Medical Cannabis & Cannabinoid Regulation 2024 Comparisons

The regulatory landscape surrounding cannabis is intricate, varying significantly based on its intended use, ranging from pharmaceutical to cosmetic, food, technical, and industrial applications. To navigate these complexities with clarity, it is practical to categorise the discussion into three distinct sections:

• medical cannabis;
• industrial hemp (from certified varieties); and
• recreational cannabis.

Medical Cannabis

In Italy, the primary legislative framework governing medical cannabis is Presidential Decree No 309/1990, the Italian Narcotics Act (Testo Unico Stupefacenti). Article 14, paragraph 1, letter b) of this Act stipulates the inclusion of cannabis and its derivatives in Table II of narcotic substances subject to supervision, prohibiting cannabis in its various forms, including flowers and leaves, oil and resin.

In Italy, cannabis is, as a rule, a narcotic substance, subject to exceptions based on its scope and intended use.

Cultivation, extraction of active ingredients, distribution, import and export are in fact subject to authorisation by the Ministry of Health – Central Narcotics Office (l'Ufficio Centrale Stupefacenti, UCS), which is the state agency for cannabis intended for scientific or research purposes.

The Ministry of Health Decree dated 9 November 2015 adopted the Collaboration Agreement between the Ministry of Health and the Ministry of Defence for the launch of the Pilot Project for the national production of cannabis-based substances and preparations of plant origin.

The purpose of this project was to develop national production in order to supplement the imports of cannabis that had hitherto been exported to Italy by the Office for Medicinal Cannabis of the Dutch Ministry of Health, Welfare and Sport (Bedrocan, Bediol, Bedrobinol and Bedica).

According to this agreement, the only national entity authorised to produce medical cannabis is the Stabilimento Chimico Farmaceutico Militare based in Firenze (SCFM), which has developed the cannabis varieties FM2 (with THC content 5/8% and CBD 7.5/12%) and FM1 (with THC content 13/20% and CBD less than 1%) produced in accordance with EU Good Manufacturing Practice (GMP) in a pharmaceutical workshop authorised by the Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA) and whose distribution is authorised by the UCS.

Recently, a public call for tenders was launched for the cultivation of cannabis for therapeutic use to be contracted to the SCFM. The selection and award process is still pending (see 3.1 Access to Medical Cannabis).

Cannabis prescription and magistral preparations

Law No 94/1998 (the so-called Di Bella Law), which regulates “off-label” drugs, is the reference law for the prescription and administration of therapeutic cannabis.

Physicians may prescribe magistral preparations to be prepared by a pharmacist upon presentation of a non-repeatable medical prescription using Dronabinol or cannabis-based plant active substance for medical use.

Physicians must supplement the prescriptions with anonymous patient data on age, sex, dosage by weight of cannabis and treatment requirements according to the relevant form, which must then be transmitted to the competent region for statistical purposes. All physicians may prescribe cannabis regardless of their specialisation. Magistral preparations can be used in two different ways: orally or by inhalation.

Reimbursability of drugs charged to the National Health System (Il Servizio Sanitario Nazionale, SSN)

Law No 172/2017 provides that medical cannabis is reimbursable through the SSN, but this reimbursement is confined to treatments for specific pathologies:

• pain therapy (potentially any type);
• pain and spasms from multiple sclerosis;
• cachexia (in anorexia, HIV, chemotherapy);
• nausea and lack of appetite induced by chemotherapy;
• glaucoma; and
• Tourette’s syndrome.

Despite the national provision for reimbursement, the practical application of this law varies significantly across different Italian regions. Each region is responsible for establishing its own technical modalities for the reimbursement process. Paid medical cannabis, on the other hand, can be bought in pharmacies outside one’s region of residence.

Extracts

As set out above, extracts are included in Table II of the Narcotics Act.

However, a key principle exists: Legislative Decree No 219/2006 prioritises regulations for medicinal products. This means if a product with specific characteristics could be classified as both a medicine and another type of product it will be treated as a medicine.

