On hemp and CBD, great chaos continues to reign. Following entirely unsubstantiated allegations of crime, it seems useful to clarify the rules to be applied to the production, processing and sale of foods containing Cannabis Sativa L. and its derivatives.
Cannabis Sativa L. and CBD, the great chaos
The European Commission, as this writer has repeatedly denounced, has failed in its duty to ensure uniformity of rules in the internal market. After a series of amendments to its guidance document on the application of the Novel Foods Regulation (EU reg. 2015/2283), which moreover has no legal value. And a change to the EU register of cosmetic ingredients (CosIng) that allows synthetic CBD but not natural CBD as well (!).
In Italy-after the anathema of the ex-minister of the Interior-the United Sections of the Court of Cassation published a ruling without head or tail, which was already in fact overtaken by a subsequent ruling of the Genoa Re-examination Court.
Industrial hemp, public controls adrift
Checks by law enforcement authorities , in the wake of the great chaos mentioned above, continue unabated, in Italy as in other member states. Especially against agricultural and agro-processing enterprises that try their hand at scrupulously applying the provisions contained in Law 242/16 and other similar national regulations.
The scenario is Kafkaesque, as obstinacy in the pursuit of wrongdoing produces a deterrent effect toward those very business ventures that the aforementioned law aspires to promote. With a view to reviving a sustainable agricultural supply chain, rooted in Italy since the Middle Ages, in a circular economy logic.
Moreover, violations of the law are unlikely when supply chains are based on the cultivation of hemp varieties listed in the European Catalogue of Approved Plants and regularly traced. And this is how we reach the paradox of witnessing the charging of nonexistent crimes. Such as the phantasmagorical allegation of violation of Article 5 set forth in Law 283/62, for selling foods that naturally contain CBD because they are made with the use of hemp inflorescence. Which, in the bold accusatory theorem, would qualify as Novel Food. Clarity is in order, in 5 points.
1. Cannabis Sativa L., European discipline
Cannabis Sativa L. ‘raw, retted, drawn, combed or otherwise prepared, but not spun; tow and waste, including garnetted stock’ qualifies as an ‘agricultural product‘ under the Treaty on the Functioning of the European Union. It also figures among ‘industrial plants‘ with regard to seed production and crops.
Cultivation of botanical species included in the Single European Catalogue of permitted varieties (selected because of their low content of the psychotropic substance THC) is permitted under current European regulations and is eligible for aid under the Common Agricultural Policy (CAP). (1)
2. Novel Food, European Discipline.
I Novel food are foods with novel molecular structures or otherwise innovative in composition and/or structure, affecting nutritional value, metabolism or the presence of ‘undesirable substances’, with no history of significant consumption in the EU prior to 15.5.97. Their placing on the internal market must be authorized in advance by the European Commission, following an appropriate application by the operator concerned and risk assessment by Efsa (European Food Safety Authority).
Regulation (EU) 2015/2283, which regulates them, however, excludes from its scope the ‘Food consisting of, isolated from, or produced by plants or parts thereof (…) that have a history of safe use as food in the Union and are consisting of, isolated from, or produced by a plant or variety of the same species‘ (art. 3.2.iv).
3. Cannabis Sativa L., inapplicability of Novel Food regulations.
The European Novel Food catalog specifically excludes Cannabis sativa L. from the scope of the aforementioned regulation, noting that ‘In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 percent (w/w). Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel’.
In turn, the Ministry of Health in Italy had already expressed itself in this direction. ‘In many countries, both European and non-European, legislation allows the use of cannabis or parts of it as a food ingredient as long as the residue of tetrahydrocannabinol (THC), a substance with psychotropic action, remains below a maximum limit, established to ensure safety. Therefore, according to current EU legislation, cannabis cannot be considered a novel food or novel food ingredient under Regulation (EC) 258/97 on Novel food‘. (Min. Sal., circular 22.5.09).
4. Extracts of Cannabis Sativa L. and assumptions for the application of Novel Food regulations
Isolated extracts of Cannabis sativa L., in some cases, may be considered Novel Food by individual national authorities. Where evidence of their significant consumption, as foods or food supplements (or their ingredients), before 15.5.97 has not been found to have been achieved. We refer, for example, to cannabidiol (CBD) extracted by solvents, supercritical CO2, and infrared rays. Although, in some member states (e.g., Hungary, Bulgaria), it has been recognized as a traditional ingredient in dietary supplements.
By contrast, plant extracts obtained by traditional non-selective techniques are definitely excluded from Novel Food status. Equally excluded are substances naturally contained in the plant, its parts or derivatives. Such as cannabinoids naturally contained in seeds and hemp oil, the use of which in dietary supplements was authorized back in 2012 by a special decree of the Ministry of Health.
5. Cannabis sativa L., Italian regulations.
Law 242/2016 – ‘Provisions for the promotion of hemp cultivation and agro-industrial supplychain’ – introduced a series of measures aimed at supporting and promoting the hemp(Cannabis sativa L) supply chain. In compliance with the requirements therein, they postulate the selection and traceability of permitted botanical varieties and the registration with the health authority of officinal laboratories dedicated to processing with food destiny (on a par with all operators in food and feed supply chains). (2)
Possible uses of hemp-derived products include ‘foods and cosmetics produced exclusively in compliance with the disciplines of the respective fields‘ (Law 242/16, Art. 2.2). The use of hemp for food use is therefore fully legitimate, subject to the set THC limits. And inflorescences-according to Ministry of the Interior note 31.7.18-are subject to precautionary THC limits (0.05 mg/kg).
Law 242/16 thus allows the use of hemp for food use, without distinguishing between the various parts that can be used.
Dario Dongo
Notes
(1) Cf. TFEU (Art. 38 and All. I, v.d. 57.01), reg. EU 1307/13, reg. EC 73/09 et al.
(2) See reg. EC 852/04 on the hygiene of foodstuffs, Article 6
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
