Regulations
Information on the Legal Process of Cannabis
Over the past 50 years, cannabis regulation has been widely debated on various levels.
In this article, we start from the Consolidated Law 309 of 1990 – Unified Text on the regulation of narcotic substances, already revised and amended several times.
The Consolidated Law states that all matters concerning narcotics fall under the jurisdiction of the Ministry of Health.
Later, the Fini–Giovanardi law, which declared the therapeutic uses of cannabis illegal, was challenged. The Constitutional Court declared it void as it was outdated in relation to how medical science was evolving.
What emerged was the need to revise the tables of Law 309 – Tables of narcotic and psychotropic substances.
In 2014, therefore, Law 79 was introduced, which:
- updates the tables in line with pre–32/2014;
- includes psychotropic substances under international control;
- includes therapeutic substances for human and veterinary use and prescribing methods;
- introduces authorization for cultivation for research and experimental purposes;
- allows cultivation for therapeutic purposes upon request by authorized private entities;
- permits collection and distribution to authorized companies for production.
The need to meet the demands of a large number of patients prompted the Ministry to review the entire therapeutic distribution system.
Minister Lorenzin issued a decree in 2015 defining several key points. Specifically, the Ministry of Health, identified as the state body for cannabis cultivation:
- regulates the national production of cannabis for medical use;
- specifies the procedures for medical prescriptions;
- defines standards for preparation and dispensing;
- introduces a monitoring protocol.
In 2016, the Chambers approved Law 242/2016, aimed at promoting the cultivation of Cannabis Sativa L. for food purposes.
This law:
- allows the cultivation of EU-certified seeds with a maximum THC threshold of 0.2%;
- gives farmers a tolerance of up to <0.6% due to natural and biological cultivation factors;
- does not permit the sale of inflorescences for recreational use.
The European Community updated various regulations in this sector, such as:
- the flavoring table with the addition of new terpenoid properties (1334/2008);
- the list of Botanicals or plants from which essential oils can be extracted, including extracts of Cannabis Sativa L.;
- the BELFRIT list (Belgium, France, Italy), an acronym of the member states that promoted the inclusion of Cannabis Sativa L.
Following these updates and legal integrations, the CBD market – and now also CBG – has significantly expanded in the food sector.
Europe has opened a dossier to classify CBD as a “Novel Food”, i.e., a new nutritional food.
Legal Update on Cannabis: Supreme Court
The most recent and important update on cannabis is a ruling by the Supreme Court on February 1, 2019.
The ruling established that if a merchant can prove that the cannabis comes from cultivations compliant with the 2016 law, then no seizure or criminal action should occur.
If, after inspection, the THC content exceeds 0.6%, it is possible to proceed with potential plant seizure or destruction, but “even in this case the farmer is not held responsible.”
The Supreme Court also ruled that, since light cannabis cultivation is legal, its sale and the sale of CBD extracts for food and topical use are also legal.
List of Cannabis Regulations
To summarize the main regulations in a list:
- 1961 – UN Convention on Narcotics
- 1974 – June 5, Ratification of the Convention in Italy
- 1990 – DPR 309/90 (Unified Text on Narcotics)
- 1997 – Ministerial Decree 11/02 for import
- 2006 – February 21, Fini–Giovanardi Law
- 2006 – July 18, Ministerial Ordinance
- 2007 – Turco Decree
- 2013 – Balduzzi Decree
- 2014 – Constitutional Court Ruling No. 32
- 2014 – Decree-Law No. 36 of March 20
- 2014 – Parliamentary resolutions during conversion
- 2014 – Interministerial agreement for pilot project
- 2015 – Lorenzin Decree
- 2016 – Closure of Phase 1 of pilot project
- 2016 – Start of distribution (December)