The Ministry of Health has finally finalized the draft regulations designed to define the THC thresholds allowed on Made in Italy hemp foods. (1)
Hemp for food use, virtues nutrition and discipline
The nutritional properties of hemp
have enabled the resulting foods to quickly reach the shelves of large-scale retailers.
Legislation on the subject has similarly evolved, particularly through Law 242/2016, Provisions for the Promotion of the Cultivation and Agroindustrial Chain of Hemp. (2)
The superficial
reading
of an opinion issued by the Superior Health Council on 10.4.18 – by the generalist press – has, however, caused misunderstandings and uncertainties
.
While waiting for clarification on THC (tetrahydrocannabinol, a psychotropic substance) thresholds below which foods can be considered safe, operators and control authorities have had to actually rely on the ‘benchmark‘ of limits set in other countries, such as Germany.
Hemp for food use, the outline of regulations of the Ministry Health
The Italian Ministry of Health notified the European Commission on Oct. 30.10.18 of a draft ‘regulation setting maximum levels of THC (tetrahydrocannabinol) in food‘. (3)
The draft regulation offers the following definitions:
(a) ‘Hemp for food use’ or ‘hemp’, Cannabis sativa L. plant meeting the requirements of Art. 32(6) of Reg. 1307/2013,
(b) ‘Food derived from hemp.
‘, parts and/or derivatives of the parts of hemp that have registered significant food consumption under Reg. (EU) 2015/2283′. (4)
The list of food products
derived from hemp, however, is limited to considering ”
seeds, flour obtained from seeds, oil obtained from seeds’
. (5) Neglecting the
inflorescences
of hemp for herbal tea use
.
Inflorescences for herbal tea use, nonetheless, have been excluded from the scope of the ‘Novel Foods‘ regulation (6) and are widely distributed in the domestic market, as well as in the EU. Their non-inclusion in the above list is therefore a cause for further uncertainty. (7)
Hemp for food use, THC thresholds allowed on Made in Italy foods
The THC limits (8) set by the Ministry of Health vary in relation to the food products considered:
– hemp seeds
(‘
including crushed, broken, ground other than flour
‘), 2.0 mg/kg,
– flour obtained from seeds, ditto c.s.
– oil
obtained from hemp seeds
, 5.0 mg/kg,
– Dietary supplements containing hemp-derived foods, 2.0 mg/kg.
For different foods , Article 2 of Regulation (EC) No. 1881/2006. (9)
Methods of sampling and analysis are finally defined, in accordance with applicable European legislation. (10)
All clear, but not clear enough.
Dario Dongo
Notes
(1) Italy has notified the draft regulation to the European Commission, DG
Growth
, on 30.10.18, Notification 2018/546/I, at
http://ec.europa.eu/growth/tools-databases/tris/en/index.cfm/search/?trisaction=search.detail&year=2018&num=546&mLang=IT
(2) See in this regard the MiPAAF Guidelines 22.5.18 for the application of Law 242/16, at
https://www.greatitalianfoodtrade.it/mercati/canapa-sativa-chiarimenti-mipaaf
(3) As in fact stipulated in Law 242/2016, Article 5.
(4) See draft regulation of the Ministry of Health, Article 2 (
Definitions
), at
http://ec.europa.eu/growth/tools-databases/tris/en/index.cfm/search/?trisaction=search.detail&year=2018&num=546&dLang=IT
(5) See outline in Note 4 above, Article 4(Hemp-derived foods) and Annex I, of the same subject.
(6) Cf. reg. EU 2015/2283
.
See also the article
https://www.foodagriculturerequirements.com/archivio-notizie/domande-e-risposte/canapa-taglio-tisana-risponde-l-avvocato-dario-dongo
(7) With the paradoxical result of hindering Italian FBOs who wish to package and market inflorescences for herbal tea use from registered and traced botanical varieties. However, without being able to hinder the sale of identical products made in other EU countries, even from raw materials imported from non-EU countries. In homage to the principle of free movement of goods, which is also referred to in the ministerial scheme, in Article 7
(8) ‘Maximum total THC limits are defined as the sum of the concentrations of (-)-trans- Δ9-THC (*) and the non-active acid precursor (Δ9-THCA-A)(**).
(*)(-) -trans- Δ9-THC: among the 4 possible stereoisomers is the one existing in nature;
(**) the non-active acid precursor (Δ9-THCA-A) accounts for 90% of the sum of the concentrations of the substance Δ9-THC and the two non-active acid precursors (Δ9-THCA-A and Δ9-THCA-B)‘ (Min. Sal. Regulation Scheme, Annex II)
(9) Cf. Reg. EC 1881/06, ‘Defining 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
(10) Food sampling must follow the criteria stipulated in reg. EC 401/2006. The method of analysis in turn follows Recommendation (EU) 2016/2115, on the monitoring of the presence of Δ9-tetrahydrocannabinol, its precursors and other cannabis derivatives in foods
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
