The subject of cannabis is governed by a complex system of regulations according to its field of application and intended use (pharmaceutical, cosmetic, food, technical, industrial, etc).

For the sake of linearity and systematic exposition, it seems appropriate to divide the various topics into:

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

Medical Cannabis

The law of reference is Presidential Decree No 309/1990, the Italian Narcotics Act (Testo Unico Stupefacenti). Its Article 14, paragraph 1(b), in laying down the criteria for the formation of the tables of narcotic substances subject to supervision, stipulates that Table II must include “cannabis and the products obtained from it”, and specifies that cannabis is prohibited in its various forms of presentation: 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 (as set out above).

Cultivation, extraction of active ingredients, distribution, importation and exportation are in fact subject to authorisation by the Ministry of Health – Central Narcotics Office (UCS), as the state agency for cannabis for essentially scientific or research purposes.

The Ministry of Health Decree of 9 November 2015 adopted the collaboration agreement between the Ministry of Health and the Ministry of Defence for the launching 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 (SCFM) based in Firenze, which has developed the cannabis varieties FM2 (with tetrahydrocannabinol (THC) content of 5–8% and cannabidiol (CBD) 7.5–12%) and FM1 (with THC content of 13–20% and CBD less than 1%) produced in accordance with EU Good Manufacturing Practices (GMP) in a pharmaceutical workshop authorised by the Italian Drug Agency (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, and will be discussed in 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 a 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 (SSN)

Law No 172/2017 provides that medical cannabis is reimbursable at the expense of the SSN, and limited to the following pathologies:

• pain therapy (potentially any type);
• pain and spasms from multiple sclerosis;
• cachexia (in anorexia, HIV, chemotherapy);
• vomiting and inappetence from chemotherapy;
• glaucoma; and
• Tourette syndrome.

Unfortunately, there are still disparities in access to medical cannabis between patients from different regions of Italy – the law is effective when each region has established the technical modalities for reimbursement.

On the other hand, paid-for medical cannabis can also be purchased in pharmacies outside one’s region of residence.

Extracts

As set out above, extracts are included in Table II of the Testo Unico Stupefacenti.

Legislative Decree No 219/2006 establishes the principle of prevalence of the regulation on medicinal products over other regulations, whereby, in the case of doubt as to whether a product (taking into account its characteristics) may fall within the definition of a medicinal product and another product, the regulation on medicinal products applies in any case.

By virtue of this provision, following the registration with the European Medicines Agency (EMA) of the medicinal product Epydiolex (ie, an MCT oil with CBD isolated and extracted from the cannabis plant)) – and thus following the presence of CBD as an active pharmaceutical ingredient (API) in the European Pharmacopoeia – a product containing isolated CBD will have to be considered a medicinal product (with the exception of the cosmetic use referred to below).

Therefore, in June 2021, the Ministry of Health published guidelines for obtaining authorisations for the cultivation of cannabis intended for CBD extraction for medical use.

These guidelines provide for a double authorisation:

• the pharmaceutical company (which is authorised by AIFA to produce API) must be authorised by the UCS and for the manufacture of cannabis extracts containing cannabinoids for the production of API; and
• the supply of starting plant material (hemp) and the destruction of the narcotic substances (THC) must also be authorised.

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 of 7 August 2023, the Ministry of Health lifted the suspension of the so-called “Speranza Decree” of 2020, which included CBD-containing preparations for oral use in the table of narcotic drugs annexed to the Narcotics Act.

The validity of this decree was confirmed by the Administrative Court, which rejected the appeal brought by the sector’s operators.

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 that 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, and 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 of up to 0.6%.

Only if, following controls by the police, the limit is found to be higher than 0.6% may the seizure and destruction of the cultivation be ordered.

However, the law provides that in any case no criminal liability can be attributed to a farmer who has complied with the provisions of Article 3 (keeping the card and seed purchase invoice).

