On 12.1.22, the State-Regions Conference approved the valuable interministerial decree outline on medicinal plants and botanical ingredients, which in one of its passages threatens to create misunderstandings about the legitimacy of using hemp leaves and flowers.
It foreshadows a real risk that public officials may incur abuse of office if the enigmatic text of the DM – a source of secondary law – is interpreted contrary to existing EU rules. Before venturing into administrative litigation, it is good to provide clarity.
Medicinal plants decree, possible misunderstandings about hemp
The interministerial decree outline refers to ‘cultivation of Cannabis plants for the purpose of producing leaves and inflorescences or active substances for medicinal use‘ as ‘governed by the Presidential Decree of October 9, 1990, no. 309, which prohibits its cultivation without the prescribed permission from the Ministry of Health.’
On the other hand, ‘the cultivation of Cannabis sativa L. of the varieties allowed for the production of seeds and seed derivatives is conducted in accordance with Law No. 2 December 2016, no. 242, on provisions for the promotion of hemp cultivation and agro-industrial supply chain‘. The DM thus seems to overlook-as noted above (1)-the legitimate use of other parts of the plant for different purposes.
Cannabis Sativa L., an industrial plant
Cannabis sativa L. – in the varieties listed on the Common Catalogue of Varieties of Agricultural Plant Species (other than those for medicinal use referred to by the DM, in the first passage above) – is qualified as an ‘agricultural product‘ and an ‘industrial plant.’ And it is therefore subject, among other things, to aid under the Common Agricultural Policy. (2) The use of any of its parts and several derivatives is allowed in the EU for different purposes:
– cosmetics. The register Cos.Ing. refers to extracts, CBD and CBG, flowers and leaves, oil extracted from flowers, leaves and stems, root extract, shoots. In addition to hemp seed oil, (3)
– Feeding. Cannabis Sativa L. is often cited as a
superfood
, because of its high protein content and balance of Omega 3 and Omega 6 fatty acids.
Novel food and free movement of goods
Natural CBD is the subject of numerous applications for marketing authorization as an ingredient in foods and/or dietary supplements under Reg. EU 2283/2015 on Novel Food. On 19.11.20, the European Court of Justice-between European Commission ballets and EFSA blackberries-affirmed the ‘ban on banning’ the marketing of CBD.
CBD dietary supplements , moreover, are regularly distributed in the domestic market following the notification in Hungary by the writer of a dozen MEDI Hemp product labels. And far more food and food supplement products with CBD are currently marketed in the UK, pending Food Standards Agency evaluations. (4)
Interim conclusions
The interministerial decree on medicinal plants and botanical ingredients is a very important guiding document for the correct application of European rules that are still exposed to wide margins of uncertainty, particularly with regard to health claims related to so-called botanicals. (5)
However, it is appropriate to clear the air of any possible misunderstanding regarding the legitimate use of Cannabis Sativa L. – in the varieties authorized in the EU as an agricultural product-in every part, including leaves and inflorescences for herbal tea use, the free movement of which certainly cannot be restricted ‘by decree.’ (6)
Dario Dongo
Notes
(1) Dario Dongo. Officinal plants and botanical ingredients, decree scheme runs aground on hemp flowers and leaves. GIFT(Great Italian Food Trade). 6/23/21, https://www.greatitalianfoodtrade.it/progresso/piante-officinali-e-ingredienti-botanici-lo-schema-di-decreto-si-incaglia-su-fiori-e-foglie-di-canapa
(2) Dario Dongo. Industrial hemp and circular economy. GIFT(Great Italian Food Trade). 8/16/19, https://www.greatitalianfoodtrade.it/progresso/canapa-industriale-ed-economia-circolare
(3) Dario Dongo. Hemp and cannabinoids, green light for CBG use in cosmetics in EU. GIFT(Great Italian Food Trade). 12/15/21, https://www.greatitalianfoodtrade.it/salute/canapa-e-cannabinoidi-via-libera-all-utilizzo-del-cbg-nei-cosmetici-in-ue
(4) Dario Dongo. CBD, novel food dossiers under review by EFSA. GIFT(Great Italian Food Trade). 9/15/21, https://www.greatitalianfoodtrade.it/mercati/cbd-i-dossier-novel-food-all-esame-di-efsa
(5) Dario Dongo. Health claims on botanicals, the Court of Justice provides clarity. GIFT(Great Italian Food Trade). 10/13/20, https://www.greatitalianfoodtrade.it/etichette/health-claims-sui-botanicals-la-corte-di-giustizia-fa-chiarezza
(6) The ruling of the Court of Justice cited in footnote 5 also finds extensive application to industrial ‘herbal tea cut’ hemp, which is widely distributed in Italy, among other places
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
