psychotropic within the meaning of the applicable United Nations Single Convention on
Narcotic Drugs of 19614
.
Article 1(1)(b) of the Narcotics Convention defines
as meaning the
flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not
accompanied by the tops) from which the resin has not been extracted, by whatever name
they may be designated . Article 1(1)(j) qualifies as drugs in the framework of the Narcotics
Convention any of the substances falling within the scope of Schedules I and II of the
Narcotics Convention. Schedule I of the Narcotics
Cannabis and
cannabis resin, and extracts and tinctures of canna
.
Although cannabidiol that can be obtained from the Cannabis sativa L plant are not explicitly
mentioned in the schedules of the International Drug Control Conventions, they are, in the
covered by the description of the production method laid
out in Schedule I of the
follows that cannabidiol, when extracted from cannabis has to be considered as a substance
falling within the scope and under the control mechanisms of that Convention and that is
Therefore, the Commission has come to the preliminary
conclusion that such cannabidiol cannot be regarded as food pursuant to Article 2(g) of
Regulation (EC) 178/2002.
Having examined your application, we understand that the substance for which you seek
authorisation as a novel food is obtained by an extraction process and subsequent purification
from the biomass which have been formed from leaves and fruiting tops of the hemp plant
(Cannabis sativa L.), the seeds being removed from mature fruiting tops after harvest.
Based on the assessment outlined above, the Commission therefore preliminarily concludes
that the substance for which you seek authorisation must be qualified as an extract from
Cannabis pursuant to Schedule I of the Narcotics Conventio
pursuant to Article 2(g) of Regulation (EC) 178/2002 and, consequently, falls outside the
scope of Regulation (EU) 2015/2283.
a period of 2 months from the receipt of this letter.
After the lapse of that period, the Commission will adopt a final decision on the validity of
your application, which will take into account the comments you submitted.
Yours sincerely,
4 United Nations Treaty Series, vol. 978, No 14152.
Commission europĆ©enne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIĆ Tel. +32 22991111
Office:
ce: B23
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