The Italian government, with an improvident summer maneuver, has included the natural CBD in the list of medicines extracted from narcotic substances. Dramatic consequences for the hemp agro-industrial chain in Italy, Cannabis Sativa L., pending the intervention of the judiciary and/or the European Commission. An insight.
1) CBD, EU Court of Justice
Court of Justice of the European Union(CJEU) – with the judgment of 19 November 2020, in case C-663/18 (BS and CA, former directors of Kanavape, vs. Ministère public et Conseil national de l'ordre des pharmaciens) – clarified that Member States cannot prohibit 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 noting the following:
- 'since CBD does not contain a psychoactive substance in the current state of scientific knowledge referred to (…), it would be contrary to the objective and general rationale of the single convention to include it in the definition of "narcotic drugs" within the meaning of that convention, as an extract of cannabis’,
- 'it follows that the CBDin question (…) it is not a narcotic, pursuant to the single agreement' [v. following paragraph 2],
- 'it must be concluded that Articles 34 and 36 TFEU [free movement of goods, prohibition having equivalent effect to quantitative restrictions on imports within the Union market, ed.] are applicable to the CBD in question' (CJEU, judgment 19.11.20 in case C-663/18, points 75,76,78).
2) CBD, UN Commission on Narcotic Substances
United Nations Commission on Narcotic Drugs(UN, CND), on 2 December 2020 in Vienna, accepted the 2017 WHO recommendation to remove both the Cannabis Sativa L., both its resin, its extracts and tinctures from Table IV of Single Convention on Narcotic Drugs (1961), which lists drugs subject to strict international surveillance regimes. Specifying that thepreparations 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
The European Commission on December 3, 2020, in the light of comments received from EIHA (European Industrial Hemp Association) and the judgment of the EU Court of Justice in case C-663/18,
- 'has revised its preliminary assessment and concludes that cannabidiol should not be considered a drug under the 1961 United Nations Single Convention on Narcotic Drugs, as it has no psychotropic effects. Consequentially,
– Cannabidiol can be considered as a food, provided that the other conditions of Article 2 of Regulation (EC) No 178/2002 are also met. XNUMX/XNUMX'. (European Commission, 3.12.20). (2)
Subsequently, the Commission has:
– updated the European register of cosmetic ingredients (CosIng), admitting the use of natural CBD and also of CBG in cosmetics (3,4),
– recognized the nature of traditional foods of hemp leaves, in June 2023. Their use as food (e.g. herbal teas) 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
The institutions of the Member States must comply with all decisions of the The Court of Justice of the European Unionaccording to its consolidated jurisprudence. And therefore, in the case of CBD:
– bearing in mind that the EU Court of Justice is the only official interpreter of European law. And that this in turn has a higher rank than the constitutional laws of the Member States, in the hierarchy of sources of law
– governments, public administrations and courts of all levels, at national and local level must follow the ruling of the Court of Justice according to which CBD is not a narcotic substance.
5) CBD and Cannabis Sativa L., jurisprudence of the Member States
Administrative judges of several Member States have already annulled measures impeding the marketing of CBD and hemp e. Some examples, already mentioned on this site:
– the Administrative Court of Düsseldorf, on May 26, 2021, annulled the city ban on the sale of products with natural CBD, (6)
– the Council of State of Paris, by order of 24 January 2022, suspended the government order which limited the use of hemp flowers and leaves to the sole industrial production of extracts, (7)
– the Supreme Administrative Court of Warsaw, with sentence of 17 February 2022, annulled the provision of Chief Sanitary Inspectorwhich qualified the Cannabis Sativa L.including novel foods (8)
- the Council of stateFrench, with sentence of 29 December 2022, definitively annulled the already suspended ministerial order referred to above, (9)
– the Regional Administrative Court (TAR) of Lazio, with sentence of 14 February 2023, annulled the 'Testo Unico Officinali' which qualified flowers, hemp leaves and their derivatives as narcotic substances, regardless of THC levels and destinations, binding production with prior authorization from the Ministry of Health. (9)
6) Italy, the CBD in the list of medicines extracted from narcotic substances
The decree of 7 August 2023, signed by the current Italian Minister of Health Orazio Schillaci, restores the effectiveness of the previous decree of 1 October 2020, which:
– had entered the CBD in a table of 'narcotic active substances including active substances for pharmaceutical use, currently in therapeutic use for human or veterinary use', attached to the Consolidated Narcotics Act (TUS, Presidential Decree 309/90),
– had been promptly suspended by the pro-tempore minister Roberto Speranza himself, by decree of 28 October 2020, because 'the question requires further investigations of a technical-scientific nature'. As in fact prescribed by the Consolidated Narcotics Act (10,11).
