Legal feasibility of the sale of C.B.D. in Spain
1.- Introduction.
At present, due to the proliferation of products with CBD content and the existence of advertisements on television and some promotion of these products on posters in pharmacies and parapharmacies or in drugstores, mainly by large cosmetic brands, the sale of hemp flowers through large internet platforms, and even the marketing of these flowers in unusual places such as tobacconists, misunderstandings are arising among those who wish to cultivate, process and sell industrial hemp products of natural origin.
The situation is due, on the one hand, to the fact that the cosmetic products marketed on a massive scale in pharmacies and parapharmacies or drugstores refer in their entirety to products whose C.B.D. content is of synthetic origin and, on the other hand, the dispensation of the flower of natural origin is marketed in the belief that its sale is absolutely legal and cannot have any criminal consequences whatsoever.
However, the lack of legal regulation of C.B.D. in Spain and the restrictive interpretation of the International Conventions by the Public Prosecutor’s Office and the FF.CC.S.E. is causing a substantial increase in police interventions both in cultivation and in sales channels.
At present, in relation to the legality of the sale of products with C.B.D. content, three positions coexist in relation to their legality, depending, as mentioned in the previous paragraph, on the interpretation of the International Conventions and Protocols on the control of narcotic substances.
A) Sale of CBD-containing products prohibited.
In accordance with this possibility, it is considered that the sale of products containing C.B.D. is illegal because they are substances that are subject to international control and, therefore, are subject to the provisions of the Criminal Code with regard to crimes against public health, on the understanding that these products with a natural origin imply a violation of the protected legal right.
This interpretation is in accordance with a literal interpretation of the International Conventions, specifically the provisions of the Single Convention on Narcotic Drugs of 1961, to which we referred earlier. Therefore, as, according to this Convention, what is controlled is the entire cannabis plant, without any reference to its T.H.C. content, the sale of these products would be absolutely prohibited.
In this sense, the Spanish Agency for Medicines and Health Products recently stated in its report of 7 November 2008 that “[…] Products containing Cannabidiol (CBD) obtained as Cannabis extract are included in Schedule I of the 1961 Single Convention on Narcotic Drugs. Substances and products included in this control list are considered to be narcotic drugs […]”, therefore, the determination of the percentage of T.H.C. contained in the plant is irrelevant.
However, we understand that this would clash head-on with the principle of criminal legality of art. 25.1 of the Spanish Constitution, according to which “No one may be convicted or punished for actions or omissions that at the time of their occurrence did not constitute a crime, misdemeanour or administrative offence, according to the legislation in force at the time”. This is so because what is subject to analysis and determination by the laboratories dependent on the Health Departments of the Government Delegations and Subdelegations is the determination of the percentage of T.H.C. and not the C.B.D.
What is being prosecuted for the criminal offence against public health are substances that cause effects on the organism, however, as we have already seen, C.B.D. does not cause any kind of psychoactive effect on the organism, nor is it harmful. It makes no sense to be convicted, after the appropriate criminal proceedings, for an offence against public health when what is seized is a substance that is harmless to the organism and incapable of causing any harmful effect.
Despite this, the majority of courts and tribunals have understood that if T.H.C. as a molecule is controlled under the 1971 Psychotropic Convention, any part of the cannabis plant containing this molecule would also be controlled.
However, although a priori this might seem a logical interpretation, the main interpreters of the Conventions, the International Narcotics Board, do not see it this way. In this regard, the INCB itself, in one of its reports, states that no plant, not even those containing piscoactive ingredients, is subject to control under the 1971 Convention.
Therefore, it is not appropriate to use this argument to control any part of the cannabis plant with THC content, since, if we look at the International Conventions, we see that the Convention on Psychotropic Substances of 1971 only controls synthetic molecules, including Dronnabinol, which is THC; whereas, if we look at the 1961 Convention, cannabis is controlled as a narcotic drug in the terms we have explained. Thus, neither the cannabis plant is controlled in the schedules, nor the leaves of the plant, not attached to the sumidad or flower, are controlled (even if they have more than 0.2% THC, which is what has been officially established as the pharmacological activity of cannabis). That cannabis leaves are not controlled is entirely logical, as it is the female flower that is consumed.
