At European level, consumable products enriched
with cannabidiol (CBD) are considered novel foods under the Food Regulation
In January 2019, the European Commission
updated the catalogue of novel foods. Since then, extracts from the cannabis
plant (Cannabis sativa L.) and derivatives containing cannabinoids have been
considered novel foods.
What about it again?
Cannabis belongs to the cannabaceae or hemp
family and is biologically classified as Cannabis sativa L.
The cannabis plant contains more than five
hundred chemical substances. Approximately 60 to 100 of these substances are
cannabis-specific and are called 'cannabinoids'.
Cannabidiol or CBD (C21H30O2) is one of the
active - but not psychoactive - cannabinoids.
In the European Union, the cultivation of
Cannabis sativa L. varieties is permitted provided that they are registered in
the EU's "Common Catalogue of
Varieties of Agricultural Plant Species" and that their
tetrahydrocannabinol (THC) levels do not exceed 0.2 %.
Novel food catalogue
Novel foods are foods and ingredients that
were not sold as food within the EU before 15 May 1997.
In order to market a product classified as
'novel food', a novel food authorisation is required.
The European Commission publishes a list of
plants (parts), products of animal origin and substances with 'novel food'
status (publicly available here). The catalogue of novel foods is not legally
binding on the member states, but serves as an indication of whether or not a
foodstuff requires a novel food authorisation.
Some products derived from the cannabis plant
or parts of the plant such as seeds, seed oil, hemp seed meal and defatted hemp
seed have a history of consumption in the EU and are therefore not novel foods
(remember, however, that the THC content in these products should never exceed
In January 2019, the European Commission
clarified that CBD and extracts of CBD should be considered novel foods, as a
history of safe use has not (yet) been demonstrated. On this basis, the
European Commission has amended its list, as a result of which these products
may no longer be sold on the market as consumable goods without prior novel
The 'novel food' status applies both to the CBD
extract as such (i.e. extracts of the plant and plant parts such as the stem,
leaves or flowers) and to products to which this extract is added as an
ingredient, regardless of the type of extract (e.g. hot/cold). It also includes
synthetically obtained CBD.
The sale of the above-mentioned
CBD-containing products or foodstuffs requires novel food authorisation. To
date, no novel food authorisation has been granted (yet) for any foodstuff
containing CBD or extracts of CBD
Before a novel food can be placed on the
market, an application must first be submitted to the European Commission,
after which the application is subjected to a scientific evaluation by the
European Food Safety Authority (EFSA).
On this basis, an authorisation will or will not be granted.
There is currently (only) one application under
consideration for the authorisation of a CBD food supplement. Cannabis Pharma
has submitted an application seeking to demonstrate the safety of the use of
CBD in food supplements for adults with a daily intake of up to 130 mg or 1.86
mg/kg body weight.
The decision is expected before the end of the
A positive decision on this application would
also be good news for other market participants, as the authorisation has a
generic character; i.e. CBD food supplements can then be marketed provided that
the specifications and conditions of use included in the authorisation are
As mentioned above, the new classification as
'novel food' implies that the sale of foodstuffs (and supplements) containing
CBD will, in principle, be restricted.
However, a large number of CBD-based products
are already freely available on the market.
The regulation therefore provides for a
transitional arrangement: foodstuffs containing CBD that were lawfully on the
market before 1 January 2018 may continue to be on the market for the time
being, provided that they submit an application for a marketing authorisation
before 2 January 2020.
Status in Belgium
Belgium maintains a very strict policy.
The Federal Agency for the Safety of the Food
Chain (FASFC) has recently clarified that the production and marketing of
foodstuffs containing cannabis and extracts from the cannabis plant is
Indeed, Cannabis sativa L. is on list 1 of
"Dangerous plants that may not be
used as or in foodstuffs" in the annex to the Royal Decree of 29
August 1997 on the manufacture of and trade in foodstuffs composed of or
containing plants or plant preparations (the Plant Decree). These provisions
also apply to hemp plants with a THC content lower than or equal to 0.2%.
Consequently, products based on cannabis are
prohibited on the Belgian market, unless a derogation is obtained from the
FASFC. Individual derogations may be requested provided that there is no risk
to public health and under specific conditions laid down in the Plant Decree.
Such an assessment is made on a case-by-case basis.
The derogations contain a detailed description
of the product with lot numbers for which the derogation was granted. The serial
numbers must be indicated on the label of the products as well as the indication
"without THC/THC-free". There is no general derogation for an outlet
or for a range of products.
The types of products that have been granted a
derogation in 2018 are e.g. hemp seeds, hemp oils, hemp meal and derived
products, such as hemp meal biscuits, hemp lemonade or beer.
However, derogations are not granted for the
consumption of leaves and flowers of the cannabis plant in the form of
infusions or teas.
No national derogations are possible for novel
foods. Since CBD is regarded as 'novel food', the FASFC is of the opinion that
a European 'novel food' market authorisation is required.
CORBUS ADVOCATEN specialises in all legal
aspects of the ever-growing market in the legal cultivation and distribution of
cannabis and cannabis derived products.
For more information on this subject, you can
always contact Anton Buntinx.
Leander Buyle (lawyer, Antwerp)
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