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Regulation of cannabis use in food and cosmetics

Traditional hemp cultivation
Cannabis as a narcotic substance
Hemp is back
Hemp used in food
Future for light cannabis

The cultivation and industrial use of hemp in Italy has a long tradition and recent changes to the law have led to a revival in this regard. While a law enacted in 2016 promotes hemp cultivation as a means to preserve biodiversity and reduce the environmental impact of agriculture, hemp-derived products for human consumption are still subject to restrictions. A recent Supreme Court judgment, delivered in joint session, had the last word on the legality of cannabis.

Traditional hemp cultivation

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 a 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.

However, hemp cultivation was almost abandoned following Italy’s ratification and implementation of international conventions on narcotics. The invention of plastic materials that replaced several uses for hemp did the rest.

In recent years, the cultivation and use of hemp has undergone a revival to the extent that the value of the hemp business in Italy is now reported to be in the range of €150 million. However, the market is highly fragmented with more than 1,500 players in the sector.

Cannabis as a narcotic substance

The Italian legal landscape regarding cannabis changed in 1961 following the adoption of the UN Single Convention on Narcotic Drugs, as amended by the 1972 protocol. The convention included cannabis (meaning any genus of the cannabis plant) and certain products derived from cannabis on its list of controlled substances. Although the convention exempted the cultivation of the cannabis plant for industrial (eg, fibre and seed) or horticultural purposes, countries that allow cannabis cultivation must introduce controls for preventing its misuse.

Narcotics in Italy are regulated by Presidential Decree 309 of 9 October 1990 (DPR 309/1990), which sets out 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 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 (delta-9-tetrahydrocannabinol (THC)), which is listed among the controlled substances of medicinal products. 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 the method and conditions of cultivation. Italian law does not consider a minimum accepted threshold of THC in cannabis leaves, inflorescences, oil or resin, which are controlled substances, irrespective of the THC content. However, as not all of the cannabis plant contains THC, there is room for cannabis products that are THC free.

Hemp is back

The European Union provides subsidies for hemp cultivation (ie, permitted varieties listed in the Common Catalogue of Varieties of Agricultural Plant Species) to obtain fibres and for its positive impact on the environment through the preservation of biodiversity (EU Regulation 1307/2013). However, the varieties used must have a THC content below 0.2%. The European Court of Justice (Court Order 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.

Law 242/2016 promotes hemp cultivation and its industrial application. The law stipulates that hemp cultivation is lawful provided that the THC content is below 0.2%, while farmers are exempted from criminal liability under DPR 309/1990 on the condition that the THC content does not exceed 0.6%. Law 242/2016 also lists the products that may be obtained from hemp, including food and cosmetics, provided that they comply with the applicable Ministry of Health regulations, including with regard to the maximum THC content permitted by law.

Although Law 242/2016’s main objective is to promote the agricultural use of hemp, some business operators have interpreted the reference to products that can be obtained from hemp (eg, foodstuffs for human consumption) as a general liberalisation of cannabis with a THC content below 0.6% (ie, so-called ‘light cannabis’). As a result, a variety of hemp products with a THC content below 0.6% have been introduced to the market and are sold primarily by a growing number of small retail shops in Italian cities. Such products are often sold as food products (to the extent that they are intended for human consumption), while others are justified as collectables or items for unspecified technical uses.

Further to sporadic enforcement against retailers and consumers of light cannabis, the courts recently 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 DPR 309/1990, court decisions were not always consistent. In order to prevent conflicting decisions and to provide guidance on the interpretation of the law, the Supreme Court addressed the matter in joint session (united sections) with a judgment that is likely to be a game changer.

Hemp used in food

With judgment 30475/2019, the Supreme Court addressed a case in which the defendant claimed that Law 242/2016 excluded light cannabis products from the list of controlled substances. However, the Supreme Court took a different view and stated that Law 242/2016 was limited to promoting hemp cultivation and its industrial application and did not contradict DPR 309/1990. The Supreme Court found that DPR 309/1990 classifies the leaves, inflorescences, oil and resin derived from cannabis as psychotropic substances, irrespective of the genus of the plant and the THC content. DPR 309/1990 sets no THC content threshold for the qualification of cannabis as a controlled psychotropic substance. The court further noted that Law 242/2016’s exemption from criminal liability applies only to farmers and hemp cultivation, provided that the maximum THC threshold of 0.6% is not exceeded (although, as a rule, hemp for cultivation and industrial uses should have a THC content below 0.2%). As a result, no type of light cannabis could be lawful under DPR 309/1990.

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

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.

While the Ministry of Health has not yet enacted the relevant regulation, the existing one (Ministerial Circular of 22 May 2009) prohibits the presence of THC in foodstuffs. Once again, the Supreme Court’s finding that no exemption applies to the production, extraction, sale, transport, distribution, commercialisation, storage, possession or any other activities relating to hemp’s inflorescences and leaves must be considered. Such activities always amount to a criminal offence under the DPR 309/1990. Thus, there is no scope at present for farmers to sell or for foodstuff or cosmetic producers to use such parts of the hemp plant.

Conversely, hemp seeds and fibres may be used in foodstuffs (eg, the oil obtained from hemp seeds, which is commonly available in Italian stores) and cosmetics. Indeed, seeds and oil obtained from hemp seeds are included in the Ministry of Health’s list of botanicals that may be used in food supplements.

However, a limited exception was acknowledged where the THC content is insufficient to produce a psychotropic effect in consumers. The Supreme Court argued that the mere detection of THC in a product is insufficient evidence of a criminal offence as long as the product has no discernible effects on the human body. Quoting earlier case law, the Supreme Court interpreted this exception narrowly and excluded that an acceptable THC content level may be considered part of the exemption granted to farmers under Law 242/2016.

Future for light cannabis

The Supreme Court judgment appears to leave no room for the commercial use of hemp’s inflorescences and leaves, including for the production of foodstuffs. The decision did not address the use of cannabis for cosmetics. However, the use of inflorescences and leaves in cosmetics poses a material issue, as their possession (eg, by a cosmetics manufacturer) could amount to a criminal offence. Under the current legal framework for the production of food and cosmetics, only parts of the hemp plant that contain no THC can be used (ie, the seeds and fibres).

Finally, Law 242/2016 refers to the Ministry of Health’s implementing regulation regarding the amount of THC content in food. However, that regulation has not yet been enacted. While they cannot contradict statutory provisions such as those contained in DPR 309/1990, new rules could nonetheless clarify outstanding issues, such as the THC content that may be accepted as having no detectable psychotropic effect. Although the Supreme Court seems to rely on an assessment carried out on a case-by-case basis, this lack of clarity is likely to jeopardise cannabusiness relating to products that are basically THC free or where THC may be detectable in traces due the raw materials used.

For further information on this topic please contact Riccardo Fruscalzo or Carlotta Busani at Hogan Lovells Studio Legale by telephone (+39 02 7202 521) or email (riccardo.fruscalzo@hoganlovells.com or carlotta.busani@hoganlovells.com). The Hogan Lovells Studio Legale website can be accessed at www.hoganlovells.com.

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