Regulation of cannabis in Italy: use in food and cosmetics
|In Italy the cultivation and the industrial use of hemp has a long tradition and recent changes in law have led to a revival. While a law enacted in 2016 promotes the cultivation of hemp as a mean to preserve biodiversity, and to reduce the environmental impact in the agriculture, hemp-derived products for human consumption are still subject to restrictions. A recent judgment of the Italian Supreme Court, delivered in joint session, has the last word on the supposedly legal cannabis.Traditional cultivation of hemp in Italy
The cultivation and industrial use of cannabis sativa L. (“hemp“), a particular genus of cannabis, has a long tradition in Italy. The plant’s cultivation was favoured by climate conditions and strong demand in the manufacture of textile and ropes in the naval 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.
Yet the cultivation of hemp was almost abandoned further to Italy’s ratification and implementation of the international conventions on narcotics. The invention of plastic materials that replaced hemp for several uses did the rest.
In the last few years, hemp’s cultivation and use is having a revival to the point that the value of hemp business in Italy is now reported to be in the range of 150 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.
Cannabis as a narcotic substance
The Italian legal landscape changed starting from the 1961 United Nations’ Single Convention on Narcotic Drugs, as amended by the 1972 Protocol. The Convention included among the controlled substances the cannabis (meaning any genus of the cannabis plant) and certain products derived from cannabis. It is true that the Convention exempted the cultivation of the cannabis plant for industrial purposes (fibre and seed) or horticultural purposes. However, countries permitting the cultivation of the cannabis plant are required to introduce controls for preventing misuse.
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”. Narcotics and psychotropic substances are 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 is back
The European Union supports with subsidies the cultivation of hemp (of the permitted varieties listed in the Common Catalogue of Varieties of Agricultural Plant Species) for the obtainment of fibres, as having a positive impact on environment for the preservation of biodiversity (Regulation No. 1307/2013). However, the varieties used shall have a THC content not exceeding 0,2 %. The Court of Justice of the European Union (order of the Court of 11 July 2008 – C-207/08, Babanov) stated that EU law precludes national legislation which has the effect of prohibiting the cultivation and possession of hemp grown for fibre covered by EU regulation.
In Italy, 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.
Although the main objective of the Law 242/2016 is the promotion of the agricultural uses of hemp, some business operators interpreted the reference to possible products that can be obtained from hemp (some of them, as foodstuffs, for human consumption) as a general liberalisation of cannabis having a THC content below 0,6% (so-called light cannabis). Thus, a variety of hemp products with a THC content declared to be below 0,6% have spread on the market, mainly sold by small retail shops mushrooming in Italian cities. Such products are often sold as food products (to the extent they are intended for human consumption), while other times are justified as collectibles or items for unspecified “technical uses”.
As a matter of fact, such businesses have long been (and are still) tolerated as supposedly harmless. Further to sporadic enforcement against retailers or consumers of light cannabis, Italian courts had the opportunity to decide on the legitimacy of such products. While the vast majority of case law held that cannabis products with THC content are in breach of the DPR 309/1990, the case law was not always consistent. In order to prevent conflicting decisions and to provide guidance in the interpretation of the law, the Italian Supreme Court decided to address the matter in joint session (Sezioni Unite) with a judgment that is likely to be a game changer.
Hemp used in food
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 Supreme Court, however, took a difference view and stated that the scope of the Law 242/2016 is limited to the promotion of the cultivation of hemp and its industrial uses, while it does not derogate to the DPR 309/1990. As a consequence, there is not such a thing as light cannabis that would be lawful as not included among the controlled substances of the DPR 309/1990. The Supreme Court found that the DPR 309/1990 classifies as psychotropic substances the leaves, inflorescences, oil and resin derived from cannabis, irrespective of the genus of the plant and the THC content. Indeed, the DPR 309/1990 does not set forth any threshold of THC content for the qualification of cannabis as a controlled psychotropic substance. The Court further 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:
While the Ministry of Health has not enacted yet that regulation, the existing one (the Ministerial Circular of 22 May 2009) does not admit any presence of THC 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.
What’s the future for light cannabis in Italy?
The judgement of the Supreme Court does not appear to leave any room for the commercial use of hemp’s inflorescences and leaves, including for the production of foodstuffs. The use of cannabis for cosmetics was not addressed by the decision. However, the use of inflorescences and leaves to that purpose seems to pose material issues, considering that even their detention (e.g. by the cosmetics’ manufacturer) may amount to a criminal offence. Under the current legal framework, for the production of food and cosmetics only the parts of the hemp that do not contain THC may be used (basically seeds and fibres).
Finally, the Law 242/2016 refers to the implementing regulation of the Ministry of Health as far as the admitted content of THC in food is concerned. That regulation has not been enacted yet. While it could not derogate to statutory provisions, as those contained in the DPR 309/1990, new rules could nonetheless clarify outstanding issues, as the THC content that may be accepted as not having any detectable psychotropic effect. Although the Supreme Court seems to rely on an assessment to be carried out on a case by case basis, the lack of clarity is likely to jeopardise even that part of the cannabis business relating to products that are basically THC free products or where THC may be detectable in traces due the raw materials used.