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Medicinal plants and botanical ingredients, the decree scheme runs aground on hemp flowers and leaves

The inter-ministerial decree scheme aimed at regulating medicinal plants and botanical ingredients (botanicals) - where Italy is at the forefront of Europe, in the supply chain and its rules - it got stuck in an unfair clause on hemp flowers and leaves.

The Minister of Agriculture Stefano Patuanelli, recalled on this point, thus withdrew a proposal for a decree of a very different scope. Just when the State-Regions Conference should have expressed the agreement on its text, on 17.6.21.

Medicinal plants and botanical ingredients, the scheme of the decree

The draft decree on botanicals it will be adopted by the Minister of Agricultural, Food and Forestry Policies, in concert with those of the Ecological Transition and Health. Based on the regulations applied to the respective areas, starting from:

- 'list of plants declared officinal'(Royal Decree 26.5.32 n. 772), (1)

- 'Consolidated text of public safety laws'(Royal Decree 18.6.31 n. 773),

- 'orientation and modernization of the agricultural sector'(pursuant to law 5.3.01 n. 57, article 7. Legislative decree 18.5.01, n. 228),

- 'provisions for the protection and enhancement of biodiversity of agricultural and food interest'(l. 1.12.15, n. 194),

- EU guidelines on GMPs (Good Manufacturing Practices) applicable to the manufacture of medicinal products of plant origin and GACP (Good Agricultural and Collection Practices),

- one-stop shop for customs at the Customs and Monopolies Agency (ADM. Law 24.12.03 n. 350),

- organic production and labeling of organic products (EC reg. 834/2007, EU reg. 2018/848),

- 'conservation of natural and semi-natural habitats, as well as wild flora and fauna'(Presidential Decree 8.9.97 n. 357, implementing directive 92/43 / EEC),

- 'framework law on protected natural areas'(l. 6.12.91, n. 394).

Botanicals. Focus on food and dietary supplements

The regulatory design it also focuses on food safety requirements, in which category also food supplements fall. By calling up:

- 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 of plant substances and preparations in food supplements' (Min. decree Ps. 10.8.18, so-called Belfrit. See note 2).

Plant species for food and cosmetic uses, herbal medicines, homeopathy

The list of species plants referred to in the Annex to the decree must be integrated 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 Medicines Quality and Health Care, DEQM),

- CosIng, Cosmetic Ingredient Database. Plant species present in the glossary of names of cosmetic ingredients (EC regulation 1223/09, article 33),

- novel foods of vegetable origin authorized pursuant to reg. EU 2015/2283,

- list of herbal substances, herbal preparations and their combinations intended for use in traditional medicinal products of plant origin (Directive 2001/83 / EC and subsequent amendments, article 16.f),

- European Union monographs drawn up by Committee on Herbal Medicine Products (HMP extension), published on the website of European Medical Agency (EMA)

- monographs for homeopathic preparation, monographs for homeopathic preparation in the European Pharmacopoeia (Council of Europe, DEQM).

Narcotic drugs, psychotropic and medicinal substances, cosmetics

The act in question also consider, of course, the rules relating to:

- ratification and execution of the single convention on 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 narcotics and psychotropic substances (DPR 9.10.90 n. 309, so-called TUS),

- European Medicines Code (Legislative Decree 24.4.06 n. 219, Dir. 2001/83 / EC)

- cosmetics regulation (EC reg. 1223/09).

Endangered and invasive species

It has respect then to CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora). So to reg. CE 338/97 on the protection of wild flora and fauna species by controlling their trade, and in reg. CE 865/2006 of its implementation. As well as the law 7.2.92 n. 150, 'regulation of crimes relating to the application in Italy of the convention on international trade in endangered animal and plant species (...)'.

Prevention and management controlled entry and spread of invasive alien species must then meet the criteria set out in reg. EU 1143/2014. Also having regard to the reg. EU 2016/1141 (updated with EU regulation 2017/1263) which, for the purposes of its application, lists the invasive alien species of EU relevance. And the legislative decree 15.12.17 n. 230 which adapts the national legislation to these rules.

Cannabis Sativa L.

