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2 Riboulet-Zemouli
Eal Jl 2020, he Eea Cii Diecae-Geeal f Healh ad Fd Safe
(DG SANTE) aced ha i igh ad a ii i hich fd dc caiig
caabidil (CBD) deied f Cannabis sativa L. (he la) ld be ahied f
ale i he Eea Ui, beig aiilaed edicie de cl (acic dg).
The ifai a ciclaed alica f he egiai f a CBD-caiig dc
ihi he EU Nel Fd eglai, b all f he: l he alica he CBD a
la-deied eceied he adice. Alica f CBD baied b fll cheical in vitro
hei ee ified.
“The Commission [...] preliminarily concludes that [plant-derived CBD] must be qualified
as an extract from Cannabis [...], cannot be qualified as ‘food’ [...] and, consequently,
falls outside the scope of [the Novel Foods] Regulation”
The aali e hich DG SANTE bae i eliia ccli i ell-ieied, ad
ackledge ke elee ch a he -icli f CBD ag he Schedle liig
acic dg ihi he ieaial dg cl Cei (IDCC).
DG SANTE aali i, hee, iclee, leadig iieeai f he lee ad
ii f he IDCC.
Thi e aale he ieeai f he IDCC b DG SANTE f a echical eecie,
fidig, ca he eliia ccli, ha:
➔CBD, , a a a , a a acic dg.
Sbace ae cl ed i he cfeci f bh edical ad fd dc, bjec
diffee eglai. The aalg ih chili ee-deied caaici i efl (. 78);
➔Sbace laced de cl accdig hei
aa eie;
➔T par hole: cl ha al he whole (caabi & caabi ei) d
al he f i parts (CBD ad he hebal cd) le, like f THC, he
part i ecificall lied i he Schedle. Oi-deied aaeie ide f a iighfl
aalg (ee . 10);
➔Thee i ea cide ha a WHO E C
D D (ECDD) a CBD alie fd ( a he -edical
dc). The ce f he Cei, ad he adae f he ECDD, a a
a . N .
D S C CBD 3
Na . a 4
D a 5
S . aa 8
T a a 9
T aa C 11
C 12
CBD as a narcotic? Food for thought. 3
Dispositions of the Single Convention exempting CBD from control
Paie ca legall ahie he ei f dg f he ha edical ad cieific
e, ece i he a -a a
eceiall S C.
1
Aicle 4, dicig he geeal bligai f cie a he Sigle Cei
Nacic dg f 1961 (C61), elai ha he eae be ake
a a he dci, aface, e, i, diibi f,
ade i, e ad ei f dg ae C.
The Cea C61, eaed b Uied Nai Secea-Geeal, elai ha he
ii hich [hi aagah] i bjec, i.e. hich ae eceed f i alicai, ae
aicle 49, aicle 2, aagah 9 (ag he).
2
Aicle 2, dicig bace de cl, ecifie i i aagah 9 ha Pa a
a C a
a a .
The UN Seceaia i f he ii ha i ca [...] be eclded ha a dg fallig de he
3
ieaial acic egie [...] igh be eeded f ide e i idial cee he
ha he f haaceical facie.
The 1971 Cei Pchic bace (C71) hich l cl THC, iclde
iila diii eeig dg ed f idial e (C71, A. 4(b)),
cbaed i he 1988 UN Cei agai illici affickig.
Addiiall, C61 Aicle 28, dicig he cliai f he caabi la, add ha hi
C a a he cliai f he caabi la a
(fibe ad eed) ad hiclal e.
The Cea elai ha a Pa eiig he cliai f he la f he dg, b
al eiig cliai elehee , al [cl]
he fe, b he lae.
4
Se hae aged ha he eei l ce fibe ad eed a ai diied
b he UN Seceaia he claifig ha he a a a
[a a ], a he e eied i aagah 2 [i.e., a
( a ) a a ]
.
5
I el ha he cliai, dci, aface, e, i, diibi f, ade i,
e ad ei f caabi ad all i ce, f he ha edical ad cieific
e, i ee f he gie f cl f C61.
1 Uied Nai Secea-Geeal (1973). Commentar on the Single Convention on Narcotic Drugs, 1961
(Prepared b the Secretar-General in accordance with paragraph 1 of Economic and Social Council
resolution 914D(XXXIV) of 3 August 1962). Ne-Yk: Uied Nai; . 113114.