This principle became relevant with the registration of the medicinal product Epydiolex (a CBD isolate with MCT oil) with the European Medical Agency (EMA). Since CBD is now an official active pharmaceutical ingredient (API) in the European Pharmacopoeia, CBD isolates are considered medical products.

In June 2021, the Ministry of Health published guidelines for obtaining authorisations for the cultivation of cannabis intended for CBD extraction for medical use. This process requires a double authorisation:

• The pharmaceutical company, already authorised by AIFA to produce APIs, must obtain additional authorisation from the UCS. This authorisation allows them to manufacture cannabis extracts containing cannabinoids for API production.
• Separate authorisation is needed for the supply of starting plant material (hemp) and the destruction of any narcotic substances (THC).

In essence, a prior agreement is required between the farm (which is authorised to grow and supply the product to the pharmaceutical company) and the pharmaceutical company (which is authorised to supply the hemp produced by the farm, as well as the extraction of API). To date, only two extraction licences have been issued.

Finally, it should be mentioned that by Ministerial Decree dated 7 August 2023, the Ministry of Health lifted the suspension of the so-called 2020 Speranza Decree, which included CBD-containing preparations for oral use in the table of narcotic drugs annexed to the Narcotics Act.

This decree has been challenged and is currently suspended by the competent Administrative Court, with the next hearing set for September 2024.

Hemp and Cannabinoids

Hemp is defined as cannabis sativa L. from certified varieties registered in the Common Catalogue of Varieties of Agricultural Plant Species, pursuant to Article 17 of Council Directive 2002/53/EC of 13 June 2002, which do not fall under the scope of the Italian Narcotics Act.

The reference law is Law No 242/2016, which consists of a framework law for the support and promotion of the agro-industrial hemp production chain.

This law incentivises:

• cultivation and processing;
• use and final consumption of semi-finished hemp products from priority local supply chains;
• development of integrated territorial supply chains that enhance the results of research and pursue local integration and real economic and environmental sustainability;
• production of foodstuffs, cosmetics, biodegradable raw materials and innovative semi-finished products for industries in various sectors; and
• implementation of bioengineering, land reclamation, educational and research activities.

The cultivation of hemp can be carried out by the farmer without the need for prior authorisation. The farmer is only obliged to keep the seed card for one year and the purchase invoice for the period required by tax regulations (ten years).

Crop controls and THC limits

Article 4 of Law 242/2016 sets the THC limits in the field at 0.2% (from 1 January 2023 the limit was raised at the European level to 0.3% following the CAP reform) with a margin of tolerance up to 0.6%.

If police controls detect THC levels exceeding 0.6%, the law mandates the seizure and destruction of the crop. However, it is critical to note that the farmer is shielded from criminal liability provided they have adhered to the stipulations of Article 3 of the same law. This includes maintaining proper documentation such as the card and seed purchase invoices, which serve as proof of compliance with regulatory requirements.

Checks must be carried out by the Carabinieri Forestali according to the method of sampling and analysis foreseen in Annex I of Reg. (EU) no. 1155/2017, but may also be carried out by any police force in the exercise of investigative activity (see 1.6 Enforcement & Penalties).

Destinations of use

According to Article 2(2) of Law 242/2016, hemp crops can be used to produce:

• foodstuffs and cosmetics produced exclusively in accordance with the regulations of the respective sectors;
• semi-finished products, such as fibres, hemp, powders, wood chips, oils or fuels, for supplies to industries and craft activities in various sectors, including the energy sector;
• material intended for green manure;
• organic material intended for bio-engineering works or products useful for bio-construction;
• material intended for phyto-purification for the reclamation of polluted sites;
• cultivations for educational and demonstrative purposes, as well as for research by public or private institutes; and
• crops intended for floriculture.

This list is considered exhaustive and requires compliance with regulations specific to each application.

Foods

Hemp-based foods in Italy are regulated by the Ministerial Decree of the Ministry of Health dated 4 November 2019, which states:

• permitted hemp-based foods are only seeds and derivatives (oil and flour); and
• the THC limits allowed are 5 ppm for oil and supplements and 2 ppm for seeds and flour.

