The Italian government, in an impromptu summer maneuver, has added natural CBD to the list of drugs extracted from narcotic substances. Dramatic consequences for the hemp agro-industrial supply chain in Italy, Cannabis Sativa L., pending intervention by the judiciary and/or the European Commission. Insight.
1) CBD, EU Court of Justice
Court of Justice of the European Union (CJEU) – in its judgment of November 19, 2020, in Case C-663/18 (B.S. and C.A., former directors of Kanavape, vs. Ministère public et Conseil national de l’ordre des pharmaciens) – clarified that member states cannot ban the marketing of CBD (cannabidiol), ‘legally produced in another member state if it is extracted from the Cannabis sativa plant in its entirety and not only from its fibers and seeds‘. (1) The Court of Justice reached these conclusions by noting the following:
– ‘since the CBD does not contain a psychoactive principle in the current state of recalled scientific knowledge (…), it would be contrary to the objective and general rationale of the Single Convention to include the latter in the definition of “narcotic drugs” within the meaning of that Convention, as an extract of cannabis.’
– ‘it follows that the CBDinquestion (…) does not constitute a narcotic drug withinthemeaning of the Single Convention‘ [see paragraph 2 below],
– ‘it must be concluded that Articles 34 and 36 TFEU [free movement of goods, prohibition of equivalent effect to quantitative restrictions on imports within the Union market, ed.] are applicable to the CBDin question’ (CJEU, judgment 19.11.20 in Case C-663/18, paragraphs 75,76,78).
2) CBD, UN Commission on Narcotic Drugs.
United Nations Commission on Narcotic Drugs (UN, CND), on December 2, 2020 in Vienna, accepted WHO’s 2017 recommendation to remove both the Cannabis Sativa L., both its resin, extracts and tinctures from Table IV of the Single Convention on Narcotic Drugs (1961), where drugs subject to strict international surveillance regimes are listed. Specifying that ‘preparations containing predominantly cannabidiol [CBD] and no more than 0.2 percent delta-9-tetrahydrocannabinol [THC] are not under international control.’ (2)
3) CBD and hemp, the positions of the European Commission.
European Commission on December 3, 2020, in light of comments received from EIHA(European Industrial Hemp Association) and the EU Court of Justice ruling in Case C-663/18,
– ‘revised its preliminary assessment and concluded that cannabidiol should not be considered a drug under the 1961 United Nations Single Convention on Narcotic Drugs because it has no psychotropic effects. Accordingly,
– cannabidiol can be considered a food, provided that the other conditions of Article 2 of the 178/2002‘. (European Commission, 3.12.20). (2)
Subsequently, the Commission has:
– updated the European register of cosmetic ingredients (CosIng), allowing the use of natural CBD and also CBG in cosmetics (3,4),
– recognized the traditional food nature of hemp leaves, to June 2023. Their use as a food (e.g., herbal tea) or food ingredient is therefore not subject to the complex authorization procedure established by the Novel Food Regulation (EU) No 2015/2283. (5)
4) CBD, duties of national institutions
Member state institutions must abide by all decisions of the Court of Justice of the European Union, according to its established case law. And therefore, in the case of CBD:
– taking into account that the EU Court of Justice is the only official interpreter of European law. And that this in turn ranks above the constitutional laws of the member states, in the hierarchy of sources of law
– governments, public administrations and courts of all ranks, nationally and locally must follow the Court of Justice’s dictum that CBD is not a drug.
5) CBD and Cannabis Sativa L., case law of member states.
