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Ladies

and Gentlemen
The fact that the scheduling of cannabis happened in 1961 without a lot of scien:fic
knowledge about cannabinoids, does not mean the officials have not been following
these rules ever since. They have and this is their job.
Our job, I believe, is to find bullet-proof ways of doing what we want to be doing: to
become successful in the emerging cannabis industry in the long run.
Name of this lecture is: “Cannabis extracts and pharma-grade cannabinoids: several
legal perspec:ves”
Its main message is: the fact that legal cannabinoids are not scheduled by UN
Conven:ons does not necessarily mean they are not regulated already; especially in
the European perspec:ve. I also believe, our industry is mature enough to allow
calling things their proper names and it can live with it.
In the first part we will discuss the original legal framework sePng rules for our governments. Do keep
in mind many countries went beyond these rules or are not completely in line with them. Also, in EU
there exist only a patchwork of regula:ons addressing hemp extracts and cannabinoids. I strongly
advise you always check with your na:onal authori:es and your lawyers before engaging in any kind
of cannabis enterprise.
General obliga:on of countries is to control the produc:on, manufacture, export, import, and
distribu:on of, trade in, use and possession of scheduled drugs, exclusively to medical and scien:fic
purposes.
UN conven:ons recognize two Categories of substances and four Schedules.
Categories are Narco:c drugs, as defined by a so called Yellow List, and Psychotropic substances, as
defined by the Green List. These lists are published by the Interna:onal Narco:cs Control Board with
last updates in 2017.
Schedules are defined by their abuse poten:al. Schedule I drugs are deemed most dangerous and
without any medicinal value. Schedule II drugs can be prescribed on a specialist prescrip:on, Schedule
Three contains various prepara:ons on regular prescrip:on and Schedule IV defines selected Schedule
I substances with poten:al medicinal and scien:fic research applica:ons le\ to discre:on of individual
countries. This “schedule IV” is a gateway to na:onal medicinal cannabis programs.
Cannabis, its resin, extracts and :nctures are Schedule I narco:c drugs. Cannabis and Cannabis resin
are also in Schedule IV.
A specific isomer of THC, the (-)-trans-delta-9, also called Dronabinol, was allowed a controlled
medicinal use and was moved into Schedule II in 1991. It was moved to Schedule III of the US
Controlled Substances Act in 2010.
As we can see, Cannabidiol and Cannabigerol, as chemical substances, are not Scheduled by
interna:onal law, however at least two countries Canada and Slovakia listed CBD into Schedule II
several years ago and they are both considered Schedule I in USA as THC analogues. It seems quite
strange that Cannabidiol (CBD) is a Schedule I substance in the USA, however this was confirmed by
DEA in 2015.
In November 2017 WHO’s Expert Commidee on Drug Dependence made a Pre-Review of Cannabidiol
as a poten:al psychotropic substance. Proceedings sent to Commission on Narco:c Drugs did not
contain recommenda:ons to put CBD under interna:onal control, however CBD-containing extracts
used for medicinal purposes will be subject to a Cri:cal review later on in 2018. The same is valid for
cannabis itself. For the first :me ever, abuse poten:al of cannabis related substances will be evaluated
Let us now discuss how the Single Conven:on defines cannabis and what makes it different from a
Cannabis plant. Note capital “C” and lower case “c” leders on the slide.
“Cannabis plant” means any plant of the genus Cannabis.
Term “cannabis” stands for the flowering or frui:ng tops of the “Cannabis plant” from which the resin
has not been extracted.
Seeds and leaves are not defined as “cannabis” if they are separated from the flowering tops.
However, countries should prevent misuse and trafficking the leaves of the Cannabis plant. (See Single
Conven:on § 28, Art. 3).
The term hemp (or industrial hemp) is not defined by any of the UN Conven:ons. It is only men:oned
in a so called “Cannabis Manual” of UN Office on Drugs and Crime. For this purpose, upper third part
of the “Cannabis plant” is probed for its cannabinoid profile, in order to differen:ate between Drug
type and Fiber type. Contents of total THC and Cannabinol are divided by total Cannabidiol content
with result of the formula lower or higher than one.
Many countries recognize whole Cannabis plant as a narco:c drug, not only the flowering tops. Several
countries such as Slovakia and Luxembourg have exempted varie:es of Cannabis sa:va listed in
Common Catalogue and its extracts and :nctures from the scope of their narco:c laws.
“Produc:on” means the separa:on of cannabis and cannabis resin from the plants from which they
are obtained. Again, this rule in the Single Conven:on does not dis:nguish between low-THC and high-
THC Cannabis plants.

