Novel foods and CBD: quo vadis?

At European level, consumable products enriched with cannabidiol (CBD) are considered novel foods under the Food Regulation (EC) 2015/2283.

In January 2019, the European Commission updated the catalogue of novel foods. Since then, extracts from the cannabis plant (Cannabis sativa L.) and derivatives containing cannabinoids have been considered novel foods. 

What about it again?

Cannabis belongs to the cannabaceae or hemp family and is biologically classified as Cannabis sativa L.

The cannabis plant contains more than five hundred chemical substances. Approximately 60 to 100 of these substances are cannabis-specific and are called 'cannabinoids'.

Cannabidiol or CBD (C21H30O2) is one of the active - but not psychoactive - cannabinoids.

In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided that they are registered in the EU's "Common Catalogue of Varieties of Agricultural Plant Species" and that their tetrahydrocannabinol (THC) levels do not exceed 0.2 %.

Novel food catalogue

‘Novel foods’ are foods and ingredients that were not sold as food within the EU before 15 May 1997.

In order to market a product classified as 'novel food', a novel food authorisation is required.

The European Commission publishes a list of plants (parts), products of animal origin and substances with 'novel food' status (publicly available here). The catalogue of novel foods is not legally binding on the member states, but serves as an indication of whether or not a foodstuff requires a novel food authorisation.

Some products derived from the cannabis plant or parts of the plant such as seeds, seed oil, hemp seed meal and defatted hemp seed have a history of consumption in the EU and are therefore not novel foods (remember, however, that the THC content in these products should never exceed 0.2%).

In January 2019, the European Commission clarified that CBD and extracts of CBD should be considered novel foods, as a history of safe use has not (yet) been demonstrated. On this basis, the European Commission has amended its list, as a result of which these products may no longer be sold on the market as consumable goods without prior novel food authorisation.

The 'novel food' status applies both to the CBD extract as such (i.e. extracts of the plant and plant parts such as the stem, leaves or flowers) and to products to which this extract is added as an ingredient, regardless of the type of extract (e.g. hot/cold). It also includes synthetically obtained CBD.

The sale of the above-mentioned CBD-containing products or foodstuffs requires novel food authorisation. To date, no novel food authorisation has been granted (yet) for any foodstuff containing CBD or extracts of CBD

Cannabis Pharma

Before a novel food can be placed on the market, an application must first be submitted to the European Commission, after which the application is subjected to a scientific evaluation by the European Food Safety Authority (EFSA).  On this basis, an authorisation will or will not be granted.

There is currently (only) one application under consideration for the authorisation of a CBD food supplement. Cannabis Pharma has submitted an application seeking to demonstrate the safety of the use of CBD in food supplements for adults with a daily intake of up to 130 mg or 1.86 mg/kg body weight.

The decision is expected before the end of the year. 

A positive decision on this application would also be good news for other market participants, as the authorisation has a generic character; i.e. CBD food supplements can then be marketed provided that the specifications and conditions of use included in the authorisation are respected.

Transition period

As mentioned above, the new classification as 'novel food' implies that the sale of foodstuffs (and supplements) containing CBD will, in principle, be restricted.

However, a large number of CBD-based products are already freely available on the market.

The regulation therefore provides for a transitional arrangement: foodstuffs containing CBD that were lawfully on the market before 1 January 2018 may continue to be on the market for the time being, provided that they submit an application for a marketing authorisation before 2 January 2020.

Status in Belgium

Belgium maintains a very strict policy.

The Federal Agency for the Safety of the Food Chain (FASFC) has recently clarified that the production and marketing of foodstuffs containing cannabis and extracts from the cannabis plant is prohibited.

Indeed, Cannabis sativa L. is on list 1 of "Dangerous plants that may not be used as or in foodstuffs" in the annex to the Royal Decree of 29 August 1997 on the manufacture of and trade in foodstuffs composed of or containing plants or plant preparations (the ‘Plant Decree’). These provisions also apply to hemp plants with a THC content lower than or equal to 0.2%.

Consequently, products based on cannabis are prohibited on the Belgian market, unless a derogation is obtained from the FASFC. Individual derogations may be requested provided that there is no risk to public health and under specific conditions laid down in the Plant Decree. Such an assessment is made on a case-by-case basis.

The derogations contain a detailed description of the product with lot numbers for which the derogation was granted. The serial numbers must be indicated on the label of the products as well as the indication "without THC/THC-free". There is no general derogation for an outlet or for a range of products. 

The types of products that have been granted a derogation in 2018 are e.g. hemp seeds, hemp oils, hemp meal and derived products, such as hemp meal biscuits, hemp lemonade or beer.

However, derogations are not granted for the consumption of leaves and flowers of the cannabis plant in the form of infusions or teas.

No national derogations are possible for novel foods. Since CBD is regarded as 'novel food', the FASFC is of the opinion that a European 'novel food' market authorisation is required. 

CORBUS ADVOCATEN specialises in all legal aspects of the ever-growing market in the legal cultivation and distribution of cannabis and cannabis derived products. 

For more information on this subject, you can always contact Anton Buntinx.

Co-author: Leander Buyle (lawyer, Antwerp)

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