December 2, 3, 2020. The days that changed the world of Cannabis Sativa L. The UN and the European Commission have finally decided what WHO and the scientific community have long suggested.
Cannabis Sativa L. and CBD, UN decision 2.12.20
The United Nations Commission on Narcotic Drugs. (CND), meeting in Vienna on 2.12.20, accepted the WHO recommendation (World Health Organization, WHO) to remove the Cannabis Sativa L., its resin, extracts and tinctures from Table IV of the Single Convention on Narcotic Drugs (1961), where drugs subject to strict international surveillance regimes are listed.
‘Preparations containing mainly cannabidiol [CBD, ed.] and no more than 0.2 percent delta-9-tetrahydrocannabinol are not under international control’ (United Nations Commission on Narcotic Drugs, 2.12.20)
Instead, substances other than hemp and its derivatives with THC content <0.2 percent are listed in Schedule I of the Convention. Therefore, they remain subject to the supervision of the drug control authorities, who will have to monitor compliance with existing regulations. Even where such regulations contemplate the presence of THC in concentrations >0.2 percent on certain categories of foods, dietary supplements and drugs. (1)
CBD, European Commission decision 3.12.20
The European Commission, on 3.12.20, finally admitted that CBD is not a narcotic. An inevitable decision after the EU Court of Justice ruled on 19.11.20 that any ban on marketing cannabidiol was illegal. In the absence of appropriate scientific evidence to justify any limitations with public health needs.
EFSA(European Food Safety Authority) can therefore resume evaluating applications for the approval of CBD as a novel food. Following the European Commission’s previous decision – manifestly unlawful, also in light of the aforementioned Court of Justice ruling – to order EFSA to suspend the scientific evaluation of the relevant dossiers. The news is given over to a few seconds of audio, 3.12.20, and a letter sent by the Commission to EHIA(European Hemp Industry Association), an excerpt of which follows.
CBD, Commission letter to EHIA
‘In light of the comments received from applicants and of the recent Court’s judgment in case C-663/184, the Commission has reviewed its preliminary assessment and concludes that cannabidiol should not be considered as drug within the meaning of the United Nations Single Convention on Narcotic Drugs of 1961 in so far as it does not have psychotropic effect.
As a consequence, cannabidiol can be qualified as food, provided that also the other conditions of Article 2 of Regulation (EC) No 178/2002 are met. (…) We hereby inform you that the verification of the validity of your application is therefore resumed’ (Bruno Gautrais, European Commission, DG Sante, Head of Unit E2, Food Technologies and Novel Food. Letter 3.12.20 to Antonio Conto, EIHA Project GmbH Consortium).
Cannabis Sativa and CBD, unresolved issues
Now that the UN has clarified what WHO has already requested, Brussels will have to address the unresolved issues. In particular:
– Define uniform THC thresholds to be allowed in the EU in the various food categories, based on the actual margins of population exposure. This compares with an Acute Reference Dose (ARfD) that EFSA had set in 2015 at 1 mg/kg body weight, having regard to milk and milk products from cows fed hemp. And of EFSA’s most recent assessment (2020), which, however, states wide margins of uncertainty due to the small number of samples tested (2,3),
– Re-introduce natural CBD to the register of cosmetic ingredients allowed in the EU(CosIng). Ending the arbitrary and shameful choice to admit only its identical synthetic matrix molecule.
Justice and progress
The European executive has shown a bad record of mala-administration, arbitrariness and bad faith, as has been repeatedly reported, with regard to the possibilities of CBD use in foods, food supplements and cosmetics (4,5).
The government and the PA (public administration) in Italy have in turn adopted measures whose illegitimacy is manifest in light of the official interpretation provided by the EU Court of Justice in its 19.11.19 judgment.
#LaCanapaBuona
, the working group organized at Égalité with the support of Wiise S.r.l. benefit company, pursues every useful initiative to affirm justice and progress in policies on the Cannabis Sativa L. supply chain. Good Hemp-an emblem of sustainable development, food and nutritional security, and circular economy-must be protected and promoted without hesitation.
Dario Dongo and Silvia Giordanengo
Notes
(1) On 2.12.20, the United Nations Commission on Narcotic Drugs also transferred-from Schedule IV to Schedule I of the Single Convention on Narcotic Drugs-the psychoactive components of cannabis. Under this rationale, dronabinol, its stereoisomer (delta-9-tetrahydrocannabinol, THC) and the six isomers of the latter may receive consideration for pharmaceutical use, with a controlled but less restrictive regime than that provided, for example, for opium derivatives (e.g., morphine). This opens the way for research and development of applications for medical cannabis, which have already garnered positive experiences in the treatment of some neurological and degenerative diseases. Such as Sativex and Epidiolex, both of which are THC-based (the latter in equal amounts with CBD), used for, respectively:
– Pain and muscle spasms in patients with multiple sclerosis,
– Dravet syndromes (DS, severe myoclonic epilepsy of childhood) and Lennox-Gastaut syndromes (LGS, a rare severe epileptic encephalopathy that appears in early life)
(2) EFSA(European Food Safety Authority), Arcella D, Cascio C and MacKay K (2020). Acute human exposure assessment to tetrahydrocannabinol (Δ9-THC). EFSA Journal 2020;18(1):5953. doi: 10.2903/j.efsa.2020.5953
(3) The THC limits allowed in the various food categories in Italy are given in the Ministry of Health Decree 4.11.19 (see https://www.greatitalianfoodtrade .it/mercati/canapa-negli-alimenti-soglie-di-thc-decreto-ministero-della-salute-4-11-19). 2 mg/kg for seeds, flour and dietary supplements, 5 mg/kg for hemp oil. The latter limit, moreover, is difficult to maintain in oil extracted by natural methods from plants listed in the European Register. And it does not appear to be justified by any exposure estimates, given the small intake of one oil in the daily diet. All the more so considering that the oil in question has a strong flavor and is therefore diluted with other milder ones, in seasonings
(4) The European Commission, it should be noted, has not suddenly come to its senses regarding the legitimacy and safe use of CBD. Instead, it persists in following the theories of Big Pharma lobbyists, in the complete absence of scientific support, as evidenced by the positions taken on 2.12.20 in Vienna (see footnote 3)
(5) European External Action Service (EEAS). Explanation of CND vote on WHO scheduling recommendations on cannabis and cannabis-related substances in Vienna on December 2, 2020. Vienna, 2.12.20 – 16:19, UNIQUE ID: 201202_40. https://eeas.europa.eu/headquarters/headquarters-homepage/89773/explanation-cnd-vote-who-scheduling-recommendations-cannabis-and-cannabis-related-substances_en
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Civil lawyer, master in Food, Law and Finance.