“Manufacture” means all processes, other than produc:on, by which drugs may be obtained and
includes refining as well as the transforma:on of drugs into other drugs.
Since we have seen that extracts and :nctures of cannabis are Schedule I narco:c drugs, obtaining
extracts and :nctures of cannabis is also classified as “manufacture” and is subject to mandatory
licensing form na:onal governments, which is also the case for our facility in Prague. Another reason is
increased concentra:on of THC during primary and secondary extrac:on processes.
As per its Ar:cle 28, the Single Conven:on does not apply to the cul:va:on of the Cannabis plant
exclusively for produc:on of fibre and seed or hor:cultural purposes. Any country that limits
produc:on of hemp seed and hemp stalks clearly goes beyond its interna:onal engagements.
If a country permits cul:va:on of the Cannabis plant for the produc:on of cannabis or cannabis resin,
it must apply the system of controls copying usage of opium poppy for medicinal purposes. They
create “cannabis agencies” and follow rules described in Ar:cle 23 of the Single Conven:on,.
As per Ar:cle 22 a country must prohibit the cul:va:on of the plant only if such a measure “is in its
opinion” required for “protec+ng the public health and welfare” but this provision, like the rest of the
Single Conven:on must be applied in good faith, i.e. the decision is le\ to judgment, but not en:rely
to the discre+on of the countries concerned.
There is absolutely no engagement by interna:onal law that commands governments to ban
cul:va:on of the fibre type, of this excellent renewable source of raw materials and ingredients, as
well as to bar their ci:zens, from accessing this amazing natural remedy under prescrip:on.
Let us dig deeper into cannabinoid agenda.
Please note that 80% chromatographic purity level is the dis:nguishing point between plant extracts
and mono-cons:tuent chemicals.
We recognize three main grades of the cannabis extract: crude, diluted (:nctures) and frac:onized.
Extrac:on of cannabis boosts concentra:on of all cannabinoids including THC. Since THC levels usually
go well over 1 per cent during extrac:on, dilu:on to less 0.2 per cent is therefore advised in order to
avoid criminal prosecu:on before placing this raw material on a business-to-business market. The
Netherlands, for instance only tolerate 0.05% of delta9-THC in marketable extracts or :nctures.
When we further discuss Cannabidiol, Cannabigerol and THC, we mean isolated chemical substances,
not hemp extracts or their :nctures.
We recognize only one oil related to hemp. The hemp seed oil. All the other „oils“ are technically
extracts or :nctures. With an excep:on of hemp essen:al oil which is a fragrance vapor dis:llate of
the green parts.
European companies exceeding a certain revenue have to report to European Commission their
trading ac:vi:es on a monthly basis according to Combined Nomenclature. The first 6 digits are
universal for all members of World Trade Organiza:on.
We have to understand logic of Nomenclature from top to bodom: From Chapters to Groups to Items.
The fact you call something a “CBD oil”, does not make it a “hemp oil”.
As we can see, Chapter 15, especially group 1515 stands for vegetable fats and oils and their frac:ons.
This clearly suggests term “hemp oil” stands for “hemp seed oil”. Any vegetable triglycerides found in
cannabis extract are a nuisance and cause problems during isola:on of cannabinoids. So a crude hemp
extract (a.k.a. CBD oil) is by defini:on a “Vegetable extract” belonging to Group 1302.
Then again, if you mix an extract with any kind of vegetable oil, it depends on actual mass balance to
decide if the final product is to be classified as a ”vegetable oil” or as a “vegetable extract.”
As to cannabinoids, they are terpeno-phenolic chemical compounds belonging to a group 2907 of the
Combined Nomenclature called Phenols and phenol-alcohols.
In the third part we will discuss possible applica:ons in medicinal segment. Specifically orphan drugs,
medicinal products and medical devices.
There is one Marke:ng Authoriza:on for THC in EU for pallia:ve care: THC is an ac:ve ingredient in
Sa:vex® together with CBD. However neither CBD, CBG or Dronabinol have been listed in European
Pharmacopoeia.
Both Dronabinol and Cannabidiolum are proposed Interna:onal Nonproprietary Names for
Pharmaceu:cal Substances under World Health Organiza:on.