6.1) Inconsistent reasons
The agriculture ministerOrazio Schillaci justifies the inclusion of CBD in the list of narcotic active substances with non-existent reasons, with respect to the fundamental question: is cannabidiol a narcotic substance, or in any case does it present a real risk to public health? In this regard, it is noted that:
– the Court of Justice has clarified that 'it is for the national authorities (…) to demonstrate in each particular case, in the light of the results of international scientific research, that their legislation is necessary in order effectively to protect the interests taken into consideration by that provision and, in particular, that the marketing of the products in question presents a real risk to public health that needs to be thoroughly assessed(judgment of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraphs 87 and 88) '. (12)
– the decree of 7 August 2023 refers instead to 'the opinion of the Higher Institute of Health, issued with a note dated 6 November 2020, in which: «in conclusion, to answer the question in question, it is emphasized that to date the studies at disposal genericallyrecommend the use of minimal doses and under medical supervision for the evaluation of the ratio
risk/benefit. Literature reviews considered they provide no informationon side effects (e.g. drowsiness, psychotropic effects) according to the different doses, nor to its different methods of intake (oral, inhaled), nor to the age, gender and physiopathological characteristics of the consumer"'. (13)
6.2) Italian politics
Assorurale's positionexpressed by the Meloni government with the decree in question has an evident political matrix, which results
– far from the farmers and operators who have invested in the (non-drug) industrial hemp supply chain in Italy, under the banner of agroecology and sustainable development, (14)
– distant from the citizens who in Italy, as in Europe and in the rest of the world, appreciate the Cannabis Sativa L. and products derived from it. For food and also non-narcotic phytotherapeutic uses, at costs well below those of Big Pharma products,
– at the service, vice versa, of LOBBYof Big Pharma. Which for years, in Rome and Brussels, have been working to obtain the exclusivity ex legein the distribution of phytocannabinoids, natural and synthetic, (15)
– in continuity, perhaps not by chance, with the previous governments. Where today's vice-premier himself, in the first government led by Giuseppe Conte, caused the flight of investments in the hemp supply chain from Italy in 2019. (15) And the minister Roberto Speranza, under the government of Mario Draghi, introduced the decree which is now effective again.
7) Provisional conclusions. Politics, science and law
Confirmingof the above, the decree of 7 August 2023 claims that ' during the 63rd session of the United Nations Commission on Drugs (CND), held in Vienna on 2 December 2020, Italy, as a member of the Commission on Drugs, rejected,
together with the European member countries of the same commission, the
WHO [WHO] recommendation 5.5 exempting preparations containing predominantly cannabidiol and a maximum of 0,2% delta-9-tetrahydrocannabinol [THC] from international drug control measures'. (10)
CBD, insists the minister Orazio Schillaci, would be an active substance and should be classified among narcotic substances because the Italian Medicines Agency 'reiterates that cannabidiol (CBD) is to be considered an active substance to all intents and purposes'. (10) The demonstration of 'results of international scientific research' indicating the existence of 'a real risk to public health' to be evaluated 'in depth' – instead prescribed by The Court of Justice of the European Union(see paragraph 6, first point above) – it is quite another matter.
Politicsthat the proclamations translate into regulations with an impact on the economic activities of operators and the lives of citizens must respond to the law, in this case also to science. Concepts of which, however, we have lost track. Ad maiora.
Dario Dongo
Footnotes
(1) Dario Dongo. Natural CBD, the EU Court of Justice declares unjustified prohibitions illegitimate. New horizons
. GIFT (Great Italian Food Trade).
(2) Dario Dongo, Silvia Giordanengo. Cannabis Sativa, CBD. Green light from the UN and the European Commission. GIFT (Great Italian Food Trade).
(3) Dario Dongo, Giulia Torre. Hemp in cosmetics, green light from Brussels to natural CBD. GIFT (Great Italian Food Trade).
(4) Dario Dongo, Giulia Torre. Hemp and cannabinoids, green light for the use of CBG in cosmetics in the EU. GIFT (Great Italian Food Trade).
(5) Dario Dongo. EU, hemp leaves do not qualify as 'novel food'. GIFT (Great Italian Food Trade).
(6) Dario Dongo. Green light to the CBD, justice to the Court of Düsseldorf. GIFT (Great Italian Food Trade).
(7) Dario Dongo. France, the Council of State suspends the ban on the sale of leaves and flowers of Cannabis sativa L.GIFTS ( Great Italian Food Trade).
(8) Dario Dongo. The Cannabis sativa L. plant is not a Novel Food. The umpteenth confirmation from Warsaw. GIFT (Great Italian Food Trade).
(9) Dario Dongo. Hemp flowers and leaves, green light in France and Italy. GIFT (Great Italian Food Trade).
(10) Ministry of Health, decree of 7 August 2023. Revocation of the decree of 28 October 2020 of «Suspension of the entry into force of the decree of 1 October 2020, containing: “Update of the tables containing the indication of narcotic and psychotropic substances, referred to in the decree of the President of the Republic of 9 October 1990, n. 309, and subsequent modifications and additions. Inclusion in the Table of Medicinal Products, section B, of the compositions for oral administration of cannabidiol obtained from Cannabis extracts"» https://tinyurl.com/5y58j23j
(11) Dario Dongo. Medicinal CBD? The Ministry of Health beats the retreat. GIFT (Great Italian Food Trade).
(12) Court of Justice of the European Union, judgment 19.11.20 in case C-663/18. https://tinyurl.com/mr3thyrpSee point 87
(13) The Istituto Superiore di Sanità (ISS) had already distinguished itself, in 2022, for an unscientific 'assist' to the Ministry of Health, on the subject of food allergens. See paragraph 2.1 in Dario Dongo. Allergens and RASFF, European blackout. GIFT (Great Italian Food Trade).
(14) Dario Dongo, Alessandra Mei. Hemp, resilience in agriculture and sustainable development. GIFT (Great Italian Food Trade).
(15) Dario Dongo. CBD, edible hemp and cosmetics. 'Big Pharma' against everyone. GIFT (Great Italian Food Trade).
(16) Dario Dongo. Industrial hemp, bad politics. GIFT (Great Italian Food Trade).
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
