The interministerial decree scheme aimed at regulating medicinal plants and botanical ingredients(botanicals)-where Italy is in the European vanguard, in the supply chain and its rules-has run aground on an abusive clause on hemp flowers and leaves.
Agriculture Minister Stefano Patuanelli, who was called out on the point, thus withdrew a proposed decree of quite a different magnitude. Just when the State-Regions Conference was supposed to express agreement on its text, on 17.6.21.
Medicinal plants and botanical ingredients, the draft decree
The draft decree on botanicals will be adopted by the Minister of Agriculture, Food and Forestry, in consultation with the Ministers of Ecological Transition and Health. Based on the regulations applied to the respective fields, starting with:
– ‘list of plants declared officinal‘ (RD 26.5.32 no. 772), (1)
– ‘Testo unico delle leggi di pubblica sicurezza‘ (RD 18.6.31 no. 773),
– ‘guidance and modernization of the agricultural sector‘ (pursuant to Law 5.3.01 No. 57, Article 7. Legislative Decree 18.5.01, No. 228),
– ‘provisions for the protection and enhancement of biodiversity of agricultural and food interest‘ (l. 1.12.15, no. 194),
– EU guidelines on GMP(Good Manufacturing Practices) applicable to the manufacture of herbal medicines and GACP(Good Agricultural and Collection Practices),
– customs single window at the Customs and Monopolies Agency (ADM. Law 24.12.03 No. 350),
– Organic production and labeling of organic products (EC reg. 834/2007, EU reg. 2018/848),
– ‘conservation of natural and semi-natural habitats and wild flora and fauna‘ (Presidential Decree 8.9.97 No. 357, implementing dir. 92/43/EEC),
– ‘framework law on protected natural areas‘ (l. 6.12.91, no. 394).
Botanicals. Focus on foods and dietary supplements
The regulatory design also focuses on food safety requirements, in which category food supplements also fall. Recalling:
– General Food Law (EC reg. 178/02) and ‘Hygiene 1’ regulation (EC reg. 852/04),
– Novel Food (EU reg. 2015/2283),
– Food Information to Consumers (EU reg. 1169/2011),
– Official Controls Regulation (reg. EU 2017/625),
– ‘regulation of the use in food supplements of herbal substances and preparations’ (Min. Sal. decree 10.8.18, c.d. Belfrit. See note 2).
Plant species for food and cosmetic uses, herbal medicines, homeopathy
The list of plant species in Annex to the decree is to be supplemented with those mentioned in:
– Belfrit list (Belgium, France, Italy. See note 2),
– Herbal Drug Monographs. Monographs on herbal medicines in the European Pharmacopoeia (Council of Europe, European Directorate on Quality of Medicines and Health Care, DEQM),
– CosIng, Cosmetic Ingredient Database. Plant species in the glossary of cosmetic ingredient names (EC Reg. 1223/09, Article 33),
– Novel foods of plant origin authorized under reg. EU 2015/2283,
– list of herbal substances, herbal preparations and combinations thereof for use in traditional herbal medicinal products (dir. 2001/83/EC as amended, article 16.f),
– European Union monographs prepared by the Committee on Herbal Medicine Products(HMPC), published on the European Medical Agency (EMA) website
– monographs for homeopathic preparation in the European Pharmacopoeia (Council of Europe, DEQM).
Narcotic drugs, psychotropic substances and medicines, cosmetics
The act under consideration also considers, as a matter of course, the regulations on:
– Ratification and execution of the Single Convention on Narcotic Drugs (NYC, 30.3.61) and its Protocol of Amendment (Geneva, 25.3.72), referred to in l. 5.6.74 no. 412,
– Consolidated Law on Narcotic Drugs and Psychotropic Substances (Presidential Decree 9.10.90 No. 309, so-called TUS),
– European Medicines Code (legislative decree 24.4.06 no. 219, dir. 2001/83/EC)
– cosmetics regulation (reg. EC 1223/09).
Endangered and invasive species
We then have regard to CITES(the Convention on International Trade in Endangered Species of Wild Fauna and Flora). Thus to reg. EC 338/97 on the protection of species of wild flora and fauna by controlling their trade, and reg. EC 865/2006 of its implementation. As well as to Law 7.2.92 no. 150, ‘regulating offenses relating to the application in Italy of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (…)‘.
Prevention and controlled management of the entry and spread of invasive alien species must then meet the criteria in Reg. EU 1143/2014. Also having regard to reg. EU 2016/1141 (updated by EU reg. 2017/1263), which lists invasive alien species of EU significance for the purpose of its application. And the d.lgs. 15.12.17 n. 230 adapting national legislation to these rules.
Cannabis Sativa L.
