Novel Food regulations in the context of CBD in food

he recent change in the Novel Food Catalogue, which is not a binding document, brought
many negative consequences on the EU industrial hemp sector. Even if hemp extracts are
not formally and legally forbidden by Europe, disproportionate and senseless measures have
been taken against food products containing CBD in many European countries.

What does the change mean?

It means that this change in wording has turned the whole previously legitimate hemp extract
and hemp (leaves/infructescense/flowers) supply into an industry that is now ‘novel’ and is
required to apply for marketing authorisation prior to placing its products onto the market.
This would be a long and very expensive process placing the entire EU hemp industry at risk.
In addition, it is wholly unnecessary, illogical and illicit considering that:

1. The hemp industry received written confirmation from the EU in 1998 that hemp
flowers/leaves are permitted for food use, and
2. Hemp has been in the human food chain for millennia and it is disingenuous to argue
that leaves and flowers in food are novel.
Analysis of the various entries relating to Cannabis Sativa L (hemp), Cannabidiol (CBD) and the recent
addition of a new category, Cannabinoids.

What can you extract from the plant?

…Following any of the above four methods mentioned, you can obtain hemp extracts rich
(but not unnaturally enriched) in CBD and other health-supporting compounds. CBD is one
of the 144 cannabinoids present in the hemp plant (mainly in the green parts of the plant).
Consumers are buying CBD mainly for its health maintaining and supporting (promoting)
properties.

Recent action by Member States and The Commission

On the 20 January 2019 the previous entries for “Cannabis sativa L.” and for “Cannabidiol”
were both rephrased.

When the NF directive (Regulation (EC) 258/97) became implemented in 1997, the
Commission requested the hemp industry provide evidence of consumption which was
collated by Hanfgesellschaft and submitted to the Commission for their consideration. In
responses from February and March 1998, the Commission confirmed in letters to two FBOs
that “hemp flowers… are considered to be food ingredients” and that “foods containing
parts of the hemp plant do not fall under the scope of the Regulation (EC) 258/97” and a
thriving hemp industry has since developed.

Below is an analysis of the various entries relating to Cannabis Sativa L (hemp), Cannabidiol
(CBD) and the recent addition of a new category, Cannabinoids.

What do the changes mean for the hemp industry?

According to the catalogue, all food/food supplements products containing hemp

leaves/infructescence (tea, snacks, muesli etc) or containing hemp extracts now need to
obtain a pre-marketing authorisation in order to being placed on the market. These
authorisations are costly in terms of time as an authorisation process takes two years plus and
significant amounts of money (€300,000+ per product). Only large operators and
corporations will be able to afford the authorisation process. This way, Small and Medium
Enterprises which mainly compose the EU market today, will be naturally left out of the
market and alongside, this could potentially destroy the entire rapidly emerging and thriving
European hemp industry.

If Europe will not allow FBOs to fully exploit the plant as a direct consequence the EU hemp
sector will collapse in favour of other markets, such as US, Canada, Switzerland and China.

European Industial Hemp Association (EIHA.org) in cooperation with EU institutions are

planning the next steps to be further developed with the aim to restore a regulation able to
fulfil both scopes (part 1 point 2 of the NF regulation): protect the consumers and guarantee a
smooth functioning of the internal market.

What else is at stake?

Hemp is emerging as one of the most rapidly growing agricultural and industrial markets in
decades.
10,000+ applications including bioplastics, construction, high protein foods and beverages,
food supplements, textiles, paper products, composites, biofuel, graphene substitutes

Major environmental benefits

 Carbon sequestration, enhanced biodiversity, land reclamation and phytoremediation,

environmentally responsible industrial and consumer products;
 Profitable cash crop for farmers when permitted to utilise the whole plant;
 Plus multi-billion-euro downstream markets.

Key environmental benefits

Hemp protects the environment

Hemp can be grown without the use of herbicides, pesticides or fungicides. Hemp is in the
top 5 out of 23 crops for biodiversity friendliness, performing better than all major crops such
as wheat, maize or rapeseed.

Excellent carbon sequestration

One hectare of industrial hemp can absorb 15 tonnes of CO2 per hectare. In comparison,
agricultural land use emits approx. 3 tonnes CO2 per hectare. Hemp’s rapid growth also
makes it one of the fastest CO2-to-biomass conversion tools available, more efficient than
agro-forestry.

Restores soil health

Hemp is a valuable preceding crop in rotations. After cultivation the soil is left in optimum
condition.

Making one tonne of steel emits 1.46 tonnes of CO2 and 198kg of CO2 is emitted to make
one tonne of reinforced concrete. One square metre of timber-framed, hemp-lime wall, after
allowing for the energy cost of transporting and assembling the materials actually stores
35.5kg of CO2.

Body panels and chassis components in cars made from hemp are lighter weight than steel or
metal which improves fuel consumption. Every bit of plastic, carpeting and upholstery in a
car can be made of hemp.

For hemp to be a viable cash crop for our farmers and processors, they need to be empowered
to utilise the entire plant.

The new Novel Food classification threatens the entire nascent environmentally friendly
European hemp industry and we seek your support to raise awareness.