.dc.g/dce/cii/CND/I_Dg_Cl_Cei/Ceaie-OfficialR
ecd/1961Cei/1961_COMMENTARY_e.df
2 Ibid., . 110111.
3 Ibid., . 72.
4 Ibid., . 314.
5 Ibid., . 312.
4 Riboulet-Zemouli
Cannabis plant. Ph: Gi Bale / Ulah
“Narcotics” vs. “narcotic drugs”
Deiai a beee EU dce, aleaiel ig he acic he
eei acic bace. I hld be ed hee ha he Cei i, abe all,
a ea eglaig dg, i.e. edicie. Nacic i eel a adjecie aached dg.
Uig Nacic Cei iead f Cei Nacic Dg ca lead
ideadig ih egad he ce f cl f he Cei.
The UN Seceaia ide e claificai, elaiig ha he e fia (i
Fech) ad eefaciee (i Saih) ae cle-d ha ced he a
a a + , acic . The eece f he dg (i.e. edical
6
dc) algide he adjecie acic i ieeial he ii f he Cei,
hich fce dg ad edical e.
I ee ha he acic i EU egla lagage ced he eei
acic dg i ieaial la, i.e., a ceai e f edicie. Thi aea f iace i
Ccil Diecie 65/65/EEC edicial dc i hich acic ae l cideed a
a be f edicial dc (ee Aicle 16).
6 Ibid., . 910.
CBD as a narcotic? Food for thought. 5
Defining and delimiting “food”
DG SANTE’s preliminary conclusions
“The definition of ‘food’ set out in Article 2 of Regulation (EC) No 178/2002 , to which
Articles 2 and 3 of Regulation (EU) 2015/2283 make reference, when defining the scope
of application of the novel food regime, excludes (under lit. g) substances that are
‘narcotic or psychotropic’ within the meaning of the applicable United Nations Single
Convention on Narcotic Drugs of 1961 (hereafter ‘Narcotics Convention’).”
D i he eaig f he alicable [C61] i clea egh: a a
S I a II, aa , a . I i
elici i he Cei, aiclal:
- i Aicle 1(1)(j), defie dg a a f he bace i Schedle I ad II, hehe
aal heic,
- ad i Aicle 2(9), ecifie ha cie ae eied al he ii f
hi Cei dg hich ae cl ed i id f he ha edical
cieific e.
A dg, f he Cei, i a bace ed f edical ad cieific e ha i
laced de cl. The alifie dg hece de efe he cheical cii f
a bace eaai, b i a f lacee i he Schedle I II ad i
e f e. A addii, delei, chage i Schedlig ill hae a a ceece ha
a aicla bace a h bece ceae be a dg. I a iila fahi, a
7
bace ceae be a dg ifa i eeig e f he cieia: liig i he
Schedle + e f edical ad cieific e. T C
a a a,
.
The l cideai f cheical cii i he eiale ade beee aal ad
heic, b, agai, i alie l (1) if he bace i lied i he Schedle ad (2) if i i
ed f edical cieific e.
7 Ibid., . 10.
6 Riboulet-Zemouli
Hemp cake. Ph: K8 / Ulah
Nii ad alieai ae edical cieific e ad, heefe,
a a, S a a
a aa [C61].
Diecie 2001/83/EC edicial dc f ha e eaicall cide acic
bace a edicial dc f ha e, aiclal i i aicle 71, 87, ad 96.
Aicle 71(2) ackledge he eiece f eei e acic dg b biig
ecial edical ecii l he acic bace ee i a -ee
ai i edicial dc. I de eed eglai ee aiie f
chedled bace.
Regulation (EC) No 178/2002
“‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially
processed or unprocessed, intended to be, or reasonably expected to be ingested by
humans. ‘Food’ includes drink, chewing gum and any substance, including water,
intentionally incorporated into the food during its manufacture, preparation or treatment.
[...] ‘Food’ shall not include: [...] (d) medicinal products within the meaning of Council
Directives 65/65/EEC and 92/73/EEC; [...] (e) cosmetics within the meaning of Council
Directive 76/768/EEC; [...] (g) narcotic or psychotropic substances within the meaning of
the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations
Convention on Psychotropic Substances, 1971.
The defiii f fd i Reglai (EC) N 178/2002 ae ha acic bace (i i
g), b al (-acic) edicial dc ( d) a ell a ceic ( e), ca be
cideed a fd.
Aicle 2 f Reglai (EC) 178/2002 de dialif cd ed f he e
be ed i fdff, i dialifie dc hich ae eaed de a diffee eglai
be ld a ch a fd fdff. Theefe, acic bace cl ed i
CBD as a narcotic? Food for thought. 7
id f he ha edical ad cieific e (icldig fd idie) ae
dg ihi he eaig f C61.