Importantly, these limits are to be considered modified due to the effect of Regulation (EU) No 1393/2022, which sets the THC limits at the European level to 7.5 ppm for hemp seed oil and 3 ppm for seeds and flours.

THC in foodstuffs is, in fact, considered a contaminant and therefore regulated by Regulation (EU) No 915/2023, which modified the previous Regulation (EC) No 1881/2006.

The Ministerial Decree in question provides for the possibility of introducing additional foodstuffs containing hemp, but this would require presenting new scientific evidence to support such inclusion. For further details, please see the Trends and Development article.

Food supplements

Food supplements are: “foodstuffs intended to supplement the common diet and which constitute a concentrated source of nutrients, such as vitamins and minerals, or other substances with a nutritional or physiological effect, in particular, but not exclusively, amino acids, essential fatty acids, fibres and extracts of plant origin, whether mono- or multi-compound, in pre-dosed forms”.

Food supplements are regulated by Regulation (EC) No 1170/2009 (which amended Directive 2002/46/EC) and at the national level by Legislative Decree No 169 of 21 May 2004 implementing Directive 2002/46/EC and by the Ministerial Decree dated 9 July 2012 on the “Regulation of the use of plant substances and preparations in food supplements”. According to the tables attached thereto, and also by virtue of the BELFRIT agreement signed with Belgium and France, only supplements based on hemp seeds or hemp seed oil are permitted in Italy.

To date, products based on parts other than seeds or extracts cannot therefore be considered food or food supplements at the regulatory level. For other issues, such as novel food and expected developments, see  3.2 Non-controlled Cannabinoids in Food and the Trends and Development article.

Cosmetics

Cosmetic products are regulated by Regulation (EC) No 1223/09. This regulation is supplemented by the Cosmetic Ingredient Database (CosIng List), which, while not legally binding, is widely regarded as a key reference point for industry professionals. The CosIng List helps standardise labelling practices across the EU, and therefore also in Italy.

In Italy, CBD and CBG in their isolated forms are recognised as permissible ingredients for use in cosmetic formulations provided they are produced synthetically or obtained from non-prohibited parts of the cannabis sativa L. plant (ie, leaves, roots, shoots and seeds), as well as extracts of such parts.

These products are therefore marketable as long as the label states the intended purpose (topical/external use), and the functionalities and commercial claims align with the cosmetic purpose.

This category can be considered the only product category in which CBD oils can be considered compliant with regulations.

Floriculture

The field of floriculture is regulated by a multitude of EU-derived regulations, which outline the scope of application of the legislation with important terminological and definitional specifications, as well as indicating the authorisation system and the requirements for conducting floricultural activities.

In particular, Article 2 of Legislative Decree No 214/2005 clarifies the definitions by establishing that “plants” refer to live plants and parts of plants, including cut flowers and leaves.

It is therefore clear that Article 2(2)(g), having included cultivation for floricultural purposes among the (mandatory) legal uses of hemp, makes it lawful to also produce these plants and their parts for ornamental purposes.

The Ministry of Agriculture, in Circular No 5059 dated 5 May 2018, has specified with reference to hemp that the production of hemp plants and their parts, such as leaves, fronds, inflorescences and ornamental cuttings, according to the sector’s regulations in force, falls within lawful activities, provided that it is a final product, not intended for further floricultural production, subject to the legal limits for THC content. It can therefore be considered that in Italy the production and sale of ornamental hemp plants is lawful provided they are germinated from certified seeds.

This guidance explicitly states that ornamental hemp, including its various plant parts like flowers, leaves, fronds, and cuttings, is lawful as long as it is intended for end-use in an ornamental capacity only. This use excludes any possibility of further floricultural activities. Since ornamental hemp is not intended for human consumption, concerns regarding its psychotropic effects are largely irrelevant. By way of analogy, one may cite the example of oleander, a plant known to be toxic, which is freely sold without any special precautions being taken. However, the regulation of flowers is complex and intrinsically linked to the issues dealt with in the appropriate section below.