Checks must be carried out by the Carabinieri Forestali according to the method of sampling and analysis foreseen in Annex I of Regulation (EU) No 1155/2017, but may also be carried out by any police force in the exercise of investigative activity (see also 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 fibre, hemp, powders, wood chips, oils or fuels, for supplies to industries and craft activities in various sectors, including the energy sector;
• material intended for the practice of green manure;
• organic material intended for bioengineering work or products useful for bio-construction;
• material intended for phyto-purification for the reclamation of polluted sites;
• cultivations dedicated to educational and demonstrative activities as well as research by public or private institutes; and
• crops intended for floriculture.

This list is to be considered exhaustive and presupposes being connected with sector regulations.

Foods

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

• the only permitted hemp-based foods are 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.

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

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

Indeed, the Ministerial Decree in question envisages the possibility of supplementation with other foodstuffs upon presentation of new scientific evidence.

For further details, please refer to the accompanying Trends and Developments 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”.

They are regulated by Regulation (EC) No 1170/2009 (which amended Directive 2002/46/EC), and at national level by Legislative Decree No 169 of 21 May 2004 implementing Directive 2002/46/EC, as well as by the Ministerial Decree of 9 July 2012 on the “Regulation of the use of plant substances and preparations in food supplements”.

According to the attached tables, and also by virtue of the BELFRIT agreement signed between Belgium and France, only supplements based on hemp seeds or hemp seed oil are permitted in Italy.

Therefore, to date, products based on parts other than seeds or extracts cannot be considered food or food supplements at the regulatory level.

Other issues such as novel food and expected developments will be dealt with in 3.2 Non-Controlled Cannabinoids in Food and in the accompanying Trends and Developments article.

Cosmetics

Cosmetic products are regulated by Regulation (EC) No 1223/09, with the specifications indicated by the Cosmetic Ingredient Database (the so-called “CosIng” list), which, although not legally binding, represents a reference for all advisers in the sector in order to standardise labelling in the EU (and therefore also in Italy).

Thus, as of today, in Italy CBD and cannabigerol (CBG) in isolated form are to be considered ingredients that can be used for the formulation of cosmetic products, provided that 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 they state on the label the intended purpose (topical/external use) and present functionalities and commercial claims in accordance with the cosmetic purpose.

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

Floriculture

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

In particular, Article 2 of Legislative Decree No 214/2005 clarifies definitions and establishes that “plants” means 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 parts of them for ornamental purposes.

The Ministry of Agriculture, through Circular No 5059 of 5 May 2018, has specified (with reference to hemp) that the production of hemp plants and parts thereof – 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 and not intended to be used for further floricultural production, though still subject to the legal limits for THC content.

Therefore, in Italy the production and sale of ornamental hemp plants can certainly be considered lawful, provided they are germinated from certified seeds.

Plant parts (flowers, leaves, fronds and cuttings) are lawful provided they are intended for an “end” use of an ornamental nature, with the exclusion of further floricultural activity.

The same ornamental use would also seem to rule out questions of psychotropic efficacy at root, since this is not intended for human consumption.

By way of analogy, one example is oleander, a plant known to be toxic and which is freely sold without any special precautions being taken.

The regulation of flowers is complex however, and is intrinsically linked to the issues dealt with in CBD Flowers (“Cannabis-Light”) below.

Fibres

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

Related problems concern the supply chain, as there are critical production issues due to the scarcity of processing plants.

CBD Flowers (“Cannabis Light”)

Following the spread in 2017 of the phenomenon of so-called “cannabis light” – that is, the sale of dried inflorescences of hemp from varieties certified for “technical use” or “collecting” – the first seizures related thereto began, and case law was divided between one side which held that the flowers were covered by Law 242/2016 and another side which instead held that they were covered by the narcotics legislation, as the flowers (like the leaves) were in any case included in the narcotics table.

The matter was referred to the United Sections of the Supreme Court of Cassation, which (while calling on the legislature to provide for clarity) ruled 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
• the marketing of flowers, leaves, oil and resins integrates the offence of dealing unless they are capable of producing psychotropic efficacy in concreto, according to the principle of offensiveness.

This judgment, in the absence of a clarifying intervention by the legislature, has led to the current situation in which the sale of CBD flowers is a widespread practice throughout the country, with various cases of seizures (and consequent criminal proceedings) that are dealt with discretionally by the authorities from case to case and area to area.

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 a drugging effect in practice.