Administrative judges in several member states have already overturned measures hindering the marketing of CBD and hemp e. Some examples, already recalled on this site:
– Düsseldorf Administrative Court, on May 26, 2021, overturned the city ban on selling products with natural CBD, (6)
– the Paris Council of State, by order January 24, 2022, suspended the government ordinance limiting the use of hemp flowers and leaves to the industrial production of extracts only, (7)
– the Supreme Administrative Court of Warsaw, in a ruling on February 17, 2022, annulled the order of the Chief Sanitary Inspector that qualified Cannabis Sativa L. as a novel food, (8)
– the French Conseil d’État, in a judgment of December 29, 2022, finally annulled the previously suspended ministerial order referred to above, (9)
– the Regional Administrative Tribunal (TAR) of Lazio, in a ruling on Feb. 14, 2023, annulled the ‘Testo Unico Officinali’ that qualified flowers, hemp leaves and their derivatives as narcotic substances, regardless of THC levels and destinations, tying production to prior authorization from the Ministry of Health. (9)
6) Italy, CBD on the list of drugs extracted from narcotic substances
The decree Aug. 7, 2023, signed by current Italian Health Minister Orazio Schillaci, restores effectiveness to the previous decree Oct. 1, 2020, which:
– had included CBD in a table of ‘active narcotic substances including active substances for pharmaceutical use, current therapeutic use for human or veterinary use,’ annexed to the Testo Unico Stupefacenti (TUS, Presidential Decree 309/90),
– had been promptly suspended by the pro-tempore minister himself, Roberto Speranza, by decree Oct. 28, 2020, because ‘the matter needs further investigation of a technical-scientific nature.’ As in fact prescribed by the Consolidated Narcotics Act (10,11).
6.1) Insubstantial reasons
Minister Orazio Schillaci justifies the inclusion of CBD in the list of narcotic active substances with nonexistent reasons, compared to the fundamental question: is cannabidiol a narcotic substance, or does it otherwise present a real risk to public health? In this regard, it is noted that:
– the Court of Justice clarified that ”It is up to the national authorities (…) to prove in each case, in light of the results of international scientific research, that their regulation is necessary to effectively protect the interests taken into consideration by this provision and, in particular, that the marketing of the products in question presents a Real risk to public health that must be thoroughly assessed (judgment of 28 January 2010, Commission v. France, C-333/08, EU:C:2010:44, paragraphs 87 and 88)‘. (12)
– The August 7, 2023 decree instead recalls ‘the opinion of the Istituto Superiore di Sanità, rendered in a note dated November 6, 2020, in which, “in conclusion, in response to the question at hand, it is emphasized that to date the studies available available generically recommend the use of minimal doses and under medical supervision for the evaluation of the ratio
risk/benefit. The literature reviews considered provide no information on secondary effects (e.g., drowsiness, psychotropic effects) depending on the different doses, nor on its different modes of intake (oral, inhalation), nor on the age, gender and pathophysiological characteristics of the consumer.”‘ (13)
6.2) Italic politics
The position expressed by the Meloni government in the decree under consideration has an obvious political matrix, which results in
– away from farmers and operators who have invested in the industrial (non-narcotic) hemp supply chain in Italy under the banner of agroecology and sustainable development, (14)
– distant from the people in Italy, as in Europe and the rest of the world, who value Cannabis Sativa L. and products derived from it. For food and even phytotherapeutic uses, not narcotics, at costs well below those of Big Pharma’s products,
– serving, conversely, the lobbies of Big Pharma. Who have been working for years, in Rome and Brussels, to obtain ex lege exclusivity in the distribution of phytocannabinoids, natural and synthetic, (15)
– in continuity, perhaps not surprisingly, with previous governments. Where today’s vice-premier himself, in the first government led by Giuseppe Conte, caused investments on the hemp supply chain to flee Italy in 2019. (15) And Minister Roberto Speranza, under Mario Draghi’s government, introduced the decree that now regains effectiveness.
