presenta,on will address legal status of hemp seed deriva,ves and hemp
cannabinoids from the perspec,ve of interna,onal law. Some local na,onal specics
may and we suggest you contact your na,onal ocials for details.
Lets begin with a li?le mathema,cs 101. Everybody in this room is familiar with
percent, represented by a brown square on a 10x10 board. 1% equals to 10000 parts
per million.
Now lets move down one decimal point. We are showing a magical 0.2 percent
value.
Lets move down one decimal point again. 0.01 percent, or one of ten thousand, is
not really a signicant value in our discussion.
Now lets jump two decimal points and we arrive to a part-per-million. You may
imagine it as two burnt-out pixels on a Full HD screen which has roughly 2 million
pixels.
This table gives a brief overview of various EU limits for contaminants in two types of
hemp foods: oil and dry products. Note some contaminants such as Dioxins are
tested on ppb level.
And this is a list of pes,cides hemp seed should be tested for, with corresponding
limits in mg/kg.
10
11
12
13
14
Lowest Observed Eect Level" (LOEL) and Acceptable Daily Intake (ADI) are commonly applied when
developing standards intended to prevent undesired side eects from chemicals.
LOEL is the lowest data point at which there was an observed eect. We may call it placebo eect.
Such eects of THC are described in the literature as temporary, mild to moderate psychomotor or
cogni,ve eects.
The term Acceptable Daily Intake (ADI) is used to describe safe daily intake of a substance that may be
deliberately added to food or an unavoidable contaminant. It is calculated by mul,plying the LOEL by
an uncertainty factor.
This table gives a brief comparison on policies or scien,c opinions on THC ADI. We start with German
policy from year 2000, then present EFSAs opinions in 2011 and 2015. Please note decrease of safety
factor from 100 to 30.
EIHA proposes that a human can allow taking two LOEL doses of THC per day since poten,al eects of
THC have a dura,on for 6 hours. EIHA also proposes safety factor lowered to 20 resul,ng in ADI
rounded to 240 micro grams per day.
Please see for comparison EFSAs opinion on opium alkaloids in poppy seed. With LOEL very similar to
that of THC, ADI is many ,mes higher because of low safety factor. Is THC really that much more
poten,ally harmful than Morphine?
15
By using consump,on data of various kinds of foods, such as fats and oils, high
volume protein or carbohydrate-based foods, low volume foods and variety of drinks,
presented values for nal products are being proposed. As you can see, a daily intake
of hemp s,ll leaves us with a margin of 3.96 micro grams of THC from ADI of 240 mcg
per day.
16
Here we show nal proposed values for ingredients traded on a B2B market. We also
show exis,ng guidance values or limits in some EU countries or outside of Europe.
17
18
19
Cannabis plant means any plant of the genus Cannabis. Legal industrial cul,vars
usually contain less then 0.2% of THC (0.3% in Canada). Upper third part of Cannabis
plant is used for tes,ng cannabinoid prole for assessment of drug type vs ber type.
THC, Cannabinol and Cannabidiol are taken into account with result of the formula
higher or lower than 1.
Cannabis means the owering or frui,ng tops of the cannabis plant (excluding the
seeds and leaves) from which the resin has not been extracted, by whatever name
they may be designated.
20
Produc3on means the separa,on of cannabis and cannabis resin from the plants
from which they are obtained.
21
Manufacture means all processes, other than produc,on, by which drugs may be
obtained and includes rening as well as the transforma,on of drugs into other
drugs.
Extracts and Tinctures of Cannabis are dened as Schedule I narco,c drugs.
CBD-OIL = Cannabis extract under UNO Single Conven3on.
When performing such ac,vi,es everybody should be well aware of the na,onal
legisla,ons in a country where this is happening. Since extrac,on also increases THC
content, the use of cannabis extract and ,nctures on B2C market is illegal or
extremely grey.
Our CBD isola,on facility in Prague has a government license for extrac,on and we
are not allowed to sell the extract, not even on B2B market, only to en,,es with the
license to handle narco,c and psychotropic substances.
22
Please note that 95% purity level is the dis,nguishing point between extracts and
chemical substances.
Whatever substance is isolated from any herbal source over this level, can be called a
chemical with its formula and CAS database number. From perspec,ve of
legisla,on it does not ma?er if it is of herbal or synthe,c origin.
23
Is this really the proper way of safe and responsible marke,ng of cannabis extracts?
24
25
26
27
28
29
By THC cri,cal we mean this. Do you want your food product to appear on this list?
See that products are being pulled from shelves for THC level around 1 ppm.
30
31