacy
requirements as all other medicinal products (Steinhoff, 2019).
However, there are some specific things
to consider due to the natural origin of
herbal raw materials that mainly relate to
their production and quality control. In addition, since medicinal plants can be exposed
to various environmental influences, special
legal requirements for their purity must be
observed. The Ph.Eur. therefore mentions
tests for pesticides, heavy metals, and microbial impurities, as well as mycotoxins, in
the general monographs for herbal drugs
and herbal drug extracts under defined conditions. In addition to these general monographs, individual monographs for a variety
of herbal drugs and for some extracts may
also contain individual rules for the absence
or limitation of certain contaminants. The
individual methods for determining these
contaminants are also described in more detail in specific chapters of the Ph.Eur. The
analytical methods used in quality control of
herbal plants and the related products such
as essential oils must generally be validated
according to individual criteria that are also
described in the Ph.Eur. in detail.
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Currently, the Ph.Eur. contains a list of
about 70 plant protection products (PPPs)
that are considered relevant in phytopharmaceutical raw materials and an individual limit
value is provided for each of these substances.
Generally, with consistent application of the
Guideline on Good Agricultural and Collection
Practice (GACP) for Starting Materials of Herbal
Origin (EMA, 2006), the responsible health
authorities may permit waiving the costintensive pesticide analyses.
The list of PPPs is continuously updated depending on the individual approval status and
adapted to the respective risk assessments made
by the European Food Safety Authority (EFSA).
Detailed information on the substances and their
permitted maximum residue levels in the respective products can be found on the website of
the European Commission (https://food.ec.
europa.eu/system/files/2021-12/pesticides_
ppp_app-proc_guide_phys-chem-ana_chemsubst.pdf, accessed 27 April 2023).
Use of plant protection products
In case of suspicion of other PPPs not listed, the
Ph.Eur. refers to the EU Regulation No. 396/2005
on pesticide residues in food (European Parliament and Council of the European Union, 2005).
Provided that the individual batches as well as the
standards of GACP (EMA, 2006) can be fully
documented, the responsible health authorities
will waive the usally mandatory testing of PPPs.
The respective analytical methods applied to determine PPPs must also be documented, according to the documents published
by the European Commission. In practice, several methods may be used, but they must be derived from the official “S19 method of the German Research Society (DFG)”. According to
guidance of the EMA’s Committee for Herbal
Medicinal Products (HMPC) for preparation of
the application dossier, it is sufficient to cite
these official methods validated on different
herbal matrices (EMA, 2016a).
Heavy metals
The general monograph entitled Herbal Drugs
of the Ph.Eur. (Council of Europe, 2016) es-
tablishes the individual limits for cadmium
(1.0 ppm), lead (5.0 ppm), and mercury (0.1
ppm). These limits are mandatory “unless
otherwise specified in an individual monograph or unless otherwise justified and approved.” Because certain herbal drugs may
have naturally occurring higher levels of certain heavy metals, there are several exemptions in the respective individual monographs with higher limits for cadmium (e.g.,
tormentil and willow bark) and for lead (Iceland moss and stinging nettle root). The
Ph.Eur. also states that “herbal drugs used
for the preparation of extracts may, in justified cases, exceed the limits for heavy metals specified in the monograph provided
that the resulting extract meets the requirements for heavy metals” (Council of Europe, 2016).
In addition, the pharmacopoeia presents modern techniques for the determination of heavy metals in herbal drugs and
herbal drug preparations, such as atomic absorption spectrometry (AAS), inductively
coupled plasma atomic emission spectrometry (ICP-AES), or inductively coupled
plasma mass spectrometry (ICP-MS).
Polycyclic aromatic hydrocarbons
Medicinal plants may be contaminated with
polyaromatic hydrocarbons (PAHs) taken up
from contaminated soil or air. In addition,
PAHs can also enter herbal drugs during drying or roasting processes by direct application
of open fire. For the food sector, Commission
Regulation No. 1881/200619 (Commission
of the European Communities, 2006) sets the
following maximum levels for PAHs in food
supplements, dried herbs, and dried spices
(except cardamom and smoked capsicum):
benzo(a)pyrene, 10.0 μg/kg; sum of the four
PAHs (benzo(a)pyrene, benz(a)anthracene,
benzo(b)fluoranthene, chrysene), 50.0 μg/kg.
The currently available information on
possible sources of PAH occurrence in herbal
preparations, such as smoking, roasting,
drying, or environmental effects, has been
presented in a reflection paper published by
the EMA’s HMPC (EMA, 2016b). This paper
describes not only the effects of PAHs on huma n
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