At present, the European Union (EU) Member States regard all CBD products designed for oral consumption as illegal. This includes oral CBD sprays, CBD capsules, CBD oils, and all other varieties of edibles. The following entry will discuss why these products are supposedly illegal and explain why Cannacares and numerous other shareholders in Europe consider the legal understanding and enforcement of the laws within the EU as incorrect.
What is a ‘Novel Food’?
The Novel Food Regulation first came into place in 1997 by Regulation (EU) 258/97 with the main objective being to create a food safety system to regulate novel, artificial or genetically manufactured food and supplements. At the beginning of 2018, a modified version was introduced; Regulation (EU) 2015/2283.
As defined by the EU, a ‘Novel Food’ is any food product which has not been consumed to a significant degree before 1997. Thus, when a food product is regarded as ‘novel’, approval by the EU commission is to be required and the product must go through a pre-market safety investigation by the European Food Safety Authority ('EFSA'), prior to it being legally sold within the EU.
The Novel Food Catalogue records all products and substances of animal, plant or other origin which are part of the Novel Food Regulation, as decided by EU Member States. The Novel Food catalogue serves as a guide on whether a product requires approval under the Novel Food Regulation, however, it is not the law and should not be used to prohibit CBD products in the EU. Sadly, this is currently the case.
If CBD wasn’t Novel before, how can it be now?
Until 2019, for CBD extracts to be regarded as ‘novel’, the concentration of CBD had to be greater than the cannabidiol concentration in the Cannabis sativa L supply. Meaning, CBD was allowed when it was naturally derived and between 2-5% concentration (the natural concentration of cannabidiol in the majority of EU-authorized hemp strains). Only concentrations of CBD greater than 5% were regarded as novel and, therefore, illegal.
Prior to this, in 1997, the EFSA confirmed in written correspondence to the European Hemp Industry (EHA) that foods containing components of the hemp plant, ‘do not fall under the scope of the regulations EC 258/97’ and that there was evidence of consumption of Cannabis Sativa L. within the EU before 1997. For instance, hemp flowers are a common food ingredient used in the production of beer, and so, the flowers and leaves that constitute part of the hemp plant do not fall under the category of ‘Novel Food’. Furthermore, The UK’s FSA also confirmed the significant
history of Cannabis Sativa L. plant within the Union before 1997. Of note, they referenced the whole hemp plant and stated, ‘it does not fall within the scope of Novel Food Regulation’.
In 2019, EU Member State commissioners modified the Novel Food Catalogue records for ‘Cannabis sativa L’ and ‘Cannabinoids’. These modifications are verifiably inappropriate, given logic and historical fact, as organizations like the EIHA and numerous other shareholders have continuously stressed to Member States, as well as the European Commission.
In the modified record for ‘Cannabis sativa L.’ any entries discussing the use of hemp leaves and flowers have been removed completely. Furthermore, the conventionally produced hemp extracts have also been removed despite extraction being regarded as an acceptable and traditional method of food processing.
In the modified record of ‘Cannabinoids’, extracts with a naturally synthesized concentration of CBD are excluded, despite them being described in the earlier entry explanation. Again, such products were already available on the market and consumed prior to 1997 on a significant scale.
EU Legislation Regarding Cannabis Extraction
CBD extracts refer to aqueous extracts, extracts by pressing, extracts based on fat extraction or extracts synthesized by traditional extraction agents (e.g. ethanol (alcohol) or Carbon Dioxide (CO2)). The EU Directive 2009/32/EC clearly explains that conventional extraction agents must be allowed by Member States in the manufacturing of food products or ingredients. In layman’s terms, this means that when a food product or ingredient is produced through a conventional production process of extraction using extraction agents, it is considered a food or food ingredient and not a ‘novel food’ product. If Cannabis Sativa L and its extracts up to 5% are not novel, then CO2 and ethanol extractions are also not novel as these processes have a vast history and use within the food supply chain.
Taking the current Directive 2009/32/EC into account, the modified version of the Novel Food Regulation (2015/2283) that followed, only covers new extraction agents and ‘new extracts’, not the extracts derived and produced by approved conventional extraction agents. To conclude, if Cannabis Sativa L is not novel, and the extraction solvent is not novel then the resulting CBD food product cannot be considered novel.
Significant Evidence on the Safety of CBD
Numerous companies within the cannabis industry in Europe have already provided significant evidence to the European Commission, proving that the hemp plant and
extracts have been safely consumed for centuries and that ‘low-THC’ varieties, referred to as industrial hemp, have always contained CBD in the past. Moreover, in these industrial hemp varieties – as well as those that were previously recorded in the EU Catalogue of varieties dating back well before 1997 – the respective ratio of CBD content to THC content is extremely greater in comparison to ‘high-THC’ cannabis varieties.
The opinion of EIHA and shared by Cannacares is that the hemp plant (including such hemp extracts from ‘low-THC varieties’) with natural concentrations of CBD are conventional foods that are not relevant to the Novel Food Regulation. This opinion coincides with the Novel Food Catalogue entries implemented prior to 2019.