In practice, CBD flowers are mostly sold for ornamental purposes as end products of the floricultural supply chain, with a THC content of less than 0.5% to avoid presenting psychotropic efficacy.

Worthy of note is the entry into force of Decree Law No 48/2025 on 11 April 2025, which amended Law 242/2016 and excluded all forms of use of inflorescences (production, possession, processing, transport and marketing) in any form (including semi-processed, crushed and dried), as well as derivatives consisting of or containing inflorescences (resins, extracts and oils) from the scope of this law, and brought them under the narcotics legislation. This topic is dealt with in more detail in the Italy Trends and Developments article in this guide.

Psychotropic Efficacy

The concept of drugging efficacy deserves its own space, as there is no unambiguous definition covering it and it is left to the judge’s evaluation on a case-by-case basis.

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

In other cases, some public prosecutors’ offices have instead sustained a radical thesis according to which flowers are always narcotics regardless of the 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.

In the authors’ opinion, the issue may be resolved in the criminal trial still pending against Luca Marola (founder of Easy Joint, a pioneer company in the sector), who is accused in Parma of drug-dealing for having possessed about 700 kg of hemp sativa with a THC content of less than 0.2% – which, according to the prosecutor’s office, would translate to about 200,000 doses.

This situation continues to represent a major problem of the Italian system characterised by chronic legal uncertainty, and which thus essentially stems from territorial business based on risk management, as discussed later.

CBD Oils

A large number of products are also sold on the Italian market as CBD oils, 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 for violation of the Narcotics Act and sometimes for violation of the Medicines Decree.

CBD oils present the same problems as CBD flowers with regard to relations with narcotics legislation, which are resolved in the assessment of psychotropic efficacy (however, they are more easily resolved as they are hardly ever marketed with a THC content of more 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, as the specific offence would not be typified and therefore the principle of the taxability of criminal offences would be violated.

These products are to be considered illegal on the Italian market following the Ministry of Health Decree of 23 August 2023 and the Lazio Regional Administrative Court ruling No 8818/2024 of 16 Aptil 2025, which rejected the appeal of the operators in the sector and confirmed the Decree.

Recreational Cannabis

The recreational use of cannabis is prohibited in Italy by the Testo Unico Stupacenti (Consolidated Text on Narcotic Drugs), even though the possession of cannabis for personal use is only administratively sanctioned (albeit with important repercussions in the personal sphere: limitations on driving licences, gun permits, documents for expatriation, residence 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 relates to the pending bills referred to in 3.3 Decriminalisation.

The regulatory bodies that oversee the system for the production of cannabis and cannabinoids  (pharmaceutical grade) 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;
• issues authorisations for pharmaceutical workshops to procure hemp and for the extraction of CBD as an API for the preparation of medicines;
• issues authorisations for cannabis cultivation for research purposes; and
• annually determines 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. It is the competent agency for the recognition of pharmaceutical workshop quality.

Furthermore, to date the SCFM is the only institution in Italy authorised to cultivate cannabis for medical use.

The regions are responsible for the reimbursability of cannabis as a medicine to citizens, and must annually communicate to the Ministry of Health data on cannabis prescribed in the 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.

There are many associations that deal in the field of medical cannabis, especially from the point of view of patients’ rights, issues of cannabis shortages, reimbursability by the SSN, and training and information activities for medical personnel.

Mention should be made of scientific societies such as the Italian Cannabis Research Society (SIRCA) and the Italian Medical Hemp Society (SICAM). Additionally, the Luca Coscioni Association has been active since 2002 in the area of the protection of civil liberties and human rights throughout the country, with particular attention paid 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.

The associations Federcanapa, Canapa Sativa Italia and Resilienza Italia are also active in the national territory, and deal with the promotion and protection of the supply chain.

Self-regulation documents have also been adopted by operators, such as:

• the protocols for production of hemp flowers adopted by Federcanapa, CIA - Agricoltori Italiani and Confagricoltura in 2018; and
• guidelines on hemp extraction adopted by Federcanapa and Agrinsieme in 2021.