Cannabis Sativa L. is recalled through:
– decree Min. Sal. 9.11.15, establishing functions of the State Cannabis Body under the Single Convention on Narcotic Drugs (NYC, 1961),
– decree Min. Sal. 4.11.19, relating to the establishment of maximum levels of THC in foods ,
– law 2.12.16 no. 242. Provisions for the promotion of hemp cultivation and agro-industrial supply chain. In turn, it is recalled, the subject of the MiPAAF circular 22.5.18. (3)
DECREE BOTANICALS. Goals
The ‘ botanicalsdecree’ – taking into account the regulations and lists mentioned above – recalls Leg. 21.5.18, n. 75, Single text on cultivation, harvesting and first processing of medicinal plants. For this purpose, the needs of:
– To define the list of cultivated medicinal plant species referred to in Article 1.3 of the Consolidated Text of Medicinal Plants,
– To regulate the activity of ‘collection and first processing of wild medicinal plant species’.
Botanical identification tools are also noted. As well as the description of the spontaneous flora found in Italy reported in the relevant scientific literature.
Definitions (Art. 1)
The notion of ‘ medicinal plants‘ includes ‘so-called medicinal, aromatic and perfume plants, as well as algae, macroscopic fungi and lichens intended for the same uses‘ (according to Legislative Decree 75/2018, Art. 1.2).
The list of ‘cultivated medicinal species‘ consists of the Annex to the draft decree under consideration, as well as the plants mentioned in the documents referred to in the paragraph above Plant species for food and cosmetic uses, herbal medicines, homeopathy.
Cultivation of medicinal species includes, ‘inaddition to cultivation in the field and in a protected environment, all operations for nursery purposes.’
Hemp, the abusive clause
‘The cultivation of Cannabis sativa L. of varieties allowed for the production of seeds and seed derivatives is conducted pursuant to Law No. 2 of December 2016. 242, on provisions for the promotion of hemp cultivation and agro-industrial supply chain‘ (Art. 1.4).
However, an anonymous ‘little hand’ – whose identity must be ascertained – has introduced, in the outline of a ministerial decree (a secondary source of law, in the hierarchy of sources), a rule that conflicts with the primary sources of law applied to hemp cultivation. Namely, Law 242/2016, the TFEU (Treaty for the Functioning of the European Union), the EU Regulation on the CAP (Common Agricultural Policy) and various others (5,6).
The clumsy attempt to boycott the agricultural supply chain of Cannabis Sativa L. is therefore expressed with the clause that ”The cultivation of Cannabis plants for the purpose of producing leaves and inflorescences or active substances for medicinal use is governed by Presidential Decree No. 309, which prohibits its cultivation without the prescribed permission from the Ministry of Health.’ A clause contrary to the TFEU and European law, as clarified by the European Court of Justice on 19.11.20, as well as the 2.12.20 resolution of the United Nations Commission on Narcotic Drugs (7,8,9).
Employee training, worker safety
The owner of the farm or his delegate ‘shall ensure that personnel engaged in the cultivation, harvesting and first processing of medicinal species‘ are:
– adequately trained in the botanical species it handles before performing tasks requiring such knowledge, and
– protected from contact with toxic species or presenting risks during handling (EMA, Good Agricultural and Collection Practice – GACP, Chapter 4).
Species marked with an asterisk in the Annex to the decree must be cultivated and subjected to first processing in a way that ensures the safety of farm workers, avoids contamination of surrounding areas, and ‘effectively signals the dangerousness of the cultivated species‘ to third parties outside the farm enterprise. With obligation to notify the start of cultivation to the Autonomous Region or Province specifying (Art. 1.5).
GACP, GMP
Cultivation, harvesting and first processing of medicinal plants mentioned in the Annex, should be carried out taking into account their intended use. In the case of plants used for the production of active substances for medicinal and medicinal use, the following shall apply:
– GACP(Good Agricultural and Collection Practice) in cultivation and harvesting,
– GMP(Good Manufacturing Practice EMA,All. 7), to first processing operations,
– Prior authorization from AIFA (Italian Drug Agency), pursuant to Legislative Decree 219/06. As well as authorization from the Min. Sal. where Presidential Decree 309/90 is applicable (Art. 1.6).
Sale of medicinal plants, more abuse on hemp
‘The sale of medicinal plants remains governed by industry regulations. The sale for further processing of plants for medicinal use must be made to workshops authorized for the production of active substances or medicines.‘
However, the abusive clause in Paragraph 4 would force farmers who grow Cannabis Sativa L. to sell leaves and flowers exclusively to pharmaceutical workshops authorized by AIFA and the Ministry of Health. This would have been intended to distort competition even on ‘agricultural products’ and ‘industrial plants,’ as defined by EU regulations. (5)
The regime imposed on hemp growers paradoxically approximates the sale of Ephedra spp. plants. and the fungus Claviceps purpurea, whose alkaloids can produce effects similar to those caused by amphetamines and LSD, respectively (Article 1.7).