Fibres

Fibres do not present any particular legal or interpretative problems as they are unquestionably lawful.

The problems, on the other hand, concern the supply chain as there are critical production issues due to the scarcity of processing plants.

CBD flowers (so-called cannabis light)

The spread in 2017 of so-called cannabis light – ie, the sale of dried inflorescences of hemp from varieties certified for “technical use” or “collecting”, sparked immediate seizures, and case law was divided between one side that held that the flowers were case covered by Law 242/2016 and another that held that they were covered by the narcotics legislation because the flowers (like the leaves) were included in the narcotics table.

The matter was referred to the United Sections of the Supreme Court of Cassation, which ruled, while also calling on the legislature to provide clarity on the matter, that:

• the marketing of flowers, leaves, oil and resins is not covered by Law 242/2016;
• Law 242/2016 is only concerned with the taxable destinations referred to in Article 2 (see above); and
• trading flowers, leaves, oil and resins generally constitutes drug dealing; however, an exception exists if these products lack the potential to induce psychoactive effects (following the principle of offensiveness.

In the absence of legislative clarification, the sale of CBD flowers has become a widespread but legally precarious practice across Italy. Enforcement varies significantly, with authorities handling cases discretionally, leading to a patchwork of legal interpretations and enforcement practices. This has resulted in numerous seizures and criminal proceedings, each treated differently depending on the region and specific circumstances.

In essence, a paradoxical situation has arisen in which industrial hemp flowers and resins are not covered by the law (at least for retail sale), but their sale does not involve criminal offences since they do not have an intoxicating effect in practice.

CBD flowers are in any case mostly sold for ornamental purposes as end products of the floricultural supply chain with a THC content of less than 0.5% to avoid psychotropic effects.

Psychotropic efficacy

The concept of “intoxicating efficacy”  lacks a clear, universally accepted definition and is subject to interpretation by individual judges on a case-by-case basis.

In some cases, the limit of 0.5% THC (sum of THC and THCA) is applied as an absolute weighted figure borrowed from forensic toxicology. Thus, in many cases, if the CBD flower limit is below this threshold, many proceedings end in dismissal or acquittal.

In other cases, some public prosecutors’ offices have taken a radical stance that flowers are always considered narcotics regardless of THC content. In such proceedings, the total active ingredient present in the seized goods is multiplied and divided by the average single dose with the consequence that the defendant is charged with dealing “doses” of narcotics.

The issue may be resolved in the pending criminal trial against Luca Marola, founder of Easy Joint, a pioneer company in the sector. He is accused in Parma of drug dealing for possessing 700 kg of hemp sativa with a THC content of less than 0.2% but which, according to the Prosecutor's Office, translates to about 200,000 doses.

This situation exemplifies the major problem plaguing the Italian system: chronic legal uncertainty. The lack of clear regulations forces businesses to navigate this uncertainty, often basing their operations on risk management strategies that vary by region.

CBD oils

A large number of products are also sold on the Italian market as CBD oil, which, except for a few that are registered in accordance with the cosmetic regulations referred to above, are sold for an unspecified use as “technical” oils.

Such oils are often seized by the authorities, sometimes citing a violation of the Narcotics Act and sometimes a violation of Legislative Decree No 219/06 on medicinal products.

CBD oils present the same problems as CBD flowers with regard to the narcotics legislation, which are resolved by assessing psychotropic efficacy (however, this is more straightforward as they are rarely marketed with a THC content higher than 0.2%).

At the same time, they present greater problems in relation to the regulation of medicinal products for the reasons set out above.

In fact, in many cases the criminal proceedings instituted following an allegation of infringement of Legislative Decree No 219/06 end with the acquittal of the accused. This stems from the lack of a clearly defined offence, violating the principle that criminal offences require a clear taxonomical definition.

In any case, the fate of these products is intrinsically linked to the appeal pending before the Administrative Court and the developments discussed in the Trends and Development article.