7) Interim conclusions. Politics, science and law
Confirming the above, the August 7, 2023 decree claims that ‘at the63rd session of the United Nations Commission on Drugs (CND), held in Vienna on December 2, 2020, Italy, as a member of the Commission on Drugs, rejected,
together with the European countries that are members of the same commission, the
WHO Recommendation 5.5 [WHO] which provided for the exemption of preparations containing predominantly cannabidiol and a maximum of 0.2 percent delta-9-tetrahydrocannabinol [THC] from international narcotics control measures’. (10)
CBD, insists Minister Orazio Schillaci, would be an active substance and should be classified as a narcotic substance because the Italian Drug Agency ‘reiterates that cannabidiol (CBD) is to be considered an active substance for all purposes.’ (10) The demonstration of ‘international scientific research findings‘ indicating the existence of ‘a real risk to public health‘ to be assessed ‘in depth‘ – instead prescribed by the Court of Justice of the European Union (see paragraph 6, first bullet, above) – is quite another matter.
Policy that from proclamations is translated into regulations with impact on the economic activities of operators and the lives of citizens must respond to law, in this case also to science. Concepts of which, however, have been lost. Ad maiora.
Dario Dongo
Notes
(1) Dario Dongo. Natural CBD, EU Court of Justice declares unjustified bans unlawful. New Horizons. GIFT(Great Italian Food Trade). 21.11.20
(2) Dario Dongo, Silvia Giordanengo. Cannabis Sativa, CBD. Green light from UN and European Commission. GIFT(Great Italian Food Trade). 7.12.20
(3) Dario Dongo, Giulia Torre. Hemp in cosmetics, green light from Brussels for natural CBD. GIFT(Great Italian Food Trade). 4.2.21
(4) Dario Dongo, Giulia Torre. Hemp and cannabinoids, green light for CBG use in cosmetics in EU. GIFT(Great Italian Food Trade). 15.12.21
(5) Dario Dongo. EU, hemp leaves do not qualify as ‘novel food’. GIFT(Great Italian Food Trade). 7.6.23
(6) Dario Dongo. Green light for CBD, justice at the Düsseldorf Tribunal. GIFT(Great Italian Food Trade). 30.5.21
(7) Dario Dongo. France, Council of State suspends ban on the sale of Cannabis sativa L. GIFT(Great Italian Food Trade) leaves and flowers. 27.1.22
(8) Dario Dongo. The Cannabis sativa L. plant is not a Novel Food. Yet another confirmation from Warsaw.. GIFT(Great Italian Food Trade). 24.6.22
(9) Dario Dongo. Hemp flowers and leaves, green light in France and Italy. GIFT(Great Italian Food Trade). 15.2.23
(10) Ministry of Health, Decree August 7, 2023. Revocation of the October 28, 2020 decree of “Suspension of the entry into force of the Decree of October 1, 2020, on: “Update of the Tables containing the indication of narcotic and psychotropic substances, referred to in Presidential Decree No. 309 of October 9, 1990, as amended and supplemented. Inclusion in the Table of Medicinal Products, Section B, of compositions for oral administration of cannabidiol obtained from extracts of Cannabis”” https://tinyurl.com/5y58j23j
(11) Dario Dongo. CBD medicinal? Ministry of Health beats retreat. GIFT(Great Italian Food Trade). 29.10.20
(12) Court of Justice of the European Union, judgment 19.11.20 in Case C-663/18. https://tinyurl.com/mr3thyrp V. para. 87
(13) The Istituto Superiore di Sanità (ISS) had already distinguished itself, in 2022, for an ascientific ‘assist’ to the Ministry of Health, on the subject of food allergens. See section 2.1 in Dario Dongo. Allergens and RASFF, European blackout. GIFT(Great Italian Food Trade). 13.7.22
(14) Dario Dongo, Alessandra Mei. Hemp, resilience in agriculture and sustainable development. GIFT(Great Italian Food Trade). 15.4.23
(15) Dario Dongo. CBD, food hemp and cosmetics. ‘Big Pharma’ vs. everyone. GIFT(Great Italian Food Trade). 1.5.19
(16) Dario Dongo. Industrial hemp, the political malaise. GIFT(Great Italian Food Trade). 10.5.19
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