Medicinal plants for food use. Third hemp abuse
The food use of plants included in the list attached to the decree, ‘where permitted by current legislation, remains governed by the 178/2002 and food hygiene and safety regulations. Any deviating behavior is punishable according to the provisions of food hygiene and safety regulations‘ (art. 1.8. See note 10).
The misunderstanding about Cannabis Sativa L. is repeated, as plants grown ‘for the purpose ofproducing leaves and inflorescences,’ abusively equated with those intended for the production ‘of active substances for medicinal use,’ would still be excluded from food use. The anonymous ‘little hand’ would thus have wanted to ban the production in Italy of hemp for herbal tea use, which in compliance with EU rules should instead be allowed to circulate freely in the domestic market, precisely because it has no psychotropic effects (7,11,12).
Wild medicinal species, collection and processing (Article 3)
The activity of collecting and first processing wild medicinal plants-for the purpose of their direct use or first processing (and sale)-is subject to the rules protecting wild species (CITES and EC Reg. 328/97). The decree under review implements Leg. 75/2018 (Article 3(1) and (2)) in subjecting such operations to the requirements of the European Organic System Regulation (Reg. EC 834/07, Art. 12.2. As of 1.1.22, reg. EU 848/18, Annex II. Detailed production standards set forth in Chapter III – Part I: Plant production standards set forth in Section 2.2. Regulations concerning the collection of wild plants).
The definitions of:
– withdrawal of medicinal species, ‘the maximum population share that can be removed in whole plant form from the environment in which it carries out its natural biological cycle.’
– harvesting, ‘the actual removal of the entire plant or parts of it.’
– Domestication, ‘the process of adaptation for the purpose of cultivation of wild species.’
Wild medicinal species, authorization and training
The collection of wild medicinal species is assigned to the responsibility of the ‘permit holder‘ referred to in Article 6.1. Who, including through his delegate, must manage and coordinate collection operations, ensuring that each collector receives sufficient and adequate training on:
– Recognition of species of officinal interest,
– Good harvesting, storage and first processing practices (Article 3.5).
Duration, minimum content and the modalities of training are defined by the Regions and Autonomous Provinces of Trento and Bolzano in agreement with universities, research institutions, agricultural professional orders and competent bodies in the territory.
Wild medicinal plants protected (internationally, EU, nationally and locally) or found within protected areas are regulated by the appropriate protection regulations.
‘Exempted from the obligations (…) are those who collect wild species for the purpose of family self-consumption.’
Collection of wild medicinal species, general rules (Article 4)
Harvesting methods must not harm the ecosystems where wild medicinal species develop, ‘ensuring in any case the optimal conditions for the regeneration of the plants themselves and the maintenance of populations also in compliance with regional laws.’
Harvesting is carried out in accordance with current EU GACP(Good Agricultural and Collection Practice). In particular, the collection:
– should be carried out only in the balsamic or commercial maturity time of each species. With the sole exception of parts intended for multiplication for study or cultivation purposes (e.g., fruits, seeds, stolons, rhizomes, bulbs), the collection of which must nevertheless ‘ensure that a proportion suitable for the survival of the species remains in situ.’
– Ensure the absence of biological contamination with other potentially toxic species,
– Trace, at different stages of the medicinal plant supply chain, the geographical area of harvesting. To ensure control over the maintenance of the balance of the natural habitat and provide additional assurance of the quality and safety standards of the finished product.
Wild species, the roles of regions and autonomous provinces
The regions and autonomous provinces of Trento and Bolzano promote specific programs for domestication of wild species to lessen the impact of their collection in the wild. Within 12 months of the publication of the decree, regions and autonomous provinces shall prepare:
– The list of areas banned from the collection or taking of wild medicinal species due to ascertained health risk or the preservation of public green areas of special scenic, natural, monumental, historical, cultural value,
– Lists of protected and unprotected wild medicinal species that are present in their territory. And any measures, including temporary measures, to contain the collection of non-protected populations to prevent their depletion. By appropriate measures, in cooperation with universities, research institutions and relevant bodies.
Wild medicinal species, authorization for collection (Art. 6)
Authorization as a ‘gatherer of wild medicinal plants‘ is issued by Regions and Autonomous Provinces of Trento and Bolzano to individuals over 18 years of age, after passing a qualifying examination that follows attendance of at least 70 percent of a special training course (minimum duration 70 hours). It is valid for five years and can be renewed for another five years with the attendance of a refresher course (maximum duration 20 hours).
