EU Regulation Of CBD In Foods And Cosmetics

There has been tremendous growth in the number of foods and cosmetics on the market that contain cannabidiol (CBD). According to recent market research studies, Europe's cannabis and CBD markets are set to continue growing exponentially over the next few years. Regulators in Europe are now taking a closer look at the market for foods and cosmetics which contain CBD.

In this Advisory, we summarise the current regulatory environment in Europe for foods and cosmetics containing CBD. We also comment on the fast-changing environment in the US.

Cannabinoids and CBD

Cannabinoids are chemical compounds, found in certain plants or manufactured synthetically, that act on cannabinoid receptors to produce a range of physiological effects. Two of the most important cannabinoids are tetrahydrocannabinol (THC), the principal psychoactive compound in cannabis and cannabidiol (CBD) which, in contrast to THC, does not cause a "high" and, according to a report from the World Health Organisation (WHO)1, does not exhibit effects indicative of abuse or dependence potential.

THC and CBD are two of some 113 cannabinoids found in cannabis plants, a genus of flowering plants in the family Cannabaceae. The classification of cannabis species is controversial; Hillig (2005)2 proposed three species of cannabis: C sativa, C indica, and C ruderalis, whereas other researchers suggest that cannabis plants comprise a single species, C sativa, with a number of subspecies.3 Cannabis has been cultivated for thousands of years. Certain varieties are grown for their fibre or edible seeds (hemp and hemp seeds), which contain low levels of THC (0.3% or less), whereas other varieties serve as sources of marijuana and hashish, and are high in THC (15 - 40%).

The WHO Expert Committee on Drug Dependence recommended on 24 January 2019 to the United Nations that preparations considered to be pure CBD should not be scheduled within the International Drug Control Conventions. The Committee proposed adding a footnote to the entry for "cannabis and cannabis resin" in Schedule I of the Single Convention on Narcotics Drugs of 1961 to specify that CBD preparations are not under international control.4

This recommendation was due to be considered by the UN Commission on Narcotic Drugs in March 2019 but the vote was postponed to allow member states more time to discuss the consequences of potential changes in scheduling of cannabis for national and international control measures. A new date for the vote has not been set yet.

Foods containing CBD

EU Position

Under European Union law, food that has not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel foods came into force, is considered as "Novel Food" and controlled in a stricter manner than regular foods under Regulation (EU) 2015/2283 ("the Novel Food Regulation").5

Novel Food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU. Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill oil rich in phospholipids) or agricultural products from third countries (chia seeds, noni fruit juice).

Food producers can place a Novel Food on the EU market only after the European Commission has processed an application for the authorisation of the novel food, has adopted an implementing act authorising its placing on the market and updated the EU list of novel foods. A food or ingredient will be authorised only if it meets the criteria laid out in Article 7, namely it is shown to be safe, not nutritionally disadvantageous and does not mislead the consumer. There are three routes by which an...