Recreational Cannabis

The recreational use of cannabis is prohibited in Italy by the Narcotics Act. Possessing cannabis for personal use is not criminally prosecuted but is subject to administrative sanctions. These sanctions can have significant personal consequences, affecting one’s eligibility for driving licenses, firearm permits, passports for international travel, and various types of work permits.

It should be noted that the Supreme Court recently affirmed the principle that the cultivation of cannabis for personal use with rudimentary means does not constitute criminally relevant conduct.

This orientation of the Supreme Court is instrumental in shaping the pending bills referred to in 3.3 Decriminalisation.

The regulatory bodies that oversee the system for the production of pharmaceutical-grade cannabis and cannabinoids are essentially the UCS in its capacity as the State Cannabis Board established under the Single Convention and AIFA.

• The UCS issues authorisations for the cultivation and supply of hemp to pharmaceutical workshops.
• The UCS issues authorisations for pharmaceutical workshops to procure hemp and for the extraction of CBD as an API for the preparation of medicines.
• The UCS issues authorisations for cannabis cultivation for research purposes.
• The UCS determines annually the quantities of medical cannabis needed on the basis of data communicated by the regions.
• AIFA is the national public body that regulates medicines for human use in Italy.
• AIFA is the competent agency for the recognition of pharmaceutical workshop quality.

The following should also be noted:

• To date, the SCFM is the only institute in Italy authorised to cultivate cannabis for medical use.
• The regions are responsible for the reimbursability of cannabis as a medicine to citizens, and on an annual basis must communicate to the Ministry of Health the data regarding the amount of cannabis prescribed in the relevant regional territory for medical use.
• The regions are also competent for the issuance of certain authorisations for medical companies provided for by Legislative Decree No 219/06 on medicinal products.

In Italy, the field of medical cannabis is supported by a diverse and active network of associations that advocate for patient rights, address issues related to cannabis availability, reimbursement by the SSN, and the education of medical personnel. They include SIRCA (the Italian Cannabis Research Society), SICAM (the Italian Medical Hemp Society), and the Luca Coscioni Association, which has been active since 2002 in the area of the protection of civil liberties and human rights throughout the country with particular attention to the freedom of scientific research and the freedom of self-determination.

In the hemp sector, the Ministry of Agriculture has set up the Hemp Sector Table, in which stakeholders in the sector at the regulatory, scientific and association levels participate, and which is working on the new hemp sector plan.

Active nationally are the associations Federcanapa, Canapa Sativa Italia, and Resilienza Italia, which deal with the promotion and protection of the supply chain.

Self-regulation documents have also been adopted by operators:

• Protocols for Production of Hemp Flowers, adopted by Federcanapa, CIA – Agricoltori Italiani and Confagricoltura in 2018; and
• Extraction Hemp Guidelines adopted by Federcanapa and Agrinsieme in 2021.

There are also many associations operating at a regional level, such as the Ente Tutela Innovazione Canapa Toscana (E.T.I.CA.) in Tuscany, which signed a memorandum of understanding with the Regional Command of the Carabinieri Forestry Department to standardise the control and analysis procedures of hemp cultivation in Tuscany.

Hemp

For years, operators in the sector in Italy have found themselves operating in a grey area, particularly regarding flowers and extracts. The United Sections of the Court of Cassation had already highlighted the need for clarifying legislation in 2019. Despite various amendment proposals, the law has not been supplemented and there is still a situation of general uncertainty, with differences in interpretation and application by the competent authorities from case to case and from area to area.

The long-standing challenge for operators in the sector has been to obtain legal and regulatory clarity for the production and sale of flowers and extracts. For this reason, the lobbying activities carried out both through dialogue with the competent authorities and by challenging decrees detrimental to the sector (see the Trends and Development article) are cornerstones for the development and regulation of the industry.