Furthermore, this interpretation, sponsored by the A.E.M.P.S. itself, would also contradict what the Agency itself stated in its 2003 and 2004 reports. In this regard, the A.E.M.P.S. Report states that ‘[…] Cannabis with a concentration in Delta 9 tetra hydrocannbinol of 0 , 2 % or less, should not be considered to be included in Schedules I and IV of the 1961 Convention on Narcotic Drugs’.
This circumstance can be seen in a multitude of court decisions in which, despite the lack of analysis in relation to the purity of cannabis, the accused is convicted for the mere fact of possessing cannabis. This position of the Court of Justice could be understandable if it were not for the fact that if what was seized was allegedly cocaine, in the absence of a confirmatory report determining the percentage of active ingredient, it would not imply any violation of the criminal precepts of the crime against public health. Thus, it is curious, to say the least, that in relation to the coca bush, the 1961 Convention and the 1971 Convention only control the leaves and their active principle, but do not control other parts of the bush other than the leaves because they have a higher or lower concentration of the cocaine alkaloid.
Furthermore, this would not only contravene the principle of criminal legality, it would also contravene the acts of the Public Authorities themselves, since on 3 October 2013, the Agreement of 3 October 2013 was signed. 013, the Framework Collaboration Agreement was signed between the General Council of the Judiciary, the State Attorney General’s Office, the Ministry of Justice, the Ministry of Finance and Public Administrations, the Ministry of the Interior and the State Agency “Spanish Agency for Medicines and Health Products”, which establishes the “Protocol to be followed in the seizure, analysis, custody and destruction of toxic drugs, narcotic drugs or psychotropic substances” and the “Practical guide for action on the seizure, analysis, custody and destruction of toxic drugs, narcotic drugs or psychotropic substances” which, in relation to the analysis of samples of alleged narcotic substances, require the determination of the richness of the active ingredient (indicating the method used to obtain it – Annex V). Furthermore, on 4 June 2008, the “II Practical Guide for action on the seizure, analysis, custody and destruction of toxic drugs, narcotic drugs or psychotropic substances” was approved, which maintains the requirements for the determination of richness.
Without prejudice to what has been affirmed, this would also imply a violation of the procedural rule, as art. 788.2 of the LECrim provides that “[…] reports issued by official laboratories on the nature, quantity and purity of narcotic substances will have the character of documentary evidence when they state that they have been carried out following the scientific protocols approved by the corresponding regulations”. It should be noted that the aforementioned article does not present any disjunctive, but rather, in order to confer the character of documentary evidence to an analytical report drawn up by the Health Departments of the Government Delegations and Subdelegations, a triple determination must be made. However, despite this, the majority doctrine of the Supreme Court understands that such a determination is indifferent.
This position held by the Public Prosecutor’s Office and the FF.CC.S.E. clashes head-on with the new Judgment of the T.J.U.E. of 19 November 2020, which allows the marketing of products with C.B.D., as the Special Anti-Drug Prosecutor’s Office maintains in its Circular of 9 June 2021 that it considers the flowers of the cannabis plant to be illegal, regardless of their T.H.C. content.
B) Free sale of CBD-containing products.
Another position, radically opposed to the previous one, affirms that the marketing of products with C.B.D. content, regardless of their natural or artificial origin, is permitted in our country.
This statement is based on the content of the 1971 Convention on Psychotropic Substances, Schedule I of which expressly includes “tetrahydrocannabinol”. Schedule I contains the substances that are subject to the most stringent type of prohibition and control by the authorities.
Article 7 of the Convention prohibits all use, except for very limited scientific and medical purposes by authorised persons in medical or scientific establishments under direct government control or expressly approved by the government; manufacture, trade, distribution or possession is subject to a special licensing or prior authorisation regime, etc. It is therefore de facto an absolutely prohibited substance.
However, given that C.B.D. is not included in any of the lists that make up the Convention, it would be a way of facilitating its production, marketing and subsequent distribution without any problem and for any purpose.