La Cannabis Sativa L. is called up through:

- decree Min. Sal. 9.11.15, carrying the functions of a State Cannabis Organization, pursuant to the Single Convention on Narcotic Drugs (NYC, 1961),

- decree Min. Sal. 4.11.19, concerning the definition of maximum levels of THC in food, 

- law 2.12.16 n. 242. Provisions for the promotion of hemp cultivation and agro-industrial chain. In turn, the subject of the MiPAAF circular 22.5.18. (3)

DECREE BOTANICALS. Targets

The 'decree botanicals' - taking into account the aforementioned regulations and lists - refers to Legislative Decree 21.5.18, n. 75 of the Consolidated Law on the cultivation, harvesting and first transformation of medicinal plants. To this end, the needs of:

- define the list of cultivated medicinal plant species referred to in Article 1.3 of the Consolidated Law on Medicinal Plants,

- regulate the activity ofcollection and first transformation of spontaneous medicinal plant species'.

It is notedalso, tools for botanical identification. As well as the description of the spontaneous flora present in Italy reported in the scientific literature of the sector.

Definitions (Article 1)

The notion of 'medicinal plants' It includes '' so-called medicinal, aromatic and perfume plants, as well as algae, macroscopic fungi and lichens intended for the same uses'(pursuant to Legislative Decree 75/2018, art.1.2).

The list of 'cultivated medicinal speciesit consists of the Annex to the draft decree in question, 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.

Oats  of the medicinal species includes, 'in addition to cultivation in the field and in a protected environment, also all operations for nursery purposes. '

Hemp, the unfair clause

'The cultivation of Cannabis sativa L. of the varieties allowed for the production of seeds and seed derivatives is carried out in accordance with the law 2 December 2016, n. 242, containing provisions for the promotion of the cultivation and agro-industrial chain of hemp'(art. 1.4). 

An anonymous 'little hand' - whose identity must be ascertained - has however introduced, in the outline of a ministerial decree (secondary source of law, in the hierarchy of sources), a rule in contrast with the primary sources of law applied to the cultivation of hemp. Namely the 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. it is therefore expressed with the clause according to which 'The cultivation of Cannabis plants for the production of leaves and inflorescences or active substances for medicinal use is governed by the decree of the President of the Republic October 9, 1990, n. 309, which prohibits its cultivation without the required authorization 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 with resolution 2.12.20 of the United Nations Commission on Narcotic Drugs (7,8,9)

Training of employees, worker safety

The owner of the farm or one of its delegates'must ensure that the personnel involved in the cultivation, harvesting and first transformation of the medicinal species' is:

- adequately educated on the botanical species it manipulates before performing tasks that require such knowledge e

- protected from contact with toxic species or species presenting risks during handling (EMA, Good Agricultural and Collection Practice - GACP, chapter 4).

The species marked with an asterisk in the Annex to the decree must be cultivated and subjected to the first transformation in order to guarantee the safety of agricultural workers, avoid contamination of the surrounding areas andeffectively report the danger of the cultivated species'to third parties unrelated to the agricultural enterprise. With the obligation of notification of the start of cultivation to the Region or autonomous province specifying (Article 1.5).

GACP, GMP

Cultivation, harvesting and first processing of the medicinal plants listed in the Annex, must 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 apply:

- GACP (Good Agricultural and Collection Practice) in cultivation and harvest,

- GMP (Good Manufacturing Practice EMA, All. 7), to first transformation operations,

- authorization preventive by AIFA (Italian Medicines Agency), pursuant to Legislative Decree 219/06. In addition to the authorization of the Min. Sal., Where DPR 309/90 is applicable (art. 1.6).

Sale of medicinal plants, another abuse of hemp

'The sale of medicinal plants remains governed by sector regulations. The sale for the subsequent processing of plants for medicinal use must be made to authorized workshops for the production of active substances or medicines.'

The unfair clause referred to in paragraph 4, however, would force farmers who cultivate Cannabis Sativa L. to sell leaves and flowers exclusively to pharmaceutical workshops authorized by AIFA and the Ministry of Health. The intention was to distort competition also on 'agricultural products' and 'industrial plants', as defined by the EU regulations. (5)

The regime imposed on hemp growers is paradoxically approximated to the sale of Ephedra spp. and the mushroom Claviceps purpurea, whose alkaloids can produce effects similar to those caused by amphetamines and LSD, respectively (art. 1.7).

Medicinal plants for food use. Third abuse of hemp

Food use of the plants included in the list attached to the decree, 'if permitted by current legislation, it remains governed by Regulation (EC) no. 178/2002 and the legislation on hygiene and food safety. Any dissimilar behavior can be punished in accordance with the provisions of the legislation on food hygiene and safety'(art. 1.8. See note 10).

