Regulations

Over the last 50 years, the regulation of cannabis use has been widely debated, on various levels.
In this article we start from TU 309 of 1990 – Consolidated Law on drug regulation, already revised and modified several times.

The Consolidated Law indicates that everything relating to drugs is the responsibility of the Ministry of Health.

Subsequently, the Fini – Giovanardi law, which declared the therapeutic value of cannabis illegal, was however challenged. In fact, the consultation declared it null and void as it was anachronistic compared to how science was evolving at a therapeutic level.

WHAT EMERGED WAS THE NEED TO REVIEW THE 309 TABLES – TABLES OF NARCOTIC AND PSYCHOTROPIC SUBSTANCES. IN 2014, THEREFORE, LAW 79 WAS CREATED WHICH:

• updates the online tables pre – 32/2014;
• places psychotropic substances under international control;
• includes therapeutic substances for human and veterinary use and prescription methods;
• introduces the authorization for cultivation for research purposes for experimental purposes;
• allows cultivation for therapeutic purposes upon request by authorized private individuals;
• allows collection and distribution to authorized manufacturing companies.

The need to provide for the needs of a good number of patients pushes the ministry to review the entire therapeutic delivery system.
Minister Lorenzin issued the decree in 2015 in which some central points were defined. Specifically, the Ministry of Health, identified as the state body for the cultivation of cannabis:

• regulates the national production of cannabis for medical use;
• specifies the medical prescription methods;
• dictates the setup and dispensing fees;
• inserts a monitoring protocol.

THEN IN 2016 THE CHAMBERS APPROVED LAW 242/2016 AIMED AT PROMOTING THE CULTIVATION OF THE SATIVA L. HEMP SUPPLY CHAIN FOR FOOD PURPOSES.

The law in question:
• allows the cultivation of CE certified seeds with a maximum THC limit of 0.2%;
• gives the farmer a tolerance of < 0.6% for natural and biological causes of cultivation;
• does not include the sale of inflorescences for recreational purposes.

The European community updates various regulations relating to this sector, such as:
• aroma table with the inclusion of new properties of terpenoids (1334/2008);
• list of botanicals or plants from which to extract essential oils including Hemp Sativa L. extracts;
• BELFRIT list (Belgium, France, Italy) acronym of the member states that have promoted the inclusion of Hemp Sativa L.

Following these updates and regulatory additions, the CBD and now CBG market has also significantly expanded in the food sector. Europe, in fact, opens a dossier to list CBD as “Nouvelle Food”, or new nutritional food.

REGULATORY UPDATE ON CANNABIS: COURT OF CASSATION

The most recent and important update on cannabis is a ruling from the Court of Cassation of 1 February 2019.
The ruling established that if the trader is able to document that the cannabis comes from crops that comply with the 2016 law, then he will not have to proceed neither with seizures nor criminally.
If, after a check, the THC content exceeds 0.6%, the plants can be seized or destroyed, but “even in this case the farmer’s responsibility is excluded”.
The Supreme Court then ruled that, since the cultivation of light cannabis is legal, its sale and CBD extracts for food and topical use are also legal.

LIST OF CANNABIS REGULATIONS

To summarize the main regulations in the list:
• 1961 – UN Convention on Narcotics
• 1974 – 5 June Ratification of the convention in Italy
• 1990 – Presidential Decree 309/90 (TU Narcotics)
• 1997 – Ministerial Decree 11/02 for importation
• 2006 – 21/ 02 Fini-Giovanardi Law
• 2006 – 18/07 Ministry of Health Ordinance
• 2007 – Turkish Decree
• 2013 – Balduzzi Decree
• 2014 – Constitutional Court Ruling n°32
• 2014 – Law Decree n°36 of 20/03
• 2014 – Odg parliamentarians at the time of conversion
• 2014 – Interministerial agreement for pilot project
• 2015 – Lorenzin decree
• 2016 – 09 closure of phase 1 pilot project
• 2016 – 12 start of distribution