According to this theory, regardless of its origin, natural or artificial, any product containing CBD would be legal and, therefore, CBD flowers or cannabis derivatives without T.H.C. content could be marketed beyond seeds and fibres. This is because, if there had been any interest in the international control of CBD, this molecule would have been expressly included in the 1971 Convention, as was the case with T.H.C.
We understand that what is relevant is that the 1961 Convention does not contemplate denatured cannabis, i.e. from which THC has been extracted or which is of a variety containing only traces of this molecule, as an object of international control.
In this sense, RIBOLET-ZEMOULI in his study on the 1961 Convention states that the parenthesis “fibre and seeds” contained in Art. 28.2 is of secondary importance, as what is really excluded and therefore not controlled is the cannabis plant intended for industrial and horticultural purposes.
The UN Secretary-General’s commentary on Art. 28.1 and 2 of the 1961 Convention states, on the one hand, that the cannabis plant is cultivated for its fibre, seeds, buds and resin and for its leaves and, on the other hand, that the horticultural purposes mentioned in paragraph 2 are of little importance. Therefore, the cultivation of the cannabis plant for industrial purposes (fibre and seeds) or horticultural purposes is exempted from the control regime offered by Art. 23 of the Convention.
In short, in order to determine the control of a crop, in addition to proving an industrial or horticultural purpose, it must be determined whether it is intended for the production of narcotic drugs. Thus, we will refer to the definition contained in art. 1.b) of the Convention, which states that only the flowering tops and attached leaves of the cannabis plant can be considered narcotic drugs and, consequently, only the extracts obtained from these parts of the plant are internationally controlled as narcotic drugs. Similarly, only cultivation for the sole purpose of producing narcotic drugs can be controlled.
As we shall see, this interpretation is corroborated by the Advocate General of the Court of Justice of the European Union, Evgeni Tanchev, in his conclusions presented on 14 May 2020 in Case C-663/18.
The main obstacle we encounter is that, beyond purely industrial purposes (seeds and fibre), the administrative authorities do not allow the natural plant product containing C.B.D. to be used for food, medical or cosmetic purposes.
Since May 2.021, interventions have been carried out in tobacconists’ shops seizing products with C.B.D. content, however, a sensu contrario, it has recently been agreed by the Tobacco Commissioner that it is a legal substance and authorised by this body to be sold in these shops.
Likewise, Criminal Court No. 8 of Valencia has issued a judgement of acquittal in which it states that “it is clear that hemp flower, with a low THC content and prevalence of CBD, cannot be considered a narcotic drug because it does not produce any effect and, therefore, cannot be considered criminally controllable”[1], with the result that the Health Department of the Government Delegation itself states that products with CBD content are not controlled, contrary to what the A.E.M.P.S. maintains, and it makes no sense for them to be controlled when the T.J.U.E. itself has stated that trade in C.B.D. cannot be restricted as it has no effect on health and is not psychoactive.
C) Mixed or horticultural theory.
Based on the literal wording of the International Conventions and Community regulations, we can articulate a path that would facilitate the production, marketing and distribution of products with CBD content of natural origin, although, given the difficulty in obtaining administrative licences for their use for food, cosmetic or health purposes, some circumstances should be qualified.
Art. 28.2 of the 1961 Single Convention on Narcotic Drugs states that “This Convention shall not apply to the cultivation of the cannabis plant intended exclusively for industrial (fibre and seeds) or horticultural purposes”; while art. 2. 9 of the same Convention states that “The Parties shall not be bound to apply the provisions of this Convention to drugs commonly used in industry for purposes other than medical or scientific purposes, provided that: (a) By appropriate denaturing processes or by other means they succeed in preventing the drugs used from lending themselves to abuse or producing harmful effects (Article 3, paragraph 3) and that it is possible in practice to recover the harmful substances; and (b) They include in the statistical data (Article 20) furnished by them figures corresponding to the quantity of each drug so used.”
Article 9 of the General Narcotics Law states that “The above provisions shall not apply to the cultivation of the “cannabis” plant intended for industrial purposes, provided that it lacks the active narcotic substance”.