A ieeig aallel i ffeed b Ccil Diecie 76/768/EEC ceic hich li i
i Ae II (bace hich ceic dc cai) acic, aal ad
heic : All bace lied i Table I ad II f he igle Cei acic dg. I
i ia e ha hi lae diecie al ide f a geeal ecli f all
edicial dc f e i ceic. Hee, f bh acic ad -acic
edicial dc, he ecli i baed he e ad ce f e, ad l
he ee cheical cii f bace de cideai.
I i eable, Ccil Diecie 76/768/EEC ae ha i eglai elae l
ceic dc ad haaceical ecialiie ad edicial dc, ha f
hi e i i ecea defie he ce f he Diecie b deliiig he field f
ceic f ha f haaceical ad elai ha ch deliiai fll i
aicla f he deailed defiii f ceic dc, hich efe bh hei aea f
alicai ad he e f hei e.
Agai, aa aa a ae he ai a f a
ceic. The a ag he defiig chaaceiic.
Thi aach eche ha f C61 decibed abe. I al ake ee becae,
a a aa, a a, , a, a a
, a a.
Chilli peppers. Ph: Ri Lecae / Ulah
A gd ad clea eale i ided he ce age f he Fech Phaaceia eci
egeable bace hich ae ha Pla he Fech ae i gaed i hi
dce hae bee ideified a ibl al beig ed a fd ad/ cdie. Thee
8
ae eeal eale f la ed f diffee e, ih diffee alicable eglai
deedig he aea f alicai ad e.
The chili ee la (Capsicum annuum L.) ad i -acic caaici cd
(eible f he ge ad h f e chilli ee fi) i e f hee. Capsicum
ad caaici ae ed a fd ad fdff, cdie ad ice. B he ae al ed a
igedie i ceic, a a cdig hebal dc ad API f edicial flai,
9
8 Phaace faaie (jaie 2020). Liste A des Plantes Mdicinales. Pai: ANSM.
a.ae.f/a/a_ie/age/igial/alicai/dc6398f1f676936f296909ec52fc2213.df
9 See f iace he e f Caaici i he CIg Daabae:
ec.ea.e/gh/l-daabae/cig/ide.cf?feaci=each.deail_2&id=74864
8 Riboulet-Zemouli
a ell a i he cfeci f he idial dc like lice-gade ad eal
10
defee a.
11
I each f hee aea, alhgh he ae dc / bace i deal ih, diffee la,
le ad adad al f diffee e, egadle f hich al i he aea.
Thee ae eial ha ad adee effec aciaed ih caaici ad chilli ee.
Accdig Aedi, caaici ca cae aie bchcici ad idce
12
cghig, eeciall i idiidal ih eee aha, eiall iggeig faal cie hich
i a aj ble ih he e f ee a a ai-i age. Hee, dici
he eglai cceig he e f caaici i a hld ad ill affec fd
eglai, he e f caaici i edicie.
The eac a a CBD.
Synthetic vs. natural
DG SANTE’s preliminary conclusions
Article 1(1)(b) of the Narcotics Convention defines the term ‘Cannabis’ 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 Convention includes
‘Cannabis and cannabis resin, and extracts and tinctures of cannabis’.
The lee fge e ha aicle 1(1)(j) f C61 al ecifie aal ad heic
ei f he bace ae cideed alike. Accdig hi defiii, DG SANTE hld
hae e i cicai, l alica f la-deied CBD, b al f
alica f in vitro CBD fdff e.
I aea ha hee i lile gd jif a diici beee bace laced de
cl accdig hei heic aal chaaceiic.
10 See f eale Eea Phaaceia, gah f Caic, Caic leei, efied
ad adadied, Caic f eac, adadied, ad Caic ice, adadied.
11 I hld be ed ha, i addii, he chili ee la f eal, he-bd cliai,
ei ad ci, i all bied a f eglai, egadle f i e
f e cliai.
12 Aedi G (2008). Caaici ad Caaiciid. I: Fa E ad Taglialaela-Scafai O (Ed).
Modern Alkaloids: Structure, Isolation, Snthesis and Biolog. 73109. Weihei: Wile.
CBD as a narcotic? Food for thought. 9
The whole is different than the sum of its parts
DG SANTE’s preliminary conclusions
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 Commission’s preliminary view, covered by the description of the production
method laid out in Schedule I of the Narcotics Convention (i.e. ‘extracts and tinctures of
cannabis’). It 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 qualified as ‘drug’ thereunder.
Thi aali i iled i i he i cide ha:
- CBD ld be a eac ad ice f caabi
- CBD ld be de cl eel f beig a f a clled bace.
