Food System

Hemp in foods, THC thresholds. Ministry of Health Decree 4.11.19

January 17, 2020

The Ministry of Health has finally published Decree 4.11.19, which is designed to define the THC thresholds allowed on Made in Italy hemp foods.

Industrial hemp, the resurgence in Italy

The renaissance of the industrial hemp supply chain in Italy begins in the fields. Crops have increased 10-fold within 5 years (!), from 400 hectares in 2013 to nearly 4,000 in 2018. Some 3,000 companies employing 12,000 workers have invested in it, with an annual market estimated to have reached 150 million euros.

The sectors affected by hemp, as noted above, are diverse. The production of foods with prodigious nutritional profiles, true superfoods. But also raw materials for animal feed, cosmetics, textiles and bioplastics, and green building.

The plant’s many uses qualify it as an emblem of thecircular economy, which fulfills functions such as soil nourishment and remediation, among others, due to its chelating functions. Not to mention its role in combating climate change by rapidly growing and capturing carbon dioxide in the atmosphere.

Industrial hemp, waiting for uniform rules

Cultivation of Cannabis Sativa L. is permitted in the Union, provided the variety grown is listed in the Common Catalogue of Approved Plant Varieties and has a THC content of no more than 0.2 percent. Its seeds and derivatives for food use are, moreover, not to be considered novel foods, as they ‘hada significant history of consumption as foods prior to 1997.’ (1)

The Italian legislature-with Law 242/2016, ‘Provisions for the promotion of the cultivation and agro-industrial supply chain of hemp‘ (2)-had laid the groundwork for the revival of this supply chain in Italy. Disinformation and misunderstanding, however, have followed, in Europe as well as in Italy, causing uncertainty and concern.

However, the European Commission is expected to adopt a proposal for a regulation for the unified regulation of the supply chain, in line with the principles announced in the Farm to Fork (f2f) policy. With the specific aim of ensuring uniform rules designed to promote and enhance the circular economy and remove technical barriers to trade that tend to penalize operators in some member states over others. With good memory of the principle of free movement of goods, the first pillar on which the Treaty for the Functioning of the European Union (TFEU 30) is based.

Hemp for food use, the decree of the Ministry of Health

The Ministry of Health decree on ‘Establishment of maximum levels of tetrahydrocannabinol (THC) in food,’ (3) finally published in the Official Gazette 15.1.20, implements the provisions of Law 242/16. Following the draft decree notified by the Italian government to the European Commission on 30.10.18.

The definitions are those already provided in the previous outline:

– Hemp, Cannabis sativa L. plant meeting the requirements of Art. 32(6) of reg. EU 1307/2013,

– Hemp-derived foods, parts and/or derivatives of the parts of hemp with significant food consumption as defined in Reg. EU 2015/2283. (4)

The list of foods derived from hemp once again considers the seeds, flour and oil obtained from them. (5) Unreasonably neglecting inflorescences from botanical varieties authorized in the EU, the marketing of which cannot be hindered in any case. Their consumption, either for herbal tea use or as a food ingredient, is indeed as legitimate as it is widespread in the Internal Market. And it is the same decree that expressly recognizes the application of the principle of free movement of goods. (6)

Hemp for food use, THC thresholds allowed on Made in Italy foods

The level of THC should not exceed the acute reference dose of 1 µg/Kg body weight, as already identified in 2005 by the European Food Safety Authority (EFSA). The limits of total allowable THC vary with the foods considered:

– Hemp seeds (including crushed, broken, ground other than flour), 2.0 mg/kg

– Supplements containing hemp-derived foods, ditto c.s.

– Hemp seed oil, 5.0 mg/kg.

For miscellaneous foods, the application of Art. 2 of EC Regulation No. 1881/2006. (7) The relevant thresholds apply, however, as a matter of course, until any European Union regulations are adopted. (8)

Sampling and monitoring

Sampling and analysis methods defined by the Ministry of Health reflect applicable European legislation. With the caution not to exceed the acute reference dose of 1 µg/Kg body weight, as identified in the cited 2015 EFSA opinion. (9)

In the meantime, the European Food Safety Authority published a monitoring report on THC levels detected in various foods and supplements on 7.1.20, prompting further reflection on whether uniform legislation should be established at the EU level. (10)

Dario Dongo and Giulia Torre

Notes

(1) See Ministry of Health Decree 4.11.19, ‘Establishment of maximum levels of tetrahydrocannabinol (THC) in food‘, Recitals.

(2) See in this regard the MiPAAF Guidelines 22.5.18 for the application of Law 242/16.

(3) See footnote 1

(4) See Law 242/2016, Article 5.

(5) See decree Min. Sal. 4.11.19, Annex I

(6) ‘Goods legally marketed in another EU member state or Turkey or from an EFTA state that is a signatory to the EEA Agreement and legally marketed in it are considered compatible with this measure‘ (Min. Sal. Decree 4.11.19, Article 7)

(7) See reg. EC 1881/06, ‘setting maximum levels for certain contaminants in foodstuffs’. Testo consolidato su https://eur-lex.europa.eu/legal-content/IT/TXT/?qid=1541539122276&uri=CELEX%3A02006R1881-20180319

(8) See reg. EEC 315/93 as amended, art. 2.3

(9) EFSA (2015). Scientific Opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin. EFSA Journal 2015;13(6):4141)

(10) EFSA (2010). Acute human exposure assessment to tetrahydrocannabinol (D9-THC), https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2020.5953