This is also corroborated by the UNODC (United Nations Office on Drugs and Organised Crime) Protocol ST/NAR 40 on Recommended methods for the identification and analysis of cannabis and cannabis products, which in its point 3.7 on industrial cannabis states: “Industrial cannabis (industrial hashish) comprises several varieties of Cannabis sativa L. grown for agricultural and industrial uses. They are cultivated for their seeds and fibres. Industrial cannabis is characterised by its low THC content and high concentration of cannabidiol (CBD). In most European countries, the current maximum legally permitted concentration for cultivation is 0.2 per cent THC (0.3 per cent in Canada). The ratio between CBD and THC concentrations is higher than 1. Many countries have “lists of approved varieties”. Those whose THC content is clearly above the legally acceptable values are removed from these lists. Harvesting of the fibres takes place at the end of flowering of the female plants and before the seeds are formed.
Therefore, we understand that, if we start from the installation of crops with certified varieties of cannabis, with low THC content and high CBD content, their legality would be guaranteed, since they would not be crops intended for medical or scientific purposes, nor would they have a narcotic active ingredient. In this sense, the operations of cultivation, processing and treatment of the biomass obtained from Cannabis sativa L. with a maximum limit of 0.2% THC, for industrial or horticultural purposes, must be placed outside any conduct with possible criminal implications, while Cannabis with a percentage of less than 0.2% THC is expressly excluded from any conduct with possible criminal implications. 2% THC is expressly excluded from the drug control legislation, and with it, all operations linked to its cultivation or further processing for the purpose of preparing the plant substance for horticultural purposes.
The logical consequence of a substance not being psychoactive is that it cannot cause a narcotic effect, as it does not affect the central nervous system. In the case of industrial hemp, as the concentration of C.B.D. is higher than that of T.H.C., the psychoactivity index would be less than 1, so there would be no narcotic effect. In spite of this, it is advisable to comply with the regulation that establishes a maximum of 0.2% to be able to define this cannabis sativa L. as industrial, excluding that the sale of industrial hemp plant product (cannabis sativa L.) can be subject to criminal or administrative sanction.
In this sense, we can highlight the Judgment of the Criminal Court No. 8 of Valencia of 30 December 2020, which understands that the hemp flower and hemp extract seized in the framework of the proceedings under investigation and with contents of up to 1.2% of T.H.C. could not be considered as a narcotic substance since, as they contain much more concentration of C.B.D. than of T.H.C., the psychoactivity index would not be exceeded.
The seed variety that would allow this cultivation is listed in the Common Catalogue of Agricultural Plant Species of the European Commission – First supplement to the 36th complete edition (2018/C 044/01) (OJEU 06.02.2018) supplemented by the 37th complete edition (2019/C 13/01) (OJEU 11.01.2019), and is not subject to any marketing restrictions as far as the variety is concerned in the European Economic Area.
Among those listed in the catalogue are the following: Antal, Armanca, Austa SK, Benico, Bialobrzeskie, Cannakomp, Carma, Carmagnola, Carmaleonte, Chamaeleon, Codimono, CS, Dacia Secuieni, Delta-405, Delta-llosa, Denise, Diana, Dioica 88, Earlina 8 FC, Eletta Campana, Epsilon 68, Fedora 17, Felina 32, Férimon, Fibranova, Fibrante, Fibrol, Fibror 79, Finola, Futura 75, Glecia, Gliana, Henola, Ivoy, KC Bonusz, KC Dora, KC Virtus, KC Zuzana, CKA Borna, Kompolti, Kompolti hybrid TC, Lipko, Lovrin 110, Marcello, Markant, Monoica, Rajan, Ratza, Santhica 23, Santhica 27, Santhica 70, Sucuieni Jubileu, Silvana, Succesiv, Szarvasi, Tiborzallasi, Tisza, Tygra, Uniko B, Uso-31, Villanova, Wielkopolskie, Wojko, Zenit.
