Cannabidiol in food: regulatory status in the European Union

Cannabidiol in food: regulatory status in the European Union

Cannabidiol, or CBD, is one of the most common cannabinoids, which are found in the hemp plant Cannabis sativa L. Extracts of Cannabis and related products are considered (not yet authorised) novel foods. According to European legislation, Novel Food is food not consumed significantly by humans in the EU before 1997, when the first Regulation on Novel Food came into force.


Authorisations of novel foods

The new EU Novel Food Regulation applies since January 2018, aiming to ensure safety for consumers, proper labelling, and appropriate consumer information.

Food business operators can place new novel foods on the EU market only upon authorisation. To obtain authorisation for a new Novel Food, operators must submit an online application to the Commission. The novel food can be placed on the market only after the Commission processed the application, adopted an implementing act authorising the placing on the market of a novel food, and updated the Union list.


Application and Risk Assessment

The applicant must submit the necessary documents to EFSA to perform the risk assessment. If there is sufficient data to publish an opinion, the Commission requests the European Food Safety Authority (EFSA) to conduct a risk assessment. After the publication of the EFSA's opinion, the Commission submits to the Standing Committee on Plants, Animals, Food and Feed a draft implementing act which authorises the placing on the market of a novel food. After a favourable vote from the Standing Committee, the food business operator can lawfully place the novel food on the EU market.


Uncertainties and data gaps on CBD

Currently, cannabinoids as a novel food are not authorised. Thus, its use in human nutrition is forbidden.

However, there were 19 ongoing applications for authorization at the EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens as of June 2022. As for now, the Panel cannot conclude on the safe use of CBD by humans as there are significant gaps in available data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-bein. In addition, studies on animals show adverse effects, especially regarding reproduction.

Therefore, it is necessary to establish whether CBD is food is safe for human consumption before its authorisation. Applicants need to fill data gaps and provide more exhaustive information in order to assess its safety and possibly allow an authorized use in the EU.


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Claudia Argenti

RA Department

08/09/2022


References:

European Commission. (2022). Request for a novel food authorization. Retrieved on 12/09/2022.

European Commission. (2022). What is Novel Food? Retrieved on 08/09/2022.

European Commission. (2022). What is the current Novel Food legislation?Retrieved on 08/09/2022.

European Food Safety Authority. (07/06/2022). Cannabidiol novel food evaluations on hold pending new data. Retrieved on 08/09/2022.

European Food Safety Authority. (07/06/2022). Statement on safety of cannabidiol as a novel food: data gaps and uncertainties. Retrieved on 08/09/2022.

Sante publique, securite de la chaine alimentaire et environnement. (10/06/2022). Le CBD – comme aliment – interdit en Europe. Retrieved on 08/09/2022.

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