BfR
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Annual Report 2014
40
Safety assessment of botanicals and
botanical preparations in food
Botanicals and botanical preparations are a significant
component of human nutrition. We have been consum-
ing fruit, vegetables, spices and herbs for centuries. It
is generally known how certain plants need to be pre-
pared in order to avoid undesired effects and which plant
parts are edible or poisonous. In the past years, interest
has grown in using new plants, extracts or specific com-
pounds of plants in food and, in particular, food supple-
ments. Effects are often attributed to plant extracts based
on their levels of secondary plant metabolites. However,
depending on the amount and other accompanying in-
gredients in extracts and preparations, these substances
can be toxic.
Many people regard plant-based products in general as
“natural” and “healthy”. Whether health risks could be as-
sociated with these products has not always been investi-
gated. Authorities do not generally check the safety of bo-
tanicals and botanical preparations in food items before
they are marketed. In the European Union, an authorisa-
tion procedure including a safety assessment is only in
place for foods that have been produced from genetically
modified organisms or are classified as novel food.
Due to the big variety of plant-based products, it is
scarcely possible for the federal states' food inspection
bodies to check all of them. For this reason, a working
group of federal and state governments – the BfR was
also a member – compiled a list containing approximately
600 relevant plants and plant parts. This list is intended
to help authorities and manufacturers in evaluating these
plants and plant parts used in foods if needed. The list
was published in September 2014.
From the list, the working group selected 18 examples
of plants and plant parts whose use as food could pose
risks. These 18 plants and plant parts were subjected to a
health assessment by the BfR in accordance with the Eu-
ropean Food Safety Authority (EFSA)'s “Guidance on safe-
ty assessment of botanicals and botanical preparations
intended for use as ingredients in food supplements”.
The BfR works according to the principle “From farm to fork”. This means that the entire food chain needs
to be considered in safety concepts if the aim is healthy food. In addition to the Food Safety Department,
the Biological Safety and Safety in the Food Chain Departments also work within the food safety field. Re-
sults gained from the toxicological, microbiological and nutritional assessments of feed and food provides
the scientific basis for the setting of maximum levels or limit values. The Department for Exposure contrib-
utes to the characterisation of risks with estimates of intake levels based on consumption studies and
with statistical evaluations. Furthermore, external, independent experts from nine committees advise the
BfR on issues of food safety on a honorary basis.
Food Safety
New plants, extracts or specific compounds of plants are
increasingly marketed as food supplements.
