Not all CBD extracts should automatically go through a novel food application

Cannabidiol and its rise in food supplements in the EU

Cannabidiol (CBD) has been capturing more and more the attention of manufacturers and consumers in many different consumer products, particularly in food supplements in view of its multiple and alleged beneficial properties for human health. CBD is a non-psychoactive compound and one of the many cannabinoids contained in Cannabis. In this article, we will be referring to cannabis intended as industrial hemp, as such, Cannabis Sativa L. plants with THC content inferior to 0.2 % as defined on the EU level by Regulation 1307/2013/EU.

It should be pointed out that some of Cannabis Sativa L. related ingredients, such as hemp seeds and hemp raw protein, were and are widely used in food, and are not considered novel food given their demonstrated relevant degree of consumption in the EU before 15 May 1997.

However, the Competent Authorities (CAs) adopted a series of different stances regarding CBD in food. Nowadays, most of the national CAs in the EU consider CBD extracts contained in supplement products as a novel food, and, as such, subject to the Novel Food Regulation 2015/2283/EU. The fact that an ingredient is considered a novel food means that it will need to go through a pre-market authorization process in which a detailed dossier is compiled and safety data is evaluated with the involvement of EFSA and EU Commission.


The novel food catalogue update in January 2019

Until the end of 2018, the novel food catalogue was indicating that only extracts of Cannabis Sativa L. containing higher levels of CBD than those naturally present in the extracts, were to be considered novel food. As such, this meant that foods containing CBD present at natural levels in hemp extracts were not to be considered novel food.

In January 2019, the novel food catalogue was amended and the current interpretation of the CAs mostly originated from that change, even though the catalogue is not legally binding. The catalogue currently mentions that “extracts of Cannabis Sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.


Different opinions on CBD extracts as novel food

Some cannabis associations and manufacturers praised and welcomed the update as a way of ensuring a more in-depth assessment on the safety of these compounds and a more regulated approach on the matter. However, not all the stakeholders agreed with the change, especially with the automatic assumption that all CBD-containing products are novel food.

The European Industrial Hemp Association (EIHA) has been pointing out how actually it is possible to demonstrate a consumption to a significant degree in the EU of hemp plant parts (such as leaves and flowers) and their extracts before May 1997. Because of this, not all CBD-containing products should automatically be considered novel food and a distinction should be made between hemp extracts on one side and CBD-enriched hemp extracts and CBD isolates on the other one.

Hemp extracts will naturally also contain CBD and, as it may be demonstrated a relevant degree of consumption for natural hemp extracts, these should not be regarded as a novel food and should, accordingly, comply with the usual obligations set out for food and food supplements in the EU.

On the contrary, CBD isolates and CBD-enriched hemp extracts do not have a relevant history of human consumption and, consequently, will unavoidably fall under the scope of application of the Novel Food Regulation.


The latest update from the German Authorities

After EIHA’s publication from the 4th of March 2020 on Linkedin, it would appear that the German Federal Ministry of Food and Agriculture (BMEL) agreed with the observations made by EIHA to revise their approach and to consider food containing hemp plant parts and food containing the natural spectrum of the cannabinoids contained in the plant as not covered by the scope of the Novel food Regulation. In contrast, the novel food regulation will still apply for CBD isolates and CBD enriched hemp extracts.

Although the above may signify a relevant change in Germany, it remains to be seen whether the CAs from the other EU Member States will follow the same approach or will keep the current more restrictive interpretation.


Alessandro Polimeno

Regulatory Affairs Expert Consultant

R&D Department

05/03/2020


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