The training-organized by regions and autonomous provinces with universities and other bodies within 12 months of the publication of the decree-must include a practical part with recognition exercises of the main wild officinal species in the area. In addition to dealing with:
– sanitation standards,
– Elements of botany and taxonomy,
– Recognition of medicinal species,
– Regional officinal flora,
– General aspects concerning medicinal species and their constituents with special attention to balsamic time,
– Toxic and allergenic medicinal species,
– Regulatory aspects of species and habitat protection,
– Community, national and regional regulations,
– Wild medicinal species subject to protection,
– Good harvesting practices, general methods and timing, and first processing,
– Post-harvest processes and good packaging and storage practices,
– Quality criteria and reference standards in Italy and EU. (13)
Official controls (Article 7)
he official controls on harvesting activities are entrusted to the Carabinieri’s Forest, Environmental and Agribusiness Protection Unit Command (CUTFAA) and the Forestry Corps in the Autonomous Regions and Provinces of Trento and Bolzano.
Competence in this area is extended to provincial hunting guards, local urban and rural police organs, ‘voluntary security guards designated by Cooperatives, Consortia, Bodies and Associations whose institutional purpose is nature protection and environmental preservation.’
The Department of the Central Inspectorate for Quality Protection and Fraud Repression (ICQRF) of the MiPAAF, as well as ASLs and public authorities with the requirements set out in Regulation (EU) 2017/625 are also involved in the controls, for particular aspects of competence.
Dario Dongo
Notes
(1) RD 772/1932 will be repealed precisely as of the entry into force of this decree, as already stipulated in Legislative Decree. 21.5.18 n. 75 (Article 10.3)
(2) Andrea Piccoli, Dario Dongo. Food supplements, the new decree on botanicals notified to Brussels. FARE(Food and Agriculture Requirements). 7/24/17, https://www.foodagriculturerequirements.com/archivio-notizie/integratori-alimentari-il-nuovo-decreto-sui-botanicals-notificato-a-bruxelles_1
(3) Dario Dongo. Sativa hemp, MiPAAF clarifications. GIFT(Great Italian Food Trade). 7.6.18, https://www.greatitalianfoodtrade.it/mercati/canapa-sativa-chiarimenti-mipaaf
(4) Legislative Decree. 21.5.18, n. 75. Single text on the cultivation, harvesting and first processing of medicinal plants, pursuant to Article 5, Law No. 28 July 2016, no. 154. https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2018-05-21;75
(5) TFEU (Art. 38 and All. I, v.d. 57.01), reg. EC 1782/03 (art. 52), reg. EC 73/09 (cons. 29, art. 39 and 87, All. I), reg. EU 1307/13 (Art. 22.6)
(6) 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
(7) Dario Dongo. Natural CBD, EU Court of Justice declares unjustified bans unlawful. New horizons. GIFT (Great Italian Food Trade). 11/21/20, https://www.greatitalianfoodtrade.it/progresso/cbd-naturale-la-corte-di-giustizia-ue-dichiara-illegittimi-i-divieti-ingiustificati-nuovi-orizzonti
(8) Dario Dongo. Cannabis Sativa, CBD. Green light from UN and European Commission. GIFT (Great Italian Food Trade). 7.12.00, https://www.greatitalianfoodtrade.it/progresso/cannabis-sativa-cbd-via-libera-da-onu-e-commissione-europea
(9) The Ministry of Health, Central Narcotics Bureau (General Directorate of Medical Devices and Pharmaceutical Service) has recently implemented, among other things, Articles 27, 28 and 29 of Presidential Decree 309/90 (Consolidated Narcotics Act). In the note 24.5.21, Min. Sal. has in fact communicated the procedures for authorizing the cultivation of Cannabis Sativa L. (from certified seeds of permitted varieties), for the supply of Cannabis Sativa L. leaves and inflorescences to pharmaceutical workshops authorized by the Italian Drug Agency (AIFA) for the production of Active Pharmaceutical Ingredient(API). Thus, authorization is prescribed only for crops intended for drug production. V. https://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano&label=servizionline&idMat=STP&idAmb=FBR&idSrv=S15&flag=P
(10) Without prejudice to the limits imposed on cultivation and processing of exotic species of EU and national importance under Leg. 230/17. As well as the ban on the release of non-native species and populations into the wild (Presidential Decree 357/97, Art. 12.3 as amended by Presidential Decree 102/19)
(11) Dario Dongo. Hemp sativa and herbal teas, ABC. GIFT (Great Italian Food Trade). 9/20/18, https://www.greatitalianfoodtrade.it/salute/canapa-sativa-e-tisane-abc
(12) Hemp cutting herbal tea? Attorney Dario Dongo replies. FARE(Food and Agriculture Requirements). 11.10.18, https://www.foodagriculturerequirements.com/archivio-notizie/domande-e-risposte/canapa-taglio-tisana-risponde-l-avvocato-dario-dongo
(13) Regions and autonomous provinces may identify degrees consistent with the subjects mentioned. Their possession exempts holders from attending courses, subject to the requirement to take the final interview. The autonomous regions and provinces then establish the list of authorized gatherers of wild medicinal plants
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
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