Many associations also operate at a regional level – for instance, the activity carried out in Tuscany by the Ente Tutela Innovazione Canapa Toscana (ETICA), 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 and Cannabinoids

For years, participants in the cannabis sector in Italy have found themselves operating in a grey area, particular regarding flowers and extracts. The United Sections of the Court of Cassation had already highlighted the need for clarifying legislative intervention in 2019.

Despite various amendment proposals, the law has not been supplemented, and a situation of general uncertainty remains with differences in interpretation and application by the competent authorities varying from case to case and area to area.

A key challenge for the sector’s operators has long been to obtain legal and regulatory clarity for the production and sale of flowers and extracts.

For this reason, the lobbying activity carried out both through dialogue with the competent authorities and by challenging decrees that are detrimental to the sector (see the adjacent Italy Trends and Developments article) is one of the keystones for the development and regulation of the sector.

The main challenge is to delineate a field of application in the category of nutraceuticals, phytotherapeutic products and food supplements, which represent an 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 just the exclusive domain of pharmaceutical companies but also of the industry in the sector, which in recent years has shown that it knows how to make the most of research results when 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.

In fact, to increase national production, it is necessary for the regions to transmit annual data on medical cannabis prescriptions to the Ministry of Health. Hence, 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 current situation is well summarised by the Istituto Superiore di Sanità report of June 2024, according to which, “[t]he data collected confirm that medical cannabis in Italy is mainly used as adjuvant therapy for chronic pain, with a good safety profile and a low incidence of adverse reactions. However, the variability in prescribed dosages and the regions’ failure to fully adhere to the ISS platform suggest the need for further standardisation and more widespread monitoring. The growing acceptance of cannabis as a therapeutic option underlines the importance of continuous regulatory and scientific updates to ensure safe, effective and accessible treatments for patients”.

It is clear that proper medical and professional training is key to the growth and development of the medical cannabis sector in Italy.

The risks are mainly concentrated in the industrial hemp sector following the entry into force of the Security Decree (referred to in the Trends and Developments article), since the medical cannabis sector has rather well-delineated regulations.

For the patient, there are no legal risks regarding the possession of cannabis as long as they have a valid medical certificate and the cannabis is regularly purchased in a pharmacy.

The biggest problems concern driving vehicles in the event of police checks. In January 2025, the new Highway Code came into force, which reformed Article 187, changing the offence of “driving under the influence of drugs” to “driving after taking drugs”.

The reform has caused great concern among patients undergoing medical cannabis treatment since, in the case of “control”, cannabinoids remain in the blood fluids for several days after consumption.

Despite calls for the rule to be corrected, to date the approach by the police is discretionary and is still based on subjective criteria at the time of the check-up inherent in the driver’s behaviour. However, after several months of the new Highway Code being in force, there have been no significant cases in which ascertaining officers have sanctioned patients under the new Article 187 offence when involving medical cannabis and possession of a valid certificate.

It should be noted that some associations have mobilised preparing operational vademecums and free legal protection and assistance services for patients (eg, www.clinn.com).

For penalties, please refer to 1.6 Enforcement & Penalties.

As outlined in previous sections, in Italy cannabis is considered a narcotic in its flower, leaf, oil and resin manifestations. Hence, controls and related sanctions – irrespective of the considerations and legal disputes previously outlined – stem from the violation of the narcotics legislation.

All Italian police forces therefore have authority, in the performance of judicial police activity, to carry out controls on cannabis and derivatives.

In particular, Law No 242/2016 provides that controls on industrial hemp crops be carried out by the Carabinieri Forestali according to the protocol provided for in Regulation (EU) No 1155/2017, All I.

If the police detect a potential offence at a stage of the supply chain, they can proceed to contest the violation of the Consolidated Narcotics Act, and consequently criminal proceedings can be opened at the competent public prosecutor’s office.

Most of these proceedings end with dismissal following laboratory analyses showing that the THC content is below the threshold of psychotropic efficacy (discussed previously).

In addition to the controls and sanctions arising from the Consolidated 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), from which penal or administrative sanctions (fines, suspension of activity, adoption of prescriptions, etc) may result.

Since many cannabis products and derivatives do not have a clear product classification (especially CBD flowers and CBD oils), it is clear that the objections that may arise from possible controls are manifold and depend on the types of controls performed and on the authorities that carried them out.