The misunderstanding on Cannabis Sativa L. is repeated, as the cultivated plants'for the purpose of producing leaves and inflorescences', illegally equated to those intended for production 'of active substances for medicinal use', would in any case be excluded from food use. The anonymous 'little hand' would thus have wanted to ban the production in Italy of hemp for herbal tea, which in compliance with EU rules must instead be able to circulate freely in the internal market, precisely because it has no psychotropic effects (7,11,12).

Spontaneous medicinal species, harvesting and processing (Article 3)

The collection activity and first transformation of spontaneous medicinal plants - for the purpose of their direct use or their first transformation (and sale) - is subject to the rules for the protection of wild species (CITES and EC regulation 328/97). The decree in question implements the legislative decree 75/2018 (article 3, paragraph 1 and 2) in subjecting these operations to the requirements set out in the European regulation on the organic system (reg. EC 834/07, art. 12.2. From 1.1.22 .848, EU reg. 18/XNUMX, Annex II. Detailed production rules referred to in Chapter III - Part I: Plant production rules referred to in paragraph 2.2. Rules relating to the collection of wild plants).

They apply the definitions of:

- withdrawal of medicinal species, 'the maximum share of the population that can be removed in the form of a whole plant from the environment in which it carries out its natural biological cycle’,

- collection, 'the actual removal of the whole plant or parts of it’,

- domestication, 'the process of adaptation for the purpose of cultivating spontaneous species'.

Spontaneous medicinal species, authorization and training

Collection of spontaneous medicinal species is attributed to the responsibility of the 'holder of the authorization'referred to in Article 6.1. Who, also through his delegate, must manage and coordinate the collection operations, ensuring that each collector receives sufficient and adequate training on:

- recognition of species of medicinal interest,

- good practices of harvesting, conservation and first processing (art. 3.5).

Duration, minimum contents and methods of training are defined by the Regions and Autonomous Provinces of Trento and Bolzano in agreement with universities, research bodies, professional agricultural associations and competent bodies in the area.
Protected spontaneous medicinal plants (internationally, EU, nationally and locally) or present within protected areas are governed by specific protection regulations.

'They are exempt from the obligations (...) those who collect spontaneous species for the purpose of family self-consumption. '

Collection of spontaneous medicinal species, general rules (article 4)

Methods of collection they must not damage the ecosystems where spontaneous medicinal species develop, 'ensuring in any case the optimal conditions for the regeneration of the plants themselves and the maintenance of the populations also in compliance with regional laws'.

Collection is performed in compliance with the GACP (Good Agricultural and Collection Practice) in force in the EU. In particular, the collection:

- it must be carried out only in the balsamic or commercial maturity time of each species. With the sole exception of the parts intended for multiplication for purposes of study or cultivation (e.g. fruits, seeds, stolons, rhizomes, bulbs), the collection of which must in any case beguarantee the remaining in situ of a quota suitable for the survival of the species’,

- ensure the absence of biological contamination with other potentially toxic species,

- trace, in the different phases of the medicinal plant supply chain, the geographical area of ​​harvest. To ensure control over the maintenance of the balance of the natural habitat and provide further guarantees on the quality and safety standards of the finished product.

Spontaneous species, the roles of regions and autonomous provinces

The Regions and Provinces autonomous Trento and Bolzano promote specific domestication programs for spontaneous species, to reduce the impact of their collection in nature. Within 12 months of the publication of the decree, the Regions and the Autonomous Provinces prepare:

- the list of areas off-limits to the collection or withdrawal of spontaneous medicinal species due to an ascertained health risk or the safeguarding of public green areas of particular landscape, naturalistic, monumental, historical, cultural value,

- lists of spontaneous medicinal species, protected and not, which are present in its territory. And any measures, even temporary, to contain the collection of populations not subject to protection, to prevent their impoverishment. With specific measures, in collaboration with universities, research bodies and competent bodies.

Spontaneous medicinal species, collection authorization (art.6)

The to 'collector of spontaneous medicinal plants'' is issued by the Regions and Autonomous Provinces of Trento and Bolzano to adults, after passing a qualification exam which follows the attendance of at least 70% of a specific training course (minimum duration 70 hours). It is valid for five years and can be renewed for another 5 years with the frequency of a refresher course (maximum duration 20 hours).