I i ladak Herbal medical products, Gaedcke ad Seihf if ha i i a deciie
13
aec ha he la a f a la hich ae ed f haaceical e ae
egaded a a acie bace i i eie ecifig ha hebal edicial dc, i
hi egad, ae ala ie f a be f bace. Sch a aach i idel
acceed ag ciei ad ke iii ch a he Gea Cii E ad he
Ccil f Ee Eea Phaaceia Cii.
Accdig hi aach, fleig fiig caabi ld be a igle bace. A
a eac ( ei) baied f ch hle-la caabi ld be cideed a diffee
bace. Ad a efied cceae eac f ha a ei ld be e ahe bace.
Sch a aach i efleced i he IDCC ad he a i hich Cannabis deiaie ae
chedled.
Bed edicie, hi aali i al idel acceed ag chei, a Weibeg elai
i Water is H2O.,Siilal, i ca be aed ha CBD is Cannabis resin, ad CBD is
14 15
Extracts and tinctures.
16
Eac ad ice f caabi, e ideed caabi ei ae a f caabi fleig
ad fiig . Ye, he ae diffee eiie, diffee legal bjec, bjec diffee
gie f cl he he ae a f he hle, ad he he ae ilaed. O hi
aicla ie, he Uied Nai Seceaia elai ha caabi ei i a dg ihi
13 Gaedcke F ad Seihff B (2003) Herbal Medicinal Products, Scientific and Regulator Basis for
Development, Qualit Assurance and Marketing Authorisation. Sga: Medha GbH Scieific
Pblihe.
14 Weibeg M (2006). Wae i not H2O. I: Baid D, Scei E ad McIe L (Ed). Philosoph of
chemistr: snthesis of a new discipline. Ne-Yk: Sige. 337345.
eb.achie.g/eb/20191123131111/h://bealeia.ad./lieae/Ph_f_Ch.df
15 See al h://bae.blg.c/2011/10/ae-i--h2.hl
16 See al . 10 i: Rible-Zeli K (2020). Caabi lgie I: Cceal ie ih Cannabis
ad caabiid eilg. Drug Science, Polic and Law 2020; i e.
10 Riboulet-Zemouli
he eaig f he Sigle Cei. I i defied eaael f caabi. Lae i i
17
ecified ha he ei, hee, bece caabi ei l he eaaed f he
la; ih ch eaai i eai a a f he caabi la, ad if i he a, f
caabi.
18
The eac ae lgic alie f eac ad ice, hich, alhgh ee defied i he
C61, ae cideed be dg diffee f caabi caabi ei, hich ideed he
legall ae accdig he Secea-Geeal' ffice.
19
THC, lied i he Schedle f he C71, i bil al legall a diffee dg.
I a a pars aa a hole,
a, a a a...
CBD!
Ial, a aallel ih aaeie, a acie cd deied f Oi ad lied
i he Schedled, hich ieaial cl de al. Paaeie, alhgh deied
f i i he ae fahi a CBD i deied f caabi caabi ei, i a
clled bace he eaaed f i.
I hld al be ed ha eac ad ice f caabi de dee he
decii f [a] dci ehd. Mehd f bei (dci, eaai, eaci,
aface) ae defied i C61 Aicle 1, a eed a i he able bel. Hee hee
ehd ae lied i he Cei i de al ecific cl alg he dci
chai ihi he haaceical ec. The d affec he a f cl f a dg, hich
deed (1) i lacee i a Schedle ad (2) i e f dci ad e.
Saring maerial
Mehod of obenion (Article of C61)
Reling drg
cannabis plant
Production (Art. 1(t))
cannabi
cannabis plant
Production (Art. 1(t))
Separation (Art. 1(c))
cannabi rein
cannabi
Manufacture (Art. 1(t))
Extraction (Art. 1(b))
Manufacture (Art. 1(t))
erac and incre
cannabis plant
Manufacture (Art. 1(t))
cannabi rein
Manufacture (Art. 1(t))
crde cannabi rein
Manufacture (Art. 1(t), 1(j))
refined cannabi rein
not a scheduled drug
(e.g.
, in vitro
synthesis)
Manufacture (Art. 1(t), 1(j))
cannabi rein
Manufacture (Art. 1(t), 1(j))
erac and incre
The products in bold are those defined as drugs in the Convention (Art. 1[j]), as of August 2020.
Table adaed f Riboulet-Zemouli, 2020.16
17 Uied Nai Secea-Geeal (1973). Commentar on the Single Convention on Narcotic Drugs,
1961 (Prepared b the Secretar-General in accordance with paragraph 1 of Economic and Social Council
resolution 914D(XXXIV) of 3 August 1962). Ne-Yk: Uied Nai; . 5.