It should also be borne in mind that in Spain there were already authorised varieties of hemp in Royal Decree 1729/1999 laying down the rules for applying for and granting aid for fibre flax and hemp, Annex 1 of which set out the 25 authorised seed varieties (Beniko. Bialobrzeskie. Carmagnola. Cs. Delta-Llosa. Delta 405. dioïca 88. epsilon 68. fasa- mo. Fédora 17. Fédora 19. Fedrina 74. Félina 32. Félina 34. Pherimon. Fibranova. Fibrimon 24. Fibrimon 56. Juso 14. Kompolti. Lovrin 110. santhica 23. Uso 31.)
In this way, traceability would be guaranteed, i.e., from the use of seeds of authorised varieties, the aim is to guarantee that from germination to obtaining the final product, it will be cannabis without psychoactive effects and, consequently, what is cultivated will comply with the provisions contained in the AEMPS Reports, obtaining cannabis that lacks pharmacological effects and, therefore, cannot be considered a narcotic drug.
2. Legal purpose of cultivation.
At this point, we must determine for what purposes the cultivation, storage, drying, conditioning and sale of plant product of Cannabis sativa L. with up to 0.2 T.H.C. germinated from certified seeds is carried out.
There is no doubt that strictly industrial purposes (production of fibre and seeds) are expressly excluded from the drug control legislation and that, therefore, if the regulatory requirements are met, cultivation does not require any kind of authorisation. It should also be borne in mind that, as it is not a cultivation of narcotic substances, the mandatory licence required by the A.E.M.P.S. will not be required; however, the reality of the industrial purposes (fibre or seeds) of the cultivation must be accredited.
On the other hand, it should be remembered that, according to Article 28.2 of the Single Convention, the Convention does not apply to the cultivation of the plant for horticultural purposes either. In this regard, according to the International Society for Horticultural Science (ISHS), horticultural purposes are not only food purposes relating to fruit and vegetables, but may also include ornamental (flowers) or aromatic and medicinal purposes.
We believe that this is the quickest and most economical way for the product obtained from the cultivation, storage, drying, packaging and sale of the plant product of Cannabis sativa L. with up to 0.2 T.H.C. as it would not require licences to be obtained from the A.E.M.P.S.
In this sense, Riboulet-Zemouli states that “The flowering tops from which the resin has been extracted are not medicinal products and do not fall under the 1961 Convention”. He explains that the Commentary to Art. 1.b of the Convention made by the UN Secretary General in 1973 states: “It can be seen that the Single Convention excludes from its definition of cannabis the flowering tops of the plant from which the resin has been extracted. The authors of the 1925 Convention did the same in their definition of Indian Hemp as the drug was commonly called. They used the same wording as the Single Convention. The exclusion could be justified on the ground that the flowering tops from which the resin has been extracted contain only a very insignificant amount of the psychoactive principle”.
This same path is the one that emerges from the conclusions of the Advocate General of the Court of Justice of the European Union, Evgeni Tanchev, presented on 14 May 2020 in Case C-663/18 and in the Judgment of the Court of Justice of the European Union (Fourth Chamber) of 19 November 2020 handed down in the aforementioned case.
In paragraph 74 of the Opinion of Advocate General Evgeni Tanchev, it appears, in summary, that if the cultivation of the cannabis plant is not intended for the production of a narcotic drug, it would fall outside the control established by the Single Convention, since, although C.B.D. could be considered an extract of cannabis (art. 1.1.b) of the Single Convention), crops intended for industrial or horticultural purposes are not controlled (art. 28.2 of the Single Convention). Finally, it states that, although the Convention on Psychotropic Substances considers T.H.C. to be a psychotropic substance, the same does not apply to C.B.D.
Along the same lines, the Judgment of the Court of Justice of the European Union (Fourth Chamber) of 19 November 2020 in Case C-663/18 clearly establishes that the spirit of the international control of narcotic drugs and psychotropic substances is the protection of health from the effects of controlled substances on the human organism, and that these purposes justify a specific regime for their production and trade. And it will be their control as a narcotic drug or their toxicity that will justify their prohibition at Community level, with the cultivation of industrial hemp for the production of flowers for extraction being licit, without the industrial purpose being justified if it is limited solely to the use of the fibre or the seed. In this sense, in the same Judgment, although, on the one hand, it is stated that, although from the literal wording of the Single Convention it could be affirmed that C.B.D. is a narcotic substance because it is obtained from a plant of the cannabis genus, on the other hand, it is affirmed that C.B.D. does not have psychotropic or harmful effects on health. Therefore, if the aim of the Single Convention is the protection of health, C.B.D. cannot be considered to be a narcotic drug merely because it is extracted from the cannabis plant.