The main challenge is to delineate a field of application in the category of nutraceuticals, phytotherapeutic products and food supplements, which represent that intermediate band between foodstuffs and pharmaceuticals. In essence, it is a matter of carving out a legal and regulated sector for the production and sale of health products that are not the exclusive domain of pharmaceutical companies, but also of the industry in the sector, which in recent years has demonstrated its ability to capitalise on research results applied to the realisation of industrial products.

Medical Cannabis

In the medical cannabis sector, the fundamental challenge is to implement and develop national production by opening it up to private companies with production know-how superior to that of the SCFM. In essence, it is a matter of overcoming the current “monopolist” approach by contracting out cannabis production to private companies capable of guaranteeing suitable quality standards. This objective presupposes a series of synergetic and strategic actions throughout the supply chain, starting with the training of medical personnel.

To increase national production, it is necessary for the regions to transmit annual data on medical cannabis prescriptions to the Ministry of Health. Therefore, it is necessary for doctors to be adequately trained and informed about the potential of medical cannabis, as medical prescriptions are an essential element of the supply chain.

The risks in the hemp industry are more pronounced compared to the medical cannabis sector, which benefits from clearer legislation. There remain numerous interpretative and application-related grey areas, creating an uncertain framework for industry operators. This is especially true for those dealing with CBD flowers and CBD oil, where legal uncertainties compel operators to make decisions based on risk management. Essentially, operating in this sector involves entrepreneurs consciously accepting a level of risk.

Understanding the local culture and legal landscape is crucial for developing and managing business operations effectively. Given the complexity of the regulations and legal interpretations involved, it is vital for operators to engage with professionals who specialise in this area.

Legal risks vary significantly across different production segments. The marketing of products, whether business-to-business (B2B) or business-to-consumer (B2C), such as CBD flowers and CBD oil, often encounters significant legal challenges, including frequent product seizures. Additionally, the extraction of cannabinoids presents its own set of issues, stemming from the overlapping jurisdictions of narcotics and industrial hemp legislation.

A thorough understanding of the specific legislation applicable to each sector, whether industrial, cosmetics, or others, is essential. Such knowledge enables proper activity framing and the effective management and profiling of associated risks. Regrettably, the industrial hemp sector still faces widespread risks, both criminal and administrative, which stem not only from narcotics legislation but also from the sector-specific regulations governing various uses.

For penalties, see 1.6 Enforcement & Penalties.

In Italy, cannabis in its forms such as flowers, leaves, oils, and resins is classified as a narcotic, subjecting it to strict controls and sanctions under narcotics legislation, despite ongoing legal disputes and differing interpretations. Consequently, all Italian police forces are authorised to conduct checks on cannabis and its derivatives as part of their judicial police duties.

Law No 242/2016 stipulates, in particular, that controls on industrial hemp crops are carried out by the Carabinieri Forestali according to the protocol provided for in Reg. (EU) No. 1155/2017, All. I. If a potential offence is detected at any stage of the supply chain, the police can initiate legal action under the Consolidated Narcotics Act, leading to possible criminal proceedings by the competent Public Prosecutor’s Office. Most of these proceedings are concluded with dismissal if laboratory analyses confirm that the THC content is below the level that can produce psychotropic effects.

In addition to the controls and sanctions arising from the Narcotics Act, it is also necessary to check compliance with the sector regulations relating to the individual uses of the products (food, cosmetics, pharmaceuticals, etc). Non-compliance can lead to penal or administrative sanctions, including fines, suspension of activities, or other regulatory measures.

Given the ambiguity in product classification, especially with CBD flowers and CBD oils, the potential issues arising from regulatory controls are varied and heavily dependent on the type of enforcement and the authority conducting it.

Given the complexity of the regulations in this field, it is imperative for operators in the sector of hemp and its derivatives to seek legal advice.

The industrial hemp and cannabinoid sector in Italy, much like in many other EU countries, continues to navigate through significant legal grey areas and risks. The stance of Italian authorities towards the hemp plant broadly aligns with that of Spain and Portugal, where currently only hemp seeds and fibres are recognised as legal.

