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

The Ministry of Health has finally published decree 4.11.19, an act to define the THC thresholds allowed in foods  Made in Italy based on hemp.

Industrial hemp, the rebirth in Italy

The rebirth of the supply chain of industrial hemp in Italy starts from the fields. Cultivations have increased 10 times in 5 years (!), from 400 hectares in 2013 to almost 4000 in 2018. About 3000 companies have invested, employing 12,000 workers, for an annual market estimated to have reached 150 million euros.

The interested sectors by hemp, as seen, are diverse. The production of foods with prodigious nutritional profiles, real  superfood. But also raw materials for feed, cosmetics, textile products and bioplastics, green building.

The multiple uses  of the plant qualify it as an emblem of the circular economy that also fulfills soil nourishment and remediation functions, thanks to its chelating functions. Not to mention its role in combating climate change, thanks to rapid growth and carbon dioxide capture from the atmosphere.

Industrial hemp, awaiting uniform regulations

The cultivation of the  Cannabis Sativa L. is allowed in the Union, provided that the cultivated variety is present in the common catalog of authorized plant varieties and has a THC content not exceeding 0.2%. Its seeds and derivatives for food use are not to be considered  novel food, inasmuch as ‘they have recorded a significant history of consumption as foods before 1997’. (1)

The legislator  Italian – with law 242/2016, ‘Provisions for the promotion of the cultivation and agro-industrial supply chain of hemp’ (2) – had laid the foundations for the revival of this supply chain in Italy. However, misinformation and misunderstandings have followed, in Europe as in Italy, causing uncertainties and concerns.

The European Commission should however adopt a draft regulation for the unified discipline of the supply chain, in line with the principles announced in the policy  Farm to Fork (f2f). With the precise aim of ensuring uniform rules, intended to promote and enhance the circular economy and remove technical barriers to trade that tend to penalize operators from some Member States compared to others. With a good memory of the principle of free movement of goods, the first pillar on which the Treaty on the Functioning of the European Union (TFEU 30) is based.

Hemp for food use, the Ministry of Health decree

The decree of the Ministry of Health on ‘Definition of maximum levels of tetrahydrocannabinol (THC) in foods’, (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 draft:

– Hemp, plant of Cannabis sativa L. meeting the requirements of art. 32, paragraph 6, of EU reg. 1307/2013,

– Foods derived from hemp, parts and/or derivatives of parts of hemp that have recorded significant food consumption, pursuant to EU reg. 2015/2283. (4)

The list of foods derived from hemp, once again considers the seeds, the flour and the oil obtained from them. (5) Unreasonably neglecting the inflorescences from botanical varieties authorized in the EU, whose marketing cannot be obstructed in any case. Their consumption, for herbal tea use that is which food ingredient, is indeed legitimate as much as 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, the THC thresholds allowed in foods  Made in Italy

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

– hemp seeds (including those crushed, broken, ground different from flour), 2.0 mg/kg

- supplements containing foods derived from hemp, idem as above

– hemp seed oil, 5.0 mg/kg.

For different foods the application of art. 2 of EC regulation no. 1881/2006 is provided. (7) The related thresholds apply, however, as obvious, until the adoption of any provisions of the European Union. (8)

Sampling and monitoring

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

The European Authority for Food Safety has meanwhile published a monitoring report on THC levels detected in various foods and supplements, on 7.1.20, which encourages further reflection on the opportunity to define a uniform legislation at the EU level. (10)

Dario Dongo and Giulia Torre

Notes

(1) Cf. Ministry of Health decree 4.11.19, ‘Definition of maximum levels of tetrahydrocannabinol (THC) in foods’, Considering

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

(3) See note 1

(4) Cf. law 242/2016, article 5

(5) See Ministry of Health decree 4.11.19, Annex I

(6) ‘Goods legally marketed in another Member State of the European Union or in Turkey or originating from an EFTA State party to the EEA agreement and legally marketed therein are considered compatible with this measure’ (Ministerial Decree Ministry of Health 4.11.19, article 7)

(7) Cf. EC regulation 1881/06, ‘which defines the maximum levels of certain contaminants in food products’. Consolidated text on  https://eur-lex.europa.eu/legal-content/IT/TXT/?qid=1541539122276&uri=CELEX%3A02006R1881-20180319

(8) Cf. EEC regulation 315/93 and subsequent amendments, 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