As of the 31st December 2016, products containing Cannabidiol that are "used for medical purposes"
are classed as medicines by the UK regulatory body, the Medicines and Healthcare products
Regulatory Agency (MHRA). As such, if a CBD-containing product is "used for medical purposes"—e.g.,
its adver:sing claims a medical benefit—it must have a product license before being sold.
The use of CBD in pharmacy-compounded prepara:ons is permided in Germany under prescrip:on
only, even though no CBD-containing monoprepara:on with a marke:ng authorisa:on is currently
available in Germany. In order to ensure the quality of such medicinal products, Supplement 2015/2 of
Deutscher Arzneimidel-Codex / Neues Rezeptur-Formularium includes a CBD monograph (C-052) as
well as a protocol (NRF 22.10.) for the prepara:on of an oily solu:on. As of 1 October 2016, CBD has
been included in the German Ordinance on the Prescribing of Medicinal Products without limita:on to
administra:on route or dosage, i.e. it may only be dispensed on presenta:on of a medical
prescrip:on.
CBD is also listed in Finnish list of pharmaceu:cal substances. Slovenian regulator have given
exemp:on for use of CBD in epilepsy treatment.
For avoidance of doubt: CBD generally cannot be a medicinal product per se; it could be an ac:ve
ingredient in a medicinal product. However it could also be an ingredient in a food (supplement) or
cosme:cs if not used for medicinal purposes.
About 30 million people living in the European Union (EU) suffer from a rare disease. Orphan drugs are
medicines for the treatment of a condi:on that is rare (i.e. affec:ng not more than five in 10,000
people in the European Union) or where the medicine is unlikely to generate sufficient profit to jus:fy
research and development costs.
Cannabidiol and Dronabinol have been granted inves:ga:onal or orphan drug status for the
indica:ons shown on the chart. This is indeed a great achievement!
There is a legi:mate use of Cannabidiol in Over-The-Counter products without prescrip:on such as
medical devices. Good examples may be suppositories or adhesive patches. Such products have to be
registered with na:onal health or medicinal agencies.
In the last part we will talk about various possibili:es of safe marke:ng of hemp deriva:ves on the
open market.
In October 2016 EIHA.org published a posi:on paper on CBD-containing products. Here we propose a
three-:er regulatory framework based on daily intake of CBD equivalent. It has been demonstrated
that pharmacological effect of CBD are not exerted below 200 mg/day for average adult. Therefore
products delivering medium doses of CBD or its equivalent in hemp extracts should be regulated as
herbal medicinal products or food supplements. Low doses less than 20mg should be freely available
in foods
Daily doses as shown on the previous slide are in line with unofficial recommenda:ons of Public Health
Commidee of Council of Europe. A so called Homeostasis approach has been used. While food
supplements maintain, support and op:mize the homeostasis, medicinal products restore, correct and
modify it.
A pragma:c Belgian approach is a nice example. If a minimum therapeu:c oral dose is well
established, then discoun:ng this dosage by 10% eliminates analy:cal uncertain:es and addi:onal
10% discount creates a distance. The result may be considered as a maximum physiological daily dose.
This schedule presents four areas of food legisla:on we shall discuss in next few slides: General food
law, Novel foods regula:ons, Food addi:ves and flavorings, Food Supplements and health claims
regula:ons.

General food law defines what is and what is not food. Foods are not medicinal products and
scheduled substances.
On one of the previous slides we have demonstrated that Cannabidiol and Cannabigerol are not
medicinal products and they cannot be medicinal products per se, they could only become
cons:tuents of a medicinal product, for example as ac:ve ingredients.
They are also not listed in any of the UN schedules. So we could assume the use of CBD and CBG on EU
food market is OK.
But there is a catch to be discussed in the next slides. The catch, we were referring to concerns novel
food legisla:on governing food sources not used in EU before year May 15, 1997. Examples are Stevia
or Chia seeds, Green Tea Extract or Coriander Seed Oil. An approval process on the European
Commission level is needed before such foods may be placed on the market.
Novel food Catalogue lis:ng for Cannabis sa+va clearly says the novel food Regula:on is not applicable
to most foods and food ingredients from this plant. ”Most" in this context could mean: all food from
the seeds and/or the leaves, but not from other parts of the plant. Leaves are added to soups in
southeast Asia.
In October 2016 European Commission also included Cannabidiol as a Novel Food ingredient. Needless
to say, notes to CBD lis:ng create more confusion than explana:on. Our understanding is crude or
diluted hemp extract do not fall under this descrip:on, since they are not enriched with CBD, rather
CBD is a natural cons:tuent of Cannabis sa:va extracts. Also, certain hemp varie:es do not really
contain CBD so their extracts are hardly to be called CBD-rich anyway. New technologies allow for
mass-scale whole plant extrac:on which makes this situa:on even more interes:ng.