At the same time, recent rulings by the Administrative Court (discussed in more detail in the Trends and Development article) have affirmed the same principles established by the French Conseil d'Etat and even earlier by the European Court of Justice on the lawfulness of using the entire hemp plant from certified varieties.

In any case, it is possible to say that the evolution of the sector, with particular reference to the food and supplement sector, will depend on the decisions at European level that will be taken by the EFSA (see 3.2 Non-controlled Cannabinoids in Food).

In general, in view of the differences in interpretation of certain product categories between the various member states, the EU has started a process of acquiring data from operators in the sector in order to define a single European regulation in order to avoid alterations to the common market.

Within the general European framework, an extremely important role will also be played by developments in the UK and Switzerland, countries which, although not part of the EU, nevertheless play a very important role in both regulatory and commercial terms.

While access to medical cannabis in Italy is not hampered by major legal hurdles, the system suffers from limitations rooted in political choices. The production of medical cannabis is tightly controlled by the Ministry of Defence through the SCFM, alongside a reliance on imports, which underscores a major limitation in the current Italian system.

A call for tenders was issued in 2022 to allow private companies to grow medical cannabis for supply to the SCFM. Companies were selected but to date the procedure is suspended while waiting for the Administrative Authority to rule on the appeals of some participants.

The SCFM’s monopoly stifles competition, hindering advancements in the quality, quantity, and efficacy of medical cannabis. The ideal solution would involve a significant policy shift, allowing private enterprises, once they have obtained the necessary authorisations, to cultivate and directly distribute medical cannabis to pharmacies in a free market system. However, such changes are complex and challenging to implement, suggesting a lengthy and difficult road ahead.

At the same time, there has been an opening for the importation of cannabis and API-based medicines from other EU member states, as the Ministry of Health has authorised the importation of such products to certain pharmaceutical companies or distributors. While this approach broadens access to medical cannabis and could serve as a model for replication, it inadvertently places domestic producers at a disadvantage.

Italy considers cannabinoids and all parts of the plant with the exception of seeds and derivatives as novel foods by not recognising their traditional use prior to 15 May 1997.

Prior authorisation by the EFSA is therefore required for their production and marketing.

At the moment, several Italian companies have started the process of obtaining this authorisation from the EFSA either individually or through participation in the Novel Food Consortium promoted by the EIHA. At present, the application for CBD isolates extracted from the plant has been submitted and the relative risk assessment is pending, which, except for suspensions due to the further request for clarifications, will end in October 2024.

The application for authorisation of full-spectrum extracts will also be submitted shortly.

Pending issues related to the use of parts other than seeds in food, also with reference to the use of hemp as a medicinal plant, are dealt with in the Trends and Development article.

For a long time, there have been periodic initiatives to regulate the recreational use of cannabis.

In December 2023, the platform “Meglio Legale” submitted a proposal for a popular initiative bill to the Court of Cassation aimed at legalising domestic cannabis cultivation. This proposal outlines specific provisions for both individual and collective cultivation. In the first case, cultivation of up to four plants and consequent possession of the proceeds is permitted, while collective cultivation consists of the opening of so-called cannabis social clubs, private associations with a maximum of 200 members each, in which it is possible to cultivate a maximum of four plants per member. In this case, the sale of the finished product to members would be capped at 30 grams per month.

The process of collecting the required 50,000 signatures to move the bill forward is expected to be completed by spring 2024. Following this, the bill will be submitted to either the Chamber of Deputies or the Senate of the Republic, where it will be scheduled for discussion. The legislative procedures differ between the two branches: the Senate is mandated to include citizens’ initiative bills in its agenda, whereas in the Chamber of Deputies, inclusion is at the discretion of the president and parliamentary groups.

Given the precedents and the quality of the majority in parliament, which is composed of parties ideologically opposed to any form of cannabis regulation, it seems predictable that this initiative will not be followed up.

The function of this initiative, however, according to the organisers, is to keep the political and social debate on narcotics alive, to create an even wider network of activists in view of future initiatives, and to demonstrate how Italian society is ready for the regulation of cannabis.