18 Ibid., . 5.
19 Ibid., . 314.
CBD as a narcotic? Food for thought. 11
The applicable Convention
The efeece he alicable Cei ilie DG SANTE' eecai ha he e f
C61, he aee (he Schedle), a chage. Accdig he Jaa 2019
a W Ha Oaa ECDD, hich ill be diced i
20
Decebe 2020, a ible chage i ideed i igh. Hee, a
agai, a a a ad fd,
fdff, feed he idial dc ihi he eaig f he C61.
Theefe, he ecedai f WHO ha cce CBD l cce edicie.
21
Peaai i be ded i he eaig f he Cei, a a edical dc
caiig a dg (i hi cae, THC).
The e ecedig he ecedai i cleal ad a
a aaa aa, ice i jifie he ecedai b eiig
edicie ih chacie effec ha ae dced a eaai f he caabi
la ad cai ace a f dela-9-eahdcaabil, giig a eale he
22
caabidil eaai aed f he eae f childhd-e eile, Eidile.
Fd caiig CBD he -edical dc (e.g. ceic) ae ee diced b
he ECDD aee leadig he ecedai.
Sch edical eaai (caiig edial CBD ad e ha 0.2 % THC)
ld be de cl if he ecedai ee aded. N a
a.
Plants on displa. Ph: 2k / Ulah
20 Lee f WHO Diec-Geeal UN Secea-Geeal fllig he 41 ECDD eeig
h://.h.i/edicie/acce/clled-bace/UNSG_lee_ECDD41_ecedai
_caabi_24Ja19.df
21 The ecedai e ha a fe be added Schedle I f he 1961 Sigle Cei
Nacic Dg ead: Peaai caiig edial caabidil ad e ha 0.2
ece f dela-9-eahdcaabil ae de ieaial cl.
22 WHO Ee Ciee Dg Deedece (2019) Fort-first report. WHO Technical Report Series
1018. Geea: Wld Healh Ogaiai.
h://a.h.i/ii/biea/hadle/10665/325073/9789241210270-eg.df
12 Riboulet-Zemouli
Conclusion
The a f CBD dc aie accdig he e f dci ad e f hee
dc. Cl l al ih egad edical ad cieific e.
The chage ilied b WHO ECDD ecedai ae eiheal, ad l cce he
cae CBD dc ae ed i edicie, a a edical dc (dg), i eeach.
O he eei f idial e ee i he C61, i a eied [...] dig he
dici f he daf f he aagah de cideai, ha he ii [eeig
idial e] a f iediae acical iace, b had bee ieed
aiciae ible fe deele. I 1973 he UN Seceaia hgh ha hee
23
deele aea ill be a f hi iig. W a 1973
a; hee deele, called aa -a , aa a
aa, a a , C61.
Name ed b EU
iniion
Name ed in C61
Prpoe
of e
C61 a
of conrol
Where food
prodc fi
Preparations of hemp
floer (flowering
/fruiting tops)
Preparations of
“cannabis”
Medical &
scientific
Controlledb
Not a food product
Industrial
Exempt from
control
Food product
Preparations of hemp
erac
Crude “cannabis resin”
or
“Extract and tinctures of
cannabis”a
Medical &
scientific
Controlledb
Not a food product
Industrial
Exempt from
control
Food product
Preparations of refined
CBD erac with % of
THC 0.2
Refined “cannabis resin”
or
“Extract and tinctures of
cannabis”a
Medical &
scientific
Controlledb
Not a food product
Industrial
Exempt from
control
Food product
Preparations of refined
CBD erac with % of
THC < 0.2
Extract and tincture of
cannabisa
Medical &
scientific
Controlledc /
Exempt from
controld
Not a food product
Industrial
Exempt from
control
Food product
a If WHO ECDD ecedai #5.4 i aded, eac ad ice f caabi ld be called eaai
f caabi.
b Ude Schedle I gie a f Ag 2020, igh be clled de a Schedle III gie (deedig
jidici) if WHO ECDD ecedai #5.6 i aded.
c Ude Schedle I gie a f Ag 2020.
d Sa f cl if WHO ECDD ecedai #5.5 i aded.
23 Uied Nai Secea-Geeal (1973). Commentar on the Single Convention on Narcotic Drugs,
1961 (Prepared b the Secretar-General in accordance with paragraph 1 of Economic and Social Council
resolution 914D(XXXIV) of 3 August 1962). Ne-Yk: Uied Nai; . 72