Market regulators may have quite contradictory opinions already! While Czech authori:es have
approved use of hemp flower extract, Austrian AGES says “cannabinoid-containing” extracts are novel
foods. As to Cannabidiol as a chemical substance, even Czech authori:es agree that it is a novel food
ingredient. There is one applica:on for authorisa:on for use of pure CBD in food supplements under
evalua:on and was submided via Czech Ministry of Agriculture. Although process is s:ll ongoing, at
least on na:onal level an expert Phyto-sanitary advisory commidee has declared that CBD has good
safety profile for food use.
Cannabis extracts or cannabinoids are not approved food addi:ves as per Regula:on EU/1130/2011.

EC Standing Commidee on Foodstuffs agreed on Dec 18, 1997 that, quote, “hemp flowers used for the
produc:on of beer-like beverages are considered as food ingredients and not addi:ves, since they are
used in the same manner as hop flowers.”
There are various hemp-flavored food products on EU market already using essen:al oils, hemp or its
extracts to add a dis:nc:ve organolep:c experience. Nice and tasty example is Cannabia: first hemp
beer of mankind introduced in 1996.
Flavorings will be exempted from Novel Food scope star:ng Jan 1, 2018.
We strongly suggest all food operators wishing to use hemp extracts in foods and food supplements to
consult with us op:ons for safe usage of hemp-derived ingredients in foods.




Food supplements are foods to supplement normal diet. Very similar safety rules apply as to regular
foodstuffs, such as "NO THC" rule (i.e. maximum ppm's according to na:onal guidelines).
Food supplements are concentrated sources of nutrients, such as vitamins and minerals, or other
substances with a nutri:onal or physiological effect, such as herbal extracts. They are marketed in
dose forms. The labeling, presenta:on and adver:sing must not adribute to food supplements the
property of preven:ng, trea:ng or curing a human disease, or refer to such proper:es.
Also, any health claims can only be selected from 222 EU-approved nutrient-specific claims.
Food operators must be aware of the mandatory no:fica:on or registra:on before placing food
supplements on the market in each individual member state.
This schedule presents a filter for keywords Cannabis and Cannabidiol in CosIng, an unofficial database
of cosme:cs ingredients in EU.
The Annex II of Regula:on 1223/2009 lists restricted raw materials and item 306 stands for Narco:cs
listed in Tables I and II of the Single Conven:on on narco:c drugs.
A restric:on on use of cannabis, cannabis resin and cannabis extract is due to their classifica:on as
Schedule I narco:cs. However extracts of flowers, leaves and stems of industrial hemp are not
restricted. Yet not TRHC can be present in any cosme:c product.
As we can see, Cannabidiol is listed in CosIng without restric:on and with four func:onal claims:
ANTIOXIDANT, ANTISEBORRHOEIC, SKIN CONDITIONING, SKIN PROTECTING. First cosme:c products
enriched with Cannabidiol start to pop-up on the EU market but only few of them have been so far
properly registered via Cosme:c Products No:fica:on Portal.

Vape pen refills without nico:ne are not governed by Tobacco Products Direc:ve. Rather, such
formula:ons should be marketed as “chemical mixtures” under General Product Safety Direc:ve.
Some countries, such as Germany do not allow CBD or CBG in e-liquids since they have issued a
posi:ve list of e-liquid ingredients.
Manufacturers should hire an authorized person to work out an MSDS and we also recommend
performing a standardized “smoke test” as per ISO 3308.
As long as the final consumer product does not contain THC above level of quan:fica:on, use of CBD
and CBG isolate or extract is business-safe, provided proper industry-grade PG/VG mixtures are used.
With this we have predy much exhausted allowed use of CBD and CBG in end user products on the
European market.
An area of veterinary dietary supplements needs to be thoroughly inves:gated. Their registra:on and
market placement happens on na:onal levels. However there is zero tolerance for narco:c drugs and
psychotropic substances.
This schedule summarizes our understanding of use of cannabinoids and cannabis extracts on
Business-To-Consumer market from perspec:ve of EU regula:ons.