In conclusion, the CJEU considers that the control and trade regime foreseen for narcotic substances is inapplicable to the cultivation of industrial hemp, regardless of whether the flowering tops of the plant are used, without its use being limited solely to obtaining fibre and seeds, it being an essential requirement that certified varieties recognised in the Common Catalogue or provisionally authorised in the European Community are used and that the purpose is not the production of narcotic drugs or proven to have adverse effects on health. The High Court considers as contrary to the principles of free movement of goods in the European Union the prohibition of trade in CBD obtained from certified hemp varieties on the grounds that they originate from the flowering tops or leaves of the plant, given that this limitation could result in only trade in synthetic CBD being permitted without any scientifically acceptable justification.
Conclusions
1ª) Specific regulation is needed in relation to the sale of products containing C.B.D. as it is a substance that does not cause negative effects on health. Likewise, it does not appear on the control lists of the International Conventions on the prohibition of toxic drugs, narcotic and psychotropic substances, as it is a harmless substance that does not produce any harmful effect on the organism or dependence.
Furthermore, it is a natural substance of plant origin which does not need to be synthesised in a laboratory but is obtained naturally and which is said to have potential pharmacological effects in the treatment of various diseases.
The economic potential that can be obtained should also be taken into account, as a market has developed around the consumption of this substance that could lead to a considerable increase in revenue for the public purse as well as the creation of thousands of jobs.
2ª) In the current legislative framework, despite the fact that both the Public Prosecutor’s Office and the Spanish Armed Forces are opposed to it, maintaining a restrictive interpretation of the International Conventions on drug control, the sale of C.B.D. of natural origin would be permitted in our State under strict compliance with a series of guidelines:
- It is necessary to guarantee the traceability of the product from the very germination of the plant with the use of any of the certified seed varieties referred to in the catalogues, in order to dispel any kind of doubt that what is intended to be obtained after the cultivation process is a cannabis variety free of psychoactive effects.
- Likewise, throughout the cultivation process, analyses of the plant must be carried out to accredit that the percentages of T.H.C. are not exceeded. Given that the margins are so small, when the percentage of T.H.C. is exceeded, the crop must be destroyed, documenting this circumstance in order to, if necessary, inform the Authorities, should this be required.
- Finally, crime prevention plans must be developed to reduce the risks of any person involved in the process of cultivation, acquisition and storage, drying and conditioning of the plant product in order to avoid the criminal consequences that could arise in the event of criminal proceedings being initiated for the alleged commission of an offence against public health.
3) However, despite strict compliance with the established guidelines, this does not mean that, in the event of any type of police investigation being initiated, criminal proceedings may be brought for the commission of an alleged crime against public health.
The fact that Cannabis sativa plants are cultivated with varieties, although without T.H.C. content, of Cannabis sativa. L poses a certain risk of possible initiation of criminal proceedings. However, strict compliance with the guidelines to be followed avoids any kind of possibility of incurring in conduct involving an activity classified as drug trafficking.
4) At present, since it is almost impossible to obtain a licence to distribute C.B.D. as a food, cosmetic or medical supplement due to the high economic costs involved and the strict requirements demanded by the Administration to grant them, when small farmers and SMEs wish to obtain a licence to cultivate hemp, it must be processed for the sole purpose of obtaining fibre and seeds.
If the intention is to market the plant product purchased, the description of the product to be marketed should avoid misleading terms such as flavours, aromas, sweetness, etc. In this case, as with cannabis seeds, it should be stated on the labelling that the product is not intended for human consumption.
[1] Judgment of the Criminal Court No. 8 of Valencia No. 359/220 of 30 December 1929.
“This article is an excerpt from Alejandro Jover Jurado’s Master’s Thesis”