For all these reasons, given the complexity of the regulations on the subject, the figure of the adviser becomes pre-eminent for operators in the sector of hemp and its derivatives.

The biggest problems concern the industrial hemp and cannabnoid sector, which, as previously outlined, still presents grey areas and legal risks common to many other EU countries. Arguably, the general position of the authorities with regard to the hemp plant is substantially similar to that of Spain and Portugal, where in fact only hemp seeds and fibre are upheld as legal.

The entry into force of Article 18 of the Security Law Decree and the recent ruling of the Lazio Regional Administrative Court No 8818/2025 that legitimised the inclusion of oral compositions containing CBD among narcotic medicinal products (which are discussed further in the Trends and Developments article) imposes a very restrictive model with enormous problems in relations with other member states.

In any case, it can be said that the evolution of the sector (particularly with reference to the food and supplement sector) will depend on the decisions at the European level taken by the European Food Safety Authority (EFSA) (see 3.2 Non-Controlled Cannabinoids in Food).

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

In Italy, there are no particular issues regarding medical cannabis. The problems are political and opportunity-related, and relate to access procedures. This requires more training for prescribing medical personnel.

The limitation of the Italian system is the political choice inherent in the production of medical cannabis, which on the one hand is left to the Ministry of Defence through the SCFM and on the other hand to the purchase of cannabis from abroad.

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 remains suspended while awaiting the administrative authority’s ruling on the appeals of certain participants.

It is evident how the entire system is held back in terms of competition and competitiveness (and consequently quality, quantity and efficacy of medical cannabis) by the exclusive concession to the Ministry of Defence (through the SCFM) of the national production of medical cannabis.

A change of course would be desirable that would allow (subject to acquisition of the relevant authorisation) the opening to private companies which should, by submitting their requirements, be free to produce medical cannabis and distribute it directly to pharmacies in a free market system.

The path in this direction seems extremely long and not easy to implement.

At the same time, space has opened up for the importation of cannabis and API-based medicines produced in other EU member states, as the Ministry of Health has authorised the importation of such products to certain pharmaceutical companies or distributors.

The main legal issues relate to driving and the reform of the Highway Code; see 1.5 Legal Risks. On 11 April 2025, the Ministries of Health and the Interior issued a circular with some operational instructions for ascertainers, including the need to ascertain that the intake took place in the hours before driving (traces in blood and urine are therefore not relevant for this purpose) and recognising the necessary assessment at both the control and analysis stage for patients undergoing treatment with narcotic drugs.

These indications affect the discretion of ascertaining officers; in practice, there are no reported cases of patients undergoing treatment with cannabis with a regular medical certificate being sanctioned under the new Article 187 offence of the Road Traffic Act.

Italy considers cannabinoids and all parts of the cannabis plant, with the exception of seeds and derivatives, as novel foods, and does not recognise their traditional use prior to 15 May 1997. Prior authorisation by the EFSA is therefore required for their production and marketing.

To date, several Italian companies have begun the process of obtaining this authorisation from the EFSA, either individually or through participation in the so-called “Novel Food Consortium” promoted by the EIHA. At present, an application for CBD isolate extracted from the plant has been submitted and the relative risk assessment is pending (which, except for suspensions due to the request for further clarifications, will end in October 2024).

An 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 Developments article.

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

In December 2023, the Meglio Legale platform filed the text of a popular initiative bill with the Court of Cassation to make domestic cannabis cultivation legal in Italy. This bill provides for the lawfulness of the cultivation of cannabis plants both individually and in association. In the first case, cultivation of up to four plants and consequent possession of the proceeds is permitted, while the associated form 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 is set at 30 grams/month.

By spring 2024, the phase of collecting the 50,000 subscriptions will be completed and the bill will be handed over to one of the two branches of parliament (Chamber of Deputies or Senate of the Republic) for scheduling in the Chamber of Deputies and subsequent discussion.

The two branches of parliament have different regulations: in the Senate, there is an obligation to include citizens’ initiative bills in the work programme, while in the House of Representatives this is only an option for the President and the 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 on.

Nevertheless, according to the organisers, the function of this initiative 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.