The use of hemp for the production of foodstuffs is contemplated by the Law No. 242 of 02 December 2016 (Law 242/2016), bearing provisions for the promotion of the hemp cultivation and of the agro-industrial hemp chain in Italy.

The use of hemp for the production of foodstuffs is contemplated by the Law No. 242 of 02 December 2016 (Law 242/2016), bearing provisions for the promotion of the hemp cultivation and of the agro-industrial hemp chain in Italy.

As noted in an earlier comment (see our recent comment here), the Law 242/2016 does not contain a regulation on the admitted THC content in food, while referring to the implementing regulation of the Ministry of Health. When the Law 242/2016 entered in force no THC was admitted in food.

On January 15, 2020, a decree issued by the Ministry of Health set the maximum amount of THC that is allowed in food (hereinafter THC Decree) and provided guidance on the appropriate method of analysis.

The THC Decree

The THC Decree sets forth a list of hemp food products (Annex I) that are in the scope of the new regulation. These are the seeds (including mashed and ground seeds other than flour) and hemp-derived ingredients that are obtained from seeds, i.e. flour and oil.

Hemp food products listed in Annex I may be placed on the market upon the condition that the THC content does not exceed the following thresholds set out in Annex II:

  • seeds and flour: 2.0 mg total THC on 1 kg of product;
  • oil obtained from hemp seeds: 5,0 mg total THC on 1 kg of product;
  • food supplements containing ingredients derived from hemp: 2,0 mg THC total on 1 kg of product.

Total THC (tetrahydrocannabinol) is defined in the THC Decree as the concentration resulting from the sum of the concentrations of the substance “Δ9 -THC ((-)-trans- Δ9 -THC)” and the non-active acid precursor “Δ9 -THCA-A (delta-9-tetrahydrocannabinolic acid A)”.

As far as the controls are concerned, the sampling must be performed in accordance with Regulation (EC) No 401/2006, while the analysis should be carried out according to the Commission Recommendation (EU) 2016/2115 of 1 December 2016 on the monitoring of the presence of Δ9-tetrahydrocannabinol, its precursors and other cannabinoids in food.

The list of hemp food products in Annex I should not be regarded as exhaustive. Other hemp food products could be placed on the market, as it is made clear by Article 5(2) of the THC Decree. However, hemp food products that are not listed in Annexes I and II of the THC Decree do not benefit from the tolerance thresholds of the THC Decree and must instead comply with Regulation (EC) No. 1881/2006 of 19 December 2006, setting maximum levels for certain contaminants in foodstuffs.

Mutual recognition

The THC Decree includes a mutual recognition provision, according to which hemp-based food products legally marketed in another state of the European Economic Area or in Turkey may be commercialized in Italy. While this may open the door to the introduction in Italy of products that may have a higher THC content, it must be added that the importation is anyway subject to the Regulation (EC) No 764/2008, laying down procedures relating to the application of certain national technical rules to products lawfully on the market in another member state. This allows a member state to require the compliance with a national technical regulation if certain conditions are met. As a consequence, the room for the commercialization of hemp food products whose THC content materially diverge from Italian law could be limited.

Comment

Some commentators welcomed the THC Decree as a liberalization of the use of hemp in food. However, at a closer look, this conclusion proves not to be justified. Indeed, from the one hand, foodstuffs that are listed in the THC Decree are essentially those that have always been on the market in Italy (flour and oil obtained from seeds) as considered THC free due to the starting materials used. On the other hand, the minimum THC content levels that are now set forth in the THC Decree refers to a THC presence in traces. This is in line with the Law 242/2016 that authorized the Ministry of Health to determine the THC “residues” in food and not actually the sale of food products with THC content. Indeed, the THC thresholds remain very restrictive for producers. In percentage, the THC limits are set at 0.0002% (for seeds, flour and food supplements containing food derived from hemp), and at 0.0005% for oil obtained from hemp seeds.

The new regulation is nonetheless helpful for the development of the hemp industry in Italy. The determination of THC residues that can be accepted in food and the method of analysis for the THC detection are key aspects for setting a clear legal framework and reduce the risk of potential liabilities.

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Photo of Riccardo Fruscalzo Riccardo Fruscalzo

Counsel, Milan

Easy to reach and ready to come back to you, Riccardo takes proud to have assisted start-up companies, from the first steps in the Italian market to established businesses, as well as to support the expansion and internationalisation of Italian clients…

Counsel, Milan

Easy to reach and ready to come back to you, Riccardo takes proud to have assisted start-up companies, from the first steps in the Italian market to established businesses, as well as to support the expansion and internationalisation of Italian clients of the firm.Starting as an IP litigator and with a PhD of the University of Parma in Intellectual Property Law, Riccardo Fruscalzo focuses on the Life Sciences Industry, providing to his clients full assistance in this sector. In patent litigation and commercial transactions, Riccardo believes that an in-depth knowledge of regulation and technology is a true strong point.

He wants to understand the client business and thinks that legal advice is a tool for the solution of problems: tell us your objective and we’ll tell you the right way to achieve it. As experienced patent litigator, he assists clients of the firm in highly complex litigations. Advising on regulatory issues, his knowledge ranges from clinical trials to authorizations procedures, from import/ export to advertising, pricing and commercialisation of products of the health care and life sciences sector.

Riccardo is a member of the Italian Life Sciences Group of the Milan American Chamber of Commerce and author of several publications in Intellectual Property Law and Life Sciences sector.