Cannabis sativa L. and Its Extracts : Regulation of Cannabidiol in the European Union and United Kingdom
Mark J. Tallon
JOURNAL OF DIETARY SUPPLEMENTS, 2020, VOL. 17, NO. 5, 503–516
Doi : 10.1080/19390211.2020.1795044
ABSTRACT
The lawful sale of Cannabis sativa L. and its extracts including Cannabidiol is not harmonized under European Union (EU) law. Such products have in the most part been classified as novel foods and thus illegal for sale in Europe without prior authorization. The regulation of such substances not only spans EU and Member State food laws but also international conventions on illicit drug and psychoactive substances. An understanding of the laws governing the sale of these compounds can help business and academia better understand the challenges consumers may face in selecting products lawfully placed on the market, whilst identifying the unique challenges imposed from the marketing of Cannabis-based foods.
KEYWORDS : Cannabidiol; Cannabis sativa; European Union; food law; United Kingdom
Introduction
Cannabis sativa L. or Hemp as it is known as a food source is one of the most phytochemically complex botanicals to be placed on the European food market. Hemp produced for agricultural purposes, versus its medical grade relative are often defined on by low (<0.2%) levels of the psychoactive compound D9-Tetrahydrocannabinol (THC). These low THC hemp foods have been present on the European market since 1994 (European Industrial Hemp Association (EIHA) 2018) In contrast, extracts and isolates are considered to have no significant history of food use, and thus considered novel.
A novel status classification by the European Commission (executive branch of the European Union (EU), responsible for proposing legislation) or competent authority with the 27 Member States would result in a product being deemed illegal for sale without prior authorization. This illegality of Cannabis extracts is further compounded due to illicit drug laws, medicines legislation, and in the United Kingdom (UK) the Psychoactive Substances Act. The aim of this article is to review the current regulatory status of the Cannabis extracts including those containing Cannabidiol and to provide a detailed perspective based on United Kingdom law.
The science of Cannabis sativa
The genus Cannabis (Hemp, Family Cannabaceae) includes up to three species, of which the focus of this article is the species Cannabis Sativa L. Although there is still debate over the taxa of Cannabis, we reference the strain used in foods as being Hemp, which is low in THC in part due to its distinct genetic structure (Sawler et al. 2015).
Over 500 compounds and 100 cannabinoids have been identified in Cannabis (Hanus et al. 2016), including Cannabidiol (CBD)(or 2-[(6R)-6-isopropenyl-3-methyl-2-cyclohexen- 1-yl]-5-pentyl-1,3 benzene-diol). The isolation of CBD was achieved in the early 1940s (Adams 1942; Todd 1946), yet its full structure was only determined in the 1960s (Mechoulam and Shvo 1963; Mechoulam and Gaoni 1967). Its presence in the dry mass of Italian-grown hemp has been suggested to be in the concentration range of 0.7–1.8% (Cappelletto et al. 2001), and in other European (Croatian) markets as low as 0.0042–0.24% (Petrovic et al. 2015). These values are in line with recent data on low- THC varieties (<0.2%) that are in compliance with the EU-authorized hemp varieties (EU Regulation 1307/2013) in the 0.056–0.27% range (Pavlovic et al. 2019).
Despite its low presence in hemp and poor bioavailability (Hawksworth and McArdle 2004), CBD has gained commercial interest as a foodstuff since its application in the treatment of brain-related conditions (Lattanzi et al. 2020) and subsequent approval as a medicine (European Medicines Agency 2019b). The resultant popularity is an estimated global market of $6.4bn, by 2025 (Cowen Research 2019), and a European market of $450 million (Orian Research 2018), of which the UK represents 30%. Despite this market growth its development has progressed under a regulatory framework where all CBD extracts and isolates are either novel, contain potentially illicit drugs (e.g., THC) or may even be viewed as a medicine or a psychoactive substance. The following addresses these restrictions as recognized under European (EU) and United Kingdom (UK) law.
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CannabissativaLandItsExtractsRegulationofCannabidiolintheEuropeanUnionandUnitedKingdom