EU Decision on Foods Containing CBD

In January 2019, the European Commission updated the Novel Food
Catalogue to state that extracts of Cannabis sativa L. and derived products
containing cannabinoids are considered as novel foods, as a history of
consumption has not been demonstrated. As a result, all extracts of hemp
and derived products containing cannabinoids (including CBD) are now
regarded by the European Commission as novel. This categorisation applies
to the extracts themselves and also any products to which they are added as
an ingredient (such as hemp seed oil). Synthetically obtained cannabinoids
are also considered to be novel.

The Novel Food Catalogue is not legally binding, but is used as a reference
by many authorities in the EU for the purposes of the Novel Food
Regulation ((EU) 2015/2283). This change to the Novel Food Catalogue
may therefore mean that authorities in the Member States refuse to permit
supply of foods and food supplements containing cannabinoids, pending
formal approval by the European Food Standards Agency (EFSA) under the
Novel Food Regulation.

This practical test will come with the outcome of the first application to the
EFSA for a CBD food, which was submitted by Cannabis Pharma s.r.o, for a
food supplement containing CBD for adults with a daily intake of up to
130mg. A spokeswoman for EFSA announced at the beginning of June that
the European Commission is currently examining this request which will
then be transferred to EFSA for further technical and scientific assessment.
If the application is successful, the European Commission will issue an
implementing regulation adding CBD as a food/ingredient to the list of
approved novel foods within seven months. That approval will also specify
any applicable conditions of use (e.g., maximum daily intake) or labelling
requirements. Any product which differs from the approval will require a
further application under the Novel Food Regulation.

In the meantime, manufacturers, distributors and consumers in the EU

market may find that the sale of CBD containing foods and food
supplements is disrupted unless the products may benefit from the
transitional provisions of the Novel Foods Regulation. These allow CBD
food products that were lawfully on the market before 1 January 2018 to
continue on the market provided an application for an authorisation is
submitted before 2 January 2020.

The European Commission (EC) has released regulations outlining the maximum

levels of THC allowed in hempseed food products for human consumption.
The EC, which establishes hemp regulations for all 27 countries in the European
Union (EU), has set the maximum THC levels for hempseed oil at 7.5 mg/kg and 3
mg/kg for dry hemp products, such as seeds and snacks, according to Lorenza
Romanese, managing director at the European Industrial Hemp Association (EIHA),
a membership advocacy organization that represents hemp farmers and producers.
"[The regulations] only apply to seeds—not hemp extract, not CBD. It's only seeds,”
Romanese tells Hemp Grower.
The maximum THC levels will also be calculated using a measurement of
uncertainty, which ranges between 40-50%, she says.
“Let's take the oil [for example]. I have the 7.5 [mg/kg] plus the uncertainty
measurement, which is between 40% and 50%. This means that an oil containing
11.25 micrograms per kilogram will be marketable in Europe. … And for dry food, [it]
is the same. So, we can have seeds containing 5.5 milligrams per kilogram, and
[they would] still be marketable in Europe.”
Growing the Market
Before the EC's regulations, Romanese says the European Food and Safety
Authority (EFSA) had “guidelines” on the THC limits in hemp seed foods; however,
they were not legally binding.
It caused inconsistencies amongst countries within the EU, and trade between
operators was difficult, she says. Some countries even set their own “more stringent”
regulations, she adds.
For example, Italy allowed 2 mg of THC per 1 kg of hempseed and flour products
and 5 mg of THC per 1 kg of hempseed oil products, according to JD Supra.
However, the EC's regulations are legally binding, and all 27 member states in
Europe must follow them, which will help create unity amongst the European hemp
market, Romanese says.
"[Creating a] single market for hemp and dried products, this is our ultimate goal,"
she says. “Because Europe is made of 27 member states that think differently and
speak different languages, it's a mess in Europe, so now we have legally binding
regulations for all."
Romanese also notes that the hemp market in Europe is very small compared to
markets for other crops, like cereal. "In Europe, we cultivate, more or less …, 60,000
hectares [about 148,000 acres]," she says. "It's very small, but what is impressive is
the margin of the growth sector. It's small, but it's growing very, very, very fast."
And now that Europe has "clear regulations" regarding hempseed, the EIHA believes
it will help grow the market and bring in outside investors, she says.
"What [the EIHA] expect[s] is that big companies outside the world of hemp might
integrate hemp into their distribution line," she says. "... You see, big player[s] might
be much more willing to use hemp because [regulations are] clear."
The Future
Although the EIHA is pleased to have regulations in place, Romanese says the
organization will still fight to increase the THC limits in hempseed foods, as she
thinks the current regulations are "too strict."
The organization is already working to conduct a clinical toxicological study on 400
participants to determine the effects foods containing CBD and other minor
cannabinoids have on the human body.
"With studies, we provide fresh science to be submitted to EFSA, the European Food
Safety Authority," she says. "Then, we will request a new risk assessment [to re-
evaluate the THC limits]."
The organization is currently recruiting people to participate in the study, she says,
adding that research will take place over the next year.
"For the time [being], we are happy, but we want more for the future," she says.