Training - organized by Regions and autonomous Provinces with universities and other bodies, within 12 months from the publication of the decree - it must include a practical part with recognition exercises of the main spontaneous medicinal species of the territory. In addition to treating:

- sanitation regulations,

- elements of botany and taxonomy,

- recognition of medicinal species,

- regional officinal flora,

- general aspects concerning medicinal species and their constituents with particular attention to the balsamic time,

- toxic and allergenic medicinal species,

- regulatory aspects on the protection of species and habitats,

- community, national and regional legislation,

- spontaneous medicinal species subject to protection,

- good harvesting practices, general methods and times, and first processing,

- post-harvest processes and good packaging and storage practices,

- quality criteria and reference regulations in Italy and the EU. (13)

Official controls (Article 7)

l official controls collection activities are entrusted to the Carabinieri Forestry, Environmental and Agri-food Protection Unit Command (CUTFAA) and to the Forestry Corps in the Regions and Autonomous Provinces of Trento and Bolzano.

The competence in this context it is extended to the provincial hunting guards, the local urban and rural police bodies, 'voluntary security guards designated by Cooperatives, Consortia, Bodies and Associations that have the protection of nature and the environment as their institutional purpose'.

They are also involved in the controls, for particular aspects of competence, the Department of the Central Inspectorate for the Protection of Quality and Fraud Repression (ICQRF) of the MiPAAF, as well as the ASLs and public authorities endowed with the requirements established in regulation (EU) 2017/625.

Dario Dongo

Footnotes

(1) The Royal Decree 772/1932 will be repealed with effect from the entry into force of the decree in question, as already established in the legislative decree 21.5.18 n. 75 (article 10.3)

(2) Andrea Piccoli, Dario Dongo. Food supplements, the new decree on botanicals notified in Brussels. DO (Food and Agriculture Requirements). 24.7.17/XNUMX/XNUMX, https://www.foodagriculturerequirements.com/archivio-notizie/integratori-alimentari-il-nuovo-decreto-sui-botanicals-notificato-a-bruxelles_1

(3) Dario Dongo. Cannabis Sativa, MiPAAF clarifications. GIFTS (Great Italian Food Trade). 7.6.18/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/mercati/canapa-sativa-chiarimenti-mipaaf

(4) Legislative Decree 21.5.18, n. 75. Consolidated law on the cultivation, harvesting and first processing of medicinal plants, pursuant to article 5, of the law of 28 July 2016, n. 154. https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2018-05-21;75

(5) TFEU (art. 38 and Annex I, see 57.01), reg. CE 1782/03 (art.52), reg. CE 73/09 (cons. 29, articles 39 and 87, Annex I), reg. EU 1307/13 (art.22.6)

(6) Dario Dongo. Industrial hemp and circular economy. GIFT (Great Italian Food Trade). 16.8.19/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/progresso/canapa-industriale-ed-economia-circolare

(7) Dario Dongo. Natural CBD, the EU Court of Justice declares unjustified prohibitions illegitimate. New horizons. GIFTS (Great Italian Food Trade). 21.11.20/XNUMX/XNUMX, 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 the UN and the European Commission. GIFTS (Great Italian Food Trade). 7.12.00/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/progresso/cannabis-sativa-cbd-via-libera-da-onu-e-commissione-europea

(9) The Ministry of Health, Central Narcotics Office (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 Law on Drugs). In the note 24.5.21, the Min. Sal. has in fact communicated the authorization procedures for the cultivation of Cannabis Sativa L. (from certified seeds of permitted varieties), for the supply of leaves and inflorescences of Cannabis Sativa L. to pharmaceutical workshops authorized by the Italian Medicines Agency (AIFA) for the production of active pharmaceutical ingredients (API, Active Pharmaceutical Ingredient). The authorization is therefore required only for crops intended for the production of drugs. 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 the cultivation and processing of exotic species of EU and national importance pursuant to Legislative Decree 230/17. As well as the ban on introducing non-native species and populations into nature (DPR 357/97, ​​art.12.3 as amended by DPR 102/19)

(11) Dario Dongo. Hemp sativa and herbal teas, ABC. GIFT (Great Italian Food Trade). 20.9.18/XNUMX/XNUMX, https://www.greatitalianfoodtrade.it/salute/canapa-sativa-e-tisane-abc

(12) Hemp herbal tea cut? The lawyer Dario Dongo answers. DO (Food and Agriculture Requirements). 11.10.18/XNUMX/XNUMX, https://www.foodagriculturerequirements.com/archivio-notizie/domande-e-risposte/canapa-taglio-tisana-risponde-l-avvocato-dario-dongo

(13) The Regions and the Autonomous Provinces can identify qualifications consistent with the subjects mentioned. Their possession exempts the owners from attending the courses, without prejudice to the obligation to take the final interview. The Regions and Autonomous Provinces then establish the list of authorized collectors of spontaneous medicinal plants

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