Increasing legitimacy and legality of medicinal plants nationwide has created great demand for qualified technical personnel and great opportunity for the skilled entrepreneur in the cannabis, herbal extract, and natural product industries.

Remember Hemp? Once upon a time, it was a typical Mediterranean plant, whose popular cultivation and uses
dates back to at least the third millennium BC in written history, and possibly further back by archaeological evidence. For millennia, the plant has been valued for its use for fibber and rope, as food and medicine, and for its psychoactive properties for religious and recreational use.

The cultivation and industrial use of cannabis sativa L. (“hemp“), a particular genus of cannabis was (and still is) favoured by microclimate conditions, as well as strongly required in the fabrication of paper, textile and ropes in the maritime industry. In the 1950s, Italy was the second largest producer of hemp in the world (behind only the Soviet Union), with almost 100,000 hectares cultivated. However, the Italian ratification and implementation of international conventions on narcotics, changed the scenario of this industry: the cultivation of hemp was
almost abandoned and plastic materials has been invented, materials that replaced hemp for several uses, even in luxury industry. (Do you remember the former French first lady and supermodel Carla Bruni in the runway, during the 90s, with plastic dresses and plastic jewellery?)

During the last decade recent changes in the Italian law have led to the promotion of the cultivation of hemp as a mean of biodiversity preservation, meanwhile hemp-derived products for human consumption are still subject to restrictions. The value of hemp business in Italy is now reported by ISTAT, to be in the range of 350 Million Euros. However, the market is highly fragmented with more than 1,500 players in the sector.

#Cannabis may be used also as medicinal product.

Even that use has attracted considerable interest in the last years. Cannabis for medical use has a remarkably higher THC content and is subject to the medicinal products’ #regulation. This comment is however concerned with #cannabis for non medical uses.

In #Italy, the matter is regulated by the Presidential Decree No. 309 of 9 October 1990 (“DPR 309/1990“),
laying down a

“Consolidated text of the laws on narcotics and psychotropic substances, the prevention, treatment and rehabilitation of drug addiction conditions”.

On the other hand, the Law No. 242 of 2 December 2016 (“#Law 242/2016“) promotes the cultivation of hemp and its industrial applications. The Law stipulates that the cultivation of hemp is lawful provided that the THC content is below 0,2%, while farmers are anyway exempted from criminal liability under the D.P.R. 309/1990 upon the condition that the THC content does not exceed 0,6%.

The Law 242/2016 also lists the products that may be obtained from hemp, including food and cosmetics, provided that they are in compliance with the applicable regulation of the Ministry of Health, including as far as the maximum tolerated THC content is concerned.

As every pharmacist knows by heart, narcotics and psychotropic substances has been classified in five different categories (“Tables“) according to the danger and risk of addiction. More specifically, Table II includes “cannabis” with an explicit reference to leaves, inflorescence, oil and resin. The psychotropic effect is caused by the active ingredient of cannabis, the delta-9-tetrahydrocannabinol (“THC“), which is also listed as such among the controlled substances in the Table of medicinal products. It must be said that the THC concentration in cannabis may vary depending on the genus of the plant, the part of the plant (there is no THC in fibres, roots and seeds) and even the method and conditions of cultivation. Italian law does not contemplate a minimum accepted threshold of
THC in cannabis’ leaves, inflorescences, oil, and resin, which are controlled substances, irrespective of the THC content. However, as not all the parts of the cannabis plant contain THC, there are still room for cannabis products that are THC free.

#Hemp used in #food and cosmetics

The #Supreme #Court, in the judgement No. 30475 of 30 May 2019, addressed one of such cases where the defendant claimed that the Law 242/2016 would have excluded the so-called light cannabis products from the list of controlled substances. The Court noted that the exemption from the criminal liability of the Law 242/2016 applies only to farmers and to the cultivation of hemp, provided that the maximum THC threshold of 0,6% is not exceeded (though, as a rule, hemp for cultivation and industrial uses should have a THC content below 0,2%).

However, the main interpretive issue the Court faced was the coordination of the Law 242/2016 with the DPR 309/1990 insofar the former allows the cultivation of hemp for the obtainment of the products as listed by
the law, which include foodstuffs and cosmetics. In that respect, the Supreme Court stated:

“For the sake of completeness, we must consider the provisions contained in the Law 242/2016 concerning foodstuffs. As it was made clear, the law does not allow the production of leaves or inflorescences. It must be ruled out that the legislature, by referring to the production of foodstuffs, wanted to make reference to the human consumption of leaves and inflorescences. On the contrary, the reference, among other products, to foodstuffs, which are to be manufactured in compliance with the sectorial regulation […], bring us to the conclusion that the legislature has imposed on the producer the obligation to strictly comply with the laws that govern the production of foodstuffs, if it intends to produce products obtained from hemp, as seeds or flour. This is all the more true that the Law 242/2016 refers to the implementing regulation to be issued by the Ministry of Health as to the maximum content of THC that is admitted in foodstuffs”.

We must consider once more the consequence of the Supreme Court’s finding that no exemption applies to the production, extraction, sale, transport, distribution, commercialisation, storage, the possession and any
other activities relating to hemp’s inflorescences and leaves. Such activities always amount to a criminal offence pursuant to the DPR 309/1990. Thus there is no room for the farmer to sell and for the producer of foodstuffs (or
cosmetics) to use such parts of the hemp plant.

On the other hand, seeds and fibres of hemp may be used for the obtainment of food (as it is the case of the oil obtained by the seeds, which is commonly available in Italian stores) or cosmetics. Indeed, seeds and oil obtained from seeds are contemplated in the Ministry of Health’s list of botanicals that may be used in food supplements.

A limited exception was, however, acknowledged for the case the THC content is not sufficient to produce any psychotropic effect in the consumer. The Supreme Court argues that the mere detection of THC in a product is not sufficient for a criminal offence to occur, as long as the product has no discernible effects in the human body. Quoting its earlier case law, the Supreme Court construed very narrowly this exception, while it was excluded that such acceptable THC content may be that provided for the exemption of farmers under the Law 242/2016.